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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)


☒			ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, ~~2024~~2025


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________ to __________

Commission file number 001-40646

ABSCI CORPORATION

(Exact name of registrant as specified in its charter)


Delaware						85-3383487
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

18105 SE Mill Plain Blvd Vancouver, WA						98683
(Address of Principal Executive Offices)						(Zip Code)

(360) 949-1041

Registrant's telephone number, including area code

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock. $0.0001 par value

ABSI

The Nasdaq Global Select Market

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐ No ☒

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C.7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes ☐ No ☒

If securities are registered pursuant to Section 12(b) of the Exchange Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to Rule 10D-1(b) under the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

As of June 30, ~~2024~~2025, the aggregate market value of the registrant's voting and non-voting common equity held by non-affiliates was approximately $~~297~~303.38 million.

The registrant had outstanding ~~127~~153,~~333~~021,~~887~~263 shares of $0.0001 par value common stock as of ~~February~~March 286, ~~2025~~2026.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s definitive Proxy Statement relating to the ~~2025~~2026 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. The proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, ~~2024~~2025.

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		Page No.
Part I.
Item 1.	Business	7
Item 1A.	Risk Factors	2835
Item 1B.	Unresolved Staff Comments	8091
Item 1C	Cybersecurity	8091
Item 2.	Properties	8193
Item 3.	Legal Proceedings	8293
Item 4.	Mine Safety Disclosures	8293
Part II.
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	8394
Item 6.	[Reserved]	8394
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	8495
Item 7A.	Quantitative and Qualitative Disclosure About Market Risk	96104
Item 8.	Financial Statements and Supplementary Data	96104
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosures	~~121~~128
Item 9A.	Controls and Procedures	~~121~~128
Item 9B.	Other Information	~~121~~128
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	~~121~~128
Part III
Item 10.	Directors, Executive Officers and Corporate Governance	~~121~~129
Item 11.	Executive Compensation	~~122~~129
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	~~122~~129
Item 13.	Certain Relationships and Related Transactions, and Director Independence	~~122~~129
Item 14.	Principal Accounting Fees and Services	~~122~~129
Part IV.
Item 15.	Exhibits, Financial Statement Schedules	~~123~~130
Item 16.	Form 10-K Summary	~~125~~132
Signatures		~~126~~133

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Risk Factor Summary

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below in Item 1A. — “Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the U.S. Securities and Exchange Commission, or the SEC, before making investment decisions regarding our common stock.

•Our ~~current~~plans ~~business~~and ~~has~~expectations aregarding ~~limited~~the ~~operating~~initiation, ~~history~~timing, ~~which~~progress, ~~may~~results, ~~make~~and itcosts ~~difficult~~of toboth ~~evaluate~~of our ~~business~~internally developed programs and ~~predict~~partnered ~~our~~programs, including current and future ~~performance;~~preclinical studies and clinical trials, and the period during which the results of such studies and trials will become available, are subject to a high degree of uncertainty.

•WeOur ~~have~~short ~~incurred~~operating ~~significant~~history ~~losses~~may ~~since~~make ~~inception,~~it wedifficult ~~expect~~for you to ~~incur~~evaluate ~~losses in~~ the ~~future~~success ~~and~~of weour ~~may~~business ~~not be able~~ to ~~generate~~date ~~sufficient~~and ~~revenue~~ to ~~achieve~~assess ~~and~~our ~~maintain~~future ~~profitability;~~viability.

•We ~~will~~have ~~need~~incurred tosignificant ~~raise~~losses ~~additional~~since ~~capital~~inception, ~~to fund our operations and improve our Integrated Drug Creation platform. If~~ we ~~are~~expect ~~unable~~ to ~~raise~~incur ~~additional~~losses ~~capital~~in onthe ~~terms~~future ~~acceptable~~and ~~to us or at all,~~ we may not be able to ~~compete~~generate ~~successfully,~~sufficient ~~which~~revenue ~~would~~to ~~harm~~achieve ~~our business, operations,~~ and ~~financial~~maintain ~~condition;~~profitability.

•~~Biologic~~We ~~drug~~will ~~development~~need isto ~~inherently~~raise ~~uncertain,~~additional ~~and~~capital itto isfund ~~possible that~~ our ~~technology~~operations, ~~may~~pre-clinical ~~not~~and ~~succeed~~clinical indevelopment ~~discovering~~of ~~appropriate~~our ~~molecules~~internally ordeveloped ~~producing~~programs, ~~cell~~and ~~lines.~~to ~~Even~~improve ifour weIntegrated doDrug ~~succeed,~~Creation itplatform. isIf ~~possible~~we ~~that~~are ~~none~~unable ofto ~~the~~raise ~~product~~additional ~~candidates~~capital ~~created~~on ~~using~~terms ~~our~~acceptable ~~Integrated~~to ~~Drug~~us ~~Creation~~or ~~platform,~~at ~~if any~~all, ~~that~~we ~~are~~may ~~further~~not ~~developed~~be byable ~~our~~to ~~partners~~continue ~~will~~to ~~achieve~~develop ~~development~~our orinternally ~~regulatory~~developed ~~milestones,~~programs ~~including marketing approval,~~ and/or ~~become~~compete ~~viable~~successfully ~~commercial~~with ~~technologies,~~our onIntegrated aDrug ~~timely~~Creation ~~basis or at all~~platform, which would harm our ~~ability~~business, tooperations, ~~generate~~and ~~revenue;~~financial condition.

•IfBiologic wedrug ordevelopment ~~our~~is ~~partners~~inherently ~~experience~~uncertain, ~~any~~and ofit ais ~~number~~possible ofthat ~~possible~~our ~~unforeseen~~technology ormay ~~negative~~not ~~events~~succeed in ~~connection~~discovering ~~with~~appropriate ~~preclinical~~product orcandidates. ~~clinical~~Even ~~development~~if we do succeed, ~~regulatory~~it ~~approval~~is orpossible ~~commercialization~~that none of the product candidates ~~generated~~created ~~through~~using our Integrated Drug Creation platform, ~~this~~if ~~could~~any, ~~negatively~~that ~~affect~~are further developed by our ~~revenue~~partners ~~opportunity~~will ~~for~~achieve ~~that~~development ~~program~~or regulatory milestones, ~~and/~~including marketing approval, or ~~have~~become ~~broader~~viable ~~deleterious~~commercial ~~effects~~technologies, on ~~our~~a ~~reputation~~timely ~~and~~basis ~~future~~or ~~partnership~~at ~~prospects;~~all, which would harm our ability to generate revenue.

•~~Preclinical~~Positive ~~development~~results isfrom ~~uncertain.~~early ~~Our~~ preclinical studies or preliminary results from clinical trials of our product candidates ~~may~~are ~~experience~~not ~~delays~~necessarily orpredictive ~~may~~of ~~never~~the ~~advance~~results toof later preclinical studies and any future clinical trials, ~~which~~of ~~would~~our ~~adversely~~product ~~affect~~candidates. ~~our~~If orwe ~~our~~cannot ~~partners’~~replicate ~~ability~~the topositive ~~obtain~~results ~~regulatory~~from ~~approvals~~our orearlier ~~commercialize~~preclinical ~~these~~studies of our product candidates onin aour ~~timely~~later ~~basis~~preclinical orstudies, atclinical ~~all~~trials and future clinical trials, ~~which~~we ~~would~~may ~~have~~be anunable ~~adverse~~to ~~effect~~successfully ondevelop, obtain regulatory approval for and commercialize our ~~business;~~product candidates.

•~~Preliminary~~If ~~data and interim results~~ we ~~disclose~~or ~~from~~ our ~~clinical~~partners ~~trials~~experience ~~may~~any ~~change~~of asa ~~more~~number ~~data~~of ~~becomes~~possible ~~available~~unforeseen or asnegative weevents ~~make~~in ~~changes~~connection towith ~~our~~preclinical or clinical ~~protocols~~development, regulatory approval or ~~processes,~~commercialization ~~and~~of ~~such~~product ~~interim~~candidates ~~results~~generated orthrough ~~results~~our ~~from~~platform, ~~earlier~~this ~~studies~~could ~~may~~negatively ~~not~~affect beour ~~predictive~~revenue ofopportunity ~~the~~for ~~final~~that ~~results~~program, and/or ofhave ~~later~~broader ~~studies~~deleterious oreffects on our reputation and future ~~clinical~~partnership ~~trials;~~prospects.

•~~The~~Preclinical ~~biopharmaceutical~~and ~~platform~~clinical ~~technology~~development ~~market~~ is ~~highly~~uncertain. ~~competitive,~~Our or our partners' preclinical and ifclinical weproduct ~~cannot~~candidates ~~compete~~may ~~successfully~~experience ~~with~~delays ~~our~~or ~~competitors~~may never advance to and/or through clinical trials, wewhich ~~may~~would beadversely ~~unable~~affect our or our partners’ ability to ~~increase~~obtain regulatory approvals or ~~sustain~~commercialize ~~our~~these ~~revenue,~~product candidates on a timely basis or ~~achieve~~at ~~and~~all, ~~sustain~~which ~~profitability;~~would have an adverse effect on our business.

•WeThe ~~rely~~markets ~~and~~in ~~expect~~which towe ~~continue~~operate, toincluding ~~rely~~those onfor ~~third~~Integrated ~~parties~~Drug toCreation ~~conduct~~platform ~~our~~technology ~~preclinical studies~~ and ~~any~~our ~~eventual~~Internally ~~clinical~~Developed ~~trials. If those third parties do not perform as contractually required~~Programs, ~~fail~~are tohighly ~~satisfy legal or regulatory requirements~~competitive, ~~miss~~and ~~expected~~if ~~deadlines~~we orare ~~the~~unable ~~relationship~~to ~~terminates~~compete ~~prematurely~~effectively, our ~~internally~~business ~~developed~~and ~~programs~~prospects could be ~~delayed,~~adversely ~~more costly or unsuccessful, and such programs may never obtain regulatory approval or commercialization;~~affected.

•IfWe werely doand ~~not~~expect ~~achieve~~to ~~our~~continue ~~projected~~to ~~development~~rely ~~goals~~on inthird ~~the~~parties ~~timeframes~~to weconduct ~~announce~~our preclinical studies and ~~expect,~~clinical ~~the~~trials. ~~commercialization~~If ofthose ~~our~~third ~~programs~~parties ~~and~~do ~~validation~~not ofperform ~~our~~as ~~Integrated~~contractually ~~Drug~~required, ~~Creation~~fail ~~platform~~to ~~may~~satisfy belegal ~~delayed~~or ~~and~~regulatory requirements, miss expected deadlines or the relationship terminates prematurely, our ~~expenses~~internally ~~may~~developed ~~increase~~programs ~~and~~could be delayed, asmore acostly ~~result~~or unsuccessful, ~~our~~and ~~stock~~such ~~price~~programs may ~~decline;~~never obtain regulatory approval or commercialization.

•Our commercial success depends on the technological capabilities of our Integrated Drug Creation platform and the advancement of our internally developed programs;

•We are substantially dependent on the successful application of our Integrated Drug Creation platform to initiate and advance partnered programs and to develop our internally developed programs that can be further developed by our current or future partners;

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•~~Our~~If ~~partnership~~we ~~strategy~~do ~~significantly~~not ~~depends~~achieve onour projected development goals in the ~~eventual~~timeframes ~~approval~~we announce and expect, the clinical development of our programs, commercialization of ~~product~~our ~~candidates~~programs, ~~developed~~and ~~under~~validation of our ~~partnerships~~Integrated ~~for~~Drug ~~which~~Creation weplatform may ~~have~~be nodelayed ~~control~~and ~~over~~our ~~the~~expenses ~~clinical~~may ~~development~~increase ~~plan~~and, ~~regulatory~~as ~~strategy~~a orresult, ~~commercialization~~our ~~efforts;~~stock price may decline.

•IfOur wecommercial ~~cannot~~success ~~maintain~~depends ~~our~~on ~~current~~the ~~relationships~~technological ~~with~~capabilities ~~partners,~~of ~~fail to expand~~ our ~~relationships~~Integrated ~~with~~Drug ~~our~~Creation ~~current~~platform ~~partners,~~and orthe ifadvancement weof ~~fail to enter into new relationships,~~ our ~~future~~Internally ~~operating~~Developed ~~results would be adversely affected as a general matter;~~Programs.

•We ~~rely~~are substantially dependent on athe ~~limited~~successful ~~number~~application of ~~suppliers~~our Integrated Drug Creation platform to identify, design and advance product candidates for ~~laboratory~~our ~~equipment~~internally developed programs. Our ability to generate and ~~materials~~progress these programs, and ~~may~~in ~~not~~some becases ~~able~~enter tointo ~~find~~potential ~~replacements~~collaboration or ~~transition~~licensing toarrangements ~~alternative~~for ~~suppliers~~further development, depends in part on athe ~~timely~~performance ~~basis,~~and orcontinued atdevelopment ~~all;~~of our platform technologies.

•Our ~~Integrated~~partnership ~~Drug~~strategy ~~Creation~~significantly ~~platform~~depends ~~may~~on ~~not~~the ~~meet~~eventual ~~the~~approval ~~expectations~~and commercialization of product candidates developed under our ~~partners,~~partnerships for which ~~means~~we ~~our~~may ~~business,~~have ~~financial~~no ~~condition,~~control ~~results~~over ofthe ~~operations~~clinical ~~and~~development ~~prospects~~plan, ~~could~~regulatory ~~suffer;~~strategy or commercialization efforts.

•~~The~~We ~~loss~~rely ofon ~~any~~a ~~member~~limited number of ~~our~~suppliers ~~senior~~for ~~leadership~~laboratory ~~team~~equipment orand ~~our~~materials ~~inability~~and tomay ~~attract~~not ~~and~~be ~~retain~~able ~~highly~~to ~~skilled~~find ~~scientists~~replacements ~~and~~or ~~business~~transition ~~development~~to ~~professionals~~alternative ~~could~~suppliers ~~adversely~~on ~~affect~~a ~~our~~timely ~~business;~~basis, or at all.

•WeOur ~~depend~~Integrated onDrug ~~our~~Creation ~~information~~platform ~~technology~~may ~~systems,~~not ~~and~~meet ~~any~~the ~~significant~~expectations ~~disruptions to or failure~~ of ~~these~~our ~~systems~~partners, ~~could~~which ~~result~~means inour ~~significant~~business, financial, ~~legal~~condition, ~~regulatory,~~results ~~business~~of operations and ~~reputational~~prospects ~~harm~~could ~~to our business; and~~suffer.

•IfThe weloss ~~are~~of ~~unable~~any tomember ~~obtain~~of ~~and~~our ~~maintain~~senior ~~sufficient~~leadership ~~intellectual~~team ~~property~~or ~~protection for~~ our ~~technologies,~~inability ~~including~~to ~~for~~attract ~~our cell line~~ and ~~expression~~retain ~~technologies,~~highly ~~generative~~skilled ~~deep~~scientists ~~learning technology, proprietary assays~~ and ~~techniques,~~business ~~and~~development ~~antibody~~professionals ~~and target discovery technology, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors~~ could ~~develop~~adversely ~~and~~affect ~~commercialize technologies similar or identical to ours, and~~ our ~~ability to successfully leverage our technologies may be impaired~~business.

•We depend on our information technology systems, and any significant disruptions to or failure of these systems could result in significant financial, legal, regulatory, business and reputational harm to our business.

•If we are unable to obtain and maintain sufficient intellectual property protection for our technologies and product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies or product candidates similar or identical to ours, and our ability to successfully leverage our technologies or product candidates may be impaired.

•Disruptions to the operations of the FDA, the SEC or other government agencies, including due to funding shortages, government shutdowns, policy changes or staffing reductions, could delay regulatory reviews, approvals or other governmental actions on which our business depends, which could adversely affect our business.

Special Note Regarding Forward Looking Statements

This Annual Report on Form 10-K includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that may relate to our plans, objectives, goals, strategies, future events, future revenue or performance, capital expenditures, financing needs and other information that is not historical information. Many of these statements appear, in particular, under the headings “Business”, “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, and “Risk Factors”. Forward-looking statements can often be identified by the use of terminology such as “may,” “might,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. In particular, these forward-looking statements include, but are not limited to:

•our plans and expectations regarding the initiation, timing, progress, results, and costs of our internal discovery, research and development programs, including current and future preclinical studies and clinical trials, and the period during which the results of such studies and trials will become available;

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•our ability and timing to advance our product candidates in, and to successfully initiate, conduct, enroll and complete, clinical trials;

•our expectations regarding the therapeutic potential of our product candidates, and the disease indications for which we intend to develop our product candidates;

•the timing and likelihood of, and our ability to obtain and maintain, regulatory clearances of our Investigational New Drug (IND) applications to initiate clinical trials and regulatory approval to commercialize our product candidates;

•our expectations regarding our further development of, successful application of, and the rate and degree of market acceptance of, our Integrated Drug Creation platform, including progress towards fully in silico biologic drug discovery;

•our expectations regarding our ability to leverage our Integrated Drug Creation platform to shorten preclinical development timelines for biologics;

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•our expectations regarding the markets for our product candidates, if approved, as well as those product candidates developed by our partners using our services and technologies, including the growth rate of the biologics market;

•our ability to attract new partners and enter into drug creation agreements that contain milestone and royalty obligations in favor of us;

•adverse public perception of the use of AI and product candidates developed using AI may negatively impact demand for, or regulatory approval of, our product candidates and adversely affect investor and marketplace perception of our platform technology;

•our potential to receive revenue from the achievement of milestones and from royalties on net sales under agreements with our partners with respect to products originating from our Integrated Drug Creation platform;

•our ability to enter into commercial license agreements for our ~~existing~~partnered ~~Active~~programs ~~Programs~~ with those partners who do not currently have milestone payment and royalty obligations to us;

•our ability to manage and grow our business by expanding our relationships with existing partners or introducing our Integrated Drug Creation platform to new partners and developing product candidates for internally developed programs;

•our expectations regarding our current and future partners’ continued development of, and ability to commercialize, biologic drugs generated utilizing our proprietary Integrated Drug Creation platform;

•our strategy, including our strategy to advance internally developed programs through preclinical studies and clinical trials;

•our estimates of our expenses, ongoing losses, future revenue, capital requirements and our need for or ability to obtain additional funding before we can expect to generate additional revenue;

•our estimates of the sufficiency of our cash, cash equivalents and ~~short-term~~marketable ~~investments~~securities;

•our calculations and estimates related to the valuation of our intangible assets;

•our ability to establish, maintain or expand collaborations, partnerships or strategic relationships;

•our ability to provide our partners with a full drug discovery solution and the use of artificial intelligence (AI) across our Integrated Drug Creation platform;

•our ability to obtain, maintain and enforce intellectual property protection for our platform, products and other technologies, the duration of such protection and our ability to operate our business without infringing on the intellectual property rights of others;

•our ability to attract, hire and retain key personnel and to manage our growth effectively;

•our expectations regarding use of our cash, cash equivalents and ~~short-term~~marketable ~~investments~~securities;

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•our financial performance and that of companies in our industry and the financial markets generally;

•the volatility of the trading price of our common stock;

•our competitive position and the development of and projections relating to our competitors or our industry;

•the impact of laws and regulations on our business and operations;

•our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (JOBS Act); and

•global economic conditions, including market volatility, acts of war and civil and political unrest, and our expectations about market trends and effects from inflation and fluctuations in interest rates.

WeAny ~~may~~forward-looking ~~not~~statements ~~actually~~in ~~achieve~~this ~~the~~Annual ~~plans,~~Report ~~intentions,~~on orForm ~~expectations~~10-K ~~disclosed~~reflect inour current views with respect to future events or to our ~~forward-looking~~future ~~statements,~~financial performance and ~~you~~involve ~~should~~known ~~not~~and ~~place~~unknown ~~undue~~risks, ~~reliance~~uncertainties onand assumptions that could cause our actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors ~~Actual~~that ~~results~~could cause or ~~events~~contribute ~~could~~to ~~differ~~such ~~materially~~differences ~~from~~include, ~~the~~but ~~plans~~are not limited to, ~~intentions~~those identified herein, and ~~expectations~~those ~~disclosed~~discussed in the section titled “Risk Factors,” set forth in Part I, Item 1A of this Annual Report on Form 10-K. You should not rely upon forward-looking statements as predictions of future events. Such forward-looking statements speak only as of the date of this report. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make or enter into.

5You should read this Annual Report on Form 10-K and the documents that we have filed as exhibits to this Annual Report on Form 10-K completely and with the understanding that our actual future results, performance or achievements may be materially different from what we expect. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

~~Table~~This Annual Report on Form 10-K includes statistical and other industry and market data, which we obtained from our own internal estimates and research, as well as from industry and general publications and research, surveys, and studies conducted by third parties. Industry publications, studies, and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of ~~Contents~~such information. While we believe that each of these studies and publications is reliable, we have not independently verified market and industry data from third‑party sources. While we believe our internal company research is reliable and the market definitions are appropriate, neither such research nor these definitions have been verified by any independent source.

~~statements~~Throughout wethis ~~make.~~Annual ~~Moreover,~~Report weon ~~operate~~Form in10-K, athe ~~competitive~~“Company,” ~~and~~“Absci,” ~~rapidly~~“Absci ~~changing~~Corporation,” ~~environment.~~“we,” ~~New~~“us,” ~~risks~~ and ~~uncertainties emerge from time to time~~“our,” ~~and~~except itwhere isthe ~~not~~context ~~possible~~requires ~~for~~otherwise, usrefer to ~~predict~~Absci ~~all~~Corporation ~~risks~~ and ~~uncertainties~~its ~~that~~consolidated ~~could~~subsidiaries; ~~have~~“our anboard ~~impact~~of ondirectors” ~~the~~refers ~~forward-looking~~to ~~statements contained in this Annual Report. Our forward-looking statements do not reflect~~ the ~~potential~~board ~~impact~~ of ~~any~~directors ~~future~~of ~~acquisitions,~~Absci ~~mergers, dispositions, collaborations, joint ventures, or investments we may make or enter into~~Corporation.

You should read this Annual Report and the documents that we file with the SEC, with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Annual Report are made as of the date of this Annual Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

Except as otherwise indicated, references in this Annual Report on Form 10-K to “Absci,” the “Company,” “we,” “us,” and “our” refer to Absci Corporation and its subsidiaries.

Market and Industry Data and Forecasts

We obtained the industry, market and competitive position data used throughout this Annual Report on Form 10-K from our own internal estimates and research, as well as from industry and general publications and surveys, governmental agencies and publicly available information. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by us based on such data and our knowledge of our industry and market, which we believe to be reasonable. In some cases, we do not expressly refer to the sources from which these data are derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires. In addition, while we believe the industry, market and competitive position data included in this Annual Report is reliable and based on reasonable assumptions, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed in Part I, Item 1A, “Risk Factors” in this Annual Report on Form 10-K. These and other factors could cause results to differ materially from those expressed in the estimates made by third parties or by us.

Trademarks

This Annual Report on Form 10-K contains references to our trademarks and service marks and to those belonging to third parties. Absci’s stylized A logo, Absci®, SoluPro®, Bionic SoluPro®, and Unlimit with us® (design), ~~and SoluPure®~~ are our registered trademarks with the U.S. Patent and Trademark Office. We also use various other trademarks, service marks and trade names in our business, including but not limited to, the Absci AI logo mark, ~~HiPrBind,~~ IgDesign, Translating Ideas into Drugs, Integrated Drug Creation, Creating drugs at the speed of Ai, ~~Better biologics for patients, faster, Breakthrough therapeutics at the click of a button, for everyone,~~ and Denovium. All other trademarks, service marks or trade names referred to in this Annual Report on Form 10-K are the intellectual property of their respective owners. Use of these marks/trade names does not imply affiliation, endorsement, or sponsorship of any kind. Solely for convenience, the trademarks and trade names in this Annual Report on Form 10-K may be referred to with or without the ® and ™ symbols, but references which omit the ® and ™ symbols should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

Availability of Other Information about Absci

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Investors and others should note that we routinely communicate with investors and the public using our website (www.absci.com) and our investor relations website (investors.absci.com) free of charge, including without limitation, through the posting of investor presentations, SEC filings (including amendments and exhibits to such filings as soon as reasonably practicable after filed with or furnished to the SEC), press releases, public conference calls and webcasts on these websites, as well as on X (Twitter), LinkedIn and YouTube. The information that we post on these websites and social media outlets could be deemed to be material information. As a result, investors, the media, and others interested in Absci are encouraged to review this information on a regular basis. The contents of our website and social media postings, or any other website that may be accessed from our website or social media postings, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Part I.

Item 1. Business

~~Our Mission~~Overview

We are a ~~data~~clinical-~~first~~stage ~~generative~~biopharmaceutical ~~AI drug creation~~ company ~~with~~using ~~the~~an ~~mission~~AI-native approach to ~~design~~develop differentiated antibody therapeutics. Our ~~Integrated~~integrated ~~Drug~~drug ~~Creation~~creation platform ~~comprises,~~combines ~~in part~~Origin-1, ~~cutting~~our ~~edge~~ generative AIdesign ~~models~~model, ~~aimed~~with atrapid ~~designing~~validation ~~better~~using ~~antibody~~our ~~therapeutics, including against hard~~lab-toin-~~drug targets. Antibody therapeutics represent a growing market and significant medical opportunity, yet~~ the ~~biopharmaceutical industry faces challenges in bringing these potentially life~~-~~changing medicines to patients~~loop. ~~Leveraging~~We ~~our~~focus ~~synthetic~~on ~~biology~~underexplored ~~roots,~~mechanisms wewhere ~~expect~~unmet ~~our~~medical ~~Integrated~~need ~~Drug~~is ~~Creation~~high ~~platform to improve upon traditional biologic drug discovery by using AI to simultaneously optimize multiple drug characteristics that may be important to development~~ and ~~therapeutic~~competition ~~benefit.~~is ~~Through these efforts, we aim to shorten time to clinic, while increasing the probability of success~~low. Our approach expands the possibilities in biopharmaceuticals — shifting from a paradigm of drug discovery to drug creation — with the goal of bringing best-in-class and first-in-class antibody therapeutics to the patients who need them.

We have advanced our first two programs from AI design to IND (or foreign equivalent) in around two years with a total investment of approximately $15 million per program, compared to an industry average of 4–6 years at a cost of greater than $50 million. This combination of underexplored target selection and capital-efficient execution is central to our strategy.

Our lead product candidate, ABS-201, is an anti-prolactin receptor (PRLR) antibody engineered with an extended half-life to support a patient-friendly dosing interval. We believe PRLR is an underexplored target with the potential to provide durable, disease-modifying effects. If successfully developed, ABS-201 could establish a new treatment category in indications where current options remain inadequate. ABS-201 is being developed for two indications, androgenetic alopecia (AGA) or pattern hair loss (PHL) and endometriosis, each with large affected populations and significant unmet need:

•Androgenetic Alopecia: ABS-201 is being evaluated in the HEADLINE™ Phase 1/2a clinical trial (NCT07317544) for AGA, a condition affecting approximately 80 million people in the United States. Our own patient and clinician surveys, as well as those of other parties, show broad dissatisfaction with current standard of care, which is limited by variable efficacy, poor compliance, and a lack of durable approaches. No approved therapy provides durable hair regrowth. We have dosed the first three single ascending dose cohorts with a favorable safety profile to date. Interim proof-of-concept data, including exploratory efficacy endpoints, are expected in the second half of 2026.

•Endometriosis: We plan to initiate a Phase 2 clinical trial of ABS-201 in endometriosis, a chronic condition estimated to affect approximately 10% of women of reproductive age worldwide. There is currently no FDA-approved disease-modifying therapy for endometriosis. The condition is associated with significant chronic pain, reduced quality of life, and impaired fertility, and treatment options are limited by inadequate long-term effectiveness and tolerability. PRLR signaling may contribute to both endometrial lesion development and pain-related pathways, which if demonstrated clinically, could support the potential for a non-hormonal and non-surgical treatment. A recent clinical trial has demonstrated clinical proof of concept for targeting PRLR for endometriosis. Our Phase 2 clinical trial for endometriosis is planned for the fourth quarter of 2026, subject to data from the ongoing HEADLINE trial and regulatory considerations.

Beyond ABS-201, we are advancing additional preclinical programs using our platform. We may seek partnerships or out-licensing arrangements for select pipeline assets, which would provide non-dilutive capital We believe we are positioned to execute on near-term catalysts while building long-term pipeline value.

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The AI Drug Creation Opportunity

Traditional drug discovery and preclinical development can take 4–6 years to go from discovery to clinical development at an aggregate cost of over $100 million per product candidate. Moreover, success rates for traditional drug discovery, as defined by successfully reaching a marketed product, are estimated at less than 5%. In all, it can take as much as 12–15 years, with costs estimated to exceed ~~more than~~ $1 billion to bring a drug to market.

~~Progress~~Advances in AI ~~has~~are ~~been~~increasingly ~~building~~being ~~for~~applied ~~decades,~~to ~~with increasing application in~~ drug discovery and development. In May 2023, the U.S. Food and Drug Administration (FDA) acknowledged that AI ~~will~~has ~~undoubtedly~~the potential to play aan ~~critical~~important role in drug development ~~and recognized its potential to enhance drug development in many ways~~, including tosupporting ~~help~~efforts ~~bring safe and effective drugs~~ to ~~patients~~improve ~~faster.~~aspects ~~A June 2023 study estimated that AI could yield time and cost savings~~ of atthe ~~least 25–50% in~~ drug ~~discovery~~development upprocess. toSome ~~the~~industry ~~preclinical~~participants ~~stage.~~and ~~Some~~ analysts ~~point~~have ~~specifically~~identified to generative AI as a ~~promising~~potential approach tofor ~~creating~~designing ~~novel~~potential ~~drugs with improved attributes, allowing~~ drug ~~development~~candidates towith ~~move~~specific ~~closer to drug design, speeding up the process and creating better-targeted drugs~~attributes. However, generative AI depends on massive high-quality training datasets to generate quality results. For example, GPT-4, a well-known generative AI model, was trained on data at scale readily available through public sources such as the internet. This type of dataset is more limited and not as accessible for biologics drug discovery.

Our Integrated Drug Creation platform is the engine of our AI-native approach, allowing us to design anti-body based therapeutics that target underexplored biological mechanisms. We continue to expand our platform’s capabilities to support aspects of antibody drug discovery. Our AI models are designed to generate antibodies, including multispecific antibodies, in silico to target specific epitopes. These models are also designed to evaluate multiple characteristics that may be relevant to drug development.

We are leveraging our Integrated Drug Creation platform to:

•Design potential first-in-class and best-in-class therapeutics: We believe our Integrated Drug Creation platform, together with our generative AI models including Origin-1 (our de novo AI model), and AI lead optimization models, enables us to access underexplored mechanisms, unlock novel biology, and design therapeutics against difficult-to-drug targets with significant unmet medical need.

•Increase the potential probability of success: Our AI models have been designed to enable multi-parametric predictions and simultaneous optimization of attributes in parallel, which we believe may enable the design of product candidates with defined characteristics that may be relevant to clinical development and thus increase the potential for clinical success.

•Reduce time and cost to clinic: We believe our platform may support more efficient preclinical development timelines. For example, we demonstrated capital-efficient development by advancing our first two internal pipeline programs through to IND (or foreign equivalent) in around two years with a total investment of approximately $15 million per program.

Our strategy is to leverage our Integrated Drug Creation platform to create differentiated antibody-based therapeutics for our own pipeline and for our partners’ pipelines. We are currently advancing two internally developed programs in clinical development, including ABS-201, that are intended to address underexplored mechanisms where there is significant unmet medical need.

Our Integrated Drug Creation Platform

~~For~~Absci ~~over~~is a ~~decade~~clinical-stage, weAI-native ~~have~~biopharmaceutical ~~used~~company. ~~synthetic~~Our ~~biology~~approach ~~technologies~~leverages ~~to generate antibodies at~~ a ~~large~~continuous ~~scale~~feedback ~~and~~loop tobetween ~~validate~~advanced ~~them~~AI inalgorithms and wet lab ~~testing,~~validation. ~~thereby~~Each ~~generating~~cycle ~~high-quality~~refines ~~large~~our ~~datasets~~data ~~that can be in turn used to train~~ and ~~refine~~strengthens our ~~AI generative~~ models~~. Specifically~~, wefacilitating ~~believe~~rapid ~~our~~innovation ~~lab-in-the-loop process allows us to rapidly improve AI models~~ and ~~accelerate~~enhancing the ~~design~~precision ~~and optimization~~ of ~~product~~our ~~candidates~~therapeutic ~~with potentially novel, best-in-class attributes. With the data to learn, the AI to create, and the wet lab to validate, we believe we can create billions of antibody~~ designs ~~and screen millions of ranked antibody sequences in weeks, allowing us to go from AI-designed to wet lab-validated product candidates in as little as six weeks~~. ~~Our proprietary Integrated Drug Creation platform enables us to build a strong pipeline of both internally developed and partnered programs that can expand therapeutic possibilities.~~

With ~~Lab~~the indata ato learn, the AI to create, and the wet lab to validate, we believe our lab-in-a-loop powers our ability to go from AI designs to wet lab-validated product candidates in as little as six weeks. Our proprietary Integrated Drug Creation platform supports the development of both internally developed and partnered programs that address underexplored biological mechanisms and enables the design of product candidates with defined target product profiles (TPPs).

7 Lab-in-a-loop

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Data to Train: We leverage a combined 77,000+ square feet ~~facility~~wet-lab and ~~wet~~dry-lab facility to generate high-quality data at scale for AI model training. ~~One~~and ~~component~~testing. ofWe ~~our~~have ~~data~~continuously ~~generation~~generated ~~platform~~high-quality isdata ~~our~~at ~~SoluPro~~scale ~~technology,~~for aAI ~~multiplex~~model ~~synthetic~~training ~~biology~~using ~~approach~~technologies ~~designed~~such toas ~~overcome the limitations of today's~~ high-throughput ~~automation~~Surface ~~labs.~~Plasmon ItResonance ~~constructs~~(SPR) ~~billions~~for ofaffinity ~~genetically-distinct~~measurements ~~cells, each containing instructions to make one version~~ of ~~a protein of interest~~antibodies, asSoluPro ~~well as a different assortment of folding~~ and ~~expression~~the ~~solutions. Our~~ ACE assay, ~~technology~~a ~~then~~bacterial ~~evaluates and sorts hundreds of millions of designs to collect the best hits~~ synthetic-biology ~~versions~~platform ofthat ~~the~~allows ~~protein-of-interest,~~for ~~based on target binding, protein quality, and expression titer. Additional technologies such as~~ affinity ~~measurements~~measurement byof ~~high-throughput~~antibody ~~Surface~~fragment ~~Plasmon Resonance (SPR)~~libraries, and enrichment/ sorting/ titration of yeast and phage displayed AI-designed libraries. ~~are~~We also ~~adopted~~regularly make use of public biological datasets. Our ~~proprietary~~ability ~~synthetic-biology~~to ~~technologies~~generate ~~and~~accurate data through efficient operational infrastructure generates high-quality data in a high-throughput manner to train and test our AI models.

AI to Create: We design product candidates using our generative AI models trained on both proprietary and public biological datasets. Our generative AI models can create epitope-specific product candidates against a therapeutic target of interest, including “hard-to-drug” targets. In addition, our AI lead optimization models enable parallel multi-parametric optimization to improve certain product candidate attributes including, but not limited to, tunable binding affinity, immunogenicity, pharmacological profile, and developability.

Wet Lab to Validate: We assess our product candidates with our wet lab's high-throughput functional validation capabilities, which are designed to prove our AI models in the lab. The quality and scale of wet lab data give us extensive training data, propelling our iterative design-build-test-learn cycle.

All together, our lab-in-the-loop capabilities can take us from AI-designed antibodies to wet lab-validated candidates in as little as six weeks.

Our Integrated Drug Creation platform enables our core competencies in three broad areas:

•Target selection and discovery: ~~There~~Target ~~are~~selection is a ~~variety~~strategic pillar of ~~manners~~our inAI-native ~~which~~approach, weallowing us to identify ~~targets~~opportunities ~~for~~where ~~our~~we ~~internally~~can ~~developed~~establish ~~programs~~first-in-class ~~and~~or ~~collaborations~~best-in-class positions. ~~Those~~We prioritize targets ~~can~~considering bemultiple ~~partner-identified~~factors, ~~targets~~including: or(1) ~~Absci-identified~~biological ~~targets.~~potential ~~One~~in ofunderexplored mechanisms; (2) relevance to diseases with significant unmet medical need; (3) prior challenges in addressing the ~~methods~~target weusing ~~use~~traditional toantibody ~~identify~~discovery ~~targets~~approaches; isand (4) suitability for design using our AI models for capital efficient development. We may also use our proprietary reverse-immunology technology. Weto ~~use~~identify ~~this~~potentially desirable targets. This technology allows us to reconstruct prevalent immune-response ~~molecules such as~~ antibodies from disease tissue ~~and~~to identify their corresponding antigens,. ~~offering~~This ~~new~~method can provide us with possible therapeutic targets, as well as ~~the~~their cognate antibody binding partners, for further potential validation and AI-optimization. In our Drug Creation Partnerships, targets are typically selected by our partners based on their own assessments.

8•AI-guided antibody drug creation: Starting with an envisioned TPP as well as an antibody framework, target antigen and epitopes, we use generative AI models, such as our proprietary Origin-1 de novo antibody design models to create a library of relevant antibody designs predicted to

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•AI-guided antibody drug creation: Starting with an envisioned drug format and target antigen, we use generative AI models such as our proprietary de novo antibody design models to generate a library of relevant sequence variants to establish the target specificity, designed to create novel therapeutic candidates with desirable attributes related to affinity, functionality, and developability.

•AI-guided lead optimization: With multi-parametric AI lead optimization, we work to simultaneously evaluate multiple sequence variants for improved target affinity, manufacturability, and other pharmacologic characteristics for further advancement, including through preclinical and clinical development.

We believe the flexibility of our platform will enable us to address specific challenges with existing targets or create product candidates across different antibody modalities.

We believe we have the potential to unlock new and differentiated value drivers:

•Enable potential first-in-class drugs: We’ve developed our Integrated Drug Creation platform which we believe enables us to access novel and differentiated biology and to address difficult-to-drug targets.

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~~•Enable~~bind ~~potential~~to ~~best-in-class~~the ~~drugs:~~target ~~Our~~epitope(s) ~~generative~~and AIdesired ~~models,~~attributes. ~~including~~These ~~our~~designs deare ~~novo~~filtered and sorted using AI models and AIthen ~~lead~~the ~~optimization~~top ~~models,~~ranking ~~can~~designs ~~help~~are ~~develop~~tested ~~drugs~~in ~~with~~our ~~multiple,~~wet-lab ~~potentially~~to ~~superior~~determine and validate key attributes, such as ~~increased~~target ~~half-life~~epitope specificity, ~~and~~affinity, ~~conditional~~functionality, ~~pH-dependent~~and ~~binding~~developability.

•~~Potential~~AI-guided ~~for~~lead ~~increased probability of success~~optimization: ~~Our~~With multi-parametric AI ~~models~~lead ~~have~~optimization, ~~been~~we ~~designed~~work to ~~enable~~simultaneously ~~multi-parameter~~evaluate ~~predictions~~and improve key attributes such as target epitope binding affinity, manufacturability, and ~~simultaneous~~other ~~optimization~~pharmacologic ofcharacteristics. The attributes inof ~~parallel,~~these ~~which~~optimized wedesigns ~~believe~~are ~~allows~~also ustested toin ~~design~~our ~~product~~wet-lab ~~candidates~~to ~~with~~confirm whether the desired ~~attributes~~targeted preclinical profile has been met, and ~~potentially~~thus ~~with~~allow ~~the~~for ~~best~~further ~~chances~~advancement ~~for~~through preclinical and, potentially, clinical ~~success~~development.

~~•Reduce~~Origin ~~time~~1: toIn ~~clinic:~~January We2026 ~~believe~~we ~~our~~released Origin-1, Absci’s platform ~~has~~for ~~the~~de ~~potential~~novo todesign ~~reduce~~of ~~the~~full-length ~~time~~monoclonal toantibodies ~~IND~~against “zero-prior” epitopes. While several de novo antibody design models have succeeded in delivering binders against solved epitopes (orbinding ~~foreign~~sites ~~equivalent)~~that ~~from~~have already been structurally characterized with a 4known protein binder, these approaches do not prioritize a critical problem in therapeutic discovery: designing antibodies for targets and epitopes lacking solved complex structures with protein binders. Origin-61 ~~year~~was ~~industry~~developed ~~average~~and validated to ~~around~~address ~~two~~this ~~years~~challenge. “Zero-prior-epitopes” refer to target sites that, ~~enabling~~to ~~more~~our ~~programs~~knowledge ~~per~~have ~~unit~~no ~~time~~published reports describing a protein (including, for example, an antibody) that binds to the target at the selected epitope.

~~•Expand~~Origin-1 ~~intellectual~~consists ~~property space~~of: We(1) ~~believe~~AbsciGen, the generative engine creating antibody structures and sequences, y structures and sequences, and (2) AbsciBind, an engine that ~~our~~scores ~~AI-driven~~and ~~drug~~filters ~~creation~~antibody ~~strategy~~candidates ~~has~~prior ~~the~~to ~~potential~~experimental characterization. In contrast to ~~generate~~traditional ~~broader~~drug IPdiscovery ~~for~~campaigns, ~~first~~Origin-in1 generated product candidates by screening fewer than 100 designs per target. Origin-~~class~~1 ~~antibody~~has ~~therapeutics~~been successfully validated against four targets to date by showing binding, developability, and ~~find~~~100nM ~~new~~functional IPpotency confirmed across 5+ orthogonal assays. Additionally, structures of top binders for ~~fast~~2 example targets (COL6A3 and AZGP1) were confirmed by cryogenic electron microscopy (Cryo-~~follower~~EM), orwith ~~best~~experimental structures matching the design models closely, confirming Origin-~~in-class~~1’s ~~antibody~~ability ~~therapeutics~~to generate epitope specific, atomically accurate binders.

Our Business Model

Our business model is focused on monetizing our Integrated Drug Creation platform by generating internally developed programs that are later partnered or out-licensed following certain value inflection points (anywhere from preclinical through clinical development) or by partnering with third parties who wish to leverage our Integrated Drug Creation platform for early discovery efforts in a variety of deal structures.

Internally Developed Programs: We believe that by developing our own pipeline, we will create optionality for enhanced monetization and validation of our Integrated Drug Creation platform. With the ability to selectively choose both novel and fast-follower targets, in addition to develop potentially best-in-class attributes, we aim to take our internally developed programs to certain value inflection points before considering partnering or out-licensing opportunities.

Partnered Programs:

•Drug Creation Programs: We enter into collaborations with third parties who are seeking to leverage our platform to solve challenging problems. We work closely with our partners on single and multi-target programs to develop product candidates against targets they have selected. We aim to expand and diversify our portfolio of partnered programs through these collaborations, each of which may include up-front fees and research fees, as well as potential clinical and/or commercial milestones and royalties.

•Co-development Programs: We enter into co-development partnerships with third parties who may offer perceived synergies with our Integrated Drug Creation platform. Our co-development programs are based on a clear alignment to take these programs through to certain value inflection points before considering partnering or out-licensing opportunities. Our co-development partnerships may be directed to either single and multi-target programs and may include mutual cost-sharing and/or technology contributions. We aim to further expand and diversify our portfolio of partnered programs through these co-development partnerships. By sharing both the risks and rewards of these programs, we ensure both parties are motivated for success.

Our evolving business model is underpinned by our Integrated Drug Creation platform which supports a strategic diversification of our program portfolio through internally developed programs, partnered drug creation programs and co-development programs. This strategic diversification allows us the potential to balance our program portfolio between internally developed programs for which we have more control and may provide more significant economic returns, and partnered programs which broaden our reach into therapeutic areas where our partner has established capabilities and expertise. Thus, the cornerstone of this business model evolution lies in the diversification of risk and potential return on investment. Our business model not only secures a focused set of therapeutic areas, but also gives us greater optionality, enhancing our ability to pivot and adapt as the programs progress. We believe we will grow and diversify our portfolio of programs through our model, ultimately driving innovation and delivering value for all stakeholders.

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~~Internally~~We ~~Developed~~believe ~~Programs~~this platform is potentially the first demonstration of de novo design of full-length monoclonal antibodies against "zero-prior" epitopes with atomically accurate complex structures and functional activity.

~~Our~~Origin-1 ~~pipeline~~was ~~reflects~~developed ~~internally~~using ~~developed~~multiple ~~programs~~years ~~which~~of ~~highlight~~proprietary ~~our~~data ~~differentiated~~generation. ~~capabilities~~Our lab-in-a-loop deplatform ~~novo~~continuously ~~antibody~~feeds ~~creation, multi~~wet-~~parametric~~lab ~~lead~~validation ~~optimization,~~data ~~and~~back ~~reverse~~into ~~immunology,~~the ~~with an initial focus on cytokine biology. As of December 31~~models, ~~2024,~~capturing wethe ~~have~~fundamental ~~identified~~binding ~~four~~mechanics ~~wholly~~and ~~owned,~~rules ~~internally~~often ~~developed~~absent ~~programs~~from ~~focusing~~public ~~on cytokine biology as well as several undisclosed internal pipeline programs currently in early discovery phases~~datasets.

~~ABS-101~~Our Business Model

Our ~~first~~business ~~development~~model ~~candidate, ABS-101~~ is indesigned ~~development~~to asdrive avalue ~~potential~~through ~~treatment~~our ~~for~~AI-native ~~Inflammatory~~approach ~~Bowel~~to ~~Disease~~therapeutic ~~(IBD).~~discovery ~~IBD is a chronic condition characterized by inflammation within the gastrointestinal tract~~ and ~~encompasses~~development. ~~two~~We ~~main~~leverage ~~disorders:~~our ~~ulcerative~~Integrated ~~colitis~~Drug ~~(UC)~~Creation ~~and~~platform ~~Crohn’s~~to ~~Disease~~ (CD1). UCbuild ~~primarily affects the colon~~ and ~~the~~advance ~~rectum,~~an ~~and~~internal ~~symptoms~~pipeline ~~include bloody diarrhea, abdominal pain, bowel urgency, and frequent bowel movements. CD can affect any part~~ of ~~the~~differentiated ~~gastrointestinal~~therapeutic ~~tract,~~programs ~~from~~that ~~the~~we ~~mouth~~advance tothrough ~~the~~clinical ~~anus,~~development and ~~symptoms include abdominal pain~~commercialization, ~~diarrhea,~~(2) ~~weight~~generating ~~loss,~~internally ~~fatigue,~~developed ~~and~~programs ~~complications~~that ~~such~~are assubsequently ~~strictures~~partnered or ~~fistulas.~~out-licensed ~~Both~~following ~~conditions~~certain ~~can~~value ~~significantly~~inflection ~~impact~~points ~~patients’~~(anywhere ~~quality~~from ofpreclinical ~~life~~through inearly ~~terms~~phases of ~~physical~~clinical ~~health, emotional well-being, and the unpredictability of symptom onset.~~

IBD affects millions of individuals worldwide, with increasing prevalence and incidence in both developed and developing countries. In the United States, it is estimated that approximately 2.4 million individuals currently have IBD, with approximately 70,000 patients newly diagnosed every year. Based on research from the Crohn's and Colitis Foundation of America, the market for IBD therapeutics is expected to experience steady growth, driven by rising disease prevalence, increasing diagnosis rates, and evolving treatment paradigms.

We believe ABS-101 may present a significant market opportunity for the treatment of IBD. Current IBD treatments face limitations such as lack of response in some patients, diminishing effectiveness over time, and a therapeutic efficacy ceiling. ABS-101 has the potential to address these limitations by providing a novel mechanism of action through blocking TL1A-driven activation of immune responses and potentially fibrosis. Additionally, ABS-101 is being developed for potential longer dosing intervals and subcutaneous injections, which we believe may improve patient compliance and quality of life. Beyond IBD, ABS-101's therapeutic relevance may extend to a range of immune-related indications, further broadening its market potential.

ABS-101 targets the immune-regulator TL1A, and in preclinical studies has demonstrated high affinity and potency, ability to bind the monomer and trimer of TL1A, anticipated low immunogenicity, and high bioavailability in non-human primates (NHPs). In addition, CMC studies have confirmed the ability to formulate ABS-101 at a high concentration of 200 mg/mL. ABS-101 is expected to be delivered via subcutaneous administration, with an anticipated dosing interval of 8-12 weeks, or even less frequently.

We are aware of first-generation advanced clinical stage product candidates targeting TL1A, including those being developed by Merck, Roche and Sanofi. For purposes of comparing the anticipated attributes of

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~~ABS-101 to these advanced competitive antibodies~~development), ~~we generated putative clinical competitor antibodies~~ and ~~performed~~(3) astrategically ~~head-to-head~~partnering ~~comparison against ABS-101. In these preclinical studies, ABS-101 exhibited properties consistent~~ with athird ~~potentially~~parties ~~superior~~to ~~product~~leverage ~~profile~~our byIntegrated ~~demonstrating~~Drug ~~equal~~Creation orplatform ~~superior potency from multiple biophysical and cellular assays, in addition~~ to ~~improved~~support ~~developability~~early ~~properties.~~discovery ~~For~~efforts ~~example,~~ in a ~~comparative~~variety ~~single-dose pharmacokinetic study conducted in NHPs, ABS-101 demonstrated a 2-3x extended half-life compared to clinical competitors, supporting an extended dosing interval~~ of ~~Q8W-Q12W~~deal structures.

~~Additionally,~~Internally ~~analysis~~Developed ofPrograms: ~~total~~Our ~~soluble~~pipeline ~~TL1A~~includes ~~(sTL1A)~~internally indeveloped ~~the~~programs ~~serum~~designed ofto ~~NHPs~~address ~~indicated~~areas ~~clear~~of ~~target~~significant ~~engagement~~unmet medical need, ~~evidenced~~including byprograms anthat ~~increase~~we inbelieve ~~sTL1A~~may ~~levels~~have ~~over~~the ~~time~~potential to represent first-in-class aor ~~dose~~disease-~~dependent~~modifying ~~manner,~~approaches. ~~reaching~~These aprograms ~~ceiling~~have ~~effect.~~been ~~The~~generated ~~high~~using ~~affinity~~our ~~and~~platform ~~extended~~capabilities, ~~half-life~~including ofde ~~ABS-101~~novo ~~resulted~~antibody indesign, ~~prolonged~~multi-parameter ~~target~~candidate ~~engagement~~optimization ~~compared~~and toreverse ~~Merck~~immunology ~~and~~approaches. ~~Roche's~~We ~~clinical~~intend ~~competitor~~to ~~molecules~~advance ~~when~~a ~~administered~~limited atnumber ~~the~~of ~~same~~internally ~~dose~~developed ~~and~~programs, ~~route.~~such as ABS-~~101~~201, ~~achieved~~through ~~comparable~~clinical ~~target~~development ~~engagement~~and ~~with~~potential ~~only~~commercialization. ~~one-fifth~~For ofother ~~the~~internally ~~dose~~generated ~~versus~~programs, ~~the~~we ~~competitor~~may ~~molecules~~seek ~~when~~to ~~administered~~enter ~~via~~into ~~the~~collaboration, ~~same~~partnership ~~route~~or ofout-licensing ~~administration.~~arrangements Aat ~~13-week~~various ~~GLP~~stages ~~toxicology~~of ~~study~~development, ~~demonstrated~~which nomay ~~treatment-related~~include ~~adverse~~preclinical ~~findings~~stages ~~during~~or ~~the~~early ~~in-life~~phases ~~phase~~of ~~and~~clinical ~~necropsy~~development, ~~with~~to asupport ~~NOAEL~~the ~~established~~advancement atof ~~600~~selected ~~mg/kg~~programs iand continued development of our platform.v.

~~Additionally,~~Partnered ~~while~~Programs: weWe ~~endeavored~~may toenter ~~create~~into ~~antibodies~~drug creation collaborations for drug creation programs and co-development partnerships with ~~the~~third ~~same~~parties. ~~attributes~~Our drug creation collaboration programs may include up-front fees and research fees, as ~~those~~well ofas ~~competitive~~potential ~~antibodies~~clinical and/or commercial milestones and royalties. Through our co-development partnerships, we ~~cannot~~collaborate ~~assure~~to ~~you~~develop ~~that~~drug ~~they~~creation ~~are~~programs ~~comparable~~ to certain value inflection points before considering partnering or ~~better~~out-licensing ~~than~~opportunities ~~those~~and ~~being~~may ~~developed~~include bymutual ~~our~~cost-sharing ~~competitors,~~and/or ~~nor~~technology ~~can~~contributions. weAbsci ~~assure~~has ~~you~~had ~~that~~a ~~direct~~track ~~comparisons~~record of ~~ABS-101~~partnerships towith ~~those~~leading ofbiopharmaceutical ~~our~~companies ~~competitors~~including ~~will~~Merck, ~~produce~~AstraZeneca, ~~similar~~Almirall ~~results~~and others.

~~Preclinical development of ABS-101 is ongoing in preparation for a potential regulatory filing in the first half of 2025, and an anticipated interim clinical readout in the second half of 2025.~~Strategy

~~ABS~~Our strategy is focused on generating internally developed programs that address underexplored biological mechanisms in areas of significant unmet medical need, including programs that we believe may have the potential to represent first-~~201~~in-class or disease-modifying approaches. We intend to advance a limited number of programs that we believe are best aligned with our capabilities through clinical development and potential commercialization. For other internally generated programs, we may seek to enter into collaboration, partnership or out-licensing arrangements at various stages of development, which may include preclinical stages or early phases of clinical development, in order to support the advancement of selected programs and the continued development of our platform

Our ~~second~~strategy ~~development~~is ~~candidate,~~driven ~~ABS~~by our AI-~~201~~native isapproach inand ~~development~~Integrated asDrug aCreation ~~potential~~platform, ~~treatment~~which ~~for~~encompasses ~~androgenic~~cutting ~~alopecia~~edge ~~(AGA).~~generative ~~AGA~~AI ismodels anthat ~~indication~~are integrated with aour ~~significant~~lab-in-the-loop, ~~clinical~~which ~~unmet~~assesses ~~need~~ and avalidates ~~potential~~our ~~patient~~AI ~~population~~model ofdesigns. ~~approximately~~By 80leveraging ~~million~~our ~~individuals~~ lab-in -the-loop, ~~United~~we ~~States~~drive ~~alone. AGA is~~ a ~~genetically~~continuous ~~predetermined~~learning ~~disorder~~cycle—data ~~that~~to ~~can~~train, ~~affect~~AI ~~over~~to 50create, ~~percent of men~~ and ~~over~~wet ~~40%~~lab ofto ~~women~~validate—that byaccelerates ~~age~~AI ~~50.~~model Itinnovation isand ~~characterized~~thus bycontinually ~~progressive~~improves ~~loss~~our ofIntegrated ~~terminal~~Drug ~~hair~~Creation ofplatform. ~~the~~With ~~scalp~~each ~~any time after puberty~~iteration, ~~and~~our ~~follows~~Integrated aDrug ~~characteristic~~Creation ~~distribution~~platform inrefines ~~both~~its ~~males~~predictive ~~and~~capabilities, ~~females.~~improving ~~Hair~~design ~~loss~~capabilities ~~is most prominent in the vertex~~ and ~~frontotemporal~~allowing ~~regions~~us into ~~males.~~create Inbetter ~~women,~~antibody-based ~~the~~therapeutics ~~frontal~~against ~~hairline~~increasingly ischallenging ~~typically~~targets ~~spared~~that ~~with~~are ~~diffuse~~beyond ~~hair loss at~~ the ~~crown~~reach ~~and top~~ of ~~the~~traditional ~~head,~~drug ~~with~~discovery ~~loss often marked by a wider center part~~approaches.

~~Current~~Advancing ~~FDA-approved~~a ~~treatments~~diverse ~~for~~portfolio ~~AGA~~of internally developed programs: We are ~~limited~~advancing ~~due~~a toportfolio ~~variable~~of ~~efficacy~~internally developed programs, ~~lack~~each ofdesigned ~~patient~~using ~~compliance~~our generative AI models, ~~potential~~including ~~sexual~~our Origin-1 de novo AI models, and ~~neurological~~our ~~side~~AI-driven ~~effects~~lead optimization models. ~~Additionally,~~These ~~incremental~~programs ~~limitations~~span ~~exist~~multiple ~~for~~therapeutic ~~women~~areas ofand ~~reproductive~~focus ~~age~~on areas with significant unmet medical need. We ~~believe~~are ~~that~~increasingly anleveraging our platform to create antibody-based ~~therapeutic~~therapeutics, ~~that~~including ismulti-specific ~~safe~~antibodies, against complex and ~~efficacious~~hard-to-drug targets. We intend to advance a limited number of programs that we believe are best aligned with ~~durable~~our ~~effects~~capabilities through clinical development and ~~convenient~~potential ~~dosing~~commercialization. ~~has~~For ~~the~~other ~~potential~~internally developed programs, we may seek to ~~unlock~~enter into collaboration, partnership or out-licensing arrangements at various stages of development, which may include preclinical stages or early phases of clinical development. Our portfolio approach ensures our value is anchored in a ~~significant~~repeatable ~~commercial~~engine ~~market~~capable ~~for~~of ~~hair~~generating a sustainable pipeline of best-~~regrowth~~in-class ~~therapy~~or first-in-class therapeutics.

Continuous investment in our team and integrated drug creation platform: We intend to maintain our technological differentiation through continued investment in our team and platform. We expect to maintain an integrated team of subject matter experts in AI, drug discovery, disease biology, protein engineering, and clinical development. We expect to grow and enhance our intellectual property portfolio to protect and secure the value of our innovations, including the assets we generate using our platform. We may continue to evaluate strategic and synergistic technology acquisitions to expand and strengthen our capabilities and deepen our expertise in the aforementioned areas.

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~~ABS-201~~Enabling ~~targets~~ the ~~prolactin~~development ~~receptor~~of ~~(PRLR)~~new ~~and,~~antibody inmodalities: ~~preclinical~~Our ~~studies~~ability ~~has~~to ~~shown high affinity and potency~~design, ~~favorable~~construct ~~safety~~ and ~~immunogenicity,~~rapidly ~~extended~~screen ~~half-life~~large ~~for~~numbers ~~convenient~~of ~~infrequent~~molecules ~~dosing,~~enables ~~favorable~~us ~~developability~~to ~~and~~evaluate ~~manufacturability~~billions ~~attributes,~~of ~~and~~unique ~~early~~protein ~~efficacy~~variants ~~data~~ in asilico ~~short-term~~and ~~hair~~hence ~~growth model compared~~ to ~~minoxidil.~~increase ~~We believe~~ the ~~innovative~~probability ~~mechanism~~ of ~~action~~finding ~~of ABS-201 relies on~~ the ~~shift~~most ofpromising ~~hair~~product ~~follicles~~candidate. ~~from~~We ~~the~~design ~~regression~~and oroptimize ~~catagen phase~~ new-to ~~the growth or anagen phase when PRLR is inhibited, which potentially may cause durable hair re~~-~~growth,~~nature ~~not~~modalities ~~just~~driven aby ~~slowing~~our ofAI ~~hair loss~~models.

WeAdvancing ~~evaluated~~AI ~~the~~drug ~~efficacy~~creation ofby ~~ABS-201~~leveraging inour aproprietary ~~preclinical~~data: ~~study~~We ~~for~~use ~~short~~data ~~term~~generated ~~hair~~through ~~growth~~our inprograms ~~mice.~~and ~~Mice~~design ~~were~~campaigns ~~shaved~~to ~~until~~support the ~~skin~~continued ~~was~~development ~~visible~~of our AI models. Through iterative design cycles, ~~then~~we ~~randomized~~seek ~~into~~to ~~treatment~~refine ~~groups~~these ~~based~~models onto ~~skin~~support ~~color~~the ~~and~~design ~~initial~~of ~~body~~antibody-based ~~weight~~therapeutics with desired pharmacologic attributes. ~~Hair~~Advancement ~~growth~~of ~~scores~~our ~~were~~AI ~~recorded~~model ~~twice~~capabilities ~~weekly~~is ~~using~~expected ato ~~predefined~~further ~~scale,~~expand ~~and~~our ~~ABS-201~~landscape ~~was~~of ~~compared~~addressable totargets 5%while ~~topical~~also ~~minoxidil.~~increasing ~~ABS-201~~the ~~increased~~speed ~~hair~~of ~~regrowth~~creating ~~compared~~drug tocandidates ~~minoxidil~~against inthose atargets. ~~short-term~~The ~~hair~~more ~~regrowth~~data ~~model~~we generate, ~~achieving~~the ~~full~~more ~~hair~~design ~~growth~~campaigns ~~after~~we 22complete, ~~days~~the more our AI models advance, ~~whereas~~all ~~minoxidil~~of ~~only~~which ~~achieved~~we ~~approximately~~believe ~~one-third~~will ~~hair~~enable ~~growth~~us into ~~the~~create ~~same~~new ~~period.~~and better antibody-based therapeutics against increasingly challenging targets.

~~Preclinical~~Strengthening our position as a partner of choice through platform differentiation: We have entered into drug creation partnerships with pharmaceutical companies, biotechnology companies and other third parties to support the development of ~~ABS-201~~programs isgenerated ~~ongoing~~using inour ~~preparation~~platform. These collaborations may include provisions for aupfront payments, research funding, milestone payments and royalties on potential ~~regulatory~~future ~~filing~~product insales. ~~the~~We ~~first~~may ~~half~~also seek to enter into collaboration, partnership or out-licensing arrangements for certain internally developed programs at various stages of ~~2026~~development, which may include preclinical stages or early phases of clinical development.

Partnered programs

We have historically defined “Active Programs” as drug creation programs that are subject to ongoing technology development activities intended to determine if the program can be pursued by our partner for future clinical development, as well as any program for which our partner obtains and maintains a license to our technology to advance the program after completion of the drug creation phase. There is no assurance, however, that our partners will advance any product candidates that are currently the subject of Active Programs into further preclinical or clinical development or that our partners will elect to license our technologies upon completion of the drug creation phase in a timely manner, or at all.

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AsInternally ofDeveloped ~~December 31, 2024, our Active~~ Programs ~~were as follows:~~

Partner

Contract Date

Active Programs

Therapeutic Area

Owkin

December 2024

Undisclosed

Invetx

December 2024

Animal health

Twist Bioscience

October 2024

Undisclosed

Memorial Sloan Kettering Cancer Center

July 2024

Oncology

PrecisionLife

December 2023

Undisclosed

Almirall

November 2023

Dermatology

AstraZeneca

November 2023

Oncology

Undisclosed

July 2023

Undisclosed

March 2023

Undisclosed

Merck

January 2022

Undisclosed

Merck

December 2019

Undisclosed

Alpha Cancer Technologies

August 2019

Oncology

SFJ Pharmaceuticals

April 2019

Hematology

Active Programs

Our pipeline is composed of internally developed programs which leverage our differentiated capabilities in de novo design, multi-parametric lead optimization, and reverse immunology. These programs have been designed to address areas with significant unmet medical needs with potential ‘first-in-class’, ‘best-in-class’, or ‘disease modifying’ profiles. As of December 31, 2025, we are advancing five wholly-owned, internally developed programs as well as several undisclosed internal pipeline programs currently in early discovery phase.

~~Our~~Clinical ~~Integrated~~Stage Drug Creation platform is utilized in our partnerships across multiple indications and targets. We have negotiated license agreements, or expected to negotiate license agreements upon completion of certain drug creation activities, with potential downstream milestone payments and royalties for all Active Programs. We are, however, not able to make accurate predictions regarding the potential timing and size of milestone payments and royalties from these agreements given the development of any drugs created under these agreements is subject to each partner’s election. As our business strategy has evolved to have a greater focus on internally developed programs, we do not intend to provide updates in our periodic filings on our Active Programs beginning with the fiscal year ending December 31, 2025.

* ABS-201

~~Strategy~~In December 2025, we initiated the HEADLINE™ Phase 1/2a clinical trial for ABS-201 (NCT07317544). This trial is designed to demonstrate safety, tolerability and proof of concept as a potential therapeutic treatment for androgenic alopecia (AGA). We have successfully dosed the first three cohorts in the single ascending dose (SAD) portion of the ongoing Phase 1/2a HEADLINE trial, and ABS-201 has been well tolerated to date, with favorable emerging safety data. We anticipate reporting preliminary safety, tolerability, and pharmacokinetic (PK) data in the first half of 2026, with interim proof-of-concept data in the second half of 2026 and full proof-of-concept data in early 2027. We believe that this study can also provide supporting first-in-human safety, tolerability, and PK data to support a Phase 2 clinical trial evaluating ABS-201 in patients with endometriosis, which we anticipate initiating in the fourth quarter of 2026, with potential proof-of-concept data in the second half of 2027. Targeting the underexplored PRLR signaling pathway, ABS-201 is designed to provide durable, disease-modifying effects for both androgenetic alopecia (AGA) and endometriosis—two indications characterized by massive patient populations and a lack of effective, durable therapies.

~~Our strategy centers on our Integrated Drug Creation platform, which comprises cutting edge generative AI models and a deep expertise in synthetic biology, wet~~ABS-~~lab~~201 ~~data~~for generation experimental validation capabilities. By leveraging our data advantage, we drive a continuous learning cycle—data to train, AI to create, and wet lab to validate—that accelerates AI model innovation and thus continually improves our Integrated Drug Creation platform. With each iteration, our Integrated Drug Creation platform refines its predictive capabilities, improving design capabilities and allowing us to create better antibody therapeutics against increasingly challenging targets beyond the ~~reach~~Treatment of ~~traditional drug discovery approaches.~~ AGA

~~Our~~Epidemiological strategy is focused on generating internally developed programs and partnered programs, allowing us to advance a diverse portfolio of AI-designed antibody therapeutics that have the potential to bring potentially life-changing medicines to patients. Overview

~~Building~~AGA, acommonly ~~Diverse~~known ~~Portfolio~~as ofpattern ~~Internally~~hair ~~Developed~~loss, ~~Programs:~~is ~~We are actively building and expanding~~ a ~~portfolio~~multifactorial ofprogressive ~~internally~~disorder ~~developed~~that ~~programs,~~affects ~~each~~approximately ~~designed~~80 ~~using~~million ~~our~~people ~~generative~~in AIthe ~~models,~~United ~~including~~States. ~~our~~For deapproximately ~~novo~~50 AImillion ~~and~~men ~~AI-driven~~in ~~lead~~the ~~optimization~~United ~~models.~~States ~~These~~with ~~programs span multiple therapeutic areas~~AGA, ~~leveraging~~hair ~~our~~loss ~~ability~~is tomost ~~design~~prominent ~~novel~~in ~~biologics~~the ~~against~~vertex ~~complex~~ and ~~hard-to-drug~~frontotemporal ~~targets~~regions. ~~Our~~For AIapproximately ~~models~~30 ~~continuously~~million ~~evolve,~~women ~~improving with each lab-~~in- the~~-loop~~ ~~cycle.~~United ~~By integrating AI-driven design with our wet-lab validation capabilities~~States, weAGA ~~are~~hair ~~rapidly~~loss ~~advancing~~is ~~multiple~~most ~~programs~~prominent ~~centered~~at ~~around~~the ~~AI-created~~crown ~~product~~and ~~candidates.~~top ~~Each~~of ~~new~~the ~~program strengthens our platform’s ability to scale drug creation with speed and precision~~head, ~~reinforcing~~which ~~our~~is ~~position~~visible as awider ~~leader~~center inparting ~~AI-driven~~of ~~biologic~~the ~~drug creation~~hair.

WeAGA ~~believe~~is ~~that~~usually ~~our~~diagnosed ~~internally~~through ~~developed~~clinical ~~programs~~evaluation, ~~create~~involving ~~optionality~~a ~~for~~history ~~enhanced~~of ~~monetization~~gradual onset after puberty and ~~validation~~often, but not necessarily, a familial history of ~~our~~baldness. ~~Integrated~~AGA ~~Drug~~can ~~Creation~~significantly ~~platform~~affect quality of life. ~~With~~Individuals ~~the~~with ~~ability~~AGA tooften ~~selectively~~experience ~~choose~~negative ~~both~~impacts ~~novel~~on self-image and ~~fast~~self-~~follower targets~~confidence, inwhich ~~addition~~can toalter ~~develop~~social ~~potentially~~behavior ~~best~~and emotional well-being. The psychosocial consequences of AGA, including increased stress, anxiety, and social withdrawal, can result in~~-class~~ ~~antibody~~meaningful ~~therapeutics~~health-related impairments, wehighlighting ~~intend~~the toimportance ~~take~~of addressing the condition.

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AGA is characterized by the progressive miniaturization of hair follicles, resulting in a transition from thick, pigmented terminal hairs to thin, short, and unpigmented vellus-like hairs. We believe, based on prior third party non-human primate studies, our ~~internally~~own ~~developed~~animal ~~programs~~studies, and our human ex-vivo hair follicle organ culture studies, that prolactin signaling is an underexplored and key upstream driver of hair follicle miniaturization. Moreover, current FDA-approved treatments for AGA, which target dihydrotestosterone (DHT) and/or seek to ~~certain~~increase ~~value~~blood ~~inflection~~flow ~~points~~to ~~before~~hair ~~considering~~follicles, ~~partnering~~provide limited and/or ~~out-licensing~~variable ~~opportunities~~efficacy, are inconvenient and thus patient compliance is limited, and some have been reported to cause potential sexual and neurological side effects. Additionally, incremental limitations exist for women of reproductive age. We believe that an antibody-based therapeutic with a favorable safety profile, meaningful and durable hair growth combined with a convenient administration profile, if successfully developed and approved, could represent a potential new category of treatment— a biologic therapy for hair loss.

~~Strengthening~~Role ~~Our Position as a Partner~~ of ~~Choice:~~prolactin ~~We have formed partnerships with large pharmaceutical companies, large biotechnology companies,~~ and ~~other third parties to continually expand the breadth and depth of our partnered drug creation programs and co~~ABS-~~development~~201 ~~programs.~~in WeAGA ~~believe our ability to design antibody therapeutics against hard~~-~~to-drug~~ ~~targets~~Mechanism ~~will enable us to build a diversified portfolio~~ of ~~programs that may offer future streams of milestone and royalty revenue.~~action

~~Continuous~~Prolactin ~~Investment~~has been reported in ~~Our~~published ~~Team~~literature to induce the catagen (regression) phase and ~~Integrated~~cessation ~~Drug~~of ~~Creation~~pigmentation ~~Platform:~~in Wehuman ~~intend~~scalp tohair ~~maintain~~follicles, ~~our~~suggesting ~~technological~~that ~~differentiation~~inhibition ~~through~~of ~~continued~~prolactin ~~investment~~receptor in(PRLR) ~~our~~signaling ~~team~~may ~~and~~influence ~~platform~~hair ~~technologies.~~follicle Wecycling ~~expect~~and topigmentation. ~~continue~~ABS-201 is designed to ~~grow~~target PRLR and ~~maintain~~inhibit anPRLR ~~integrated~~signaling. ~~team~~We ofbelieve ~~subject~~this ~~matter~~mechanism ~~experts~~may inrepresent AIa ~~and~~potential ~~drug~~therapeutic ~~creation,~~approach ~~thereby~~for ~~bolstering~~the ~~our~~treatment ~~capabilities~~of inAGA. ~~areas~~By ~~such~~inhibiting asPRLR ~~disease biology~~signaling, ~~molecular~~ABS-201 ~~sciences,~~is ~~protein~~intended ~~engineering,~~to ~~computational~~influence ~~drug~~the ~~design,~~balance ~~deep~~of ~~learning,~~hair ~~and~~follicle ~~AI.~~cycling Webetween ~~expect~~the tocatagen ~~grow~~(regression) and ~~enhance~~anagen ~~our~~(growth) ~~intellectual~~phases. ~~property~~Preclinical ~~portfolio~~data tosuggest ~~protect~~that ~~and~~PRLR ~~secure~~signaling ~~the~~may ~~value~~act upstream of ~~our~~DHT ~~innovations~~in pathways associated with hair growth and related signaling factors. WeIn addition, inhibition of PRLR signaling may ~~continue~~influence tohair ~~evaluate~~follicle ~~strategic~~stem cell dynamics and ~~synergistic~~hair ~~technology~~follicle ~~acquisitions~~function, which as depicted in the figure below, could contribute to ~~expand~~hair growth and ~~strengthen~~pigmentation; ~~our~~however, ~~capabilities~~these ~~and~~potential ~~deepen~~effects ~~our~~have ~~expertise~~not been demonstrated in ~~the~~any ~~aforementioned~~clinical ~~areas~~studies of ABS-201 to date.

Prolactin Screenshot 2026-03-10 at 3.42.11 PM.jpg

~~Enabling~~Preclinical ~~the~~human ~~Development~~ex ofvivo ~~New~~hair ~~Antibody~~follicle ~~Modalities:~~organ ~~Our~~culture ability to design, construct and rapidly screen large numbers of molecules enables us to evaluate billions of unique protein variants and increase the probability of finding the most promising product candidate. We design and optimize new-to-nature modalities driven by our AI models. We also harness the power of nature, using synthetic biology approaches with our E. coli SoluPro strains to create complex proteins and new modalities. Unlike other biologic drug discovery methods, we evaluate the variants of these desired proteins in the fully-constructed scaffold to enable creation of biologics while optimizing for target affinity. We believe that our platform will empower us and our partners to bring new and better biologic drugs to market.studies

~~Advancing~~We AIevaluated ~~Drug~~the ~~Creation~~proposed bymechanism ~~Leveraging~~of ~~Our~~action ~~Proprietary~~of ~~Data~~ABS-201 ~~and~~in ~~Generative~~a AIpreclinical ~~Capabilities:~~study ~~Our~~using AIhuman ~~models~~ex ~~learn~~vivo ~~and~~hair ~~improve~~follicle ~~with~~organ ~~each~~cultures ~~new~~derived ~~program~~from frontotemporal male scalp skin. WeThis ~~are~~area ~~enhancing~~of the ~~predictive~~scalp ~~power~~is ofknown ~~our~~to AIbe ~~models~~androgen-sensitive and most commonly affected by ~~training~~AGA. ~~our~~This ~~deep~~model ~~learning~~is ~~models~~a ~~with~~relevant ~~our~~preclinical ~~own~~translational ~~unique~~tool ~~multi-dimensional~~for ~~data~~assessing ~~sets.~~the ~~With~~biological ~~enough~~mechanisms ~~data~~underlying ~~and~~human ~~iterations,~~hair growth. In this study we ~~aim~~organ-cultured tomale ~~achieve~~scalp skin with ABS-201, or IgG control in ~~silico~~presence ~~creation~~or absence of ~~novel~~PRL ~~antibody~~for ~~therapeutics~~6 ~~with~~days ~~desired~~and ~~pharmacologic~~performed ~~attributes~~quantitative (immuno) histomorphometry analyses. ~~Moreover,~~ABS-201 ~~our~~blocked AIPRLR ~~models~~signaling, ~~are~~promoted the ~~link~~anagen ~~that~~phase ~~correlates~~of ~~business~~the ~~scale~~human ~~with~~hair ~~speed~~follicles, and ~~precision~~promoted hair shaft production. The ~~more~~study ~~data~~also wedemonstrated ~~generate,~~that ~~the~~ABS-201 ~~more~~protected ~~design~~and ~~campaigns~~expanded wethe ~~complete~~hair follicle niche, which is the ~~more~~local ~~our~~microenvironment AIin ~~models~~the ~~learn~~hair follicle that maintains and ~~advance,~~regulates ~~all~~hair offollicle ~~which~~stem wecells. ~~believe~~Importantly, ~~enables~~ABS-201 usalone to(without ~~create~~the ~~new~~addition ~~and~~of ~~better~~exogenous ~~antibody~~PRL) ~~therapeutics~~compared ~~against~~to ~~increasingly~~immunoglobulin ~~challenging~~control ~~targets.~~also demonstrated growth-promoting effects,

Competition

Absci is a data-first generative AI drug creation company with the mission to to design differentiated antibody therapeutics. Our Integrated Drug Creation platform comprises, in part, cutting edge generative AI models aimed at designing better antibody therapeutics, including against hard-to-drug targets and improves upon traditional biologic drug discovery by using AI to simultaneously optimize multiple drug characteristics important to development and therapeutic benefit. The market for technologies that enable biopharmaceutical research and development, such as ours, includes multiple categories of pharmaceutical and biotechnology industries where competitors are similarly working to address certain steps in target identification, biologic drug discovery, or adjacent aspects of the broad process, including:

•in the field of AI-guided drug design and discovery, we may face competition from companies attempting to use AI to design novel biologic drugs such as Generate Biomedicines, Inc., and Xaira Therapeutics, Inc., among others. In addition, we may face competition in the future from companies currently offering adjacent technology (e.g. AI-enabled small molecule design) that may seek to develop antibody design capabilities, such as Recursion Pharmaceuticals, Inc., Relay Therapeutics, Inc., Isomorphic Labs Limited, and Schrodinger, Inc., among others. Moreover, other pharmaceutical and biotechnology companies seeking to develop AI capabilities for biologic drug design may also pose competition;

•in the field of novel target identification, we may face competition from academic, pharmaceutical, and biotechnology research initiatives, as well as from private and publicly traded companies focused on novel methods for target identification, including GV20 Therapeutics, Alchemab Therapeutics, and 3T Biosciences, Inc., however, in some cases we may collaborate with such companies if synergies with our Integrated Drug Creation platform are identified;

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Inindicating ~~the~~neutralization ~~broader field~~ of ~~antibody~~intrafollicular ~~therapeutics,~~PRL. weAs ~~may~~shown ~~face~~in ~~competition~~the ~~from~~graphic ~~pharmaceutical~~below, ~~and~~ABS-201 ~~biotechnology~~was ~~companies~~shown ~~that~~to ~~are~~prolong ~~developing~~anagen ~~therapeutics~~and ~~that~~inhibit ~~address~~catagen ~~the same disease targets~~ and~~/or~~ ~~indications~~stimulate ~~addressed~~hair bymatrix ~~our internally developed programs, including:~~proliferation.

~~•several~~Key ~~companies~~preclinical ~~with~~findings ~~product~~demonstrated ~~candidates~~hair ~~targeting~~growth ~~TL1A~~activity of ABS-201 in ~~clinical~~human ~~development~~ex ~~for~~vivo ~~the~~hair ~~treatment~~follicle oforgan ~~IBD,~~culture ~~including~~with ~~Merck’s~~the ~~MK-7240,~~potential ~~Roche/Roivant’s~~to ~~RVT-3101,~~reverse ~~Sanofi/Teva’s~~miniaturization ~~TEV-48574~~by ~~TL1A,~~facilitating ~~Spyre’s~~vellus ~~SPY002,~~to ~~and~~terminal ~~Xencor’s~~hair ~~XmAb942;~~follicle ~~and~~reconversion include:

•~~Hope~~ABS-201 ~~Medicine’s~~prolonged ~~product~~the ~~candidate~~anagen ~~targeting~~(growth) ~~PRLR~~phase inof ~~clinical~~the ~~development~~hair ~~for~~cycle and inhibited the ~~treatment~~transition ofto ~~androgenic~~catagen ~~alopecia~~(regression) phase.

~~For~~•ABS-201 aincreased ~~discussion~~key ofhair ~~the~~growth ~~risks~~factors welike ~~face~~IGF1 ~~relating~~and toFGF7 competition, see “Risk Factors—Risks Related to Biologic Drug Development—We face competition from entities that have made substantial investments into the rapid development of novel treatments for the therapeutic indications in which wesupport ~~are~~follicle ~~engaged~~viability ~~in partnered programs~~ and ~~internally~~follicle ~~developed~~growth, ~~programs~~respectively, ~~including large~~ and ~~specialty~~promoted ~~pharmaceutical~~proliferation ~~and~~of ~~biotechnology~~hair ~~companies”~~matrix keratinocytes.

~~Human~~•ABS-201 ~~Capital~~protected and expanded the hair follicle stem cell niche by preventing the death of K15+ stem cells involved in follicle regeneration and restoring CD34+ progenitors that activate hair follicle stem cells.

~~Our~~•ABS-201 ~~employees,~~increased ~~who~~hair wequality ~~refer~~by tostimulating askeratin ~~“Unlimiters”,~~production ~~are~~independent ~~essential~~of tothe ~~our~~hair ~~ability to achieve our mission to design differentiated antibody therapeutics~~cycle.

~~Our~~Preclinical ~~corporate~~mouse ~~values guide both our daily decision-making and our long-term cultural development, setting the tone for how we work together with a focus on respect for patients, diversity, and community:~~ study

•We ~~believe~~evaluated ABS-201 in a preclinical study for short term hair growth in female mice. Up to 11 mice per group were shaved until the ~~impossible~~skin was visible, then randomized into treatment groups based on skin color and initial body weight. Hair growth scores were recorded twice weekly using a predefined scale. ABS-201 isotype control (both biweekly i.p.) and 5% daily topical minoxidil were compared to untreated animals. ABS-201 significantly increased hair regrowth compared to minoxidil and corresponding controls in this short-term

•We are one team with one finish line

•We deliver results

•We innovate because lives depend on it

•We embrace our differences

•We do the right thing

We have integrated our values into our people processes, including performance management, the candidate selection and employee promotion processes, and recognition. Incorporating these values into our culture enables our people to translate ideas into impact as we strive to create a better, faster path to new medicines. Collectively and individually we are defying conventions and disrupting the biopharmaceutical industry with bold ideas and passionate pursuit of new possibilities.

As of December 31, 2024, we had 157 employees, of which 156 were full-time employees, many of whom have advanced post-graduate degrees.

To facilitate talent attraction and retention, we strive to make Absci an inclusive, safe, and attractive workplace with opportunities to grow, develop, and connect, supported by competitive compensation and benefits, as well as social, community, health and well-being programs.

Compensation and benefits: Our compensation philosophy is designed to establish and maintain a fair and flexible compensation program that attracts and rewards talented individuals who possess the skills necessary to support our mission, drive achievement of company and individual goals and create long-term value for our stockholders. We provide employees with competitive cash compensation, an all employee equity program, and a wide range of benefits. Our short-term incentive or cash bonus program is designed to recognize and reward achievement of company goals and individual performance. Individual performance is measured by delivery of results and impact and demonstration of our corporate values. The principal purposes of our equity plans are to attract, retain, and motivate employees, consultants and directors through the granting of stock-based compensation awards that align the interests of our employees with our stockholders. All full-time employees receive an equity grant upon hire and are eligible for annual equity grants thereafter. Our employee benefits may vary by country and generally include an employee stock purchase plan, healthcare benefits for employees and their families, life and disability insurance, unlimited vacation, parental leave, retirement contributions, referral bonuses, access to mental health resources, wellness programs, and onsite services;

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~~Training~~hair ~~and~~regrowth ~~development:~~model ~~We offer a number of educational resources and development opportunities with emphasis on internal mobility and fair and equitable talent practices~~(p<0. ~~Employees take advantage of live courses~~0001), ~~leadership~~achieving ~~programs,~~full ~~online~~hair ~~training,~~growth ~~team~~after ~~building~~22 ~~events~~days, ~~seminars,~~whereas ~~conferences,~~minoxidil ~~lectures,~~achieved ~~university~~only ~~programs,~~approximately ~~peer~~one-~~to-peer~~third ~~and~~hair ~~leadership-guided~~growth ~~training,~~in ~~and other learning opportunities across~~ the ~~company.~~same ~~All Unlimiters are eligible for an annual monetary stipend for continuing education and career development. Additionally~~period, weas ~~have~~shown ain ~~paid internship program that offers university or graduate students real-world experience and~~ the ~~chance~~figure ~~to work with our extraordinary people, while helping Absci identify and develop the next generation of Unlimiters~~below.

Mouse study Screenshot 2026-03-10 at 3.44.18 PM.jpg

~~Ethics~~Evidence ~~and~~from ~~compliance:~~external We have adopted and regularly review the Code of Business Conduct and Ethics (the Code) to aid our directors, officers and employees in making ethical and legal decisions when conducting business and performing day-to-day duties. All directors, officers and employees are required to review and sign an acknowledgment regarding the Code and to agree on an annual basis to comply with the Code. We have established a reporting hotline and web form that enables employees to anonymously report any suspected violations of the Code, and we have a strict non-~~retaliation~~human ~~policy~~primate ~~for all claims brought forward in good faith.~~study

~~Communication~~In ~~and employee engagement: We employ~~ a ~~variety~~published ofpreclinical ~~tools~~study toconducted ~~facilitate~~in ~~open~~aged ~~and~~stump-tailed ~~direct~~macaques, ~~communication~~treatment ~~including open forums~~ with ~~executives,~~a ~~employee~~prolactin ~~surveys~~receptor ~~and~~antibody ~~engagement~~was ~~through~~associated ~~company-~~with ~~and~~stimulation ~~employee-led~~of ~~groups~~hair ~~and~~growth, ~~committees.~~nearly ~~Our~~doubling ~~campuses~~the ~~are~~number ~~intentionally~~of ~~designed~~terminal tohairs ~~create~~after asix ~~space~~months ~~for~~even ~~collaboration~~in ~~and~~previously ~~connection.~~fully Webald ~~hold~~areas ~~company wide meetings monthly~~ and ~~regularly~~showing ~~schedule~~a ~~time~~sustainable ~~for~~impact ~~our~~even ~~colleagues~~after tofour ~~connect.~~years ~~We appraise and refine our employee programs through our company pulse surveys~~post-treatment. ~~Our~~Notably, ~~annual~~the ~~employee engagement survey process utilizes a third~~stump-~~party~~tail ~~survey~~macaque ~~tool,~~model ~~and~~is weconsidered ~~supplement~~to ~~this~~be ~~process~~a ~~with~~predictive ~~periodic~~animal ~~pulse~~model ~~surveys~~for tomale ~~help us gauge ongoing progress~~ and ~~employee~~female ~~sentiment.~~pattern ~~The~~hair ~~senior~~loss ~~leadership~~in ~~team continues to identify key initiatives that tie directly back to employee feedback to further increase employee engagement~~humans.

~~Diversity,~~Preclinical ~~equity,~~toxicology inclusion and belonging (DEIB): Our vision is to deliver breakthrough therapeutics that address unmet medical needs for broad and diverse patient populations. Achieving that vision isn’t possible unless we have a diverse and talented team and unless we live in a diverse and equitable world, where everyone can benefit from the potentially life-changing therapeutics we’re creating. We are committed to building a team with a variety of backgrounds, skills and perspectives. We encourage grassroots efforts by our employees. We continue to evolve and advance our DEIB efforts. We believe that inclusiveness helps drive innovation and increases our understanding of the diverse group of patients we seek to benefit.studies

~~Health,~~ABS-201 ~~safety,~~was well~~-being:~~ Wetolerated ~~are~~in ~~committed~~GLP-compliant torepeat-dose ~~promoting~~toxicology ~~the~~studies ~~health,~~in ~~safety,~~rats and ~~well-being~~cynomolgus ~~of our employees~~monkeys. ~~Our~~Across ~~Employee~~the ~~Safety~~4-week ~~Committee~~rat isstudy ~~comprised~~and ofthe ~~cross~~4-~~departmental~~week ~~members~~ and ~~meets~~26-week ~~regularly~~nonhuman toprimate ~~review~~studies, ~~workplace~~no ~~safety~~findings ~~and~~of ~~adherence~~human torelevance ~~safety~~were ~~policies.~~observed ~~We require annual workplace safety training to reinforce workplace safety procedures that may be useful~~ in ~~the~~both ~~event~~species ofup ~~emergency situations and~~ to ~~assist~~600 ~~our employees in helping to prevent workplace accidents. We have numerous employees with current first aid~~mg/kg, ~~CPR,~~the ~~and~~highest ~~AED~~dose ~~certifications for emergency preparedness~~tested.

Intellectual Property

We strive to protect and enhance the proprietary technology, inventions, know-how and improvements that we believe are commercially important to our business by seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties, that cover our Integrated Drug Creation platform, as well as our internally developed programs. We also rely on trade secret protection and confidentiality agreements to protect our proprietary technologies and know-how to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. We also endeavor to continue to innovate and seek in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of AI-guided drug creation. Our success will depend significantly on our ability to obtain and maintain patent and other proprietary protection for our technology, our ability to defend and enforce our intellectual property rights and our ability to operate without infringing any valid and enforceable patents and proprietary rights of third parties. We also protect the integrity and confidentiality of our data, know-how and trade secrets by maintaining physical security of our premises and physical and electronic security of our information systems.

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~~discovery,~~Clinical internally developed programs (such as composition of matter, method of use etc.), and technology relevant to our proprietary assays, cell lines and expression technology. Overall, our intellectual property estate includes 79 issued or granted patents and 159 pending patent applications worldwide, which includes ten issued U.S. patents and 24 pending regular U.S. patent applications. We also have granted patents in the EU, Australia, Japan, Canada, China, Hong Kong, Israel, Mexico and South Korea. This number does not include provisional applications we have filed. Our patents and patent applications, if issued, are expected to expire between August 2033 and December 2044, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.Trials

AsIn of December ~~31,~~ ~~2024~~2025, we ~~owned~~initiated ~~registered~~a ~~trademarks~~Phase ~~for~~1/2a ~~Absci~~clinical trial of ABS-201, ~~our~~referred ~~stylized~~to ~~“A”~~as ~~mark,~~HEADLINE™ ~~Bionic~~(NCT07317544). ~~SoluPro~~This trial is designed to evaluate the safety, ~~SoluPro~~tolerability and ~~SoluPure~~preliminary efficacy of ABS-201 in ~~the~~healthy ~~United~~volunteers ~~States~~with and without AGA. The trial is a randomized, asdouble-blind, ~~well~~placebo-controlled asstudy ~~nineteen~~expected ~~trademark~~to ~~registrations~~enroll inup ~~other~~to ~~jurisdictions~~227 male and female healthy volunteers at multiple sites in Australia.

In December 2025, the first participant was dosed in the HEADLINE clinical trial. As of March 24, 2026, the first three single ascending dose (SAD) cohorts were fully enrolled and dosed, with eight healthy volunteers in each cohort. Enrollment of the fourth SAD cohort, which is expected to include eight healthy volunteers, is ongoing. We currently expect to initiate three multiple ascending dose (MAD) cohorts in the second quarter of 2026, each planned to enroll approximately 49 healthy volunteers with AGA.

This clinical trial is primarily designed to evaluate the safety and tolerability of ABS-201 in healthy volunteers with and without AGA and includes exploratory analyses that may inform preliminary assessments of efficacy. Primary endpoints include the incidence of treatment-emergent adverse events, changes in clinical laboratory parameters, vital signs, electrocardiogram assessments and injection-site reactions. Secondary endpoints include pharmacokinetic/pharmacodynamic parameters, immunogenicity assessments and exploratory efficacy measures related to hair growth. The planned MAD cohort sample size is large enough to detect a nominally significant difference in target area hair count between the ABS-201 and placebo groups. However, such an analysis would not be multiplicity-adjusted and report only nominal p-values, consistent with its exploratory nature. We currently expect to report interim safety and tolerability data in the first half of 2026. Additional interim analyses, including evaluation of exploratory efficacy endpoints, are currently expected in the second half of 2026. The complete proof-of-concept data is anticipated in early 2027, with one-year safety follow-up data expected later in 2027. We believe that an antibody-based therapeutic like ABS-201, with a favorable safety profile, meaningful and durable hair growth combined with a convenient administration profile, if successfully developed and approved, could represent a potentially new category of treatment: a biologic therapy for hair loss.

ABS-201 for the Treatment of Endometriosis

Epidemiological Overview

Endometriosis is a chronic, estrogen-dependent, inflammatory disease defined by endometrial-like lesions found outside the uterus and is prevalent in up to 10% of reproductive age women worldwide. Pain is the most common symptom of endometriosis and can be chronic or “cyclical,” meaning that the sensation of pain worsens before and during the period.

Endometriosis may be diagnosed based on patient history, physical examination, and/or imaging findings. Definitive diagnosis, however, typically requires surgical visualization and biopsy of suspected endometriosis lesions. Endometriosis is diagnosed in 12–32% of women having surgery for pelvic pain, and in up to 50% of women having surgery for infertility. Access to early diagnosis is limited in many settings and the average time to diagnosis is between 4 and 12 years. Endometriosis remains underdiagnosed, which is predicted to improve if better treatments are developed. Current therapeutic options are limited and there are currently no disease modifying therapeutics approved by the FDA for the treatment of endometriosis.

Mechanism of action

Published literature suggests that PRL and PRLR may play a role in the development of endometrial lesions and associated pain in patients with endometriosis. PRL and PRLR expression has been reported to be elevated in endometrial tissue from patients with endometriosis, and prolactin signaling has been associated with processes involved in lesion growth, inflammatory signaling and pain pathways. Based on these observations, inhibition of PRLR signaling may influence pathways associated with lesion development and pain perception. As a result, ABS-201 may have the potential to affect both lesion growth and pain-related pathways. Because prolactin signaling is independent of sex-hormone pathways, targeting PRLR may represent a non-hormonal therapeutic approach; however, the safety and efficacy of ABS-201 for the treatment of endometriosis have not been established.

Preclinical mouse study

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In an endometriosis mouse model, we were able to show that ABS-201 decreased overall pain experience. This effect was observed across both spontaneous and evoked pain measures in a homologous transplant mouse model of endometriosis, where animals treated with ABS-201 showed significantly increased locomotion (a surrogate for reduced non-evoked pain) compared to control treated animals, as shown in the graphic below, and improved mechanical withdrawal thresholds in Von Frey testing compared to control treated animals. These functional improvements were accompanied by reductions in inflammatory cytokines, including TNFα, IL-1β, and CCL2 in peritoneal fluid, supporting a link between prolactin receptor blockade, decreased inflammation, and reduced pain behavior.

Clinical Trials

We intend to evaluate, and if possible, rely on the data generated from the HEADLINE trial, together with other available information, as part of our assessment of potential next steps for the ABS-201 program. We believe that this study will provide supporting first-in-human safety, tolerability, and PK data to support a Phase 2 clinical trial evaluating ABS-201 in patients with endometriosis. Based on these and other considerations, we anticipate initiating a Phase 2 clinical trial evaluating ABS-201 in endometriosis in the fourth quarter of 2026, subject to review of available data, regulatory considerations and other factors, with potential proof-of-concept data in the second half of 2027.

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ABS-101

ABS-101 is in development as a potential treatment for Inflammatory Bowel Disease (IBD). In May 2025, we initiated a Phase 1 clinical trial in healthy volunteers. Despite a favorable early safety profile and not withstanding positive interim Phase 1 results as announced in November 2025, we made the strategic decision to prioritize ABS-201 in the development of AGA and endometriosis where there are significant unmet medical needs and greater potential return on investment. As such, we will seek a partner for ABS-101 rather than advance it through later-stage development ourselves, including a partnership focused on exploring a potential first-in-class indication outside of IBD.

Preclinical Stage Programs

We are advancing early-stage oncology and immunology and inflammation programs, which include ABS-301, a potential first-in-class oncology asset discovered through our reverse immunology platform and ABS-501, a potentially differentiated HER2 program. We continue to use our platform to develop additional early-stage programs addressing challenging targets in various indications with areas of significant unmet medical need. We plan to provide more information about these additional programs selectively and to seek partnerships or out-licenses for select programs as they advance.

Competition

Internally developed programs

We may face competition from pharmaceutical and biotechnology companies that are developing therapeutics that address the same disease targets and/or indications addressed by our internally developed programs. Competitors may obtain FDA or other regulatory approval for their products more rapidly or earlier than us, which could result in our competitors establishing a strong market position before we are able to enter the market. Competition for our active internally developed programs may include:

•ABS-201 in AGA: Existing FDA-approved treatments for AGA include oral minoxidil, oral finasteride, oral dutasteride, and topical minoxidil, which are currently established as standard of care despite their limitations. We are aware of several drug candidates that are in clinical development for AGA including Hope Medicine’s HMI-115, Veradermics’ VDPHL01, Pelage Pharmaceuticals’ PP405, and Cosmo Pharmaceuticals’ Clascoterone.

•ABS-201 in Endometriosis: Newer development candidates for non-hormonal antibody-based therapies for endometriosis currently include Hope Medicine’s HMI-115, Chugai Pharmaceuticals’ AMY-109, and GenSci’s Genakumab as well as other non-antibody-based clinical trials focused on non-hormonal pain treatments.

•ABS-101: There are several companies with product candidates targeting TL1A in clinical development for the treatment of IBD, including Merck’s MK-7240, Roche/Roivant’s RVT-3101, Sanofi/Teva’s TEV-48574 TL1A, Spyre’s SPY002, AbbVie’s ABBV-701, and Xencor’s XmAb942. Beyond the competitors for IBD, there will be additional competitors for the indications outside of IBD that we or a potential partner may explore.

Integrated Drug Creation platform

Our Integrated Drug Creation platform comprises, in part, cutting edge generative AI models aimed at designing differentiated antibody-based therapeutics, including against hard-to-drug targets. There are multiple potential competitors developing technologies that seek to improve target identification and drug design or discovery.

More specifically, in the field of AI-based drug design and discovery we may face competition from companies attempting to use AI to design therapeutics. Representative examples include Generate Biomedicines, Inc. and Xaira Therapeutics, Inc., among others. In the future we may face competition from companies currently offering adjacent technology (e.g. AI-enabled small molecule design) that may seek to develop antibody design capabilities. Representative examples include Recursion Pharmaceuticals, Inc., and Isomorphic Labs Limited, among others. Moreover, other pharmaceutical and biotechnology companies seeking to develop AI capabilities for biologic drug design may also pose competition.

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We also face competition from entities that have made substantial investments in developing treatments for the therapeutic indications which our internal programs and partnered programs target. These competitors may include large and specialty pharmaceutical and biotechnology companies.

For a discussion of the risks we face relating to competition, see “Risk Factors—Risks Related to Biologic Drug Development”.

Intellectual Property

We have a broad intellectual property estate that includes numerous patent families covering key aspects of our Integrated Drug Creation platform and internally developed programs which is intended to provide multiple layers of protection. These patent families encompass filings covering AI-guided drug design and discovery, internally developed programs (such as composition of matter, method of use etc.), and technology relevant to our proprietary assays, cell lines and expression technology. Overall, our intellectual property estate includes 69 issued or granted patents and 53 pending patent applications worldwide, which includes 12 issued U.S. patents and 20 pending regular U.S. patent applications. We also have granted patents in the EU, Australia, Japan, Canada, China, Hong Kong, Israel, Mexico and South Korea, as well as other countries. Our patents and patent applications, if issued, are expected to expire between August 2033 and December 2045, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.

As of December 31, 2025, we owned registered trademarks and service marks to Absci’s stylized A logo, Absci®, SoluPro®, Bionic SoluPro®, and Unlimit with us® (design). We also use various other trademarks, service marks and trade names in our business, including but not limited to, the Absci AI logo mark, IgDesign, Translating Ideas into Drugs, Integrated Drug Creation, Creating drugs at the speed of Ai, and Denovium.

In addition to patent and trademark protection, we also utilize other forms of intellectual property protection, including copyright, internal know-how and trade secrets, when such other forms are better suited to protect a particular aspect of our intellectual property position. For example, our trade secrets encompass certain algorithms associated with our AI-guided drug creation deep learning AI models, our computational antibody and target discovery technology, manufacturing protocols for our E. coli SoluPro strains, libraries of protein folding solutions and design of molecular libraries for drug discovery. We believe our proprietary rights are strengthened by our comprehensive approach to intellectual property protection. It is our policy to require our employees, consultants, advisors and other independent contractors to execute confidentiality and invention assignment agreements upon accepting employment, consulting or similar relationships with us. These agreements provide that all confidential information concerning our business or financial affairs developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. We also take precautions through the use of security measures to prevent the release of our proprietary information to third parties.

Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees, consultants, advisors and other independent contractors, these agreements may be breached and we may not have adequate remedies for any breach. In addition, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology. As a result, we may not be able to meaningfully protect our trade secrets and other proprietary technology. For a discussion of the risks we face relating to intellectual property, see “Risk Factors—Risks Related to our Intellectual Property.”

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meaningfully protect our trade secrets and other proprietary technology. For a discussion of the risks we face relating to intellectual property, see “Risk Factors—Risks Related to our Intellectual Property.”

Environmental, Social and Governance (ESG)

We are integrating ESG considerations into our business strategy as we continue to grow. The Nominating and Corporate Governance Committee of the Board (the “Committee”) oversees and coordinates with the Board and its other committees the periodic review of corporate responsibility and ESG matters pertaining to the Company, which may include the evaluation of industry practices, investor views, reputational impact, legal standards, and overall risks and benefits of ESG initiatives, as well as public reporting on these matters.

Government Regulation

Regulations Related to the Discovery, Development, Approval and Commercialization of Biotherapeutics

Our focus is on the use of our Integrated Drug Creation platform to enable us and our partners to improve the speed and success of biologic product discovery and development efforts. As such, we are subject to a number of regulations, such as those governing our laboratory facilities as well as regulations that ordinarily apply to companies in the life sciences, biotechnology and pharmaceutical sectors and industries. We believe that the long-term success of our business depends, in part, on our, and our current or future partners’ ability to successfully develop and sell products identified and created through our platform technology.

Government authorities in the United States, at the federal, state and local level, and in the European Union and other countries and jurisdictions, extensively regulate, among other things, the research, clinical development, testing, manufacturing, quality control approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of pharmaceutical products, including biological products such as those that we or our partners develop. The processes for obtaining marketing approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources. If we or our partners fail to comply with applicable laws or regulations at any time, we or our partners may become subject to administrative or judicial sanctions or other legal consequences, including among other things, restrictions on marketing or manufacturing, withdrawal of products, product recalls, fines, warning letters, untitled letters, clinical holds on clinical studies, refusal of the FDA to approve pending applications or supplements to approved applications, suspension or revocation of product approvals, product seizure or detention, refusal to permit the import or export of products, consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs, mandated modification of promotional materials, issuance of safety alerts, Dear Healthcare Provider letters, injunctions or the imposition of civil or criminal penalties.

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develop. The processes for obtaining marketing approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources. If we or our partners fail to comply with applicable laws or regulations at any time, we or our partners may become subject to administrative or judicial sanctions or other legal consequences, including among other things, restrictions on marketing or manufacturing, withdrawal of products, product recalls, fines, warning letters, untitled letters, clinical holds on clinical studies, refusal of the FDA to approve pending applications or supplements to approved applications, suspension or revocation of product approvals, product seizure or detention, refusal to permit the import or export of products, consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs, mandated modification of promotional materials, issuance of safety alerts, Dear Healthcare Provider letters, injunctions or the imposition of civil or criminal penalties.

We or our partners must obtain the requisite approvals from the applicable regulatory authority prior to the commencement of clinical studies or marketing of a biological product in those countries. The requirements and process governing the conduct of clinical trials, product licensing, coverage, pricing and reimbursement vary from country to country. In the United States, biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other federal, state, local and foreign statutes and regulations. The process required by the FDA before biologics may be marketed in the United States generally involves the following:

•completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s applicable good laboratory practices regulations (GLP);

•submission to the FDA of an application for an IND, which must become effective before clinical trials may begin;

•approval of the protocol and related documentation by an independent institutional review board (IRB), or ethics committee at each clinical site before each trial may be initiated;

•performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practices (GCPs), and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;

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•preparation of and submission to the FDA of a biologics license application (BLA), for marketing approval that includes sufficient evidence of establishing the safety, purity, and potency of the proposed biological product for its intended indication, including from results of nonclinical testing and clinical trials;

•satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with current good manufacturing practices (cGMPs), to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity;

•potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA;

•review of the product candidate by an FDA advisory committee, where appropriate and if applicable;

•payment of user fees for FDA review of the BLA (unless a fee waiver applies); and

•FDA review and approval of the BLA, resulting in the licensure of the biological product for commercial marketing.

We intend to selectively create our own product candidates and to advance such product candidates to certain value inflection points, anywhere from preclinical validation through clinical development to clinical proof of concept in humans trials with requisite cGMP manufacturing scale-up.

Preclinical and Clinical Development

Before testing in humans, a product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluations of drug chemistry, formulation and stability, as well as in vitro and animal studies to assess safety and in some cases to establish the rationale for therapeutic use. The conduct of preclinical studies is subject to applicable federal/national, supranational, state and local level regulations and requirements, including GLP, requirements for safety/toxicology studies. The results of the preclinical studies, together with manufacturing information and analytical data, must be submitted to the FDA as part of an IND or to a foreign regulatory authority through a comparable application, such as a clinical trial application (CTA). An IND is a request for authorization from the FDA to administer an investigational new drug to humans. In the United States, an IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

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studies to assess safety and in some cases to establish the rationale for therapeutic use. The conduct of preclinical studies is subject to applicable federal/national, supranational, state and local level regulations and requirements, including GLP, requirements for safety/toxicology studies. The results of the preclinical studies, together with manufacturing information and analytical data, must be submitted to the FDA as part of an IND or foreign equivalent such as a clinical trial application (CTA). An IND is a request for authorization from the FDA to administer an investigational new drug to humans. In the United States, an IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under written trial protocols detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for subsequent protocol amendments. Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed. Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may recommend halting the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries.

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For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

•Phase 1—The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

•Phase 2—The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

•Phase 3—The investigational product is administered to an expanded patient population to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval and product labeling.

In some cases, the FDA may require, or firms may voluntarily pursue, post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up. During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical trial investigators.

Concurrent with clinical trials, companies usually complete additional animal studies and also must develop additional information about the chemistry and physical characteristics of the biological product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP. To help reduce the risk of the introduction of adventitious agents with use of biological products, the Public Health Service Act emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

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defined. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final biological product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical study investigators. Progress reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected suspected adverse events, findings from other studies suggesting a significant risk to humans exposed to the biologic, findings from animal or in vitro testing that suggest a significant risk for human subjects, and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.

The FDA, the sponsor or the IRB may suspend a clinical study at any time on various grounds, including a finding that the research patients or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the IRB’s requirements or if the biological product candidate has been associated with unexpected serious harm to patients. Additionally, if the trial is being overseen by a data safety monitoring board or committee, this group may recommend halting the clinical trial if it determines that there is an unacceptable safety risk for subjects or on other grounds, such as interim data suggesting a lack of efficacy.

Biologics License Application (BLA) Submission and Review

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, preclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product candidate for one or more indications. The BLA must include all relevant data available from preclinical studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product candidate’s chemistry, manufacturing, controls, and proposed labeling, among other things. Under the Prescription Drug User Fee Act (PDUFA), as amended, each BLA must be accompanied by a significant application user fee to the FDA, unless a waiver or exemption applies, which is adjusted on an annual basis. The FDA has sixty days from the applicant’s submission of a BLA to either issue a refusal to file letter or accept the BLA for filing, indicating that it is sufficiently complete to permit substantive review. The FDA has substantial discretion in the approval process and may refuse to accept any application or decide that the data is insufficient for approval, and may require additional preclinical, clinical or other studies before it accepts the filing.

Once a BLA has been accepted for filing, the FDA’s goal is to review standard applications within ten months after it accepts the application for filing, or, if the application qualifies for priority review, six months after the FDA accepts the application for filing. In both standard and priority reviews, the review process may be significantly extended by FDA requests for additional information or clarification. The FDA reviews a BLA to determine, among other things, whether a product candidate is safe, pure and potent for its intended use, and whether the facility in which it is manufactured, processed, packed or held meets standards designed to assure and preserve the product’s identity, safety, strength, quality, and purity. The FDA may convene an advisory committee, typically a panel that includes clinicians and other experts, to provide clinical insight on applications which present difficult questions of safety or efficacy and to review, evaluate and recommend whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. 24

Before approving a BLA, the FDA will conduct a pre-approval inspection of the facility or facilities where the product is manufactured to determine whether the facilities comply with cGMPs. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically audit data from clinical trials to ensure compliance with GCPs. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional

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~~testing~~candidate’s chemistry, manufacturing, controls, and proposed labeling, among other things. Under the Prescription Drug User Fee Act (PDUFA), as amended, each BLA must be accompanied by a significant application user fee to the FDA, unless a waiver or ~~information~~exemption applies, which is adjusted on an annual basis. ~~Notwithstanding~~The FDA has sixty days from the applicant’s submission of ~~any~~a ~~requested~~BLA ~~additional~~to ~~information,~~either issue a refusal to file letter or accept the ~~FDA~~BLA ~~ultimately~~for ~~may~~filing, ~~decide~~indicating that it is sufficiently complete to permit substantive review. The FDA has substantial discretion in the approval process and may refuse to accept any application ~~does~~or ~~not~~decide ~~satisfy~~that the ~~regulatory~~data ~~criteria~~is insufficient for approval, and may require additional preclinical, clinical or other studies before it accepts the filing.

After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be manufactured, the FDA may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the application will not be approved in its present form. A Complete Response Letter usually describes all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the Complete Response Letter without first conducting required inspections, testing submitted product lots and/or reviewing proposed labeling. In issuing the Complete Response Letter, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information or clarification, which may include the potential requirement for additional clinical studies and/or other significant and time-consuming requirements related to preclinical studies and manufacturing. If a Complete Response Letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, withdraw the application or request a hearing. Even if such data and information is submitted, the FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

If regulatory approval of a product is granted, such approval will be granted for a particular indication(s) and may entail limitations on the indicated uses for which such product may be marketed. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling or may condition the approval of the BLA on other changes to the proposed labeling, development of adequate controls and specifications, or a commitment to conduct post-market testing or clinical trials and surveillance to monitor the effects of approved products. The FDA may also place other conditions on approvals including the requirement of a Risk Evaluation and Mitigation Strategy (REMS), to assure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.

~~Expedited Development and Review Programs~~ 25

The FDA offers a number of expedited development and review programs for qualifying product candidates. The fast track program is intended to expedite or facilitate the process for reviewing new product candidates that meet certain criteria. Specifically, product candidates are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the disease or condition. Fast track designation applies to the combination of the product and the specific indication for which it is being studied. A sponsor may request fast track designation of a product candidate concurrently with, or at any time after, submission of an IND, and the FDA must determine if the product candidate qualifies for such designation within 60 day of receipt of the sponsor’s request. The sponsor of a fast track product has opportunities for frequent interactions with the FDA review team during product development and, once a BLA is submitted, the product may be eligible for priority review. A fast track product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

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restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.

Expedited Development and Review Programs

The FDA offers a number of expedited development and review programs for qualifying product candidates. The fast track program is intended to expedite or facilitate the process for reviewing new product candidates that meet certain criteria. Specifically, product candidates are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and nonclinical or clinical data demonstrate the potential to address areas of significant unmet medical needs for the disease or condition. Fast track designation applies to the combination of the product and the specific indication for which it is being studied. A sponsor may request fast track designation of a product candidate concurrently with, or at any time after, submission of an IND, and the FDA must determine if the product candidate qualifies for such designation within 60 day of receipt of the sponsor’s request. The sponsor of a fast track product has opportunities for frequent interactions with the FDA review team during product development and, once a BLA is submitted, the product may be eligible for priority review. A fast track product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if it is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. A sponsor may request that a product candidate be designated as a breakthrough therapy concurrently with, or at any time after, the submission of an IND, and the FDA must determine if the product candidate qualifies for breakthrough therapy designation within 60 days of receipt of the sponsor’s request. The benefits of breakthrough therapy designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product, including involvement of senior managers and experienced review staff in a cross-disciplinary review.

Any marketing application for a product candidate submitted to the FDA for approval, including a product candidate with a fast track designation and/or breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite the FDA review and approval process, such as priority review and accelerated approval. A product candidate is eligible for priority review if it has the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious disease or condition compared to available therapies. For original BLAs, priority review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date. The FDA will attempt to direct additional resources to the evaluation of an application for a new drug or biological product designated for priority review in an effort to facilitate the review.

Additionally, product candidates studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the product candidate generally provides a meaningful advantage over available therapies and demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate and well-controlled post-marketing clinical trials to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022 (FDORA), the FDA is now permitted to require, as appropriate, that such trials be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval. Sponsors are also required to send updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA must promptly post this information publicly. Under FDORA, the FDA has increased authority for expedited procedures to withdraw approval of a drug or indication approved under accelerated approval if, for example, the sponsor fails to conduct such studies in a timely manner and send the necessary updates to the FDA, or if a confirmatory trial fails to verify the predicted clinical benefit of the product. In addition, for products being considered for accelerated approval, the FDA generally requires, unless otherwise informed by the agency, that all advertising and promotional materials intended for dissemination or publication within 120 days of marketing approval be submitted to the agency for review during the pre-approval review period, which could adversely impact the timing of the commercial launch of the product.

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post-marketing clinical trials to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022 (FDORA), the FDA is permitted to require, as appropriate, that such trials be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval. Sponsors are also required to send updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA must promptly post this information publicly. Under FDORA, the FDA has increased authority for expedited procedures to withdraw approval of a drug or indication approved under accelerated approval if, for example, the sponsor fails to conduct such studies in a timely manner and send the necessary updates to the FDA, or if a confirmatory trial fails to verify the predicted clinical benefit of the product. In addition, for products being considered for accelerated approval, the FDA generally requires, unless the sponsor is otherwise informed by the agency, that all advertising and promotional materials intended for dissemination or publication within 120 days of marketing approval be submitted to the agency for review during the pre-approval review period, which could adversely impact the timing of the commercial launch of the product.

Fast track designation, breakthrough therapy designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process. Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Orphan Drug Designation and Exclusivity

Under the Orphan Drug Act, the FDA may grant orphan designation to a biological product candidate intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or 200,000 or more individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the United States a product for this type of disease or condition will be recovered from sales in the United States for that product. Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

23If a product candidate that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same product for the same approved use or indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity or if the holder of the orphan exclusivity cannot assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. Orphan exclusivity does not prevent the FDA from approving a different product for the same disease or condition, or the same product for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA application fee.

~~Table~~A designated orphan drug may not receive orphan exclusivity if it is approved for a use or indication that is broader than the indication for which it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of ~~Contents~~the product to meet the needs of patients with the rare disease or condition.

the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

If a product candidate that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same product for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity or if the holder of the orphan exclusivity cannot assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. Orphan exclusivity does not prevent the FDA from approving a different product for the same disease or condition, or the same product for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA application fee.

A designated orphan drug may not receive orphan exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Pediatric Trials and Exclusivity

Under the Pediatric Research Equity Act (PREA), a BLA or supplement to a BLA must contain data to assess the safety and efficacy of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA requires that a sponsor who is planning to submit a marketing application for a product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan (PSP), within sixty days of an end-of-Phase 2 meeting or as may be agreed between the sponsor and FDA. The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from nonclinical studies, early phase clinical trials, and/or other clinical development programs. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of data or full or partial waivers. Sponsors who conduct studies of their product candidate in children are eligible for pediatric exclusivity. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which attaches to the twelve-year exclusivity period for reference biologics, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial, provided that at the time pediatric exclusivity is granted there is not less than nine months of term remaining.

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from pediatric studies along with supporting information. The FDA and the sponsor must reach agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from nonclinical studies, early phase clinical trials, and/or other clinical development programs. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of data or full or partial waivers. Sponsors who conduct studies of their product candidate in children can be eligible for pediatric exclusivity. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which attaches to the twelve-year exclusivity period for reference biologics, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued “Written Request” for such a trial, provided that at the time pediatric exclusivity is granted there is not less than nine months of term remaining.

Post-Approval Requirements

Any products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims or changes of the site of manufacture, are subject to prior FDA review and approval. There also are continuing user fee requirements, under which the FDA assesses an annual program fee for each product identified in an approved BLA.

The FDA regulations require that products be manufactured in specific approved facilities and in accordance with cGMPs. Biological product manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs, which impose certain organizational, procedural and documentation requirements with respect to manufacturing and quality assurance activities. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMPs and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. BLA holders using contract manufacturers, laboratories or packagers are responsible for the selection and monitoring of qualified firms, and, in certain circumstances, qualified suppliers to these firms. These firms and, where applicable, their suppliers are subject to inspections by the FDA at any time, and the discovery of violative conditions, including failure to conform to cGMP, could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured, processed or tested by them. Manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.

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investigation and correction of any deviations from cGMPs and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. BLA holders using contract manufacturers, laboratories or packagers are responsible for the selection and monitoring of qualified firms, and, in certain circumstances, qualified suppliers to these firms. These firms and, where applicable, their suppliers are subject to inspections by the FDA at any time, and the discovery of violative conditions, including failure to conform to cGMP, could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured, processed or tested by them. Manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

a.restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls;

b.fines, warning or untitled letters or holds on post-approval clinical studies;

c.refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;

d.product seizure or detention, or refusal of the FDA to permit the import or export of products;

e.consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

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f.mandated modification of promotional materials and labeling and the issuance of corrective information;

g.the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or

h.injunctions or the imposition of civil or criminal penalties.

The FDA closely regulates the marketing, labeling, advertising and promotion of biological products. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. However, companies may share truthful and not misleading information that is otherwise consistent with a product’s FDA approved labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict a manufacturer’s communications on the subject of off-label use of their products.

U.S. Patent Term Restoration

Depending upon the timing, duration and specifics of the FDA approval of the use of our biological product candidates, some of our U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of a BLA plus the time between the submission date of a BLA and the approval of that application. Only one patent applicable to an approved biological product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. In addition, a patent can only be extended once and only for a single product. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we may intend to apply for restoration of patent term for one of our patents, if and as applicable, to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.

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from the product’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of a BLA plus the time between the submission date of a BLA and the approval of that application. Only one patent applicable to an approved biological product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. In addition, a patent can only be extended once and only for a single product. The U.S. Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we may intend to apply for restoration of patent term for one of our patents, if and as applicable, to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.

Biosimilars and Reference Product Exclusivity

The Affordable Care Act of 2010 (ACA) includes a subtitle called the Biologics Price Competition and Innovation Act (BPCIA), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-approved reference biological product. This amendment to the Public Health Service Act attempts to minimize duplicative testing. Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. “First licensure” typically means the initial date the particular product at issue was licensed in the United States. This does not include a supplement for the biological product or a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or other related entity) for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength, unless that change is a modification to the structure of the biological product and such modification changes its safety, purity, or potency. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products.

~~Foreign Regulation~~29

InTable ~~order to market any product outside~~ of the United States, we would need to comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding quality, safety, and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions. Although many of the issues discussed above with respect to the United States apply similarly in the context of the European Union, the approval process varies between countries and jurisdictions and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others.Contents

this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products.

Government Regulation Outside the United States

In addition to regulations in the United States, we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical studies and any commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical studies or marketing of the product in those countries. Certain countries outside of the United States have a similar process that requires the submission of a clinical study application much like the IND prior to the commencement of human clinical studies.

The requirements and process governing the conduct of clinical studies, product licensing, pricing and reimbursement vary from country to country. If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

The requirements for conducting clinical trials in Australia, where we are conducting a Phase 1/2a clinical trial for ABS-201, are as follows:

Conducting clinical trials for therapeutic drug candidates in Australia is subject to regulation by Australian governmental entities. Approval for inclusion in the Australian Register of Therapeutic Goods (“ARTG”) is required before a pharmaceutical drug product may be marketed in Australia.

Typically, the process of obtaining approval of a new therapeutic drug product for inclusion in the ARTG requires compilation of clinical trial data. Clinical trials conducted using “unapproved therapeutic goods” in Australia, being those which have not yet been evaluated by the Therapeutic Goods Administration (“TGA”) for quality, safety and efficacy must occur pursuant to either the CTN or Clinical Trial Exemption (“CTX”), process.

The CTN process broadly involves: (i) completion of pre-clinical laboratory and animal testing; (ii) submission to a Human Research Ethics Committee (HREC) of all material relating to the clinical trial; (iii) final approval for the conduct of the clinical trial by the institution or organization at which the clinical trial will be conducted (Approving Authority), having due regard to the advice from the HREC; and (iv) notification of the clinical trial to the TGA.

The CTX process broadly involves: (i) submission of an application to conduct a clinical trial to the TGA for evaluation and comment; (ii) a sponsor cannot commence a CTX trial until written advice has been received from the TGA regarding the application and approval for the conduct of the trial has been obtained from an ethics committee and the institution at which the trial will be conducted; (iii) receipt of written advice from the TGA regarding the application; and (iv) receipt of approval for the conduct of the trial from an ethics committee and the institution.

In each case, it is required that: (i) adequate and well-controlled clinical trials demonstrate the quality, safety and efficacy of the therapeutic product; (ii) evidence is compiled which demonstrates that the manufacture of the therapeutic drug product complies with the principles of cGMP; (iii) manufacturing and clinical data is derived to submit to the Australian Committee on Prescription Medicines, which makes recommendations to the TGA as to whether or not to grant approval to include the therapeutic drug product in the ARTG; and (iv) an ultimate decision is made by the TGA whether to include the therapeutic drug product in the ARTG.

Pre-clinical studies include laboratory evaluation of the therapeutic drug product as well as animal studies to assess the potential safety and efficacy of the drug. The results of the pre-clinical studies form part of the materials submitted to the HREC in the case of a CTN trial and part of the application to the TGA in the case of a CTX trial.

Clinical trials involve administering the investigational product to healthy volunteers or patients under the supervision of a qualified principal investigator. The TGA has developed guidelines for a CTN. Under the CTN process, all material relating to the proposed trial is submitted directly to the HREC of each institution at

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which the trial is to be conducted. An HREC is an independent review committee set up under guidelines of the Australian National Health and Medical Research Council. The role of an HREC is to ensure the protection of rights, safety and wellbeing of human subjects involved in a clinical trial by, among other things, reviewing, approving and providing continuing review of trial protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The TGA is formally notified by submission of a CTN application but does not review the safety of the drug or any aspect of the proposed clinical trial. The approving authority of each institution gives the final approval for the conduct of the clinical trial, having due regard to advice from the HREC. Following approval, responsibility for all aspects of the trial conducted under a CTN application remains with the HREC of each investigator’s institution.

The standards for clinical research in Australia are set by the TGA and the National Health and Medical Research Council, and compliance with GCP is mandatory. Guidelines, such as those promulgated by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), are required across all fields, including those related to pharmaceutical quality, nonclinical and clinical data requirements and study designs. The basic requirements for preclinical data to support a first-in-human study under ICH guidelines are applicable in Australia. Requirements related to adverse event reporting in Australia are similar to those required in other major jurisdictions.

Biopharmaceutical Coverage and Reimbursement

Patients in the United States and in other countries generally rely on third-party payors to cover and reimburse all or part of the costs associated with their treatment, including the cost of prescription drugs. Adequate coverage and reimbursement from governmental healthcare programs (such as Medicare and Medicaid) and commercial payors is important to the acceptance of any product we may commercialize.

The process for determining whether a third-party payor will provide coverage for a product may be separate from the process for determining the reimbursement rate that the payor will pay once coverage is approved. Third-party payors increasingly challenge the prices charged for pharmaceuticals, examine medical necessity, and review cost-effectiveness, and may impose utilization management controls (such as formularies, prior authorization, step therapy, quantity limits, and site-of-care restrictions). Payors may limit coverage to narrower patient subpopulations than those included in a product’s approved labeling, or may not cover a product at all. Even if coverage is provided, reimbursement levels may not be sufficient to support pricing levels necessary to achieve a reasonable return on investment, and net prices may be reduced by mandatory discounts, rebates, or other pricing concessions required by government healthcare programs or demanded by private payors.

In the United States, reimbursement decisions for new drugs are often influenced by the Centers for Medicare & Medicaid Services (“CMS”), and private payors may follow CMS coverage and payment policies to a substantial degree. Outside the United States, pricing and reimbursement of prescription pharmaceuticals are subject to government control in many countries, and there can be no assurance that favorable coverage and reimbursement levels will be available for any product we may develop.

Healthcare Laws and Regulations

Biopharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business. These laws and regulations may constrain the business and financial arrangements and relationships through which we conduct our operations, including our relationships with our partners, customers, healthcare providers, and third-party payors. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, and transparency laws and regulations (including laws and regulations related to drug pricing and reimbursement; payments and other transfers of value ~~made~~ to physicians and other healthcare providers; and, to the extent applicable, patient privacy and data protection and anti-bribery requirements). If our operations or those of our partners, vendors, service providers, collaborators, or other third parties with whom we do business are found to be in violation of any of such laws or any other governmental regulations that apply, by extension, we may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, integrity oversight and reporting obligations, exclusion from participation in federal and state healthcare programs and responsible individuals may be subject to imprisonment, any of which could adversely affect our business, financial condition, results of operations, and prospects.

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healthcare providers. If our partners’ operations are found to be in violation of any of such laws or any other governmental regulations that apply, by extension, we may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, integrity oversight and reporting obligations, exclusion from participation in federal and state healthcare programs and responsible individuals may be subject to imprisonment.

Additional Regulations

In addition to the foregoing, state and federal U.S. laws regarding environmental protection and hazardous substances affect our business. These and other laws govern our use, handling and disposal of various biological, chemical and radioactive substances used in, and wastes generated by, our operations. If our operations result in contamination of the environment or expose individuals to hazardous substances, we could be liable for damages and governmental fines. We believe that we are in material compliance with applicable environmental laws and that continued compliance therewith will not have a material adverse effect on our business. We cannot predict, however, how changes in these laws may affect our future operations.

Healthcare Reform

Payors, whether domestic or foreign, or governmental or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically adapted for new technologies. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to ~~sell~~obtain coverage and adequate reimbursement for our products, if approved, and to sell them profitably. In particular, in 2010, the ACA was enacted, which, among other things, subjected biologic products to potential competition by lower-cost biosimilars; addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (later increased to 70%, effective as of January 1, 2019, and subsequently replaced altogether by the Manufacturer Discount Program implemented by the Inflation Reduction Act of 2022 (IRA)) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and provided incentives to programs that increase the federal government’s comparative effectiveness research. Furthermore in August 2022, the Inflation Reduction Act (IRA) was enacted, which among other things: allows for the Centers for Medicare & Medicaid Services to impose price controls for certain single-source drugs and biotherapeutics reimbursed under Medicare Part B and Part D.

The IRA also enacted significant changes intended to reduce prescription drug spending and beneficiary out-of-pocket costs, including redesigning the Medicare Part D benefit beginning in 2025 (including a lower annual out-of-pocket threshold), replacing the prior coverage gap discount framework with a new Part D Manufacturer Discount Program, requiring inflation-based rebates in certain contexts, and establishing a Medicare Drug Price Negotiation Program that permits CMS to set a “maximum fair price” for certain qualifying single-source drugs and biologics reimbursed under Medicare Part B and/or Part D. Subsequent legislation has further modified the Medicare negotiation framework. For example, the One Big Beautiful Bill Act of 2025 (“OBBBA”) expanded the scope of the orphan drug exclusion from Medicare price negotiation beginning with the initial price applicability year 2028, which may affect which products are eligible for negotiation and when, and it also included significant Medicaid-related changes (including provisions addressing eligibility processes and work requirements) that could place increased pressure on state Medicaid budgets and, in turn, utilization and reimbursement dynamics for prescription drugs.

Furthermore the IRA also allows for the Centers for Medicare & Medicaid Services to negotiate maximum prices for certain single-source drugs and biotherapeutics reimbursed under Medicare Part B and Part D, and makes other changes that affect manufacturer discount and rebate obligations and the Medicare Part D benefit design over time.

In addition, executive actions and proposed regulatory initiatives in 2025 and beyond have focused on further reducing prescription drug prices, including through “most-favored-nation” (“MFN”) pricing concepts and changes to distribution and purchasing models. CMS and its Innovation Center have also proposed and/or described MFN-based or international benchmark-based demonstration approaches for Medicare Part B and Part D (including the “GLOBE” model and related proposals), which, if implemented, could affect manufacturer rebate obligations and pricing and reimbursement dynamics for covered drugs.

Even where reforms are targeted to government programs, payors often look to Medicare coverage and payment policy as a reference point, and changes in government reimbursement or pricing dynamics can influence commercial reimbursement levels and contracting expectations. In addition, federal and state policymakers continue to consider and implement measures intended to increase pricing transparency, limit

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patient out-of-pocket costs, encourage substitution or the use of lower-cost alternatives, regulate or restrict certain manufacturer support programs, and otherwise reduce drug spending, including through proposals to establish most-favored-nation-based pricing in the United States.

Outside the United States, many jurisdictions impose price controls, reference pricing, health technology assessments, and other market-access requirements, and may delay or limit reimbursement or constrain permissible pricing. We cannot predict the likelihood, nature, timing, or extent of future healthcare reform initiatives; however, ongoing reforms and cost-containment measures could materially adversely affect the pricing, coverage, reimbursement, and commercial viability of any products we may develop.

Anti-Corruption Laws

We are subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended (FCPA), the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities, such as the UK Bribery Act 2010 and the UK Proceeds of Crime Act 2002 (Anti-Corruption Laws). Among other matters, such Anti-Corruption Laws prohibit corporations and individuals from directly or indirectly paying, offering to pay or authorizing the payment of money or anything of value to any foreign government official, government staff member, political party or political candidate, or certain other persons, in order to obtain, retain or direct business, regulatory approvals or some other advantage in an improper manner. We can also be held liable for the acts of our third party agents under the FCPA, the UK Bribery Act 2010 and possibly other Anti-Corruption Laws. In the healthcare sector, anti-corruption risk can also arise in the context of improper interactions with doctors, key opinion leaders and other healthcare professionals who work for state-affiliated hospitals, research institutions or other organizations.

Human Capital

Our employees, who we refer to as “Unlimiters”, are essential to our ability to achieve our mission to design differentiated antibody-based therapeutics.

Our corporate values guide both our daily decision-making and our long-term cultural development, setting the tone for how we work together with a focus on respect for patients, diversity, and community:

•We believe in the impossible

•We are one team with one finish line

•We deliver results

•We innovate because lives depend on it

•We embrace our differences

•We do the right thing

We have integrated our values into our people processes, including the candidate selection and employee promotion processes, performance management, and recognition. Incorporating these values into our culture enables our people to translate ideas into impact as we strive to create a better, faster path to new medicines. Collectively and individually we are defying conventions and disrupting the biopharmaceutical industry with bold ideas and passionate pursuit of new possibilities.

As of December 31, 2025, we had 140 employees, many of whom have advanced post-graduate degrees, primarily engaged in research and development and general and administrative functions.

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measured by delivery of results and impact and demonstration of our corporate values. The principal purposes of our equity plans are to attract, retain, and motivate employees, consultants and directors through the granting of stock-based compensation awards that align the interests of our employees with our stockholders. All full-time employees receive an equity grant upon hire and are eligible for annual equity grants thereafter. Our employee benefits may vary by country and generally include an employee stock purchase plan, healthcare benefits for employees and their families, life and disability insurance, unlimited vacation, parental leave, retirement contributions, referral bonuses, access to mental health resources, wellness programs, and onsite services;

Training and development: We offer a number of educational resources and development opportunities with emphasis on internal mobility and fair and equitable talent practices. Employees take advantage of live courses, leadership programs, online training, team building events, seminars, conferences, lectures, university programs, peer-to-peer and leadership-guided training, and other learning opportunities across the company. All Unlimiters are eligible for an annual monetary stipend for continuing education and career development. Additionally, we have a paid internship program that offers university or graduate students real-world experience and the chance to work with our extraordinary people, while helping Absci identify and develop the next generation of Unlimiters.

Ethics and compliance: We have adopted and regularly review the Code of Business Conduct and Ethics (the Code) to aid our directors, officers and employees in making ethical and legal decisions when conducting business and performing day-to-day duties. All directors, officers and employees are required to review and sign an acknowledgment regarding the Code and to agree on an annual basis to comply with the Code. We have established a reporting hotline and web form that enables employees to anonymously report any suspected violations of the Code, and we have a strict non-retaliation policy for all claims brought forward in good faith.

Communication and employee engagement: We employ a variety of tools to facilitate open and direct communication including open forums with executives, employee surveys and engagement through company- and employee-led groups and committees. Our campuses are intentionally designed to create a space for collaboration and connection. We hold company wide meetings monthly and regularly schedule time for our colleagues to connect. We appraise and refine our employee programs through our company pulse surveys. Our annual employee engagement survey process utilizes a third-party survey tool, and we supplement this process with periodic pulse surveys to help us gauge ongoing progress and employee sentiment. The senior leadership team continues to identify key initiatives that tie directly back to employee feedback to further increase employee engagement.

Diversity, equity, inclusion and belonging (DEIB): Our vision is to deliver breakthrough therapeutics that address areas of significant unmet medical needs for broad and diverse patient populations. Achieving that vision isn’t possible unless we have a diverse and talented team and unless we live in a diverse and equitable world, where everyone can benefit from the potentially life-changing therapeutics we’re creating. We are committed to building a team with a variety of backgrounds, skills and perspectives. We believe that inclusiveness helps drive innovation and increases our understanding of the diverse group of patients we seek to benefit.

Health, safety, well-being: We are committed to promoting the health, safety, and well-being of our employees. Our Employee Safety Committee is comprised of cross-departmental members and meets regularly to review workplace safety and adherence to safety policies. We require annual workplace safety training to reinforce workplace safety procedures that may be useful in the event of emergency situations and to assist our employees in helping to prevent workplace accidents. We have numerous employees with current first aid, CPR, and AED certifications for emergency preparedness.

Corporate Information

We were originally formed in August 2011 as an Oregon limited liability company and later converted into a Delaware limited liability company in April 2016 under the name AbSci LLC. In October 2020, we completed a reorganization whereby we were converted from a Delaware limited liability company named AbSci LLC to a Delaware corporation under the name Absci Corporation.

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Our principal executive offices are located at 18105 SE Mill Plain Boulevard, Vancouver, Washington 98683. Our telephone number is (360) 949-1041. Our website address is https://www.absci.com/. Information contained on, or that can be accessed through, our website should not be considered to be part of this Annual Report.

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You are advised to read this Annual Report in conjunction with other reports and documents that we file from time to time with the SEC. In particular, please read our Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K that we may file from time to time. You may obtain copies of these reports directly from us or from the SEC. In addition, the SEC maintains information for electronic filers (including Absci Corporation) at its website at www.sec.gov. We make our periodic and current reports available on our internet website, free of charge, as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC.

Available information

Our Annual Reports on Form 10‑K, Quarterly Reports on Form 10‑Q, Current Reports on Form 8‑K, proxy and information statements and amendments to reports filed pursuant to Sections 13(a), and 15(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act), are filed with the SEC. We are subject to the informational requirements of the Exchange Act and file or furnish reports, proxy statements and other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. Such documents and other information filed by us with the SEC are available free of charge on our investor relations website (https://investors.absci.com/) when such reports are available on the SEC’s website.

Investors and others should note that we may announce material information to the public through filings with the SEC, on our investor relations website (https://investors.absci.com/), press releases, public conference calls, and public webcasts. We encourage our investors and others to review the information disclosed through such channels as such information could be deemed to be material information. Please note that this list may be updated from time to time.

Item 1A. Risk Factors

This report contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in this report. Factors that could cause or contribute to these differences ininclude, ~~our~~but ~~future~~are ~~financial~~not limited to, those discussed below and ~~operating~~elsewhere ~~results~~in ~~include~~this ~~those~~report ~~discussed~~and in any documents incorporated in this report by reference. You should carefully consider the following risk factors, ~~set~~together ~~forth~~with all other information in this ~~Annual~~report, ~~Report~~including onour ~~Form~~financial ~~10-K.~~statements ~~The~~and ~~risks~~notes ~~described~~thereto, and in ~~this~~our ~~Annual~~other ~~Report~~filings ~~and~~with ~~are~~the ~~not~~U.S. ~~the~~Securities ~~only~~and ~~risks~~Exchange ~~that~~Commission, weor ~~face~~SEC. ~~Additional~~If any of the following risks, or other risks not presently known to us or that we docurrently ~~not~~believe ~~currently~~to ~~consider~~not be significant, ~~may~~develop ~~also~~into ~~have~~actual anevents, ~~adverse~~then ~~effect~~our onbusiness, ~~the~~financial ~~Company~~condition, results of operations or prospects could be materially adversely affected. If ~~any~~that ofhappens, the ~~risks~~market ~~actually~~price ~~occur,~~of our ~~business,~~common ~~results~~shares ofcould ~~operations~~decline, ~~cash~~and ~~flows~~shareholders may lose all or ~~financial~~part ~~condition~~of ~~could~~their ~~suffer~~investment.

~~Risk Factors~~35

Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this Annual Report and in our other public filings in evaluating our business. The occurrence of any of the events or developments described below could materially harm our business, financial condition, results of operations and prospects. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.

Risks Related to Our Financial Condition and Need for Additional Capital

Our current business has a limited operating history, which may make it difficult to evaluate our business and predict our future performance.

Our current business has a limited operating history. We began commercial operations in 2018. Before engaging in commercial operations, we focused primarily on technology development. Our revenue to date has been generated primarily from drug creation activities through partnerships, and we do not anticipate generating any revenue from commercial product sales, if ever, until we successfully complete the clinical development of, and achieve regulatory approval for, any of our internally developed programs, all of which are still in preclinical development. We are still early in the adoption phase of our drug creation model, and, as of February 28, 2025, no partner has entered into a license for clinical or commercial use of any intellectual property rights related to a product candidate or cell lines. We also have only recently begun to develop programs for our own product candidates and may experience difficulties advancing these programs through

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toRisks ~~clinical~~Related ~~development~~to ~~and~~Our ~~generating~~Financial ~~value~~Condition ~~from them. We may never achieve commercial success~~ and weNeed ~~have~~for ~~limited~~Additional historical financial data upon which we may base our projected financial performance. We also have limited historical financial data upon which we may base our planned operating expenses or upon which you may evaluate our business and prospects. Based on our limited experience, we may not be able to effectively:Capital

~~•develop~~Our ~~and~~short ~~advance~~operating ~~our~~history ~~product~~may ~~candidates~~make ~~from~~it ~~our~~difficult ~~internally~~for ~~developed~~you ~~programs~~to ~~through~~evaluate ~~preclinical~~the ~~and~~success ~~clinical~~of ~~development~~our business to date and ~~potential~~to ~~marketing~~assess ~~approval~~our ~~and~~future ~~commercialization;~~viability.

~~•drive~~We ~~adoption~~are ofa clinical-stage company. Our operations to date have been limited to organizing and staffing our ~~Integrated~~company, ~~Drug~~business ~~Creation~~planning, ~~platform~~raising bycapital, ~~validating~~acquiring ~~them~~and ~~through~~developing ~~the~~our ~~advancement~~technology, ofidentifying potential product candidates and undertaking preclinical and early clinical studies related to our internally developed programs. All of our product candidates are still in preclinical and byearly ~~attracting~~clinical development. We have not yet demonstrated our ability to successfully complete any clinical trials, including large-scale, pivotal clinical trials, obtain marketing approvals, manufacture a commercial scale medicine, or arrange for a third party to do so on our behalf, or conduct sales and ~~retaining~~marketing ~~partners;~~activities necessary for successful commercialization. Typically, it takes about 10 to 15 years to develop one new medicine from the time it is discovered to when it is available for treating patients. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history. In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition from a company with a research focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

~~•enter~~We ~~into~~do not anticipate generating any revenue from commercial product sales, ~~maintain~~if ~~and~~ever, ~~potentially~~until ~~expand~~we successfully complete the ~~scope~~clinical development of, ~~partnerships~~and ~~with~~achieve ~~third~~regulatory ~~parties~~approval ~~that~~for, ~~contain~~any ~~economic~~of ~~terms~~our ~~sufficient~~internally todeveloped ~~make~~programs, ~~our~~all ~~business~~of ~~model~~which ~~viable;~~are still in clinical and preclinical development.

~~•raise~~In ~~sufficient~~addition ~~capital~~to orthe ~~achieve~~development ~~sufficient~~of ~~near~~our ~~term~~internally ~~revenue~~developed toprograms, we ~~sustain~~began ~~our~~entering ~~business~~into todrug ~~enable~~creation uscollaborations tofor ~~recognize~~drug ~~value~~creation ~~from~~programs ~~our~~and ~~internally~~co-development ~~developed~~partnerships ~~programs~~with ~~and~~third ~~receive~~parties in 2018. We are still early in the ~~downstream~~adoption ~~economics~~phase of our ~~existing~~drug creation collaboration business model, and, as of March 24, 2026, no partner has entered into a license for clinical or ~~future~~commercial ~~partnerships;~~use of any intellectual property rights related to a product candidate or cell lines.

~~•anticipate~~Our ~~and~~revenue ~~adapt~~to date has been generated primarily from drug creation activities conducted through these partnered programs. In addition, we expect our expenses to ~~changes~~increase inas ~~the~~we ~~existing~~advance our internally developed programs into and ~~emerging~~through ~~markets~~clinical indevelopment. ~~which~~Accordingly, if we ~~operate;~~do not generate revenue as and when anticipated, our losses may be greater than expected and our operating results will suffer.

•focus our efforts related to our Integrated Drug Creation platform in areas that generate returns on these efforts;

•succeed in achieving goals related to our Integrated Drug Creation platform;

•maintain and develop strategic relationships with suppliers to acquire necessary materials and equipment for the development of our Integrated Drug Creation platform and product candidates on appropriate timelines, or at all;

•create a pipeline of internally developed programs that generate future partnership opportunities;

•scale our drug creation activities to meet potential demand at a reasonable cost;

•acquire, in-license or otherwise obtain technologies that enable us to expand our capabilities;

•avoid infringement of third-party intellectual property rights;

•obtain licenses to third-party intellectual property rights on commercially reasonable terms, as needed for our current and planned operations;

•obtain and maintain valid and enforceable patents and other intellectual property rights that give us a competitive advantage;

•protect our proprietary technologies, including our Drug Creation platform and internally developed programs and corresponding product candidates; and

•attract, retain and motivate qualified personnel.

In addition, a substantial portion of our expenses have been and will continue to be fixed, and we expect our expenses to increase as we advance our internally developed programs into and through clinical development. Accordingly, if we do not generate revenue as and when anticipated, our losses may be greater than expected and our operating results will suffer.

We have incurred significant losses since inception, we expect to incur losses in the future and we may not be able to generate sufficient revenue to achieve and maintain profitability.

We have incurred significant losses since our inception. For the years ended December 31, ~~2024~~2025 and ~~2023~~2024, we incurred net losses of $~~103~~115.12 million and $~~110~~103.61 million, respectively. As of December 31, ~~2024~~2025, we had an accumulated deficit of $~~509~~624.68 million. We expect that our operating expenses will continue to increase as we grow our business and advance our internally developed programs. Since our inception, we have financed our operations primarily from private placements of our equity securities, convertible promissory notes, the sale of common stock in our initial public offering (IPO), subsequent follow-on offering, the incurrence of other indebtedness and other financing activities, and to a lesser extent, revenue derived from our drug creation activities leveraging our Integrated Drug Creation platform. We have devoted substantially all of our

29Since our inception, we have financed our operations primarily from private placements of our equity securities, convertible promissory notes, the sale of common stock in our initial public offering (IPO), subsequent follow-on offerings, the incurrence of other indebtedness and other financing activities, and to a lesser extent, revenue derived from our drug creation activities leveraging our Integrated Drug Creation platform. We have devoted substantially all of our resources to the development of our Integrated Drug Creation platform and commercialization of resulting drug creation capabilities, and the research and development of our internally developed programs. We will need to generate significant additional revenue to achieve and sustain profitability, and even if we achieve profitability, we cannot be sure that we will remain profitable for any substantial period of time. We may never be able to generate sufficient revenue to achieve or sustain profitability and our recent and historical financial and operating results should not be considered indicative of our future performance.

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~~resources~~We towill ~~the~~need ~~development~~to ofraise ~~our~~additional ~~Integrated~~capital ~~Drug~~to ~~Creation~~fund ~~platform~~our ~~and commercialization of resulting drug creation capabilities~~operations, ~~and~~pre-clinical ~~the research~~ and clinical development of our internally developed programs., Weand ~~will need~~ to ~~generate~~improve ~~significant~~our ~~additional~~Integrated ~~revenue~~Drug toCreation ~~achieve~~platform. ~~and~~If ~~sustain profitability, and even if~~ we ~~achieve~~are ~~profitability,~~unable weto ~~cannot~~raise beadditional ~~sure~~capital ~~that~~on weterms ~~will~~acceptable ~~remain~~to ~~profitable~~us ~~for~~or ~~any~~at ~~substantial~~all, ~~period~~we ~~of time. We~~ may ~~never~~not be able to ~~generate~~continue ~~sufficient revenue~~ to ~~achieve~~develop orour ~~sustain~~internally ~~profitability~~developed programs and/or ~~our~~compete ~~recent~~successfully ~~and~~with ~~historical~~our ~~financial~~Integrated ~~and~~Drug ~~operating~~Creation ~~results~~platform, ~~should~~which ~~not~~would beharm ~~considered~~our ~~indicative~~business, ofoperations, ~~our~~and ~~future~~financial ~~performance~~condition.

As of December 31, 2025, we had $144.3 million in cash, cash equivalents and marketable securities. We expect our current cash, cash equivalents and marketable securities and anticipated cash flows from operations will ~~need~~be sufficient to ~~raise~~meet ~~additional~~our working capital toand ~~fund~~capital expenditure needs over at least the next 12 months. If our available resources and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements, including because of higher expenses than we anticipate related to internally developed programs or our investments in our Integrated Drug Creation platform or any other technology, lower demand from existing and ~~improve~~potential partners for our Integrated Drug Creation platform., Ifor the realization of other risks described in this "Risk Factors” section, we ~~are~~will ~~unable~~be required to raise additional capital onthrough ~~terms~~issuances ~~acceptable~~of toequity us or atconvertible ~~all~~debt securities, weentrance ~~may~~into ~~not~~a becredit ~~able~~facility toor ~~compete~~another ~~successfully~~form of third party funding, ~~which~~or ~~would~~seek ~~harm~~other ~~our~~sources ~~business,~~of ~~operations,~~financing. ~~and~~Such ~~financial~~additional ~~condition~~financing may not be available on terms acceptable to us or at all.

As of December 31, 2024, we had $112.4 million in cash, cash equivalents and short term investments. We expect our current cash, cash equivalents and short term investments and anticipated cash flows from operations will be sufficient to meet our working capital and capital expenditure needs over at least the next 12 months. If our available resources and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements, including because of higher expenses than we anticipate related to internally developed programs or our investments in our Integrated Drug Creation platform or any other technology, lower demand from existing and potential partners for our Integrated Drug Creation platform, or the realization of other risks described in this "Risk Factors” section, we will be required to raise additional capital through issuances of equity or convertible debt securities, entrance into a credit facility or another form of third party funding, or seek other sources of financing. Such additional financing may not be available on terms acceptable to us or at all.

In any event, we may consider raising additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. For example, this may include reasons such as to:

•advance our existing internally developed programs through preclinical and clinical development;

•advance new or additional internally developed programs through preclinical and clinical development;

•further advance our AI capabilities, including AI capabilities related to our Integrated Drug Creation platform;

•further expand the capabilities of our Integrated Drug Creation platform into additional areas of biopharmaceutical research and development, such as target discovery or translational medicine;

•increase our business development efforts to drive market recognition of our Integrated Drug Creation platform, our internally developed programs and address competitive developments;

•fund business development efforts for our current or future internally developed programs and partnered programs;

•acquire, license or invest in additional technologies or complementary businesses or assets; and

•finance capital expenditures and general and administrative expenses.

Our present and future funding requirements will depend on many factors, including:

•the cost of expanding our operations, including our ongoing and planned preclinical and clinical development activities for our internally developed programs;

•preclinical and clinical development, including costs associated with building our internal clinical and regulatory capabilities and contracting with third-party clinical investigators, contract research organizations (CROs), manufacturers and suppliers, or clinical data management organizations;

•our ability to achieve and sustain sufficient revenues from partnerships and other business development activities;

•our rate of progress in working with partners to leverage our Integrated Drug Creation platform and business development activities associated therewith;

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•our rate of progress in, and cost of, developing new technologies;

•the effect of competing technological and market developments; and

•costs related to any domestic and international expansion.

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The various ways we could raise additional capital carry potential risks. If we raise funds by issuing equity securities, dilution to our stockholders would result. Any preferred equity securities issued also would likely provide for rights, preferences or privileges senior to those of holders of our common stock. If we raise funds by issuing debt securities, those debt securities may have rights, preferences and privileges senior to those of holders of our common stock. Debt financing and preferred equity financing, if available, may also involve agreements that include covenants restricting our ability to take specific actions, such as incurring additional debt, selling or licensing our programs, making asset acquisitions, making capital expenditures, or declaring dividends.

If we are unable to obtain adequate financing or financing on terms satisfactory to us, if we require it, our ability to continue to pursue our business objectives and to respond to business opportunities, challenges, or unforeseen circumstances could be significantly limited, and could have a material adverse effect on our business, financial condition, results of operations and prospects.

Substantially all of our historical revenue is related to partnered drug creation activities, and we have not demonstrated the ability to enter into a sufficient number of partnerships providing for long-term license arrangements under which we are entitled to receive milestone payments or royalties on net product sales. We have not received any such milestone or royalty revenues to date, and it may be years before we realize any such revenues, if at all.

For the year ended December 31, ~~2024~~2025, ~~substantially~~ all of our revenue was generated by ~~technology development fees through~~ performing drug creation activities for our partnered programs. To date, such fees have generally been payable upon both the inception of, and the demonstration of technical achievement of program milestones, under drug creation agreements with our partners. Our business model depends, in part, on the successful completion of the drug creation phase under these arrangements and on our subsequent entry into long-term license arrangements with our partners that entitle us to development, regulatory and commercial milestones and/or royalties with respect to product candidates generated through our Integrated Drug Creation platform, as well as product candidates discovered and/or manufactured in cell lines developed by us. We are still in the very early stages of implementing our drug creation model and, to date, no partner has entered into a license for clinical or commercial use of any intellectual property rights related to product candidates discovered thereunder or cell lines developed by us. If we are unable to maintain these partnerships (including if such partnerships are terminated prior to or upon completion of the drug creation phase) or we are otherwise unable to enter into commercial license agreements for our partnered programs, we will not receive any downstream payments, which may have a material and adverse effect on our business prospects. Additionally, any such license agreements that we may enter into may not be on terms that are favorable to us and may not result in meaningful revenues to us, or at all, or such license agreements may be terminated.

~~Technology~~Fees ~~development fees are~~ generated by drug creation activities that we perform for our partners, the timing and nature of which are dictated by the timing of program commencement, which depends on various permissions, information and supplies provided by our partners and/or third party vendors as well as the pace of program progression and receipt of ongoing input from our partners. Our eligibility to receive milestone payments from our partnerships is generally subject to the negotiation of future arrangements, as described above. As a result, we currently do not generate significant recurring revenue and, until we are able to establish significant recurring revenue, if at all, we will be prone to regular and significant fluctuations in our revenue dependent on the timing of our entry into partnership agreements, our partners advancing such programs, and our partners achieving development milestones or commercial sales with respect to product candidates discovered and/or manufactured in cell lines developed by us.

Risks Related to Biologic Drug Development

Biologic drug development is inherently uncertain, and it is possible that our technology may not succeed in discovering appropriate ~~molecules~~product ~~or producing cell lines~~candidates. Even if we do succeed, it is possible that none of the product candidates created using our Integrated Drug Creation platform, if any, that are further developed by our partners will achieve development or regulatory milestones, including marketing approval, or become viable commercial technologies, on a timely basis or at all, which would harm our ability to generate revenue.

31We use our Integrated Drug Creation platform both to advance our internally developed programs and to create product candidates for partners that are engaged in biologic drug discovery and development. In addition, we may enter into partnerships for the further development and commercialization of our internally developed programs during later stages of clinical development. While we currently receive

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~~regulatory~~payments for performing drug creation activities and successfully completing technical program deliverables and milestones for our partners with respect to our partnered programs, ~~including~~we anticipate that the vast majority of the economic value of the agreements that we enter into with our partners will be in the downstream payments that would be payable if certain milestones are met by our partners with respect to product candidates generated utilizing our Integrated Drug Creation platform and royalties on net sales if such product candidates are approved for marketing ~~approval~~and successfully commercialized. As a result, orour ~~become~~future ~~viable~~growth ~~commercial~~is ~~technologies~~dependent on our ability to successfully advance our internally developed programs through clinical development and eventual marketing approval and commercialization, and the ability of our partners to successfully develop and commercialize therapies based on aproduct ~~timely~~candidates ~~basis~~generated orusing atour ~~all~~Integrated Drug Creation platform. Risks relating to clinical development, ~~which~~including ~~would~~risks ~~harm~~related to manufacturing and clinical supply, regulatory clearance, authorization or approval and commercialization apply to us both directly with respect to our ~~ability~~internally developed programs and indirectly through the activities of our partners with respect to ~~generate~~their ~~revenue~~programs that are generated pursuant to a drug creation agreement. Even if our Integrated Drug Creation platform is capable of identifying high quality product candidates, there can be no assurance that we or our partners will successfully develop, secure marketing approvals for and commercialize any product candidates discovered and developed under a partnered program. As a result, we may not realize the intended benefits of our internal research and development efforts or our partnerships.

We use our Integrated Drug Creation platform both to advance our internally developed programs and to create product candidates for partners that are engaged in biologic drug discovery and development. In addition, we may enter into partnerships for the further development and commercialization of our internally developed programs during later stages of clinical development. While we currently receive payments for performing drug creation activities and successfully completing technical program deliverables and milestones for our partners with respect to our partnered programs, we anticipate that the vast majority of the economic value of the agreements that we enter into with our partners will be in the downstream payments that would be payable if certain milestones are met by our partners with respect to product candidates generated utilizing our Integrated Drug Creation platform and royalties on net sales if such product candidates are approved for marketing and successfully commercialized. As a result, our future growth is dependent on our ability to successfully advance our internally developed programs through to clinical development and eventual marketing approval and commercialization, and the ability of our partners to successfully develop and commercialize therapies based on product candidates generated using our Integrated Drug Creation platform. Risks relating to clinical development, including risks related to manufacturing and clinical supply, regulatory clearance, authorization or approval and commercialization apply to us both directly with respect to our internally developed programs and indirectly through the activities of our partners with respect to their programs that are generated pursuant to a drug creation agreement. Even if our Integrated Drug Creation platform is capable of identifying high quality product candidates, there can be no assurance that we or our partners will successfully develop, secure marketing approvals for and commercialize any product candidates discovered and developed under a partnered program. As a result, we may not realize the intended benefits of our internal research and development efforts or our partnerships.

Due to the uncertain, time-consuming and costly clinical development and regulatory approval process, we or our partners may not successfully develop any product candidates generated using our Integrated Drug Creation platform, or we or our partners may choose to discontinue the development of these product candidates for a variety of reasons, including due to safety, risk versus benefit profile, exclusivity, competitive landscape, commercialization potential, production limitations or prioritization of their resources. It is possible that none of these product candidates will ever receive regulatory approval and, even if approved, such product candidates may never be successfully commercialized. Most product candidates that commence clinical trials are never approved, and there can be no assurance that any of our partnered programs or any internally developed programs will ultimately be successful.

In addition, even if these product candidates receive regulatory approval in the United States, our partners may never obtain approval or commercialize outside of the United States, which would limit their full market potential and therefore our ability to realize their potential downstream value. In addition, regulatory authorities may approve any of the product candidates that we may develop for fewer or more limited indications than requested. Furthermore, approved drugs may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales would be limited. Likewise, we or our partners have to make decisions about which clinical stage and preclinical product candidates to develop and advance, and we or our partners may not have the resources to invest in all of the product candidates generated using our Integrated Drug Creation platform, or clinical data and other development considerations may not support the advancement of one or more product candidates. Decision-making about which product candidates to prioritize involves inherent uncertainty, and we or our partners’ decision-making and resource prioritization decisions, which in the case of our partners are outside of our control, may adversely affect the potential value of those partnerships. Additionally, subject to its contractual obligations to us, if one more of our partners is involved in a business combination, the partner might de-emphasize or terminate the development or commercialization of any product candidate generated using our Integrated Drug Creation platform. If one of our partners terminates its agreement with us, we may find it more difficult to attract new partners.

We are also subject to industry-wide FDA and other regulatory risk. For example, the number of BLAs approved by the FDA varies significantly over time and if changes in applicable laws, regulations, or policy or other events, such as staffing changes or shortages at the FDA, lead to an extended reduction in the number of BLAs approved by the FDA or otherwise reduce the number of biologics in development, our industry would contract and our business would be materially harmed.

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We or our partners’ failure to effectively develop or commercialize any product candidates generated using our platform could have a material adverse effect on our business, financial condition, results of operations and prospects, and cause the market price of our common stock to decline. In addition to the inherent uncertainty in drug development addresses above, our ability to forecast our future financial performance and revenues may be limited.

Preclinical development is uncertain. Our preclinical product candidates may experience delays or may never advance to clinical trials, which would adversely affect our or our partners’ ability to obtain regulatory approvals or commercialize these product candidates on a timely basis or at all, which would have an adverse effect on our business. 39

WeTable have limited experience as a company in conducting clinical trials, and to date we have not initiated any clinical trials for any product candidates. We cannot guarantee that any clinical trials will be initiated or conducted as planned or completed on schedule, if at all. We also cannot be sure that submission of an IND (or foreign equivalent) will result in the FDA or other regulatory authority, as applicable, allowing clinical trials to begin in a timely manner, if at all. Moreover, even if these trials begin, issues may arise that could suspend or terminate such clinical trials. A failure of one or more clinical trials can occur at any stage of testing, and our future clinical trials may not be successful. If our preclinical product candidates experience delays or never advance to clinical trials, it would have an adverse effect on our business.Contents

InPositive ~~order~~results tofrom ~~obtain~~early ~~FDA~~preclinical ~~approval~~studies ~~to market a new biological product, we~~ or ~~our~~preliminary ~~partners~~results ~~must~~from ~~demonstrate proof of safety, purity and potency or efficacy in humans. To meet these requirements we or our partners will have to conduct adequate and well-controlled~~ clinical trials. ~~Before~~of ~~we or~~ our ~~partners can commence clinical trials for a~~ product ~~candidate,~~candidates ~~we or our partners must complete extensive preclinical testing and studies that support our planned INDs in the United States. All of our internally developed programs~~ are innot ~~preclinical~~necessarily ~~development.~~predictive ~~We cannot be certain~~ of the ~~timely~~results ~~completion or outcome~~ of ~~our~~later ~~or our partners'~~ preclinical ~~testing and~~ studies and ~~cannot~~any ~~predict~~future ~~if the FDA will accept our or our partners' proposed~~ clinical ~~programs~~trials ~~or if the outcome~~ of our ~~or our partners' preclinical testing and studies will ultimately support the further development of our~~ product candidates. AsIf ~~a result,~~ we cannot bereplicate ~~sure~~the ~~that~~positive weresults orfrom our ~~partners~~earlier ~~will~~preclinical bestudies ~~able~~of ~~to submit INDs or similar applications for~~ our product candidates onin ~~the~~our ~~timelines~~later wepreclinical ~~expect~~studies, ifclinical attrials ~~all,~~ and wefuture ~~cannot~~clinical betrials, ~~sure~~we ~~that~~may ~~submission~~be ofunable ~~INDs~~to orsuccessfully ~~similar~~develop, ~~applications~~obtain ~~will result in the FDA or other~~ regulatory ~~authorities~~approval ~~allowing~~for ~~clinical~~and ~~trials~~commercialize toour ~~begin~~product candidates.

Positive results from early preclinical studies, exploratory analyses or preliminary results from clinical trials of our product candidates may not be predictive of the results of later preclinical studies or future clinical trials. Many companies in the biopharmaceutical industry have experienced significant setbacks in later-stage clinical trials after achieving positive results in early-stage development, and we cannot be certain that we will not face similar setbacks. The results of preclinical studies and early-stage clinical trials may not be replicated in later preclinical studies or in larger or more advanced clinical trials conducted under different protocols or conditions.

Preclinical studies are conducted in laboratory models and animals and may not accurately predict the safety, tolerability, pharmacokinetics, pharmacodynamics or efficacy of a product candidate in humans. Similarly, early clinical trials are typically conducted in small patient populations and over relatively short durations, and therefore may not be indicative of results obtained in larger or longer-term trials. Differences in trial design, patient populations, endpoints, dosing regimens, statistical analyses, or other factors may also lead to results in later trials that differ materially from earlier findings.

In addition, preliminary or interim data from our clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as additional patient data become available and are subject to further verification and analysis. Preliminary or interim results that we report from time to time may not reflect the final results of the trial, and final results may differ materially from the preliminary data we previously reported. We may also report results based on exploratory endpoints, biomarker data or other early indicators of activity that may not ultimately translate into clinically meaningful outcomes or regulatory approval. Regulatory authorities may also interpret the data differently than we do and may require additional studies before approving any of our product candidates.

If we are unable to replicate positive results from our earlier preclinical studies or preliminary clinical trials in subsequent studies or trials, if biomarker or exploratory signals do not translate into clinically meaningful outcomes, or if our product candidates demonstrate unacceptable safety profiles or insufficient efficacy, the development of our product candidates could be delayed, limited or terminated. Any such setbacks could materially harm our business, financial condition, results of operations and prospects and may prevent us from successfully developing, obtaining regulatory approval for, and commercializing our product candidates.

In addition, our discovery efforts rely in part on proprietary technologies, computational approaches and artificial intelligence-enabled platforms to identify and design potential product candidates. While we believe these technologies may help accelerate aspects of the drug discovery process, the application of artificial intelligence and computational methods to drug discovery is still evolving and has not yet consistently resulted in the successful development and regulatory approval of new therapeutic products. Product candidates identified or optimized using these technologies may not demonstrate the expected safety, tolerability, pharmacokinetic properties or therapeutic activity in preclinical studies or clinical trials. Even if our platform generates promising product candidates, we may not be able to successfully advance those candidates through clinical development, obtain regulatory approval or achieve commercial success. As a result, our platform technologies may not result in the discovery or development of commercially viable product candidates, which could materially adversely affect our business, financial condition, results of operations and prospects.

Preclinical and clinical development is uncertain. Our or our partners' preclinical and clinical product candidates may experience delays or may never advance to and/or through clinical trials, which would adversely affect our or our partners’ ability to obtain regulatory approvals or commercialize these product candidates on a timely basis or at all, which would have an adverse effect on our business.

We are very early in our development of product candidates and have focused our efforts to date on platform development, discovery, research, preclinical and early clinical development. We have only recently dosed the first participants in our Phase 1 clinical trials of ABS-101 and ABS-201, and all of our other

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programs are still in the research or preclinical stage of development. Thus, we have limited experience as a company in conducting clinical trials.

We cannot guarantee that any clinical trials will be initiated or conducted as planned or completed on schedule, if at all. For example, following a favorable early safety profile and notwithstanding positive interim Phase 1 results as announced in November 2025, we made the strategic decision to seek a partner for ABS-101 rather than advance it through later-stage development ourselves.

We also cannot be sure that submission of an IND (or foreign equivalent) will result in the FDA or other regulatory authority, as applicable, allowing clinical trials to begin in a timely manner, if at all. Moreover, even if these trials begin, issues may arise that could cause us or a regulatory authority to suspend or terminate such clinical trials. A failure of one or more clinical trials can occur at any stage of testing, and our current and future clinical trials may not be successful. If our preclinical product candidates experience delays or never advance to clinical trials, it would have an adverse effect on our business.

In order to obtain FDA approval to market a new biological product, we or our partners must demonstrate proof of safety, purity and potency or efficacy in humans. To meet these requirements we or our partners will have to conduct adequate and well-controlled clinical trials. Before we or our partners can commence clinical trials for a product candidate, we or our partners must complete extensive preclinical testing and studies that support our planned INDs in the United States. All of our internally developed programs are in early clinical or preclinical development. We cannot be certain of the timely completion or outcome of our or our partners' preclinical testing and studies and cannot predict if the FDA will accept our or our partners' proposed clinical programs or if the outcome of our or our partners' preclinical testing and studies will ultimately support the further development of our product candidates. As a result, we cannot be sure that we or our partners will be able to submit INDs or similar applications for our product candidates on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin. Further, changes and cuts in FDA staffing have been reported as resulting in delays in the FDA’s responsiveness or in its ability to review IND submissions, or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion.

Conducting preclinical testing is a lengthy, time-consuming and expensive process. The length of time may vary substantially according to the type, complexity and novelty of the program, and often can be several years or more per program. Delays associated with programs for which we are directly conducting preclinical testing and studies may cause us or our partners to incur additional operating expenses. The commencement and rate of completion of preclinical studies and clinical trials for a product candidate may be delayed by many factors, including, for example:

•inability to generate sufficient preclinical or other in vivo or in vitro data to support the initiation of clinical studies;

•delays in reaching a consensus with regulatory agencies on study design; ~~and~~

•the FDA not allowing us to rely on previous findings of safety and efficacy for other similar but approved products and published scientific literature; and

•use of our product candidates could be associated with adverse side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us or our partners to suspend or discontinue preclinical or clinical trials, abandon a product candidate, limit the commercial profile of an approved product or result in other significant negative consequences.

Moreover, even if clinical trials do begin for our product candidates, our or our partners' development efforts may not be successful, and clinical trials that we or our partners conduct or that third parties conduct on our or our partners' behalf may not demonstrate sufficient safety, purity and potency or efficacy to obtain the requisite regulatory approvals for any of product candidates we develop. Even if we or our partners obtain positive results from preclinical studies or initial clinical trials, we or our partners may not achieve the same success in future trials.

If we or our partners experience any of a number of possible unforeseen or negative events in connection with preclinical or clinical development, regulatory approval or commercialization of product candidates generated through our platform, this could negatively affect our revenue

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~~product candidates generated through our platform, this could negatively affect our revenue~~ opportunity for that program, and/or have broader deleterious effects on our reputation and future partnership prospects.

We or our partners may experience numerous unforeseen events during, or as a result of, preclinical studies or any clinical trials that could delay or prevent the ability to conduct further development or obtain regulatory approval or licensure of, or commercialize, product candidates, including:

•preclinical studies designed to enable the submission of IND applications, or other preclinical development activities, by our partners may not result in data sufficient to support the advancement of the applicable product candidates into clinical development, or our partners may abandon development activities for such product candidates prior to any IND submission for a variety of reasons;

•regulatory authorities or ethical review boards, including IRBs, may not authorize commencement of a clinical trial or conduct a clinical trial at a prospective trial site;

•there may be delays in reaching or failure to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

•the FDA or other regulatory authorities may disagree with a clinical trial design or a sponsor’s interpretation of data even after such regulatory authorities have reviewed and commented on the clinical trial design;

•differences in trial design between early stage clinical trials and later-stage clinical trials may make it difficult to extrapolate the results of earlier clinical trials to later-stage clinical trials;

•the FDA or other regulatory authorities may disagree about whether study endpoints are clinically meaningful or recommend study endpoints that require lengthy periods of observation;

•the number of ~~patients~~participants, or amount of data, required to complete clinical trials may be larger than anticipated, ~~patient~~participant enrollment in these clinical trials may be slower than anticipated or patients may drop out of clinical trials at a higher rate than anticipated;

•CROs and other contracted third parties may fail to perform their duties in accordance with the study protocol or applicable laws and regulations;

•changes may be made to product candidates after commencing clinical trials, which may require that previously completed stages of clinical testing be repeated or delay later stages of testing;

•clinical trials may fail to satisfy the applicable regulatory requirements of the FDA or other regulatory authorities responsible for oversight of the conduct of clinical trials in other countries;

•regulators may elect to impose a clinical hold, or we or our partners, governing IRBs, data safety monitoring boards or ethics committees may elect to suspend or terminate our or our partners’ clinical research or trials for various reasons, including non-compliance with regulatory requirements or a finding that the participants are being exposed to undesirable side effects that could lead to serious adverse events or other unacceptable risks to their health or the privacy of their health information being disclosed;

•the cost of clinical trials of the applicable product candidates, or improvements to such product candidates, may be greater than we or our partners anticipate, causing us or our partners to delay or terminate applicable clinical development efforts;

•CROs and other contracted third parties may fail to perform their duties in accordance with the relevant manufacturing and/or clinical supply agreements;

•the supply or quality of materials necessary to conduct clinical trials of the applicable product candidates may be insufficient or inadequate;

•the outcome of our or our partners’ preclinical studies and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results;

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•product candidates may be associated with negative or inconclusive results in clinical trials, and we or our partners may decide to deprioritize or abandon these partnered product candidates, or regulatory authorities may require our partners to abandon them or may impose onerous changes or requirements, which could lead to de-prioritization or abandonment;

•the data collected from clinical trials of product candidates that we or our partners may identify and pursue may not be sufficient to support the submission of a BLA or other submission for regulatory approval in the United States or elsewhere; and

•we may be unable to demonstrate to the FDA or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable, or clinical trials may suggest or demonstrate that products are not safe and effective, or as safe and effective as competing therapies on the market or in development.

In addition, disruptions caused by a continued and prolonged public health emergency, such as the COVID-19 pandemic may increase the likelihood that we or our partners encounter such difficulties or delays in initiating, enrolling, conducting or completing planned and ongoing clinical trials. Delays of this nature could also allow competitors to bring products to market before we or our partners do, potentially impairing our or our partners’ abilities to successfully commercialize products generated using our platform technology and harming our business and results of operations. Any delays in, or suspension of, the development of the product candidates developed by us or by our partners using our technology may significantly harm our business, financial condition and prospects. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory clearance, authorization or approval of partnered product candidates in development.

Preliminary data and interim results we disclose from our clinical trials may change as more data becomes available or as we make changes to our clinical protocols or processes, and such interim results or results from earlier studies may not be predictive of the final results, or of later studies or future clinical trials.

We may from time to time disclose results from preclinical testing or preliminary data or interim results from clinical trials of our product candidates. Such results from preclinical testing, process development and manufacturing activities, and clinical studies, including interim clinical trial results as of specified data cutoff dates and results of earlier preclinical or clinical studies with similar product candidates, are not necessarily predictive of future results, including later clinical trial results. In addition, results in one indication may not be predictive of results to be expected for the same or a similar product candidate in another indication. A number of companies in the biopharmaceutical industry have suffered significant setbacks in clinical trials due to lack of efficacy or unfavorable safety profiles, notwithstanding promising results in preclinical development or earlier trials.

The results of our current and future clinical trials may differ from results achieved in earlier preclinical and clinical studies for a variety of reasons, including:

•we may not demonstrate the potency and efficacy benefits observed in previous studies;

•our efforts to improve, standardize and automate the manufacture and supply of our product candidates and any resulting deviations in the manufacture of our product candidates, may adversely affect the safety, purity, potency, stability, or efficacy of such product candidates;

•differences in study design, including differences in eligibility criteria and patient populations;

•advancements in the standard of care may affect our ability to demonstrate efficacy or achieve study endpoints in our future clinical trials; and

•safety issues or adverse events in patients who enroll in our clinical trials.

From time to time, we may publish interim, “top-line,” or preliminary data from our clinical studies based on a preliminary analysis of then-available data. Preliminary or interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as ~~patient~~participant enrollment continues, the duration of treatment increases and more patient data become available. For example, we may encounter unacceptable side effects for our product candidates as patient dosing progresses in our clinical trials and additional data become available. Our preliminary or interim results and related conclusions also are subject

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to change following a more comprehensive review of the data related to the particular study or trial. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Material adverse changes between preliminary, “top-line,” or interim data and final data could significantly harm our business prospects, financial condition and results of operations.

The clinical development of our product candidates could be substantially delayed if we are required to conduct unanticipated studies, including preclinical studies or clinical trials, or if the FDA imposes other requirements or restrictions including on the manufacture, of our product candidates.

The FDA may require us to generate additional preclinical, product, manufacturing, or clinical data as a condition to initiating and conducting any future clinical trials of our or our partners’ product candidates generated using our platform technology. Additionally, the FDA may in the future have comments, or impose requirements, on the initiation and conduct of our clinical trials or those of our partners, including trial endpoints and the protocols, processes, materials and facilities we or our partners use to manufacture our product candidates in support of clinical trials. Any requirements to generate additional data, or redesign or modify applicable endpoints, protocols, processes, materials or facilities, or other additional comments, requirements or impositions by the FDA, may cause delays in the initiation or conduct of future clinical trials for our or our partners’ product candidates and subsequent development activities, and could require us to incur additional development or manufacturing costs and resources, seek funding for these increased costs or resources or delay our timeline for, or cease, our preclinical or clinical development activities for our product candidates, or could create uncertainty and additional complexity in our ability to obtain regulatory approval for our product candidates and to achieve revenue-generating milestones under our agreements with our partners.

Further, if the results of our clinical trials are inconclusive, or if there are safety concerns or adverse events associated with our or our partners’ product candidates, we or our partners may:

•be delayed in obtaining, or unable to obtain, regulatory approval for such product candidates;

•be required to amend the protocols for the applicable clinical trials, perform additional nonclinical studies or clinical trials to support approval or be subject to additional post-marketing testing requirements;

•obtain approval for indications or patient populations that are not as broad as intended or desired;

•obtain approval with labeling that includes significant use or distribution restrictions or safety warnings or contraindications; or

•in the event a product candidate is approved, have regulatory authorities withdraw their approval of the product or impose restrictions on its use.

Even if our planned clinical trials are successful, we will need to conduct additional clinical trials, which may include registrational trials, trials in additional patient populations or under different treatment conditions, and trials using different manufacturing protocols, processes, materials or facilities or under different manufacturing conditions, before we are able to seek approvals for our product candidates from the FDA and regulatory authorities outside the United States to market and sell these product candidates. In addition, changes in regulatory policies, priorities or ~~the~~interpretations ~~administration~~by asregulatory aauthorities ~~result of the 2024 U.S. presidential election~~ may result in delays in ~~the~~ regulatory review and approval ~~process~~processes ~~and~~or ~~cause~~create uncertainty regarding approval pathways. If we fail to meet ~~the~~regulatory requirements necessary to support continued clinical development, if our clinical development activities ~~for any of our product candidates~~ are delayed or suspended, or if we ~~fail~~are unable to obtain or maintain regulatory approvals with an acceptable scope, our business, prospects, financial condition and results of operations ~~will~~could be ~~harmed~~adversely affected.

IfWe weare orcurrently ~~our~~conducting ~~partners~~and ~~encounter~~may ~~difficulties~~in ~~enrolling~~the ~~patients~~future inconduct clinical trials offor our product candidates ~~developed~~outside ~~using~~the ~~our~~United ~~Integrated Drug Creation platform~~States, ~~our~~ and ~~our~~the ~~partners’~~FDA ~~clinical~~may ~~development~~not ~~activities~~accept ~~could~~data befrom ~~delayed~~such ~~or otherwise adversely affected~~trials.

We are ~~required~~currently toevaluating ~~identify~~ABS-201 ~~and~~in ~~enroll~~ a ~~sufficient~~clinical ~~number~~trial ofin ~~patients~~Australia, ~~with~~and ~~the~~we ~~disease~~expect ~~under~~to ~~investigation~~continue ~~for~~to ~~each~~conduct oftrials for our ~~planned~~current and future product candidates internationally in the future. Conducting clinical trials ofin ~~internally~~foreign ~~developed~~jurisdictions ~~product~~may ~~candidates,~~expose us to additional risks and ~~our~~uncertainties, ~~partners~~including ~~are~~differences ~~subject~~in regulatory

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~~to the same~~ requirements, ~~with~~clinical ~~respect~~trial tostandards ~~product~~and ~~candidates~~regulatory ~~they~~interpretation ~~are~~by ~~developing~~foreign authorities. WeFor orexample, ~~our~~clinical ~~partners~~trials ~~may~~in ~~not~~Australia beare ~~able~~subject to ~~identify~~oversight ~~and~~by ~~enroll~~the aTherapeutic ~~sufficient~~Goods ~~number~~Administration ~~of patients~~(TGA), oras ~~those~~well ~~with~~as ~~required~~local orhuman ~~desired~~research ~~characteristics~~ethics ~~and~~committees. ~~who~~Compliance ~~meet~~with ~~specified~~these ~~enrollment~~requirements ~~criteria,~~may result in adelays ~~timely~~or ~~manner.~~additional ~~In addition~~costs, we and ~~our~~regulatory ~~partners~~authorities may ~~face~~impose ~~competition~~requirements ~~from~~that ~~other~~differ ~~clinical~~from ~~trials~~those of ~~product candidates being developed by our competitors in~~ the ~~same~~FDA. ~~therapeutic~~If ~~areas,~~we ~~and~~experience ~~potential~~delays ~~patients who might be eligible for enrollment~~ in ~~one~~initiating ~~of our~~ or conducting our ~~partners’~~ clinical trials ~~may instead choose to enroll~~ in aAustralia, ~~trial being conducted by a competitor. We and~~ our ~~partners~~development timelines may ~~also~~be ~~face~~adversely ~~an unwillingness of investigative sites to participate in our clinical trials~~affected.

Moreover, the acceptance of data from clinical trials conducted outside the United States by the FDA may be subject to certain conditions, or the FDA may not accept such data at all. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, regardless of whether such trials were conducted under an IND, the FDA will generally not approve the application on the basis of foreign data alone unless the data are applicable to the U.S. population and U.S. medical practice, the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations, and the FDA can validate the data through on-site inspections or other appropriate means. Many foreign regulatory authorities have similar approval requirements, including in relation to the use of data from clinical trials conducted in foreign jurisdictions. In addition, such foreign trials are subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA will accept data from trials conducted outside of the United States. If the FDA does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in any product candidates that we develop being delayed or not receiving approval for commercialization. Additionally, recent policy proposals in the United States may make acceptance by the FDA or inclusion in a marketing application of foreign data more difficult or costly.

Conducting clinical trials in Australia may expose us to operational and logistical challenges that could delay our development programs

Clinical trials conducted in Australia may involve additional operational and logistical challenges, including coordinating activities across international sites, managing clinical trial supply chains, and complying with foreign regulatory requirements. In addition, geopolitical events, public health emergencies, travel restrictions, or other factors could disrupt trial operations, participant enrollment or monitoring activities. Any such delays or disruptions could increase the cost of our clinical trials and delay the development of our product candidates.

Changes in Australian regulatory requirements or ethics committee processes could delay our clinical trials.

Clinical trials in Australia are subject to approval by local human research ethics committees and may also involve notification or review by the TGA. Changes in regulatory requirements, review procedures or timelines could delay the initiation or continuation of our clinical trials. If regulatory authorities or ethics committees impose additional requirements or determine that our trials do not comply with applicable regulations or guidelines, we may be required to modify or suspend our trials, which could adversely affect our development timelines.

If we or our partners encounter difficulties enrolling patients in clinical trials of product candidates developed using our Integrated Drug Creation platform, our and our partners’ clinical development activities could be delayed or otherwise adversely affected.

We are required to identify and enroll a sufficient number of patients with the disease under investigation for each of our planned clinical trials of internally developed product candidates, and our partners are subject to the same requirements with respect to product candidates they are developing. We or our partners may not be able to identify and enroll a sufficient number of patients, or those with required or desired characteristics and who meet specified enrollment criteria, in a timely manner. In addition, we and our partners may face competition from other clinical trials of product candidates being developed by our competitors in the same therapeutic areas, and potential patients who might be eligible for enrollment in one of our or our partners’ clinical trials may instead choose to enroll in a trial being conducted by a competitor. We and our partners may also face an unwillingness of investigative sites to participate in our clinical trials.

Our ability, and the ability of our partners, to enroll patients in clinical trials of product candidates developed using our platform technology is affected by factors including:

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•the ability to identify clinical trial sites and recruit clinical trial investigators with the appropriate capabilities, competencies and experience;

•the ability to open clinical trial sites;

•the ability to identify, solicit and recruit a sufficient number of patients;

•the severity of the disease under investigation;

•the design of the clinical trial and whether the FDA agrees to the design and implementation of the trial;

•the size and nature of the patient populations to be investigated in the applicable clinical trials;

•eligibility criteria for the clinical trials in question;

•clinicians’ and patients’ perceptions as to the potential risks and benefits of the product candidate under study, including any perceived risks associated with product candidates;

•changing medical practices or guidelines related to the indications we or our partners are investigating;

•the availability of competing therapies and clinical trials;

•efforts to facilitate timely enrollment in clinical trials;

•the availability of time and resources at the institutions at which our or our partners’ clinical trials will be conducted, including any constraints on resources, or policies and procedures implemented, at hospitals and clinical trial sites as a result of any public health crisis;

•the ability to monitor patients adequately during and after treatment; and

•the proximity and availability of clinical trial sites for prospective patients.

In addition, clinical trial sites may need to delay or pause ~~patient~~participant enrollment or treatment in clinical trials as a result of public health crises, supply chain shortages or a variety of factors beyond our control. The extent and duration of such delays and disruptions, and the overall impact on the timing and conduct of our or our partners’ clinical trials, are uncertain. If we or our partners have difficulties enrolling a sufficient number of patients to conduct clinical trials as planned, we or our partners may need to delay or terminate ongoing or planned clinical trials, which would have an adverse effect on our business, prospects, financial condition, results of operations, and the market price of our common stock.

The ~~biopharmaceutical~~markets ~~platform~~in ~~technology~~which ~~market~~we isoperate, ~~highly~~including ~~competitive,~~those ~~and~~for ifIntegrated weDrug ~~cannot~~Creation ~~compete~~platform ~~successfully~~technology ~~with~~and our ~~competitors~~Internally Developed Programs, weare ~~may~~highly becompetitive, ~~unable~~and toif ~~increase~~we orare ~~sustain~~unable ~~our~~to ~~revenue~~compete effectively, orour ~~achieve~~business and ~~sustain~~prospects ~~profitability~~could be adversely affected..

WeInternally face significant competition in the biopharmaceutical platform technology market, including from other pharmaceutical and biotechnology companies seeking to develop AI capabilities for biologic drug design. Our technologies address therapeutic discovery and bioproduction challenges that are addressed by other platform technologies controlled by companies that have a variety of business models, including the development of internally developed programs~~, technology licensing, discovery screening, cell line generation~~

37We may face competition from pharmaceutical and biotechnology companies that are developing therapeutics that address the same disease targets and/or indications addressed by our internally developed programs. Competitors may obtain FDA or other regulatory approval for their products more rapidly or earlier than us, which could result in our competitors establishing a strong market position before we are able to enter the market. Competition for our active internally developed programs may include:

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~~and~~•ABS-101: There are several companies with product candidates targeting TL1A in clinical development for the ~~sale~~treatment of ~~instruments~~IBD, ~~and~~including ~~devices.~~Merck’s ~~Potential~~MK-7240, ~~competitors~~Roche/Roivant’s ~~addressing~~RVT-3101, ~~certain~~Sanofi/Teva’s ~~steps~~TEV-48574 inTL1A, ~~the~~Spyre’s ~~target~~SPY002, ~~identification~~AbbVie’s ABBV-701, ~~drug~~and ~~discovery~~Xencor’s XmAb942. Beyond the competitors for IBD, orthere ~~adjacent~~will ~~aspects~~be additional competitors for the indications outside of ~~these~~IBD ~~broad~~that ~~processes~~we ~~include~~or ~~the~~a ~~following:~~potential partner may explore.

~~•we~~Integrated ~~may~~Drug ~~face~~Creation ~~competition from companies attempting to use AI to design novel biologic drugs such as Generate Biomedicines, Inc., and Xaira Therapeutics, Inc., among others;~~platform

~~•we~~Our ~~may~~Integrated ~~face~~Drug ~~competition~~Creation ~~from~~platform ~~companies~~comprises, ~~currently~~in ~~offering~~part, ~~adjacent~~cutting ~~technology~~edge ~~(e.g.~~generative AI~~-enabled~~ ~~small~~models ~~molecule~~aimed ~~design)~~at ~~that~~designing ~~may~~differentiated ~~seek~~antibody-based totherapeutics, ~~develop~~including ~~antibody~~against ~~design~~hard-to-drug ~~capabilities,~~targets. ~~such~~There asare ~~Recursion~~multiple ~~Pharmaceuticals,~~potential ~~Inc.,~~competitors ~~Relay~~developing ~~Therapeutics,~~technologies ~~Inc.,~~that ~~Isomorphic~~seek ~~Labs~~to ~~Limited,~~improve ~~and~~target ~~Schrodinger,~~identification ~~Inc.,~~and ~~among~~drug ~~others;~~design ~~and~~or discovery.

•More specifically, in the field of AI-based drug design and discovery we may face competition from ~~academic,~~companies ~~pharmaceutical~~attempting to use AI to design therapeutics. Representative examples include Generate Biomedicines, Inc. and ~~biotechnology~~Xaira ~~research~~Therapeutics, ~~initiatives~~Inc., asamong ~~well~~others. asIn ~~from~~the ~~private~~future ~~and~~we ~~publicly~~may ~~traded~~face competition from companies ~~focused~~currently onoffering ~~novel~~adjacent ~~methods~~technology ~~for~~(e.g. ~~target~~AI-enabled ~~identification~~small molecule design) that may seek to develop antibody design capabilities. Representative examples include Recursion Pharmaceuticals, ~~including~~Inc., ~~GV20~~and ~~Therapeutics~~Isomorphic Labs Limited, ~~Alchemab~~among ~~Therapeutics~~others. Moreover, other pharmaceutical and 3Tbiotechnology ~~Biosciences,~~companies ~~Inc~~seeking to develop AI capabilities for biologic drug design may also pose competition.

~~However,~~We inalso ~~some~~face ~~cases,~~competition wefrom ~~may~~entities ~~wish~~that tohave ~~collaborate~~made ~~with~~substantial ~~such~~investments ~~companies~~in ifdeveloping ~~synergies~~treatments ~~with~~for the therapeutic indications which our ~~Integrated~~internal ~~Drug~~programs ~~Creation~~and ~~platform~~partnered ~~are~~programs ~~identified~~target. These competitors may include large and specialty pharmaceutical and biotechnology companies.

In the broader field of antibody therapeutic development, we may face competition from pharmaceutical and biotechnology companies that are developing therapeutics that address the same disease targets and/or indications addressed by our internally developed programs, including:

•in the field of developing antibody therapeutics targeting TL1A for the treatment of inflammatory bowel disease, we are aware of several companies with product candidates in clinical development, including Merck’s MK-7240, Roche/Roivant’s RVT-3101, Sanofi/Teva’s TEV-48574 TL1A, Spyre’s SPY002, and Xencor’s XmAb942; and

•in the field of developing antibody therapeutics targeting PRLR for the treatment of androgenic alopecia, we are aware of Hope Medicine’s HMI-115.

Our partners may also elect to develop their processes on in-house systems, or using other methods, rather than implementing our technologies and may decide to stop using our technologies. These companies are likely to exhaust all internal alternatives to our technology before adopting our technologies. In addition, there are many large established companies in the life science technology market that we do not currently compete with but that could develop systems, technologies, tools or other products that will compete with us in the future. These large established companies have substantially greater financial and other resources than us, including larger research and development organizations or more established marketing and sales forces.

Our competitors and potential competitors may enjoy a number of competitive advantages over us. For example, these may include:

•longer operating histories;

•larger partner bases;

•greater brand recognition and market penetration;

•greater financial resources;

•greater technological and research and development resources;

•better system reliability and robustness;

•greater business development capabilities; and

•better established, larger scale and lower cost manufacturing capabilities.

As a result, our platform-based competitors and potential competitors may be able to respond more quickly to changes in partner requirements, devote greater resources to the development, promotion and sale of their platforms or solutions than we can, or sell their platforms or solutions, or offer solutions competitive with our Integrated Drug Creation platform and solutions at prices designed to win significant levels of market share. In addition, we may encounter challenges in marketing our solutions with our pricing model, which is structured to capture the potential downstream revenues associated with product candidates that were discovered using our platform. Our partners and potential partners may prefer one or more pricing models employed by our competitors that involve upfront payments rather than downstream revenues. We may not be able to compete effectively against these organizations.

38In addition, competitors may be acquired by, receive investments from or enter into other commercial relationships with larger, well-established and well-financed companies. Certain of our competitors may be

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~~competitors~~able ~~that~~to ~~involve~~secure ~~upfront~~key ~~payments~~inputs ~~rather~~from vendors on more favorable terms, devote greater resources to marketing and promotional campaigns, adopt more aggressive pricing policies and devote substantially more resources to technology and platform development than ~~downstream~~we ~~revenues~~can. WeIf ~~may~~we ~~not~~are beunable ~~able~~ to compete ~~effectively~~successfully against ~~these~~current ~~organizations~~and future competitors, we may be unable to increase market adoption of our platform technologies for the biologic drug discovery and cell line development, which could prevent us from increasing our revenue or achieving and sustaining profitability.

InWe ~~addition,~~face ~~competitors~~competition ~~may~~from beentities ~~acquired~~that ~~by,~~have ~~receive~~made substantial investments ~~from or enter~~ into ~~other~~the ~~commercial~~rapid ~~relationships~~development ~~with larger, well-established and well-financed companies. Certain~~ of ~~our~~novel ~~competitors~~treatments ~~may~~for bethe ~~able~~therapeutic toindications ~~secure~~in ~~key~~which inputs from vendors on more favorable terms, devote greater resources to marketing and promotional campaigns, adopt more aggressive pricing policies and devote substantially more resources to technology and platform development than we ~~can. If we~~ are ~~unable~~engaged toin ~~compete~~internally ~~successfully~~developed ~~against~~programs ~~current~~ and ~~future~~partnered ~~competitors~~programs, weincluding ~~may~~large ~~be unable to increase market adoption of our platform technologies for the biologic drug discovery~~ and ~~cell~~specialty ~~line~~pharmaceutical ~~development, which could prevent us from increasing our revenue or achieving~~ and ~~sustaining~~biotechnology ~~profitability~~companies.

We face competition from entities that have made substantial investments into the rapid development of novel treatments for the therapeutic indications in which we are engaged in partnered programs and internally developed programs, including large and specialty pharmaceutical and biotechnology companies.

The discovery and development of therapies is highly competitive. Many of our competitors have significantly greater resources and experience than we do and we or our partners may not be able to successfully compete in therapeutic development. We will likely face substantial competition from multiple sources, including large and specialty pharmaceutical and biotechnology companies, hospitals and clinics, academic research institutions and governmental agencies and public and private research institutions, some of which have more advanced product candidates. We anticipate that we will continue to face increasing competition as new therapies and combinations thereof, and related data, emerge.

To compete successfully, we and our partners must demonstrate that the relative cost, method of administration, safety, tolerability or efficacy of the related product candidates provides a better alternative to existing and future therapies and, we must do the same with respect to any future internally developed product candidates. Our commercial opportunity and likelihood of success will be reduced or eliminated if these product candidates are not ultimately demonstrated to be safer, more effective, more conveniently administered, or less expensive than the then current standard of care. Furthermore, even if these product candidates demonstrate meaningful improvements in these attributes, acceptance of our products may be inhibited by the reluctance of physicians to switch from existing therapies to our products, or if physicians choose to reserve our products for use in limited circumstances.

The market for our platform, including potential partners and potential investors, may be skeptical of the viability and benefits of our Integrated Drug Creation platform because it is based on novel and complex synthetic biology and AI technologies.

The market for our Integrated Drug Creation platform, including potential partners and potential investors, may be skeptical of the viability and benefits of our technology platform because it is based on novel and complex synthetic biology and AI technologies. There can be no assurance that our technologies will be understood, approved, or accepted by potential partners and potential investors or that we will be able to enter into new partnerships with new or existing partners. The synthetic biology and AI-powered drug discovery markets are relatively new, and potential partners may be hesitant to allocate resources in relatively unproven fields. If we are unable to convince these potential partners of the utility and value of our technologies or that our technologies are superior to the technologies they currently use, we will not be successful in entering these markets and our business and results of operations will be adversely affected. If potential investors are skeptical of the success of our technologies, our ability to raise capital and the value of our stock may be adversely affected.

We rely and expect to continue to rely on third parties to conduct our preclinical studies and ~~any eventual~~ clinical trials. If those third parties do not perform as contractually required, fail to satisfy legal or regulatory requirements, miss expected deadlines or the relationship terminates prematurely, our internally developed programs could be delayed, more costly or unsuccessful, and such programs may never obtain regulatory approval or commercialization.

We have relied and intend to rely in the future on third-party clinical investigators, contract development and manufacturing organizations (CDMOs), CROs, and clinical data management organizations to conduct, supervise and monitor preclinical studies and any eventual clinical trials of our current or future internally developed programs. Because we currently rely and intend to continue to rely on these third parties, we will have less control over the timing, quality and other aspects of preclinical studies and any eventual clinical trials than if we conducted them independently. These parties are not, and will not be, our employees and we will have limited control over the amount of time and resources that they dedicate to our programs. Additionally, such parties may have contractual relationships with other entities, some of which may be our competitors, which may draw time and resources from our programs.

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~~have~~Our ~~less~~reliance ~~control~~on ~~over~~these ~~the~~third ~~timing,~~parties ~~quality~~for ~~and~~development ~~other~~activities ~~aspects~~will ofreduce ~~preclinical~~our ~~studies~~control ~~and~~over ~~any~~these ~~eventual~~activities. ~~clinical~~Nevertheless, ~~trials~~we ~~than~~will ifremain weresponsible ~~conducted~~for ~~them~~ensuring ~~independently.~~that ~~These~~each ~~parties~~of our preclinical studies are ~~not,~~conducted ~~and~~in ~~will~~accordance ~~not~~with ~~be,~~good ~~our~~laboratory ~~employees~~practices and wethat ~~will~~our ~~have~~clinical ~~limited~~trials ~~control~~are ~~over~~conducted ~~the~~in ~~amount~~accordance ofwith ~~time~~GCPs. ~~and~~Moreover, ~~resources~~our ~~that~~business ~~they~~may ~~dedicate~~be tosignificantly ~~our~~impacted ~~programs.~~if ~~Additionally~~our CROs, ~~such~~clinical ~~parties~~investigators ~~may~~or ~~have~~other ~~contractual~~third ~~relationships~~parties ~~with~~violate ~~other~~federal ~~entities,~~or ~~some~~state ofhealthcare ~~which~~fraud ~~may~~and beabuse ~~our~~or ~~competitors,~~false ~~which~~claims ~~may~~laws ~~draw~~and ~~time~~regulations ~~and~~or ~~resources~~healthcare ~~from~~privacy ~~our~~and ~~programs~~security laws.

~~Our~~In ~~reliance~~the onevent ~~these~~we ~~third~~are ~~parties~~required ~~for~~to ~~development~~repeat, ~~activities~~extend, ~~will~~delay ~~reduce~~or terminate our ~~control~~preclinical ~~over~~or ~~these~~clinical development activities. ~~Nevertheless,~~due weto ~~will~~one ~~remain~~or ~~responsible~~more ~~for~~third ~~ensuring~~parties ~~that~~not ~~each~~successfully ofcarrying ~~our~~out ~~preclinical~~its ~~studies~~contractual ~~are~~duties, ~~conducted~~meeting expected deadlines, or conducting development activities in accordance with ~~good~~regulatory ~~laboratory~~requirements ~~practices~~or ~~and~~our ~~that~~stated ~~any~~protocols, ~~eventual~~we ~~clinical~~may ~~trials~~not ~~are~~be ~~conducted~~able to achieve, or may be delayed in ~~accordance~~achieving, ~~with~~product ~~GCPs~~development milestones, including our internal timelines or certain regulatory requirements. ~~Moreover~~As a result, our ~~business~~results ~~may~~of beoperations ~~significantly~~and ~~impacted~~the ifcommercial prospects for our ~~CROs,~~internally ~~clinical~~developed ~~investigators~~programs orwould ~~other~~be ~~third~~harmed, ~~parties~~our ~~violate~~costs ~~federal~~could orincrease, ~~state~~and ~~healthcare~~our ~~fraud~~ability to generate revenue and ~~abuse~~platform orvalidation ~~false~~could ~~claims~~be ~~laws~~delayed. To the extent we are unable to successfully identify and ~~regulations~~manage orthe ~~healthcare~~performance ~~privacy~~of third-party service providers in the future, our business may be materially and ~~security~~adversely ~~laws~~affected.

In ~~the~~addition, ~~event~~from time to time we ~~are~~have ~~required~~relied upon, and may continue to ~~repeat,~~rely ~~extend~~upon, ~~delay~~third orparties ~~terminate~~that ~~our~~are ~~preclinical~~based orin ~~any~~jurisdictions ~~eventual~~outside ~~clinical~~the ~~development~~United ~~activities~~States, ~~due~~including toChina. ~~one~~In orDecember ~~more~~2025, ~~third~~as ~~parties~~part ~~not~~of ~~successfully~~the ~~carrying~~Fiscal ~~out~~Year ~~its~~2026 ~~contractual~~National ~~duties~~Defense Authorization Act, ~~meeting~~the ~~expected~~BIOSECURE ~~deadlines,~~Act orwas ~~conducting~~enacted ~~development~~and ~~activities~~restricts U.S. federal agencies from entering into certain contracts and providing certain grants or loans in ~~accordance~~connection with ~~regulatory~~the ~~requirements~~procurement or ~~our~~use ~~stated~~of ~~protocols,~~biotechnology weequipment ~~may~~or ~~not~~services beprovided ~~able~~by toentities ~~achieve~~designated as “biotechnology companies of concern,” orand ~~may~~also berestricts ~~delayed~~federal incontracting, ~~achieving~~grants, ~~product~~and ~~development~~loans ~~milestones,~~to ~~including~~entities ~~our~~that ~~internal~~use ~~timelines~~such biotechnology equipment or ~~certain~~services ~~regulatory~~in ~~requirements~~performance of covered federal awards. AsAlthough aearlier ~~result~~legislative proposals commonly referred to as the “BIOSECURE Act” identified certain China-based biotechnology service providers by name, ~~our~~the ~~results~~enacted law contemplates an implementing process under which the Office of ~~operations~~Management and ~~the~~Budget ~~commercial~~is ~~prospects~~expected to publish an initial list of biotechnology companies of concern within one year of enactment, and implementing guidance and procurement rule updates are expected to follow. If any third parties upon whom we rely, including for ~~our~~example, ~~internally~~WuXi ~~developed~~entities, ~~programs~~are ~~would~~designated bein ~~harmed~~the future, or if our ~~costs~~current ~~could~~or ~~increase~~prospective partners, ~~and~~customers, ~~our~~or ~~ability~~counterparties tochange ~~generate~~their ~~revenue~~policies ~~and~~or ~~platform~~contractual ~~validation~~requirements ~~could~~in beresponse ~~delayed~~to the BIOSECURE Act or related U.S. Tonational ~~the~~security ~~extent~~measures, we ~~are~~could ~~unable~~face supply-chain disruptions, delays, increased costs, constraints on our ability (or our partners’ ability) to ~~successfully~~perform ~~identify~~under ~~and~~certain ~~manage~~government-funded projects, or the ~~performance~~need ofto ~~third-party~~transition to alternative suppliers or service providers, inany ~~the~~of ~~future,~~which could adversely affect our business, ~~may~~results beof ~~materially~~operations, and ~~adversely affected~~prospects.

In addition, from time to time we have relied upon, and may continue to rely upon, third parties that are based in jurisdictions outside the United States. Legislative proposals are pending that, if enacted, could negatively impact U.S. funding for certain biotechnology providers having relationships with foreign adversaries or which pose a threat to national security. If any of the third parties upon whom we rely are impacted by these legislative proposals, the potential downstream adverse impacts are unknown but may include supply chain disruptions or delays.

If any of our relationships with these third parties terminate for any reason, including due to involuntary termination, regulatory or other compliance requirements, or strategic reprioritization, we may not be able to enter into alternative arrangements or do so on commercially reasonable terms. Switching or adding additional contractors requires additional resources and demands management time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, delays could occur, which could compromise our ability to meet our internal development timelines. In addition, if an agreement with any of our partners terminates, our access to technology and intellectual property licensed to us by that partner may be restricted or terminate entirely, which may delay our continued development of our internally developed programs utilizing the partner’s technology or intellectual property or require us to stop development of those internally developed programs completely.

In addition, principal investigators for our clinical trials, ~~if any,~~ may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA. The FDA may conclude that a financial relationship between us and/or a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA and may ultimately lead to the denial of regulatory approval of one or more of our product candidates~~, if any~~.

We could experience clinical supply and manufacturing problems that result in delays in the development, approval or commercialization of our product candidates or otherwise harm our business.

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The manufacturing process used to produce antibodies may be complex. Several factors could cause production interruptions, including inability to develop appropriate manufacturing processes, equipment malfunctions, facility contamination, raw material shortages or contamination, natural disasters, including pandemics, disruption in utility services, human error or disruptions in the operations of our suppliers, including acquisition of a supplier by a third party or declaration of bankruptcy. The expertise required to manufacture our product candidates may be unique to a particular third-party contract manufacturing organization, and as a result, it would be difficult and time consuming to find an alternative third-party contract manufacturing organization. Failure or process defects in any of the interrelated systems at either our manufacturing facility or those of our third-party manufacturers, could adversely impact our ability to manufacture and supply cell therapy product candidates and certain components thereof intended for research, clinical and, if approved, commercial production. In addition, we may rely on third-party contract manufacturers outside the United States for certain components of our product candidates, and may be subject to importation regulations that may affect our ability to manufacture or increase the cost of our product candidates.

Our product candidates will require processing steps that are more complex than those required for most small molecule drugs. Moreover, unlike small molecules, the physical and chemical properties of biologics such as antibody-based therapeutics generally cannot be fully characterized. As a result, assays of the finished product may not be sufficient to ensure that the product will perform in the intended manner. Accordingly, we will employ multiple steps to control the manufacturing process to assure that the process works and the product candidate is made strictly and consistently in compliance with the process. Problems with the manufacturing process, even minor deviations from the normal process, could result in product defects or manufacturing failures that result in lot failures, product recalls, product liability claims or insufficient inventory, or other supply disruptions. If microbial, viral or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, production at such manufacturing facilities may be interrupted for an extended period of time to investigate and remedy the contamination. We may encounter problems achieving adequate quantities and quality of clinical grade materials that meet FDA, the EMA or other applicable standards or specifications with consistent and acceptable production yields and costs.

We also may encounter problems hiring and retaining directly or through third-party contract manufacturing organizations the experienced scientific, quality assurance, quality control and manufacturing personnel needed to operate our manufacturing processes, which could result in delays in production or difficulties in maintaining compliance with applicable regulatory requirements. Any problems in our supply chain, manufacturing process or facilities could result in delays in ongoing or planned clinical trials and increased costs, and could make us a less attractive collaborator for potential partners, including larger pharmaceutical companies and academic research institution.

If we do not achieve our projected development goals in the timeframes we announce and expect, the clinical development of our programs, commercialization of our programs, and validation of our Integrated Drug Creation platform may be delayed and our expenses may increase and, as a result, our stock price may decline.

From time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of preclinical studies and clinical trials, as well as the submission of regulatory filings. From time to time, we may publicly announce the expected timing of achieving certain of these milestones. All of these milestones are and will be based on numerous assumptions. The actual timing of these milestones can vary dramatically compared to our estimates, in some cases for reasons beyond our control. If we do not meet these milestones as publicly announced, or at all, the commercialization of our programs or the validation of our platform technologies based on anticipated achievement of these milestones, may be delayed or never achieved and, as a result, our stock price may decline. Additionally, delays relative to our projected timelines are likely to cause overall expenses to increase, which may require us to raise additional capital sooner than expected and prior to achieving targeted development milestones.

The medical insurance coverage and reimbursement status of newly approved therapeutics is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for current or ~~future products and services could limit our partners’ ability to successfully commercialize product candidates, which would decrease our ability to generate revenue.~~

The availability and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford any antibody therapeutics generated using our Integrated Drug Creation platform. In addition, because the product candidates we generate may represent new classes of treatments for diseases, we and our partners cannot accurately estimate how such future antibody therapeutics would be priced, whether reimbursement could be obtained or any potential revenue generated. Sales of such antibody therapeutics will depend substantially, both domestically and internationally, on the extent to which the costs of such antibody therapeutics are paid by health maintenance, managed care, pharmacy 50

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~~benefit~~future ~~and~~products ~~similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers~~ and ~~other~~services ~~third-party~~could ~~payors.~~limit ~~If reimbursement is not available, or is available only to limited levels,~~ our partners’ ~~may~~ability ~~not be able~~ to successfully commercialize ~~some~~product ~~antibody therapeutics generated with our technology. Even if coverage is provided~~candidates, ~~the~~which ~~approved~~would ~~reimbursement~~decrease ~~amount may not be high enough to allow~~ our ~~partners~~ability to ~~establish~~generate or maintain pricing sufficient to realize an adequate return on their investment in such antibody therapeutics, and may lead to discontinuation or deprioritization of development, marketing and sales efforts for such productsrevenue. ~~Changes in the reimbursement landscape may occur, which are outside of our control, and may impact the commercial viability of our drug creation services and/or product candidates.~~

~~There~~The availability and extent of reimbursement by governmental and private payors is ~~significant~~essential ~~uncertainty~~for ~~related~~most patients to be able to afford any antibody-based therapeutics generated using our Integrated Drug Creation platform. In addition, because the ~~insurance~~product ~~coverage~~candidates ~~and~~we ~~reimbursement~~generate may represent new classes of ~~newly~~treatments ~~cleared~~for diseases, ~~authorized~~we orand ~~approved~~our partners cannot accurately estimate how such future antibody-based therapeutics inwould ~~the~~be ~~United~~priced, ~~States~~whether ~~and~~reimbursement ~~other~~could ~~jurisdictions.~~be ~~Due~~obtained toor ~~the~~any ~~trend~~potential ~~toward~~revenue ~~value~~generated. Sales of such antibody-based ~~pricing~~therapeutics will depend substantially, both domestically and ~~coverage~~internationally, on the ~~increasing~~extent ~~influence~~to which the costs of such antibody-based therapeutics are paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and ~~additional~~other ~~legislative~~third-party ~~changes~~payors. If reimbursement is not available, weor ~~expect~~is available only to limited levels, our partners tomay ~~experience~~not ~~pricing~~be ~~pressures~~able onto successfully commercialize some antibody-based therapeutics generated ~~using~~with our ~~Integrated~~technology. ~~Drug~~Even ~~Creation~~if ~~platform~~coverage ~~that~~is provided, the approved reimbursement amount may not be high enough to allow our partners ~~may~~to ~~commercialize.~~establish ~~The~~or ~~downward~~maintain ~~pressure~~pricing sufficient to realize an adequate return on ~~healthcare~~their ~~costs~~investment in ~~general,~~such ~~particularly~~antibody-based ~~novel~~ therapeutics, ~~has~~and ~~become~~may ~~very~~lead ~~intense.~~to Asdiscontinuation aor ~~result~~deprioritization of development, ~~increasingly~~marketing ~~high~~and ~~barriers~~sales ~~are~~efforts ~~being~~for ~~erected~~such toproducts. Changes in the ~~entry~~reimbursement oflandscape ~~new~~may ~~products~~occur, which ~~would~~are ~~negatively~~outside of our control, and may impact the commercial viability of our ~~ability~~drug tocreation ~~generate~~services ~~revenues.~~and/or product candidates.

There is significant uncertainty related to the insurance coverage and reimbursement of newly cleared, authorized or approved antibody-based therapeutics in the United States and other jurisdictions. Due to the trend toward value-based pricing and coverage, the increasing influence of health maintenance organizations and additional legislative changes, we expect our partners to experience pricing pressures on antibody-based therapeutics generated using our Integrated Drug Creation platform that our partners may commercialize. The downward pressure on healthcare costs in general, particularly novel therapeutics, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products, which would negatively impact our ability to generate revenues.

For more information about third-party coverage and reimbursement for pharmaceutical products, see the section of this Annual Report titled, “Business—Government Regulation—Biopharmaceutical Coverage and Reimbursement.”

The pharmaceutical industry is intensely competitive. If we are unable to compete effectively with existing drugs, new treatment methods and new technologies, we may be unable to commercialize successfully any drugs that we develop

The pharmaceutical industry is intensely competitive and rapidly changing. Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are pursuing the development of novel drugs for the same diseases that we are targeting or expect to target. Many of our competitors have:

• much greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization of products;

• more extensive experience in designing and conducting preclinical studies and clinical trials, obtaining regulatory approvals, and manufacturing, marketing and selling pharmaceutical products;

• product candidates that are based on previously tested or accepted technologies;

• products that have been approved or are in late stages of development; and

• collaborative arrangements in our target markets with leading companies and research institutions.

We will face intense competition from drugs that have already been approved and accepted by the medical community for the treatment of the conditions for which we may develop products. We also expect to face competition from new drugs that enter the market. We believe a significant number of drugs are currently under development, and may become commercially available in the future, for the treatment of conditions that our current or future product candidates are or may be designed to treat. These drugs may be more effective, safer, less expensive, or marketed and sold more effectively, than any products we develop. Our competitors may develop or commercialize products with significant advantages over any products we are able to develop and commercialize based on many different factors, including:

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• the safety and effectiveness of our products relative to alternative products, if any;

• the ease with which our products can be administered and the extent to which patients accept relatively new routes of administration;

• the timing and scope of regulatory approvals for these products;

• the availability and cost of manufacturing, marketing and sales capabilities;

• price;

• more extensive coverage and higher levels of reimbursement; and

• patent position.

Our competitors may therefore be more successful in developing and/or commercializing their products than we are, which could adversely affect our competitive position and business. Competitive products may make any products we develop obsolete or noncompetitive before we can recover the expenses of developing and commercializing our product candidates.

If we or third parties with whom we do business fail to comply with applicable healthcare laws and regulations, we could be subject to enforcement actions and other consequences.

Our business is subject to extensive federal, state, local, and foreign healthcare laws and regulations that may constrain the financial arrangements and relationships through which we conduct our operations, including our relationships with third-party payors, healthcare providers, and other third parties. These laws and regulations include, among others, U.S. federal and state anti-kickback, fraud and abuse, and false claims laws; healthcare transparency and reporting requirements (including reporting of payments and other transfers of value to certain healthcare professionals and institutions); certain government price reporting and drug pricing transparency requirements; and, to the extent applicable, patient privacy and data protection and anti-bribery laws. Many of these laws are broad, and their scope and enforcement are subject to evolving interpretation and enforcement priorities.

If our operations, or the operations of our collaborators, vendors, service providers, or other third parties with whom we do business, are found to be in violation of applicable healthcare laws or regulations, we could be subject to significant consequences, which may include administrative, civil, and criminal penalties; damages, fines, and disgorgement; reputational harm; the curtailment or restructuring of operations; enhanced compliance obligations (including integrity oversight and reporting); and exclusion from participation in federal and state healthcare programs, and responsible individuals may be subject to imprisonment. Any investigation or enforcement action, even if ultimately resolved favorably, could be costly, could divert management attention, and could materially adversely affect our business, financial condition, results of operations, and prospects.

For additional information, see the section of this Annual Report titled, “Business—Government Regulation—Healthcare Laws and Regulations.”

Healthcare reform efforts aimed at lowering the price of biopharmaceutical products may impact our ability to maintain sufficient profits.

Payors, whether domestic or foreign, or governmental or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically adapted for new technologies. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably, including through increased pricing and reimbursement pressure, expanded manufacturer discount and rebate obligations, and other cost-containment measures affecting access to and payment for biopharmaceutical products. In particular, in 2010, the Patient Protection and Affordable Care Act, as amended by the ACA, was enacted, which, among other things, subjected biologic products to potential competition by lower-cost biosimilars; addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, effective as of January 1, 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and provided incentives to programs that increase the federal government’s comparative effectiveness research. If efforts to contain the price of biopharmaceutical products are successful, the magnitude of milestone payments and royalties we would expect to receive in connection with our partners’ future prioritization and investment in developing novel biologics may be impacted.

Furthermore in August 2022, the IRA was enacted, which among other things: allows for the Centers for Medicare & Medicaid Services to impose price controls for certain single-source drugs and biotherapeutics reimbursed under Medicare Part B and Part D. Over time, the IRA could reduce the revenues we are able to collect from sales of products developed using our platform; however, the degree of impact that the IRA will ultimately have upon our business remains unclear.52

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increase the federal government’s comparative effectiveness research. If efforts to contain the price of biopharmaceutical products are successful, the magnitude of milestone payments and royalties we would expect to receive in connection with our partners’ future prioritization and investment in developing novel biologics may be impacted.

The growing legislative and enforcement interest in the United States with respect to drug pricing practices has resulted in several U.S. Congressional inquiries and federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs, and review the relationship between pricing and manufacturer patient programs. These initiatives, and other future reforms, may increase pricing and reimbursement pressure on manufacturers, expand discount and rebate obligations, constrain permissible pricing practices, increase reporting and compliance burdens, and otherwise adversely affect the commercial viability of biopharmaceutical products. We cannot predict the likelihood, nature, timing, or extent of future healthcare reform initiatives, executive actions, or other policy changes; however, ongoing reforms and cost-containment measures could materially and adversely affect our business, financial condition, results of operations, and prospects. For additional information, see the section of this Annual Report titled, “Business—Government Regulation—Healthcare Reform.”

Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.

In June 2024, the U.S. Supreme Court overruled the Chevron doctrine, which gave deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous. This decision may result in more lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, which could undermine the FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, any of which could delay the FDA’s review of our regulatory submissions. We cannot predict the full impact of this decision, future judicial challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative action. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability.

42Disruptions to the operations of the FDA, the SEC or other government agencies, including due to funding shortages, government shutdowns, policy changes or staffing reductions, could delay regulatory reviews, approvals or other governmental actions on which our business depends, which could adversely affect our business.

The ability of the FDA or comparable foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes that may otherwise affect the FDA’s ability to perform routine functions. In addition, government funding of the SEC and other government agencies or comparable foreign regulatory authorities on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would harm our business. Changes and cuts in FDA staffing have been reported as resulting in delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion.

Similar consequences would also result in the event of another significant shutdown of the federal government. For example, over the last several years, including from October 1, 2025 to November 12, 2025, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, or if geopolitical or global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Such changes could significantly impact the ability of the FDA to timely review and take action on our regulatory submissions, which could have a material adverse effect on our business, including, for example, INDs placed on clinical holds or delayed new

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ofdrug ~~new~~approvals. ~~requirements~~If orthe ~~policies,~~FDA oris ifconstrained wein ~~are~~its ~~not~~ability ~~able~~ to ~~maintain~~engage ~~regulatory~~in ~~compliance~~oversight and implementation activities in the normal course, weour business may ~~lose~~be ~~any~~negatively ~~marketing~~impacted. ~~approval~~Further, ~~that~~in weour ~~may~~operations ~~have~~as ~~obtained~~a public company, future government shutdowns or substantial leadership, personnel, and wepolicy ~~may~~changes ~~not~~could ~~achieve~~impact orour ~~sustain~~ability ~~profitability~~to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

~~Changes~~There inis ~~funding~~ongoing ~~for,~~uncertainty orregarding ~~disruptions~~potential changes to the ~~operations~~requirements, policies and priorities of, the FDA, ~~the SEC~~ and other ~~government~~regulatory ~~agencies,~~authorities ~~including~~with ~~from~~jurisdiction ~~government~~over ~~shut~~our ~~downs,~~product ~~could~~candidates ~~hinder~~and ~~their~~any ~~ability~~products tofor ~~hire~~which ~~and~~we ~~retain~~may ~~key~~seek ~~leadership~~approval. ~~and~~Changes ~~other~~in ~~personnel~~governmental policies, ~~prevent~~agency ~~new~~priorities, ~~products~~funding ~~and~~levels ~~services~~or ~~from~~personnel ~~being~~at ~~developed~~regulatory oragencies ~~commercialized~~could inaffect athe agencies’ ability to provide timely ~~manner~~guidance, review regulatory submissions or ~~otherwise~~approve ~~prevent~~product ~~those~~candidates. ~~agencies~~For ~~from~~example, ~~performing~~reductions ~~normal~~in ~~business~~staffing ~~functions~~levels onor ~~which~~other ~~the~~operational ~~operation~~changes ofat regulatory agencies could result in delays in our ~~business~~ability ~~may~~to ~~rely,~~obtain ~~which~~regulatory ~~could~~feedback ~~negatively~~or ~~impact~~approvals for our ~~business~~product candidates.

~~Currently~~In addition, federal, ~~agencies~~state inor ~~the~~other ~~United~~governmental ~~States~~authorities ~~are~~may ~~operating~~adopt ~~under~~new alaws, ~~continuing~~regulations, ~~resolution~~policies ~~that~~or isguidance ~~set~~that toaffect ~~expire~~the ondevelopment, ~~September 30~~approval, ~~2025.~~manufacturing ~~Without~~or ~~appropriation~~commercialization of ~~additional~~therapeutic ~~funding to federal agencies, our business operations related to our product development activities for the U~~products.S. ~~market~~Such changes could becreate ~~impacted.~~additional ~~The~~regulatory ~~ability~~requirements, ofincrease the ~~FDA~~cost toor ~~review~~complexity ~~and approve new products can be affected by a variety~~ of ~~factors~~development, ~~including~~or ~~government~~otherwise ~~budget~~adversely ~~and~~affect ~~funding~~our ~~levels,~~ ability to ~~hire~~develop and ~~retain~~obtain ~~key~~approval ~~personnel~~for ~~and~~our ~~accept~~product ~~the~~candidates. ~~payment~~Any ofsuch ~~user fees, and statutory, regulatory and policy~~ changes. ~~Average~~could ~~review times at the agency~~ have ~~fluctuated in recent years as~~ a ~~result.~~material ~~Disruptions~~adverse ateffect ~~the~~on ~~FDA~~our ~~and~~business, ~~other~~financial ~~agencies~~condition ~~may also slow the time necessary for new product candidates to be reviewed~~ and~~/or~~ ~~approved~~results byof ~~necessary government agencies, which would adversely affect our business~~operations.

For example, over the last several years the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

We expect to make significant investments in our continued research and development of new technology, which may not be successful.

We are seeking to expand the scope of our capabilities, which may or may not be successful. This includes, but is not limited to, drug discovery, and application of AI across our Integrated Drug Creation platform. We expect to incur significant expenses to advance these research and development efforts or to invest in, or acquire complementary technologies, but these efforts may not be successful. For instance, we have limited experience with the discovery and development of antibody-based therapeutics. Additional development will be required for the routine and robust use of these technologies in both our internally developed and partnered programs. Through the course of additional technology development, significant unanticipated challenges may arise that adversely affect our future internally developed programs and partnership prospects. We continue to invest in the development and identification of new technologies to further broaden and deepen our capabilities and expertise in AI-powered drug creation and integrate generative AI deep learning technology and computational antibody and target discovery technology into our Integrated Drug Creation platform to shorten drug discovery timelines. Our long-term goals for this technology, such as constructing deep learning models capable of in silico target identification and drug and cell line design, continue to require significant investment and long development timelines and may ultimately never fully materialize.

Developing new technologies is a speculative and risky endeavor. Technologies that initially show promise may fail to achieve the desired results or may not achieve acceptable levels of analytical accuracy or clinical utility. We may need to alter our technologies in development before we identify a potentially successful technology. Technology development is expensive, may take years to complete and can have uncertain outcomes. Failure can occur at any stage of the development. Additionally, development of any technology may be disrupted or made less viable by the development of competing technologies, and changes in the industry in which our technologies are applied could obsolete our technologies. New potential technologies may fail any stage of development or commercialization and if we determine that any of our current or future technologies are unlikely to succeed, we may abandon them without any return on our investment. If we are unsuccessful in developing or acquiring additional technologies, our potential for growth may be impaired.

The industries in which we operate are characterized by significant enhancements and evolving industry standards. As a result, our partners’ needs are rapidly evolving. If we do not successfully innovate and invest in new technologies, including within the field of AI, our platform may become less competitive, we may fail to advance our internally developed programs, and our partners could move to new technologies or engage in drug creation activities themselves. Without the timely introduction of technological advancements, our technologies will likely become less competitive over time, in which case our competitive position and results of operations could suffer. To the extent we fail to timely introduce new and innovative technologies,

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to advance our internally developed programs, and our partners could move to new technologies or engage in drug creation activities themselves. Without the timely introduction of technological advancements, our technologies will likely become less competitive over time, in which case our competitive position and results of operations could suffer. To the extent we fail to timely introduce new and innovative technologies, adequately predict our partners’ needs or fail to obtain desired levels of market acceptance, our business may suffer and our results of operations could be adversely affected.

Risks Related to Our ~~Partnership~~ Business Strategy

Our commercial success depends on the technological capabilities of our Integrated Drug Creation platform and the advancement of our ~~internally~~Internally ~~developed~~Developed ~~programs~~Programs.

We utilize our Integrated Drug Creation platform to identify promising opportunities for development and potential commercialization by us and our partners. As a result, the quality and sophistication of our Integrated Drug Creation platform and technologies are critical to our ability to conduct our drug creation activities and to generate more promising product candidates and cell lines and to shorten and lower the costs of therapeutic development for us and our existing and potential partners, as compared to other methods. ~~In particular, our business depends, among other things, on:~~

•We utilize our ~~ability~~Integrated toDrug ~~successfully~~Creation platform to identify and design product candidates for our Internally Developed programs and, ~~production~~to ~~cell~~a ~~lines~~lesser ~~through~~extent, our Partnered Programs (i.e. programs developed in collaboration with third parties). As a result, the performance and capabilities of our Integrated Drug Creation platform and ~~provide~~related ~~them~~technologies are important to our ~~partners~~ability onto ~~the~~identify ~~desired~~and ~~timeframes~~advance product candidates for our internal programs. If our platform does not perform as expected, or if we are unable to continue to develop and refine our platform technologies, our ability to identify, develop and advance product candidates for ~~further~~our ~~development;~~internally developed programs could be adversely affected.”

~~•our~~In ~~partners’~~particular, ~~determination that the product candidates and/or cell lines that we provide to them can ultimately be used to advance~~ our ~~partners’~~business ~~clinical~~depends, ~~development~~among ~~programs;~~other things, on:

•our ~~partners'~~ability ~~entering into license agreements with economic terms that are acceptable~~ to ~~us,~~successfully ~~which~~identify isand ~~based~~design ~~substantially~~product oncandidates ~~the~~for ~~value~~ our ~~partners~~internally ~~believe~~developed ~~can~~programs beusing ~~recognized~~our ~~from~~Integrated ~~the~~Drug ~~product~~Creation ~~candidates and/or cell lines that we provide to them~~platform;

•~~our~~advance ~~ability to execute on~~ our ~~strategy~~internally todeveloped ~~enter~~product ~~into~~candidates ~~new~~through ~~partnerships~~preclinical ~~with~~and ~~new~~clinical ordevelopment and, ~~existing~~if ~~partners~~approved, ~~on terms that are acceptable to us~~commercialization;

•~~our~~continue ~~ability~~ to ~~identify~~develop, ~~partners~~refine toand ~~license~~validate orour ~~acquire~~generative ~~rights~~AI tomodels ~~our~~and ~~internally~~platform ~~developed~~technologies ~~programs~~to ~~for~~support ~~further~~product ~~preclinical~~candidate ordiscovery ~~clinical~~and development;

•~~our~~maintain ~~ability~~the toreliability, ~~use~~scalability ~~our~~and ~~generative~~performance AIof ~~models~~our toIntegrated ~~create~~Drug ~~actionable~~Creation ~~biological~~platform ~~insights~~and related technologies;

•~~our~~generate ~~ability~~and toanalyze ~~increase~~sufficient ~~awareness~~biological ofdata to support the ~~capabilities~~continued training and improvement of our ~~technologies~~AI ~~and solutions~~models;

•adapt our ~~partners’~~assays, ~~and~~screening ~~potential~~technologies ~~partners’~~and ~~willingness~~biological systems to ~~adopt~~support ~~our~~the ~~Integrated~~discovery ~~Drug~~and ~~Creation~~development ~~platform~~of ;product candidates across different targets and therapeutic modalities;

•~~whether~~develop ~~our~~and ~~Integrated~~scale ~~Drug~~manufacturing ~~Creation platform reliably provides advantages over legacy~~ and other ~~alternative~~processes ~~technologies~~to ~~and~~support isresearch, ~~perceived~~preclinical byand ~~partners~~clinical todevelopment ~~be cost effective~~activities;

•~~the~~obtain ~~rate~~and ofmaintain ~~adoption~~regulatory ofapprovals ~~our~~for ~~technologies~~any byproduct ~~pharmaceutical~~candidates ~~companies,~~that ~~biotechnology~~we ~~companies~~or ofour ~~all~~collaborators ~~sizes, government organizations and non-profit organizations and others~~develop;

•~~prices~~compete weeffectively ~~charge~~with ~~for~~other ~~our~~companies ~~technology~~that ~~and~~are ~~the~~developing ~~discoveries~~technologies, platforms or therapeutics that wemay ~~make~~compete with our platform or product candidates; and

•~~the~~continue ~~relative~~to ~~reliability~~invest in and ~~robustness~~enhance of our ~~Integrated~~research ~~Drug~~and ~~Creation~~development ~~platform;~~capabilities to support the advancement of our internally developed programs.

•our ability to develop new technologies for partners;

•our Integrated Drug Creation platform’s ability to offer sufficient cost effectiveness, efficiency, and performance to warrant partners’ continued adoption of and ongoing reliance on our technologies;

•our Integrated Drug Creation platform’s ability to screen a high number of cells and product candidates and leverage this data to train our generative AI models;

•whether competitors develop a platform that enables drug creation more effectively than our platform;

•our ability to bioengineer our proprietary E. coli SoluPro and Bionic SoluPro strains to produce certain types of proteins, validate protein sequences and further train our AI models;

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•our ability to adapt our assays to screen effectively for certain types of therapeutic modalities or targets;

•our ability to adapt our assays to de-orphan antibodies we create using our technology;

•our ability to construct diverse genetic libraries covering sufficient diversity of protein sequence variants and folding and expression solutions combinations;

•our ability to reliably adapt our assays to each program to screen large strain libraries and routinely identify molecules/strains that meet the program deliverable requirements;

•our ability to optimize our fermentation conditions to scale at an effective level;

•our platform’s ability to create new drug modalities and novel conjugates;

•the timing and scope of any approval that may be required by the U.S. Food and Drug Administration (FDA) or any other regulatory body for drugs that are developed based on molecules discovered and/or manufactured using our Integrated Drug Creation platform technologies;

•our partners’ and the biopharmaceutical industry’s continued interest and investment in antibody therapeutics development, and the continued market growth and clinical and regulatory success of this category collectively;

•the impact of our investments in innovation and commercial growth;

•negative publicity regarding our or our competitors’ technologies resulting from defects or errors;

•our ability to further validate and enhance our Integrated Drug Creation platform through research and development activities;

•our ability to leverage our Integrated Drug Creation platform technologies to create product candidates for internal development and advancement into clinical trials.

There can be no assurance that we will successfully address any of these or other factors that may affect the market acceptance of our Integrated Drug Creation platform or our technology. If we are unsuccessful in achieving and maintaining market acceptance of our Integrated Drug Creation platform, our business, financial condition, results of operations and prospects could be adversely affected.

We are substantially dependent on the successful application of our Integrated Drug Creation platform to initiate and advance partnered programs and to develop our internally developed programs that can be further developed by our current or future partners.55

The antibody therapeutic development business is capital intensive. Our success significantly depends on our ability to apply our Integrated Drug Creation platform for partnered programs, develop promising internally developed programs, and enter into agreements with our current and future partners to further develop these programs. We have only recently expanded our Integrated Drug Creation platform into antibody therapeutic discovery, both for programs that we develop with our partners and those that we internally develop. In order to realize the full benefits of our Integrated Drug Creation platform, we will need to succeed in advancing it, developing our internally developed programs and marketing our expanded capabilities to existing and potential new partners.

Our future revenue growth and market potential will depend on our ability to continue leveraging our Integrated Drug Creation platform, together with our custom libraries, data sets and other proprietary tools, for drug creation and other areas of biopharmaceutical drug development. However, we may not be able to successfully validate that our Integrated Drug Creation platform will shorten the hit identification and lead optimization steps of biologic drug creation or that our platform will enable us to create promising biologic candidates for further development.

Our inability to continue these initiatives and advance new drug creation efforts could result in a failure to develop our platform, improve upon existing technologies, partner internally developed programs for clinical development, and expand our addressable market, each of which could have a material and adverse impact on our business development, business, financial position and results of operations.

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We doare ~~not~~substantially ~~expect~~dependent toon ~~generate~~the ~~significant~~successful ~~recurring~~application ~~revenue~~of ~~from~~ our ~~partnership~~Integrated ~~arrangements~~Drug ~~unless~~Creation ~~and~~platform ~~until~~to ~~such time as we enter into further agreements that~~identify, indesign ~~the aggregate, result in regular~~ and ~~continuous~~advance ~~fees~~product ~~for~~candidates ~~our performance of drug creation activities or agreements under which we would be eligible~~ for ~~future payments upon~~ our ~~partners’~~internally ~~achievement~~developed ~~of development and regulatory milestones or commencement of commercial sales with respect to any product candidates generated using our platform~~programs. WeOur ~~are~~ability ~~unable~~ to ~~predict~~generate ~~whether~~ and ~~the~~progress ~~extent~~these ~~to which payments will be made to us under our partnership arrangements~~programs, and ~~whether~~in ~~and~~some ~~the~~cases ~~extent to which we will be able to~~ enter into ~~future~~potential ~~arrangements~~collaboration ~~under~~or ~~which~~licensing wearrangements ~~are~~for ~~eligible~~further ~~to generate additional revenues~~development, ordepends ~~the~~in ~~timing~~part ofon the ~~achievement~~performance ~~of any milestones under these agreements, if they are achieved at all. The timing~~ and ~~likelihood~~continued ~~of payments to us under these agreements is dependent on our partners’ successful~~ development ~~and commercialization~~ of ~~the molecules created using~~ our platform, ~~which may be outside of our control~~technologies. ~~Because of these factors, our operating results are difficult to predict and could vary materially from quarter to quarter.~~

The development of antibody-based therapeutics is capital intensive, and our success depends in significant part on our ability to apply our Integrated Drug Creation platform to identify, design and advance product candidates for our internally developed programs. We have only recently expanded the application of our Integrated Drug Creation platform into antibody therapeutic discovery. In order to realize the potential benefits of our platform, we will need to continue advancing its capabilities and successfully develop and progress our internally developed programs through preclinical and clinical development. In some cases, we may seek to enter into collaboration or licensing arrangements with third parties for the further development of certain programs.

Our future growth prospects will depend in part on our ability to continue leveraging our Integrated Drug Creation platform, together with our proprietary libraries, data sets and related technologies, to support the discovery and development of product candidates. However, we may not be able to demonstrate that our platform will successfully identify or generate product candidates suitable for further development, or that it will provide advantages over other drug discovery approaches.

If we are unable to continue developing and enhancing our platform technologies or successfully advance product candidates identified using our platform, we may be unable to expand our pipeline of internally developed programs or progress them through development. Any such failure could have a material adverse effect on our business, financial condition and results of operations.

In addition, although we may enter into collaboration or licensing arrangements for certain programs, we may not be able to identify suitable partners or enter into such arrangements on acceptable terms, if at all. Any payments under such arrangements, including upfront payments, milestone payments or royalties, would depend on the successful development, regulatory approval and commercialization of product candidates, which may not occur. As a result, our operating results may vary significantly from period to period and may be difficult to predict.

Our partnership strategy significantly depends on the eventual approval and commercialization of product candidates developed under our partnerships for which we may have no control over the clinical development plan, regulatory strategy or commercialization efforts.

Our partnership strategy depends on the eventual progression of biologic product candidates discovered or initially developed utilizing our Integrated Drug Creation platform into clinical trials and commercialization. This requires us to attract partners and enter into agreements with them that contain obligations for the partners to pay us milestone payments as well as royalties on sales of approved products for the product candidates that they develop and were generated utilizing our Integrated Drug Creation platform. Given the nature of our relationships with our partners and future partners, we often do not fully control the progression, clinical development, regulatory strategy or eventual commercialization, if approved, of these partnered product candidates. As a result, our future success and the potential to receive milestones and royalties are significantly dependent on our partners’ efforts, over which we have little control. If a partner determines not to proceed with the future development of a product candidate discovered or initially developed utilizing our Integrated Drug Creation platform, if it implements a clinical or regulatory strategy that ultimately does not enable the further development, approval or commercialization of the product candidate, or if we cannot find a partner to advance an internally developed program, we will not receive the benefits of our partnerships, which may have a material and adverse effect on our operations.

In addition, antibody therapeutic development is inherently uncertain and very few product candidates ultimately progress through clinical development and receive approval for commercialization. See the risk factor section titled, “Risks Related to Biologic Drug Development” for additional information related to the risks of biologic drug development. If our partners do not receive regulatory approval for a sufficient number of product candidates originating from our Integrated Drug Creation platform, we may not be able sustain our business model.

While as a general matter we intend to periodically report on the status of our business development initiatives, including anticipated next steps, we may not provide forward-looking guidance on the timing of those next steps. In addition, we do not control the timing of disclosure by our partners of any milestones or other information related to product candidates generated using our Integrated Drug Creation platform. Any disclosure by us or our partners of data or other information regarding any such product candidates that is perceived as negative may have a material adverse impact on our stock price or overall valuation. Our stock price may also decline as a result of negative results from any eventual clinical trial, including adverse safety events, involving any product candidate that is subject to one of our partnerships.

If we cannot maintain our current relationships with partners, fail to expand our relationships with our current partners, or if we fail to enter into new relationships, our future operating results would be adversely affected as a general matter.56

In the years ended December 31, 2024 and 2023, revenue from two partners accounted for 99% and 89% of our partner program revenue, respectively. The revenue attributable to these partnerships may fluctuate in the future, which could have an adverse effect on our business, financial condition, results of operations and prospects. Our existing partners may cease to use our technologies depending on their own technological developments, availability of other competing technologies, and internal decisions regarding allocation of time and resources to the discovery and development of biologic product candidates, over which we have no control. Our existing and potential future partners may have limited resources to initiate new programs, which could limit their adoption or scale of application of our technologies. In addition, existing partners may

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~~choose~~those tonext ~~produce~~steps. ~~some~~In oraddition, ~~all~~we ofdo ~~their~~not ~~requirements~~control ~~internally~~the timing of disclosure by ~~using~~our partners of any milestones or ~~internally~~other ~~developing~~information ~~their~~related ~~own~~to ~~capabilities~~product orcandidates bygenerated using ~~capabilities~~our ~~from~~Integrated ~~acquisitions~~Drug ofCreation ~~assets~~platform. Any disclosure by us or ~~entities~~our ~~from~~partners ~~third~~of ~~parties~~data ~~with~~or ~~such~~other ~~capabilities.~~information ~~While~~regarding ~~our~~any ~~business~~such product candidates that is ~~not~~perceived ~~substantially~~as ~~dependent~~negative onmay ~~partner~~have ~~program~~a ~~revenues~~material ~~from~~adverse ~~any~~impact ~~individual~~on ~~partner,~~our ~~because~~stock weprice ~~currently~~or ~~have~~overall avaluation. ~~limited~~Our ~~number~~stock ofprice ~~partnerships,~~may aalso ~~loss~~decline ofas ~~one~~a result of ~~our~~negative ~~partners~~results ~~could~~from ~~adversely~~any ~~impact~~eventual ~~our~~clinical ~~revenue~~trial, ~~results~~including ofadverse ~~operations~~safety events, ~~cash~~involving ~~flows~~any orproduct ~~reputation~~candidate inthat ~~any~~is ~~given~~subject ~~period~~to one of our partnerships.

Our partnership strategy’s future success also depends on our ability to expand relationships with our existing partners and to establish relationships with new partners. We engage in discussions with third parties regarding potential drug creation, license, and asset sale opportunities on an ongoing basis, which can be time consuming. There is no assurance that any of these discussions will result in a drug creation, asset sale, and/or license agreement, or if an agreement is reached, that the resulting relationship will be successful, or that the terms of such agreement will be favorable to us. We target partnerships with biotechnology and pharmaceutical companies. Macro-economic market conditions have had, and may continue to have, a significant effect on the formation, funding and research and development budgets of these types of entities and could have a significant effect on the number of viable companies with whom we may partner or the programs viable partners may elect to pursue. Our partners and future partners may also determine their research and development budgets based on other factors, including conservation of cash resources, changes in business priorities, the need to develop new products, technological expertise, continued availability of governmental and other funding, competition, and intellectual property landscape. If research and development budgets of viable partners are reduced or the number of viable partners decline, the impact could adversely affect our business, financial condition, results of operations and prospects.

In addition, our ability to monitor the achievement of clinical, regulatory and commercial milestones by our partners and enforce the payment of any corresponding fees is limited. Furthermore, the termination of any of these relationships could result in a temporary or permanent loss of revenue. Additionally, speculation in the industry about our existing or potential commercial relationships can be a catalyst for adverse speculation about us and our technology, which can adversely affect our reputation and our business.

We cannot assure investors that we will be able to maintain or expand our existing partnerships or that our technologies will achieve adequate market adoption among new partners. Any failure to increase penetration in our existing markets or new markets would adversely affect our ability to improve our operating results from our partnership strategy.

Our revenue under our partnered programs for any particular period, or on an absolute basis, can be difficult to forecast.

Because of the complexities and long development timelines inherent in the biologic drug development business, it is difficult to predict the timing of payments under our drug creation and other partner agreements. In particular, payments under our drug creation agreements are subject to the achievement of project milestones and our partners’ decisions to initiate or continue the drug creation work, and any future downstream payments with respect to product candidates generated using our Integrated Drug Creation platform will be subject to our partners’ advancement of the product candidates, over which we have no control. As a result, our revenue for any particular period can be difficult to forecast. Our revenue may grow at a slower rate than in past periods or even decline on a year-over-year basis. Because of these factors, our operating results could vary materially from quarter to quarter from our forecasts. Also, due to the limited probability of success for advancement of a product candidate by a partner at any given stage of development and the unpredictability of when a partner may choose to continue development of a product candidate and whether any milestone payments will be due to us, our revenue may be difficult to forecast on an absolute basis.

Additionally, we recognize revenue either as we perform our drug creation activities, upon completion of performing our drug creation activities or upon achieving certain licensing, clinical, regulatory, and commercialization milestones. As a result, much of our revenue is generated from agreements entered into during previous periods. Consequently, a decline in demand for our platform, a decline in new or renewed business in any one quarter or any delays in the achievement, or any failure to achieve, development, regulatory and commercial milestones by our partners with respect to product candidates generated using our platform, may not significantly reduce our revenue for that quarter but could negatively affect our revenue in future quarters. Our revenue recognition model also makes it difficult for us to rapidly increase our revenue through increased operations in any period, as revenue from partners is recognized over the course of their drug development and commercialization efforts.

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The failure of our drug creation partners to meet their contractual obligations to us could adversely affect our business.

Our reliance on our partners poses a number of additional risks, including the risk that they may not perform their contractual obligations to us to our standards, in compliance with applicable legal or contractual requirements, in a timely manner or at all; they may not maintain the confidentiality of our proprietary information; and disagreements or disputes could arise that could cause delays in, or termination of, the research, development or commercialization of products generated using our platform or result in litigation or arbitration.

In addition, certain of our partners are large, multinational organizations that run many programs concurrently, and we are dependent on their ability to accurately track and make milestone payments to us pursuant to the terms of our agreements with them. Any failure by them to inform us when milestones are reached and make related payments to us could adversely affect our results of operations.

Moreover, some of our future partners may be located in markets subject to political and social risk, armed conflict, corruption and infrastructure problems, and could be subject to country-specific privacy and data security risk as well as burdensome legal and regulatory requirements. Any of these factors could adversely impact their financial condition and results of operations, which could impair their ability to meet their contractual obligations to us and have a material adverse effect on our business, financial condition and results of operations.

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Our partners may not achieve projected discovery and development milestones and other anticipated key events in the expected timelines or at all, which could have an adverse impact on our business and our anticipated revenue.

From time to time, we may make public statements regarding the expected timing of certain milestones and key events, as well as regarding developments and milestones under our partnerships, to the extent that our partners have publicly disclosed such information or permit us to make such disclosures. Certain of our partners may in the future make statements about their goals and expectations for partnerships with us. The actual timing of these events can vary dramatically due to a number of factors such as delays or failures in our or our current and future partners’ drug discovery and development programs, the amount of time, effort, and resources committed by us and our current and future partners, and the numerous uncertainties inherent in the development of drugs. Additionally, to date, none of our partners has successfully completed a regulatory submission, such as an IND application or BLA, for a product candidate generated using our Integrated Drug Creation platform. There can be no assurance that our partners’ current and future programs will advance or be completed in the time frames we or they expect. If our partners fail to achieve one or more of these milestones or other key events as planned, our business could be materially adversely affected and we may never receive the anticipated revenues from these partnerships.

Our partners have significant discretion in determining when and whether to make announcements, if any, about the status of our partnerships, including about clinical developments and timelines for advancing partnered programs, and the price of our common stock may decline as a result of announcements of unexpected or negative results or developments.

Our partners have significant discretion in determining when and whether to make announcements about the status of our partnerships, including about preclinical and clinical developments and timelines for advancing product candidates generated using our Integrated Drug Creation platform. We do not plan to disclose the development status and progress of individual product candidates of our partners, unless and until those partners do so first. Our partners may wish to report such information more or less frequently than we expect, or they may not report such information at all, in which case we would not report that information either, unless material to our financial statements. In addition, if a partner chooses to announce a partnership with us, there is no guarantee that we will receive payments related to partner program revenue in that quarter or even the following quarter, as such payments are only payable to us in accordance with the terms of the agreements governing such partnerships. The price of our common stock may decline as a result of the public announcement of unexpected results or developments in our partnerships, or as a result of our partners withholding such information.

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Risks Related to Our Operations

We rely on a limited number of suppliers for laboratory equipment and materials and may not be able to find replacements or transition to alternative suppliers on a timely basis, or at all.

We rely on a limited number of suppliers to provide certain consumables and equipment that we use in our laboratory operations, as well as reagents and other laboratory materials involved in the development of our technology. Fluctuations in the availability and price of laboratory materials and equipment could have an adverse effect on our ability to meet our drug creation activity timelines and requirements for our internally developed programs or our drug creation goals with our partners and thus our results from operations as well as future partnership opportunities. An interruption in our laboratory operations or technology transfer activities could occur if we encounter delays, quality issues or other difficulties in securing these consumables, equipment, reagents or other materials, and if we cannot then obtain an acceptable substitute. In addition, we would likely be required to incur significant costs and devote significant efforts to find new suppliers, acquire and qualify new equipment, validate new reagents and revalidate aspects of our existing assays, which may cause delays in our processing of samples or development and commercialization of our technology. Any such interruption could significantly affect our business, financial condition, results of operations and reputation.

In particular, we have purchased and rely on a bioreactor system and related equipment, consumables and liquid handling robotics, and associated consumables. We obtain our supplies of equipment and materials under purchase orders and do not have supply contracts in place with certain suppliers. Any disruption in the supply chain for these products could materially affect our business. While there are alternative types of equipment that we could use as a replacement, switching to different systems could require significant capital investment, long lead times and significant training and validation.58

Our Integrated Drug Creation platform may not meet the expectations of our partners, which means our business, financial condition, results of operations and prospects could suffer.

Our success depends on, among other things, the market’s confidence that our Integrated Drug Creation platform is capable of substantially shortening the amount of time necessary to perform certain activities as compared to the use of legacy and other alternative technologies, and will enable more efficient or improved preclinical and clinical development and/or biomanufacturing. There is no assurance that we will be able to fully accomplish this in the future, or at all. To date, we have not yet had a product candidate from our Integrated Drug Creation platform advance into clinical testing, which may reduce our existing and prospective partners' confidence in our platform. We also believe that pharmaceutical and biotechnology companies are likely to be particularly sensitive to defects in, or suboptimal performance of, our Integrated Drug Creation platform, including if it fails to deliver meaningful reduction of certain research timelines accompanied by results at least as good as the results generated using legacy or other alternative technologies. There can be no guarantee that our Integrated Drug Creation platform will meet the expectations of pharmaceutical and biotechnology companies.

We will need to develop and expand our workforce, commercial infrastructure and laboratory operations to support anticipated growth in demand for our drug creation programs, and we may encounter difficulties in managing this development and expansion.

We will need to expand our workforce, commercial infrastructure and laboratory operations to support anticipated growth in demand for our drug creation programs. If we are unable to support fluctuations in the demand for our drug creation programs, including ensuring that we have adequate capacity to meet increased demand, our business could suffer. We expect to continue to develop our employees and the scope of our operations as we continue to enhance our technologies and expand our number of programs. As we seek to increase the number of our partnerships, expand the scope of our existing partnerships, pursue internally developed programs and further develop our technological capabilities, we may need to incorporate new equipment, implement new technology systems and laboratory processes and hire new personnel with different qualifications. Failure to manage this growth or transition could result in turnaround time delays, higher research and development costs, declining drug creation program quality, deteriorating alliance management success, and slower responses to competitive challenges. Moreover the successful execution of our programs requires ongoing integration amongst our employees who come from a variety of technical backgrounds. As we increase the number of partnered and internally developed programs, we must ensure alignment and effective collaboration between our wet-lab biologists and AI scientists which we may not achieve due to the challenge of integrating these disparate domains. A failure in

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~~any~~Our ~~one~~Integrated ofDrug ~~these~~Creation ~~areas~~platform ~~could~~may ~~make~~not itmeet ~~difficult~~the ~~for~~expectations usof toour ~~meet~~partners, ~~market~~which ~~expectations~~means ~~for~~ our ~~technologies~~business, ~~and~~financial ~~could~~condition, ~~damage~~results ~~our~~of ~~reputation~~operations and ~~the~~ prospects ~~for~~could ~~our business~~suffer.

Our success depends on, among other things, the market’s confidence that our Integrated Drug Creation platform is capable of substantially shortening the amount of time necessary to perform certain activities as compared to the use of legacy and other alternative technologies, and will enable more efficient or improved preclinical and clinical development and/or biomanufacturing. There is no assurance that we will be able to fully accomplish this in the future, or at all. To date, we have only advanced one product candidate, ABS-101, from our Integrated Drug Creation platform into clinical testing, and any inability to advance additional product candidates into clinical development may reduce our existing and prospective partners' confidence in our platform. We also believe that pharmaceutical and biotechnology companies are likely to be particularly sensitive to defects in, or suboptimal performance of, our Integrated Drug Creation platform, including if it fails to deliver meaningful reduction of certain research timelines accompanied by results at least as good as the results generated using legacy or other alternative technologies. There can be no guarantee that our Integrated Drug Creation platform will meet the expectations of pharmaceutical and biotechnology companies.

We may need to develop and expand our workforce, commercial infrastructure and laboratory operations to support anticipated growth in demand for our drug creation programs, and we may encounter difficulties in managing this development and expansion.

We may need to expand our workforce, commercial infrastructure and laboratory operations to support anticipated growth in demand for our drug creation programs. If we are unable to support fluctuations in the demand for our drug creation programs, including ensuring that we have adequate capacity to meet increased demand, our business could suffer. We expect to continue to develop our employees and the scope of our operations as we continue to enhance our technologies and expand our number of programs. As we seek to pursue and advance internally developed programs, increase the number of our partnerships, expand the scope of our existing partnerships, and further develop our technological capabilities, we may need to incorporate new equipment, implement new technology systems and laboratory processes and hire new personnel with different qualifications. Failure to manage this growth or transition could result in turnaround time delays, higher research and development costs, declining drug creation program quality, deteriorating alliance management success, and slower responses to competitive challenges. Moreover the successful execution of our programs requires ongoing integration amongst our employees who come from a variety of technical backgrounds. As we increase the number of partnered and internally developed programs, we must ensure alignment and effective collaboration between our wet-lab biologists and AI scientists which we may not achieve due to the challenge of integrating these disparate domains. A failure in any one of these areas could make it difficult for us to meet market expectations for our technologies, and could damage our reputation and the prospects for our business.

To manage future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Also, our management team may need to divert a disproportionate amount of its attention away from its day-to-day activities and devote a substantial amount of time to managing growth activities. Due to our limited resources and early stage of growth, we may not be able to effectively manage this simultaneous execution and the expansion of our operations. This may result in weaknesses in our infrastructure, operational mistakes, slower development of our drug creation partnered programs and internally developed programs, loss of business opportunities, loss of employees and reduced productivity among our employees.

If our management is unable to effectively manage our expected development and growth, our expenses may increase more than expected, our ability to generate or increase our revenue could be reduced and we may not be able to implement our business strategy. Our future financial performance, and our ability to develop and commercialize our technologies and compete effectively, will depend, in part, on our ability to effectively manage our future development and growth.

We have in the past and may in the future need to reduce our workforce, which may not achieve our intended outcomes and could result in unintended consequences.

In order to optimize our cost structure and improve operational efficiency, we have in the past, and may in the future need to undertake workforce reductions or other restructuring activities. These types of cost-reduction activities can be complex and may result in unintended consequences and costs, including the loss of institutional knowledge and expertise, attrition beyond any intended reduction in headcount, and

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decreased morale among our remaining employees. Furthermore, any such workforce reductions may make it difficult to retain competent personnel and to attract qualified candidates in the future, which could adversely impact our ability to execute on our business strategy. There can be no assurance that any future workforce reduction would result in the anticipated efficiency gains or cost savings, and the costs associated with such actions could exceed the benefits realized. If we are unable to realize the anticipated benefits of any future restructuring, our business, financial condition, and results of operations could be materially and adversely affected.

The loss of any member of our senior leadership team or our inability to attract and retain highly skilled scientists and business development professionals could adversely affect our business.

Our success depends on the skills, experience and performance of key members of our senior leadership team, ~~including~~as ~~Sean~~well ~~McClain,~~as ~~our~~highly ~~founder~~skilled ~~and~~employees ~~Chief~~in ~~Executive~~certain ~~Officer,~~technical ~~Zachariah Jonasson, our Chief Financial Officer and Chief Business Officer, and Andreas Busch, Ph~~fields.~~D.,~~ ~~our Chief Innovation Officer.~~ The individual and collective efforts of these employees will be important as we continue to develop our Integrated Drug Creation platform and our technology, and as we expand our commercial and development activities. The loss or incapacity of existing members of our executive management team could adversely affect our operations if we experience difficulties in hiring qualified successors. While our executive officers are party to employment contracts with us, their employment with us is at-will, which means that either we or the executive may terminate their employment at any time, and we therefore cannot guarantee their retention for any period of time.

Our research and development activities depend on our ability to attract and retain highly skilled personnel. We may not be able to attract or retain qualified personnel due to the intense competition for highly skilled scientists, including those focused on AI-powered biologic drug discovery and cell line development, as well as qualified business development and sales professionals, among life sciences companies. Competition for personnel with expertise in AI-powered drug discovery is particularly intense. Additionally, our headquarters located in Vancouver, Washington, which does not have as high a concentration of innovative biotechnology or AI companies as other geographic locations, may negatively impact our ability to attract and retain top talent. Further, some of the qualified personnel that we hire and recruit may not be U.S. citizens. Changes to U.S. immigration policies, particularly to H-1B and other visa programs, could restrain the flow of technical and professional talent into the United States and may inhibit our ability to hire qualified personnel, as well as increase related hiring costs.

We also face competition from universities and public and private research institutions in recruiting and retaining highly qualified scientific personnel. We may have difficulties locating, recruiting or retaining qualified salespeople. Recruiting and retention difficulties can limit our ability to support our research and business development programs. A key risk in the area of retention is that all of our employees are at-will.

We in the past have, and in the future may, make technology acquisitions, acquire businesses or assets, or make investments in other companies or technologies that could negatively affect our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.

We have made technology acquisitions in the past and ~~expect~~may, toin the future, pursue acquisitions of businesses and assets in the future. We also may pursue strategic alliances, joint ventures or other commercial deal structures that leverage our technologies and industry experience to expand our offerings. Additionally, we intend to invest in certain wholly-owned preclinical and/or clinical development programs with the goal of licensing or selling them to partners for clinical development. Although we have acquired other businesses or assets in the past, we may not be able to find suitable partners or acquisition or asset purchase candidates in the future, and we may not be able to complete such transactions on favorable terms, if at all. The competition for partners or acquisition candidates may be intense, and the negotiation process will be time-consuming and complex. If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, these acquisitions may not strengthen our competitive position, the transactions may be viewed negatively by partners or investors, we may be unable to retain key employees of any acquired business, relationships with key suppliers, manufacturers or partners of any acquired business may be impaired due to changes in management and ownership, and we could assume unknown or contingent liabilities. Any future acquisitions also could result in the incurrence of debt, contingent liabilities or future write-offs of intangible assets or goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations and prospects. We cannot guarantee that we will be able to fully recover the costs of any acquisition. Integration of an acquired company also may disrupt ongoing operations and require management resources that we would otherwise focus on developing our existing

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~~negatively by partners or investors, we may be unable to retain key employees of any acquired~~ business~~, relationships with key suppliers, manufacturers or partners of any acquired business may be impaired due to changes in management and ownership, and we could assume unknown or contingent liabilities~~. Any future acquisitions also could result in the incurrence of debt, contingent liabilities or future write-offs of intangible assets or goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations and prospects. We ~~cannot guarantee that we will be able to fully recover the costs of any acquisition. Integration of an acquired company also~~ may ~~disrupt ongoing operations and require management resources that we would otherwise focus on developing our existing business. We may~~ not realize the anticipated benefits of any acquisition, technology license, strategic alliance, joint venture, or other commercial deal structure. We also may experience losses related to investments in other companies, which could have a material adverse effect on our business, financial condition, results of operations and prospects. Acquisitions may also expose us to a variety of international and business related risks, including intellectual property, regulatory laws, local laws, tax and accounting.

To finance any acquisitions or asset purchase, we may choose to issue securities as consideration, which would dilute the ownership of our stockholders. Additional funds may not be available on terms that are favorable to us, or at all. If the price of our common stock is low or volatile, we may not be able to acquire companies or assets using our securities as consideration.

We may be subject to laws that generally govern the biopharmaceutical industry.

Our equipment financing agreements may contain covenants that restrict our operating activities, and we may be required to repay the outstanding indebtedness in an event of default, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

We have entered into a Master Financing Agreement (MFA) pursuant to which the lender agreed to provide us equipment financing. Until we have repaid such indebtedness, the MFA subjects us to various customary covenants, including requirements as to financial reporting, liquidity ratios and maintaining insurance. Our business may be adversely affected by these restrictions on our ability to operate our business.

We may be required to repay the outstanding indebtedness under the MFA if an event of default occurs under the MFA. An event of default will occur if, among other things, we fail to make required payments under the MFA; we breach any of our covenants under the MFA, subject to specified cure periods with respect to certain breaches; the lender determines that a material adverse change (as defined in the MFA) has occurred; we or our assets become subject to certain legal proceedings, such as bankruptcy proceedings; we are unable to pay our debts as they become due; or we default on contracts with third parties which would permit the third party to accelerate the maturity of such indebtedness or that could have a material adverse change on us. We may not have enough available cash, cash equivalents and ~~short-term~~marketable ~~investments~~securities or be able to raise additional funds through equity or debt financings to repay such indebtedness at the time any such event of default occurs. In such a case, we may be required to delay, limit, reduce or terminate our operations or grant to other parties the rights to develop and market our Integrated Drug Creation platform that we would otherwise prefer to develop and market ourselves. The lender could also exercise its rights as secured lender to take possession of and to dispose of the collateral securing the MFA, which collateral includes substantially all of our property. Our business, financial condition, results of operations and prospects could be materially adversely affected as a result of any of these events.

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Our inability to collect on our accounts receivable by a significant number of partners may have an adverse effect on our business, financial condition and results of operations.

Invoices issued to our partners are generally made on open credit terms. While we have not experienced any significant challenges in collecting on accounts receivable from our partners historically, they may occur in the future. Management assesses the need to maintain an allowance for potential credit losses each reporting period. If our partners’ cash flow, working capital, financial conditions or results of operations deteriorate, they may be unable or even unwilling to pay trade receivables owed to us promptly or at all. As a result, we could be exposed to a certain level of credit risk. If a major partner experiences, or a significant number of partners experience, financial difficulties, the effect on us could be material and have an adverse effect on our business, financial condition and results of operations.

If our operating facility becomes damaged or inoperable or we are required to vacate our facility, our ability to conduct and pursue our drug creation and internal research and development efforts may be jeopardized.

We currently operate primarily through a single facility located in Vancouver, Washington. Our facility and equipment could be harmed or rendered inoperable or inaccessible by natural or man-made disasters or other circumstances beyond our control, including fire, earthquake, power loss, communications failure, war or terrorism, or another catastrophic event, such as a pandemic or similar outbreak or public health crisis, which may render it difficult or impossible for us to support our partners, advance internal research and development activities, and develop updates, upgrades and other improvements to our technology and platform, advanced automation systems, and advanced application for some period of time. We may be unable to execute on our drug creation and additional research and development activities if our facility is inoperable or suffers a loss of utilization for even a short period of time. This may result in the loss of partners or harm to our reputation, which we may be unable to regain or repair in the future. This may interrupt the development of our internally developed programs, which may delay our ability to monetize such programs. Furthermore, our facility and the equipment we use to perform our drug creation activities could be unavailable or costly and time-consuming to repair or replace. It would be difficult, time-consuming and expensive to rebuild our facility, to locate and qualify a new facility or license or transfer our proprietary technology to a third party. Even in the event we are able to find a third party to assist in drug creation efforts, we may be unable to negotiate commercially reasonable terms to engage with the third party.

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inoperable or suffers a loss of utilization for even a short period of time. This may result in the loss of partners or harm to our reputation, which we may be unable to regain or repair in the future. This may interrupt the development of our internally developed programs, which may delay our ability to monetize such programs. Furthermore, our facility and the equipment we use to perform our drug creation activities could be unavailable or costly and time-consuming to repair or replace. It would be difficult, time-consuming and expensive to rebuild our facility, to locate and qualify a new facility or license or transfer our proprietary technology to a third party. Even in the event we are able to find a third party to assist in drug creation efforts, we may be unable to negotiate commercially reasonable terms to engage with the third party.

Our current and future use of evolving technologies, such as artificial intelligence (AI), may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to operational challenges, reputational harm and potential liability.

Our technology development activities depend on sophisticated AI algorithms and computational systems to conduct drug creation activities. These activities require substantial computational resources, including high-performance computing systems and cloud computing services. The availability of these resources is critical to our ability to efficiently process large datasets, perform complex simulations, and analyze vast amounts of genetic and molecular information. Limited access to, or the inability to expand, these computational resources could pose significant risks to our business and operations in the following ways:

•Insufficient computational power could slow down our R&D activities, leading to delays in drug creation partnerships, internally developed programs and technology development activities. This slowdown could adversely affect our ability to meet project milestones and delay program development;

•Relying on external providers for additional computational resources can significantly increase our operational costs. Unexpected increases in these costs could impact our financial condition, especially if we are unable to pass these costs onto our customers or adequately budget for them;

•Our ability to remain competitive depends on our capacity to leverage cutting-edge AI technologies and computational methods. Limited access to computational resources could hinder our ability to innovate and maintain our technological advantage;

52•Limited computational resources may lead to operational bottlenecks, affecting our ability to process data and execute tasks efficiently. This inefficiency could impair our productivity and operational effectiveness, impacting our overall business performance; and

~~Table~~•Expanding ofour ~~Contents~~computational infrastructure or resorting to third-party cloud services to meet our computational needs could expose us to increased compliance and security risks. Ensuring data protection and meeting regulatory requirements may become more challenging as we scale our computational resources, potentially leading to financial penalties and reputational damage.

•Limited computational resources may lead to operational bottlenecks, affecting our ability to process data and execute tasks efficiently. This inefficiency could impair our productivity and operational effectiveness, impacting our overall business performance; or

•Expanding our computational infrastructure or resorting to third-party cloud services to meet our computational needs could expose us to increased compliance and security risks. Ensuring data protection and meeting regulatory requirements become more challenging as we scale our computational resources, potentially leading to financial penalties and reputational damage.

We continually assess our computational need s and strategically invest in our infrastructure, including access to compute via cloud computing arrangements, to mitigate these risks. However, there is no assurance that these measures will be sufficient to prevent the adverse effects associated with limited access to computational resources. Our failure to effectively manage and scale our computational resources could have a material adverse effect on our business, financial condition, and operational results.

~~Additionally,~~The ~~if we enable or~~ use ~~solutions~~of ~~that~~evolving ~~draw~~technologies, ~~controversy~~such ~~due~~as ~~to perceived or actual negative societal impact~~AI, wein ~~may~~our ~~experience brand or reputational harm~~operations, ~~competitive harm or legal liability. A growing number of legislators~~ and ~~regulators are adopting laws and regulations and have focused enforcement efforts on~~ the ~~adoption~~operations of ~~artificial~~third ~~intelligence,~~parties ~~and~~upon ~~use~~which ofwe ~~such~~rely, ~~technologies~~presents inrisks ~~compliance with ethical standards~~ and ~~societal~~challenges ~~expectations.~~that ~~These~~could ~~developments~~negatively ~~may~~impact ~~increase~~ our ~~compliance~~business, ~~burden~~including ~~and~~cybersecurity, ~~costs~~data inprivacy, ~~connection~~IT, ~~with~~intellectual ~~use~~property, ofregulatory, ~~artificial intelligence and lead to~~ legal ~~liability if we fail to meet evolving legal standards or if use of such technologies results in harms or other causes of action we did not predict. For example~~, ~~the EU’s Artificial Intelligence Act (“AI Act”) entered into force on August 1~~operational, ~~2024~~competitive, ~~with most provisions becoming effective on August 2~~reputational, ~~2026. This legislation imposes significant obligations on providers~~ and ~~deployers~~other ofrisks ~~artificial intelligence systems,~~ and ~~encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems~~challenges. ~~The scope of requirements depends on legal and risk determinations that rely on novel legal provisions that have not yet been interpreted by courts or regulators~~Specifically, ~~and~~risks ~~non-compliance~~related ~~can lead~~ to ~~significant fines. Likewise~~bias, inAI ~~the U.S.~~hallucinations, ~~several states~~discrimination, ~~including~~harmful ~~Colorado and California~~content, ~~passed laws that will take effect in 2026~~misinformation, ~~to regulate various uses of artificial intelligence~~fraud, ~~including to make consequential decisions. In addition~~scams, ~~various~~targeted ~~federal~~attacks ~~regulators~~such ~~have~~as ~~issued~~model ~~guidance~~poisoning ~~and focused enforcement efforts on the use of AI in regulated sectors. If we develop~~ or ~~use~~data AIpoisoning, ~~systems~~surveillance, ~~governed~~data ~~by these laws or regulations~~leakage, weloss ~~will need to meet higher standards~~ of ~~data~~consensus ~~quality~~reality, ~~transparency~~inequality, ~~monitoring~~environmental ~~and human oversight~~harms, and weother ~~would~~harms ~~need~~may toflow ~~adhere~~from toour ~~specific and potentially burdensome and costly ethical~~development, ~~accountability~~use, ~~and administrative requirements, with the potential for significant enforcement~~ or ~~litigation~~deployment ~~in the event~~ of ~~any~~AI ~~perceived non-compliance~~technologies.

~~The~~If ~~rapid~~we ~~evolution~~enable ofor ~~artificial~~use ~~intelligence~~AI ~~will~~solutions ~~require the application of significant resources to design, develop, test and maintain such systems to help ensure~~ that ~~artificial~~draw ~~intelligence~~controversy isdue ~~implemented in accordance with applicable law and regulation and in a socially responsible manner and~~ to ~~minimize~~perceived ~~any real~~ or ~~perceived~~actual ~~unintended~~negative ~~harmful~~societal ~~impacts. The use of certain artificial intelligence technologies can also give rise to intellectual property risks~~impact, ~~including~~we bymay ~~disclosing~~experience orbrand ~~otherwise compromising our confidential~~ or ~~proprietary~~reputational ~~intellectual property~~harm, orcompetitive byharm ~~undermining our ability to assert~~ or ~~defend~~legal ~~ownership~~liability. ~~rights~~A ingrowing ~~intellectual~~number ~~property created with the assistance~~ of ~~artificial~~legislators ~~intelligence~~and ~~tools.~~regulators ~~Our~~are ~~vendors~~adopting ~~may~~laws ~~in turn incorporate artificial intelligence tools into their offerings,~~ and ~~the~~regulations ~~providers of these artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy~~ and ~~data~~have ~~security.~~focused ~~Further,~~enforcement ~~bad~~efforts ~~actors~~on ~~around~~ the ~~world~~adoption ~~use increasingly sophisticated methods, including the use~~ of artificial intelligence, ~~to engage in illegal activities involving the theft~~ and ~~misuse~~use of ~~personal~~such ~~information,~~technologies ~~confidential information and intellectual property. Any of these effects could damage our reputation, result~~ in ~~the~~compliance ~~loss~~with ofethical ~~valuable~~standards ~~property~~ and ~~information, cause us to breach applicable laws and regulations, and adversely impact our business.~~

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societal expectations. These developments may increase our compliance burden and costs in connection with use of artificial intelligence and lead to legal liability if we fail to meet evolving legal standards or if use of such technologies results in harms or other causes of action we did not predict. For example, the EU’s Artificial Intelligence Act (“AI Act”) entered into force on August 1, 2024, with significant provisions expected to become effective in August 2026. As currently enacted, the AI Act, which may be amended as part of the EU’s Digital Omnibus, imposes significant obligations on providers and deployers of artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems. The scope of requirements depends on legal and risk determinations that rely on novel legal provisions that have not yet been interpreted by courts or regulators, and non-compliance can lead to significant fines. In the U.S., the AI regulatory environment is complex and uncertain. Dozens of states have advanced, and in some cases passed, laws focusing on AI governance and regulation, including on deployment of AI in healthcare settings. At the federal level, the Trump administration has endorsed a federal moratorium on the enforcement of state AI laws, including through a December 11, 2025 executive order on “Ensuring a National Policy Framework for Artificial Intelligence.” So far, these efforts have not been successful at curtailing state action on AI regulation, contributing to a complicated legislative patchwork, which may be litigated in state and federal courts. If we develop or use AI systems governed by these laws or regulations, we will need to meet higher standards of data quality, transparency, monitoring and human oversight, and we would need to adhere to specific and potentially burdensome and costly ethical, accountability, and administrative requirements, with the potential for significant enforcement or litigation in the event of any perceived non-compliance.

The rapid evolution of AI will require the application of significant resources to design, develop, test and maintain such systems to help ensure that AI is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts. The use of certain AI technologies can also give rise to intellectual property risks, including by disclosing or otherwise compromising our confidential or proprietary intellectual property, or by undermining our ability to assert or defend ownership rights in intellectual property created with the assistance of AI tools. Our vendors may in turn incorporate AI tools into their offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security. Further, bad actors around the world use increasingly sophisticated methods, including the use of AI, to engage in illegal activities involving the theft and misuse of personal information, confidential information and intellectual property, including advanced cyber attacks, cyber espionage campaigns, exploitation of expanded attack surfaces, and other activities. In addition, the use of generative AI models in our internal or third-party systems may create new attack surfaces or methods for adversaries, which could impact us and our vendors. Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to be in violation of applicable laws and regulations, and adversely impact our business. Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, and adversely impact our business.

We depend on our information technology systems, and any significant disruptions to or failure of these systems could result in significant financial, legal, regulatory, business and reputational harm to our business.

Significant disruptions to our and our service providers’ information technology systems or data security incidents could result in significant financial, legal, regulatory, business and reputational harm to us. We are increasingly dependent on information technology systems and infrastructure, including services licensed, leased or purchased from third parties such as cloud computing infrastructure and operating systems, for significant elements of our business operations, including the operation of our Integrated Drug Creation platform (which includes our proprietary AI models, antibody discovery software platform and computational biology system), our knowledge management system, our partner reporting, our advanced automation systems, and advanced application software. These systems involve computational resources and data storage distributed between onsite servers, cloud computing infrastructure hosted by third-party providers, and a private graphics processing unit cluster owned by us but located and maintained at a facility in Texas.

53In the ordinary course of business, we collect, store, process and transmit large amounts of sensitive information, including intellectual property, proprietary business information, personal information and other confidential information. It is critical that we do so in a secure manner to maintain the confidentiality, integrity and availability of such sensitive information. We have installed, and expect to expand, a number of enterprise software systems that affect a broad range of business processes and functional areas, including for example, systems handling human resources, procurement, financial controls and reporting, contract

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~~platform (which includes for example our proprietary AI models, our antibody discovery software platform, our computational biology system), our knowledge~~ management ~~system~~, ~~our~~regulatory ~~partner~~compliance ~~reporting, our advanced automation systems,~~ and ~~advanced~~other ~~application~~infrastructure ~~software~~operations. These ~~systems~~implementations ~~involve~~were ~~computational~~expensive ~~resources~~ and ~~data~~required ~~storage~~significant ~~distributed~~time ~~between onsite servers, cloud computing infrastructure hosted by third-party providers,~~ and ~~a private graphics processing unit cluster owned by us but located and maintained at a facility in Texas~~effort.

InWe ~~the~~have ~~ordinary~~also ~~course~~outsourced elements of ~~business,~~our weoperations ~~collect,~~(including ~~store,~~elements ~~process and transmit large amounts~~ of ~~sensitive~~our information, ~~including~~technology ~~intellectual~~infrastructure) ~~property,~~to ~~proprietary~~third ~~business information~~parties, ~~personal information~~ and ~~other~~as ~~confidential~~a ~~information.~~result, Itwe ismanage ~~critical~~a ~~that~~number weof dothird-party sovendors inwho amay ~~secure~~have ~~manner~~access to ~~maintain~~our ~~the~~networks ~~confidentiality,~~or ~~integrity~~our ~~and~~confidential ~~availability~~information. ofWhile ~~such~~we ~~sensitive~~take ~~information.~~measures Weto ~~have~~safeguard ~~installed,~~ and ~~expect~~protect tothis ~~expand~~information, athreats ~~number~~to ofnetwork ~~enterprise~~and ~~software~~data ~~systems~~security ~~that~~are ~~affect~~constantly aevolving ~~broad~~and ~~range~~growing ofin ~~business~~frequency ~~processes~~ and ~~functional~~sophistication ~~areas~~and, ~~including~~like ~~for~~other ~~example,~~companies ~~systems~~in ~~handling~~our ~~human resources~~industry, ~~procurement,~~we ~~financial controls~~ and ~~reporting,~~our ~~contract~~third-party ~~management,~~vendors ~~regulatory~~have ~~compliance~~experienced threats and ~~other~~cybersecurity ~~infrastructure~~incidents ~~operations.~~relating ~~These~~to ~~implementations~~information ~~were~~technology ~~expensive~~systems and ~~required significant time and effort~~infrastructure.

We have ~~also~~taken ~~outsourced~~steps ~~elements~~to ofenhance our ~~operations~~cybersecurity ~~(including~~posture, ~~elements~~but ofremain ~~our~~subject ~~information~~to ~~technology~~cybersecurity ~~infrastructure)~~risks tothat ~~third~~could ~~parties,~~adversely ~~and~~affect asour abusiness. ~~result~~For example, we ~~manage~~face aincreased cybersecurity risks due to our reliance on internet technology and the number of ~~third-party~~our ~~vendors~~employees ~~who~~working remotely, which may ~~have~~create ~~access~~additional opportunities for cybercriminals to ~~our~~exploit ~~networks~~vulnerabilities. orIn response, we have extended the capabilities of both our ~~confidential~~preventative ~~information.~~and ~~While~~detective wesecurity ~~take~~controls ~~measures~~by toaugmenting ~~safeguard~~the monitoring and ~~protect~~alerting ~~this~~functions, the network design and the automatic countermeasure operations of our technical systems. Our information technology and telecommunications systems support a variety of functions, ~~threats~~including tomanufacturing ~~network~~operations, ~~and~~laboratory operations, data ~~security~~analysis, ~~are~~quality ~~constantly~~control, ~~evolving~~partner service and ~~growing~~support, inbilling, ~~frequency~~research and ~~sophistication.~~development activities, scientific and general administrative activities.

WeDespite ~~may~~these ~~also~~measures, ~~face~~we ~~increased~~cannot ~~cybersecurity~~guarantee ~~risks~~that ~~due to~~ our ~~reliance~~security oncontrols ~~internet~~will ~~technology~~be ~~and~~sufficient ~~the~~to ~~number~~prevent ofall ~~our~~cyber ~~employees~~threats ~~working~~or ~~remotely,~~unauthorized ~~which~~access ~~may~~to ~~create~~our ~~additional~~systems. ~~opportunities~~A ~~for~~significant ~~cybercriminals~~risk toin ~~exploit~~implementing ~~vulnerabilities.~~and Wemaintaining ~~intend~~these tosystems ~~extend~~includes the ~~capabilities~~integration ~~of both our preventative~~ and ~~detective~~communication ~~security~~between ~~controls~~separate byIT ~~augmenting~~systems, ~~the~~and ~~monitoring~~any ~~and~~failure ~~alerting~~to ~~functions,~~integrate ~~the~~these ~~network~~systems ~~design~~effectively ~~and~~could ~~the~~adversely ~~automatic~~affect ~~countermeasure~~various ~~operations~~aspects of our ~~technical systems~~operations. ~~These~~Any ~~information~~cybersecurity ~~technology~~breach ~~and~~or ~~telecommunications~~ systems ~~support~~failure acould ~~variety~~result ofin ~~functions,~~disruptions ~~including~~to ~~manufacturing~~our operations, ~~laboratory~~loss ~~operations,~~of ~~data~~sensitive ~~analysis~~data, ~~quality~~regulatory ~~control~~penalties, ~~partner~~reputational ~~service~~harm, and ~~support,~~materially ~~billing,~~adverse ~~research~~effects ~~and~~on ~~development~~our ~~activities~~business, ~~scientific~~financial ~~and general administrative activities. A significant risk in implementing these systems includes the integration and communication between separate IT systems~~condition, and ~~any~~results ~~failure to integrate these systems effectively could adversely affect various aspects~~ of ~~our~~ operations.

International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.

Because we currently market our technologies and our partners may market products derived from our technologies outside of the United States and we or our partners may market future technologies, products and services outside of the United States, if cleared, authorized or approved, our business is subject to risks associated with doing business outside of the United States, including an increase in our expenses, disruptions to our supply chain, security threats and diversion of our management’s attention from the development of future products and services. In addition, we currently maintain offices and have employees located in Zug, Switzerland and Belgrade, Serbia. Our current and planned international operations could expose us to additional risks that may adversely affect our business and financial results, including:

•multiple, conflicting and changing laws and regulations such as privacy security and data use regulations, tax laws, export and import controls and restrictions, tariffs, economic sanctions and embargoes, employment laws, anticorruption laws, regulatory requirements, reporting and disclosure obligations, reimbursement or payor regimes and other governmental approvals, permits and licenses;

•failure by us, our partners or our distributors to obtain regulatory clearance, authorization or approval for the use of our technologies in various countries;

•additional potentially relevant third-party patent rights;

•complexities and difficulties in obtaining intellectual property protection and enforcing our intellectual property;

•difficulties in staffing and managing foreign operations;

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•complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

•difficulties in negotiating favorable reimbursement ~~negotiations~~arrangements with governmental authorities;

•complexities in technology transfer regulations and logistics related to delivery of our bioengineered E. coli to partners;

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•logistics and regulations associated with shipping samples, including infrastructure conditions and transportation delays;

•limits in our ability to penetrate international markets if we are not able to conduct our operations locally;

•financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our technologies, exposure to foreign currency exchange rate fluctuations and different tax jurisdictions;

•natural disasters, political and economic instability, including wars, terrorism, political unrest and global conflicts such as Russia’s invasion of Ukraine, ongoing conflicts in the Middle East and heightened tensions in the Pacific region, outbreak of disease or other public health crises, such as the COVID-19 pandemic, boycotts, curtailment of trade, including as a result of tariffs, export controls and sanctions implemented by or against the United States in relation to other countries or jurisdictions, and other business restrictions;

•certain expenses, including expenses for travel, translation services, labor and employment costs and insurance;

•regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’ activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act (FCPA), its books and records provisions, or its anti-bribery provisions; and

•onerous anti-bribery requirements under laws similar to the FCPA in other jurisdictions in which we may now or in the future operate, including those of several member states in the European Union (EU), such as the United Kingdom’s Bribery Act of 2010, and other countries that are constantly changing and require disclosure of information to which U.S. legal privilege may not extend.

Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenue and results of operations.

Our business activities are subject to the FCPA and other anti-bribery and anti-corruption laws of the United States and other countries in which we operate, as well as U.S. and certain foreign export controls and trade sanctions. Violations of such legal requirements could subject us to liability.

We are subject to the FCPA, which among other things prohibits companies and their third-party intermediaries from offering, promising, giving or authorizing others to give anything of value, either directly or indirectly, to non-U.S. government officials for the purpose of obtaining or retaining business or securing any other improper advantage. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Companies in the biotechnology and biopharmaceutical field are highly regulated and therefore involve interactions with public officials, including officials of non-U.S. governments. Additionally, in many other countries, hospitals are owned and operated by the government, and doctors and other hospital employees would be considered foreign officials under the FCPA. These laws are complex and far-reaching in nature, and, as a result, there is no certainty that all of our employees, agents or contractors will comply with such laws and regulations. Any violations of these laws, or allegations of such violations, could disrupt our operations, involve significant management distraction, involve significant costs and expenses, including legal fees, and could result in a material adverse effect on our business, financial condition, results of operations and prospects. We could also suffer severe penalties, including criminal and civil penalties, disgorgement and other remedial measures.

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We use biological and hazardous materials that require considerable expertise and expense for handling, storage and disposal and may result in claims against us.

We work with materials, including chemicals, biological agents and compounds that could be hazardous to human health and safety or the environment. Our operations also produce hazardous and biological waste products. Our SoluPro system is based on bioengineered E. coli, which could pose a health risk if improperly handled. Additionally, we employ various synthetic biology processes, which could involve the use or emission of harmful materials. Federal, state and local laws and regulations govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes. We may be subject to periodic inspections by relevant authorities to ensure compliance with applicable laws. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental laws and regulations may restrict our operations. If we do not comply with applicable regulations, we may be subject to fines and penalties.

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relevant authorities to ensure compliance with applicable laws. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental laws and regulations may restrict our operations. If we do not comply with applicable regulations, we may be subject to fines and penalties.

In addition, we cannot eliminate the risk of accidental injury or contamination from these materials or wastes, which could cause an interruption of our commercialization efforts, drug creation partnered programs and internally developed programs and business operations, as well as environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations. In the event of contamination or injury, we could be liable for damages or penalized with fines in an amount exceeding our resources and our operations could be suspended or otherwise adversely affected. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance.

Public health crises such as pandemics or similar outbreaks could cause a disruption of the development of our platform technologies, and adversely impact our business.

As a result of public health crises, such as the COVID-19 pandemic, we have previously experienced and may in the future experience severe delays and disruptions, including, for example:

•interruption of or delays in receiving products and supplies from third parties;

•limitations on our business operations by local, state and/or federal governments that could impact our ability to conduct our technology development and other activities;

•delays in negotiations with partners and potential partners;

•increases in facilities costs to comply with physical distancing guidance;

•business disruptions caused by workplace, laboratory and office closures and an increased reliance on employees working from home, travel limitations, cyber security and data accessibility, or communication or mass transit disruptions; and

•limitations on employee resources that would otherwise be focused on the conduct of our activities, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people.

Any of these factors could severely impact drug creation, internal program, manufacturing, other research and development activities, business operations and business development, or delay necessary interactions with local regulators, and other important contractors and partners. These and other factors may adversely impact our ability to conduct our business generally and have a material adverse impact on our operations and financial condition and results.

We rely and expect in the future to rely on a limited number of outside parties to perform the cGMP manufacturing for preclinical development, clinical development and commercialization of any biologic product candidates produced using our technology. Limitations in this global cGMP manufacturing capacity could delay or prevent preclinical development, clinical development and/or commercialization efforts.

We develop manufacturing processes that are required to use our cell lines, but we do not currently have capabilities to manufacture products in accordance with cGMPs. We rely on the in-house manufacturing capabilities of our partners or capabilities of established third-party CDMOs to manufacture our and our partners product candidates. Manufacturing capacity maintained by our partners or third-party CDMOs is a finite resource that is in demand. Shortages in cGMP manufacturing capacity are difficult to predict and could hamper our operations and harm our business.

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In addition, from time to time we have relied upon, and may continue to rely upon, third party CDMOs that are based in jurisdictions outside the United States. Legislative proposals are pending that, if enacted, could negatively impact U.S. funding for certain biotechnology providers having relationships with foreign adversaries or which potentially pose a threat to national security. If any of our third party CDMOs are impacted by these legislative proposals, the potential downstream adverse impacts on us are unknown but may include supply chain disruptions or delays.

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While we have no active plans to operate a manufacturing facility designed to comply with cGMPs, future market pressures or the lack of available capacity at third-party cGMP manufacturing facilities may necessitate our entry into this market, which could result in our incurring additional time and expenses to establish our own cGMP manufacturing capabilities and have an adverse effect on our business, financial condition and results of operations.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain sufficient intellectual property protection for our technologies, ~~including for our cell line~~ and ~~expression~~product ~~technologies~~candidates, ~~generative deep learning technology, proprietary assays and techniques, and antibody and target discovery technology,~~ or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies or product candidates similar or identical to ours, and our ability to successfully leverage our technologies or product candidates may be impaired.

We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property rights protection and contractual restrictions to protect our proprietary technologies, all of which provide limited protection and may not adequately protect our rights or permit us to gain or keep a competitive advantage. If we fail to protect our intellectual property, third parties may be able to compete more effectively against us. In addition, we may incur substantial litigation costs in our attempts to recover or restrict the use of our intellectual property.

To the extent our intellectual property offers inadequate protection, or is found to be invalid or unenforceable, we would be exposed to a greater risk of direct competition. If our intellectual property does not provide adequate coverage of our competitors’ products and services, our competitive position could be adversely affected, as could our business. Both the patent application process and the process of managing patent disputes can be time-consuming and expensive.

Our success depends in large part on our ability to obtain and maintain adequate protection of the intellectual property we may own solely and jointly with others or otherwise have rights to, particularly patents, in the United States and in other countries with respect to our platform, our software and our technologies, without infringing the intellectual property rights of others.

We strive to protect and enhance the proprietary technologies that we believe are important to our business, including seeking patents intended to cover our Integrated Drug Creation platform and related technologies and uses thereof, as we deem appropriate. Our patents and patent applications in the United States and certain foreign jurisdictions relate to our technology. However, obtaining and enforcing patents in our industry is costly, time-consuming, and complex, and we may fail to apply for patents on important products and technologies in a timely fashion or at all, or we may fail to apply for patents in potentially relevant jurisdictions. There can be no assurance that the claims of our patents (or any patent application that is issued to us as a patent), will exclude others from making, using, or selling our technology or technology that is substantially similar to ours. We also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection. In countries where we have not sought and do not seek patent protection, third parties may be able to manufacture and sell our technology without our permission, and we may not be able to stop them from doing so. We may not be able to file and prosecute all necessary or desirable patent applications, or maintain, enforce, and license any patents that may issue from such patent applications, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our technology development output before it is too late to obtain patent protection. We may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the rights to patents licensed to third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.

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We own issued, or granted, patents and have pending patent applications worldwide, which include issued U.S. patents and pending U.S. patent applications. It is possible that none of our pending patent applications will result in issued patents in a timely fashion or at all, and even if patents are granted, they may not provide a basis for intellectual property protection of commercially viable products or services, may not provide us with any competitive advantages, or may be challenged and invalidated by third parties. It is possible that others will design around our current or future patented technologies. As a result, our owned and licensed patents and patent applications comprising our patent portfolio may not provide us with sufficient rights to exclude others from commercializing technology and products similar to any of our technology.

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It is possible that in the future some of our patents, licensed patents and patent applications may be challenged at the USPTO or in proceedings before the patent offices of other jurisdictions. We may not be successful in defending any such challenges made against our patents or patent applications. Any successful third party challenge to our patents could result in loss of exclusivity or freedom to operate, patent claims being narrowed, the unenforceability or invalidity of such patents, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, limit the duration of the patent protection of our technology, and increased competition to our business. We may have to challenge the patents or patent applications of third parties. The outcome of patent litigation or other proceeding can be uncertain, and any attempt by us to enforce our patent rights against others or to challenge the patent rights of others may not be successful, or, if successful, may take substantial time and result in substantial cost, and may divert our efforts and attention from other aspects of our business.

As another example, the European Unified Patent Court (UPC) came into force in June 2023. The UPC is a common patent court to hear patent infringement and revocation proceedings effective for member states of the European Union. Should we file under the UPC and have one or more issued patents through this new system we could be adversely affected. A single forum could enable third parties to seek revocation of any of our European patents in a single proceeding at the UPC rather than through multiple proceedings in each of the jurisdictions in which the European patents have previously been issued. Any such revocation and loss of patent protection could have a material adverse impact on our business and our ability to commercialize or license our technology and products. Moreover, the controlling laws and regulations of the UPC will develop over time and may adversely affect the breadth of patents filed thereunder, or our ability to defend any such patent and/or our ability to enforce our European patents or defend the validity thereof. We may decide to opt out our European patents and patent applications from the UPC. If certain formalities and requirements are not met, however, our European patents and patent applications could be challenged for non-compliance and brought under the jurisdiction of the UPC. Likewise, at this point we cannot be certain that our European patents and patent applications will avoid falling under the jurisdiction of the UPC, even if we decide to opt out of the UPC.

Any changes we make to our technology, including changes that may be required for commercialization or that cause them to have what we view as more advantageous properties may not be covered by our existing patent portfolio, and we may be required to file new applications and/or seek other forms of protection for any such alterations to our technology. There can be no assurance that we would be able to secure patent protection that would adequately cover an alternative to our technology.

The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in such companies’ patents has emerged to date in the United States or elsewhere. Courts frequently render opinions in the biotechnology field that may affect the patentability of certain inventions or discoveries.

Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our technologies.

Changes in either the patent laws or in interpretations of patent laws in the United States or other countries or regions may diminish the value of our intellectual property. We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third party patents. We may not develop additional proprietary platforms, methods and technologies that are patentable.

Assuming that other requirements for patentability are met, prior to March 16, 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. On or after March 16, 2013, under the Leahy-Smith America Invents Act (America Invents Act) enacted on September 16, 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO on or after March 16, 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent application. Because patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we

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first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO on or after March 16, 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent application. Because patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our technology or (ii) invent any of the inventions claimed in our or our licensor’s patents or patent applications.

The America Invents Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect patent litigation. These include allowing third party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned or any future in-licensed patent applications and the enforcement or defense of our owned or any future in-licensed issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

In addition, the patent position of companies in the biotechnology field is particularly uncertain. Various courts, including the United States Supreme Court have rendered decisions that affect the scope of patentability of certain inventions or discoveries relating to biotechnology. These decisions state, among other things, that a patent claim that recites an abstract idea, natural phenomenon, or law of nature (for example, the relationship between particular genetic variants and cancer) are not themselves patentable. Precisely what constitutes a law of nature or abstract idea is uncertain, and it is possible that certain aspects of our technology could be considered natural laws.

In another example, in Amgen Inc. v. Sanofi, or Amgen, the U.S. Supreme Court held that certain of Amgen’s patent claims defined a class of antibodies by their function of binding to a particular antigen and not by structure and that a skilled artisan would have to use significant trial and error to identify and make all of the molecules in that class. The U.S. Supreme Court ultimately held that Amgen failed to properly enable its patent claims. While we do not believe that any of our patents will be found invalid based on this or other decisions, we cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may impact the value of our patents. In 2023, the Federal Circuit issued a decision in In re Cellect, LLC involving the interaction of patent term adjustment, or PTA, terminal disclaimers, and obviousness-type double patenting which may affect the patent term of any issued patents that rely on any PTA. In 2022, Congress passed the IRA, which authorizes the Secretary of the Department of Health and Human Services, or HHS, to negotiate prices directly with participating manufacturers for selected medicines covered by Medicare even if these medicines are protected by an existing patent. While we do not believe that the IRA or its effects will impact our ability to obtain patents in the near future, we cannot be certain that it will not affect our patent strategy in the long run. Additionally, there have been recent proposals for additional changes to the patent laws of the United States and other countries that, if adopted, could impact our ability to obtain patent protection for our proprietary technology or our ability to enforce our proprietary technology. Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

Issued patents covering our Integrated Drug Creation platform and other technologies could be found invalid or unenforceable if challenged.

The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability. Some of our patents or patent applications (including licensed patents) may be challenged at a future point in time in opposition, derivation, reexamination, inter partes review, post-grant review or interference. Any successful third party challenge to our patents in this or any other proceeding could result in the unenforceability or invalidity of such patents or amendment to our patents in such a way that they no longer cover our Integrated Drug Creation platform and our technology, which may lead to increased competition to our business, which could harm our business. In addition, in patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. The outcome following legal assertions of invalidity and unenforceability during patent litigation is unpredictable. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of

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~~third party challenge to our patents in this or any other proceeding could result in~~ the unenforceability or invalidity of such patents or amendment to our patents in such a way that they no longer cover our Integrated Drug Creation platform and our technology, which may lead to increased competition to our business, which could harm our business. In addition, in patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. The outcome following legal assertions of invalidity and unenforceability during patent litigation is unpredictable. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on certain aspects of our platform technologies. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future products.

We may not be aware of all third party intellectual property rights potentially relating to our Integrated Drug Creation platform or technology. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until approximately 18 months after filing or, in some cases, not until such patent applications issue as patents. We or our licensors might not have been the first to make the inventions covered by each of our pending patent applications and we or our licensors might not have been the first to file patent applications for these inventions. There is also no assurance that all of the potentially relevant prior art relating to our patents and patent applications, or licensed patents and patent applications has been found, which could be used by a third party to challenge their validity or prevent a patent from issuing from a pending patent application.

To determine the priority of these inventions, we may have to participate in interference proceedings, derivation proceedings or other post-grant proceedings declared by the USPTO that could result in substantial cost to us. The outcome of such proceedings is uncertain. No assurance can be given that other patent applications will not have priority over our patent applications. In addition, changes to the patent laws of the United States allow for various post-grant opposition proceedings that have not been extensively tested, and their outcome is therefore uncertain. Furthermore, if third parties bring these proceedings against our patents, we could experience significant costs and management distraction.

We may come to rely on in-licenses from third parties. If we were to lose these rights, our business could be materially adversely affected, our ability to develop improvements to our Integrated Drug Creation platform or technologies could be negatively and substantially impacted, and if disputes arise, we could be subjected to future litigation as well as the potential loss of or limitations on our ability to incorporate the technology covered by these license agreements.

We may need to obtain licenses from third parties to advance our research, development, and commercialization activities. We expect that any future exclusive in-license agreements will impose various development, diligence, commercialization, and other obligations on us. We may enter into engagements in the future with other licensors under which we obtain certain intellectual property rights relating to our Integrated Drug Creation platform and technologies. These engagements may take the form of an exclusive license or of actual ownership of intellectual property rights or technologies from third parties. Our rights to use the technologies we license may be subject to the continuation of and compliance with the terms of those agreements. In some cases, we may not control the prosecution, maintenance or filing of the patents to which we hold licenses, or the enforcement of those patents against third parties.

Moreover, disputes may arise with respect to our licensing or other upstream agreements, including:

•the scope of rights granted under the agreements and other interpretation-related issues;

•the extent to which our technology development processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

•the sublicensing of patent and other rights under our partnership agreements;

•our diligence obligations under the license agreements and what activities satisfy those diligence obligations;

•the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and

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•the priority of invention of patented technology.

In spite of our efforts to comply with our obligations under any future in-license agreements, our licensors might conclude that we have materially breached our obligations under our license agreements and might therefore, including in connection with any aforementioned disputes, terminate the relevant license agreement, thereby removing or limiting our ability to develop and commercialize technology covered by these license agreements. If any such in-license is terminated, or if the licensed patents fail to provide the intended exclusivity, competitors or other third parties might have the freedom to market or develop technologies similar to ours. In addition, absent the rights granted to us under such license agreements, we may infringe the intellectual property rights that are the subject of those agreements, we may be subject to litigation by the licensor, and if such litigation by the licensor is successful we may be required to pay damages to our licensor, or we may be required to cease our technology development and commercialization activities which are deemed infringing, and in such event we may ultimately need to modify our activities or technologies to design around such infringement, which may be time- and resource-consuming, and which may not be ultimately successful. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

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these license agreements. If any such in-license is terminated, or if the licensed patents fail to provide the intended exclusivity, competitors or other third parties might have the freedom to market or develop technologies similar to ours. In addition, absent the rights granted to us under such license agreements, we may infringe the intellectual property rights that are the subject of those agreements, we may be subject to litigation by the licensor, and if such litigation by the licensor is successful we may be required to pay damages to our licensor, or we may be required to cease our technology development and commercialization activities which are deemed infringing, and in such event we may ultimately need to modify our activities or technologies to design around such infringement, which may be time- and resource-consuming, and which may not be ultimately successful. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

In addition, our rights to future components of our Integrated Drug Creation platform may be licensed to us on a non-exclusive basis. The owners of these non-exclusively licensed technologies would therefore be free to license them to third parties, including our competitors, on terms that may be superior to those offered to us, which could place us at a competitive disadvantage. Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights. In addition, certain of our agreements with third parties may provide that intellectual property arising under these agreements, such as data that could be valuable to our business, will be owned by the counterparty, in which case, we may not have adequate rights to use such data or have exclusivity with respect to the use of such data, which could result in third parties, including our competitors, being able to use such data to compete with us.

If we cannot acquire or license rights to use technologies on reasonable terms or if we fail to comply with our obligations under such agreements, we may not be able to commercialize new technologies or services in the future and our business could be harmed.

In the future, we may identify third party intellectual property and technologies we may need to acquire or license in order to engage in our business, including to develop or commercialize new technologies or services, and the growth of our business may depend in part on our ability to acquire, in-license or use these technologies. However, we may not be able to acquire or in-license rights to these technologies on acceptable terms or at all. The licensing or acquisition of third party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third party intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, capital resources and greater technological development or commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Even if such licenses are available, we may be required to pay the licensor in return for the use of such licensor’s technology, upfront or technology access fees, payments based on certain development, regulatory or commercial milestones such as sales volumes, or royalties based royalties received or milestones achieved by our partners. In addition, such licenses may be non-exclusive, which could give our competitors access to the same intellectual property licensed to us.

In spite of our best efforts, our licensors might conclude that we have materially breached our license agreements and might therefore terminate the license agreements, thereby removing our ability to develop and commercialize technologies covered by these license agreements. If these licenses are terminated, or if the underlying intellectual property fails to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, technologies identical to ours. This could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects. Additionally, termination of these agreements or reduction or elimination of our rights under these agreements, or restrictions on our ability to freely assign or sublicense our rights under such agreements when it is in the interest of our business to do so, may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technologies or impede, or delay or prohibit the further development or commercialization of one or more technologies that rely on such agreements.

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While we still face all of the risks described herein with respect to those agreements, we cannot prevent third parties from also accessing those technologies. In addition, our licenses may place restrictions on our future business opportunities.

In addition to the above risks, intellectual property rights that we license in the future may include sublicenses under intellectual property owned by third parties, in some cases through multiple tiers. The actions of our licensors may therefore affect our rights to use our sublicensed intellectual property, even if we are in compliance with all of the obligations under our license agreements. Should our licensors or any of the upstream licensors fail to comply with their obligations under the agreements pursuant to which they obtain the rights that are sublicensed to us, or should such agreements be terminated or amended, our or our partners’ ability to further commercialize our technologies or products generated using our technologies may be materially harmed.

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actions of our licensors may therefore affect our rights to use our sublicensed intellectual property, even if we are in compliance with all of the obligations under our license agreements. Should our licensors or any of the upstream licensors fail to comply with their obligations under the agreements pursuant to which they obtain the rights that are sublicensed to us, or should such agreements be terminated or amended, our or our partners’ ability to further commercialize our technologies or products generated using our technologies may be materially harmed.

Further, we may not have the right to control the prosecution, maintenance, and enforcement of all of our licensed and sublicensed intellectual property, and even when we do have such rights, we may require the cooperation of our licensors and upstream licensors, which may not be forthcoming. Our business could be adversely affected if we or our licensors are unable to prosecute, maintain and enforce our licensed and sublicensed intellectual property effectively.

Our licensors may have relied on third-party consultants or partners or on funds from third parties such that our licensors are not the sole and exclusive owners of the patents and patent applications we in-license. If other third parties have ownership rights to patents or patent applications we in-license, they may be able to license such patents to our competitors, and our competitors could market competing technologies and services. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

Our business, financial condition, results of operations and prospects could be materially and adversely affected if we are unable to enter into necessary agreements on acceptable terms or at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the licenses or fail to prevent infringement by third parties, or if the acquired or licensed patents or other rights are found to be invalid or unenforceable. Moreover, we could encounter delays in advancing ongoing or initiating new technology development programs while we attempt to develop alternatives. Defense of any lawsuit or failure to obtain any of these licenses on favorable terms could prevent us from developing technologies or advancing partnerships, which could harm our business, financial condition, results of operations and prospects.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, and defending patents on our Integrated Drug Creation platform, technologies, software, systems, and processes in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States, and even where such protection is nominally available, judicial, and governmental enforcement of such intellectual property rights may be lacking. Whether filed in the United States or abroad, our patent applications may be challenged or may fail to result in issued patents. Further, we may encounter difficulties in protecting and defending such rights in foreign jurisdictions. Consequently, we may not be able to prevent third parties from practicing our inventions in some or all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own platform or technologies and may also sell their products or services to territories where we have patent protection, but enforcement is not as strong as that in the United States. These platforms and technologies may compete with ours. Our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. In addition, certain countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to other parties. Furthermore, many countries limit the enforceability of patents against other parties, including government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of any patents. In many foreign countries, patent applications and/or issued patents, or parts thereof, must be translated into the native language. If our patent applications or issued patents are translated incorrectly, they may not adequately cover our technologies; in some countries, it may not be possible to rectify an incorrect translation, which may result in patent protection that does not adequately cover our technologies in those countries.

62Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of many other countries do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the misappropriation or other violations of our intellectual property rights

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~~technologies;~~including infringement of our patents in ~~some~~such countries. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business, itcould ~~may~~put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not beissuing, ~~possible~~and could provoke third parties to ~~rectify~~assert anclaims ~~incorrect~~against ~~translation,~~us. ~~which~~We may ~~result~~not prevail in ~~patent~~any ~~protection~~lawsuits that ~~does~~we initiate, or that are initiated against us, and the damages or other remedies awarded, if any, may not ~~adequately~~be ~~cover~~commercially ~~our~~meaningful. ~~technologies~~In addition, changes in ~~those~~the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain adequate protection for our technologies and the enforcement of intellectual property. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of many other countries do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the misappropriation or other violations of our intellectual property rights including infringement of our patents in such countries. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, or that are initiated against us, and the damages or other remedies awarded, if any, may not be commercially meaningful. In addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain adequate protection for our technologies and the enforcement of intellectual property. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

•others may be able to make products that are similar to any product candidates generated by our Integrated Drug Creation platform that our partners may develop but that are not covered by the claims of the patents that we own or may license or own in the future;

•we, or our current or future partners, might not have been the first to make the inventions covered by the issued patents and pending patent applications that we own or may license or own in the future;

•we, or our current or future partners, might not have been the first to file patent applications covering certain of our or their inventions;

•others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or any future licensed intellectual property rights;

•it is possible that our pending patent applications or those that we may own in the future will not lead to issued patents;

•issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

•our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

•we cannot ensure that any patents issued to us, or our licensors will provide a basis for an exclusive market for our commercially viable technologies or will provide us with any competitive advantages;

•we cannot ensure that our commercial activities or technologies will not infringe upon the patents of others;

•we cannot ensure that we or our partners or future licensees will be able to further commercialize our technologies on a substantial scale, if approved, before the relevant patents that we own or may license expire;

•we cannot ensure that any of our patents, or any of our pending patent applications, if issued, or those of our licensors, will include claims having a scope sufficient to protect our technology;

•we may not develop additional proprietary technologies that are patentable;

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•the patents or intellectual property rights of others may harm our business; and

•we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.

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If we are unable to protect the confidentiality of our information and our trade secrets, the value of our technologies could be materially adversely affected, and our business could be harmed.

We rely heavily on trade secrets and confidentiality agreements to protect our unpatented know-how, technologies, and other proprietary information, including parts of our Integrated Drug Creation platform, and to maintain our competitive position. However, trade secrets and know-how can be difficult to protect. In addition to pursuing patents on our technologies, we take steps to protect our intellectual property and proprietary technologies by entering into agreements, including confidentiality agreements, non-disclosure agreements and intellectual property assignment agreements, with our employees, consultants, academic institutions, corporate and/or strategic partners, potential or existing investors and, when needed, our advisers. However, we cannot be certain that such agreements have been entered into with all relevant parties, and we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. For example, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Such agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements, and we may not be able to prevent such unauthorized disclosure, which could adversely impact our ability to establish or maintain a competitive advantage in the market. If we are required to assert our rights against such party, it could result in significant cost and distraction.

Monitoring unauthorized disclosure and detection of unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets, it would be expensive and time-consuming, and the outcome would be unpredictable. In addition, some courts both within and outside the United States may be less willing, or unwilling, to protect trade secrets. Further, we may need to share our trade secrets and confidential know-how with current or future business partners, collaborators, contractors, and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors.

We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached. If any of our confidential proprietary information were to be lawfully obtained or independently developed by a competitor or other third party, absent patent protection, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position. If any of our trade secrets were to be disclosed to or independently discovered by a competitor or other third party, it could harm our business, financial condition, results of operations and prospects.

We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

We have employed and expect to employ individuals who were previously employed at universities or other companies. Although we try to ensure that our employees, consultants, advisors and independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that our employees, advisors, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information of their former employers or other third parties, or to claims that we have improperly used or obtained such trade secrets. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights and face increased competition to our business. A loss of key research personnel work product could hamper or prevent our ability to commercialize potential technologies and solutions, which could harm our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

64In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual

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~~competition~~property to ~~our~~us, ~~business.~~we Amay ~~loss~~be ofunsuccessful ~~key~~in ~~research~~executing ~~personnel~~such ~~work~~an ~~product~~agreement ~~could~~with ~~hamper~~each party who, in fact, conceives or ~~prevent~~develops intellectual property that we regard as our ~~ability~~own. toThe ~~commercialize~~assignment ~~potential~~of ~~technologies~~intellectual ~~and~~property ~~solutions~~rights may not be self-executing, ~~which~~or ~~could~~the ~~harm~~assignment ~~our~~agreements ~~business.~~may ~~Even~~be ifbreached, and we ~~are~~may ~~successful~~be inforced ~~defending~~to bring claims against ~~these~~third parties, or defend claims that they may bring against us, ~~litigation~~to determine the ownership of what we regard as our intellectual property. Any of the foregoing could ~~result~~harm inour ~~substantial~~business, ~~costs~~financial ~~and~~condition, beresults aof ~~distraction~~operations toand ~~management~~prospects.

InWe ~~addition,~~are ~~while~~or itmay isbecome ~~our~~subject ~~policy~~ to ~~require~~U.S. ~~our employees~~ and ~~contractors~~foreign ~~who~~laws ~~may~~regarding ~~be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us~~privacy, wedata ~~may be unsuccessful in executing such an agreement with each party who~~protection, inand ~~fact,~~data ~~conceives~~security ~~or develops intellectual property~~ that wecould ~~regard~~require assubstantial ~~our~~compliance ~~own. The assignment of intellectual property rights may not be self-executing~~costs, ~~or the assignment agreements may be breached,~~ and weany ~~may~~failure ~~be forced to bring claims against third parties,~~ or ~~defend~~perceived ~~claims~~failure ~~that they may bring against us,~~ to ~~determine~~comply ~~the~~with ~~ownership~~them ~~of what we regard as our intellectual property. Any of the foregoing~~ could ~~harm~~subject ~~our~~us ~~business,~~to ~~financial~~significant ~~condition, results of operations and prospects~~liability.

The global landscape of privacy, data protection and data security laws has been rapidly evolving and is expected to become increasingly complex in the years to come. Numerous complex federal and state laws and regulations govern the collection, use, disclosure, storage and transmission of personally identifiable information, including protected health information. State laws in the United States may be even more restrictive and may be subject to varying interpretations by the courts and government agencies. These laws and regulations, including their interpretation by governmental agencies, are subject to frequent change and could have a negative impact on our business. Further, these varying interpretations could create complex compliance issues for us and our partners and potentially expose us to additional expense, liability, penalties, negatively impact our client relationships, and lead to adverse publicity, and all of these risks could adversely affect our business in the short and long term.

Numerous states now have enacted comprehensive privacy laws, adding complexity, variation in requirements, restrictions and potential legal risk requiring additional investment of resources in compliance programs. Certain states have passed laws regulating specific aspects of privacy. For example, the State of Washington recently passed a law that regulated health and medical information that is not subject to the Health Insurance Portability and Accountability Act and a small number of states, such as Illinois and Texas, have enacted laws that specifically target the collection and use of biometric information.

Regulators and legislators in the U.S. are also increasingly scrutinizing and restricting certain personal data transfers and transactions involving foreign countries. For example, the Department of Justice’s January 8, 2025, rule on “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” prohibits data brokerage transactions involving certain sensitive personal data categories, including health data, genetic data, and biospecimens, to countries of concern, including China. The regulations also restrict certain investment agreements, employment agreements and vendor agreements involving such data and countries of concern, absent specified cybersecurity controls. Actual or alleged violations of these regulations may be punishable by criminal and/or civil sanctions and may result in exclusion from participation in federal and state programs.

Internationally, virtually every jurisdiction in which we operate has established its own data security and privacy legal framework with which we or our customers must comply. Cross-border data transfers and other future developments regarding local data residency and access could increase the cost and complexity of delivering our services in some markets and may lead to governmental enforcement actions, litigation, fines and penalties or adverse publicity, which could adversely affect our business and financial position could greatly increase our cost of providing our products and services, require significant changes to our operations or even prevent us from offering certain services in specific jurisdictions. In addition, any limitation on our ability to use or transmit health information outside of the U.S. could impose restrictions on our ability to recruit and maintain employees residing outside of the U.S., which could, in turn, adversely affect our business.

We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest thereby harming our competitive position.

The registered or unregistered trademarks or trade names that we own may be challenged, infringed, circumvented, declared generic, lapsed, or determined to be infringing on or dilutive of other marks. We may not be able to protect our rights in these trademarks and trade names, which we need in order to build name recognition. In addition, third parties may in the future file for registration of trademarks similar or identical to our trademarks, thereby impeding our ability to build brand identity and possibly leading to market confusion. If they succeed in registering or developing common law rights in such trademarks, and if we are not successful in challenging such rights, we may not be able to use these trademarks to develop brand recognition of our technologies or platform. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Further, we have and may in the future enter into agreements with owners of such third party trade names or trademarks to avoid potential trademark litigation which may limit our ability to use our trade names or trademarks in certain fields of business.

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infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Further, we have and may in the future enter into agreements with owners of such third party trade names or trademarks to avoid potential trademark litigation which may limit our ability to use our trade names or trademarks in certain fields of business.

Although we have registered some of our trademarks with the USPTO and certain other jurisdictions, we have not yet registered certain of our trademarks in all of our potential markets, and failure to secure those registrations could adversely affect our business. If we apply to register these trademarks in other countries, and/or other trademarks in the United States and other countries, our applications may not be allowed for registration in a timely fashion or at all; and further, our registered trademarks may not be maintained or enforced. In addition, opposition or cancellation proceedings may in the future be filed against our trademark applications and registrations, and our trademarks may not survive such proceedings. In addition, third parties may file first for our trademarks in certain countries. If they succeed in registering such trademarks, and if we are not successful in challenging such third party rights, we may not be able to use these trademarks to market our technologies in those countries. If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively, which could harm our business, financial condition, results of operations and prospects. And, over the long-term, if we are unable to establish name recognition based on our trademarks, then our business development abilities may be materially adversely impacted.

We may pursue litigation, quasi-litigation, quasi-arbitral, or adversarial proceedings before trademark offices, courts, or other administrative tribunals or courts in order to enforce our trademark rights or to determine the scope, coverage and validity of our rights. The outcome of any such action might not be favorable to us, and even if we were to prevail, such litigation or administrative ruling could result in substantial costs and diversion of resources and could have a material adverse effect on our business, operating results or financial condition.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

We or any future licensors may be subject to claims that former employees, partners or other third parties have an interest in our patents or any future in-licensed patents, trade secrets or other intellectual property as an inventor or co-inventor. Litigation may be necessary to defend against these and other claims challenging inventorship of our or such licensors’ ownership of our owned or any future in-licensed patents, trade secrets or other intellectual property. If we or our future licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our systems. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees, and certain partners may defer engaging with us until the particular dispute is resolved. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

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trade secrets or other intellectual property. If we or our future licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our systems. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees, and certain partners may defer engaging with us until the particular dispute is resolved. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

If we become involved in patent litigation or other proceedings related to a determination of rights, we could incur substantial costs and expenses, substantial liability for damages or be required to stop our development and commercialization efforts of our technologies.

There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the life sciences, clinical diagnostics and drug discovery industries, including patent infringement lawsuits, declaratory judgment litigation and adversarial proceedings before the USPTO, including interferences, derivation proceedings, ex parte reexaminations, post-grant review and inter partes review, as well as corresponding proceedings in foreign courts and foreign patent offices.

We may, in the future, become involved with litigation or actions at the USPTO or foreign patent offices with various third parties. We expect that the number of such claims may increase as our business, visibility and partnership base expand and the number of our technology development programs and resultant licensed technologies increases, and as the level of competition in our industry increases. Any infringement claim, regardless of its validity, could harm our business by, among other things, resulting in time-consuming and costly litigation, diverting management’s time and attention from the development of our business, requiring ~~the payment of monetary damages (including treble damages, attorneys’ fees, costs, and expenses) or royalty payments.~~

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the payment of monetary damages (including treble damages, attorneys’ fees, costs, and expenses) or royalty payments.

It may be necessary for us to pursue litigation or adversarial proceedings before the patent office in order to enforce our patent and proprietary rights or to determine the scope, coverage, and validity of the proprietary rights of others. The outcome of any such litigation might not be favorable to us, and even if we were to prevail, such litigation could result in substantial costs and diversion of resources and could have a material adverse effect on our business, operating results, or financial condition.

As we move into new markets and expand our technology offerings, incumbent participants in such markets may assert their patents and other proprietary rights against us as a means of slowing our entry into such markets or as a means to extract substantial license and royalty payments from us. In addition, future litigation may involve patent holding companies or other adverse patent owners who have no relevant product or service revenue and against whom our own patents may provide little or no deterrence or protection.

Third parties may assert that we are employing their proprietary technology without authorization. Given that biologic drug discovery and cell line development platform technology fields are highly competitive areas, there may be third-party intellectual property rights that others believe could relate to our technologies.

Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our current or future products, technologies and services may infringe. We cannot be certain that we have identified or addressed all potentially significant third-party patents in advance of an infringement claim being made against us. In addition, similar to what other companies in our industry have experienced, we expect our competitors and others may have patents or may in the future obtain patents and claim that making, having made, using, selling, offering to sell, or importing our technologies infringes these patents. Defense of infringement and other claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and employee resources from our business. Parties making claims against us may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Parties making claims against us may be able to obtain injunctive or other relief, which could block our ability to develop, commercialize and sell products or services and could result in the award of substantial damages against us, including treble damages, attorney’s fees, costs, and expenses if we are found to have willfully infringed. In the event of a successful claim of infringement against us, we may be required to pay damages and ongoing royalties and obtain one or more licenses from third parties or be prohibited from selling certain products or services. We may not be able to obtain these licenses on acceptable or commercially reasonable terms, if at all, or these licenses may be non-exclusive, which could result in our competitors gaining access to the same intellectual property. In addition, we could encounter delays in product or service introductions while we attempt to develop alternative products or services to avoid infringing third-party patents or proprietary rights. Defense of any lawsuit or failure to obtain any of these licenses could prevent us from commercializing products or services, and the prohibition of sale of any of our technologies could materially affect our business and our ability to gain market acceptance for our technologies.

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terms, if at all, or these licenses may be non-exclusive, which could result in our competitors gaining access to the same intellectual property. In addition, we could encounter delays in product or service introductions while we attempt to develop alternative products or services to avoid infringing third-party patents or proprietary rights. Defense of any lawsuit or failure to obtain any of these licenses could prevent us from commercializing products or services, and the prohibition of sale of any of our technologies could materially affect our business and our ability to gain market acceptance for our technologies.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, during the course of this kind of litigation, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

In addition, our agreements with some of our partners, suppliers, or other entities with whom we do business require us to defend or indemnify these parties to the extent they become involved in infringement claims, including the types of claims described above. We could also voluntarily agree to defend or indemnify third parties in instances where we are not obligated to do so if we determine it would be important to our business relationships. If we are required or agree to defend or indemnify third parties in connection with any infringement claims, we could incur significant costs and expenses that could adversely affect our business, operating results, or financial condition.

Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by ~~governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.~~

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governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on issued United States and most foreign patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States at several stages over the lifetime of the patents and/or applications in order to maintain such patents and patent applications. We have systems in place to remind us to pay these fees, and we engage an outside service to pay such fees due to patent agencies. The USPTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, if we or any future licensors fail to maintain the patents and patent applications covering technologies our competitors may be able to enter the market with similar or identical products or technology without infringing our patents and this circumstance would have a material adverse effect on our business.

Patent terms may be inadequate to protect our competitive position with our technology for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our platform or technologies are obtained, once the patent life has expired, we may be open to competition from others. If our platform or technologies require extended development and/or regulatory review, patents protecting our platform or technologies might expire before or shortly after we are able to successfully commercialize them. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing processes or technologies similar or identical to ours.

Some of our jointly owned intellectual property has been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies, and compliance with such regulations may limit our exclusive rights and our ability to contract with non-U.S. manufacturers.

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a preference for U.S.-based companies, and compliance with such regulations may limit our exclusive rights and our ability to contract with non-U.S. manufacturers.

The United States federal government retains certain rights in inventions produced with its financial assistance under the Bayh-Dole Act. The federal government retains a “nonexclusive, nontransferable, irrevocable, paid-up license” for its own benefit. The Bayh-Dole Act also provides federal agencies with “march-in rights”. March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants” if it determines that (1) adequate steps have not been taken to commercialize the invention and achieve practical application of the government-funded technology, (2) government action is necessary to meet public health or safety needs, (3) government action is necessary to meet requirements for public use under federal regulations or (4) we fail to meet requirements of federal regulations. If the patent owner refuses to do so, the government may grant the license itself. Some of our jointly owned or licensed patents are subject to the provisions of the Bayh-Dole Act. If our licensors fail to comply with the regulations of the Bayh-Dole Act, they could lose title to any patents subject to such regulations, which could affect our license rights under the patents and our ability to stop others from using or commercializing similar or identical technology and products, or limit patent protection for our technology and products.

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Risks Related to Our Common Stock

Our share price may be volatile, and you could lose all or part of your investment.

The market price of our common stock is volatile and subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including:

•adverse results or delays in our preclinical studies or clinical trials;

•any delay in filing an IND (or foreign equivalent) or BLA (or foreign equivalent) for our product candidates and any adverse development or perceived adverse development with respect to the FDA’s review of that IND or BLA;

•our failure to successfully develop and commercialize, or otherwise generate revenues from partnered and/or internally developed programs;

•our inability to obtain sufficient funding to advance our internally developed programs and invest in our Integrated Drug Creation platform;

•actual or anticipated fluctuations in our financial condition and operating results, including fluctuations in our quarterly and annual results;

•the termination of partnership agreements by our partners or announcements that our partners will cease developing a product candidate from our Integrated Drug Creation platform;

•the introduction of new technologies or enhancements to existing technology by us or others in our industry;

•our inability to establish additional partnerships or expand the scope of existing partnerships;

•the recruitment or departures of key personnel;

•announcements of clinical data, significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

•our failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;

•changes in the regulatory landscape that subject us to additional regulatory and legal requirements;

•publication of research reports about us, our industry or our competitors, or biologic drug discovery in particular, or positive or negative recommendations or withdrawal of research coverage by securities analysts;

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•release of unfavorable publicity about us, our partners, our competitors, or the biopharmaceutical industry, including through press coverage or social media;

•changes in the market valuations of similar companies;

•overall performance of the equity markets;

•sales of our common stock by us or our stockholders in the future;

•trading volume of our common stock;

•disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

•significant lawsuits, including patent or stockholder litigation;

•the impact of public health crises, including the COVID-19 pandemic, on our business;

•general political and economic conditions; and

•other events or factors, many of which are beyond our control.

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In addition, the stock market in general, and the Nasdaq Global Select Market and technology and life sciences companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated and/or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. In the past, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, financial condition and results of operations.

We in the past have had, and in the future may have, a material weakness in our internal control over our financial reporting process. If we are unable to remediate an identified material weakness, we may not be able to accurately or timely report our financial condition or results of operations.

In the past, we and our independent registered public accounting firm identified control deficiencies in the design and operation of our internal control over financial reporting that constituted a material weakness. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected on a timely basis. Although we were able to remediate this past material weakness, there is no guarantee that we will not identify material weaknesses or significant deficiencies in our internal control over financial reporting in the future or that we will be able to remediate any such material weakness or significant deficiency in a timely manner or at all.

If we identify future material weaknesses or significant deficiencies in our internal control over financial reporting, we may be unable to accurately report our financial results or report them within the timeframes required by law or stock exchange regulations. Failure to comply with Section 404 of the Sarbanes-Oxley Act could also potentially subject us to sanctions or investigations by the SEC or other regulatory authorities. If additional material weaknesses exist or are discovered in the future, and we are unable to remediate any such material weakness, our reputation, results of operations and financial condition could suffer and our stock price may decline.

We are obligated to develop and maintain proper and effective internal control over financial reporting. These internal controls may not be determined to be effective, which may adversely affect investor confidence in our company and, as a result, the value of our common stock.

We are required, pursuant to Section 404 of the Sarbanes–Oxley Act, to furnish a report by management on the effectiveness of our internal control over financial reporting on an annual basis. This assessment includes disclosure of any material weaknesses identified by our management in our internal control over financial reporting. During the evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal control over financial reporting is effective. Any failure to remediate new significant deficiencies or material weaknesses identified by us or to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements. If we identify one or more material weaknesses in the future, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements, which may harm the market price of our common stock, and we may be subject to investigation or sanctions by the SEC.

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by us or to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements. If we identify one or more material weaknesses in the future, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements, which may harm the market price of our common stock, and we may be subject to investigation or sanctions by the SEC.

We have historically identified, and may continue to identify, key business metrics to evaluate our business and technology, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions, and any such metrics may not accurately reflect all aspects of our business needed to make such evaluations and decisions, in particular as our business continues to grow.

In addition to our financial results, we have historically reviewed a number of operating and financial metrics, including number of programs under contract, the trend of potential downstream revenue terms (milestone payments and royalties) of the portfolio, the performance of the portfolio in probability of success in achieving clinical milestones as compared to historical averages and the performance of the portfolio in the time taken to achieve clinical milestones on a Net Present Value (NPV) basis, to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions. To date, we have only entered into a limited number of programs with respect to which we have or are positioned to negotiate royalty- and milestone-bearing licenses. Accordingly, we do not presently have sufficient information to make accurate predictions regarding our potential revenue and future financial performance.

Any metrics that we may identify may not accurately reflect all aspects of our business and we anticipate that these metrics may change or may be substituted for additional or different metrics as our business grows and as we introduce new solutions. For example, we have historically applied the number of Active Programs to assess the adoption of our platform technology and our ability to generate future revenues; however, as our business strategy has evolved to have a greater focus on internally developed programs , we currently do not intend to continue using Active Programs as a key business metric. We continue to evaluate our key business metrics in light of our current strategy and determine how to accurately measure the initiation, advancement, and overall progress of our internally developed programs. We cannot guarantee that the business metrics we choose to disclose related to our internally developed programs will be effective in measuring the potential of our pipeline or accurately predict the future development progress of any of our current or future programs. If we fail to review other relevant information or change or substitute the key business metrics we review as our business grows, our ability to accurately formulate financial projections and make strategic decisions may be compromised and our business, financial results and future growth prospects may be adversely impacted. 80

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we have or are positioned to negotiate royalty- and milestone-bearing licenses. Accordingly, we do not presently have sufficient information to make accurate predictions regarding our potential revenue and future financial performance.

Any metrics that we may identify may not accurately reflect all aspects of our business and we anticipate that these metrics may change or may be substituted for additional or different metrics as our business grows and as we introduce new solutions. We continue to evaluate our key business metrics in light of our current strategy and determine how to accurately measure the initiation, advancement, and overall progress of our internally developed programs. We cannot guarantee that the business metrics we choose to disclose related to our internally developed programs will be effective in measuring the potential of our pipeline or accurately predict the future development progress of any of our current or future programs. If we fail to review other relevant information or change or substitute the key business metrics we review as our business grows, our ability to accurately formulate financial projections and make strategic decisions may be compromised and our business, financial results and future growth prospects may be adversely impacted.

Future sales and issuances of our common stock or rights to purchase common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.

We expect that significant additional capital will be needed in the future to continue our planned operations, including for expanded drug creation and technology development activities. To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities, investors may be materially diluted by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights, preferences, and privileges senior to the holders of our common stock.

Pursuant to our 2021 Stock Option and Incentive Plan (2021 Plan) we are authorized to grant stock options, restricted stock units, stock appreciation rights and other stock-based awards to our employees, directors and consultants. Pursuant to our 2021 Employee Stock Purchase Plan (2021 ESPP), we may sell shares of our common stock to eligible employees at a discount to the market price of our common stock.

As of ~~January 1~~December 31, 2025 the aggregate number of shares of our common stock that may be issued pursuant to our 2021 Plan, 2021 ESPP, and 2023 Inducement Plan are 106,~~039~~458,~~361~~888 shares, 3,~~465~~132,~~877~~960 shares, and 1,~~887~~724,~~000~~200 shares, respectively. The number of shares of common stock that may be issued pursuant to the 2021 Plan does not include outstanding equity awards. The number of shares of common stock reserved for issuance under the 2021 Plan and 2021 ESPP are automatically increased on each January 1 by 5% and 1%, respectively, of the total number of shares of common stock outstanding on December 31 of the preceding calendar year or a lesser number of shares determined by our board of directors. Unless our board of directors elects not to increase the number of shares available for future issuance each year, our stockholders will experience additional dilution, which could cause our share price to fall.

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respectively, of the total number of shares of common stock outstanding on December 31 of the preceding calendar year or a lesser number of shares determined by our board of directors. Unless our board of directors elects not to increase the number of shares available for future issuance each year, our stockholders will experience additional dilution, which could cause our share price to fall.

In addition, we have filed a universal shelf registration statement on Form S-3 (which allows us to offer and sell securities from time to time pursuant to one or more offerings at prices and terms to be determined at the time of sale) subject to an aggregate offering amount stated therein, as well as registration statements on Form S-8 registering all shares of common stock that we may issue under our equity compensation and equity inducement plans or pursuant to equity awards made to newly hired employees outside of equity compensation plans. Such registered shares can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates.

We do not intend to pay dividends on our common stock, so any returns will be limited to the value of our common stock.

We currently anticipate that we will retain future earnings for the development, operation, expansion and continued investment into our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, we may enter into agreements that prohibit us from paying cash dividends without prior written consent from our contracting parties, or which other terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock. Any return to stockholders will therefore be limited to the appreciation of their common stock, which may never occur.

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Our principal stockholders and management own a significant percentage of our shares and will be able to exert significant influence over matters subject to stockholder approval.

As of ~~February~~March 286, ~~2025~~2026, our executive officers, directors, and 5% stockholders beneficially owned over 4544% of our common stock. Therefore, these stockholders have the ability to influence us through this ownership position. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

Future sales of our common stock in the public market could cause our share price to fall.

Sales of a substantial number of shares of our common stock in the public market, including any time following the expiration of legal restrictions on resale or the perception in the market that the holders of a large number of shares of our common stock intend to sell shares, could reduce the market price of our common stock and impair our ability to raise capital through the sale of additional equity securities. In August ~~2022~~2025, we filed a registration statement on Form S-3 with respect to potential future sales of our securities, which was declared effective in ~~September~~August ~~2022~~2025. We have also filed registration statements on Form S-8 to register our common stock issuable pursuant to our equity incentive plans. Shares registered under the registration statements on Form S-8 will be available for sale in the public market subject to vesting arrangements and exercise of options. Additionally, certain holders of our common stock are entitled to rights with respect to registration of such shares under the Securities Act pursuant to a registration rights agreement between such holders and us. If such holders, by exercising their registration rights, sell a large number of shares, they could adversely affect the market price for our common stock.

Additionally, onin ~~June~~August 162025, ~~2023,~~ we entered into ~~a sales agreement (~~the Sales Agreement) with ~~Cowen~~TD ~~and~~Securities ~~Company,~~(USA) LLC (the Sales Agent), with respect to an “at the market offering” program under which we may offer and sell, from time to time ~~at our sole discretion~~, shares of our common stock having an aggregate offering price of up to $100.0 million through the Sales Agent ~~(the ATM)~~. We will pay the Sales Agent a commission up to 3.0% of the gross sales proceeds of any shares sold under the Sales Agreement. Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares of our common stock intend to sell shares, could reduce the market price of our common stock.

An active trading market for our common stock may not continue to be maintained.

Our common stock began trading on the Nasdaq Global Select Market in July 2021, and we can provide no assurance that we will be able to continue maintaining an active trading market on the Nasdaq Global Select Market or any other exchange in the future. If an active trading market for our common stock is not maintained, or if we fail to satisfy the continued listing standards of the Nasdaq Global Select Market for any reason and our common stock is delisted, it may be difficult for our stockholders to sell shares without depressing the market price for the shares or at all. An inactive market may also impair our ability to raise additional capital by selling shares and may impair our ability to acquire other companies or technologies by using our shares as consideration.

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Market or any other exchange in the future. If an active trading market for our common stock is not maintained, or if we fail to satisfy the continued listing standards of the Nasdaq Global Select Market for any reason and our common stock is delisted, it may be difficult for our stockholders to sell shares without depressing the market price for the shares or at all. An inactive market may also impair our ability to raise additional capital by selling shares and may impair our ability to acquire other companies or technologies by using our shares as consideration.

Provisions in our corporate charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our amended and restated certificate of incorporation (the “Restated Certificate”) and our amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. Among others, these provisions include that:

•our board of directors has the right to expand the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;

•our board of directors is divided into three classes, Class I, Class II and Class III, with each class serving staggered three-year terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;

•our stockholders may not act by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders;

•a special meeting of stockholders may be called only by the chairperson of the board of directors, the chief executive officer, or a majority of the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors;

•our amended and restated certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

•our board of directors may alter our bylaws without obtaining stockholder approval;

•the required approval of the holders of at least 75% of the voting power of all of the then outstanding shares of voting stock to adopt, amend or repeal our bylaws or repeal the provisions of our amended and restated certificate of incorporation regarding the election and removal of directors;

•stockholders must provide advance notice and additional disclosures in order to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of our company;

•stockholders must include management’s nominees on its proxy card in contested director elections, which may decrease the likelihood that a potential acquiror can replace a majority of the Board; and

•our board of directors is authorized to issue shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

72Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain disputes between us and our stockholders and that the federal district courts of the United States will be the exclusive forum for certain

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~~voting~~actions ~~stock~~under ~~from~~federal ~~merging~~securities orlaws, ~~combining~~which ~~with~~could uslimit ~~for~~our astockholders’ ~~period~~ability ofto ~~three~~obtain ~~years~~a ~~after~~favorable ~~the~~judicial ~~date~~forum offor ~~the~~disputes ~~transaction~~with inus ~~which~~or ~~the person acquired in excess of 15% of~~ our ~~outstanding voting stock~~directors, ~~unless~~officers ~~the merger~~ or ~~combination is approved in a prescribed manner~~employees.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain disputes between us and our stockholders and that the federal district courts of the United States will be the exclusive forum for certain actions under federal securities laws, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation specifies that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for most legal actions involving actions brought against us by stockholders; provided that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware. Our amended and restated bylaws also provide that the federal district courts of the United States of America are the exclusive forum for the resolution of any complaint asserting a cause of action against us or any of our directors, officers, employees or agents and arising under the Securities Act. The choice of forum provisions do not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.

We believe these provisions may benefit us by providing increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable, particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation. These choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims or make such lawsuits more costly for stockholders, although our stockholders will not be deemed to have waived our compliance with federal securities laws and the rules and regulations thereunder. There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of forum provisions in other companies’ charter documents has been challenged in legal proceedings. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and there can be no assurance that such provisions will be enforced by a court in those other jurisdictions. If a court were to find these types of provisions to be inapplicable or unenforceable, and if a court were to find the exclusive forum provision in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could materially adversely affect our business.

Our ability to use our net operating losses and certain other tax attributes may be limited.

~~Under~~Our Sections 382 and 383 of the Internal Revenue Code of 1986, as amended if a corporation undergoes an “ownership change,” generally defined as a cumulative change of more than 50 percentage points (by value) in its equity ownership by certain stockholders over a rolling three-year period, the corporation’s ability to use ~~its~~our ~~pre-change~~U.S. ~~net~~federal ~~operating loss (NOL) carryforwards~~ and ~~other~~state ~~pre-change~~net ~~tax~~operating ~~attributes~~losses (~~such as research tax credits~~“NOLs”) to offset ~~its~~potential ~~post-change~~future taxable income ~~or taxes may be limited. We have experienced at least one ownership change in the past,~~ and werelated ~~may~~income ~~experience~~taxes ~~ownership~~that ~~changes~~would inotherwise ~~the~~be ~~future~~due asis adependent ~~result~~upon ~~of shifts in~~ our ~~stock~~generation ~~ownership (some~~ of ~~which~~future ~~shifts are outside our control). As a result, if we earn net~~ taxable income~~, our ability to use our pre-change NOL carryforwards to offset such taxable income may be subject to limitations~~. ~~Similar~~We ~~provisions~~cannot ofpredict ~~state~~with ~~tax~~certainty ~~law~~when, ~~may~~or ~~also apply to limit our use of accumulated state tax attributes. As a result~~whether, ~~even if~~ we ~~attain~~will ~~profitability,~~generate wesufficient ~~may~~taxable beincome ~~unable~~ to use aall ~~material portion~~ of our ~~NOL carryforwards and other tax attributes, which could adversely affect our future cash flows~~NOLs.

Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended if a corporation undergoes an “ownership change,” generally defined as a cumulative change of more than 50 percentage points (by value) in its equity ownership by certain stockholders over a rolling three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change taxable income or taxes may be limited. We have experienced at least one ownership change in the past, and we may experience ownership changes in the future as a result of shifts in our stock ownership (some of which shifts are outside our control). As a result, even if we generate sufficient taxable income, our ability to use our pre-change NOL carryforwards to offset such taxable income may be subject to limitations. Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes. As a result, even if we attain profitability, we may be unable to use a material portion of our NOL carryforwards and other tax attributes, which could adversely affect our future cash flows.

Changes in tax law may adversely affect us or our investors.

The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock. For example, ~~under~~on ~~Section~~July ~~174~~4, of2025, the ~~Code~~OBBBA was signed into law, inwhich ~~taxable~~enacts ~~years~~significant ~~beginning~~changes ~~after~~to ~~December~~U.S. ~~31,~~tax ~~2021,~~and ~~expenses~~related ~~that~~laws. Some of the provisions of the OBBBA affecting corporations include but are ~~incurred~~not ~~for~~limited to (i) allowing one hundred percent expensing of domestic research and development inexpenses ~~the~~for ~~U.S.~~tax ~~are~~years ~~now~~beginning ~~capitalized~~after ~~and~~December ~~amortized~~31, ~~which~~2024, ~~may~~(ii) ~~have~~increasing anthe ~~adverse~~limit ~~effect~~of onthe ~~our~~deduction ~~future~~of ~~cash~~business ~~flows.~~interest Inexpense ~~recent~~deduction ~~years,~~to ~~many~~thirty ~~such~~percent ~~changes~~of earnings before interest, depreciation and

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amortization and (iii) allowing one hundred percent bonus depreciation on eligible property acquired after January 19, 2025. We have analyzed the impacts of the OBBBA and reflected them in the current period. These impacts do not have a material effect on the tax rate for the year ended December 31, 2025. Certain provisions under OBBBA, primarily related to the international taxation provisions, will take effect in future years. We do not anticipate a material impact to our effective income tax rate in the future as these international provisions become effective. In recent years, many such changes have been made, and changes are likely to continue to occur in the future. It cannot be predicted whether, when, in what form or with what effective dates tax laws, regulations and rulings may be enacted, promulgated or issued, which could result in an increase in our or our ~~shareholders~~stockholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law.

General Risk Factors

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. If an insufficient number of securities or industry analysts commence and continue coverage of our company, the trading price for our common stock would likely be negatively impacted. After securities or industry analysts initiate coverage, if one or more of the analysts who cover us downgrades our common stock or publishes inaccurate or unfavorable research about our business, our share price may decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease, which might cause our share price and trading volume to decline.

Unfavorable U.S. or global economic conditions could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and financial markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for our technologies and our ability to raise additional capital when needed on favorable terms, if at all. Recently, the rate of inflation has increased throughout the U.S. economy. Inflation may adversely affect us by increasing the costs associated with performing research and development on internal research initiatives and partnered programs. We may experience significant increases in the prices of labor, consumables, and other costs of doing business. In an inflationary environment, such cost increases may outpace our expectations, causing us to use cash faster than forecasted. A weak or declining economy may also strain our partners, possibly resulting in supply disruption, or cause delays in their payments to us. In addition, the U.S. has recently imposed blanket tariffs of at least 10% on virtually all imports to the U.S. and significantly higher tariffs applicable to imports from many countries, which have resulted in other countries imposing additional tariffs on imports from the U.S. The Trump administration has threatened to impose additional significant tariffs on pharmaceutical products, which could lead to corresponding punitive actions by the countries with which the U.S. trades. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.

Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past, ~~and~~such ~~may~~as in the ~~future~~case ~~lead~~of ~~to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (SVB) was closed by~~ the ~~California~~closure ~~Department~~and ofsubsequent ~~Financial~~placement ~~Protection~~into ~~and~~receivership ~~Innovation,~~with ~~which appointed~~ the Federal Deposit Insurance Corporation (FDIC) asof ~~receiver.~~Silicon ~~Although~~Valley aBank ~~statement~~in byMarch ~~the U.S. Department of the Treasury~~2023, ~~the~~and ~~Federal~~may ~~Reserve~~in ~~and~~ the ~~FDIC~~future ~~indicated~~lead ~~that all depositors of SVB would have access~~ to ~~all~~market-wide ofliquidity ~~their~~problems. ~~money~~In ~~after~~those ~~only one business day of closure~~cases, ~~including funds held in uninsured deposit accounts,~~ borrowers under credit agreements, letters of credit and certain other financial instruments with ~~SVB or~~ any ~~other~~ financial institution that is placed into receivership by the FDIC may be unable to access undrawn amounts thereunder. ~~Although~~If ~~we are not a borrower or party to~~ any ~~such instruments with SVB or any other financial institution currently in receivership, if any~~ of our customers, suppliers or other parties with whom we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution, such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments to us could be adversely affected.

Although the U.S. Department of Treasury, FDIC and Federal Reserve Board have announced a program to provide up to $25 billion of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial institutions for 85

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~~immediately liquidity may exceed the capacity of such program.~~ Additionally, there is no guarantee that the U.S. Department of Treasury, FDIC and Federal Reserve Board will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions, or that they would do so in a timely fashion. Although we assess our banking and other business relationships as we believe necessary or appropriate, our access to funding sources and other credit arrangements in amounts adequate to finance or capitalize our current and projected future business operations could be significantly impaired by factors that affect us, the financial institutions with which we have credit agreements or arrangements directly, or the financial services industry or economy in general. These factors could include, among others, events such as liquidity constraints or failures, the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industry or the supervision thereof.

In addition, investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all. Any decline in available funding or access to our cash and liquidity resources could, among other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other obligations, result in breaches of our financial and/or contractual obligations or result in violations of federal or state wage and hour laws. Any of these impacts, could have material adverse impacts on our liquidity and our current and/or projected business operations and financial condition and results of operations.

Any further deterioration in the macroeconomic economy or financial services industry could also lead to losses or defaults by our partners or vendors, which in turn, could have a material adverse effect on our current and/or projected business operations and results of operations and financial condition. For example, a partner may fail to make payments when due, default under their agreements with us, become insolvent or declare bankruptcy, or a vendor may determine that it will no longer deal with us as a customer. In addition, a partner or vendor could be adversely affected by any of the liquidity or other risks that are described above as factors that could result in material adverse impacts on us, including but not limited to delayed access or loss of access to uninsured deposits or loss of the ability to draw on existing credit facilities involving a troubled or failed financial institution. Any partner or vendor bankruptcy or insolvency, or the failure of any partner to make payments when due, or any breach or default by a partner or vendor, or the loss of any significant vendor relationships, could result in material losses to us and may have a material adverse impact on our business.

Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies.

We may seek additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. Any incurrence of indebtedness would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or grant licenses on terms unfavorable to us.

Additionally, pursuant to the ATM, the number of shares that are sold by the Sales Agent, if any, after we request that sales be made will fluctuate based on the market price of our common stock during the sales period and limits we set with Sales Agent. Therefore, it is not possible to predict the number of shares that will be ultimately issued and sold by us, ~~if any,~~ pursuant to the Sales Agreement, but any ~~such~~additional sales will cause immediate dilution to our then existing stockholders.

Our employees, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, and insider trading.

We are exposed to the risk of fraud or other misconduct by our employees, consultants, advisors, and partners. Misconduct by these parties could include intentional failures to comply with the applicable laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us. These laws and regulations may restrict or prohibit a wide range of pricing, discounting and other business arrangements. Such misconduct could result in legal or regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and any other precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions

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and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us. These laws and regulations may restrict or prohibit a wide range of pricing, discounting and other business arrangements. Such misconduct could result in legal or regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and any other precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant civil, criminal and administrative penalties, which could have a significant impact on our business. Whether or not we are successful in defending against such actions or investigations, we could incur substantial costs, including legal fees and divert the attention of management in defending ourselves against any of these claims or investigations.

Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.

We do not carry insurance for all categories of risk that our business may encounter and our policies have limits and significant deductibles. Some of the policies we currently maintain include general liability, property, umbrella and directors’ and officers’ insurance.

Any additional insurance coverage we acquire in the future, may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive and in the future we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. A successful liability claim or series of claims in which judgments exceed our insurance coverage could adversely affect our business, financial condition, results of operations and prospects, including preventing or limiting the use of our platform to generate products.

Operating as a public company makes it difficult and more expensive for us to maintain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage than as a private company. As a result, it may be more difficult for us to attract and retain qualified people to serve on our board of directors, our board committees or as executive officers. We do not know if we will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our business, financial condition, results of operations and prospects.

Cybersecurity incidents, data breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.

In the ordinary course of our business, we generate and store confidential and sensitive data, including research data, intellectual property and proprietary business information owned or controlled by ourselves or our employees, partners and other third parties upon which we rely. We manage and maintain our applications and data utilizing a combination of on-site systems and cloud-based data centers. We utilize external security and infrastructure vendors to manage parts of our data centers. These applications and data encompass a wide variety of business-critical information, including research and development information, commercial information and business and financial information. We face a number of risks relative to protecting this critical information, including loss of access risk, inappropriate use or disclosure, accidental exposure, unauthorized access, inappropriate modification, wrongful conduct by employees or vendors, remediation costs, lost revenues, damages to our competitiveness, stock price and long-term stockholder value, and the risk of our being unable to adequately monitor and audit and modify our controls over our critical information. This risk extends to the third party vendors, subcontractors and partners we use to manage this sensitive data or otherwise process it on our behalf. Further, to the extent our employees may work remotely, additional risks may arise ~~as a result of~~ depending on the networking and security put into place by the employees and where they choose to work, including at home, while in transit or in other public locations. The secure processing, storage, maintenance and transmission of this critical information are vital to our operations and business strategy, and we devote significant resources to protecting such information.

Like other companies in our industry, we, and our third-party vendors, have experienced threats and cybersecurity incidents relating to our information technology systems and infrastructure. Although we seek to take reasonable measures to protect confidential and sensitive data from unauthorized access, use or disclosure, ~~no security measures can be perfect and~~ our information technology systems and infrastructure, and those of our vendors, subcontractors, and partners upon which we rely, are vulnerable to cyberattacks, computer viruses, bugs, worms, or other malicious codes, malware (including as a result of advanced persistent threat intrusions), and other attacks by computer hackers, cracking, application security attacks, ransomware, extortion events, social engineering fraud (including through phishing attacks), supply chain attacks and vulnerabilities through our third-party service providers, denial-of-service attacks (such as credential stuffing), credential harvesting, personnel misconduct or error, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets,

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and partners upon which we rely, are vulnerable to cyberattacks, computer viruses, bugs, worms, or other malicious codes, malware (including as a result of advanced persistent threat intrusions), and other attacks by computer hackers, cracking, application security attacks, ransomware, extortion events, social engineering fraud (including through phishing attacks), supply chain attacks and vulnerabilities through our third-party service providers, denial-of-service attacks (such as credential stuffing), credential harvesting, personnel misconduct or error, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, and other similar threats by hackers or breaches or compromises caused by erroneous actions or inactions by our employees, consultants, third parties or their contracted service providers, malfeasance or other malicious or inadvertent disruptions. Any such cybersecurity incident, data breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost, or misused, or stolen. Any such access, breach, or other loss of information could require us to notify impacted stakeholders (including affected individuals, regulators and investors) and result in legal claims or proceedings and related legal exposure and liabilities, including fines and penalties. Unauthorized access, loss, misuse, or dissemination could also disrupt our operations and damage our reputation, any of which could adversely affect our business.

The activities of cyber threat actors and other third parties, including nation-state actors directly and indirectly associated with military and geopolitical conflicts and defense activities have been increasing in number and sophistication. During times of war and other major conflicts, we, the third parties upon which we rely, and our partners may be vulnerable to a heightened risk of such ~~cyber-attacks~~cyberattacks, including retaliatory cyberattacks, that could materially disrupt our systems and operations, supply chain, and ability to develop our programs. In the event we experience a cyber-attack, data breach, cybersecurity incident, or other security event, third parties may gather, collect, or infer sensitive information about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization, which could be used to undermine our competitive advantage or market position.

The costs related to cybersecurity incidents, data breaches, disruptions or other security events could be significant and cause reputational damage and loss of existing and future business and could cause us to incur substantial fines and related expenses and legal exposure. If the information technology systems of our partners, contractors or consultants become subject to disruptions or cybersecurity incidents or data breaches, we may have insufficient recourse against such third parties and we may have to expend significant resources in connection with our efforts to mitigate the impact of such events, and to develop and implement processes and other remedial measures to address future impacts to our business. Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our privacy and data security obligations.

Although we maintain cybersecurity insurance coverage, we cannot be certain that such coverage will be adequate ~~for~~to completely cover all data security liabilities actually incurred, ~~will~~or ~~cover~~ any indemnification claims against us relating to any incident, nor that it will continue to be available to us on economically reasonable terms, or at all, or that any insurer will not deny coverage as to any future claim. The successful assertion of one or more large claims against us that exceed available insurance coverage, or the occurrence of changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements, could adversely affect our reputation, business, financial condition ~~and~~or results of operations. Additionally, our cybersecurity insurance coverage is unlikely to cover indirect or consequential damages, such as reputational harm or loss of current or future business relationships as a result of a security incidents or ~~cyber-attack~~cyberattack.

Natural and man-made disasters, including ~~cyber-attacks~~cyberattacks and other events beyond our control could severely disrupt our operations, or those of our partners, and have a material adverse impact on our business, results of operations, financial condition and prospects. If a natural disaster, power outage, cybersecurity attack or other event occurred that prevented us from using all or a significant portion of our headquarters, damaged critical infrastructure, such as our laboratory facilities or those of our partners, limited our or our partners’ ability to access or use our respective digital information systems or that otherwise disrupted our respective operations, it may be difficult or, in certain cases, impossible for us or our partners to continue our respective businesses for a substantial period of time. The disaster recovery and business continuity plans we and our partners currently have in place may not prove adequate in the event of a serious disaster or similar event, which could have a material adverse impact on our business.

~~Social media platforms present new risks and challenges to our business.~~88

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weSocial ~~have adopted policies and procedures around the use of social~~ media byplatforms ~~our~~present ~~employees,~~new werisks ~~may~~and bechallenges ~~unable~~ to ~~control the disclosure of non-public information by~~ our workforce. Any of these events or our failure to comply with applicable regulations could expose us to liability, restrictive regulatory actions, irreversible damage to our reputation, brand image and goodwill, or have a material adverse effect on our business~~, prospects, operating results, and financial condition and could adversely affect the price of our common stock~~.

As social media continues to expand, it also presents us with new risks and challenges. Social media is increasingly being used to communicate information about us, our technology and our programs. Social media practices in the pharmaceutical and biotechnology industries are evolving, which creates uncertainty and risk of noncompliance with regulations applicable to our business. In addition, there is risk of inaccurate disclosure of information about us, our technology, or our programs on any social media platform. Although we have adopted policies and procedures around the use of social media by our employees, we may be unable to control the disclosure of non-public information by our workforce. Any of these events or our failure to comply with applicable regulations could expose us to liability, restrictive regulatory actions, irreversible damage to our reputation, brand image and goodwill, or have a material adverse effect on our business, prospects, operating results, and financial condition and could adversely affect the price of our common stock.

We are an emerging growth company, and the reduced reporting requirements applicable to emerging growth companies could make our common stock less attractive to investors.

We are an emerging growth company, as defined in the JOBS Act., ~~For~~and aswill ~~long~~remain ~~as we continue to be~~ an emerging growth company, weuntil ~~may~~the ~~take~~earlier ~~advantage~~ of ~~exemptions~~(a) ~~from~~the ~~various~~last ~~reporting~~day ~~requirements~~of ~~that~~the ~~are~~fiscal ~~applicable~~year toin ~~other~~which ~~public~~we ~~companies~~have ~~that~~total ~~are~~annual ~~not~~gross ~~emerging~~revenue ~~growth~~of ~~companies,~~$1.235 ~~including~~billion ~~not~~or ~~being~~more; ~~required~~(b) toDecember ~~comply~~31, ~~with~~2026, the ~~auditor~~last ~~attestation~~day ~~requirements~~ of ~~Section~~the ~~404~~fiscal ofyear following the ~~Sarbanes-Oxley~~fifth ~~Act~~anniversary of ~~2002~~the ~~reduced~~date ~~disclosure~~of ~~obligations~~the ~~regarding~~completion ~~executive~~of ~~compensation~~our ininitial ~~our~~public ~~periodic~~offering; ~~reports~~(c) ~~and~~the ~~proxy~~date ~~statements,~~on ~~exemptions~~which ~~from~~we ~~the~~have ~~requirements~~issued ofmore ~~holding~~than ~~nonbinding~~$1.0 ~~advisory~~billion ~~votes~~in onnonconvertible ~~executive~~debt ~~compensation~~during ~~and~~the ~~stockholder~~previous ~~approval~~three ofyears; ~~any~~or ~~golden~~(d) ~~parachute~~the ~~payments~~date ~~not~~we ~~previously~~qualify ~~approved,~~as ~~and~~a an“large ~~exemption~~accelerated ~~from~~filer,” ~~compliance~~which ~~with~~requires the ~~requirement~~market value of ~~the~~our ~~PCAOB~~common ~~regarding~~stock ~~the~~that ~~communication~~are ofheld ~~critical~~by ~~audit~~non-affiliates ~~matters~~to inexceed ~~the~~$700.0 ~~auditor’s~~million ~~report~~as onof the ~~financial~~prior ~~statements~~June 30th. WeUnder ~~could~~the beJOBS anAct, emerging growth ~~company~~companies ~~for~~can updelay toadopting ~~five~~new ~~years~~or ~~following~~revised accounting standards issued subsequent to the ~~year~~enactment inof ~~which~~the weJOBS ~~completed~~Act ~~our~~until ~~IPO,~~such ~~although~~time ~~circumstances~~as ~~could~~those ~~cause~~standards usapply to ~~lose~~private ~~that~~companies. ~~status~~Section ~~earlier.~~107 Weof ~~will~~the ~~remain~~JOBS Act provides that an emerging growth company ~~until~~may ~~the~~take ~~earlier~~advantage of the extended transition period provided in Section 7(a)(2)(B) of the ~~last~~Securities ~~day~~Act of ~~the~~1933 ~~fiscal~~for ~~year~~complying inwith ~~which~~new weor ~~have~~revised ~~total~~accounting ~~annual~~standards ~~gross~~issued ~~revenue~~subsequent to the enactment of ~~$1.235~~the ~~billion~~JOBS orAct ~~more;~~until ~~(b)~~such ~~December~~time ~~31,~~as ~~2026,~~those ~~the~~standards ~~last~~apply ~~day~~to private companies. Section 107 of the ~~fiscal~~JOBS ~~year~~Act ~~following~~provides ~~the~~that ~~fifth~~we ~~anniversary~~can ofelect ~~the~~to ~~date~~opt out of the ~~completion~~extended oftransition ~~our~~period ~~IPO;~~at ~~(c)~~any ~~the~~time, ~~date~~which onelection ~~which~~is weirrevocable. We have ~~issued~~elected ~~more~~to ~~than~~use ~~$1.0~~this ~~billion~~extended intransition ~~nonconvertible~~period ~~debt~~for ~~during~~complying with new or revised accounting standards that have different effective dates for public and private companies until the ~~previous~~earlier ~~three~~of ~~years;~~the date we (i) are no longer an emerging growth company or (dii) ~~the~~affirmatively ~~date~~and weirrevocably ~~qualify~~opt asout aof ~~“large~~the ~~accelerated~~extended ~~filer,”~~transition ~~which~~period ~~requires~~provided in the ~~market~~JOBS ~~value~~Act. ofAs ~~our~~a ~~common~~result, ~~stock~~our ~~that~~financial ~~are~~statements ~~held~~may bynot ~~non-affiliates~~be comparable to ~~exceed~~companies ~~$700.0~~that ~~million~~comply with new or revised accounting pronouncements as of ~~the~~public ~~prior~~company ~~June~~effective ~~30th~~dates.

InSubject ~~addition,~~to ~~the~~certain ~~JOBS~~conditions, ~~Act~~as ~~provides that~~ an emerging growth company, ~~can~~we ~~take~~may ~~advantage~~rely ofon ancertain ~~extended~~other ~~transition~~exemptions ~~period~~and ~~for~~reduced ~~complying~~reporting ~~with~~requirements, ~~new~~including orwithout ~~revised~~limitation ~~accounting~~(i) ~~standards.~~providing ~~This allows~~ an ~~emerging~~auditor’s ~~growth~~attestation ~~company~~report toon ~~delay~~our ~~the~~system ~~adoption~~ of ~~certain~~internal ~~accounting~~controls ~~standards~~over ~~until~~financial ~~those~~reporting ~~standards~~pursuant ~~would otherwise apply~~ to ~~private~~Section ~~companies.~~404(b) Weof ~~have~~the ~~elected~~Sarbanes-Oxley toAct ~~use~~and ~~this~~(ii) ~~extended transition period for~~ complying with ~~new~~any orrequirement ~~revised~~by ~~accounting standards that have different effective dates for public and private companies until~~ the ~~earlier~~Public ofCompany ~~the~~Accounting ~~date~~Oversight weBoard (iPCAOB) ~~are~~regarding nomandatory ~~longer~~audit anfirm ~~emerging~~rotation ~~growth company~~ or ~~(ii)~~a ~~affirmatively~~supplement ~~and~~to ~~irrevocably~~the ~~opt~~auditor’s ~~out~~report ofproviding ~~the~~additional ~~extended~~information ~~transition~~about ~~period~~the ~~provided~~audit inand the ~~JOBS~~consolidated ~~Act. As a result, our~~ financial statements, ~~may~~known ~~not be comparable to companies that comply with new or revised accounting pronouncements~~ as ofthe ~~public~~auditor ~~company~~discussion ~~effective~~and ~~dates~~analysis.

WeIn ~~cannot~~addition, ~~predict~~we ifare ~~investors~~also ~~will~~a ~~find~~“smaller ~~our~~reporting ~~common~~company” ~~stock~~as ~~less~~defined ~~attractive~~in ~~because~~Rule we12b-2 ~~may~~of ~~rely~~the onExchange Act and have elected to take advantage of certain of the scaled back disclosure requirements available to smaller reporting ~~exemptions~~companies ~~and~~such as avoiding the ~~extended~~extensive ~~transition~~narrative ~~period~~disclosure ~~for~~required ~~complying~~of ~~with~~other ~~new~~reporting orcompanies, ~~revised~~particularly ~~accounting~~in ~~standards~~the description of executive compensation. We Ifwill ~~some~~remain ~~investors~~a ~~find~~smaller reporting company until (a) the last day of the fiscal year in which we have total annual gross revenue of less than $100 million and the market value of our common stock ~~less~~held ~~attractive~~by non-affiliates exceeds $700.0 million as aof ~~result~~the prior June 30th, ~~there~~or ~~may~~(b) bethe alast ~~less~~day ~~active~~of ~~trading~~the fiscal year in which we have total annual gross revenue exceeding $100 million and the market ~~for~~value of our common stock held by non-affiliates exceeds $250.0 million. In August 2025, the SEC released a Compliance and ~~our~~Disclosure ~~share~~Interpretation ~~price~~clarifying ~~may~~the befiler ~~more~~status ~~volatile~~transition for registrants that lose their smaller reporting company status based on the revenue tests. Due to this interpretation, we will remain a non-accelerated filer for filings due in the fiscal year immediately following the loss of smaller reporting company status, allowing us to retain the exception from the auditor attestation requirement on internal control over financial reporting. However, the interpretation specifies that we will lose eligibility for all other smaller reporting company accommodations beginning with the Form 10-Q for the first fiscal quarter of the year after losing smaller reporting company status.

We have incurred and will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives. 89

As a public company, we have incurred and will continue to incur significant legal, accounting, insurance and other expenses. We are subject to the reporting requirements of the Exchange Act, which require, among other things, that we file with the SEC annual, quarterly and current reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC, and the Nasdaq Global Select Market to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in these areas, such as “say-on-pay” and proxy access. The JOBS Act permits emerging growth companies to implement many of these requirements over a longer period and up to five years from the pricing of our IPO. We intend to take advantage of the reduced reporting requirements available to emerging growth companies under the JOBS Act, but we cannot guarantee that we

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In addition, the loss of emerging growth company status will not beimpact ~~required~~our to“non-accelerated ~~implement~~filer” ~~the~~status, ~~more~~which ~~stringent~~also ~~requirements~~provides ~~sooner~~an ~~than~~exemption ~~budgeted~~from orthe ~~planned~~auditor ~~and~~attestation ~~thereby~~requirement ~~incur~~with ~~unexpected~~respect ~~expenses.~~to internal control over financial reporting.

As a public company, we have incurred and will continue to incur significant legal, accounting, insurance and other expenses. We are subject to the reporting requirements of the Exchange Act, which require, among other things, that we file with the SEC annual, quarterly and current reports with respect to our business and financial condition. In addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC, and the Nasdaq Global Select Market to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) was enacted. There are significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and regulations in these areas, such as “say-on-pay” and proxy access. The JOBS Act permits emerging growth companies to implement many of these requirements over a longer period and up to December 31, 2026, the last day of the fiscal year following the fifth anniversary of the pricing of our IPO. As an emerging growth company, we are currently taking advantage of the reduced reporting requirements available to emerging growth companies under the JOBS Act, but we will be required to implement the more stringent requirements once we no longer qualify as an emerging growth company, and may incur significant additional expenses as a result.

Stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate. In the ordinary course as a public company, the SEC and other U.S. and foreign regulatory and governmental agencies have initiated and may in the future initiate requests, comments and/or investigations regarding legal, regulatory and compliance matters of the Company, which could require us to devote significant time, attention and resources to respond to these, and, if unfavorably resolved, could result in our being subject to sanctions or civil penalties or fines, all of which could have a material adverse impact on our business, results of operation and financial condition. We cooperate with any requests from any regulatory and governmental agencies.

These rules and regulations applicable to public companies have increased and will continue to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly. If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse effect on our business, financial condition, and results of operations. The increased costs will decrease our net income or increase our net loss and may require us to reduce costs in other areas of our business, limit our investments in business expansion, or increase the technology development fees and other payment terms we negotiate with partners. For example, these rules and regulations have made it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees, or as executive officers.

Pursuant to Section 404, we are required to furnish a report by our management on our internal control over financial reporting. To achieve compliance with Section 404 annually, we will engage in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, engage outside consultants, execute our detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing whether such controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404. In addition, investors’ perceptions that our internal controls are inadequate or that ~~we are unable to produce accurate financial statements on a timely basis may harm the market price of our stock.~~

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we are unable to produce accurate financial statements on a timely basis may harm the market price of our stock.

Our results of operations and financial condition could be materially adversely affected by changes in accounting principles.

The accounting for our business is subject to change based on the evolution of our business model, interpretations of relevant accounting principles, enforcement of existing or new regulations and changes in policies, rules, regulations and interpretations, of accounting and financial reporting requirements of the SEC or other regulatory agencies. Adoption of a change in accounting principles or interpretations could have a significant effect on our reported results of operations and could affect the reporting of transactions completed before the adoption of such change. It is difficult to predict the impact of future changes to accounting principles and accounting policies over financial reporting, any of which could adversely affect our results of operations and financial condition and could require significant investment in systems and personnel.

If our estimates or judgments relating to our critical accounting policies prove to be incorrect or financial reporting standards or interpretations change, our results of operations could be adversely affected.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, as provided in “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates.” The results of these estimates form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Significant assumptions and estimates used in preparing our consolidated financial statements include the estimated variable consideration included in the transaction price in our contracts with partners, contingent consideration, goodwill impairment, and long-lived asset impairment evaluations. Our results of operations may be adversely affected if our assumptions change or if actual circumstances differ from those in our assumptions, which could cause our results of operations to fall below the expectations of securities analysts and investors, resulting in a decline in the trading price of our common stock.

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Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates.” The results of these estimates form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Significant assumptions and estimates used in preparing our consolidated financial statements include the estimated variable consideration included in the transaction price in our contracts with partners, contingent consideration, goodwill impairment, and long-lived asset impairment evaluations. Our results of operations may be adversely affected if our assumptions change or if actual circumstances differ from those in our assumptions, which could cause our results of operations to fall below the expectations of securities analysts and investors, resulting in a decline in the trading price of our common stock.

Additionally, we regularly monitor our compliance with applicable financial reporting standards and review new pronouncements and drafts thereof that are relevant to us. As a result of new standards, changes to existing standards and changes in their interpretation, we might be required to change our accounting policies, alter our operational policies, and implement new or enhance existing systems so that they reflect new or amended financial reporting standards, or we may be required to restate our published financial statements. Such changes to existing standards or changes in their interpretation may have an adverse effect on our reputation, business, financial position, and profit.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

We are subject to certain reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected.

Item 1B. Unresolved Staff Comments

Not applicable.

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Item 1C. Cybersecurity

Risk Management and Strategy

In the ordinary course of our business, we use, store and process data including data of our employees, partners, collaborators, and vendors. We have implemented a cybersecurity risk management program that is designed to identify, assess, and mitigate risks from cybersecurity threats to this data and our systems.

Our cybersecurity risk management program includes a number of components, including information security program assessments and continuous monitoring of critical risks from cybersecurity threats using automated tools. We periodically engage third parties to conduct risk assessments on our systems, including penetration testing on an annual basis. We also conduct cybersecurity simulation exercises, including in connection with our disaster recovery procedures. In addition, we have a process to assess the security practices of certain third-party vendors, including through the use of vendor security questionnaires, as appropriate. We continue to develop and update a comprehensive cybersecurity strategy to guide cybersecurity risk management activities, align corporate security standards, and guide requirements for all technology across the organization with regards to cybersecurity.

We ~~maintain~~have ~~policies~~taken ~~and~~additional ~~processes~~steps ~~for~~to ~~assessing~~further mature our cybersecurity monitoring and response, ~~identifying~~vulnerability management, and ~~managing~~incident ~~risks~~response ~~from~~capabilities ~~cybersecurity~~through ~~threats~~new vendor partnerships to centralize and develop additional detection and response capabilities. In addition to the risk assessments described above, we utilize a managed detection and ~~have~~response ~~integrated~~(MDR) ~~these~~service that provides continuous monitoring of our network environment and assists with threat detection and incident response. These third parties also assist us in our design and implementation of our cybersecurity policies and ~~processes~~procedures ~~into~~and in our ~~overall~~assessment ~~risk~~and ~~management~~testing ~~strategy~~of our security safeguards. ~~Our~~As part of our cybersecurity risk management program, iswe ~~informed~~also bymaintain ~~standards~~processes ~~established~~to byassess and review the ~~National~~cybersecurity ~~Institute~~practices of ~~Standards~~third-party vendors and ~~Technology~~suppliers ~~(NIST)~~when applicable. Moreover, we maintain an established process to notify management of identified cybersecurity incidents and to provide an assessment of the ~~Center~~potential criticality and impact of such incidents. We have also implemented procedures for ~~Internet~~response ~~Security~~and ~~(CIS)~~containment efforts to address the actual or potential impact of identified cybersecurity incidents, as applicable.

WeAs ~~also~~a ~~engage~~public ~~assessors~~company, ~~consultants, auditors, or other third parties in connection with~~ our ~~risk~~information ~~assessment~~technology ~~processes~~systems ~~to assist us in our design~~ and ~~implementation~~related ~~of our~~ cybersecurity ~~policies~~controls ~~and~~are ~~procedures~~also ~~and~~subject ~~in our assessment and testing of our security safeguards. This includes a third-party managed detection and response team (MDR)~~ to ~~conduct~~review ~~ongoing network monitoring and to support incident management and threat assessment. Additionally,~~ as apart ~~public company, we are subject to regulatory requirements and undergo audits~~ of our financial ~~statements,~~statement ~~which~~audit ~~include~~and ainternal ~~review~~control ofover ~~related~~financial ~~cybersecurity~~reporting ~~controls and information technology systems~~processes.

80Additionally, we have implemented an employee education program that is designed to raise awareness of cybersecurity threats, including risks posed by phishing attempts. This training is included during the employee onboarding process and periodically thereafter.

~~Table~~We, like other companies in our industry, face a number of ~~Contents~~cybersecurity risks in connection with our business. Although our business strategy, results of operations, and financial condition have not, to date, been materially affected by risks from cybersecurity threats, we have, from time to time, experienced threats to and security incidents related to our and our third-party vendors’ information systems data and systems, including for example, phishing attacks. For more information about the cybersecurity risks we face, please refer to Item 1A, “Risk Factors,” in this annual report on Form 10-K, including the risk factor titled “Cybersecurity incidents, data breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.”

We maintain a cybersecurity awareness training program for employees, which is provided during onboarding and on an annual basis thereafter. Our training program includes simulated phishing campaigns, which are designed to increase awareness and detection and to equip our personnel with effective tools to identify and address cybersecurity threats.

Although risks from cybersecurity threats have not materially affected, and are not reasonably likely to materially affect our company, including our business strategy, results of operations, or financial condition, to date, we have, from time to time, experienced threats to and security incidents related to our and our third-party vendors’ information systems. For more information about the cybersecurity risks we face, please refer to Item 1A, “Risk Factors,” in this annual report on Form 10-K, including the risk factor titled “Cybersecurity incidents, data breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.”

Governance

Under the ultimate direction of our chief executive officer, or CEO, and our executive management team (including our Chief Legal Officer, who also serves as our Chief Compliance Officer), with oversight from our audit committee of the board of directors (Audit Committee), our Head of Information Technology (Head of IT) has primary responsibility for assessing, operating and managing our cybersecurity threat management program. Our Head of IT meets periodically with our Chief Legal Officer to discuss current developments in the cybersecurity landscape and our cybersecurity risk management program, including providing updates regarding the sources and nature of critical risks we face and how the IT department assesses those risks, including the likelihood of such risks, the severity of impact, and progress on vulnerability remediation.

AsOur ~~we are in the process of hiring a new Director of Information Technology, our~~ Chief Legal Officer isand ~~fulfilling~~Head ~~these~~of ~~functions~~IT inconsult ~~the interim~~ with ~~assistance~~other ~~from~~members ~~third-party information technology and cybersecurity experts. Although our Chief Legal Officer does not have direct cybersecurity expertise obtained through certifications, her experience as a member~~ of our ~~company’s~~information ~~senior~~technology ~~management team and overseeing enterprise risks~~department, ~~which includes consulting~~ and ~~coordinating as necessary~~ with third~~-party~~ ~~information~~parties ~~technology~~with ~~and~~expertise ~~cybersecurity~~in ~~experts~~cybersecurity, ~~enables her~~ to ~~assess~~develop ~~and~~strategies ~~manage material risks from cybersecurity threats. We maintain an established process~~ to ~~notify~~assess, ~~management~~address ofand ~~identified~~align cybersecurity ~~incidents~~efforts ~~and~~with toour ~~provide~~business anobjectives ~~assessment of the potential criticality~~ and ~~impact~~operational ~~of such incidents~~requirements. WeThe ~~have~~Head ~~also implemented procedures for response and containment efforts to address the actual or potential impact~~ of ~~identified~~IT ~~cybersecurity~~role ~~incidents, as applicable.~~

As part of our board of directors’ enterprise risk management program, our board of directors has responsibility for oversight of cybersecurity risk management. Our board of directors has delegated to our Audit Committee oversight of our cybersecurity risk management program, including oversight of information security and cybersecurity threats and related compliance and disclosure requirements. On an annual basis, our Chief Legal Officer provides an update to our Audit Committee regarding our cybersecurity risk management program, including as relates to critical cybersecurity risks, ongoing cybersecurity initiatives and strategies, and applicable regulatory requirements and industry standards. The Audit Committee periodically reports on cybersecurity risk management to the full board of directors.92

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is currently held by an individual with over 25 years of experience leading information security, corporate systems, technology risk, and compliance management, bringing deep expertise in cybersecurity and digital infrastructure operations across diverse industries and regulatory environments.

As part of our board of directors’ enterprise risk management program, our board of directors has responsibility for oversight of cybersecurity risk management. Our board of directors has delegated to our Audit Committee oversight of our cybersecurity risk management program, including oversight of information security and cybersecurity threats and related compliance and disclosure requirements. On a quarterly basis, our Head of IT provides an update to our Audit Committee regarding our cybersecurity risk management program, including as relates to critical cybersecurity risks, ongoing cybersecurity initiatives and strategies, and applicable regulatory requirements and industry standards. The Audit Committee periodically reports on cybersecurity risk management to the full board of directors.

Item 2. Properties

Our corporate headquarters and primary research and development facilities are located in Vancouver, Washington in a 77,974 square foot facility that includes general administrative office and laboratory space. Our AI Research Lab is located in New York, New York and our Innovation Center is located in Zug, Switzerland. Additionally, we have research and development presence in Belgrade, Serbia. Substantially all of our office space is leased with varying expiration dates. We believe our facilities are adequate and suitable for our current and near future needs.

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Item 3. Legal Proceedings

We are not currently a party to any material litigation or other legal proceedings. From time to time, we may, however, in the ordinary course of business face various claims brought by third parties, and we may, from time to time, make claims or take legal actions to assert our rights. Any such claims and associated legal proceedings could, in the opinion of our management, have a material adverse effect on our business, financial condition, results of operations or prospects. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

Item 4. Mine Safety Disclosures

Not applicable.

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Part II.

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Market Information

Our common stock has been listed on the Nasdaq Global Select Market under the trading symbol “ABSI” since July 22, 2021. Prior to that date, there was no public trading market for our common stock.

Holders of Common Stock

As of ~~February~~March 286, ~~2025~~2026, there were 4638 holders of record of our common stock. The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees.

Dividend Policy

We have not declared or paid any cash dividends on our capital stock since our inception. We intend to retain future earnings for the development, operation, expansion and continued investment into our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Payment of future cash dividends, if any, will be at the discretion of our board of directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs, the requirements and contractual restrictions of then-existing debt instruments and other factors that our board of directors deems relevant.

Equity Compensation Plans

Information regarding securities authorized for issuance under equity compensation plans is included in Part III, Item 12 of this report.

Unregistered Sales of Equity Securities

~~There~~Other than as disclosed in Part II, Item 2 of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, there were no unregistered sales of equity securities during the year ended December 31, ~~2024~~2025.

Issuer Purchases of Equity Securities

None.

Item 6. [Reserved]

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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Overview

~~Traditional~~We ~~drug~~have ~~discovery~~advanced ~~and~~our ~~preclinical~~first ~~development~~two ~~can~~programs ~~take~~from ~~4–6~~AI ~~years~~design to goIND ~~from~~(or ~~discovery~~foreign toequivalent) ~~clinical~~in ~~development.~~around ~~Moreover,~~two ~~success~~years ~~rates~~with ~~for~~a ~~traditional~~total ~~drug~~investment ~~discovery,~~of asapproximately ~~defined~~$15 bymillion ~~successfully~~per ~~reaching a marketed product~~program, ~~are~~compared ~~estimated~~to atan ~~less~~industry ~~than~~average ~~5%.~~of In4–6 ~~all,~~years itat ~~can~~a ~~take~~cost asof ~~much~~greater asthan ~~12–15~~$50 ~~years,~~million. ~~with~~This ~~costs~~combination ~~estimated~~of tounderexplored ~~exceed~~target ~~more~~selection ~~than~~and $1capital-efficient ~~billion~~execution tois ~~bring~~central ~~a drug~~ to ~~market.~~our strategy.

~~Progress~~Our inlead AIproduct ~~has been building for decades~~candidate, ~~with increasing application in drug discovery. In May 2023~~ABS-201, ~~the~~is ~~U.S.~~an ~~Food~~anti-prolactin ~~and~~receptor ~~Drug Administration~~ (~~FDA~~PRLR) ~~acknowledged~~antibody ~~that~~engineered AIwith ~~will~~an ~~undoubtedly~~extended ~~play~~half-life ~~a critical role in drug development and recognized its potential~~ to ~~enhance~~support ~~drug~~a ~~development~~patient-friendly indosing ~~many ways, including to help bring safe and effective drugs to patients faster~~interval. AWe ~~June~~believe ~~2023~~PRLR ~~study~~is ~~estimated~~an ~~that~~underexplored AItarget ~~could~~with ~~yield time and cost savings of at least 25–50% in drug discovery up to~~ the ~~preclinical~~potential ~~stage. Some analysts point specifically~~ to ~~generative~~provide ~~AI as a promising approach to creating novel drugs with improved attributes~~durable, ~~allowing~~disease-modifying ~~drug~~effects. ~~development~~If tosuccessfully ~~move closer to drug design~~developed, ~~speeding up the process and creating better~~ABS-~~targeted~~201 ~~drugs.~~could ~~However,~~establish ~~generative~~a AInew ~~depends~~treatment oncategory ~~massive~~in ~~high-quality~~indications ~~training~~where ~~datasets~~current tooptions ~~generate~~remain ~~quality results~~inadequate. ~~For example, GPT~~ABS-4,201 ais ~~well-known~~being ~~generative~~developed AIfor ~~model~~two indications, ~~was~~androgenetic ~~trained~~alopecia on(AGA) ~~data~~or atpattern ~~scale~~hair ~~readily~~loss ~~available~~(PHL) ~~through~~and ~~public~~endometriosis, ~~sources~~each ~~such~~with aslarge ~~the~~affected ~~internet.~~populations ~~This type of dataset is more limited~~ and ~~not~~significant asunmet ~~accessible for biologics drug discovery.~~need:

~~With~~•Androgenetic ~~the~~Alopecia: ~~data~~ABS-201 tois ~~learn,~~being evaluated in the AIHEADLINE™ toPhase ~~create~~1/2a clinical trial (NCT07317544) for AGA, ~~and~~a condition affecting approximately 80 million people in the ~~wet~~United ~~lab~~States. toOur ~~validate,~~own wepatient ~~believe~~and weclinician ~~can~~surveys, ~~create~~as ~~billions~~well as those of ~~antibody~~other ~~designs~~parties, ~~and~~show ~~screen~~broad ~~millions~~dissatisfaction with current standard of ~~ranked~~care, ~~antibody~~which ~~sequences~~is inlimited ~~weeks,~~by ~~allowing~~variable usefficacy, topoor gocompliance, ~~from~~and ~~AI-designed~~a tolack ~~wet~~of ~~lab-validated~~durable ~~product~~approaches. ~~candidates~~No inapproved astherapy ~~little~~provides asdurable ~~six~~hair ~~weeks~~regrowth. ~~Our~~We ~~proprietary~~have ~~Integrated~~dosed ~~Drug~~the ~~Creation~~first ~~platform~~three ~~enables~~single usascending todose ~~build~~cohorts with a ~~strong~~favorable ~~pipeline~~safety profile to date. Interim proof-of-concept ~~both~~data, ~~internal~~including ~~and~~exploratory ~~partnered~~efficacy ~~programs~~endpoints, ~~that~~are ~~can~~expected ~~expand~~in ~~therapeutic~~the ~~possibilities~~second half of 2026.

~~Our~~•Endometriosis: ~~business~~We ~~model~~plan to initiate a Phase 2 clinical trial of ABS-201 in endometriosis, a chronic condition estimated to affect approximately 10% of women of reproductive age worldwide. There is ~~focused~~currently onno ~~monetizing~~FDA-approved ~~our~~disease-modifying ~~Integrated~~therapy ~~Drug~~for ~~Creation~~endometriosis. ~~platform~~The bycondition ~~generating~~is ~~internally~~associated ~~developed~~with ~~programs~~significant ~~that~~chronic pain, reduced quality of life, and impaired fertility, and treatment options are ~~later~~limited ~~partnered~~by orinadequate ~~out~~long-~~licensed~~term ~~following~~effectiveness ~~certain~~and ~~value~~tolerability. ~~inflection~~PRLR ~~points~~signaling ~~(anywhere~~may ~~from~~contribute ~~preclinical~~to ~~through~~both ~~clinical~~endometrial lesion development) orand bypain-related ~~partnering~~pathways, ~~with~~which ~~third~~if ~~parties~~demonstrated ~~who~~clinically, ~~wish~~could tosupport ~~leverage~~the ~~our~~potential ~~Integrated~~for ~~Drug~~a ~~Creation~~non-hormonal ~~platform~~and non-surgical treatment. A recent clinical trial has demonstrated clinical proof of concept for ~~early~~targeting ~~discovery~~PRLR ~~efforts~~for inendometriosis. aOur ~~variety~~Phase 2 clinical trial for endometriosis is planned for the fourth quarter of ~~deal~~2026, ~~structures~~subject to data from the ongoing HEADLINE trial and regulatory considerations.

~~Internally~~Beyond ~~Developed Programs: We believe that by developing our own pipeline~~ABS-201, we ~~will~~are ~~create~~advancing ~~optionality~~additional ~~for~~preclinical ~~enhanced~~programs ~~monetization~~using ~~and validation of~~ our ~~Integrated Drug Creation~~ platform. ~~With~~We ~~the~~may ~~ability~~seek topartnerships ~~selectively~~or ~~choose~~out-licensing ~~both~~arrangements ~~novel~~for ~~and~~select ~~fast-follower~~pipeline ~~targets~~assets, inwhich ~~addition~~would toprovide ~~develop~~non-dilutive ~~potentially~~capital ~~best-in-class~~We ~~attributes,~~believe we ~~aim~~are topositioned ~~take our internally developed programs~~ to ~~certain~~execute ~~value~~on ~~inflection~~near-term ~~points~~catalysts ~~before~~while ~~considering~~building ~~partnering or out~~long-~~licensing~~term ~~opportunities~~pipeline value.

~~Partnered~~Financial ~~Programs:~~ results

~~•Drug~~Revenue ~~Creation~~was ~~Programs:~~$2.8 Wemillion ~~enter~~for ~~into~~the ~~collaborations~~year ~~with~~ended ~~third~~December ~~parties~~31, ~~who~~2025 ~~are~~compared ~~seeking~~ to ~~leverage~~$4.5 ~~our~~million ~~platform~~for the year ended December 31, 2024 due to ~~solve~~the ~~challenging~~number ~~problems~~of ongoing partnered programs and respective timing of project-based milestones achieved. We ~~work~~incurred ~~closely~~a ~~with~~net ~~our~~loss ~~partners~~of on$115.2 ~~single~~million ~~and~~for ~~multi-target~~the ~~programs~~year toended ~~develop~~December ~~product~~31, ~~candidates~~2025 ~~against~~compared ~~targets~~to ~~they~~a ~~have~~net ~~selected~~loss of $103.1 Wemillion ~~aim~~for tothe ~~expand~~year ended December 31, 2024. Research and ~~diversify~~development ~~our~~expenses ~~portfolio~~increased ofby ~~partnered~~$17.6 ~~programs~~million, ~~through~~or ~~these~~27%, ~~collaborations~~for the year ended December 31, ~~each~~2025 ofcompared to the year ended December 31, 2024.

84As of December 31, 2025, we had an accumulated deficit of $624.8 million and cash equivalents and marketable securities totaling $144.3 million.

~~which may include up-front fees and research fees, as well as potential clinical and/or commercial milestones and royalties.~~ 95

Total revenue was $4.5 million for the year ended December 31, 2024, compared to $5.7 million for the year ended December 31, 2023, a decrease of $1.2 million due to the number of ongoing partnered programs and respective timing of project-based milestones achieved. We incurred a net loss of $103.1 million for the year ended December 31, 2024, compared to a net loss of $110.6 million for the year ended December 31, 2023. Research and development expenses increased by $15.8 million, or 33%, for the year ended December 31, 2024 compared to the year ended December 31, 2023. The net loss for the year ended December 31, 2023 included a non-cash goodwill impairment charge in the amount of $21.3 million recorded during the quarter ended June 30, 2023.

As of December 31, 2024, we had an accumulated deficit of $509.6 million and cash and cash equivalents and short-term investments totaling $112.4 million.

We expect to continue to incur significant expenses in connection with our ongoing activities, including as we:

•develop ~~our~~ABS-201 and other internally developed programs across diverse indications, including the advancement of these product candidates through preclinical and clinical development;

•continue to engage in discovery, research and development efforts and scale our activities tothrough ~~meet~~our ~~potential~~existing ~~demand~~and ~~from~~potential ~~both~~ new ~~and existing partners~~partnerships;

•execute an effective business development strategy to drive adoption of our Integrated Drug Creation platform by new and existing partners and, as relevant, to identify partners for internally developed programs;

•develop, acquire, in-license or otherwise obtain technologies that enable us to expand our Integrated Drug Creation platform capabilities; and

•attract, retain and motivate highly qualified personnel to join Absci in our mission.

Our corporate headquarters and primary research and development facilities are located in Vancouver, Washington in a 77,974 square foot facility that includes general administrative office space and laboratory space. Our AI Research Lab is located in New York, New York and our Innovation Center is located in Zug, Switzerland. Additionally, we have a research and development presence in Belgrade, Serbia.

~~Key~~AMD ~~Factors~~strategic ~~Affecting Our Results of Operations and Future Performance~~collaboration

WeIn ~~believe~~January ~~that~~2025, ~~our~~we ~~future~~entered ~~financial~~into ~~performance~~a ~~will~~strategic becollaboration ~~primarily~~with ~~driven~~Advanced byMicro ~~multiple~~Devices, ~~factors~~Inc. as(AMD) ~~described~~with ~~below,~~a ~~each~~goal to optimize the performance of ~~which~~AMD ~~presents~~InstinctTM ~~growth~~accelerators ~~opportunities~~and ~~for~~ROCmTM software to support our ~~business.~~AI ~~These~~drug ~~factors~~creation, ~~also~~including ~~pose~~our ~~important~~de ~~challenges~~novo ~~that~~antibody wedesign ~~must~~models. ~~successfully~~Additionally, ~~address~~AMD ininvested ~~order~~$20.0 tomillion ~~sustain~~through ~~our~~the ~~growth~~purchase ~~and~~of ~~improve~~5,714,285 shares of our ~~results~~common ofstock a private investment in public equity (PIPE) at a premium over the market price.

operations. Our ability to successfully address these challenges is subject to various risks and uncertainties, including those described in the sections of this Annual Report on Form 10-K for the year ended December 31, 2024 titled “Risk Factors”.

•Build out our internally developed programs: We are in the process of selectively creating our own programs and intend to advance them to certain value inflection points anywhere from preclinical validation through clinical development prior to out-licensing for further clinical advancement by a partner or other third party. We may also utilize significant resources in the design and execution of clinical trials to support our internally developed programs.

•Establish new partnerships: Our potential to grow revenue and long-term earnings will require us to successfully identify, establish and maintain programs with new and existing partners.

•Successfully complete our drug creation activities with partners and enter into licensing agreements: Our business model relies upon entering into licensing agreements with our partners to advance the product candidates we generate through preclinical validation through clinical development to commercialization. Both our ability to successfully complete drug creation activities to meet the needs of a partner, and the partner’s prioritization of the relevant program, impact the likelihood and timing of any election by a partner to enter into a follow-on licensing agreement. There is no assurance that a partner will elect to license our intellectual property for the development of any product candidates.

•Developing and commercializing product candidates generated with our Integrated Drug Creation platform: Our business model is dependent on the eventual progression of product candidates discovered or initially developed utilizing our Integrated Drug Creation platform into clinical trials by us or our partners and through commercialization by our partners or other third parties. Given the nature of our relationships with our partners, we often do not fully control the progression, clinical development, regulatory strategy, public disclosure or eventual commercialization, if approved, of our partnered programs. As a result, our future success and our potential eligibility to receive milestone payments and royalties are significantly dependent on our partners’ efforts over which we have no control. The timing and scope of any approval that may be required by the U.S. Food and Drug Administration (FDA), or any other regulatory body, for drugs that are developed based on molecules discovered and/or manufactured using our Integrated Drug Creation platform can significantly impact our results of operations and future performance.

•Continued significant investments in our research and development of new technologies and expansion of our Integrated Drug Creation platform: We are seeking to further refine and expand the scope of our capabilities, which may or may not be successful. This includes, but is not limited to, novel target identification, de novo discovery, and application of artificial intelligence across our Integrated Drug Creation platform. We expect to incur significant expenses to advance our discovery, research and development efforts or to invest in and/or acquire complementary technologies, but these efforts may not be successful.

•Drive commercial adoption of our Integrated Drug Creation platform capabilities: Driving the adoption of our Integrated Drug Creation platform across existing and new markets will require significant investment. We plan to further invest in research and development to support the expansion of our capabilities, including to discover and validate new product candidates for existing partners or help expand our capabilities to support new markets.

Key Business Metrics

We have historically identified key business metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate financial projections and make strategic decisions. Our key business metrics have changed as our business strategy has evolved and may be substituted for additional or different metrics as our business continues to develop. We have historically applied the number of Active Programs to assess the adoption of our Integrated Drug Creation platform and our ability to generate future revenues; however, as our business strategy has evolved to have a greater focus on internally developed programs, we currently do not intend to continue using or reporting on Active Programs as a key business metric. We continue to evaluate our key business metrics in light of our current strategy and determine how

to accurately measure the initiation, advancement, and overall progress of our partnered and internally developed programs.

During the years ended December 31, 2024 and 2023, we believed the following metrics were the most important for understanding our business trajectory.

	December 31,	December 31,
	2024	2023
Partners, Cumulative (1)	28	24
Active Programs (2)	25	16

(1) Partners represents the unique number of partners with whom we have executed drug creation agreements. We view this metric as an indication of our ability to execute our business development activities and level of our market penetration.

(2) Active Programs represents partnered programs that are subject to ongoing development activities intended to determine if the program can be pursued by our partner for future preclinical or clinical development, as well as any program for which our partner obtains and maintains a license to our technology to advance such program after completion of the drug creation phase. There is no assurance, however, that our partners will advance any product candidates that are currently the subject of Active Programs into further preclinical or clinical development or that our partners will elect to license our technologies upon completion of the drug creation phase in a timely manner, or at all. In light of the inherent risks and uncertainties associated with drug development, we anticipate that our partners may from time to time abandon or terminate the development of one or more product candidates generated from our Integrated Drug Creation platform. As Active Programs terminate, we have historically removed the subject programs from our Active Programs count.

As of December 31, 2024, our Active Programs were as follows:

Partner

Contract Date

Active Programs

Therapeutic Area

Owkin

December 2024

Undisclosed

Invetx

December 2024

Animal Health

Twist Bioscience

October 2024

Undisclosed

Memorial Sloan Kettering Cancer Center

July 2024

Oncology

PrecisionLife

December 2023

Undisclosed

Almirall

November 2023

Dermatology

AstraZeneca

November 2023

Oncology

Undisclosed

July 2023

Undisclosed

March 2023

Undisclosed

Merck

January 2022

Undisclosed

Merck

December 2019

Undisclosed

Alpha Cancer Technologies

August 2019

Oncology

SFJ Pharmaceuticals

April 2019

Hematology

Total Active Programs

Internally Developed Programs

Our pipeline reflects internally developed programs which highlight our differentiated capabilities, including in de novo antibody design, multi-parametric lead optimization, and reverse immunology, with an initial focus on cytokine biology. As of December 31, 2024, we have identified four wholly owned, internally developed programs focusing on cytokine biology, as well as several undisclosed internal pipeline programs currently in early discovery phases

ABS-101

Our first development candidate, ABS-101 is in development as a potential treatment for Inflammatory Bowel Disease (IBD). IBD is a chronic condition characterized by inflammation within the gastrointestinal tract and encompasses two main disorders: ulcerative colitis (UC) and Crohn’s Disease (CD). UC primarily affects the colon and the rectum, and symptoms include bloody diarrhea, abdominal pain, bowel urgency, and frequent bowel movements. CD can affect any part of the gastrointestinal tract, from the mouth to the anus, and symptoms include abdominal pain, diarrhea, weight loss, fatigue, and complications such as strictures or fistulas. Both conditions can significantly impact patients’ quality of life in terms of physical health, emotional well-being, and the unpredictability of symptom onset.

Preclinical development of ABS-101 is ongoing in preparation for a potential regulatory filing in the first half of 2025, and an anticipated interim clinical readout in the second half of 2025.

ABS-201

Our second development candidate, ABS-201 is in development as a potential treatment for androgenic alopecia (AGA). AGA is an indication with a significant clinical unmet need and a potential patient population of approximately 80 million individuals in the United States alone. AGA is a genetically predetermined disorder that can affect over 50 percent of men and over 40% of women by age 50. It is characterized by progressive loss of terminal hair of the scalp any time after puberty, and follows a characteristic distribution in both males and females. Hair loss is most prominent in the vertex and frontotemporal regions in males. In women, the frontal hairline is typically spared with diffuse hair loss at the crown and top of the head, with loss often marked by a wider center part.

Current FDA-approved treatments for AGA are limited due to variable efficacy, lack of patient compliance, potential sexual and neurological side effects. Additionally, incremental limitations exist for women of reproductive age. We believe that an antibody therapeutic that is safe and efficacious with durable effects

and convenient dosing has the potential to unlock a significant commercial market for hair-regrowth therapy.

Preclinical development of ABS-201 is ongoing in preparation for a potential regulatory filing in the first half of 2026.

Components of Results of Operations

Revenue

Our revenue currently consists primarily of fees earned from our partners in conjunction with drug creation agreements utilizing our Integrated Drug Creation platform, which are presented as partner program revenue in our results of operations. These fees are earned and paid at various points throughout the terms of these agreements including upfront, upon the achievement of specified project-based milestones, and throughout the program. Future revenue may also be earned from our partners’ achievements of certain clinical, regulatory, and commercial milestones and through royalties as a percentage of net product sales.

We expect that our revenue will fluctuate from period to period due to, for example, the timing of executing additional partnerships, the contractual structure of future partnerships, the measurement of progress towards completion of each program, the uncertainty of the timing of milestone achievements and dependence on our partners’ program-related decisions. We expect revenue to increase over time as we grant licenses to our partners for the clinical and commercial use of product candidates, and as the partnered product candidates advance into and through clinical development and commercialization.

Operating Expenses

Research and development

Research and development expenses include ~~the~~ personnel-related costs (comprised of salaries, benefits and share-based compensation), contract research services, contract manufacturing, consulting fees, laboratory supplies and facilities, and certain technology costs. These expenses are exclusive of depreciation and amortization. Research and development activities consist of continued development of our Integrated Drug Creation platform, internally developed programs, and partnered programs. We derive improvements to our Integrated Drug Creation platform from each type of activity. Research and development efforts apply to our Integrated Drug Creation platform broadly, as well as ~~and~~ across programs.

We expect research and development expenses to increase in absolute dollars over the long term as we develop and advance our internally developed programs through pre-clinical and clinical activities, enter into additional partnerships, and continue to invest in technology enhancements.

At this time, we cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in preclinical and clinical activities related to developing our product candidates, as our product candidates advance into later stages of development, as we begin to

conduct larger clinical trials, as we seek regulatory approvals for any product candidates that successfully complete clinical trials, and incur expenses associated with hiring additional personnel to support our research and development efforts.

Selling, general, and administrative

Selling, general, and administrative expenses include personnel-related costs (comprised of salaries, benefits and share-based compensation) for executive, business development, legal, finance, human resources, information technology and other administrative functions. ~~Business development expenses include costs associated with attending conferences and other promotion efforts of our Integrated Drug Creation platform.~~ General and administrative expenses include certain professional service expenses, such as, external legal, accounting, and other consultants, as well as insurance, certain technology costs, and allocated facility costs. These expenses are exclusive of depreciation and amortization.

As we ~~grow~~expand our ~~operations,~~clinical wedevelopment ~~expect~~and ~~personnel-related~~regulatory ~~costs~~operations ~~to increase in absolute dollars~~ and werequire ~~expect~~further toadministrative ~~actively~~support, ~~manage other general~~ and ~~administrative~~also ~~expenses.~~prepare Wefor ~~expect~~a ~~these~~potential ~~expenses~~future tocommercial ~~vary~~launch ~~from~~of ~~period~~a toproduct ~~period~~candidate, aswe aexpect ~~percentage~~personnel-related ofcosts ~~revenue~~may increase in ~~the~~absolute ~~near~~dollars ~~term,~~ and towe ~~decrease~~expect asto acontinue ~~percentage~~to ofactively ~~revenue~~manage inother ~~the~~general ~~long~~and ~~term~~administrative expenses.

We have a comprehensive intellectual property portfolio directed towards the many aspects of our Integrated Drug Creation platform, including those related to our internally developed programs, product candidates proprietary cell lines and protein expression technologies, proprietary screening assays, antibody discovery methods, and generative AI models. We regularly file patent applications to protect innovations arising from our research and development. We also hold trademarks and trademark applications in the United States and foreign jurisdictions. Costs to secure and defend our intellectual property are expensed as incurred and are classified as selling, general and administrative expenses.

Depreciation and amortization

Depreciation and amortization expense consists of the depreciation expense of our property and equipment and amortization of our intangibles. Our equipment is used most actively as part of our lab operations.

We expect depreciation expense to fluctuate in future periods in line with continued growth ~~and compute demands~~ in absolute dollars as we purchase additional equipment.

Goodwill impairment

Goodwill is tested for impairment on an annual basis in the fourth fiscal quarter, or sooner if an indicator of impairment exists. We performed a quantitative impairment evaluation of goodwill as of June 30, 2023 and recorded a full impairment charge in the amount of $21.3 million.

Other income (expense)

Interest expense

Interest expense, net, consists primarily of interest related to borrowings under our term debt and financed laboratory equipment.

Other income, net

Other income, net consists primarily of interest income from our cash, cash equivalents and ~~short-term~~marketable ~~investments~~securities and realized and unrealized gains and losses on foreign currency transactions.

Results of Operations

The results of operations presented below should be reviewed in conjunction with our consolidated financial statements and notes included elsewhere in this Annual Report. The following tables set forth our results of operations for the periods presented (In thousands):

For the Years Ended December 31,

2024

2023

2025

2024

Revenues

Partner program revenue

2,800

4,534

Partner program revenue

4,534

5,718

Total revenues

4,534

5,718

Operating expenses

Research and development

6381,~~859~~418

4863,~~067~~859

Selling, general and administrative

3635,~~174~~058

3736,~~832~~174

Depreciation and amortization

1311,~~389~~742

13,~~999~~389

Goodwill impairment

—

21,335

Gain on settlement of contingent consideration

(5,101)

—

Total operating expenses

~~113~~123,~~422~~117

~~121~~113,~~233~~422

Operating loss

(~~108~~120,~~888~~317)

(~~115~~108,~~515~~888)

Other income (expense)

Interest expense

(~~565~~209)

(~~1,010~~565)

Other income, net

65,~~417~~412

6,~~059~~417

Total other income, net

5,~~852~~203

5,~~049~~852

Loss before income taxes

(~~103~~115,~~036~~114)

(~~110~~103,~~466~~036)

Income tax expense

(7069)

(~~100~~70)

Net loss

(~~103~~115,~~106~~183)

(~~110~~103,~~566~~106)

90Comparison of the Years Ended December 31, 2025 and 2024

Comparison of the Years Ended December 31, 2024 and 2023

The following table summarizes our results of operations for the years ended December 31, 2024 and 2023 (In thousands, except for percentages):

Revenue

	For the Years Ended December 31,
	2024		2023		$ Change		% Change
Revenues
Partner program revenue	$	4,534	$	5,718	$	(1,184)	(21)	%
Total revenues	$	4,534	$	5,718	$	(1,184)	(21)	%

Partner program revenue decreased by $1.7 million, or 38%, for the year ended December 31, 2025 compared to the year ended December 31, 2024, driven by a combination of the timing of achieving project-based milestones and the mix of ongoing program activity under our drug creation agreements. For the year ended December 31, 2025, three partners represented 95% of partner program revenue. For the year ended December 31, 2024, two partners represented 99% of partner program revenue.

Partner program revenue decreased by $1.2 million, or 21%, for the year ended December 31, 2024 compared to the year ended December 31, 2023, driven by a combination of the timing of achieving project-based milestones and the mix of ongoing program activity under our drug creation agreements. For the years ended December 31, 2024 and 2023, two partners represented approximately 99% and 89% of partner program revenue, respectively.

Operating expenses

The following ~~table~~tables ~~summarizes~~summarize our operating expenses for the years ended December 31, ~~2024~~2025 and ~~2023~~2024 (In thousands, except for percentages):

	For the Years Ended December 31,
	2024		2023		$ Change		% Change
	2025		2024		$ Change		% Change
Operating expenses
Research and development	$	6381,~~859~~418	$	4863,~~067~~859	$	1517,~~792~~559	3327	%
Selling, general and administrative	3635,~~174~~058		3736,~~832~~174		(1,~~658~~116)		(43)	%
Depreciation and amortization	1311,~~389~~742		13,~~999~~389		(~~610~~1,647)		(412)	%
Goodwill impairment	—		21,335		(21,335)		100	%
Gain on settlement of contingent consideration	(5,101)		—		(5,101)		100	%
Total operating expenses	$	~~113~~123,~~422~~117	$	~~121~~113,~~233~~422	$	(79,~~811)~~695	~~(6)~~9	%

Research and development

Research and development expenses increased by $1517.86 million, or 3327%, for the year ended December 31, ~~2024~~2025 compared to the year ended December 31, ~~2023~~2024. The increase was primarily attributable to the advancement of our drug creation programs representing $1117.83 million of this increase, ~~which~~including ~~also~~$13.1 ~~included~~million of direct costs associated with ~~IND-enabling~~external ~~studies~~preclinical ~~for~~and clinical development of our internally developed programs including ABS-101 and ABS-201, and an increase ~~in stock-based compensation~~ of $21.89 million, of personnel costs and anstock-based ~~increase~~compensation, inoffset ~~impairment~~by ~~expense~~a decrease of $01.96 million ~~for~~in ~~assets~~other lab costs.

Selling, general and administrative expenses

Selling, general, and administrative expenses decreased by $1.71 million, or 43%, for the year ended December 31, ~~2024~~2025 compared to the year ended December 31, ~~2023~~2024. The decrease was primarily attributable to a decrease ~~in personnel costs~~ of $41.~~2 million, decreased other administrative costs of $2.7 million, offset by a $~~5.2 million ~~increase~~ in personnel and stock-based compensation costs.

Depreciation and amortization

Depreciation and amortization expense decreased by $01.6 million, or 412%, for the year ended December 31, ~~2024~~2025 compared to the year ended December 31, ~~2023~~2024, ~~remaining~~primarily ~~relatively~~due ~~consistent~~to ~~between~~disposals ~~periods~~of lab equipment.

~~Goodwill~~Gain ~~impairment~~on settlement of contingent consideration

WeIn ~~performed~~June 2021, we entered into a ~~quantitative~~merger ~~impairment~~agreement ~~evaluation~~with Totient, Inc. (“Totient”). Pursuant to the merger agreement, at closing, Totient shareholders received $40.0 million in cash, and 2,212,208 shares of ~~goodwill~~the asour common stock, and became eligible to receive contingent consideration of ~~June~~$15.0 million 30in cash payable upon the achievement of specified milestones. In October 2025, ~~2023~~we ~~and~~entered ~~recorded~~into an ~~impairment~~agreement ~~charge~~with inthe selling stockholders of Totient to settle the ~~amount~~contingent consideration liability for a payment of approximately $217.36 million and to release the remaining $8.7 million, held as restricted cash on the consolidated balance sheets, from escrow to the Company. In 2025, we recognized a $5.1 million gain on this settlement.

Other income (expense)

Interest expense

Interest expense was $0.62 million for the year ended December 31, ~~2024~~2025, compared to $1.0.6 million for the year ended December 31, ~~2023~~2024, representing a decrease of $0.4 million, or 4463%,. This decrease was primarily attributable to decreased finance lease and long-term debt obligations.

Other income, net

Other income, net, was $65.4 million for the year ended December 31, ~~2024~~2025, compared to $6.14 million for the year ended December 31, ~~2023~~2024, representing ana ~~increase~~decrease of $01.30 million, or 616%, primarily attributable to ~~increases~~realized inand ~~investment~~unrealized ~~income~~gains ~~from cash, cash equivalents~~ and ~~short-term~~losses ~~investments~~on ~~due~~foreign tocurrency ~~higher~~transactions ~~balances~~ and ~~interest~~a ~~rates,~~decrease ~~offset~~in byinvestment ~~impairment~~income offrom acash, ~~non-marketable~~cash ~~equity~~equivalents ~~investment~~and investments.

Liquidity and Capital Resources

Overview

As of December 31, ~~2024~~2025, we had $~~112~~144.43 million of cash, cash equivalents and ~~short-term~~marketable ~~investments~~securities.

We have incurred net operating losses since inception. As of December 31, ~~2024~~2025, our accumulated deficit was $~~509~~624.68 million. To date, we have funded operations through issuances and sales of equity securities and debt, in addition to revenue generated from our drug creation agreements. We believe that our cash, cash equivalents and ~~short-term~~marketable ~~investments~~securities will be sufficient to meet our operating expenses, working capital and capital expenditure needs over at least the next 12 months following the date of this filing.

Our future capital requirements will depend on many factors, including, but not limited to our ability to raise additional capital through equity or debt financing, the development of our internally developed programs including the progress and strategy of ~~any~~our ~~pre-clinical~~preclinical and clinical activities, our ability to successfully ~~secure~~enter into additional partnerships ~~under contract~~ with new ~~partners~~ and ~~increase the number of programs covered under contracts with~~ existing partners, the advancement of technology development activities with existing and future partners, the successful preclinical and clinical development by us and our partners of product candidates generated using our Integrated Drug Creation platform, and the successful commercialization by us and our partners of any such product candidates that are approved. If we are unable to execute on our business plan and adequately fund operations, or if our business plan requires a level of spending in excess of cash resources, we may be required to change our strategies related to ~~pre-clinical~~preclinical and clinical development and our approach to negotiating partnerships. Alternatively, we may need to seek additional equity or debt financing, which may not be available on terms acceptable to us or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants restricting our ability to take specific actions, such as incurring additional debt, selling or licensing our programs, making product acquisitions, making capital expenditures, or declaring dividends. If we are unable to generate sufficient revenue or raise additional capital when desired, our business, financial condition, results of operations and prospects would be adversely affected.

ability to take specific actions, such as incurring additional debt, selling or licensing our programs, making product acquisitions, making capital expenditures, or declaring dividends. If we are unable to generate sufficient revenue or raise additional capital when desired, our business, financial condition, results of operations and prospects would be adversely affected.

Sources of liquidity

Since our inception, we have financed our operations primarily from the issuance and sale of our redeemable convertible preferred stock, issuances of equity securities, borrowings under long-term debt agreements, and to a lesser extent, cash flow from operations.

~~Equipment~~At-the-market ~~financing~~offering

In ~~2022~~June 2023, wethe ~~received~~Company entered into a ~~total~~Sales Agreement with Cowen and Company, LLC, as Sales Agent (the “Prior Sales Agreement”), with respect to an “at the market offering” program under which the Company had the ability to offer and sell, from time to time, shares of its common stock, par value $~~12.~~0.0001 ~~million~~per share, having an aggregate offering price of ~~proceeds~~up ~~from~~to ~~equipment~~$100.0 million ~~financing~~through ~~arrangements~~the Sales Agent. ~~Terms~~The ofCompany agreed to pay the ~~agreements~~Sales ~~require~~Agent ~~monthly~~a ~~payments~~commission ~~over~~up ~~42-48~~to ~~month~~3.0% ~~periods~~of ~~with~~the ~~imputed~~gross ~~interest~~sales ~~rates~~proceeds ~~ranging~~of ~~from~~any ~~8%-10%~~shares sold under the Prior Sales Agreement. AsDuring ofthe year ended December 31, ~~2024~~2025, the ~~combined~~Company ~~outstanding~~issued ~~balance~~10,377,752 onshares ~~these~~and ~~agreements~~received is $435.07 million in net proceeds from the sale of securities pursuant to the Prior Sales Agreement.

92In August 2025, the Company entered into a Sales Agreement with TD Securities (USA) LLC, as Sales Agent (the “Sales Agreement”), with respect to an “at the market offering” program under which the Company may offer and sell, from time to time, shares of its common stock having an aggregate offering price of up to $100.0 million through the Sales Agent. The Company has agreed to pay the Sales Agent a commission of up to 3.0% of the gross proceeds of any shares sold under the Sales Agreement. Upon execution, the Sales Agreement terminated and superseded the Prior Sales Agreement in its entirety. During the year ended December 31, 2025, the Company issued 927,855 shares and received $3.5 million in net proceeds from the sale of securities pursuant to the Sales Agreement.

~~Shelf~~Public ~~registration~~offerings ~~statement~~of oncommon ~~form S-3~~stock

On ~~August~~March 241, ~~2022~~2024, we ~~filed~~sold aan ~~shelf~~aggregate ~~registration~~of ~~statement~~19,205,000 onshares ~~Form~~of ~~S-3~~our ~~(the~~common ~~Shelf~~stock, ~~Registration~~pursuant ~~Statement)~~to an underwriting agreement with ~~the~~Morgan ~~SEC~~Stanley ~~relating~~& toCo. ~~the~~LLC ~~registration~~and ofCowen upand toCompany, anLLC ~~aggregate~~at a public offering price of $~~250~~4.050 ~~million~~per inshare, ~~shares~~before ofunderwriting ~~our~~discounts ~~common~~and ~~stock,~~commissions. ~~preferred~~We ~~stock,~~received ~~debt~~total ~~securities,~~net ~~warrants~~proceeds ~~and~~from ~~units~~the oroffering ~~any~~of ~~combination thereof~~$80.8 ~~The~~million ~~Shelf~~after ~~Registration~~deducting ~~Statement~~underwriting ~~was~~discounts ~~declared~~and ~~effective~~commissions byand ~~the~~offering ~~SEC~~expenses onpayable ~~September~~by ~~2, 2022~~us.

On ~~June~~July 1628, ~~2023~~2025, we ~~entered~~sold ~~into a Sales Agreement with Cowen and Company, LLC, as Sales Agent, with respect to~~ an ~~“at~~aggregate ~~the~~of ~~market offering” program under which we may offer and sell~~16, ~~from time to time at our sole discretion~~670,000 shares of our common stock, ~~par~~pursuant ~~value~~to ~~$0.0001 per share, having~~ an ~~aggregate~~underwriting ~~offering~~agreement ~~price~~with ofMorgan upStanley to& ~~$100~~Co.0 ~~million~~LLC, ~~through the Sales Agent~~J.P. WeMorgan ~~will~~Securities ~~pay~~LLC, ~~the~~Jefferies ~~Sales~~LLC ~~Agent~~and aTD ~~commission~~Securities up(US) toLLC ~~3.0%~~at ofa ~~the~~public ~~gross~~offering ~~sales~~price ~~proceeds~~ of ~~any shares sold under the Sales Agreement~~$3.00 Asper ~~of December 31~~share, ~~2024,~~before weunderwriting ~~have~~discounts ~~issued~~and ~~377,996~~commissions. ~~shares~~We ~~and~~ received ~~$1.6~~total ~~million~~ net proceeds from the ~~sale~~offering of ~~securities registered pursuant to the Sales Agreement~~$46.7 ~~Subsequent~~million toafter ~~December 31,~~deducting ~~2024,~~underwriting ~~the~~discounts ~~Company~~and ~~issued~~commissions and ~~sold~~offering ~~5,269,192~~expenses ~~shares~~payable ofby ~~common stock for net proceeds of $21~~us.~~7 million pursuant to the Sales Agreement.~~

OnPrivate ~~March~~investment 1,in ~~2024, we closed the sale of an aggregate of 19,205,000 shares of our common stock, pursuant to an underwriting agreement with Morgan Stanley & Co. LLC and Cowen and Company, LLC at a~~ public offering price of $4.50 per share, before underwriting discounts and commissions. We received total net proceeds from the offering of $80.8 million after deducting underwriting discounts and commissions and offering expenses payable by us.equity

~~Private~~In ~~Investment~~January 2025, we entered into a strategic collaboration with AMD and sold an aggregate of 5,714,285 shares of our common stock to AMD for net proceeds of $20.0 million through a private investment in ~~Public~~public ~~Equity~~equity (PIPE). The issuance of stock to AMD was at a premium of approximately $2.5 million over the market price on the issuance date.

On January 7, 2025, we closed the sale of an aggregate of 5,714,285 shares of our common stock, through a private investment in public equity (PIPE) to Advanced Micro Devices, Inc. (AMD), at an offering price of $3.50 per share. We received total net proceeds from the offering of $20.0 million.100

Cash Flows

The following summarizes our cash flows (In thousands):

	For the Years Ended December 31,
	2024		2023
	2025		2024
Net cash provided by (used in)
Operating activities	(7292,~~402~~925)		(6472,~~636~~402)
Investing activities	(4150,~~577~~160)		81(41,~~944~~577)
Financing activities	82105,~~526~~949		(482,~~483)~~526
Net (decrease) increase in cash, cash equivalents, and restricted cash	$	(31,453)	$	12,825
Net decrease in cash, cash equivalents, and restricted cash	$	(37,136)	$	(31,453)

Cash flows from operating activities

In the year ended December 31, ~~2024~~2025, net cash used in operating activities was $7292.49 million and consisted primarily of a net loss of $~~103~~115.12 million adjusted for non-cash items, including depreciation and amortization expense of $1311.47 million, stock-based compensation expense of $1918.53 million, and ~~impairment~~a ofnet ~~$1.4~~decrease ~~million~~in ~~for~~operating assets ~~that~~and ~~met~~liabilities ~~the~~in ~~held for sale criteria during~~ the ~~period,~~amount ~~partially offset by $3.7 million~~ of ~~accretion of discount on short-term investments. Net cash used in operations increased by~~ $70.84 million ~~year-over-year primarily due to increased research and development costs, including ABS-101 IND-enabling studies~~.

In the year ended December 31, ~~2023~~2024, net cash used in operating activities was $6472.64 million and consisted primarily of a net loss of $~~110~~103.61 million adjusted for non-cash items, including depreciation and amortization expense of $1413.04 million, stock-based compensation expense of $1119.45 million, ~~and goodwill~~ impairment of $211.34 million for asset that met the held for sale criteria during the period, partially offset by $23.7 million of accretion of discount on ~~short-term~~marketable ~~investments~~securities.

Net cash used in operations increased by $20.5 million year-over-year primarily due to increased research and development costs, including external preclinical and clinical development costs related to our internally developed programs.

Cash flows from investing activities

In the year ended December 31, ~~2024~~2025, net cash used in investing activities was $4150.62 million primarily from purchases of ~~short-term~~marketable ~~investments~~securities of $~~186~~119.19 million, partially offset by cash provided by maturities of ~~short-term~~marketable ~~investments~~securities of $~~144~~69.05 million.

93In the year ended December 31, 2024, net cash used in investing activities was $41.6 million primarily from purchases of marketable securities of $186.1 million, partially offset by maturities of marketable securities of $144.0 million.

In the year ended December 31, 2023, net cash provided by investing activities was $81.9 million primarily from maturities of short-term investments of $229.9 million, partially offset by cash used for purchases of short-term investments of $147.3 million and purchases of lab equipment of $0.9 million.

Cash flows from financing activities

In the year ended December 31, ~~2024~~2025, net cash provided by financing activities was $82105.59 million. The net cash provided resulted primarily from aggregate proceeds of $82105.48 million from the issuance of common stock ~~from~~pursuant ato ~~public~~the ~~offering~~PIPE ~~and~~with AMD, the ~~Sales~~issuance ~~Agreement,~~of common stock pursuant to ~~the~~our ~~“at~~July ~~the~~2025 ~~market~~underwritten offering” ~~program~~and pursuant to the Sales Agreement and Prior Sales Agreement, and proceeds of $43.2 3 million from the issuance of common stock from stock option exercises and our 2021 ESPP, partially offset by principal payments of $43.02 million made for financed equipment.

In the year ended December 31, ~~2023~~2024, net cash ~~used~~provided inby financing activities was $482.5 million primarily from ~~cash~~proceeds ~~used~~of ~~for~~$82.4 ~~principal~~million ~~payments~~from the issuance of ~~$5.3~~common ~~million~~stock ~~made~~from ~~for~~a ~~financed~~public ~~equipment,~~offering ~~partially~~and ~~offset~~the byPrior Sales Agreement and proceeds of $04.92 million from the issuance of common stock from option exercises and our 2021 ESPP, partially offset by principal payments of $4.0 million made for financed equipment.

Income taxes

Income tax expense for the year ended December 31, ~~2024~~2025 represents ~~state income tax obligations and~~ taxes in foreign jurisdictions for which we conduct business. Income tax expense for the year ended December 31, ~~2023~~2024 represents our federal and certain state income tax obligations and taxes in foreign jurisdictions for which we conduct business. As of ~~December 31, 2024, we have recorded a full valuation allowance on our U.S. federal and state deferred tax assets.~~

Our effective income tax rate from continuing operations was (0.1)% and (0.1)% for the years ended December 31, 2024 and 2023, respectively. The difference between the effective rate and the statutory rate is primarily attributed to the change in the valuation allowance against net deferred tax assets.101

December 31, 2025, we have recorded a full valuation allowance on our U.S. federal and state deferred tax assets.

Our effective income tax rate from continuing operations was (0.1)% for the years ended December 31, 2025 and 2024.

Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with United States Generally Accepted Accounting Principles (US GAAP). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements, as well as the reported amounts of revenue and expenses during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in Note 2: Summary of significant accounting policies, we believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates. Critical accounting policies and estimates are those that we consider the most important to the portrayal of our financial condition and results of operations because they require our most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of the matters that are inherently uncertain.

Revenue recognition

We recognize revenue as control of our products and services are transferred to our customers in an amount that reflects the consideration expected to be received in exchange for those products and services. This process involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when or as the performance obligations are satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. We consider a performance obligation satisfied once control of a good or service has been transferred to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. Partner program revenue includes revenue associated to the discovery, development and technology readiness phases of drug creation agreements. We refer to our customers as “partners” when describing our relationship in an agreement.

Partner program revenue

Our drug creation agreements related to our partnered programs generally include multiple stages of drug creation that combined represent a single performance obligation. The primary goal of the drug creation phase includes target creation, product candidate creation, and development or optimization of a product candidate(s). For the drug creation phase, partners may request a scope that includes, but is not limited to: a specified disease area, a target for creation of a product candidate, or supply a specified product candidate for AI-driven optimization. These agreements may include options for additional goods and services such as readying the technology to transfer to the partner and licensing terms. The transaction prices for these arrangements include fixed and variable consideration for the single performance obligation as well as variable consideration for success-based achievements. Any variable consideration is constrained to the extent that it is probable that a significant reversal of cumulative revenue will not occur. Primarily all of our contracts with our partners include an enforceable right to payment. While there is no alternative use for the asset created, the agreement’s terms vary as to whether an enforceable right to payment exists for performance completed as of that date.

We measure progress toward the completion of the performance obligations satisfied over time using an input method based on actual costs incurred and estimated cost to complete at each reporting date to satisfy a performance obligation. This method provides an appropriate depiction of completed progress toward fulfilling our performance obligations for each respective arrangement. In certain drug creation agreements ~~that require a portion of the contract consideration to be received in advance at the commencement of the contract, such advance payment is initially recorded as a contract liability.~~

~~Contingent Consideration~~102

Wethat ~~utilized~~require ~~the~~a ~~acquisition~~portion ~~method~~ of ~~accounting for our business combination related to~~ the ~~Totient~~contract ~~acquisition~~consideration ~~which included allocating the purchase price of the acquisition~~ to ~~the~~be ~~various~~received ~~tangible and intangible assets acquired and liabilities assumed based on their estimated fair values. The contingent consideration of $15.0 million held~~ in ~~escrow~~advance isat ~~included in restricted cash on~~ the ~~consolidated~~commencement ~~balance sheets. The contingent consideration shall be paid upon the achievement~~ of the ~~milestone of either entering into agreements meeting certain financial criteria with third parties using~~contract, orsuch ~~relating~~advance ~~to,~~payment ~~Totient~~is ~~technology~~initially orrecorded ~~the~~as ~~first commercial sale of~~ a ~~Totient~~contract ~~product. We utilize a probability-weighted approach to estimate the fair value of the~~ liability ~~included in contingent consideration on the consolidated balance sheets~~. As of December 31, 2024 and 2023, contingent consideration payable was $12.8 million. Changes in fair value of the contingent consideration liability are included within research and development expense on the consolidated statements of operations and comprehensive loss.

Accrued preclinical and clinical development expenses

We expense all research and development costs in the periods in which they are incurred. Preclinical and clinical development costs compose a component of research and development costs, in which we typically contract with third parties, including CROs and CDMOs, to conduct and manage preclinical studies and clinical trials, research services, and clinical manufacturing services on our behalf. When billing terms under these contracts do not coincide with the timing of when the work is performed, we estimate our obligations for services provided but not yet billed as of the period end based on a number of factors that include, but are not limited to, our knowledge of the research and development programs and clinical manufacturing activities, the status of the programs and activities, invoicing to date, and the provisions in the contracts. Further, we accrue expenses related to clinical trials based on the status of participant enrollment and activity according to the related agreement. We monitor participant enrollment levels and related activity to the extent reasonably possible and make judgments and estimates in determining the accrued balance in each reporting period. We obtain information regarding unbilled services directly from outside service providers and perform procedures to support our estimates based on our internal understanding of the services provided to date. However, we may also be required to estimate these services based on information available to our internal preclinical and clinical and administrative staff if such information is not able to be obtained timely from our service providers.

Accrued preclinical and clinical development expenses are included in accounts payable and accrued expenses on the consolidated balance sheets. In the event that advance payments are made to a CRO, CDMO or other outside service providers, the payments are recorded within prepaid expenses and other current assets on the consolidated balance sheets and subsequently recognized as research and development expense when the associated services are performed. If we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates, resulting in adjustments to expense in future periods.

Recent Accounting Pronouncements

See “Recently issued accounting pronouncements” under Note 2: Summary of significant accounting policies to our financial statements included elsewhere in this Annual Report for more information.

Emerging Growth Company Status

We are an emerging growth company, as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. Section 107 of the JOBS Act provides that an emerging growth company may take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933 for complying with new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. Section 107 of the JOBS Act provides that we can elect to opt out of the extended transition period at any time, which election is irrevocable. We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.

Subject to certain conditions, as an emerging growth company, we may rely on certain other exemptions and reduced reporting requirements, including without limitation (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement by the Public Company Accounting Oversight Board (PCAOB) regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the consolidated financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier of (a) the last day of the fiscal year in which we have total annual gross revenue of $1.235 billion or more; (b) December 31, 2026, the last day of

95In addition, we are also a “smaller reporting company” as defined in Rule 12b-2 of the Exchange Act and have elected to take advantage of certain of the scaled back disclosure requirements available to smaller

the fiscal year following the fifth anniversary of the date of the completion of our IPO; (c) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; or (d) the date we qualify as a “large accelerated filer,” which requires the market value of our common stock that are held by non-affiliates to exceed $700.0 million as of the prior June 30th.103

reporting companies such as avoiding the extensive narrative disclosure required of other reporting companies, particularly in the description of executive compensation. We will remain a smaller reporting company until (a) the last day of the fiscal year in which we have total annual gross revenue of less than $100 million and the market value of our common stock held by non-affiliates exceeds $700.0 million as of the prior June 30th, or (b) the last day of the fiscal year in which we have total annual gross revenue exceeding $100 million and the market value of our common stock held by non-affiliates exceeds $250.0 million. In August 2025, the SEC released a Compliance and Disclosure Interpretation clarifying the filer status transition for registrants that lose their smaller reporting company status based on the revenue tests. Due to this interpretation, we will remain a non-accelerated filer for filings due in the fiscal year immediately following the loss of smaller reporting company status, allowing us to retain the exception from the auditor attestation requirement on internal control over financial reporting. However, the interpretation specifies that we will lose eligibility for all other smaller reporting company accommodations beginning with the Form 10-Q for the first fiscal quarter of the year after losing smaller reporting company status.

In addition, the loss of emerging growth status will not impact our “non-accelerated filer” status, which also provides an exemption from the auditor attestation requirement with respect to internal control over financial reporting.

Item 7A. Quantitative and Qualitative Disclosure About Market Risk

Not applicable.

Item 8. Financial Statements and Supplementary Data

Report of Independent Registered Public Accounting Firm (PCAOB ID: 42)			97105
Consolidated Balance Sheets as of December 31, 2024 and 2023			98
Consolidated Balance Sheets as of December 31, 2025 and 2024			106
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2024 and 2023			99
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2025 and 2024			107
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2024 and 2023			100
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2025 and 2024			108
Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023			101
Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024			109
Notes to the Consolidated Financial Statements			~~102~~110

96104

Report of Independent Registered Public Accounting Firm

To the Stockholders and the Board of Directors of Absci Corporation

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Absci Corporation (the Company) as of December 31, ~~2024~~2025 and ~~2023~~2024, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, ~~2024~~2025 and ~~2023~~2024, and the results of its operations and its cash flows for the years then ended, in conformity with U.S. generally accepted accounting principles.

Basis for Opinion

These financial statements are the responsibility of the Company'’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Ernst & Young LLP

We have served as the Company’s auditor since 2021.

San Jose, California

March 1824, ~~2025~~2026

97105

Table of Contents

ABSCI CORPORATION

CONSOLIDATED BALANCE SHEETS

	December 31,		December 31,
(In thousands, except for share and per share data)	~~2024~~2025		~~2023~~2024
ASSETS
Current assets:
Cash and cash equivalents	$	4120,~~213~~025	$	7241,~~362~~213
Restricted cash	~~15,947~~—		1615,~~193~~947
Short-term investments	71,212		25,297
Marketable securities	124,267		71,212
Accounts receivable, net	—		2,189
Prepaid expenses and other current assets	5,281		5,459
Prepaid expenses and other current assets	5,459		4,537
Total current assets	149,573		133,831
Total current assets	133,831		120,578
Operating lease right-of-use assets	2,914		3,968
Operating lease right-of-use assets	3,968		4,490
Property and equipment, net	20,860		29,167
Property and equipment, net	29,167		41,328
Intangibles, net	41,514		44,883
Intangibles, net	44,883		48,253
Restricted cash, long-term	1,053		1,054
Restricted cash, long-term	1,054		1,112
Other long-term assets	383		705
Other long-term assets	705		1,537
TOTAL ASSETS	$	216,297	$	213,608
TOTAL ASSETS	$	213,608	$	217,298
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	3,529	$	1,503
Accounts payable and accrued expenses	$	19,348	$	10,449
Accrued expenses	6,842		6,553
Contingent consideration	—		12,750
Contingent consideration	12,750		12,750
Long-term debt	873		2,733
Long-term debt	2,733		3,258
Operating lease obligations	1,805		1,608
Operating lease obligations	1,608		1,679
Deferred revenue	739		1,116
Financing lease obligations	78		641
Total current liabilities	22,765		28,656
Deferred revenue	1,116		3,174
Long-term debt, net of current portion	—		1,257
Total current liabilities	28,656		29,558
Operating lease obligations, net of current portion	2,624		4,429
Long-term debt, net of current portion	1,257		4,660
Deferred revenue, long-term	436		—
Operating lease obligations, net of current portion	4,429		5,643
Other long-term liabilities	1,023		133
Deferred revenue, long-term	—		966
TOTAL LIABILITIES	26,848		34,475
Other long-term liabilities	133		295
Commitments (See Note 11)
TOTAL LIABILITIES	34,475		41,122
Commitments (See Note 10)
STOCKHOLDERS' EQUITY
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of December 31, 2024 and 2023	—		—
Preferred stock	—		—
Common stock, $0.0001 par value; 500,000,000 shares authorized; 115,362,265 and 93,087,675 shares issued and outstanding as of December 31, 2024 and 2023, respectively	12		9
Common stock	15		12
Additional paid-in capital	~~688~~813,~~726~~627		~~582~~688,~~699~~726
Accumulated deficit	(~~509~~624,~~601~~784)		(~~406~~509,~~495~~601)
Accumulated other comprehensive loss	(4)		(37)
Accumulated other comprehensive income (loss)	591		(4)
TOTAL STOCKHOLDERS' EQUITY	~~179~~189,~~133~~449		~~176~~179,~~176~~133
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	~~213~~216,~~608~~297	$	~~217~~213,~~298~~608

The accompanying notes are an integral part of these consolidated financial statements.

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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

For the Years Ended December 31,

(In thousands, except for share and per share data)

~~2024~~2025

~~2023~~2024

Revenues

Partner program revenue

2,800

4,534

Partner program revenue

4,534

5,718

Total revenues

4,534

5,718

Operating expenses

Research and development

6381,~~859~~418

4863,~~067~~859

Selling, general and administrative

3635,~~174~~058

3736,~~832~~174

Depreciation and amortization

1311,~~389~~742

13,~~999~~389

Goodwill impairment

—

21,335

Gain on settlement of contingent consideration

(5,101)

—

Total operating expenses

~~113~~123,~~422~~117

~~121~~113,~~233~~422

Operating loss

(~~108~~120,~~888~~317)

(~~115~~108,~~515~~888)

Other income (expense)

Interest expense

(~~565~~209)

(~~1,010~~565)

Other income, net

65,~~417~~412

6,~~059~~417

Total other income, net

5,~~852~~203

5,~~049~~852

Loss before income taxes

(~~103~~115,~~036~~114)

(~~110~~103,~~466~~036)

Income tax expense

(7069)

(~~100~~70)

Net loss

(~~103~~115,~~106~~183)

(~~110~~103,~~566~~106)

Net loss per share:Basic and diluted

(0.9484)

(10.2094)

Weighted-average common shares outstanding:Basic and diluted

~~110~~136,~~239~~776,~~870~~885

92110,~~028~~239,~~016~~870

Comprehensive loss:

Net loss

(~~103~~115,~~106~~183)

(~~110~~103,~~566~~106)

Foreign currency translation adjustments

~~(26)~~448

40(26)

Unrealized gain on investments

Unrealized gain on marketable securities

147

Comprehensive loss

(~~103~~114,~~073~~588)

(~~110~~103,~~483~~073)

The accompanying notes are an integral part of these consolidated financial statements.

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STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(In thousands, except for share and per share data)	Common Stock	Additional Paid-In Capital	Accumulated Deficit		Accumulated Other Comprehensive Loss			Total Stockholders' Equity
(In thousands, except for share data)	Common Stock	Additional Paid-In Capital	Accumulated Deficit		Accumulated Other Comprehensive Income (Loss)			Total Stockholders' Equity
							Shares			Amount
Balances - December 31, 2022			92,411,103		$	9		$	570,454	$	(295,929)	$	(120)	$	274,414
Balances - December 31, 2023			93,087,675		$	9		$	582,699	$	(406,495)	$	(37)	$	176,176
Issuance of shares under stock plans, net of shares withheld for tax payments			777,602		—			862		—		—		862
Issuance of shares, net of issuance costs of $465			19,582,996	—	2			82,396		—		—		82,398
Stock-based compensation			—		—			11,383		—		—		11,383
Forfeiture of common stock			(101,030)		—			—		—		—		—
Foreign currency translation adjustments			—		—			—		—		40		40
Unrealized gain on investments			—		—			—		—		43		43
Net loss			—		—			—		(110,566)		—		(110,566)
Balances - December 31, 2023			93,087,675		9			582,699		(406,495)		(37)		176,176
Issuance of shares, net of issuance costs of $465			19,582,996		2			82,396		—		—		82,398
Issuance of shares under stock plans, net of shares withheld for tax payments			2,729,480		1			4,158		—		—		4,159
Stock-based compensation			—		—			19,473		—		—		19,473
Forfeiture of common stock			(37,886)		—			—		—		—		—
Foreign currency translation adjustments			—		—			—		—		(26)		(26)
Unrealized gain on investments			—		—			—		—		59		59
Unrealized gain on marketable securities			—		—			—		—		59		59
Net loss			—		—			—		(103,106)		—		(103,106)
Balances - December 31, 2024			115,362,265		$12	12		$688,726	~~688,726~~	$(509,601)	~~(509,601)~~	$(4)	~~(4)~~	$179,133	~~179,133~~
Issuance of common shares, net of issuance costs of $3,710			33,689,892		3			103,302		—		—		103,305
Issuance of shares under stock plans, net of shares withheld for tax payments			2,462,922		—			3,309		—		—		3,309
Stock-based compensation			—		—			18,290		—		—		18,290
Foreign currency translation adjustments			—		—			—		—		448		448
Unrealized gain on marketable securities			—		—			—		—		147		147
Net loss			—		—			—		(115,183)		—		(115,183)
Balances - December 31, 2025			151,515,079		$	15		$	813,627	$	(624,784)	$	591	$	189,449
46022

The accompanying notes are an integral part of these consolidated financial statements.

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CONSOLIDATED STATEMENTS OF CASH FLOWS

	For the Years Ended December 31,
(In thousands)	~~2024~~2025		~~2023~~2024
Cash Flows From Operating Activities
Net loss	~~(103,106)~~$	(115,183)	~~(110,566)~~$	(103,106)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	1311,~~389~~742		13,~~999~~389
Stock-based compensation	1918,~~452~~321		1119,~~416~~452
Goodwill impairment	—		21,335
Accretion of discount on marketable securities	(2,543)		(3,743)
Accretion of discount on short-term investments	(3,743)		(2,671)
Gain on settlement of contingent consideration	(5,101)		—
Other	~~1,974~~(584)		~~334~~1,974
Changes in operating assets and liabilities:
Accounts receivable, net	~~2,239~~—		~~(666)~~2,239
Prepaid expenses and other current assets	(~~484~~424)		~~1,598~~(484)
Operating lease right-of-use assets and liabilities	(~~762~~555)		(~~856~~762)
Other long-term assets	~~(68)~~249		(~~255~~68)
Accounts payable	2,026		(786)
Accounts payable and accrued expenses	1,094		1,731
Accrued expenses and other liabilities	(295)		(1,213)
Deferred revenue	59		(3,024)
Deferred revenue	(3,024)		3,695
Net cash used in operating activities	(92,925)		(72,402)
Net cash used in operating activities	(72,402)		(64,636)
Cash Flows From Investing Activities
Purchases of property and equipment	(~~404~~1,107)		(~~860~~404)
Investment in short-term investments	(186,112)		(147,347)
Investment in marketable securities	(119,866)		(186,112)
Proceeds from maturities of short-term investments	144,000		229,897
Proceeds from maturities of marketable securities	69,501		144,000
Proceeds from sales of property and equipment	~~939~~1,312		~~254~~939
Net cash (used in) provided by investing activities	(41,577)		81,944
Net cash used in investing activities	(50,160)		(41,577)
Cash Flows From Financing Activities
Principal payments on long-term debt	(3,~~388~~117)		(3,~~012~~388)
Principal payments on finance lease obligations	(~~643~~79)		(~~2,333~~643)
Proceeds from issuance of common stock through follow-on offering, net	80,827		—
Proceeds from issuance of common stock, net	105,835		82,398
Proceeds from issuance of common stock through at-the-market offerings, net	1,571		—
Proceeds from issuance of common stock through employee equity plans, net	3,310		4,159
Proceeds from issuance of common stock through employee equity plans, net	4,159		862
Net cash provided by financing activities	105,949		82,526
Net cash provided by (used in) financing activities	82,526		(4,483)
Net decrease in cash, cash equivalents, and restricted cash	(37,136)		(31,453)
Net (decrease) increase in cash, cash equivalents, and restricted cash	(31,453)		12,825
Cash, cash equivalents and restricted cash - Beginning of period	58,214		89,667
Cash, cash equivalents and restricted cash - Beginning of year	89,667		76,842
Cash, cash equivalents, and restricted cash - End of period	$	21,078	$	58,214
Cash, cash equivalents, and restricted cash - End of period	$	58,214	$	89,667
Supplemental Disclosure of Cash Flow Information
Cash paid during the period for interest	~~561~~$	178	~~970~~$	561
Supplemental Disclosure of Non-Cash Investing and Financing Activities
Right-of-use assets obtained in exchange for operating lease obligation	~~433~~—		—433
Payments on long-term debt by third-party through sale of equipment	~~540~~—		—540

The accompanying notes are an integral part of these consolidated financial statements.

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1.Organization and nature of operations

Absci Corporation (the “Company”) is a ~~data~~clinical-~~first~~stage ~~generative~~biopharmaceutical ~~AI drug creation~~ company ~~that~~using ~~combines~~an AI-native ~~with~~approach ~~scalable wet lab technologies~~ to ~~design~~develop differentiated antibody-based therapeutics. Absci leverages its integrated drug creation platform (the “Integrated Drug Creation platform”) to improve upon traditional biologic drug discovery by using AI to simultaneously optimize multiple drug characteristics important to development and therapeutic benefit. The Company was organized in the State of Oregon in August 2011 as a limited liability company and converted to a limited liability company (“LLC”) in Delaware in April 2016. In October 2020, the Company converted from a Delaware LLC to a Delaware corporation. The Company’s headquarters are located in Vancouver, Washington.

The Company was organized in the State of Oregon in August 2011 as a limited liability company and converted to a limited liability company (“LLC”) in Delaware in April 2016. In October 2020, the Company converted from a Delaware LLC to a Delaware corporation. The Company’s headquarters are located in Vancouver, Washington.

2.Summary of significant accounting policies

Basis of presentation

The consolidated financial statements are prepared in accordance with US GAAP as defined by the Financial Accounting Standards Board (“FASB”). The consolidated financial statements include the Company’s wholly-owned subsidiaries and entities under its control. The Company has eliminated all intercompany transactions and accounts. Certain amounts in prior years' financial statements have been reclassified to conform to the current year's presentation.

Use of estimates

The preparation of financial statements in accordance with US GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Such estimates include, but are not limited to, revenue recognition including estimated timing of the satisfaction of performance obligations, the fair value of stock-based compensation awards, ~~quantitative~~and ~~impairment~~ evaluations of ~~goodwill and~~ recoverability of long-lived assets~~, and the fair value of contingent consideration~~. The Company bases its estimates on historical experiences, and other relevant factors that it believes to be reasonable under the circumstances. Actual results could differ from those estimates.

Segment information

The Company operates as a single operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources, making operating decisions and evaluating performance (see Note 1716: Segment Reporting).

Filing Compare · Absci Corp