UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

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


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

For the fiscal year ended December 31, 2024

For the fiscal year ended December 31, 2023


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

☐	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: 001-39619

Commission File Number: 001-39169

Kiromic BioPharma, Inc.

(Exact name of registrant as specified in its charter)

Delaware		46-4762913
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)


7707 Fannin Street, Suite 200, Houston, TX		77054
Delaware		46-4762913
(Address of Principal Executive Offices)		Zip Code
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)


7707 Fannin Street, Suite 200, Houston, TX		77054
(Address of Principal Executive Offices)		Zip Code

(832) 968-4888

(Registrant’s telephone number)

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

Title of Each Class		Trading symbol		Name of Exchange on which registered
Common Shares, par value $0.001 per share		KRBP		The OTCQB Market


Title of Each Class	Trading symbol	Name of Exchange on which registered
Common Shares, par value $0.001 per share	KRBP	The OTCQB Market

Securities registered pursuant to Section 12(g) of the Act: None

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 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 if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 232.405 of this chapter) is not contained herein, and will not be contained, to the best of Registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☐

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

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. ☐

If securities are registered pursuant to Section 12(b) of the 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 §240.10D-1(b). ☐

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

The aggregate market value of the registrant’s Common Shares held by non-affiliates of the registrant was approximately $3,377,900 based on the closing price of the Common Stock on the OTCQB Stock Market on June 30, 2024.

~~The~~As ~~aggregate market value~~ of ~~the~~February ~~registrant’s~~10, ~~Common~~2025, ~~Shares~~there ~~held~~were ~~by non-affiliates of the registrant was approximately $3~~1,~~175~~533,~~902~~272 shares ~~based on the closing price~~ of the ~~Common~~registrant’s ~~Stock~~common onstock ~~the Nasdaq Stock Market on June 30, 2023~~outstanding.

As of March 18, 2024, there were 1,288,235 shares of the registrant’s common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

None

Part III of the Form 10-K incorporates by reference certain portions of the registrant’s definitive proxy statement for its 2024 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission (“SEC”) not later than 120 days after the end of the fiscal year covered by this report.

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Kiromic BioPharma, Inc.

Annual Report on Form 10-K

Year Ended December 31, ~~2023~~2024

TABLE OF CONTENTS

Page PART I Item 1. Business 7 Item 1A. Risk Factors 31 Item 1B. Unresolved Staff Comments 61 Item 1C. Cybersecurity 62 Item 2. Properties 62 Item 3. Legal Proceedings 63 Item 4. Mine Safety Disclosures 64 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 65 Item 6. [Reserved] 65 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 65 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 76 Item 8. Financial Statements and Supplementary Data 76 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 76 Item 9A. Controls and Procedures 77 Item 9B. Other Information 78 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 78 PART III Item 10. Directors, Executive Officers and Corporate Governance 78 Item 11. Executive Compensation 78 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 78 Item 13. Certain Relationships and Related Transactions, and Director Independence 78 Item 14. Principal Accountant Fees and Services 78 PART IV Item 15. Exhibits and Financial Statement Schedules 79 Item 16. Form 10-K Summary 79

		Page
PART I

Item 1. Business		7

Item 1A. Risk Factors		38

Item 1B. Unresolved Staff Comments		68

Item 1C. Cybersecurity		69

Item 2. Properties		69

Item 3. Legal Proceedings		70

Item 4. Mine Safety Disclosures		71

PART II

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities		72

Item 6. [Reserved]		72

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations		72

Item 7A. Quantitative and Qualitative Disclosures About Market Risk		87

Item 8. Financial Statements and Supplementary Data		87

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure		87

Item 9A. Controls and Procedures		88

Item 9B. Other Information		89

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections		89

PART III

Item 10. Directors, Executive Officers and Corporate Governance		89

Item 11. Executive Compensation		89

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters		89

Item 13. Certain Relationships and Related Transactions, and Director Independence		89

Item 14. Principal Accountant Fees and Services		89
PART IV

Item 15. Exhibits and Financial Statement Schedules		90

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Cautionary Note on Forward-Looking Statements

Certain ~~CAUTIONARY~~statements ~~NOTE~~contained ONin ~~FORWARD~~this prospectus may constitute “forward-~~LOOKING~~looking ~~STATEMENTS~~statements” for purposes of federal securities laws. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements appear in a number of places in this prospectus.” In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “contemplate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “will,” “would” and other similar words and expressions (including the negative of any of the foregoing), but the absence of these words does not mean that a statement is not forward-looking.

~~Various~~These forward-looking statements ~~made~~are inbased ~~this~~on ~~Annual~~information ~~Report~~available onas ~~Form~~of ~~10-K~~the ~~are~~date ~~forward-looking~~of ~~and~~this ~~involve~~prospectus ~~risks~~ and ~~uncertainties.~~our ~~All~~management's current ~~statements~~expectations, ~~that~~forecasts ~~address~~and ~~activities~~assumptions, ~~events~~and orinvolve ~~developments~~a ~~that~~number weof ~~intend~~judgments, ~~expect~~known orand ~~believe~~unknown ~~may~~risks ~~occur~~and inuncertainties ~~the~~and ~~future~~other ~~are~~factors, ~~forward-looking~~many ~~statements~~of ~~within~~which ~~the~~are ~~meaning~~outside ofthe ~~Section 27A~~control of the ~~Securities~~Company ~~Act~~and ofour ~~1933~~directors, asofficers ~~amended,~~ and ~~Section~~affiliates. ~~21E~~There ofcan ~~the~~be ~~Securities~~no ~~Exchange~~assurance ~~Act~~that offuture ~~1934,~~developments aswill ~~amended.~~be ~~Such~~those ~~statements~~that ~~give~~have ~~our~~been ~~current~~anticipated. ~~expectations~~Accordingly, orforward-looking ~~forecasts~~statements ofshould ~~future events and are~~ not ~~statements~~be ofrelied ~~historical~~upon oras ~~current~~representing ~~facts.~~our ~~These~~views ~~statements~~as ~~include,~~of ~~among~~any ~~others,~~subsequent ~~statements about:~~date.

These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.

These risks and uncertainties include, but are not limited to, those factors described in “Risk Factors,” our periodic filings with the SEC and the following:

●	Our goals and strategies.

●	Our future business development, financial condition and results of operations.

●	Our expected timing of human clinical trials and other related milestones.

●	Expected changes in our revenue, costs or expenditures.

●	Our ability to obtain financing in amounts sufficient to fund our operations and continue as a going concern and avoid seeking protection under Chapters 7 or 11 of the United States Bankruptcy Code.

●	Difficulties or delays in the product development process, including the results of preclinical studies or clinical trials.

●	Difficulties or delays in the regulatory approval process.

●	Manufacturing, sales, marketing and distribution of any of our products that may be successfully developed and approved for commercialization.

●	Growth of and competition trends in our industry.

●	Our expectations regarding demand for, and market acceptance of, our products.

●	Our expectations regarding our relationships with investors, institutional funding partners and other parties we collaborate with.

● Fluctuations in general economic and business conditions in the markets in which we operate~~; including those fluctuations caused by COVID-19~~.

●	Our ability to raise capital when needed.

●	Relevant government policies and regulations relating to our industry.

●	The outcome of any pending or threatened litigation.

~~Forward-looking~~● ~~statements~~Our ~~also~~results include statements other than statements of current or historical fact, including, without limitation, all statements related to any expectations of revenues, expenses, cash flows, earnings or losses from ~~operations,~~preclinical ~~cash~~studies ~~required to maintain current~~ and ~~planned~~early-stage ~~operations,~~clinical ~~capital~~trials ormay ~~other~~not ~~financial~~be ~~items;~~predictive ~~any statements~~ of ~~the~~results ~~plans,~~from ~~strategies~~late-stage ~~and objectives of management for future operations; any plans~~ or ~~expectations with respect to product research, development and commercialization, including regulatory approvals; any~~ other ~~statements~~clinical ~~of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing~~trials. ~~We often, although not always,~~

Forward-looking statements also include statements other than statements of current or historical fact, including, without limitation, all statements related to any expectations of revenues, expenses, cash flows, earnings or losses from operations, cash required to maintain current and planned operations, capital or other financial items; any statements of the plans, strategies and objectives of management for future operations; any plans or expectations with respect to product research, development and commercialization, including regulatory approvals; any other statements of expectations, plans, intentions or beliefs; and any statements of assumptions underlying any of the foregoing. We often, although not always, identify forward-looking statements by using words or phrases such as “may," "could," "will," "should," "would," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "potential," "project" or "continue".

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identify forward-looking statements by using words or phrases such as “may," "could," "will," "should," "would," "expect," "plan," "intend," "anticipate," "believe," "estimate," "predict," "potential," "project" or "continue".

The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements:

●	The effectiveness and timeliness of our preclinical studies and clinical trials, and the usefulness of the data.

●	Our expectations regarding the timing and clinical development of our product candidates.

●	Our ability to achieve profitable operations and access to needed capital.

●	Fluctuations in our operating results.

●	The success of current and future license and collaboration agreements.

●	Our dependence on contract research organizations, vendors and investigators.

●	Effects of competition and other developments affecting development of products.

●	Market acceptance of our products.

●	Protection of intellectual property and avoiding intellectual property infringement.

●	Product liability.

●	Other factors described in our filings with the SEC.

We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. The risks set forth under Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 ~~2023~~ and subsequent quarterly reports on Form 10-Q describe major risks to our business, and you should read and interpret any forward-looking statements together with these risks. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements.

Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized, except as may be required by law.

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RISK FACTOR SUMMARY

The risk factors summarized below could materially harm our business, operating results and/or financial condition, impair our future prospects and/or cause the price of our common stock to decline. For more information, see “Item 1A. Risk Factors” in this Annual Report on Form 10-K for the year ended December 31, ~~2023~~ 2024.

Material risks that may affect our business, operating results and financial condition include, but are not necessarily limited to, the following:

Risks Related to Our Financial Position

●	We have incurred losses since inception and may never achieve or sustain profitability.

●	We will need substantial additional funding and cannot be certain that additional capital will be available.

● IfOur wefinancial ~~are~~situation ~~unable~~creates todoubt ~~raise~~as ~~substantial~~to ~~additional~~whether ~~capital,~~ we ~~may~~will be ~~forced~~able to ~~delay,~~continue ~~reduce~~as ora ~~eliminate~~going ~~some or all of our research programs, product development activities and commercialization efforts~~concern.

● Our financial situation creates doubt whether we will continue as a going concern.

Risks Related to our Business

● We have a limited operating history, which makes it difficult to evaluate our current business and future prospects.

● As a company, we have never commercialized a product.

● We must maintain quality controls and compliance with manufacturing standards.

● Our future success depends on our ability to retain our key executives and qualified personnel.

● We may experience difficulties in managing our growth, which could disrupt our operations.

● Our governing documents could limit our stockholders’ ability to obtain a favorable judicial forum for disputes.

● We are an emerging growth company, and we cannot be certain if the reduced reporting requirements make our shares less attractive to investors.

● We may be subject to securities laws claims regarding past disclosures.

● We face risks associated with increased political uncertainty.

Risks Related to our Product Candidates

●	Our tumor-specific cancer immunotherapy approach exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval.

● We face substantial competition from other pharmaceutical and biotechnology companies.

● Other existing or future technologies may provide significant advantages over our technologies.

● We may expend resources pursuing programs or products that may be less successful than others.

●	If we experience delays or difficulties in patient enrollment for clinical trials, our research and development efforts and the receipt of necessary regulatory approvals could be significantly delayed or prevented.

●	Delays in the commencement and completion of clinical trials could increase costs and delay or prevent regulatory approval and commercialization of our product candidates.

●	Our product candidates are in clinical development, and, as with any investigational therapy, there is a risk of adverse events, including serious adverse events (SAEs) or deaths.

●

We may be required to perform additional or unanticipated clinical trials to obtain approval or be subject to post-marketing testing requirements to maintain regulatory approval. If our immunotherapy candidates prove to be ineffective, unsafe or commercially unviable, our entire technology platform and pipeline would have little, if any, value.

● Results from preclinical studies and early-stage clinical trials may not be predictive.

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● ~~Preliminary~~Interim ~~interim~~ or “top-line” data that we announce may change as more data becomes available.

● Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any products that we develop alone or with collaborators.

● Our product candidates are complex and difficult to manufacture.

● If we are unable to obtain sufficient quantities of raw materials and supplies, at acceptable prices and on a timely basis, it could harm our business.

● The market opportunities for our product candidates may be smaller than we estimate.

Risks Related to Government Regulation

●	The U.S. Food and Drug Administration (the “FDA”) regulatory approval process is lengthy and time-consuming, and we may continue to experience significant delays.

●	We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates.

● ~~Our~~We expect that the product candidates ~~may~~we ~~cause~~develop ~~undesirable~~will ~~side~~be ~~effects~~regulated oras ~~have~~biological ~~other~~products, ~~properties~~or ~~that~~biologics, ~~delay~~and ortherefore ~~prevent~~they ~~their~~may ~~regulatory~~be ~~approval~~subject orto ~~limit~~competition ~~their~~sooner ~~commercial~~than ~~potential~~anticipated.

● We expect the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to competition sooner than anticipated.

● The regulatory landscape that will govern our product candidates is uncertain.

● The FDA may disagree with our plans, and we may fail to obtain regulatory approval of our product candidates.

● We may be unable to obtain orphan drug designation or to maintain the associated benefits.

● We may not be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

● Our products will be subject to ongoing regulatory obligations and continued regulatory review.

● Healthcare reform measures may have a material adverse effect on our product candidates’ commercial success.

Risks Related to Our Reliance on Third Parties

●	We depend on collaborations with third parties for certain research, development and commercialization activities, and if any such collaborations are not successful, it may harm our business and prospects.

● Our relationships with healthcare professionals, clinical investigators, Contract Research Organizations (“CROs”), and third-party payors may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws.

Risks Related to Intellectual Property

●	Patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our business position.

● Our ability to compete effectively in our markets may decline if we do not adequately protect our proprietary rights, and our proprietary rights do not necessarily address all potential threats to our competitive advantages.

● We could lose license rights that are important to our business if we fail to comply with our obligations in the agreements under which we license such intellectual property.

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

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

Risks Related to the Market for Our Common Stock

● Our common stock may be volatile or may decline regardless of our operating performance.

● If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the market price for the shares and trading volume could decline.

● We do not expect to pay dividends in the foreseeable future.

● Our stockholders may experience substantial dilution if we issue additional shares of our capital stock.

● We may issue additional debt and equity securities, which could materially adversely affect the market price of our common stock.

● Failure to meet listing requirements of OTCQB Market, LLC (“OTCQB”) could result in the delisting of our common stock, negatively impact the price of our common stock and negatively impact our ability to raise additional capital.

Risks Related to Going Concern and Bankruptcy

●	We may not be able to continue as a going concern and holders of our common stock could suffer a total loss of their investment.

●	In the event we pursue Bankruptcy Protection, we will be subject to the risks and uncertainties associated with such proceedings.

●

In the event we are unable to pursue Bankruptcy Protection under Chapter 11 of the United States Bankruptcy Code, or, if pursued, successfully emerge from such proceedings, it may be necessary to pursue Bankruptcy Protection under Chapter 7 of the United States Bankruptcy Code for all or a part of our businesses.

~~Risks~~PART ~~Related to Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure~~ I

●ITEM 1. ~~We are increasingly dependent on our information technology systems and infrastructure for our business~~BUSINESS.

~~● Any security breach of other incident, whether real or perceived, could cause us to suffer reputational damage.~~Overview

●Kiromic BioPharma, Inc. (the "Company" or “We”) is a clinical stage, fully integrated biotherapeutics company formed under the Texas Business Organizations Code in December 2012. We maintain offices in Houston, Texas. We have not generated any revenue to date.

~~ITEM~~We 1are an allogeneic Gamma Delta T-cell therapy company featuring unique, proprietary end-to-end bioinformatic, AI targeting and manufacturing technologies to address solid tumors. ~~BUSINESS~~Our end-to-end approach consists of target discovery and validation, product development, and on-site current Good Manufacturing Practices (“cGMP”) which we believe will allow us to leverage a new framework for the next generation of cell therapies.

~~Overview~~ 7

~~Kiromic~~ Table ~~BioPharma,~~of Inc. and subsidiaries (the “Company”) is a clinical stage, fully integrated biotherapeutics company formed under the Texas Business Organizations Code in December 2012. The Company maintains offices in Houston, Texas. The Company has not generated any revenue to date. Contents

~~The~~From ~~Company~~a isdevelopment anstandpoint, ~~allogeneic~~we ~~Gamma~~utilize ~~Delta~~innovative, Tnon-~~cell~~engineered ~~therapy~~and ~~company~~engineered ~~featuring~~allogeneic ~~unique,~~Gamma ~~proprietary~~Delta ~~end-to-end~~T ~~bioinformatic,~~(GDT) AIcell ~~targeting,~~technologies and ~~manufacturing~~are ~~technologies~~developing toproprietary, ~~address~~virus-free ~~solid~~cell ~~tumors.~~engineering ~~Our~~methods ~~end-~~to~~-end~~ ~~approach~~develop ~~consists~~novel oftherapies ~~target~~for ~~discovery~~solid ~~and~~tumors ~~validation,~~that ~~product development, and on-site current good manufacturing practices (“cGMP”), which~~ we believe will ~~allow~~be useffective toand ~~leverage a new framework for the next generation of cell therapies~~cost-efficient.

~~From~~We a development standpoint, we utilize innovative non-engineered and engineered Gamma Delta T cell (GDT) technologies and are developing proprietary, virus-free cell engineering methods to develop novel therapies for solid tumors that we believe will be effective and cost-efficient. DeltacelÔ (Deltacel) is our first allogeneic, off-the-shelf GDT cell-based product in Phase 1 clinical stage. Our ProcelÔ (“Procel”) and IsocelÔ (“Isocel”) product candidates consist of allogeneic, engineered, off-the-shelf CAR-GDT cells, and they are currently inhave ~~the~~three ~~preclinical development stage. Our Procel~~ product ~~candidate consists of engineered GDTs that target PD-L1. Our Isocel product candidate consists of~~ candidates:

71) Deltacel: Non-engineered GDT cell-based product, off-the shelf, expanded and activated with proprietary technology.

~~Table~~2) ofIsocel: ~~Contents~~GDTs engineered with an anti-Mesothelin isoform Chimeric Antigen Receptor.

~~engineered GDTs that target Mesothelin Isoform 2 positive tumors (“Iso-Meso”~~3). ~~Our~~Procel: ~~Deltacel~~GDTs ~~product candidate consists of non-~~engineered ~~GDTs~~with ~~which we expand, enrich, and activate ex- vivo through~~ a ~~proprietary process, and it is intended to treat solid tumors regardless of the specific tumor antigen expression. Procel consists of engineered GDTs targeting~~ PD-L1 ~~positive tumors, while Isocel consists of engineered GDTs targeting solid tumors expressing a tumor-specific variant (Isoform) of Mesothelin (“Iso-Meso”)~~Receptor.

WeOur ~~currently~~leading ~~have~~candidate ~~three~~is ~~product~~Deltacel™ ~~candidates:~~(“Deltacel”), which is currently in a Phase 1) ~~DeltacelÔ,~~clinical ~~non~~trial. We are evaluating Deltacel in combination with low-~~engineered~~dose ~~GDTs,~~targeted ~~expanded~~radiation ~~and~~for ~~activated~~patients with advanced ~~proprietary~~non-small ~~technology;~~cell 2lung cancer (“NSCLC”). ~~IsocelTM~~Depending on pre-clinical evidence, ~~GDTs~~ ~~engineered~~we ~~with~~may ansubmit ~~anti-Mesothelin~~one ~~isoform~~IND ~~Chimeric~~for ~~Antigen~~Isocel ~~Receptor;~~(“Isocel”) and 3one for Procel (“Procel”) ~~ProcelÔ~~, ~~GDTs~~ ~~engineered~~for a total of two new INDs to study our product candidates either with aor PDwithout low-1dose ~~switch receptor~~radiation.

We expect to have a total of five clinical programs to study our key product candidates:

1) Deltacel-01: This ~~phase 1~~ clinical trial is active and is evaluating Deltacel in combination with low-dose targeted radiation for patients with advanced non-small cell lung cancer (NSCLC). Deltacel was granted Fast-Track Designation (“FTD”) status by the FDA in August 2024. This trial entered the second part, dose-expansion phase, in September 2024.

2) ~~Isocel combination~~Alexis-ISO-1: This ~~phase 1~~ clinical trial iswill ~~expected to~~ evaluate Isocel in ~~combination with low-dose radiation for~~ patients with Mesothelin Isoform 2 positive solid malignancies.

3) Alexis-~~ISO~~PRO-1: This ~~phase 1~~ clinical trial iswill ~~expected to~~ evaluate ~~Isocel~~Procel in patients with ~~Mesothelin~~PD-L1 ~~Isoform 2~~ positive solid malignancies.

4) ~~Procel~~Isocel combination: This ~~phase 1~~ clinical trial iswill ~~expected to~~ evaluate ~~Procel~~Isocel in combination with low-dose radiation for patients with ~~PD-L1~~Mesothelin Isoform 2 positive solid malignancies.

5) ~~Alexis-PRO-1~~Procel combination: This ~~phase 1~~ clinical trial iswill ~~expected to~~ evaluate Procel in combination with low-dose radiation for patients with PD-L1 positive solid malignancies.

The Company is developing a novel and virus-independent engineering method, which will result in the submission of new IND applications (clinical programs 2, 3, 4 and 5). These applications are expected to be ready for submission to the FDA in the first half of 2025, subject to sufficient financing to support the progression of the developments of those additional clinical trial candidates. Depending on evidence from preclinical studies, we may limit the new IND submission to two instead of four: one for Isocel and one for Procel. 8

We Table ~~submitted the IND for the Deltacel trial on March 31, 2023, and we began the activation~~ of the clinical trial process during the second quarter of 2023. In December 2023, we entered the enrollment phase and are currently conducting part 1 (dose escalation) of the study. On October 23, 2023, we entered into a clinical trial agreement with Beverly Hills Cancer Center (BHCC) to conduct our Deltacel-01 Phase 1 Study in patients with stage 4 Non-Small Cell Lung Cancer (NSCLC). Lung cancer counts more than 2 million new diagnoses globally each year and is almost three times as deadly as breast and ovarian cancers. On December 13, 2023, the first patient in the Deltacel-01 trial received the first dose of Deltacel at BHCC. We report no dose-limiting toxicities to date and a favorable preliminary outcome showing stabilization of disease at the 6-week follow-up, and a reduction of the tumor lesion at the two-month follow-up. As we continue to monitor this patient, we enrolled two additional patients at BHCC. On February 28, 2024, we activated a second clinical trial site with Virginia Oncology Associates, PC in our Deltacel-01 Phase 1 Study, where patient enrollment is expected to begin in April 2024. Also, we plan to open the study at one additional clinical site by the end of March 2024.Contents

We plan to continue the development of Isocel and Procel, and we expect to be able to be beginning the activation process for clinical programs 2 to 5 by the first half of 2025, subject to obtaining sufficient financing to support the progression of the development of these additional clinical trial candidates.Deltacel

Deltacel is our first off-the-shelf, non-engineered GDT cell-based product currently in a Phase 1 clinical trial. Our Deltacel product candidate consists of non-engineered GDTs which we expand, enrich, and activate ex-vivo through a proprietary process, and is intended to treat solid tumors regardless of the specific tumor antigen expression.

~~From~~In athe ~~target~~second ~~discovery~~half ~~standpoint~~of 2022, ~~our~~we ~~proprietary~~started ~~target~~the ~~discovery~~development ~~engine~~of isDeltacel ~~called~~based ~~"Diamond."~~on ~~The Diamond platform is~~ a ~~suite~~proprietary methodology of ~~data~~expanding ~~mining algorithms that identify cancer-specific immunotherapy targets~~ and AIactivating ~~models~~GDT ~~that~~cells ~~evaluate~~from ~~the~~healthy ~~quality of potential targets~~donors. We ~~believe~~submitted ~~that~~the ~~Diamond~~IND ~~dramatically~~application ~~accelerates~~for the ~~development~~Deltacel-01 oftrial ~~live~~in ~~drug~~March ~~technologies~~2023. byOn ~~quickly~~April ~~locating~~28, ~~rare~~2023, ~~cancer-specific~~the ~~targets~~FDA inauthorized ~~vast~~us ~~databases~~to ofproceed ~~billions~~with ofthe ~~genomic~~study. ~~datapoints~~We ~~and~~began ~~by applying~~ the ~~latest~~clinical intrial ~~machine~~activation ~~learning~~process ~~methods~~during tothe ~~eliminate~~second ~~targets~~quarter ~~likely~~of to2023. ~~fail~~On ~~prior~~October to23, ~~costly~~2023, ~~laboratory~~we ~~validation~~entered ~~and~~into ~~development. From~~ a ~~development~~clinical ~~standpoint,~~trial ~~Kiromic~~agreement ~~utilizes~~with ~~innovative~~Beverly ~~engineered~~Hills ~~GDT~~Cancer ~~manufacturing~~Center ~~technologies~~(BHCC) ~~and~~to isconduct ~~developing~~our ~~proprietary, virus~~Deltacel-~~free~~01 ~~engineering~~Phase ~~tools,~~1 toStudy ~~develop~~in ~~novel~~patients ~~therapies~~with ~~for~~stage ~~solid~~4 ~~tumors~~Non-Small ~~that~~Cell ~~will~~Lung beCancer ~~effective and~~ (NSCLC).

8On December 11, 2023, the first patient started treatment in the Deltacel-01 trial BHCC. As of January 31, 2025, ten patients have been enrolled in the Deltacel-01 clinical trial (see Clinical Update section for details). Additionally, we have registered a 6-month median Progression Free Survival (PFS) with a median length of follow-up of over 10 months and the longest PFS of 12 months, which is the maximum length of time patients are monitored after receiving our treatment.

~~Table~~None of ~~Contents~~the enrolled patients developed a dose-limiting toxicity. The Deltacel-01 study consists of two parts:

~~cost-efficient.~~1) ~~Our~~Part ~~Allogeneic~~1 ~~Lead~~is ~~Exogenous~~designed ~~Isoforms~~to ~~(“ALEXIS”)~~identify ~~platform~~the ~~consists~~optimal dose of ~~allogeneic cell therapy products~~Deltacel, ~~currently~~following inrecommendation by the ~~pre-Investigational~~Safety ~~New~~Monitoring ~~Drug~~Committee ~~development stage. Investigational New Drug~~ (“~~IND~~SMC ”) ~~application enabling, non-clinical pharmacology studies are supportive for the GDT-based therapy~~.

~~Our~~2) ~~ALEXIS-PRO-1~~Part ~~trial~~2 ~~candidate~~(“the isExpansion ~~our~~Phase ~~allogeneic~~”) ~~GDT~~is ~~therapy~~designed ~~product~~to ~~targeting~~further ~~PD-L1.~~assess ~~Our~~the ~~ALEXIS-ISO-1 trial candidate is our allogeneic GDT~~ therapy’s ~~product~~effectiveness ~~targeting~~at anthe ~~isoform~~optimal ofdose ~~Mesothelin~~identified ~~that~~in isPart ~~preferentially present on tumor cells, namely Mesothelin Isoform 2 (“Isomeso”)~~1.

~~From~~Based aon ~~manufacturing~~the ~~standpoint,~~promising ~~Kiromic~~survival ~~uses~~benefits in~~-house~~ ~~R&D~~the ~~laboratory~~absence ~~facilities,~~of ~~current~~limiting ~~good~~toxicities, ~~manufacturing~~we ~~practices~~activated ~~(“cGMP”)~~the ~~production~~Expansion ~~facilities~~Phase ~~for~~in ~~cell~~September ~~manufacturing~~2024, ~~with dedicated on-site quality control~~ and ~~environmental~~the ~~monitoring~~first ~~laboratories,~~patient ~~which~~in wethis ~~believe~~phase ~~will~~started ~~ensure~~treatment ~~rapid~~in ~~discovery,~~October ~~validation,~~2024. ~~development~~We ~~and~~expect a ~~streamlined~~total ~~clinical~~of ~~product~~approximately ~~release.~~9 Wepatients ~~believe~~will ~~that~~be ~~our~~enrolled ~~allogeneic,~~in ~~off-~~the~~-shelf~~ ~~(“OTS”)~~expansion ~~manufacturing~~phase, ~~process~~and that enrollment will ~~result~~be incompleted ~~short~~by ~~lead~~March ~~times~~2025 ~~and~~(subject ~~low~~to ~~costs~~change, ~~opening~~depending upon ~~opportunities~~actual ~~for~~patients' ~~outpatient~~accrual ~~treatment~~at each clinical site).

~~Target~~On ~~Discovery:~~October ~~Diamond~~1, ~~(Identify~~2024, ~~Screen~~based upon our insights from the favorable results of the first phase of our trial, ~~Prioritize)~~we submitted an IND protocol amendment to the FDA that includes changes in the study that we believe can further improve our therapeutic approach and the benefits for the patients, and to shorten the follow-up time from 24 to 12 months for each patient. The changes became effective on November 1, 2024.

~~Diamond~~Depending ~~addresses~~on the ~~main~~response ~~challenges~~rates inregistered ~~today's~~during ~~clinical~~our ~~pipeline:~~Deltacel-01 ~~target~~Phase ~~identification,~~1 ~~patient~~clinical ~~stratification~~trial, ~~and~~in ~~donors’~~the ~~selection.~~second half of 2025 we may be able to initiate a pivotal Phase 2 trial to support a Biologics License Application (BLA) to accelerate the clinical development of Deltacel.

Target Discovery: Diamond (Identify, Screen, Prioritize)

~~Successful~~Diamond ~~development~~addresses ofthe ~~precision~~main ~~immunotherapies~~challenges ~~requires~~in atoday's ~~distinguishing~~clinical ~~feature~~pipeline: oftarget ~~tumor cells~~identification, apatient ~~target. The~~stratification, ~~target must be common on tumor cells but not on normal cells. It also must be accessible~~ and ~~able to trigger an effective immune response~~donor selection. ~~It is both critical and extremely difficult to find good immunotherapy targets.~~

~~Kiromic’s~~Successful ~~Diamond~~development ~~does~~of ~~just~~precision ~~that.~~immunotherapies ~~Diamond~~requires isa andistinguishing ~~integrated~~feature ~~suite~~ of ~~data~~tumor ~~mining~~cells, ~~and~~a ~~AI algorithms that can identify and validate novel cancer immunological targets~~target. The ~~targets~~target itmust ~~identifies~~be ~~are~~common ~~segments~~on ~~of cell surface proteins (peptides) that are specific to~~ tumor cells ~~and~~but ~~that~~not ~~can~~on benormal ~~bound by immune T~~ cells ~~or B cells~~. ~~Diamond~~ ~~generates~~It aalso ~~prioritized~~must ~~list~~be ofaccessible ~~cancer~~and ~~immunological~~able ~~targets. These targets can be used~~ to ~~create~~trigger ~~therapies~~an ~~such~~effective asimmune ~~antibody~~response. ~~therapies,~~It Tis ~~cell~~both ~~therapies,~~critical ~~Chimeric~~and ~~Antigen~~extremely ~~Receptor~~difficult Tto ~~cell~~find ~~(“CAR-T~~good ~~cell”)~~immunotherapy ~~therapies and vaccine therapies~~targets.

Diamond ~~has~~is aour ~~large~~Artificial ~~and~~Intelligence ~~growing~~platform ~~database~~for ofthe ~~genomics,~~identification ~~proteomics,~~and ~~cytometry,~~prioritization ~~demographics,~~of 3Dthe ~~structures,~~next ~~and~~generation ~~gene~~of ~~models and annotations~~biomarkers. ~~The~~ ~~data~~Cancer ~~base~~immunotherapy has ~~approximately~~recently 2delivered ~~billion~~impressive ~~data~~results. ~~points~~However, ~~and~~major isroadblocks anprevent ~~integrated~~the ~~collection~~deployment of ~~large~~immune-oncology ~~public~~approaches ~~consortium~~to ~~datasets~~the ~~and~~majority ~~Kiromic~~of ~~proprietary~~cancer ~~study~~patients, ~~data. The~~especially ~~data~~those ~~covers~~with 38solid ~~types~~tumors. ofChimeric ~~cancer~~antigen ~~and~~receptor 47(CAR) ~~types~~T-cell oftherapies, ~~normal~~for ~~human~~example, ~~tissue~~are ~~with~~far ~~hundreds~~from ofbeing ~~samples~~successfully ~~and millions of datapoints for each~~implemented.

WeA ~~believe~~bottleneck ~~that~~in ~~the~~modern ~~Diamond~~immunotherapy ~~data~~of ~~mining~~cancer ~~tools~~is ~~drive~~the ~~discovery~~identification byof ~~sifting~~molecules ~~these~~that ~~billions~~allow effective targeting of ~~data~~the ~~points~~tumor towhile ~~identify~~leaving ~~rare~~normal ~~cancer~~tissues untouched. Historically, all major clinical developments have been focusing on tumor-~~specific~~associated ~~immunotherapy~~antigens ~~targets~~(TAA). ~~Diamond~~The AIlandscape ~~predictions~~of ~~then~~TAAs, ~~validate~~however, ~~targets~~is torestricted, ~~find~~with ~~those~~TAAs ~~that~~limited ~~are~~to ~~most~~cancer/testis ~~likely~~antigens, towhich beshowed ~~stably~~promising ~~presented~~pre-clinical onand ~~the~~clinical ~~surface~~results ofbut ~~tumor~~are ~~cells~~targetable ~~and~~in ~~that~~only ~~have~~a ~~strong~~limited ~~immunological~~number ~~binding~~of ~~properties~~malignancies. We ~~believe~~Furthermore, ~~that~~ the ~~predictions~~magnitude ~~speed~~of ~~development~~the ~~and~~immune ~~reduce~~response ~~costs~~against byhyper-expressed ~~quickly~~antigens ~~eliminating~~is ~~targets~~hindered ~~that~~by ~~would~~the ~~likely~~general ~~fail~~low ~~later~~affinity inof ~~laboratory~~T-cell ~~validation~~receptors or(TCRs) ~~development~~for self-antigens.

9Recent efforts have, therefore, been directed towards the discovery and validation of neoantigens that arise from mutations in cancer cells. Emerging alternatives to neoantigens are mutational hotspot antigens and cancer-specific isoforms of widespread proteins.

~~Table~~To overcome the problem of ~~Contents~~identifying shared “common” cancer-specific antigens derived from alternative splicing and cancer-specific isoforms formation, Kiromic Biopharma has also developed a fully integrated in silico prediction model of cancer-specific isoforms.

~~Most~~Diamond ~~damaged~~allows ~~cells~~for ~~are quickly identified and eliminated by~~ the ~~immune~~prediction ~~system. Damaged cells that become cancer are those that acquire changes, allowing them to evade the immune system~~ and toprioritization ~~proliferate. One~~of ~~common~~isoantigens ~~change~~which ofcould ~~this~~serve ~~type~~as isa annovel ~~alteration~~source of ~~messenger~~tumor ~~RNA~~targets, ~~(“mRNA”)~~highly ~~splicing~~specific ~~patterns. Changes~~for inneoplastic ~~mRNA~~cells ~~splicing~~but ~~lead~~without ~~to altered proteins (isoforms) that provide selective advantages to~~ the ~~tumor~~drawback ~~cells~~of ~~but~~being ~~also~~highly ~~provide~~patient-specific ~~potential~~ as ~~cancer-specific~~the ~~immunotherapy~~aforementioned ~~targets~~neoantigens.

ToDiamond ~~solve~~allows the ~~problem~~user ofto ~~identifying~~select ~~common~~a ~~cancer-specific~~TCGA ~~antigens~~tissue ~~derived~~type ~~from~~along ~~alternative~~with ~~splicing~~thresholds for filtering isoforms (minimum tumor TPM, wemaximum ~~have~~normal ~~developed~~TPM). aBased ~~fully~~on ~~integrated~~the intissue ~~silico~~selected, ~~methodology~~it todisplays ~~predict~~a ~~cancer-specific~~sorted list of isoforms with the strongest tumor to normal differences. Differential analysis is performed and used to generate types of lists:

~~Diamond allows for the prediction and prioritization of iso-antigens which are~~ a) ~~novel~~Isoforms ~~source~~expressed ofin ~~tumor~~tumors ~~targets, highly specific for neoplastic cells~~ but ~~without~~not ~~the~~expressed ~~drawback~~in ofnatural ~~also~~counterparts, ~~being highly patient-specific.~~and;

~~Diamond~~b) ~~analyzes~~Isoforms ~~tens of thousands of isoforms from 10,000+ tumor samples and 7,000+ normal samples to create a rank order list of isoforms that are strongly~~ expressed inat ~~tumor~~much ~~but~~higher ~~not~~levels in ~~normal~~tumors ~~samples.~~than Itnatural ~~supports identification of targets for specific tumor types, sub-populations of patients, or cross-tumor type targets~~counterparts. In each case, tumor expression is compared to all profiled normal tissues. Diamond can distinguish splicing alterations that lead to unique protein regions or unique protein sequence junctions. The unique regions are the basis for identification of a target peptide. Diamond can also refine results to focus on just proteins that are presented on the surface of cells.

~~After~~Diamond athen ~~prioritized~~allows ~~list~~the ofuser ~~cancer-specific~~to ~~protein~~click ~~isoforms~~on isan ~~developed~~isoform byin ~~our~~the ~~data~~list ~~mining~~to ~~tools,~~select a specific ~~target~~isoform ~~peptide must be selected and targets must be vetted with in-silico methods~~ to ~~quickly~~display ~~eliminate those likely to fail later~~ in ~~development.~~a ~~The~~detailed ~~Diamond~~panel, ~~platform~~which ~~includes~~shows athe ~~suite~~multi-sequence ofalignment ~~AI,~~for ~~machine~~the ~~learning~~isoform ~~models~~and ~~that~~all ~~assist~~the inother ~~selection~~isoforms of the ~~most promising targets~~gene. ~~These include:~~

~~Transmembrane~~Finally, ~~prediction. Immunotherapies~~Diamond ~~like~~also ~~CAR-T~~shows ~~cell~~a ~~therapies~~box ~~work~~plot ~~optimally~~by ontissue ~~proteins~~of ~~with~~expression ~~cancer-specific alterations~~ of ~~cell~~the ~~surface~~isoform ~~proteins. Generally,~~in ~~cell~~normal ~~surface~~TCGA ~~proteins~~tissue ~~have~~and a ~~portion~~box ~~that~~plot ~~stays~~of ~~inside~~ the ~~cell~~matching ~~(cytoplasmic),~~isoform ain ~~portion~~the ~~that~~GTEX ~~crosses~~normal ~~the~~data. ~~cell~~The ~~membrane~~sequence ~~(transmembrane),~~of ~~and~~amino aacids ~~portion~~ that is ~~outside~~specific ~~on the cell’s surface (extracellular). A good target~~ for ~~CAR-T cells needs to be on~~ the ~~extracellular~~selected ~~portion of a protein that is altered by~~ cancer ~~but~~isoforms ~~that~~ is ~~not~~then sodirectly ~~dramatically~~fed ~~altered~~to ~~that it is no longer a transmembrane protein. A~~ Diamond™'s ~~machine~~artificial ~~learning~~neural ~~model~~capsule ~~trained~~network onfor ~~the~~peptide ~~properties~~design ofand ~~transmembrane~~prioritization ~~proteins~~across isall ~~used~~major toHLA-A, ~~ensure~~HLA-B, ~~that~~and ~~these~~HLA-DRB1 ~~criteria are met~~alleles.

~~Protein~~Diamond ~~Structure~~has ~~prediction. Diamond~~a ~~leverages~~large ~~the~~and ~~latest~~growing ~~advances~~database inof genomics, proteomics, cytometry, demographics, 3D ~~protein~~structures, ~~folding~~and /gene ~~structure~~models ~~prediction~~and ~~using~~annotations. ~~deep~~The ~~neural~~database ~~networks~~has toapproximately ~~model~~2 ~~the~~billion ~~shape~~data points and is an integrated collection of ~~cancer-specific~~large ~~protein~~public ~~alterations~~consortium datasets and Kiromic proprietary study data. The ~~predicted~~data ~~structure~~covers is38 ~~used~~types toof ~~evaluate~~cancer ~~the~~and ~~stability~~47 types of ~~the~~normal ~~altered~~human ~~protein~~tissue ~~and~~with ~~the~~hundreds ~~accessibility~~of samples and millions of ~~potential~~datapoints ~~targets~~for each.

~~Proteomic~~We ~~validation.~~ believe that the Diamond ~~includes~~data amining ~~database~~tools ofdrive ~~mass~~discovery ~~spectrometry~~by ~~proteomic~~sifting ~~data~~these ~~that~~billions ~~was~~of ~~reprocessed~~data points to ~~broadly~~ identify ~~protein~~rare ~~fragments~~cancer-specific ~~from~~immunotherapy ~~alternative~~targets. ~~gene~~Diamond ~~isoforms. This~~AI ~~data~~predictions ~~can~~then invalidate ~~some~~targets ~~cases~~to befind ~~used~~those that are most likely to ~~validate~~be stably presented on the surface of tumor cells and that ~~cancer-specific~~have ~~alterations~~strong ~~present~~immunological inbinding ~~the~~properties. ~~transcriptome~~We dobelieve ~~in-fact~~that ~~result~~the inpredictions ~~production~~speed ofdevelopment ~~altered~~and ~~proteins~~reduce costs by ~~the~~quickly ~~tumor~~eliminating ~~cells~~targets that would likely fail later in laboratory validation or development.

Research assistant. Even with many AI tools assisting in target selection, skilled human researchers still need to perform detailed investigation of potential targets. Many of these tasks are repetitive and time consuming so Diamond includes an automated assistant that speeds up this research by gathering relevant publications, figures, gene annotations, and connections to useful external tools. 9

~~The~~ Table Diamond platform is now developed entirely by Kiromic’s in-house bioinformatics group who interact regularly with Kiromic researchers selecting targets and designing therapies. This close, responsive collaboration allows for rapid evolution and improvement of the system in meeting research needs. Further, the system has been reconstructed to have a modular, pluggable architecture that is able to quickly accommodate advances in scientific or computational methods as well as new immunotherapy designs. Contents

WeDevelopment: ~~have~~Using ~~made~~Engineered ~~significant~~Allogeneic ~~progress in the use of bioinformatics data to develop a simple test which will allow us to pre-screen donors with the goal to identify those whose~~ GDT ~~cells~~Based ~~have the most efficient expansion and activation potential. This will further reduce the costs of manufacturing by making our proprietary process more efficient.~~Therapies

InAfter ~~addition,~~Diamond weallows ~~are~~us ~~developing~~to aidentify ~~third~~targets ~~module~~on ofsolid ~~the~~tumors, ~~Diamond~~we ~~platform~~seek to ~~predict~~use ~~which~~those ~~patients~~targets ~~will~~to ~~best~~train ~~respond~~immune tocells. ~~our~~The ~~GDT~~trained ~~cell~~immune ~~therapies~~cells generate a therapeutic immune response in patients. ~~This~~These ~~will~~peptide ~~allow~~sequences, usknown toas ~~personalize~~tumor-specific ~~the~~iso-antigens ~~treatment~~(“TSIAs”), ~~approach~~generate ~~depending~~an onimmunological ~~the~~response ~~patient’s~~and ~~tumor~~therefore ~~features~~eradicate cancer cells.

Our goal is to defeat cancer by developing immunotherapies that rely on improving target discovery and validation. With better targets, we believe that our therapies will be more effective than the current crop of immunotherapies using older targets.

10Next Generation Allogeneic Therapy Summary

~~Table~~We ofbelieve ~~Contents~~that our Next Generation Allogeneic Approach results in the following:

~~Development~~1. Addressing a Growing Market: ~~Using~~Solid ~~Engineered~~tumors ~~Allogeneic~~represent ~~GDT~~approximately ~~Based~~90% ~~Therapies~~of new cases according to the American Cancer Society. We believe that our therapies can address a significant contingency of these cases.

~~After~~2. ~~Diamond~~Exploitation ~~allows~~of usGDT’s toNatural ~~identify~~Potency: ~~targets~~Further, onby ~~solid~~using ~~tumors~~GDT, we ~~seek~~believe tothat ~~use~~our ~~those~~trial ~~targets~~candidates tocan ~~train~~achieve ~~immune~~superior ~~cells.~~safety ~~The~~and ~~trained~~superior ~~immune~~efficacy ~~cells~~based ~~generate~~on aour ~~therapeutic immune response in patients. These peptide sequences, known as tumor~~pre-~~specific~~clinical ~~iso-antigens (“TSIAs”), generate an immunological response and therefore eradicate cancer cells~~results.

~~Our~~We ~~goal~~are ~~is to defeat cancer by~~ developing ~~immunotherapies~~our ~~that~~brand ~~rely~~of cell onproduct ~~improving~~candidates ~~target~~designed ~~discovery~~to ~~and~~treat ~~validation.~~cancer ~~With~~by ~~better~~capitalizing ~~targets,~~on ~~we believe that our therapies will be more effective than~~ the ~~current~~immune ~~crop~~system's ofability ~~immunotherapies~~to ~~using~~destroy ~~older~~cancer ~~targets~~cells.

~~Next~~The ~~Generation~~following ~~Allogeneic~~presents ~~Therapy~~a ~~Summary~~detailed explanation of each component listed above:

WeAddressing ~~believe~~a ~~that~~Growing ~~our~~Target ~~Next~~Market ~~Generation Allogeneic Approach results in the following:~~

1.The ~~Addressing~~global aT ~~Growing~~cell ~~Market:~~therapy ~~Solid~~market ~~tumors~~is ~~represent~~expected ~~approximately~~to ~~90%~~grow ~~of new cases according~~ to ~~the~~over ~~American~~$33B ~~Cancer~~by ~~Society~~20271. WeCurrently ~~believe~~approved ~~that~~cell ~~our~~ therapies ~~can~~only address ahematological ~~significant~~malignancies, ~~contingency~~while 90% of ~~these~~newly ~~cases~~diagnosed cancers per year are solid tumors, which our pipeline is designed to address2.

2.We ~~Targeting~~believe ~~Antigen~~that ~~Escape~~the byoverall ~~Targeting~~global PDCAR-~~L1:~~T ~~Similarly~~cell therapy market could surpass the estimated $33 billion by 2027. Additionally, ~~since~~by ~~many~~focusing ~~solid~~on ~~tumors~~an ~~have~~allogeneic approach, we believe that we can provide a ~~wide~~simplified ~~expression~~and ofefficient ~~PD-L1~~supply chain with improved product availability compared to the autologous therapies. WeAllogeneic CAR-T cell therapies involve engineering healthy donor T cells, which we believe ~~that~~will ~~our~~allow ~~ALEXIS~~for the creation of an inventory of off-~~PRO~~the-1shelf ~~trial~~(“OTS”) ~~candidate~~products that can ~~effectively~~be ~~treat~~delivered ~~most~~to ~~solid~~a ~~cancers~~larger portion of eligible patients throughout the world.

3.Allogeneic ~~Exploitation~~engineered ofT ~~GDT’s~~cells ~~Natural~~are ~~Potency~~manufactured in a similar manner as autologous, but with two key differences: ~~Further~~(i) allogeneic T cells are derived from healthy donors, bynot ~~using~~cancer ~~GDT~~patients, weand ~~believe~~(ii) ~~that~~allogeneic ~~our~~T ~~trial~~cells ~~candidates~~have ~~can~~a ~~achieve~~decreased ~~superior~~risk ~~safety~~of ~~and~~GvHD, ~~superior~~a ~~efficacy~~condition ~~based~~where onT ~~our~~cells ~~pre-clinical~~recognize ~~results~~the patient's normal tissues as foreign and cause damage to the patient.

WeFirst, ~~are~~we ~~developing~~plan ~~our~~to ~~brand~~study ofnon-engineered ~~CAR~~T-cells ~~cell~~in ~~product~~the ~~candidates~~Deltacel ~~designed~~clinical totrial. ~~treat~~This ~~cancer~~will byallow ~~capitalizing~~us onto better establish the ~~immune~~efficacy ~~system's~~and ~~ability~~tolerability toof ~~destroy~~our ~~cancer~~unique GDT cells., ~~These~~which ~~products~~are derived from healthy donors and are expanded and activated in vitro through a proprietary methodology. Moreover, Deltacel will allow us to move into the ~~pre-IND~~clinical ~~stage~~arena offaster than Procel and Isocel, considering the ~~FDA~~following ~~clinical~~advantages ~~trial~~of ~~process.~~non-engineered GDT cells:

~~The~~Deltacel ~~following~~targets ~~presents~~are ashared ~~detailed~~by ~~explanation~~multiple solid tumors; simplified manufacturing due to absence of ~~each~~T ~~component~~cell ~~listed~~engineering; ~~above:~~reduced risk of on-target off-tumor tox; allogeneic and off-the-shelf (cryopreserved).

~~Addressing~~In aaddition, ~~Growing~~Deltacel ~~Target~~development ~~Market~~will allow us to acquire manufacturing and clinical experience to support more complex products, such as Procel and Isocel.

~~CAR-T~~1. ~~cell~~Global ~~therapy,~~CAR aT-Cell ~~form~~Therapy ~~of cancer immunotherapy~~Market, ~~has~~By ~~recently~~Product ~~emerged as a revolutionary and potentially curative therapy for patients with hematologic cancers~~Type, ~~including~~By ~~refractory~~Tumor ~~cancers. In 2017~~Type, ~~two~~By ~~autologous anti-CD19 CAR-T cell therapies~~Indication, ~~Kymriah,~~By ~~developed~~Treatment ~~by Novartis International AG~~Type, ~~and~~By ~~Yescarta,~~Targeted ~~developed by Kite Pharma~~Antigen, ~~Inc.,~~ ~~(now~~By ~~part~~End ~~of Gilead)~~User, ~~were~~By ~~approved by the FDA for the treatment of relapsed/recurrent B cell precursor acute lymphoblastic leukemia and relapsed/recurrent large B cell lymphoma~~Region, ~~respectively. Autologous CAR-T cell therapies are manufactured individually for the patient's use by modifying the patient's own T cells outside the body~~Competition, ~~causing~~Forecast ~~the T cells to express CARs. The entire manufacturing process is dependent on the viability of each patient's T cells~~ and ~~takes~~Opportunities, ~~approximately three to four weeks.~~ 2017-2027

~~It’s~~2. ~~important~~American toCancer ~~note that the aforementioned therapies were for only hematological indications. Currently~~Society, ~~these~~Cancer ~~indications~~Facts ~~represent~~& ~~about 10% of new cases~~Figures, ~~while solid cancers comprise approximately 90% of new cases~~2022. https://www.cancer.org/research/cancer-facts-statistics.html

Further, we believe that the overall global CAR-T cell therapy market could expand to more than $33 billion by 2027. Additionally, by focusing on an allogeneic approach, we believe that we can provide a simplified and efficient supply chain with improved product availability compared to the autologous therapies. Allogeneic CAR-T cell therapies involve engineering healthy donor T cells, which we believe will allow for the creation of an inventory of OTS products that can be delivered to a larger portion of eligible patients throughout the world. 10

~~Allogeneic~~ Table engineered T cells are manufactured in a similar manner as autologous, but with two key differences: (i) allogeneic T cells are derived from healthy donors, not cancer patients, and (ii) allogeneic T cells have a decreased risk of ~~GvHD, a condition where T cells recognize the patient's normal tissues as foreign and cause damage to the patient.~~Contents

~~First,~~Development we plan to study non-engineered T-cells in the Deltacel clinical trial. This will allow us to better establish the efficacy and tolerability of our unique GDT cells, which are derived from healthy donors and are expanded and activated in vitro through a proprietary methodology. Moreover, Deltacel will allow us to move into the clinical arena faster than Procel and Isocel, considering the following advantages of non-engineered GDT cells:Plan

Deltacel ~~targets~~is ~~are~~currently ~~shared~~being bystudied ~~multiple~~in ~~solid~~a ~~tumors;~~Phase ~~simplified~~1, ~~manufacturing~~First-in-Human, ~~due~~Open-label, toDose ~~absence~~Escalation ofStudy Tfor ~~cell~~patients with ~~engineering;~~Stage ~~reduced~~4 ~~risk~~or oflocally onadvanced non-~~target~~small ~~off-tumor~~cell ~~tox;~~lung ~~allogeneic~~cancer ~~and~~(NSCLC). ~~off-~~In this trial, the product candidate, KB-~~shelf~~GDT-01, ~~(cryopreserved)~~is studied in combination with low dose radiotherapy.

InThe ~~addition~~primary goal is to assess safety, ~~Deltacel~~tolerability and ~~development~~preliminary ~~will~~efficacy ~~allow~~of usKB-GDT-01 at increasing dose levels in order to ~~acquire~~estimate ~~manufacturing~~the ~~and~~recommended ~~clinical~~Phase ~~experience~~2 dose (“RP2D”). The RP2D was identified in September 2024, when the SMC recommended to ~~support~~initiate ~~more~~the ~~complex~~dose ~~products~~expansion phase, ~~such~~which asis ~~Procel~~currently ongoing with the scope of confirming tolerability data and ~~Isocel.~~further investigating the therapy’s efficacy in a total of 9 additional patients

11As of February 7th, 2025, we have enrolled 4 of the 9 additional patients, and we expect to complete enrollment in this phase by March 2025 (subject to change, depending on actual patient accrual at each clinical site). Based on the long-term follow-up data from the Deltacel-01 trial, around June 2025, we plan to seek feedback from the FDA regarding the design of the pivotal Phase 2 trial. We think that such a trial could represent the basis for a BLA application in 2027. At the same time, in the second half of 2025, we may be in the position to submit a breakthrough therapy designation (“BTD”) application.

~~Table~~By the end of ~~Contents~~2025, we expect to have obtained sufficient data to support the submission of the IND for the pivotal Deltacel phase 2 trial and the IND for Isocel (subject to obtaining sufficient financing to support the continuation of Isocel development). Isocel will be studied alone or in combination with low-dose radiation for subjects with Mesothelin Positive Metastatic or Progressive Locally Advanced Solid Malignancies.

~~Thwarting~~Procel ~~Antigen~~will ~~Escape~~be bystudied ~~Targeting~~in a Phase 1, First-in-Human, Open-label, Dose Escalation Study of an Allogeneic Gamma Delta PD1 T Cell Switch Receptor Therapy (KB-PD1) for subjects with PD-L1 Positive Metastatic or Progressive Locally Advanced Solid Malignancies. Similar to Isocel, Procel will also be studied alone or in combination with low-dose radiation.

ToPrior ~~further~~to ~~boost the potency of our effector cells~~treatment, weall ~~have~~patients ~~developed~~are anexpected ~~off~~to ~~the~~undergo ~~shelf~~selected ~~chimeric~~screening ~~gamma~~process ~~delta~~in ~~PD1~~order Tto ~~cell~~assure ~~switch receptor therapy~~ that ~~interferes~~they ~~with~~meet all the ~~inhibitory~~corresponding ~~"checkpoint"~~inclusion ~~protein,~~and ~~PD-L1,~~exclusion ~~found~~criteria ~~on most tumor cells~~ and ~~cells~~are ofexpressing the ~~tumor~~intended ~~microenvironment~~targets (~~“TME”). We believe that most solid cancers such as lung~~Iso-MESO, ~~melanoma,~~defined ~~gastric,~~below ~~esophagus,~~or ~~colorectal, breast, prostate, liver, urothelial, renal, cervical, and head and neck can potentially now be effectively treated by targeting the checkpoint inhibitor~~ PD-L1). By converting what is normally an inhibitory signal into an activating signal, we predict that this will overcome the resistance of the TME and mitigate the issue of antigen loss typically seen with solid malignancies.

WeThe ~~believe~~development ~~our~~of ~~engineered~~both ~~GDTs significantly enhance the immune response. First~~technologies, itincluding ~~blocks~~ the ~~ability~~submission of ~~checkpoint~~their ~~like~~IND ~~PD-L1~~applications, ~~from~~and ~~inactivating~~their aadvancement ~~T cell (similar~~ to ~~checkpoint~~clinical ~~inhibitors).~~stage ~~Second, engineered GDTs~~ are ~~now~~subject ~~able~~ to ~~kill~~sufficient ~~cancer cells with enhanced potency upon binding with the PD-L1 receptor~~financing.

~~The chPD1 Receptor is activated by engagement with PD-L1+ (or even PD-L2+) tumors.~~ 11

~~Typical~~ Table ~~checkpoint~~of inhibitors block PD-1 and PD-L1, although they have limitations since they do nothing to actually activate/energize the T cell into action, and since typically the subject’s T cells are not working properly, the results are not as optimized as they would otherwise be.Contents

~~Our~~Exploitation ~~chPD-1~~of ~~(chimeric~~GDT’s ~~PD-1)~~Natural ~~thus~~Potency takes it a step further by converting PD-1 and PD-L1 from an inhibitory signal to an activation signal. This transformation allows our chimeric T cells to then kill solid tumor cells and the cells of the TME.

~~Although~~We this chimeric PD1 GDT can effectively lyse both hematologic and solid tumors expressing PD-L1, the focus of the first related IND submission will focus on solid malignancies that express PD-L1 as this represents one of the greatest needs in oncology at this time. This IND submission is supported by strong in vitro and in vivo tumor cytotoxicity data, and thus far no significant adverse effects have ~~been~~two ~~noted~~simple inclaims ~~the~~with ~~animal~~respect ~~models~~to ~~tested,~~our ~~which~~allogeneic ~~has~~AI ~~included~~driven ~~the~~GDT ~~testing~~engineering ~~of multiple types of solid malignancies~~approach.

1. We believe that our GDTs are safer than other CAR-T cell approaches;

~~Development~~2. ~~Plan~~We believe that our GDTs are more efficacious than other CAR-T cell approaches.

~~Deltacel will be studied in a Phase 1~~Below, ~~First-in-Human,~~safety ~~Open-label, Dose Escalation Study Subjects with metastatic~~ and ~~refractory~~efficacy ~~non-small~~are ~~cell~~discussed ~~lung cancer (NSCLC). In this trial, the product candidate, KB-GDT-01, will be studied~~ in ~~combination~~greater ~~with low dose radiotherapy~~detail.

The ~~primary~~Deltacel ~~goal~~IND ~~will~~was besupported toby ~~assess~~two ~~safety, tolerability, and preliminary efficacy of KB~~non-~~GDT-01~~clinical ~~at increasing dose levels~~ in ~~order~~vivo ~~to estimate the recommended Phase 2 dose (RP2D) which will serve as the dose for up to additional 12 subjects in the expansion phase~~studies.

We1. ~~submitted~~A ~~the~~pharmacology ~~IND~~study ~~for~~that evaluated the ~~Deltacel~~potential ~~trial~~therapeutic inbenefit ~~March~~of ~~2023~~Deltacel, ~~obtained~~in ~~FDA~~combination ~~authorization~~with inlow-dose ~~April~~radiotherapy ~~2023,~~(“LDRT”) ~~and~~using wea ~~began~~mouse ~~the~~model ~~activation~~ of ~~clinical trial process in May 2023~~NSCLC. ~~The study is conducted in two parts.~~

In2. ~~Part~~A 1GLP-compliant ~~(Dose~~toxicology ~~Escalation),~~and ~~the~~biodistribution safety study ~~will~~that ~~attempt~~evaluated ~~to identify~~ the ~~best~~safety ~~dose with the lowest incidence~~ of ~~adverse~~a ~~effects.~~very Inhigh ~~Part 2 (Expansion) the best~~ dose ~~will be further investigated in up to 12 additional participants. In December 2023, we entered the enrollment phase, and we are currently evaluating the first dose~~ level of ~~the~~Deltacel ~~dose-escalation~~in ~~part~~a ofmouse ~~the trial~~model.

~~Isocel~~Pharmacology ~~will be studied alone or in combination with low-dose radiation for subjects with Mesothelin Positive Metastatic or Progressive Locally Advanced Solid Malignancies~~Study.

~~Procel~~No ~~will~~impact, beadverse ~~studied~~treatment-associated ~~in a Phase 1~~reactions, ~~First-in-Human,~~or ~~Open~~treatment-~~label,~~related ~~Dose~~toxicities were ~~Escalation~~seen. ~~Study~~The combination of anDeltacel ~~Allogeneic~~and ~~Gamma~~LDRT ~~Delta~~effectively ~~PD1~~controlled Ttumor ~~Cell~~progression ~~Switch~~and ~~Receptor~~offered ~~Therapy~~a ~~(KB-PD1)~~survival ~~for subjects with PD-L1 Positive Metastatic or Progressive Locally Advanced Solid Malignancies~~advantage.

~~The~~Toxicology ~~primary~~and ~~goal~~biodistribution ~~of these studies will be to assess~~ safety, tolerability, and preliminary efficacy of Kiromic’s cell therapy products at increasing dose levels in order to estimate the maximum tolerated dose (MTD) which will serve as the dose for an expansion cohortstudy.

~~Prior~~Mice were given Deltacel at a dose approximately 8 times higher than the maximum dose we planned to ~~treatment,~~administer ~~all~~to patients. Mice ~~are~~tolerated ~~expected~~the totherapy ~~undergo~~well, ~~selected~~with ~~screening~~no ~~process~~toxicities. toWe ~~assure~~found that ~~they~~Deltacel ~~meet~~was ~~all~~primarily reaching the ~~corresponding~~lungs, ~~inclusion~~ and ~~exclusion~~lymphoid ~~criteria~~organs ~~and~~such ~~are~~as ~~expressing~~ the ~~intended~~spleen ~~targets~~and ~~(Iso-MESO~~lymph ~~or PD-L1)~~nodes.

12Isocel™ and Procel™

~~Table~~Our Isocel™ and Procel™ product candidates consist of ~~Contents~~allogeneic, engineered, off-the-shelf GDT cells and they are currently in the preclinical development stage. Our Isocel product candidate targets Mesothelin Isoform 2 (“IsoMSLN2”), a target that we have discovered and prioritized using our Diamond AI bio-informatic platform. Our Procel product candidate targets PD-L1. Isocel targets solid tumors expressing a tumor-specific variant (Isoform) of Mesothelin (“Iso-Meso”), while Procel targets PD-L1 positive tumors.

~~Exploitation~~We are developing a novel and virus-independent engineering method, which we believe may result in the submission of ~~GDT’s~~new ~~Natural~~IND ~~Potency~~applications. The first of these applications will study Isocel and is expected to be ready for submission to the FDA in the second half of 2025. The second will study Procel and is expected to be ready for submission to the FDA in 2026. The development of both technologies and their advancement to clinical stage are subject to sufficient financing. Depending on evidence from preclinical studies, we may study the new candidates in combination with low-dose radiation or as stand-alone therapies.

WeIsocel ~~have~~is ~~two~~a ~~simple~~CAR-modified ~~claims~~gdT ~~with~~product ~~respect~~targeting toa ~~our~~tumor-specific ~~allogeneic~~variant AIof ~~driven~~the ~~GDT~~known ~~engineering~~tumor-associated ~~approach~~antigen, Mesothelin (“MSLN”). MSLN is a glycoprotein over-expressed on the cell surface by multiple solid tumors, and therefore a candidate for targeted immunotherapies. However, MSLN is also expressed at a low level by mesothelial cells in healthy tissues including omentum, pericardium, and pleura, potentially leading to long-term limiting toxicities of anti-MSLN CAR therapies.

1In the effort to generate a safer and effective anti-pan solid tumor CAR therapies, we studied the differential expression of MSLN isoforms between normal and cancer cells, and we identified a tumor-specific variant carrying a unique sequence of amino acids which is not found in normal MSLN positive cells and can be targeted by monoclonal antibodies and CAR. We ~~believe~~generated ~~that~~cancer ~~our~~isoform-specific ~~GDTs~~CAR ~~are~~constructs, ~~safer~~and ~~than~~we ~~other~~showed that anti-cancer isoform-MSLN CAR-transduced gamma-delta T ~~cell~~cells ~~approaches;~~effectively and specifically eliminate isoform mesothelin-expressing target cells in vitro an in vivo, without toxicities. Furthermore, we showed that the CAR T cells were persistent and effective in mice for 125 days.

2.Procel Weis ~~believe~~an ~~that~~allogeneic ~~our~~cell ~~GDTs~~therapy ~~are~~based ~~more~~on ~~efficacious~~gamma ~~than~~delta ~~other~~T ~~CAR~~cells engineered with a PD1 chimeric molecule (chPD1), which overruns PDL1-Tmediated ~~cell~~signals ~~approaches~~and ultimately activates cytotoxic functions of effector cells.

~~Below~~The main obstacles preventing effective CAR therapies for solid tumors are the complex and immune-suppressive tumor microenvironment, ~~safety~~the lack of specific tumor targets, and ~~efficacy~~the use of autologous, patient-derived cells, which are ~~discussed~~sub-optimal due to chemotherapy. We investigated a novel strategy to overcome these barriers by using gamma delta T cells and a chimeric PD-1 switch receptor. Cells were tested for killing efficiency, cytokines secretion, and memory differentiation in ~~greater~~vitro ~~detail~~and in vivo. Cells were well tolerated in mice, without damage to normal PD-L1+ cells. Upon contact with PD-L1+ cancers, chPD1-gdT cells, but not untransduced gdT cells, expressed markers of memory phenotype and secreted inflammatory cytokines. In vivo, chPD1-gdT cells, but not untransduced gdT cells, cleared PD-L1+ tumors without significant elevation of CRS-related cytokines, nor off-tumor toxicities. chPD1-gdT cells are potent and safe in vitro and in vivo.

~~Safety~~ 12

~~Deltacel~~ Table of Contents

WeManufacturing ~~conducted~~Operations ~~a pivotal IND-enabling Toxicology and Pharmacology study of Deltacel in tumor-bearing NSG mice (N=120).~~

~~Deltacel~~We ~~was~~have ~~given~~invested atresources ~~the~~to ~~human~~optimize ~~equivalent~~our ~~dose~~manufacturing process, including the development of 12improved ~~billion~~analytical ~~cells~~methods. ~~(24~~We ~~billion~~plan ~~cumulative~~to ~~dose),~~continue ~~which~~to isinvest ~~7.5x~~in ~~the~~process ~~human~~science, ~~equivalent~~product ~~dose~~characterization ~~(with~~and ~~respect~~manufacturing to ~~the~~continuously ~~highest~~improve ~~planned~~our ~~IND~~production ~~dose)~~and supply chain capabilities over time.

ItOur ~~was~~product ~~well~~candidates ~~tolerated~~are ~~with~~designed noand ~~incidence~~manufactured onvia ~~mice~~a ~~weight~~platform orcomprised ~~impact~~of ondefined ~~survival~~unit ~~(both~~operations ~~overall~~ and ~~event~~technologies. The process is gradually developed from small to larger scales, incorporating compliant procedures to create current cGMP conditions. Although we have a platform-~~free)~~based manufacturing model, each product is unique and for each new product candidate, a developmental phase is necessary to individually customize each engineering step and to create a robust procedure that can later be implemented in a cGMP environment to ensure the production of clinical batches. This work is performed in our research and development environment to evaluate and assess variability in each step of the process in order to define the most reliable production conditions.

~~Clinical~~Our ~~Pathology~~headquarters ~~did~~in ~~not~~Houston, ~~evidence~~Texas, ~~any~~supports ~~significant~~our ~~Deltacel-induced~~clinical ~~abnormalities~~manufacturing inoperations. ~~blood~~These ~~chemistry,~~manufacturing ~~with~~areas ~~the~~are ~~exception~~within of a ~~minor~~common ~~increase~~office inbuilding ~~Alanine~~complex ~~Aminotransferase~~but inshare ~~female~~no ~~mice~~relationship ~~receiving~~with ~~Deltacel~~any ~~compared~~other ~~with~~tenants. ~~controls~~All Kiromic areas are security and access controlled to prevent any unauthorized access. ~~This~~The ~~was~~manufacturing ~~not~~space ~~associated~~maintains a separate chiller and air handler that provides dedicated air to this space, preventing any ~~defect~~mixing inof ~~liver~~air ~~function~~with the other building areas.

~~Histopathology~~We ~~examination~~have onroughly ~~multiple~~4,000 ~~organs~~sq ~~did~~feet ~~not~~of ~~evidence~~manufacturing space which includes two separate ISO 7 cleanrooms with adjacent ISO 8/ISO 9 entrance and exit corridors and gowning/locker rooms. A cold storage area and material warehouse maintains raw materials and final products for manufacturing. The facility also includes two backup pods for product development, improvement and translation of any ~~abnormalities~~manufacturing ~~after~~projects ~~Deltacel~~along ~~administration~~with a dedicated waste storage area to house waste until properly disposed.

~~The~~Additionally, ~~graphics~~we ~~below~~have ~~show~~a Quality Control Laboratory that ~~Deltacel~~includes ~~did~~both ~~not~~an ~~cause~~analytical ~~significant~~testing ~~changes~~laboratory inas ~~mice's~~well ~~body~~as a ~~weight,~~Microbiology ~~did~~and ~~not~~Environmental ~~affect~~Monitoring (MICRO/EM) ~~survival,~~Laboratory ~~and~~to ~~did~~support ~~not~~any ~~alter~~manufacturing ~~metabolic~~process. ~~functions~~Each of the spaces are provided with High Efficiency Particulate Air (HEPA) filtered air to ensure a clean environment and are separated for process isolation.

~~Percent~~If ~~Group~~any ~~Mean~~of ~~Body~~our ~~Weight~~product ~~Changes~~candidates ~~from~~are ~~Day~~approved 1for commercial distribution, we anticipate that we will need to obtain additional manufacturing capacity in order to meet projected sale quantities.

Benefits

13We believe that the manufacturing of our therapies with these processes and infrastructure results in the following key benefits:

~~Table~~1. No Lead Time – OTS therapies are ready on demand. They are produced in advance of ~~Contents~~patient visits and are cryogenically frozen. Conversely, autologous therapies have approximately three to five weeks of lead time.

~~Survival~~2. ~~rates~~Outpatient Treatment – This means reduced hospitalization and other treatment-related costs. Current hospitals struggle to break even if CAR-T cell therapies are administered in the inpatient setting.

~~Complete~~3. ~~metabolic~~Lower ~~panel~~Production Costs – We have In-house cGMP manufacturing (full control and vertical integration of the manufacturing process) for vector production and cell therapy production.

14 13

Table of Contents

15Our Product Pipeline and Development

~~Table~~Using our proprietary technologies, we are researching and developing multiple product candidates for the treatment of ~~Contents~~solid tumors. Our product candidates are allogeneic, non-engineered, and engineered GDTs to be used for specific patients as treatments for metastatic or progressive locally advanced solid malignancies.

~~Procel~~Our product pipeline and clinical program projected timelines are represented in the diagrams below (clinical timelines and final patient accrual numbers are predicated upon FDA review and will be modified in accordance with FDA requirements):

~~Current~~Assuming ~~FDA~~we ~~approved~~will ~~CAR-T~~continue ~~cell~~to ~~therapy~~obtain ~~products~~proof ~~carry~~of aefficacy ~~high~~and ~~risk~~tolerability ofbased ~~side~~on ~~effects~~the ~~including~~results from the ~~Cytokine~~patients ~~Release~~enrolled ~~Syndrome~~in ~~(“CRS”)~~the dose expansion phase of the Deltacel-01 Phase 1 study, and ~~Immune~~leveraging ~~Cell~~the ~~Associated~~FTD ~~Neurotoxicity~~status, ~~Syndrome~~we ~~(“ICANS”).~~may Webe ~~believe~~in ~~that~~the ~~GDTs~~position ~~contain~~of ~~minimal~~initiating toa noPhase ~~CRS~~2 ortrial ~~ICANS,~~before orthe ~~GvHD~~end ~~between~~of ~~donors~~2025 with ~~and~~the ~~patients~~first patient being dosed in the first quarter of 2026.

~~The~~Our ~~graphic~~Intellectual below demonstrates that our GDTs for checkpoint PD-L1 are shown to be safe in animal testing. The graphs demonstrate serological tests of organ damage biomarkers. In the experiment, the athymic Balb/c Nude mice were subcutaneously implanted with NCI-H226 and were treated intravenously with checkpoint PD-L1 GDTs. Serum biomarkers were measured. Graphs show the means out of 5 mice per group, while error bars indicate standard deviations.Property

Our commercial success depends in part on our ability to obtain and maintain proprietary protection for our product candidates, as well as novel discoveries, product development technologies, and know-how.

16Our commercial success also depends in part on our ability to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights. Our policy is to develop and maintain protection of our proprietary position by, among other methods, filing or in-licensing U.S. and foreign patents and applications related to our technology, inventions, and improvements that are important to the development and implementation of our business.

~~Table~~We also rely on trademarks, trade secrets, know-how, continuing technological innovation, confidentiality agreements, and invention assignment agreements to develop and maintain our proprietary position. Our confidentiality agreements are designed to protect our proprietary information, and our invention assignment agreements are designed to grant us ownership of ~~Contents~~technologies that are developed for us by our employees, consultants, or other third parties. We seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in our agreements and security measures, either may be breached, and we may not have adequate remedies. In addition, our trade secrets may otherwise become known or independently discovered by competitors.

~~The~~With ~~safety~~respect ~~laboratory~~to ~~analyses~~both licensed and ~~safety~~company-owned ~~monitoring~~intellectual ~~visits~~property, ~~conducted~~we socannot ~~far~~be onsure that patents will be granted with respect to any of our ~~first~~pending ~~subject~~patent ~~enrolled~~applications or with respect to any patent applications filed by us in the ~~Deltacel-01~~future, ~~clinical~~nor ~~trial~~can ~~confirmed~~we ~~such~~be asure ~~safety~~that ~~profile~~any ~~and~~of ~~revealed~~our existing patents or any patents that may be granted to us in the ~~treatment~~future ~~was~~will be commercially useful in protecting our commercial products and ~~continues~~methods toof beusing ~~well~~and ~~tolerated~~manufacturing the same.

~~Isocel~~ 14

We Table ~~also performed preclinical experiments on safety on our ALEXIS-ISO-1 clinical candidate, which contains allogeneic GDTs expressing the isoform~~ of mesothelin. The experiments tested for inflammatory cytokines in mice. The cytokines in panel were not significantly different in CAR GDT treated mice compared with untreated or non-transduced GDT treated mice. In effect, our scientific team drew the conclusion that there was no significant difference in inflammatory markers with our engineered GDTs.Contents

~~Efficacy~~Patents

We continue building an intellectual property portfolio around our product candidates and our discovery programs, based on intellectual property we own as well as licensed intellectual property. We are the owners of or the licensee of multiple patents and patent applications in the U.S. and worldwide. We are the licensee of one patent dealing with the PD1 switch receptor contained in Procel (see “License agreements”). Our patent portfolio includes patent applications having claims directed to aspects of our lead product candidates, Deltacel, Procel, and Isocel, as well as other research-stage candidates and our bioinformatics discovery platform. Our patent portfolio and filing strategy is designed to provide multiple layers of protection by pursuing claims directed toward: (1) manufacturing processes, (2) methods of treatment for therapeutic indications, (3) antigen binding domains directed to the targets of our product candidates, (4) CAR constructs and engineered molecules.

WeThe ~~conducted~~term anof ~~IND-enabling~~individual ~~pivotal~~patents ~~Efficacy~~depends ~~study~~upon the legal term of the patents in ~~mice~~the ~~(N=80~~countries in which they are obtained. In most countries in which we file, 40the ~~females~~patent term is 20 years from the date of filing of the first non-provisional application to which priority is claimed. In the U.S., patent term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the U.S. Patent and 40Trademark ~~males~~Office (the “USPTO”) in granting a patent or may be shortened if a patent is terminally disclaimed over an earlier-filed patent. In the U.S., ~~where~~the ~~Deltacel~~term ~~was~~of ~~given~~a ~~alone~~patent orthat incovers ~~combination~~an toFDA-approved drug may also be eligible for a ~~standard~~patent ~~anti~~term extension of up to five years under the Hatch-~~tumor~~Waxman ~~therapy~~Act, which is designed to ~~animals~~compensate ~~bearing~~for ~~advanced~~the ~~lung~~patent ~~cancer~~term ~~tumors~~lost ~~implanted~~during ~~sub~~the FDA regulatory review process. The length of the patent term extension involves a complex calculation based on the length of time it takes for regulatory review. A patent term extension under the Hatch-~~cutaneously~~Waxman Act cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one patent applicable to an approved drug may be extended. Moreover, a patent can only be extended once, and thus, if a single patent is applicable to multiple products, it can only be extended based on one product. Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug.

~~Adding~~The patent term restoration period is generally one-half the ~~standard~~time ~~tumor~~between ~~therapy~~the ~~treatment~~effective todate of an IND and the ~~Delatcel~~submission ~~(KB-GDT-01)~~date ~~injections~~of ~~prolonged~~a BLA plus the ~~duration~~time between the submission date of a BLA and the ~~magnitude~~approval of that application. Only one patent applicable to an approved product is eligible for the ~~benefit~~extension ~~afforded~~and bythe application for the ~~cell~~extension ~~treatment~~must ~~alone~~be submitted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and itapproves ~~was~~the ~~superior~~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 currently owned or licensed patents to add patent life beyond its current expiration date, depending on the ~~standard~~expected ~~therapy~~length ~~when~~of ~~compared~~the clinical trials and other factors involved in the filing of the relevant BLA.

17License Agreements

~~Table~~Longwood ~~of Contents~~University

~~with~~Effective ~~the~~March 25, ~~untreated~~2020, ~~control~~we ~~group~~entered into a license agreement with Longwood University (~~vehicle~~“Longwood”). ~~These~~Pursuant ~~effects~~to ~~were~~this ~~not~~license ~~associated~~agreement, toLongwood ~~any~~granted ~~effect~~us onthe ~~multi-organ~~exclusive ~~functions~~right ~~and~~to ~~metabolism~~negotiate asa ~~evidenced~~worldwide, byexclusive alicense ~~clinical~~for ~~chemistry~~certain ~~analysis~~patent rights. ~~Based~~The onpatent ~~the~~rights ~~mRNA~~pertain ~~profile~~to by"T ~~NanoString~~cells ~~analysis,~~expressing ~~adding~~a ~~the~~chimeric-PD ~~standard anti~~l-~~tumor~~ ~~therapy~~CD3zeta toreceptor ~~KB-GDT-01~~reduce ~~appeared~~tumor toburden ~~favor~~in amultiple ~~pro-inflammatory~~murine ~~tumor~~syngeneic ~~microenvironment~~models of solid cancer." AAs ~~unique~~compensation ~~gene~~for ~~expression~~this ~~signature~~right, ~~was~~we ~~identified~~agreed into ~~mice~~pay ~~treated~~Longwood ~~with~~an ~~the~~upfront ~~combination~~fee ~~therapy~~of ~~that~~$15,000. ~~could~~We ~~not~~also beagreed ~~obtained~~to ~~with~~reimburse ~~either~~Longwood ~~monotherapies~~for fees and ~~could~~expenses ~~represent~~incurred afor ~~set~~the ofpreparation, ~~biomarkers~~filing, ~~that~~prosecution ~~may~~and bemaintenance ~~associated~~of tosuch ~~Deltacel~~patent ~~in patients~~rights.

~~Changes~~ Table of ~~average tumor size in each group during the in-life observation period. No statistically significant differences were observed.~~Contents

~~Changes~~Our of average tumor size in each group during the in-life observation period. Combination therapy versus cell monotherapy. The combination therapy significantly reduced the size of tumors compared with those from mice in the cell monotherapy group. The average size of the combination therapy group’s tumors remained smaller than that of the cell monotherapy group.Competition

~~Combination~~Our ~~therapy~~products ~~versus~~will ~~standard~~compete ~~therapy~~in ~~alone.~~the ~~Except~~solid ~~for~~tumors' atherapies ~~temporary~~market ~~effect~~with ~~from~~products ~~day~~developed 9by ~~until~~biopharmaceutical ~~day 11 (included)~~companies, ~~where~~academic ~~the~~research ~~combination~~institutions, ~~therapy~~governmental ~~group~~agencies ~~mean~~and ~~tumor~~public ~~volume~~or ~~was~~private ~~significantly~~research ~~smaller than that of the standard therapy alone~~institutions, ~~the mean tumor volume of mice~~ in ~~the~~addition ~~combination~~to ~~therapy group was not significantly different from that of mice in the~~ standard ~~therapy alone group. However, on average, from day 16 until the end~~ of ~~the~~care ~~experiments, it remained 24% smaller than that of the standard therapy group~~treatments.

~~Combination~~Due ~~therapy~~to ~~versus~~the ~~vehicle~~promising ~~control.~~therapeutic ~~The~~effect ~~combination~~of ~~therapy~~T ~~significantly~~cell ~~reduced~~therapies in clinical trials, and the ~~size~~advantages ofoffered ~~tumors~~by ~~compared~~allogeneic ~~with~~products, ~~those~~we ~~from~~anticipate ~~mice~~increasing incompetition ~~the~~from ~~vehicle~~existing ~~control~~and ~~group~~new ~~starting~~companies ~~from~~developing allogeneic ~~day~~T 5,cell itherapies.~~e.,~~ ~~around~~These 48can ~~hours~~be ~~after~~based ~~the~~on “conventional” ~~injection~~alpha/beta ofT ~~the~~cells ~~first~~or ~~cell~~gamma/delta ~~dose.~~T cells.

~~Cells~~Potential ~~monotherapy~~solid ~~versus~~tumors ~~standard~~allogeneic ~~therapy~~cell ~~or vehicle. During the 39-day observation window after the administration of the second dose of cells, the cells monotherapy was never better than standard~~ therapy incompetitors ~~controlling tumor growth, while~~ include:

18• Alpha/Beta T cell platform companies: Fate Therapeutics, Poseida Therapeutics, Allogene Therapeutics.

~~Table~~• ofGamma/delta ~~Contents~~T cell platform companies: Adicet Bio, Inc., Cytomed Therapeutics, IN8 Bio, Inc. TC Biopharm Limited, GammaDelta Therapeutics Limited (acquired by Takeda).

itWe ~~significantly~~believe ~~reduced~~to ~~tumor~~be ~~size~~unique ~~compared~~in ~~with~~our ~~the~~position ~~vehicle~~to ~~control~~target ~~group~~multiple ~~starting~~solid ~~from~~malignancies ~~day~~with 5,a ~~i.e.~~combination of non-engineered and engineered, ~~around~~but 48not ~~hours~~gene-edited, ~~after~~allogeneic off-the-shelf ~~injection~~GDT ofcells and to be the first ~~cell~~to use an innovative low-dose. radiation protocol in combination with our cell products.

~~Standard~~Competition ~~therapy~~might ~~versus~~also ~~vehicle~~arise from non-cell-based immune and other biologics pursued by small-cap biotechnology and large-cap pharmaceutical companies including Amgen Inc., ~~Tumor~~AstraZeneca plc, ~~growth~~Bristol-Myers inSquibb ~~the~~Company, ~~mice~~Incyte ~~from~~Corporation, ~~the~~Merck & Co., Inc., ~~standard~~and ~~therapy~~F. ~~group~~Hoffmann-La ~~was~~Roche ~~not~~AG. ~~significantly~~For ~~different~~instance, we may experience competition from companies, such as Amgen Inc., Regeneron Pharmaceuticals, Inc., Xencor Inc., MacroGenics, Inc., GlaxoSmithKline plc and F. Hoffmann-La Roche AG, that are pursuing bispecific antibodies, which target both the cancer antigen and TCR, thus bringing both cancer cells and T cells in close proximity to maximize the likelihood of ~~mice~~an ~~from~~immune response to the ~~vehicle~~cancer ~~group~~cells. Additionally, ~~except~~companies, ~~for~~such aas ~~temporary~~Amgen Inc., ~~effect~~GlaxoSmithKline plc ~~observed~~and ~~only~~Seattle onGenetics, Inc., ~~day~~are 5pursuing antibody drug conjugates, which utilize the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.

~~Probability~~Many of ~~survival~~our ~~for~~competitors, ~~each~~either ~~treatment~~alone ~~group:~~or nowith ~~statistically~~their ~~significant~~collaboration ~~differences~~partners, inmay ~~survival~~have ~~rates~~significantly ~~among~~greater ~~groups~~financial ~~were~~resources in ~~observed~~research ~~(Log~~and development, pre-~~rank~~clinical ~~test~~testing, clinical trials, manufacturing, and ~~Gehan-Breslow-Wilcoxon~~marketing ~~test~~than ~~p>0~~we do.~~05).~~ ~~There~~Future ~~was~~collaborations noand ~~statistically~~mergers ~~significant~~and ~~difference~~acquisitions may result in further resource concentration among ~~groups~~a smaller number of competitors.

~~Procel~~Our commercial potential could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market or make our development more complicated. The key competitive factors affecting the success of all of our programs are likely to be efficacy, safety, and convenience.

WeThese ~~believe~~competitors ~~that~~may ~~our~~also ~~engineered~~compete ~~checkpoint~~for ~~PD-L1~~a ~~GDT~~similar ~~approach~~pool ~~is potentially more efficacious than non-engineered GDT approaches. The figures below demonstrate our experimentation~~ of ~~that~~qualified ~~hypothesis.~~scientific ~~The results indicate the in vivo efficacy~~ and ~~tolerability~~management oftalent, ~~GDTs~~suitable ~~(5 x 106 cells) in athymic Balb/c Nude mice subcutaneously implanted with the PD-L1+ cell line~~sites, ~~NCI-H226 (10 (6) cells). The dotted vertical line indicates the day when the GDTs were administered (day +15). Graphs show the average (A) tumor volumes~~ and ~~(B)~~patient ~~weights~~populations offor 10clinical ~~mice (Saline~~trials, ~~GDTs,~~as ~~chPD1~~well ~~GDTs),~~as orfor ~~five~~complementary ~~mice~~or ~~(tumor-free),~~necessary ~~with~~technologies afor ~~95%~~our ~~confidence interval~~programs.

InCorporate summation, our GDT therapy reduced tumor size to zero within approximately eight days in mice, while showing no weight loss. Conversely, mice treated intravenously with either non-engineered GDTs or untreated (saline) experienced statistically significant tumor growth.Information

~~Isocel~~Our principal executive office is 7707 Fannin Street, Suite 200, Houston, TX 77054. Our telephone number is (832) 968-4888. Our website is www.kiromic.com. The information contained on our website is not a part of this annual filing, nor is such content incorporated by reference herein, and should not be relied upon in determining whether to make an investment in our common stock.

Similarly, we believe that our engineered GDTs targeting the isoform of mesothelin are potentially more efficacious than non-engineered GDT approaches. The figures below demonstrate our experimentation of that hypothesis. We tested the in vivo efficacy and tolerability of a high dose of GDT in Balb/c nude mice sub-cutaneously implanted with the mesothelioma cell line, NCI-H226. Fifteen days after tumor cell implantation, mice with comparable tumor volumes were then divided into three groups (n=10 mice/group) and were (i) injected with our CAR GDTs, (ii) injected with non-engineered GDTs, iii) injected with saline solution. Tumor volumes and mice weight were measured daily for an additional 30 days. The dotted vertical line indicates the day when the GDTs were administered. Graphs show the tumor growth/reduction and 16

19 Table of Contents

~~Table~~Government ~~of Contents~~Regulation

~~body~~As ~~weight~~a ~~from~~company that operates in the ~~ten~~U.S., ~~tested~~we ~~mice~~are ~~(Saline~~subject to extensive regulation. Biological products, such as our ~~CAR~~clinical ~~GDTs~~trial candidates, ~~non-engineered~~are ~~GDTs~~subject to regulation under the Federal Food, Drug, and Cosmetic Act (“the FDCA”), orthe ~~five~~Public ~~mice~~Health Service Act (~~tumor-free~~the “PHSA”), ~~with~~FDA aregulations ~~95%~~under ~~confidence~~Title ~~interval~~21 of the Code of Federal Regulations (“21 CFR”), as well as other federal, state and local statutes and regulations.

InGovernment ~~summation~~authorities in the U.S. (at the federal, state and local level) and in other countries extensively regulate, among other things, the research, development, testing, manufacturing, quality control, safety, efficacy approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of biopharmaceutical products such as those we are developing. Our product candidates must be approved by the FDA before they may be legally marketed in the U.S. and by the appropriate foreign regulatory agency before they may be legally marketed in foreign countries. Generally, our ~~GDT~~activities ~~therapy~~in ~~reduced~~other ~~tumor~~countries ~~size~~will be subject to ~~zero~~regulation ~~within~~that ~~approximately~~is ~~eight~~similar ~~days~~in nature and scope as that imposed in ~~mice~~the U.S., ~~while~~although ~~showing~~there nocan ~~weight~~be ~~loss~~important differences. ~~Conversely~~Additionally, ~~mice~~some ~~treated~~significant ~~intravenously~~aspects ~~with~~of ~~either~~regulation ~~non~~in Europe are addressed in a centralized way, but country-~~engineered~~specific ~~GDTs~~regulation orremains ~~untreated~~essential ~~(saline)~~in ~~experienced~~many ~~statistically~~respects. ~~significant~~The ~~tumor~~process ~~growth~~for obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.

~~For our allogeneic products, the cells are collected from a healthy donor~~U.S. ~~The~~Product ~~collected~~Development ~~cells are then sent to the Kiromic processing facility, where the peripheral blood mononuclear cells, including GDTs, are isolated.~~ Process

~~These~~In ~~cells~~the ~~are~~U.S., ~~stimulated~~the toFDA ~~proliferate~~regulates pharmaceutical and biological products under the FDCA, ~~then~~the ~~purified~~PHSA, and ~~cryopreserved~~their implementing regulations. InThe process of obtaining regulatory approvals and the ~~case~~subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of ~~Procel~~substantial time and ~~Isocel,~~financial ~~they~~resources. ~~are~~Failure ~~transfected~~to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. FDA sanctions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a ~~virus-free~~clinical ~~methodology~~hold, warning letters, product recalls or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. The process required by the FDA before a biological product may be marketed in the U.S. generally involves the following:

~~These~~• ~~cells~~Completion ~~can~~of benonclinical ~~propagated~~laboratory intests ~~cell~~and ~~culture~~animal ~~bags~~studies ~~until~~according ~~sufficient~~to ~~cells~~good ~~are~~laboratory ~~available.~~practices ~~The~~(“GLPs”) ~~GDTs~~and ~~are~~applicable ~~then~~requirements ~~washed,~~for ~~frozen,~~the ~~and~~humane ~~shipped~~use toof laboratory animals, such as the ~~clinical~~Animal ~~sites.~~Welfare Act, or other applicable regulations.

~~Manufacturing~~• ~~Operations~~Submission to the FDA of an IND, which must become effective before human clinical trials may begin.

We have invested resources to optimize our manufacturing process, including the development of improved analytical methods. We plan to continue to invest in process science, product characterization and manufacturing to continuously improve our production and supply chain capabilities over time. 17

~~Our~~ Table ~~product candidates are designed and manufactured via a platform comprised~~ of defined unit operations and technologies. The process is gradually developed from small to larger scales, incorporating compliant procedures to create current cGMP conditions. Although we have a platform-based manufacturing model, each product is unique and for each new product candidate, a developmental phase is necessary to individually customize each engineering step and to create a robust procedure that can later be implemented in a cGMP environment to ensure the production of clinical batches. This work is performed in our research and development environment to evaluate and assess variability in each step of the process in order to define the most reliable production conditions.Contents

~~Our~~• ~~headquarters~~Approval inby ~~Houston,~~an ~~Texas,~~independent ~~support~~institutional review board (“IRB”) or ethics committee at each clinical ~~manufacturing~~site ~~operations~~before the trial is commenced at that site.

If• ~~any~~Performance of ~~our~~adequate ~~product~~and ~~candidates~~well-controlled ~~are~~human ~~approved,~~clinical trials according to ~~meet~~the ~~projected~~FDA’s ~~needs~~good ~~for~~clinical ~~commercial~~practice ~~sale~~requirements ~~quantities~~(“GCPs”), weand ~~anticipate~~any ~~that~~additional werequirements ~~will~~for ~~need~~the protection of human research patients and their health information, to ~~obtain~~establish ~~additional~~the ~~manufacturing~~safety ~~capacity~~and efficacy of the proposed biological product for its intended use.

~~Benefits~~• Submission to the FDA of a Biologics License Application (“BLA”) for marketing approval that includes substantial evidence of safety, purity, and potency from results of nonclinical testing and clinical trials, as well as detailed information about the chemistry, manufacturing and controls, and proposed labeling and packaging for the product candidate.

We• ~~believe~~Consideration ~~that~~by ~~the~~an ~~manufacturing~~FDA ofAdvisory ~~our~~Committee, ~~therapies~~if ~~with these processes and infrastructure results in the following key benefits:~~applicable.

1.• NoSatisfactory ~~Lead~~completion ~~Time~~of –an ~~OTS~~FDA ~~therapies~~inspection ~~are~~of ~~ready~~the onmanufacturing ~~demand.~~facility ~~They~~or ~~are~~facilities where the biological product candidate is produced into ~~advance~~assess ofcompliance ~~patient~~with ~~visits~~cGMP, to assure that the facilities, methods and controls are ~~cryogenically~~adequate ~~frozen.~~to ~~Conversely~~preserve the biological product’s identity, ~~autologous~~strength, ~~therapies~~quality ~~have~~and ~~approximately~~purity ~~three~~and, toif ~~five~~applicable, ~~weeks~~the FDA’s current good tissue practices (“cGTPs”) for the use of ~~lead~~human ~~time~~cellular and tissue products.

2.• ~~Outpatient~~Satisfactory ~~Treatment~~completion –of ~~This~~potential ~~means~~FDA ~~reduced~~audits ~~hospitalization~~of ~~and~~the ~~other~~nonclinical ~~treatment-related~~study ~~costs.~~and ~~Current~~clinical ~~hospitals~~trial ~~struggle~~sites tothat ~~break~~generated ~~even~~the ifdata ~~CAR-T~~in ~~cell~~support ~~therapies~~of ~~are administered in~~ the ~~inpatient setting~~BLA.

20• FDA review and approval, or licensure, of the BLA, including agreement on post-marketing commitments, if applicable.

~~Table~~Before testing any biological product candidate, including our product candidates in humans, the product candidate enters the preclinical testing stage. Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of ~~Contents~~product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the product candidate. The conduct of the preclinical tests must comply with federal regulations and requirements including GLPs and the Animal Welfare Act. The clinical trial sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. Some preclinical testing may continue even after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day period. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA may also impose clinical holds on an IND at any time before or during clinical trials for a biological product candidate due to safety concerns or non-compliance. If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by the FDA. Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate such trials.

3.Clinical ~~Lower~~trials ~~Production~~involve ~~Costs~~the –administration Weof ~~have~~the ~~In-house~~biological ~~cGMP~~product ~~manufacturing~~candidate ~~(full~~to patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor's control. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and ~~vertical~~exclusion ~~integration~~criteria, and the parameters to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events should occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the ~~manufacturing~~IND. ~~process)~~Clinical trials must be conducted and monitored in accordance with the FDA's regulations and GCP requirements, which establish standards for ~~vector~~conducting, ~~production~~recording data from, and ~~cell~~reporting ~~therapy~~the ~~production~~results of clinical trials, with the goals of assuring that the data and results are credible and accurate and that study participants’ rights, safety, and well-being are protected. GCP requirements also include the requirement that all research patients provide informed consent. Further, each clinical trial must be reviewed and approved by an independent IRB at or servicing each institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as the SMC, that may carry out important aspects of clinical trial monitoring. A clinical trial SMC is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The SMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial.

~~Our~~ Table ~~Product~~of ~~Pipeline and Development~~Contents

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

~~Using~~● ~~our~~Phase ~~proprietary~~1. ~~technologies,~~The webiological ~~are~~product ~~researching~~candidate ~~and~~is ~~developing~~initially ~~multiple~~introduced ~~product~~into ~~candidates~~healthy human subjects and tested for ~~the~~safety ~~treatment~~and ofto ~~solid~~develop ~~tumors.~~detailed ~~Our~~profiles ~~product~~of ~~candidates~~its ~~are~~pharmacological ~~allogeneic~~and pharmacokinetic actions, ~~non-engineered~~determine side effects associated with increasing doses, and, ~~engineered~~if ~~GDTs~~possible, togain beearly ~~used~~evidence ~~for~~of ~~specific~~effectiveness. ~~patients~~In asthe ~~treatments~~case of some products for ~~metastatic~~severe or ~~progressive~~life-threatening ~~locally~~diseases, ~~advanced~~especially ~~solid~~when ~~malignancies~~the product candidate may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

~~Our~~● ~~product~~Phase ~~pipeline~~2. ~~and~~The ~~clinical~~biological ~~program~~product ~~projected~~candidate ~~timelines~~is ~~are~~evaluated ~~represented~~ in ~~the~~a ~~diagrams~~limited ~~below~~patient ~~(clinical~~population ~~timelines~~to identify possible adverse effects and ~~final~~safety ~~patient~~risks, ~~accrual~~to ~~numbers~~preliminarily ~~are~~evaluate ~~predicated~~the ~~upon~~efficacy ~~FDA~~of ~~review~~the product for specific targeted diseases and ~~will~~to bedetermine ~~modified~~dosage intolerance, ~~accordance~~optimal ~~with~~dosage ~~FDA~~and ~~requirements):~~dosing schedule.

If● wePhase ~~achieve~~3. ~~preliminary~~Clinical ~~proof~~trials ofare undertaken to further evaluate dosage, clinical efficacy, ~~from~~potency, ~~our~~and ~~patients~~safety in ~~the~~an ~~Deltacel-01~~expanded ~~phase~~patient 1population at geographically dispersed clinical trial, wesites. ~~plan~~These clinical trials are intended to ~~apply~~establish ~~for~~the aoverall ~~breakthrough~~risk ~~designation~~to inbenefit ratio of the ~~summer~~product ofcandidate ~~2024~~and provide an adequate basis for product labeling.

~~Our~~Post-approval ~~Intellectual~~clinical ~~Property~~trials, sometimes referred to as Phase 4 clinical trials, may be conducted 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. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA. Written IND safety reports must be promptly submitted to the FDA, and the investigators for serious and unexpected adverse events, any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant risk for human patients, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor's initial receipt of the information. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all. The FDA or the sponsor or its SMC may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB's requirements or if the biological product has been associated with unexpected serious harm to patients.

~~Our~~Human ~~commercial~~immunotherapy ~~success~~products ~~depends~~are ina ~~part~~new oncategory ~~our~~of ~~ability~~therapeutics. toBecause ~~obtain~~this ~~and~~is ~~maintain~~a ~~proprietary~~relatively ~~protection~~new ~~for~~and ~~our~~expanding ~~product~~area ~~candidates~~of novel therapeutic interventions, asthere ~~well~~can be no assurance as ~~novel~~to ~~discoveries~~the length of the trial period, ~~product~~the ~~development~~number ~~technologies~~of patients the FDA will require to be enrolled in the trials in order to establish the safety, efficacy, purity and ~~know-how~~potency of immunotherapy product candidates, or that the data generated in these trials will be acceptable to the FDA to support marketing approval.

~~Our~~Concurrently ~~commercial~~with ~~success~~clinical trials, companies usually complete additional nonclinical studies and must also ~~depends~~develop additional information about the physical characteristics of the biological product as well as finalize a process for manufacturing the product in ~~part~~commercial onquantities ~~our~~in ~~ability~~accordance towith ~~operate~~cGMP ~~without~~requirements. ~~infringing~~To onhelp reduce the ~~proprietary~~risk ~~rights~~of the introduction of ~~others~~adventitious ~~and~~agents towith ~~prevent~~use ~~others~~of ~~from~~biological ~~infringing~~products, ~~our~~the ~~proprietary~~PHSA ~~rights~~emphasizes the importance of manufacturing control for products whose attributes cannot be precisely defined. ~~Our~~The ~~policy~~manufacturing isprocess tomust ~~develop~~be ~~and~~capable ~~maintain~~of ~~protection~~consistently producing quality batches of ~~our~~the ~~proprietary~~product ~~position~~candidate byand, among other ~~methods~~things, ~~filing~~the orsponsor ~~in-licensing~~must ~~U.S.~~develop ~~and~~methods ~~foreign~~for ~~patents~~testing the identity, strength, quality, potency and ~~applications~~purity ~~related~~of tothe ~~our~~final ~~technology~~biological product. Additionally, ~~inventions~~appropriate packaging must be selected and tested, and ~~improvements~~stability ~~that~~studies ~~are~~must ~~important~~be conducted to demonstrate that the ~~development~~biological ~~and~~product ~~implementation~~candidate ofdoes ~~our~~not ~~business~~undergo unacceptable deterioration over its shelf life.

We also rely on trademarks, trade secrets, know-how, continuing technological innovation, confidentiality agreements, and invention assignment agreements to develop and maintain our proprietary position. The confidentiality agreements are designed to protect our proprietary information and the invention assignment agreements are designed to grant us ownership of technologies that are developed for us by our employees, consultants, or other third parties. We seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in our agreements and security measures, either may be breached, and we may not have adequate remedies. In addition, our trade secrets may otherwise become known or independently discovered by competitors. 19

~~With~~ Table ~~respect to both licensed and company-owned intellectual property, we cannot be sure that patents will be granted with respect to any~~ of ~~our pending patent applications or with respect to any patent applications filed by us in the future,~~ Contents

21The sponsor of a clinical trial or the sponsor’s designated responsible party may be required to register certain information about the trial and disclose certain results on government or independent registry websites, such as ClinicalTrials.gov. Additionally, a manufacturer of an investigational drug for a serious disease or condition is required to make available, such as by posting on its website, its policy on evaluating and responding to requests for individual patient access to such investigational drug. This requirement applies on the earlier of the first initiation of a Phase 2 or Phase 3 trial of the investigational drug or, as applicable, 15 days after the drug receives a BTD, FTD, or regenerative medicine advanced therapy designation.

~~Table~~U.S. ofReview ~~Contents~~and Approval Processes

~~nor~~After ~~can~~the wecompletion beof ~~sure~~clinical ~~that~~trials ~~any~~ of ~~our~~a ~~existing~~biological ~~patents~~product, orFDA ~~any~~approval ~~patents~~of ~~that~~a ~~may~~BLA must be ~~granted~~obtained tobefore uscommercial inmarketing of the ~~future~~biological ~~will~~product. beThe ~~commercially~~BLA ~~useful~~submission inmust ~~protecting~~include ~~our~~results ~~commercial~~of ~~products~~product development, laboratory and ~~methods~~animal studies, human trials, information on the manufacture and composition of ~~using~~the product, proposed labeling and ~~manufacturing~~other relevant information. The testing and approval processes require substantial time and effort and there can be no assurance that the ~~same~~FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.

~~Patents~~ Under the Prescription Drug User Fee Act, as amended (“PDUFA”), each BLA must be accompanied by a significant user fee. The FDA adjusts the PDUFA user fees on an annual basis. The PDUFA also imposes an annual program fee for biological products. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.

WeWithin ~~continue~~60 days ~~building~~following ansubmission ~~intellectual~~of ~~property~~the ~~portfolio~~application, ~~around~~the ~~our~~FDA ~~product~~reviews ~~candidates~~a ~~and~~BLA ~~our~~submitted ~~discovery~~to ~~programs,~~determine ~~based~~if onit ~~intellectual~~is ~~property~~substantially wecomplete ~~own~~before asthe ~~well~~agency asaccepts ~~licensed~~it ~~intellectual~~for ~~property~~filing. WeThe ~~are~~FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the ~~owners~~time of submission and may request additional information. In this event, cothe BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-~~owners~~depth substantive review of, orthe BLA. FDA performance goals generally provide for action on a BLA within 10 months of the ~~licensee~~60-day filing date, which would be within 12 months of ~~multiple~~its ~~patents~~submission. ~~and~~That ~~patent~~deadline ~~applications~~can inbe extended under certain circumstances, including by the UFDA’s requests for additional information.S. The targeted action date can also be shortened to six months of the 60-day filing date, or eight months after submission, for products that are granted priority review designation because they are intended to treat serious or life-threatening conditions and ~~worldwide.~~demonstrate ~~Our~~the ~~patent~~potential ~~portfolio~~to ~~includes~~address ~~patent~~unmet ~~applications~~medical ~~having~~needs. ~~claims~~The ~~directed~~FDA reviews the BLA to ~~aspects~~determine, ofamong ~~our~~other ~~lead~~things, whether the proposed product ~~candidates~~is safe, ~~Deltacel~~potent, ~~Procel~~and/or effective for its intended use, and ~~Isocel~~has an acceptable purity profile, asand ~~well~~whether asthe ~~other~~product ~~research-stage~~is ~~candidates~~being manufactured in accordance with cGMP to assure and ~~our~~preserve ~~Bioinformatics~~the ~~discovery~~product's ~~platform.~~identity, ~~Our~~safety, ~~patent~~strength, ~~portfolio~~quality, potency and ~~filing~~purity. ~~strategy~~The isFDA ~~designed~~may torefer ~~provide~~applications ~~multiple~~for ~~layers~~novel ofbiological ~~protection~~products byor ~~pursuing~~biological ~~claims~~products ~~directed~~that ~~toward:~~present ~~(1)~~difficult ~~manufacturing~~questions ~~processes~~of safety or efficacy to an advisory committee, ~~(2) methods~~typically ofa ~~treatment~~panel ~~for~~that ~~therapeutic~~includes ~~indications~~clinicians and other experts, ~~(3)~~for ~~antigen~~consideration, ~~binding~~discussion ~~domains~~and ~~directed~~a vote on specific questions relevant to the ~~targets~~approval decision. The FDA is not bound by the recommendations of ~~our~~an ~~product~~advisory ~~candidates~~committee, ~~(4) CAR~~but ~~constructs~~it ~~and~~considers ~~engineered~~such ~~molecules~~recommendations carefully when making decisions.

~~The~~During ~~term of individual patents depends upon~~ the ~~legal~~biological ~~term~~product ofapproval ~~the patents in the countries in which they are obtained. In most countries in which we file~~process, the ~~patent~~FDA ~~term~~also iswill ~~20 years~~determine ~~from~~whether ~~the date of filing of the first non-provisional application to which priority is claimed. In the U.S., patent term may be lengthened by patent term adjustment, which compensates~~ a ~~patentee~~Risk ~~for~~Evaluation ~~administrative delays by the U.S. Patent~~ and ~~Trademark~~Mitigation ~~Office~~Strategy (~~the~~ “~~USPTO~~REMS”) ~~in granting a patent or may be shortened if a patent is terminally disclaimed over an earlier-filed patent. In the U.S.~~, ~~the term of a patent that covers an FDA-approved drug may also be eligible for a patent term extension of up to five years under the Hatch-Waxman Act, which~~ is ~~designed~~necessary to ~~compensate~~assure ~~for~~ the ~~patent~~safe ~~term~~use ~~lost during the FDA regulatory review process. The length~~ of the ~~patent~~biological term extension involves a complex calculation based on the length of time it takes for regulatory review. A patent term extension under the Hatch-Waxman Act cannot extend the remaining term of a patent beyond a total of 14 years from the date of product ~~approval and only one patent applicable to an approved drug may be extended~~. Moreover, a patent can only be extended once, and thus, if a single patent is applicable to multiple products, it can only be extended based on one product. Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug.

A REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use, and could include a medication guide, communication plan, or elements to assure safe use, such as required healthcare provider or pharmacy certification, a patient registry and other risk minimization tools. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS, and the FDA will not approve a BLA without a REMS.

~~License~~Before ~~Agreements~~approving a BLA, the FDA will inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to ensure consistent production of the product within required specifications. For immunotherapy products, the FDA also will not approve the product if the manufacturer is not in compliance with the GTPs, to the extent applicable. These are FDA regulations and guidance documents that govern the methods used in, and the facilities and controls used for, the manufacture of human cells, tissue, and cellular and tissue-based products (“HCT/Ps”), which are human cells or tissue intended for implantation, transplant, infusion, or transfer into a human recipient. The primary intent of the GTP requirements is to ensure that cell and tissue-based products are manufactured in a manner designed to prevent the introduction, transmission and spread of communicable disease. FDA regulations also require tissue establishments to register and list their HCT/Ps with the FDA and, when applicable, to evaluate donors through screening and testing.

~~Longwood University~~ 20

~~Effective~~ Table March 25, 2020, we entered into a license agreement with Longwood University (“Longwood”). Pursuant to this license agreement, Longwood granted to us the exclusive right to negotiate a worldwide, exclusive license for certain patent rights. The patent rights pertain to "T cells expressing a chimeric-PD l- CD3zeta receptor reduce tumor burden in multiple murine syngeneic models of solid cancer." As compensation for this right, we agreed to pay Longwood an upfront fee of $15,000. We also agreed to reimburse Longwood for fees and expenses incurred for the preparation, filing, prosecution and maintenance of such patent rights.Contents

Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements and GCP requirements. To ensure cGMP, GTP and GCP compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.

~~Our~~Notwithstanding ~~Research~~the submission of relevant data and ~~Development~~information, ~~Collaborations~~the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data. If the agency decides not to approve the BLA in its present form, the FDA will issue a complete response letter that describes the specific deficiencies in the BLA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for example, requiring additional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant may take for the FDA to consider the application. If a complete response letter is issued, the applicant may either resubmit the BLA, addressing the deficiencies identified in the letter, or withdraw the application.

~~Molipharma~~If ~~Agreement~~a product receives regulatory approval, the approval may be limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a REMS, or otherwise limit the scope of any approval. In addition, the FDA may require post marketing clinical trials, sometimes referred to as Phase 4 clinical trials, designed to further assess a biological product's safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized.

OnIn ~~April 3~~addition, ~~2020~~under the Pediatric Research Equity Act, wea ~~entered~~BLA ~~into~~or supplement to a ~~joint~~BLA ~~venture~~must ~~agreement~~contain ~~("Joint~~data ~~Venture")~~to ~~with~~assess ~~Molipharma,~~the Ssafety and effectiveness 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.R The FDA may grant deferrals for submission of data or full or partial waivers.L. ~~("Molipharma")~~Unless otherwise required by regulation, the Pediatric Research Equity Act does not apply to ~~collaborate~~any inproduct ~~(1) a~~for ~~clinical~~an ~~trial~~indication ~~program~~for inwhich ~~oncology~~orphan ~~development~~designation ~~("Oncology")~~has ~~and~~been ~~(2)~~ granted. However, if only one indication for a ~~clinical~~product ~~trial~~has ~~program~~orphan indesignation, ~~COVID-19~~a ~~Vaccine~~pediatric ~~("COVID~~assessment may still be required for any applications to market that same product for the non-19orphan ~~Vaccine"~~indication(s).

~~With~~Orphan ~~respect~~Drug to Oncology, we will grant a low single digit royalty to Molipharma for turnover of the marketing of ovarian cancer research in Europe. With respect to COVID-19 Vaccine, economic rights in Europe will transfer to Molipharma, and economic rights in the U.S. will transfer to us. Molipharma agreed to financially support the research program for COVID-19 and we agreed to financially support the research program in oncology. The Joint Venture has a duration of five years, extendable for a further five years, unless notice of non-renewal is sent one year before the expiration date. The parties may withdraw from the Joint Venture only for serious and justified reasons or by mutual consent.Designation

OnUnder ~~February~~the 28Orphan Drug Act, ~~2024~~the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, wewhich ~~notified~~is ~~Molipharma~~generally a disease or condition that affects fewer than 200,000 individuals in the U.S., or more than 200,000 individuals in the U.S. and for which there is no reasonable expectation that the cost of developing and making available in the ~~Company’s~~U.S. ~~intent~~a ~~not~~drug toor ~~renew~~biologic for this type of disease or condition will be recovered from sales in the U.S. for that drug or biologic. Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, ~~allowing~~the generic identity of the ~~Joint~~therapeutic ~~Venture~~agent toand ~~expire~~its onpotential ~~April~~orphan 2use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, ~~2025~~or shorten the duration of, the regulatory review or approval process.

22If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic 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 user fee.

~~Table of Contents~~ 21

~~Our~~ Table ~~Competition~~of Contents

~~Our~~A ~~products~~designated ~~will~~orphan ~~compete~~drug ~~with~~may ~~novel~~not ~~therapies~~receive ~~developed~~orphan bydrug ~~biopharmaceutical~~exclusivity ~~companies,~~if ~~academic~~it ~~research~~is ~~institutions,~~approved ~~governmental~~for ~~agencies~~a ~~and~~use ~~public~~that ~~and~~is ~~private~~broader ~~research~~than ~~institutions~~the indication for which it received orphan designation. In addition, exclusive marketing rights in ~~addition~~the U.S. may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to ~~standard~~assure sufficient quantities of ~~care~~the ~~treatments~~product to meet the needs of patients with the rare disease or condition.

InExpedited ~~2017,~~Development ~~two autologous anti-CD19 CAR-T cell therapies, Kymriah, developed by Novartis International AG,~~ and ~~Yescarta,~~Review developed by Kite Pharma, Inc., were approved by the FDA for the treatment of relapsing/remitting B cell precursor acute lymphoblastic leukemia and relapsing/remitting large B cell lymphoma, respectively.Programs

~~Due~~The FDA has a fast-track program that is intended to expedite or facilitate the ~~promising~~process ~~therapeutic~~for ~~effect~~development and review of Tnew ~~cell~~products ~~therapies~~that inmeet ~~clinical~~certain ~~trials~~criteria. Specifically, wenew ~~anticipate~~products ~~increasing~~are ~~competition~~eligible ~~from~~for ~~existing~~FTD if they are intended to treat a serious or life-threatening disease or condition and ~~new~~demonstrate ~~companies~~the ~~developing~~potential ~~these~~to ~~therapies~~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. For a product which receives FTD, asthe ~~well~~FDA asmay inconsider for review sections of the ~~development~~BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of ~~allogeneic~~the Tsections ~~cell~~of ~~therapies~~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. FTD may be rescinded if the FDA determines the program no longer meets the qualifying criteria for the fast-track program.

~~Potential~~Any ~~cell~~product submitted to the FDA for approval including a product with FTD, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority review, breakthrough therapy ~~competitors~~designation, ~~include:~~and accelerated approval. A product is eligible for priority review if is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA will attempt to direct additional resources to the evaluation of an application for a new product designated for priority review in an effort to facilitate the review on a 6 month, rather than the standard 10-month, timeline. Additionally, a product may be eligible for accelerated approval. Products 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 has 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 require that a sponsor of a drug or biological product receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies. In addition, the FDA requires as a condition for accelerated approval that promotional materials be submitted in advance of initial dissemination, which could adversely impact the timing of the commercial launch of the product.

•BTD is ~~Autologous~~also Tintended ~~cell~~to expedite the development and review of products that treat serious or life-threatening conditions. The designation by the FDA requires preliminary clinical evidence that a product candidate, alone or in combination with other drugs and biologics, demonstrates substantial improvement over currently available therapy ~~competition:~~on ~~Adaptimmune~~one ~~Therapeutics~~or ~~PLC~~more clinically significant endpoints, ~~Amgen~~such ~~Inc~~as substantial treatment effects observed early in clinical development., ~~Autolus~~BTD comes ~~Therapeutics~~with ~~plc~~all the benefits of fast-track designation, ~~bluebird~~which means that the sponsor may file sections of the BLA for review on a rolling basis if certain conditions are satisfied, ~~Gilead~~including ~~(acquired~~an ~~Kite~~agreement with the FDA on the proposed schedule for submission of portions of the application and the payment of applicable user fees before the FDA may initiate a review. BTD may be rescinded if the FDA determines the program no longer meets the qualifying criteria for breakthrough therapy. Regenerative Medicine Advanced Therapy (“RMAT”), ~~Novartis~~designation ~~International~~was AGestablished by FDA in 2017 to facilitate an efficient development program for, ~~Celgene~~and expedite review of, any drug that meets the following criteria: (~~acquired~~1) it ~~Juno~~qualifies as a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions; (2) it is intended to treat, ~~Tmunity~~modify, ~~Therapeutics~~reverse, ~~Inc~~or cure a serious or life-threatening disease or condition; and (3) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition. RMAT designation provides potential benefits that may include more frequent meetings with the FDA to discuss the development plan for the product candidate and ~~Unum~~eligibility ~~Therapeutics~~for ~~Inc~~rolling review and priority review.

•Products ~~Allogeneic~~granted TRMAT ~~cell~~designation ~~therapy~~may ~~competition:~~also ~~Atara~~be ~~Biotherapeutics,~~eligible ~~Inc.,~~for ~~Celyad~~accelerated ~~S.A.,~~approval ~~CRISPR~~on ~~Therapeutics~~the ~~AG,~~basis ~~Fate~~of ~~Therapeutics~~a ~~Inc.,~~surrogate ~~Intellia~~or ~~Therapeutics,~~intermediate ~~Inc.,~~endpoint ~~Gilead~~reasonably ~~(acquired~~likely ~~Kite),~~to ~~Allogene~~predict ~~Therapeutics,~~long-term ~~Inc.~~clinical benefit, ~~Poseida~~or ~~Therapeutics~~reliance upon data obtained from a meaningful number of sites, ~~Inc~~including through expansion to additional sites. Once approved, ~~Precision~~when ~~Biosciences~~appropriate, ~~Inc.~~the FDA can permit fulfillment of post-approval requirements under accelerated approval through the submission of clinical evidence, ~~Sangamo~~clinical ~~Therapeutics~~studies, ~~Inc.~~patient registries, ~~and~~or ~~Cytomed~~other ~~Therapeutics~~sources ~~Pte,~~of ~~Ltd~~real-world evidence such as electronic health records; through the collection of larger confirmatory datasets; or through post-approval monitoring of all patients treated with the therapy prior to approval.

• Table ~~GDT~~of cell therapy competition: Adicet Bio, Inc., Lava Therapeutics N.V., IN8 Bio, Inc. TC Biopharm Limited, Acepodia Inc., GammaDelta Therapeutics Limited (acquired by Takeda), ImCheck Therapeutics SAS, Immatics/BMS NV.Contents

FTD, priority review, RMAT and BTD do not change the standards for approval but may expedite the development or approval process.

~~We believe to be unique in our position to target multiple solid malignancies with a combination of non~~Post-~~engineered~~Approval ~~and engineered, but not gene-edited, allogeneic off-the-shelf GDT cells and to be the first to use an innovative low-dose radiation protocol in combination with our cell products.~~Requirements

~~Competition~~Any ~~will~~products ~~also~~for ~~arise~~which ~~from~~we ~~non-cell~~receive ~~based~~FDA ~~immune~~approvals ~~and~~will ~~other~~be ~~pursued~~subject byto ~~small-cap~~continuing ~~biotechnology~~regulation ~~and~~by ~~large-cap~~the ~~pharmaceutical~~FDA, ~~companies~~ including ~~Amgen Inc.~~, ~~AstraZeneca plc~~among other things, ~~Bristol~~record-~~Myers~~keeping ~~Squibb Company~~requirements, ~~Incyte~~reporting ~~Corporation,~~of ~~Merck & Co.~~adverse experiences with the product, ~~Inc.,~~ ~~and~~providing F.the ~~Hoffmann-La~~FDA ~~Roche~~with ~~AG.~~updated ~~For~~safety ~~instance,~~and weefficacy ~~may~~information, ~~experience~~product ~~competition~~sampling ~~from~~and ~~companies~~distribution requirements, ~~such~~and asFDA ~~Amgen Inc.~~promotion and advertising requirements, ~~Regeneron~~which ~~Pharmaceuticals~~include, ~~Inc.,~~ ~~Xencor Inc.~~among others, ~~MacroGenics~~standards for direct-to-consumer advertising, ~~Inc.,~~ ~~GlaxoSmithKline plc~~restrictions ~~and~~on F.promoting ~~Hoffmann-La~~products ~~Roche~~for ~~AG,~~uses or in patient populations that are ~~pursuing~~not ~~bispecific~~described ~~antibodies,~~in ~~which~~the ~~target~~product's ~~both~~approved ~~the~~uses ~~cancer~~(known ~~antigen~~as ~~and~~"off-label ~~TCR~~use"), ~~thus~~limitations ~~bringing~~on ~~both~~industry-sponsored ~~cancer~~scientific ~~cells~~ and Teducational ~~cells~~activities, inand ~~close~~requirements ~~proximity~~for topromotional ~~maximize~~activities involving the ~~likelihood~~internet. ofAlthough ana ~~immune~~physician ~~response~~may toprescribe ~~the~~a ~~cancer~~legally ~~cells.~~available ~~Additionally,~~product ~~companies~~for an off-label use, if the physicians deem such asproduct ~~Amgen Inc.,~~to ~~GlaxoSmithKline plc~~be ~~and~~appropriate ~~Seattle~~in ~~Genetics~~his/her professional medical judgment, ~~Inc~~ a manufacturer may not market or promote off-label uses. However, ~~are~~it ~~pursuing~~is ~~antibody~~permissible ~~drug~~to ~~conjugates,~~share ~~which~~in ~~utilize~~certain ~~the~~circumstances ~~targeting~~truthful ~~ability~~and ofnot ~~antibodies~~misleading toinformation ~~deliver~~that ~~cell-killing~~is ~~agents~~consistent ~~directly~~with tothe ~~cancer~~product's ~~cells~~approved labeling.

~~Many~~In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the long-term stability of ~~our~~the ~~competitors~~product. cGMP regulations require among other things, ~~either~~quality ~~alone~~control orand ~~with~~quality ~~their~~assurance ~~collaboration~~as ~~partners,~~well ~~have~~as ~~significantly~~the ~~greater~~corresponding ~~financial~~maintenance ~~resources~~of records and ~~expertise~~documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers and other entities involved in ~~research~~the manufacture and ~~development,~~distribution ~~pre-clinical~~of ~~testing~~approved products 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 cGMP and other laws. Accordingly, ~~clinical~~manufacturers ~~trials~~must continue to expend time, ~~manufacturing~~money, and ~~marketing~~effort ~~than~~in wethe ~~do.~~area ~~Future~~of ~~collaborations~~production and ~~mergers~~quality ~~and~~control ~~acquisitions~~to maintain cGMP compliance. Discovery of problems with a product after approval may result in ~~further~~restrictions ~~resource~~on ~~concentration~~a product, manufacturer, or holder of an approved BLA, including, among aother ~~smaller~~things, ~~number~~recall or withdrawal of ~~competitors~~the product from the market. In addition, changes to the manufacturing process are strictly regulated, and depending on the significance of the change, may require prior FDA approval before being implemented. Other types of changes to the approved product, such as adding new indications and claims, are also subject to further FDA review and approval.

~~Our~~The ~~commercial~~FDA ~~potential~~also ~~could~~may berequire ~~reduced~~post-marketing ortesting, ~~eliminated~~known ifas ~~our~~Phase 4 ~~competitors~~testing, ~~develop~~ and ~~commercialize~~surveillance ~~products~~to ~~that~~monitor ~~are~~the ~~safer,~~effects ~~more~~of ~~effective,~~an ~~have~~approved ~~fewer~~product. orDiscovery ~~less~~of ~~severe~~previously ~~side~~unknown ~~effects,~~problems ~~are~~with ~~more~~a ~~convenient~~product or ~~are~~the ~~less~~failure ~~expensive~~to ~~than~~comply ~~products~~with ~~that~~applicable weFDA ~~may~~requirements ~~develop.~~can ~~Our~~have ~~competitors~~negative ~~also~~consequences, ~~may~~including ~~obtain~~adverse ~~FDA~~publicity, judicial or ~~other~~administrative ~~regulatory~~enforcement, ~~approval~~warning ~~for~~letters ~~their~~from ~~products~~the ~~more~~FDA, ~~rapidly~~mandated ~~than~~corrective weadvertising ~~may~~or ~~obtain~~communications ~~approval~~with ~~for ours~~doctors, ~~which~~and ~~could~~civil ~~result~~or incriminal ~~our~~penalties, ~~competitors~~among ~~establishing~~others. aNewly ~~strong~~discovered ~~market~~or ~~position~~developed ~~before~~safety weor ~~are~~effectiveness ~~able~~data tomay ~~enter~~require ~~the~~changes ~~market~~to ora ~~make~~product's ~~our~~approved ~~development~~labeling, ~~more~~including ~~complicated.~~the ~~The~~addition ~~key~~of ~~competitive~~new ~~factors~~warnings ~~affecting~~and ~~the~~contraindications, ~~success~~and ofalso ~~all~~may ofrequire ~~our~~the ~~programs~~implementation ~~are~~of ~~likely~~other torisk bemanagement ~~efficacy, safety, and convenience~~measures.

~~These~~Also, ~~competitors~~new ~~may~~government ~~also~~requirements, ~~vie~~including ~~for~~those aresulting ~~similar~~from ~~pool~~new oflegislation, ~~qualified~~may ~~scientific~~be ~~and management talent~~established, ~~sites~~or ~~and~~the ~~patient~~FDA's ~~populations~~policies ~~for~~may ~~clinical trials~~change, aswhich ~~well~~could asdelay ~~for~~or ~~technologies~~prevent ~~complementary~~regulatory ~~to,~~approval orof ~~necessary~~our ~~for,~~products ~~our~~under ~~programs~~development.

~~Corporate Information~~ 23

~~Our~~ Table principal executive office is 7707 Fannin, Suite 200, Houston, TX 77054. Our telephone number is (832) 968-4888. Our website is www.kiromic.com. The information contained on our website is not a part of ~~this annual filing, nor is such~~ Contents

23U.S. Marketing Exclusivity

~~Table~~The Biologics Price Competition and Innovation Act (“BPCIA”) amended the PHSA to authorize the FDA to approve similar versions of ~~Contents~~innovative biologics, commonly known as biosimilars. A competitor seeking approval of a biosimilar must file an application to establish its molecule as highly similar to an approved innovator biologic, among other requirements. This abbreviated approval pathway is intended to permit a biosimilar to come to market more quickly and less expensively by relying to some extent on the data generated by the reference product’s sponsor, and the FDA’s previous review and approval of the reference product. Under the BPCIA, a biosimilar sponsor’s ability to seek or obtain approval through the abbreviated pathway is limited by periods of exclusivity granted by the FDA to the holder of the reference product’s BLA. In general, no biosimilar application may be accepted by the FDA for review until 4 years after the date the reference product was first licensed by the FDA, and no biosimilar application, once accepted, may receive final approval until 12 years after the reference product was first licensed by the FDA.

~~content~~Pediatric ~~incorporated~~exclusivity byis ~~reference~~another ~~herein~~type of regulatory market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and ~~should~~patent ~~not~~terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be ~~relied~~granted ~~upon~~based inon ~~determining~~the ~~whether~~voluntary tocompletion ~~make~~of ana ~~investment~~pediatric trial in ~~our~~accordance ~~common~~with ~~stock~~an FDA-issued "Written Request" for such a trial.

~~GreenPlanet~~Other ~~Pharma~~U.S. Healthcare Laws and Compliance Requirements

~~Our~~In ~~wholly~~the ~~owned~~U.S., ~~subsidiary~~our activities are potentially subject to regulation by various federal, ~~GreenPlanet~~state ~~Pharma~~and local authorities in addition to the FDA, ~~Inc~~ including but not limited to, the Centers for Medicare and Medicaid Services (“CMS”), other divisions of the Department of Health and Human Services (“HHS”) (e.g., the ~~operates~~Office anof ~~oral~~Inspector ~~healthcare~~General, ~~business~~the U.S. ItDepartment ~~has~~of ~~developed~~Justice a(“DOJ”), ~~mouthwash~~and ~~using~~individual aU.S. ~~high~~Attorney ~~quality~~offices within the DOJ, ~~safe~~and state and local governments). For example, our business practices, including any future sales, marketing and ~~natural~~scientific/educational ~~ingredient~~grant ~~formulation~~programs may be required to ~~provide~~comply ~~effective~~with ~~symptomatic~~the ~~relief~~anti-fraud ~~for~~and aabuse ~~wide~~provisions ~~range~~of the Social Security Act, the false claims laws, the patient data privacy and security provisions of ~~oral~~the ~~irritations~~Health Insurance Portability and ~~health~~Accountability ~~concerns~~Act of 1996 (“HIPAA”), transparency requirements, and similar state, local and foreign laws, each as amended.

~~This~~The ~~business~~federal ~~has~~Anti-Kickback ~~not~~Statute ~~generated~~prohibits, among other things, any ~~revenues~~person ~~nor~~or ~~other~~entity, ~~income~~from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for ~~Kiromic~~purchasing, ~~during~~leasing, ordering or arranging for the ~~years~~purchase, ~~ended~~lease ~~December~~or 31order of any item, ~~2023~~good, facility or ~~2022~~service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term remuneration has been interpreted broadly to include anything of value. The federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, formulary managers, and other individuals and entities on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. The exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection.

~~InSilico~~Practices ~~Solutions~~that involve remuneration that may be alleged to be intended to induce prescribing, ~~LLC~~purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Our practices may not in all cases meet all of the criteria for protection under a statutory exception or regulatory safe harbor.

Our wholly owned subsidiary, InSilico Solutions, LLC (“InSilico”), operated a world class bioinformatics and AI services company. The Company completed its acquisition of InSilico on July 26, 2021, which was fully absorbed into Kiromic as of December 31, 2022, and no longer operates as an entity. 24

~~This~~ Table ~~business~~of ~~has not generated any revenues nor other income for Kiromic during the years ended December 31, 2023 or 2022.~~Contents

~~Government~~Additionally, ~~Regulation~~the intent standard under the federal Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, collectively, the Affordable Care Act, to a stricter standard such that a person or entity no longer needs to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. Rather, if "one purpose" of the remuneration is to induce referrals, the federal Anti-Kickback Statute is violated. In addition, the Affordable Care Act codified case law that a claim that includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (discussed below).

AsThe acivil ~~company~~monetary ~~that~~penalties ~~operates~~statute inimposes ~~the~~penalties ~~U.S.,~~against weany ~~are~~person ~~subject~~or toentity ~~extensive~~who, ~~regulation.~~among ~~Biological~~other ~~products~~things, ~~such~~is asdetermined ~~our~~to ~~clinical~~have ~~trial~~presented ~~candidates,~~or ~~are~~caused ~~subject~~ to ~~regulation~~be ~~under~~presented ~~the~~a ~~Federal~~claim ~~Food~~to, ~~Drug~~among others, ~~and~~a ~~Cosmetic~~federal ~~Act~~healthcare ~~(“the~~program ~~FDCA”),~~that the ~~Public~~person ~~Health~~knows ~~Service~~or ~~Act~~should ~~(the~~know ~~“PHSA”),~~is ~~the~~for ~~FDA~~a ~~regulations~~medical ~~under~~or ~~Title~~other 21item ofor ~~the~~service ~~Code~~that ofwas ~~Federal~~not ~~Regulations~~provided ~~(21 CFR),~~ as ~~well~~claimed asor ~~other~~is ~~federal,~~false ~~state~~or ~~and local statutes and regulations~~fraudulent.

~~Government~~The ~~authorities in the U.S. (at the~~ federal, ~~state~~civil ~~and~~False ~~local~~Claims ~~level)~~Act ~~and in other countries extensively regulate~~prohibits, among other things, ~~the~~any ~~research,~~person ~~development,~~or ~~testing,~~entity ~~manufacturing,~~from ~~quality~~knowingly ~~control~~presenting, ~~safety,~~or ~~efficacy~~causing ~~approval,~~to ~~labeling,~~be ~~packaging~~presented, ~~storage,~~a ~~record-keeping,~~false ~~promotion,~~claim ~~advertising,~~for ~~distribution,~~payment ~~post-approval monitoring and reporting~~to, ~~marketing~~or ~~and~~approval ~~export and import of biopharmaceutical products such as those we are developing. Our product candidates must be approved~~ by, the ~~FDA~~federal ~~before~~government ~~they~~or ~~may~~knowingly bemaking, ~~legally~~using, ~~marketed~~or incausing ~~the~~to ~~U.S. and by the appropriate foreign regulatory agency before they may~~ be ~~legally~~made ~~marketed~~or inused ~~foreign~~a ~~countries.~~false ~~Generally,~~record ~~our~~or ~~activities~~statement inmaterial ~~other countries will be subject~~ to ~~regulation~~a ~~that~~false isor ~~similar~~fraudulent inclaim ~~nature~~to ~~and scope as that imposed in~~ the ~~U.S.,~~federal ~~although there can be important differences~~government. ~~Additionally,~~As ~~some~~a ~~significant~~result ~~aspects~~ of ~~regulation in Europe are addressed in~~ a ~~centralized~~modification ~~way,~~made ~~but~~by ~~country-specific~~the ~~regulation~~Fraud ~~remains~~Enforcement ~~essential in many respects. The process for obtaining regulatory marketing approvals~~ and ~~the~~Recovery ~~subsequent~~Act ~~compliance~~of ~~with appropriate federal~~2009, ~~state,~~a ~~local~~claim ~~and~~includes ~~foreign~~"any ~~statutes~~request ~~and~~or ~~regulations~~demand" ~~require~~for ~~the~~money ~~expenditure~~or ofproperty ~~substantial~~presented ~~time~~to ~~and~~the ~~financial~~U.S. ~~resources~~government.

~~U.S.~~HIPAA ~~Product~~created ~~Development~~additional ~~Process~~federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

~~In the U.S.~~Also, ~~the~~many ~~FDA~~states ~~regulates~~have ~~pharmaceutical~~similar ~~and~~fraud ~~biological products under the FDCA, the PHSA,~~ and ~~their~~abuse ~~implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign~~ statutes ~~and~~or regulations ~~require~~that ~~the~~apply ~~expenditure~~to ofitems ~~substantial time~~ and ~~financial~~services ~~resources.~~reimbursed ~~Failure~~under toMedicaid ~~comply~~and with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. FDA sanctions could include, among other ~~actions,~~state ~~refusal to approve pending applications~~programs, ~~withdrawal of an approval, a clinical hold, warning letters, product recalls~~ or ~~withdrawals from the market~~, ~~product~~in ~~seizures,~~several ~~total or partial suspension of production or distribution injunctions~~states, ~~fines,~~apply ~~refusals~~regardless of ~~government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. The process required by~~ the ~~FDA before a biological product may be marketed in the U~~payor.~~S. generally involves the following:~~

•We ~~Completion~~may ofbe ~~nonclinical~~subject ~~laboratory~~to ~~tests~~data privacy and ~~animal~~security ~~studies~~regulations ~~according~~by toboth ~~good~~the ~~laboratory~~federal ~~practices~~government (and the states in which we conduct our business. HIPAA, and its implementing regulations, imposes requirements on covered entity health care providers, health plans, and health care clearinghouses, as well as their “~~GLPs~~business associates”) – certain persons or covered entities that create, receive, maintain, or transmit protected health information in connection with providing a specified service or performing a function on behalf of a covered entity. Although we are not directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we may obtain health information from third parties that are subject to privacy and ~~applicable~~security requirements ~~for~~under ~~the~~HIPAA, ~~humane~~and other privacy and data security and consumer protection laws, and we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly receive individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA, and subject to other civil and/or criminal penalties if we obtain, use, or disclose information in a manner not permitted by other privacy and data security and consumer protection laws. In addition, state laws govern the privacy and security of ~~laboratory~~health ~~animals~~information in specified circumstances, ~~such~~many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Many of the state laws enable a state attorney general to bring actions and provide private rights of action to consumers as enforcement mechanisms. There is also heightened sensitivity around certain types of health data, which may be subject to additional protections. The landscape of federal and state laws regulating personal data is constantly evolving, and compliance with these laws requires a flexible privacy framework and substantial resources, and compliance efforts will likely be an increasing and substantial cost in the ~~Animal~~future. ~~Welfare~~Failure ~~Act~~to comply with these laws and regulations could result in government enforcement actions and create liability for us (which could include civil and/or criminal penalties), private litigation, and/or ~~other~~adverse ~~applicable~~publicity. ~~regulations~~Federal regulators, state attorneys general, and plaintiffs’ attorneys have been active in this space.

~~• Submission to the FDA of an IND, which must become effective before human clinical trials may begin.~~ 25

24 Table of Contents

~~Table~~The Federal Trade Commission (“FTC”) also sets expectations for failing to take appropriate steps to keep consumers’ personal information secure, or failing to provide a level of ~~Contents~~security commensurate to promises made to individuals about the security of their personal information (such as in a privacy notice) may constitute unfair or deceptive acts or practices in violation of Section 5(a) of the Federal Trade Commission Act (“FTC Act”). The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards. With respect to privacy, the FTC also sets expectations that companies honor the privacy promises made to individuals about how the company handles consumers’ personal information; any failure to honor promises, such as the statements made in a privacy policy or on a website, may also constitute unfair or deceptive acts or practices in violation of the FTC Act. While we do not intend to engage in unfair or deceptive acts or practices, the FTC has the power to enforce promises as it interprets them, and events that we cannot fully control, such as data breaches, may result in FTC enforcement. Enforcement by the FTC under the FTC Act can result in civil penalties or other enforcement actions.

•Additionally, ~~Approval~~the byfederal anPhysician ~~independent~~Payments ~~institutional~~Sunshine ~~review~~Act ~~board~~within the Affordable Care Act, and its implementing regulations require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (~~“IRB”~~with certain exceptions) annually report information to CMS related to certain payments or ~~ethics~~other ~~committee~~transfers atof ~~each~~value ~~clinical~~made ~~site~~or ~~before~~distributed ~~the~~to ~~trial~~physicians isand ~~commenced~~teaching hospitals, or to entities or individuals at ~~that~~the ~~site~~request of, or designated on behalf of, physicians and teaching hospitals and certain ownership and investment interests held by physicians and their immediate family members.

•In ~~Performance~~order to distribute products commercially, we must comply with state laws that require the registration of ~~adequate~~manufacturers and ~~well-controlled~~wholesale ~~human~~distributors ~~clinical~~of ~~trials~~drug ~~according~~and tobiological ~~the~~products ~~FDA’s~~in ~~good~~a ~~clinical~~state, ~~practice~~including, ~~requirements~~in ~~(“GCPs”)~~certain states, manufacturers and ~~any~~distributors ~~additional~~who ~~requirements~~ship ~~for~~products into the ~~protection~~state even if such manufacturers or distributors have no place of ~~human~~business ~~research~~within ~~patients~~the ~~and~~state. ~~their~~Some ~~health~~states ~~information,~~also impose requirements on manufacturers and distributors to establish the ~~safety~~pedigree of product in the chain of distribution, including some states that require manufacturers and ~~efficacy~~others to adopt new technology capable of ~~the~~tracking ~~proposed~~and ~~biological~~tracing product ~~for~~as ~~its~~it ~~intended~~moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.

•If ~~Submission~~our operations are found to ~~the~~be ~~FDA~~in violation of aany ~~Biologics~~of ~~License~~the ~~Application~~federal ~~(BLA)~~and ~~for~~state ~~marketing~~healthcare ~~approval~~laws described above or any other governmental regulations that ~~includes~~apply ~~substantial~~to ~~evidence~~us, ofwe ~~safety~~may be subject to penalties, ~~purity~~including without limitation, civil, criminal and ~~potency~~administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from ~~results~~participation ofin ~~nonclinical~~government ~~testing~~programs, such as Medicare and ~~clinical~~Medicaid, ~~trials~~injunctions, asprivate ~~well~~"qui astam" ~~detailed~~actions ~~information~~brought ~~about~~by individual whistleblowers in the ~~chemistry~~name of the government, ~~manufacturing~~or ~~and~~refusal ~~controls~~to allow us to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and ~~proposed~~future ~~labeling~~earnings, additional reporting requirements and/or ~~packaging~~oversight ~~for~~if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the ~~product~~curtailment ~~candidate~~or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

~~• Consideration by an FDA Advisory Committee~~Coverage, ifPricing ~~applicable.~~and Reimbursement

•Significant ~~Satisfactory~~uncertainty ~~completion~~exists as to the coverage and reimbursement status of anany ~~FDA~~product ~~inspection~~candidates for which we obtain regulatory approval. In the U.S. and markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the ~~manufacturing~~extent ~~facility~~to which third-party payors provide coverage, and establish adequate reimbursement levels for such products. In the U.S., third-party payors include federal and state healthcare programs, private managed care providers, health insurers and other organizations. The process for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price of a product or ~~facilities~~for ~~where~~establishing the ~~biological~~reimbursement rate that such a payor will pay for the product. ~~candidate~~Third-party ispayors ~~produced~~may limit coverage to ~~assess~~specific ~~compliance~~products ~~with~~on ~~cGMP~~an approved list, toor ~~assure~~also ~~that~~known ~~the~~as ~~facilities~~a formulary, ~~methods~~which ~~and~~might ~~controls~~not include all of the FDA-approved products for a particular indication. Third-party payors are ~~adequate~~increasingly tochallenging ~~preserve~~the price, examining the ~~biological~~medical ~~product’s~~necessity ~~identity~~and reviewing the cost-effectiveness of medical products, ~~strength~~therapies and services, ~~quality~~in addition to questioning their safety and ~~purity~~efficacy. We may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and, ifcost-effectiveness ~~applicable~~of our products, in addition to the costs required to obtain the FDA’ approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor's ~~current~~decision ~~good~~to ~~tissue~~provide ~~practices~~coverage ~~(“cGTPs”)~~for a product does not imply that an adequate reimbursement rate will be approved. Further, one payor's determination to provide coverage for a product does not ensure that other payors will also provide coverage for the ~~use~~product. ofAdequate ~~human~~third-party ~~cellular~~reimbursement ~~and~~may ~~tissue~~not ~~products~~be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

~~• Satisfactory completion of potential FDA audits of the nonclinical study and clinical trial sites that generated the data in support of the BLA.~~ 26

• Table ~~FDA review and approval, or licensure,~~ of ~~the BLA, including agreement on post-marketing commitments, if applicable.~~Contents

~~Before~~Different ~~testing~~pricing ~~any~~and ~~biological~~reimbursement ~~product~~schemes ~~candidate,~~exist ~~including~~in ~~our~~other ~~product~~countries. ~~candidates,~~In ~~in humans,~~ the ~~product~~European ~~candidate~~Union ~~enters~~ (the ~~preclinical testing stage. Preclinical tests~~“EU”), ~~also~~governments ~~referred~~influence tothe asprice ~~nonclinical~~of ~~studies,~~pharmaceutical ~~include~~products ~~laboratory~~through ~~evaluations~~their ofpricing ~~product~~and ~~chemistry,~~reimbursement ~~toxicity~~rules and ~~formulation,~~control asof ~~well~~national ashealth ~~animal~~care ~~studies~~systems tothat ~~assess~~fund ~~the~~a ~~potential~~large ~~safety~~part ~~and activity~~ of the ~~product~~cost ~~candidate. The conduct~~ of ~~the~~those ~~preclinical~~products ~~tests~~to ~~must~~consumers. ~~comply~~Some ~~with~~jurisdictions ~~federal~~operate ~~regulations~~positive and ~~requirements~~negative ~~including~~list ~~GLPs~~systems ~~and~~under ~~the~~which ~~Animal~~products ~~Welfare~~may ~~Act.~~only ~~The~~be ~~clinical~~marketed ~~trial~~once ~~sponsor~~a ~~must~~reimbursement ~~submit~~price ~~the~~has ~~results~~been ofagreed. ~~the~~To ~~preclinical~~obtain ~~tests,~~reimbursement ~~together with manufacturing information, analytical data, any available clinical data~~ or ~~literature~~pricing ~~and a proposed clinical protocol~~approval, tosome ~~the FDA as part~~ of ~~the~~these ~~IND.~~countries ~~Some preclinical testing~~ may ~~continue~~require ~~even after~~ the ~~IND~~completion isof ~~submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed~~ clinical trials ~~and~~that ~~places~~compare the ~~trial~~cost-effectiveness onof a ~~clinical~~particular ~~hold~~product ~~within~~candidate ~~that~~to ~~30-day~~currently ~~time~~available ~~period~~therapies. InOther ~~such~~member astates ~~case,~~allow ~~the~~companies ~~IND~~to ~~sponsor~~fix ~~and~~their ~~the~~own ~~FDA~~prices ~~must~~for ~~resolve~~medicines but ~~any~~monitor ~~outstanding~~and ~~concerns~~control ~~before~~company ~~the clinical trial can begin~~profits. The ~~FDA~~downward ~~may~~pressure ~~also impose clinical holds~~ on anhealth ~~IND~~care atcosts ~~any~~has ~~time~~become ~~before~~very ~~or during clinical trials for a biological product candidate due to safety concerns or non-compliance~~intense. IfAs ~~the FDA imposes~~ a ~~clinical hold~~result, ~~trials~~increasingly ~~may~~high ~~not~~barriers ~~recommence~~are ~~without~~being ~~FDA~~erected ~~authorization~~to ~~and then only under terms authorized by~~ the ~~FDA.~~entry ~~Accordingly, we cannot be sure that submission~~ of annew ~~IND~~products. ~~will~~In ~~result~~addition, in ~~the~~some ~~FDA allowing clinical trials to begin~~countries, orcross-border ~~that,~~imports ~~once~~from ~~begun,~~low-priced ~~issues~~markets ~~will~~exert ~~not~~commercial ~~arise~~pressure ~~that~~on ~~suspend~~pricing orwithin ~~terminate~~a ~~such trials~~country.

~~Clinical~~The ~~trials~~marketability ~~involve the administration~~ of ~~the~~any ~~biological~~ product ~~candidate~~candidates tofor ~~patients~~which ~~under~~we ~~the~~receive ~~supervision~~regulatory ofapproval ~~qualified~~for ~~investigators,~~commercial ~~generally~~sale ~~physicians~~may ~~not~~suffer ~~employed~~if ~~by or under~~ the ~~trial~~government ~~sponsor's control. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection~~ and ~~exclusion~~third-party ~~criteria,~~payors ~~and~~fail ~~the parameters~~ to beprovide ~~used~~adequate tocoverage ~~monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events should occur. Each protocol~~ and ~~any amendments to the protocol must be submitted to the FDA as part of the IND~~reimbursement. ~~Clinical~~In ~~trials~~addition, ~~must~~emphasis beon ~~conducted~~managed ~~and~~care ~~monitored~~ in ~~accordance with~~ the FDA's regulations and GCP requirements, which establish standards for conducting, recording data from, and reporting the results of clinical trials, with the goals of assuring that the data and results are credible and accurate and that study participants’ rights, safety, and well-being are protectedU. ~~GCP requirements also include the requirement that all research patients provide informed consent~~S. ~~Further,~~has ~~each~~increased ~~clinical trial must be reviewed~~ and ~~approved~~we byexpect ~~an independent IRB at or servicing each institution at which the clinical trial~~ will becontinue ~~conducted. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks~~ to ~~individuals~~increase ~~participating in~~ the ~~clinical~~pressure ~~trials~~on ~~are~~healthcare ~~minimized and are reasonable in relation to anticipated benefits~~pricing. ~~The~~Coverage ~~IRB~~policies ~~also approves the form~~ and ~~content~~third-party ofreimbursement ~~the~~rates ~~informed~~may ~~consent~~change ~~that~~at ~~must~~any ~~be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed~~time. Certain clinical trials involving human gene transfer research also must be overseen by an Institutional Biosafety Committee (“IBC”), a standing committee to provide peer review of the safety of research plans, procedures, personnel training and environmental risks of work involving recombinant DNA or RNA molecules. IBCs are typically assigned certain review responsibilities relating to the use of recombinant DNA or RNA molecules, including

25Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

~~Table~~Healthcare ~~of Contents~~Reform

~~reviewing~~In ~~potential~~the ~~environmental~~U.S. ~~risks,~~and ~~assessing~~some ~~containment~~foreign ~~levels~~jurisdictions, ~~and~~there ~~evaluating~~have ~~the~~been, ~~adequacy~~and ofcontinue ~~facilities~~to be, ~~personnel~~several ~~training,~~legislative and ~~compliance~~regulatory ~~with~~changes ~~the~~and ~~National~~proposed ~~Institutes~~changes ofregarding ~~Health~~the ~~Guidelines.~~healthcare ~~Some~~system ~~studies~~that ~~also~~could ~~include~~prevent ~~oversight~~or bydelay anmarketing ~~independent~~approval ~~group~~ of ~~qualified~~product ~~experts~~candidates, ~~organized~~restrict byor ~~the~~regulate ~~clinical~~post-approval ~~study sponsor~~activities, ~~known~~and asaffect athe ~~data~~ability ~~safety~~to ~~monitoring~~profitably ~~board~~sell ~~(“DSMB”),~~product ~~which~~candidates ~~provides authorization~~ for ~~whether~~which ormarketing ~~not~~approval ais ~~study~~obtained. ~~may~~Among ~~move~~policy ~~forward~~makers atand ~~designated~~payors ~~check~~in ~~points based on access to certain data from~~ the ~~study~~U.S. and ~~may~~elsewhere, ~~halt~~there ~~the~~is ~~clinical~~significant ~~trial~~interest ifin itpromoting ~~determines~~changes ~~that~~in ~~there~~healthcare issystems anwith ~~unacceptable~~the ~~safety~~stated ~~risk~~goals ~~for~~of ~~subjects~~containing orhealthcare ~~other grounds~~costs, ~~such~~improving asquality noand/or ~~demonstration~~expanding ofaccess. ~~efficacy~~In the U.S., ~~There~~the ~~are~~pharmaceutical ~~also~~industry ~~requirements~~has ~~governing~~been ~~the~~a ~~reporting~~particular focus of ~~ongoing~~these ~~clinical~~efforts ~~trials~~ and ~~clinical~~has ~~trials~~been ~~results~~significantly toaffected ~~public~~by ~~registries~~major legislative initiatives.

~~Human~~For ~~clinical~~example, ~~trials~~the ~~are~~Affordable ~~typically~~Care ~~conducted~~Act has substantially changed healthcare financing and delivery by both governmental and private insurers. Among the Affordable Care Act provisions of importance to the pharmaceutical and biotechnology industries, in ~~three~~addition ~~sequential~~to ~~phases~~those ~~that~~otherwise ~~may~~described ~~overlap~~above, orare bethe ~~combined~~following:

●• ~~Phase~~Created 1.an ~~The biological product candidate is initially introduced into healthy human subjects and tested for safety and to develop detailed profiles of its pharmacological and pharmacokinetic actions~~annual, ~~determine~~nondeductible ~~side~~fee ~~effects~~on ~~associated~~any ~~with~~entity ~~increasing~~that ~~doses,~~manufactures ~~and, if possible, gain early evidence of effectiveness. In the case of some products for severe~~ or ~~life-threatening~~imports ~~diseases,~~certain ~~especially~~specified ~~when~~branded ~~the~~prescription ~~product~~drugs ~~candidate~~and ~~may~~biologic beagents ~~too~~apportioned ~~inherently~~among ~~toxic~~these toentities ~~ethically~~according ~~administer~~ to ~~healthy~~their ~~volunteers,~~market ~~the~~share ~~initial~~in ~~human~~some ~~testing~~government ishealthcare ~~often~~programs ~~conducted~~that began in ~~patients~~2011.

●• ~~Phase~~Increased 2.the ~~The~~statutory ~~biological~~minimum ~~product~~rebates ~~candidate~~a ismanufacturer ~~evaluated~~must inpay aunder ~~limited~~the ~~patient~~Medicaid ~~population~~Drug toRebate ~~identify~~Program, ~~possible~~retroactive ~~adverse~~to ~~effects~~January ~~and~~1, ~~safety risks~~2010, to ~~preliminarily~~23.1% ~~evaluate~~and ~~the~~13% ~~efficacy~~ of the ~~product~~average manufacturer price (“AMP”) for ~~specific~~most ~~targeted~~branded ~~diseases~~and generic drugs, respectively, and tocapped ~~determine~~the ~~dosage~~total ~~tolerance,~~rebate ~~optimal~~amount ~~dosage~~for ~~and~~innovator ~~dosing~~drugs ~~schedule~~at 100% of the AMP.

• Created a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70% point-of-sale discounts, off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturers' outpatient drugs to be covered under Medicare Part D.

●• ~~Phase~~Extended 3.manufacturers' ~~Clinical~~Medicaid ~~trials~~rebate ~~are~~liability ~~undertaken~~ to ~~further~~covered ~~evaluate~~drugs ~~dosage,~~dispensed ~~clinical~~to ~~efficacy,~~individuals ~~potency,~~who ~~and~~are ~~safety~~enrolled in anMedicaid ~~expanded~~managed ~~patient~~care ~~population at geographically dispersed clinical trial sites~~organizations. ~~These clinical trials are intended to establish the overall risk to benefit ratio of the product candidate and provide an adequate basis for product labeling.~~

• Expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and added new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers' Medicaid rebate liability.

~~Post-approval~~• ~~clinical~~Expanded ~~trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical trials are used to gain additional experience from~~ the ~~treatment~~list of ~~patients~~entities ineligible ~~the intended therapeutic indication, particularly~~ for ~~long-term~~discounts ~~safety~~under 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. Annual progress reports detailing the ~~results~~340B ofDrug ~~the~~Discount ~~clinical trials must be submitted to the FDA~~Program. Written IND safety reports must be promptly submitted to the FDA, and the investigators for serious and unexpected adverse events, any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant risk for human patients, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor's initial receipt of the information. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all. The FDA or the sponsor or its DSMB may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB's requirements or if the biological product has been associated with unexpected serious harm to patients.

Human immunotherapy products are a new category of therapeutics. Because this is a relatively new and expanding area of novel therapeutic interventions, there can be no assurance as to the length of the trial period, the number of patients the FDA will require to be enrolled in the trials in order to establish the safety, efficacy, purity and potency of immunotherapy product candidates, or that the data generated in these trials will be acceptable to the FDA to support marketing approval. 27

~~Concurrently~~ Table ~~with clinical trials, companies usually complete additional nonclinical studies and must also develop additional information about the physical characteristics~~ of the biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. To help reduce the risk of the introduction of adventitious agents with use of biological products, the PHSA 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, Contents

26• Created a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.

~~Table~~• ofExpanded ~~Contents~~healthcare fraud and abuse laws, including the Foreign Corrupt Practices Act (the “FCPA”), and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance.

~~appropriate~~• ~~packaging~~Created ~~must~~a benew ~~selected~~methodology ~~and~~by ~~tested,~~which ~~and~~rebates ~~stability~~owed ~~studies~~by ~~must~~manufacturers beunder ~~conducted~~the toMedicaid ~~demonstrate~~Drug ~~that~~Rebate ~~the~~Program ~~biological~~are ~~product~~calculated ~~candidate~~for ~~does~~drugs ~~not~~that ~~undergo~~are ~~unacceptable~~inhaled, ~~deterioration~~infused, ~~over~~instilled, ~~its~~implanted, ~~shelf~~or ~~life~~injected.

~~The~~• ~~sponsor~~Required reporting of ~~a clinical trial or the sponsor’s designated responsible party may be required to register~~ certain ~~information~~financial ~~about~~arrangements ~~the~~with ~~trial~~physicians and ~~disclose~~teaching ~~certain results on government or independent registry websites, such as ClinicalTrials~~hospitals.gov. Additionally, a manufacturer of an investigational drug for a serious disease or condition is required to make available, such as by posting on its website, its policy on evaluating and responding to requests for individual patient access to such investigational drug. This requirement applies on the earlier of the first initiation of a Phase 2 or Phase 3 trial of the investigational drug or, as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative medicine advanced therapy.

~~U.S.~~• ~~Review~~Required annual reporting of certain information regarding drug samples that manufacturers and ~~Approval~~distributors ~~Processes~~provide to physicians.

~~After~~• ~~the~~Established ~~completion of clinical trials of~~ a ~~biological~~Center ~~product,~~for ~~FDA~~Medicare ~~approval of a BLA must be obtained before commercial marketing of the biological product. The BLA submission must include results of product development, laboratory~~ and ~~animal~~Medicaid ~~studies,~~Innovation ~~human~~at ~~trials,~~CMS ~~information~~to ontest ~~the~~innovative ~~manufacture~~payment and ~~composition~~service ofdelivery ~~the~~models ~~product,~~to ~~proposed~~lower ~~labeling~~Medicare and ~~other~~Medicaid ~~relevant information~~spending. The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.

~~Under~~• ~~the~~Created ~~Prescription Drug User Fee Act, as amended (“PDUFA”), each BLA must be accompanied by~~ a ~~significant~~licensure ~~user~~framework ~~fee. The FDA adjusts the PDUFA user fees on an annual basis. The PDUFA also imposes an annual program fee~~ for ~~biological~~follow products. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on ~~BLAs~~biologic ~~for~~ products ~~designated as orphan drugs, unless the product also includes a non-orphan indication~~.

~~Within~~There ~~60 days~~have ~~following~~been ~~submission~~legal ofchallenges ~~the~~and ~~application,~~legislative ~~the~~changes ~~FDA reviews a BLA submitted~~ to ~~determine~~certain ifaspects ~~it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time~~ of ~~submission and may request additional information. In this event,~~ the ~~BLA~~Affordable ~~must~~Care ~~be resubmitted with the additional information~~Act. ~~The~~For ~~resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing~~example, ~~the FDA begins an~~ in~~-depth~~ ~~substantive~~December ~~review~~2017, ofCongress ~~the~~repealed, ~~BLA.~~effective ~~FDA~~January ~~performance goals generally provide for action on a BLA within 10 months of the 60-day filing date~~1, ~~which would be within 12 months of its submission. That deadline can be extended under certain circumstances~~2019, ~~including by~~ the ~~FDA’s~~tax ~~requests~~penalty for ~~additional~~an ~~information.~~individual's ~~The~~failure ~~targeted action date can also be shortened~~ to ~~six~~maintain ~~months~~Affordable ofCare ~~the 60~~Act-~~day~~mandated ~~filing~~health ~~date~~insurance, orcommonly ~~eight~~known ~~months~~as ~~after submission, for products that are granted priority review designation because they are intended to treat serious or life-threatening conditions and demonstrate~~ the ~~potential~~"individual ~~to address unmet medical needs. The FDA reviews the BLA to determine~~mandate", ~~among~~as ~~other~~part ~~things,~~of ~~whether~~ the ~~proposed~~Tax ~~product~~Cuts ~~is safe, potent,~~ and~~/or~~ ~~effective~~Jobs ~~for~~Act its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product's identity, safety, strength, quality, potency and purity. The FDA may refer applications for novel biological products or biological products that present difficult questions of ~~safety~~2017 ~~or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for consideration, discussion and a vote on specific questions relevant to~~ (the ~~approval~~“Tax ~~decision~~Act”). ~~The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.~~

~~During~~Congress is continuing to consider legislation that would alter other aspects of the ~~biological~~Affordable ~~product~~Care ~~approval~~Act. ~~process~~The ultimate content, ~~the~~timing ~~FDA~~or ~~also~~effect ~~will~~of ~~determine~~any ~~whether~~healthcare areform ~~Risk~~legislation ~~Evaluation~~on ~~and~~the ~~Mitigation~~U.S. ~~Strategy~~healthcare ~~(“REMS”),~~industry is ~~necessary~~unclear. It is unclear how efforts to ~~assure~~modify or challenge the ~~safe~~Affordable ~~use~~Care ofAct or its implementing regulations, or portions thereof, will affect our business. Additional legislative and regulatory changes, and further judicial challenges, related to the ~~biological~~Affordable Care Act remain possible. Any such changes or challenges could have a material adverse effect on our industry generally and on our ability to successfully commercialize our product candidates.

AWe ~~REMS~~anticipate isthat athe ~~safety~~Affordable ~~strategy~~Care toAct, ~~manage~~if asubstantially ~~known~~maintained orin ~~potential~~its ~~serious~~current ~~risk~~form, ~~associated~~will ~~with~~continue ato ~~medicine~~result ~~and~~in toadditional ~~enable~~downward ~~patients~~pressure toon ~~have~~coverage ~~continued~~and ~~access~~the toprice ~~such~~that ~~medicines~~we byreceive ~~managing~~for ~~their~~any ~~safe~~approved ~~use~~product, and could ~~include~~seriously harm our business. Any reduction in reimbursement from Medicare and other government programs may result in a ~~medication~~similar ~~guide,~~reduction ~~communication~~in ~~plan,~~payments orfrom ~~elements~~private topayors. ~~assure~~The ~~safe~~implementation ~~use,~~of ~~such~~cost ascontainment ~~required~~measures or other healthcare ~~provider~~reforms ormay ~~pharmacy~~prevent ~~certification,~~us afrom ~~patient~~being ~~registry~~able ~~and~~to ~~other~~generate ~~risk~~revenue, ~~minimization~~attain ~~tools~~profitability, or commercialize our products. IfSuch ~~the~~reforms ~~FDA~~could ~~concludes~~have aan ~~REMS~~adverse iseffect ~~needed,~~on ~~the~~anticipated ~~sponsor~~revenue offrom ~~the~~product ~~BLA~~candidates ~~must~~that ~~submit~~we amay ~~proposed~~successfully ~~REMS,~~develop and ~~the~~for ~~FDA~~which ~~will~~we ~~not~~may ~~approve~~obtain aregulatory ~~BLA~~approval ~~without~~and amay ~~REMS~~affect our overall financial condition and ability to develop product candidates.

~~Before~~Further ~~approving~~legislation aor ~~BLA~~regulation could be adopted that could harm our business, financial condition and results of operations. Other legislative changes have been proposed and adopted since the ~~FDA~~Affordable ~~will~~Care ~~inspect~~Act was enacted. For example, in August 2011, President Obama signed into law the ~~facilities~~Budget atControl Act of 2011, which, among other things, created the ~~product~~Joint isSelect ~~manufactured~~Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The ~~FDA~~Joint ~~will~~Select Committee on Deficit Reduction did not ~~approve~~achieve ~~the~~a ~~product~~targeted ~~unless~~deficit itreduction ~~determines~~of ~~that~~at least $1.2 trillion for fiscal years 2012 through 2021, triggering the ~~manufacturing~~legislation's ~~processes~~automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year, which went into effect beginning on April 1, 2013, and, ~~facilities~~due ~~are~~to subsequent legislation, will stay in ~~compliance~~effect through 2030, with ~~cGMP~~the ~~requirements~~exception ~~and~~of ~~adequate~~a temporary suspension from May 1, 2020, through May 31, 2022, due to ~~assure~~the ~~consistent~~COVID-19 ~~production~~pandemic. The law provides for 1% Medicare sequestration in the second quarter of 2022 and allows the ~~product~~full ~~within~~2% ~~required~~sequestration ~~specifications~~thereafter until 2030. ~~For~~To ~~immunotherapy~~offset ~~products,~~the temporary suspension during the ~~FDA~~COVID-19 ~~also~~pandemic, in 2030, the sequestration will ~~not~~be ~~approve~~2.25% for the ~~product~~first ifhalf of the ~~manufacturer~~year, isand ~~not~~3% in ~~compliance~~the ~~with~~second half of the ~~GTPs~~year. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to ~~the~~several ~~extent~~types ~~applicable.~~of ~~These~~providers, ~~are~~including ~~FDA~~hospitals, ~~regulations~~imaging centers and ~~guidance~~cancer ~~documents~~treatment ~~that~~centers, ~~govern~~and increased the ~~methods~~statute ~~used~~of ~~in,~~limitations ~~and~~period for the government to recover overpayments to providers from three to five years.

27 28

Table of Contents

Additionally, there has been increasing legislative, regulatory and enforcement interest in the ~~facilities~~U.S. with respect to specialty and ~~controls~~other ~~used~~drug ~~for~~pricing practices. Among other things, ~~the~~there ~~manufacture~~have ofbeen ~~human~~several ~~cells~~U.S. Congressional inquiries and federal and state legislative and regulatory activity designed to, ~~tissue~~among other things, ~~and~~bring ~~cellular~~more transparency to drug pricing, reduce the cost of prescription drugs under Medicare and ~~tissue-based~~other ~~products~~government ~~(“HCT/Ps”)~~programs, ~~which~~examine ~~are~~the ~~human~~relationship ~~cells~~between orpricing ~~tissue~~and ~~intended~~manufacturer patient programs, and reform government program reimbursement methodologies for ~~implantation~~drugs. For example, ~~transplant~~at the federal level, ~~infusion~~in September 2018, orCMS ~~transfer~~announced ~~into~~that ait ~~human~~will ~~recipient.~~allow ~~The~~Medicare ~~primary~~Advantage ~~intent~~Plans ofthe option to use step therapy for Part B drugs beginning January 1, 2019. Congress and the ~~GTP~~U.S. ~~requirements~~President's isadministration tohave ~~ensure~~each indicated that ~~cell~~it will continue to seek new legislative and/or ~~tissue-based~~administrative ~~products~~measures ~~are~~to ~~manufactured~~control drug costs. Individual states in athe ~~manner~~United States have also become increasingly active in passing legislation and implementing regulations designed to ~~prevent~~control ~~the~~pharmaceutical ~~introduction~~product pricing, ~~transmission~~including ~~and~~those ~~spread~~regarding ofprice ~~communicable~~or ~~disease.~~patient ~~FDA~~reimbursement ~~regulations~~constraints, ~~also~~discounts, ~~require~~restrictions ~~tissue~~on ~~establishments~~certain toproduct ~~register~~access, and ~~list~~marketing ~~their~~cost ~~HCT/Ps~~disclosure ~~with~~and ~~the~~transparency ~~FDA~~measures, and, ~~when~~in ~~applicable~~some cases, toimportation ~~evaluate~~from ~~donors~~other ~~through~~countries ~~screening~~ and ~~testing~~bulk purchasing.

~~Additionally,~~The ~~before~~Foreign ~~approving~~Corrupt aPractices BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical trials were conducted in compliance with IND trial requirements and GCP requirements. To assure cGMP, GTP and GCP compliance, an applicant must incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.Act

~~Notwithstanding~~The ~~the~~FCPA ~~submission~~prohibits ofany ~~relevant~~U.S. ~~data~~individual ~~and~~or ~~information,~~business ~~the~~from ~~FDA~~paying, ~~may~~offering, ~~ultimately~~or ~~decide~~authorizing ~~that~~payment ~~the~~or ~~BLA~~offering ~~does~~of ~~not~~anything ~~satisfy~~of ~~its~~value, ~~regulatory~~directly ~~criteria~~or ~~for~~indirectly, ~~approval.~~to ~~Data~~any ~~obtained~~foreign ~~from~~official, ~~clinical~~political ~~trials~~party ~~are~~or ~~not~~candidate ~~always~~for ~~conclusive and~~ the ~~FDA~~purpose ~~may~~of ~~interpret~~influencing ~~data~~any ~~differently~~act ~~than~~or wedecision ~~interpret~~of the ~~same~~foreign ~~data.~~entity ~~If the agency decides not~~ to ~~approve~~assist the ~~BLA~~individual inor ~~its~~business ~~present~~in ~~form,~~obtaining ~~the~~or ~~FDA~~retaining ~~will~~business. ~~issue~~The aFCPA ~~complete~~also ~~response~~obligates ~~letter~~companies ~~that~~whose ~~describes~~securities ~~all~~are oflisted ~~the specific deficiencies~~ in the ~~BLA identified by the FDA~~U.S. ~~The~~to ~~deficiencies~~comply ~~identified~~with ~~may~~accounting beprovisions ~~minor, for example,~~ requiring ~~labeling changes, or major, for example, requiring additional clinical trials. Additionally,~~ the ~~complete~~company ~~response~~to ~~letter~~maintain ~~may~~books ~~include~~and ~~recommended~~records ~~actions~~ that ~~the~~accurately ~~applicant~~and ~~may~~fairly ~~take~~reflect ~~for~~all ~~the~~transactions ~~FDA~~of ~~to consider~~ the ~~application.~~corporation, Ifincluding ainternational ~~complete response letter is issued~~subsidiaries, ~~the~~and ~~applicant~~to ~~may~~devise ~~either~~and ~~resubmit~~maintain ~~the~~an ~~BLA,~~adequate ~~addressing~~system ~~all~~ of ~~the~~internal ~~deficiencies~~accounting ~~identified~~controls infor ~~the~~international ~~letter, or withdraw the application~~operations.

IfAdditional a product receives regulatory approval, the approval may be limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing in the form of a REMS, or otherwise limit the scope of any approval. In addition, the FDA may require post marketing clinical trials, sometimes referred to as Phase 4 clinical trials, designed to further assess a biological product's safety and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized.Regulation

In addition to the foregoing, ~~under~~state and federal laws regarding environmental protection and hazardous substances, including the ~~Pediatric~~Occupational ~~Research~~Safety ~~Equity~~and Health Act, athe ~~BLA~~Resource orConservancy ~~supplement~~and toRecovery aAct ~~BLA~~and ~~must~~the ~~contain~~Toxic ~~data~~Substances toControl ~~assess~~Act, affect our business. These and other laws govern our use. The General Data Protection Regulation (the ~~safety~~“GDPR”) applies extraterritorially, and ~~effectiveness~~we may be subject to the GDPR because of our data processing activities that involve the ~~product~~personal ~~for~~data of individuals located in the ~~claimed~~EU, ~~indications~~such as in ~~all~~connection ~~relevant~~with ~~pediatric~~our ~~subpopulations~~EU ~~and~~clinical totrials. ~~support~~Failure ~~dosing~~to ~~and~~comply ~~administration~~with ~~for~~the ~~each~~requirements ~~pediatric~~of ~~subpopulation~~the ~~for~~GDPR ~~which~~and the ~~product~~applicable isnational ~~safe~~data ~~and~~protection ~~effective.~~laws ~~The~~of ~~FDA~~the ~~may~~EU ~~grant~~member ~~deferrals~~states ~~for~~may ~~submission~~result in fines of ~~data~~up orto ~~full~~€20,000,000 or ~~partial~~up ~~waivers.~~to ~~Unless~~4% ~~otherwise~~of ~~required~~the bytotal ~~regulation,~~worldwide ~~the~~annual ~~Pediatric~~turnover ~~Research~~(i.e. ~~Equity~~revenue) ~~Act~~of ~~does~~the ~~not~~preceding ~~apply~~financial toyear, ~~any~~whichever ~~product~~is ~~for~~higher, anand ~~indication~~other ~~for~~administrative ~~which~~penalties. ~~orphan~~GDPR ~~designation~~regulations ~~has~~may ~~been~~impose ~~granted.~~additional ~~However,~~responsibility ifand ~~only~~liability ~~one~~in ~~indication~~relation ~~for~~to athe ~~product~~personal ~~has~~data ~~orphan~~that ~~designation~~we process, aand ~~pediatric~~we ~~assessment~~ may ~~still~~ be required ~~for~~to ~~any~~put ~~applications~~in toplace ~~market~~additional ~~that~~mechanisms ~~same~~to ~~product~~ensure ~~for~~compliance with the ~~non-orphan~~new ~~indication(s)~~data protection rules.

~~Orphan~~The ~~Drug~~GDPR ~~Designation~~imposes strict obligations and restrictions on the ability to collect, analyze and transfer personal data. In particular, these obligations and restrictions concern the consent of the individuals to whom the personal data relates, the information provided to the individuals, the sharing of personal data with third parties, the transfer of personal data out of the EU, security breach notifications, security and confidentiality of the personal data and imposition of substantial potential fines for violations of the data protection obligations. Specifically regarding the transfer of personal data outside of the EU, while there are legal mechanisms available to lawfully transfer personal data outside of the EU, including to the United States, there are certain unsettled legal issues regarding such data transfers, the resolution of which may adversely affect our ability to transfer personal data or otherwise may cause us to incur significant costs to come into compliance with applicable data transfer impact assessments and implementation of legal data transfer mechanisms. On July 16, 2020, the European Court of Justice ruled the EU-US Privacy Shield to be an invalid data transfer mechanism and confirmed that the Model Clauses remain valid, and in June 2021, the European Commission published updated versions of the Model Clauses, which must be incorporated into new and existing agreements within prescribed timeframes in order to continue to lawfully transfer personal data outside of the EU. Data protection authorities from the different EU member states, as well as in the United Kingdom and Switzerland, have promulgated national privacy laws that impose additional requirements, which add to the complexity of processing and transferring EU personal data, with the United Kingdom and Switzerland following the EU with the publication of new Model Clauses to be incorporated in all applicable contracts within a specified timeframe in order to legitimize data transfers from those jurisdictions. Our ability to continue to transfer personal data outside of the EU, United Kingdom, or Switzerland may become significantly more costly and may subject us to increased scrutiny and liability under the GDPR or similar local laws, and we may experience operating disruptions if we are unable to conduct these transfers in the future.

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the U.S., or more than 200,000 individuals in the U.S. and for which there is no reasonable expectation that the cost of developing and making available in the U.S. a drug or biologic for this type of disease or condition will be recovered from sales in the U.S. for that drug or biologic. 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. The orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process. 29

If Table a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic 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 user fee.Contents

28California Consumer Privacy Act

~~Table~~The California Consumer Privacy Act (“CCPA”) creates new individual privacy rights for consumers (as that word is broadly defined in the law) and places increased privacy and security obligations on entities handling personal data of ~~Contents~~consumers or households. The CCPA requires covered companies to provide new disclosures to California consumers, provide such consumers with new ways to opt-out of certain sales of personal information, and allow for a new cause of action for data breaches. The CCPA and its implementing regulations have already been amended multiple times since their enactment. In November 2020, California voters approved the California Privacy Rights Act (“CPRA”) ballot initiative which introduced significant amendments to the CCPA and established and funded a dedicated California privacy regulator, the California Privacy Protection Agency (“CPPA”). The amendments introduced by the CPRA went into effect on January 1, 2023, and new implementing regulations are expected to be introduced by the CPPA. Failure to comply with the CCPA may result in, among other things, significant civil penalties and injunctive relief, or potential statutory or actual damages. In addition, California residents have the right to bring a private right of action in connection with certain types of incidents. These claims may result in significant liability and potential damages. We implemented processes to manage compliance with the CCPA and continue to assess the impact of the CPRA, and other state legislation, on our business as additional information and guidance becomes available. Similarly, there are several legislative proposals in the United States at both the federal and state level that could impose new obligations or limitations in the area of consumer protection. These laws and regulations are evolving and may impose limitations on our business activities. The obligations to comply with new privacy laws may require us, among other things, to update our notices and develop new processes internally and with our service providers to facilitate consumer rights requests, and such laws may impose restrictions on our processing of personal information that may impact the way we operate our business. We may be subject to fines, penalties, or private actions in the event of non-compliance with such laws.

AHuman designated orphan drug may not receive orphan drug 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 U.S. 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.Capital

~~Expedited~~Our ~~Development~~Employees. As of December 31, 2024, we had a total of 44 employees all located in the United States of America. Our highly qualified and ~~Review~~experienced ~~Programs~~team includes scientists, physicians, laboratory technicians, finance professionals, and administrative professionals. We also utilize consultants for part-time, specialized roles.

~~The~~We ~~FDA~~believe ~~has a fast-track program~~ that iswe ~~intended~~maintain toa ~~expedite~~satisfactory orworking ~~facilitate~~relationship ~~the~~with ~~process~~our ~~for development and review of new products that meet certain criteria. Specifically~~employees, ~~new products are eligible for fast-track designation if they are intended to treat a serious or life-threatening disease or condition~~ and ~~demonstrate~~we ~~the~~have ~~potential~~not toexperienced ~~address~~any ~~unmet~~significant ~~medical~~labor ~~needs~~disputes ~~for the disease~~ or ~~condition.~~any ~~Fast~~difficulty ~~track~~in ~~designation~~recruiting ~~applies~~staff ~~to the combination of the product and the specific indication~~ for ~~which~~our ~~it is being studied~~operations. ~~For~~None ~~a fast track-designated product, the FDA may consider for review sections~~ of ~~the~~our ~~BLA~~employees onare arepresented ~~rolling~~by ~~basis before the complete application is submitted, if the sponsor provides~~ a ~~schedule~~labor 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 BLAunion. ~~Fast track designation may be rescinded if the FDA determines the program no longer meets the qualifying criteria for the fast-track program.~~

~~Any~~Employee ~~product submitted to the FDA for approval including a product with a fast-track designation~~Engagement, ~~may~~Talent ~~also~~Development be& ~~eligible for other types of FDA programs intended to expedite development and review, such as priority review, breakthrough therapy designation, and accelerated approval~~Benefits. AWe ~~product~~believe isthat ~~eligible~~our ~~for~~future ~~priority~~success ~~review~~largely ifdepends is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA will attempt to direct additional resources to the evaluation of an application for a new product designated for priority review in an effort to facilitate the review on a 6 month, rather than the standard 10-month, timeline. Additionally, a product may be eligible for accelerated approval. Products studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon aour ~~determination~~continued ~~that~~ability ~~the product has an effect on a surrogate endpoint that is reasonably likely~~ to ~~predict~~attract 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~~retain ~~availability~~highly orskilled ~~lack of alternative treatments~~employees. AsWe aprovide ~~condition~~our ofemployees accelerated approval, the FDA will require that a sponsor of a drug or biological product receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies. In addition, the FDA requires as a condition for accelerated approval that promotional materials be submitted in advance of initial dissemination, which could adversely impact the timing of the commercial launch of the product. Breakthrough therapy designation is also intended to expedite the development and review of products that treat serious or life-threatening conditions. The designation by the FDA requires preliminary clinical evidence that a product candidate, alone or in combination with ~~other~~competitive ~~drugs~~salaries and ~~biologics~~bonuses, demonstrates substantial improvement over currently available therapy on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Breakthrough therapy designation comes with all of the benefits of fast-track designation, which means that the sponsor may file sections of the BLA for review on a rolling basis if certain conditions are satisfied, including an agreement with the FDA on the proposed schedule for submission of portions of the application and ~~the~~opportunities ~~payment of applicable user fees before the FDA may initiate a review. Breakthrough Therapy designation may be rescinded if the FDA determines the program no longer meets the qualifying criteria~~ for ~~breakthrough~~equity ~~therapy~~ownership. Regenerative Medicine Advanced Therapy (“RMAT”), designation was established by FDA in 2017 to facilitate an efficient development program for, and expedite review of, any drug that meets the following criteria: (1) it qualifies as a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions; (2) it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and (3) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition. RMAT designation provides potential benefits that may include more frequent meetings with the FDA to discuss the development plan for the product candidate and eligibility for rolling review and priority review.

~~Products~~Overseas ~~granted~~Government RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites. Once approved, when appropriate, the FDA can permit fulfillment of post-approval requirements under accelerated approval through the submission of clinical evidence, clinical studies, patient registries, or other sources of real-world evidence such as electronic health records; Regulation

29In addition to regulations in the U.S., we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and distribution of our products. Whether or not we obtain FDA approval of a product, we must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the U.S. have a similar process that requires the submission of a clinical trial application much like the IND prior to the commencement of human clinical trials. In the EU, for example, a clinical trial application must be submitted to each country's national health authority and an independent ethics committee, much like the FDA and IRB, respectively. Once the clinical trial application is approved in accordance with a country's requirements, clinical trial development may proceed. Because biologically sourced raw materials are subject to unique contamination risks, their use may be restricted in some countries.

~~Table of Contents~~ 30

~~through~~ Table ~~the collection~~ of ~~larger confirmatory datasets; or through post-approval monitoring of all patients treated with the therapy prior to approval.~~Contents

~~Breakthrough~~The ~~therapy~~requirements ~~designation~~and isprocess ~~also~~governing ~~intended to expedite~~ the ~~development~~conduct ~~and review~~ of ~~products that treat serious or life-threatening conditions. The designation by FDA requires preliminary~~ clinical ~~evidence~~trials, ~~that a~~ product ~~candidate~~licensing, ~~alone~~pricing ~~or in combination with other drugs~~ and ~~biologics,~~reimbursement ~~demonstrates~~vary ~~substantial~~from ~~improvement~~country ~~over~~to ~~currently available therapy on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development~~country. ~~Breakthrough~~In ~~therapy designation comes with~~ all ~~of the benefits of fast-track designation~~cases, ~~which means that~~ the ~~sponsor~~clinical ~~may~~trials ~~file~~must ~~sections~~be ofconducted ~~the~~in ~~BLA~~accordance ~~for review on a rolling basis if certain conditions are satisfied, including an agreement~~ with ~~FDA~~GCP onand the ~~proposed~~applicable ~~schedule~~regulatory ~~for~~requirements ~~submission of portions of the application~~ and the ~~payment~~ethical ofprinciples ~~applicable~~that ~~user~~have ~~fees~~their ~~before~~origin in the ~~FDA~~Declaration ~~may~~of ~~initiate a review~~Helsinki.

~~Fast~~To ~~Track~~obtain ~~designation,~~regulatory ~~priority~~approval ~~review~~of an investigational drug or biological product under EU regulatory systems, ~~RMAT~~we ~~and~~must ~~breakthrough~~submit ~~therapy~~a ~~designation~~marketing doauthorization ~~not~~application. ~~change~~The application used to file the ~~standards~~BLA ~~for~~in ~~approval~~the ~~but~~EU is ~~may~~similar ~~expedite~~to that required in the ~~development~~U.S., orwith ~~approval~~the ~~process~~exception of, among other things, country-specific document requirements.

~~Post-Approval~~For ~~Requirements~~other countries outside of the EU, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, the clinical trials must be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

~~Any~~If ~~products for which~~ we ~~receive~~or ~~FDA~~our ~~approvals~~potential ~~will~~collaborators befail ~~subject~~ to ~~continuing~~comply ~~regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences~~ with ~~the~~applicable ~~product,~~foreign ~~providing~~regulatory ~~the FDA with updated safety and efficacy information, product sampling and distribution~~ requirements, ~~and~~we ~~FDA~~may ~~promotion~~be ~~and~~subject ~~advertising requirements~~to, ~~which include,~~ among ~~others~~other things, ~~standards for direct-to-consumer advertising~~fines, ~~restrictions~~suspension ~~on promoting products for uses~~ or inwithdrawal ~~patient~~of ~~populations~~regulatory ~~that are not described in the product's approved uses (known as "off-label use")~~approvals, ~~limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet. Although a physician may prescribe a legally available~~ product ~~for an off-label use~~recalls, ifseizure ~~the~~of ~~physicians deem such product to be appropriate in his/her professional medical judgment~~products, aoperating ~~manufacturer~~restrictions ~~may not market or promote off-label uses. However, it is permissible to share in certain circumstances truthful~~ and ~~not~~criminal ~~misleading information that is consistent with the product's approved labeling~~prosecution.

InEU ~~addition,~~General ~~quality~~Data ~~control~~Protection and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the long-term stability of the product. cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers and other entities involved in the manufacture and distribution of approved products 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 cGMP and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including, among other things, recall or withdrawal of the product from the market. In addition, changes to the manufacturing process are strictly regulated, and depending on the significance of the change, may require prior FDA approval before being implemented. Other types of changes to the approved product, such as adding new indications and claims, are also subject to further FDA review and approval.Regulation

~~The~~In ~~FDA~~addition ~~also~~to ~~may~~EU ~~require~~regulations ~~post-marketing~~related ~~testing,~~to ~~known~~the asapproval ~~Phase 4~~and ~~testing~~commercialization of our products, ~~and~~we ~~surveillance~~may tobe ~~monitor~~subject to the ~~effects~~GDPR. ofThe anGDPR ~~approved~~imposes ~~product.~~stringent ~~Discovery~~requirements offor ~~previously~~controllers ~~unknown~~and ~~problems~~processors ~~with~~of apersonal ~~product~~data orof persons in the ~~failure~~EU, toincluding, ~~comply~~for ~~with~~example, ~~applicable~~more ~~FDA~~robust ~~requirements~~disclosures ~~can~~to ~~have~~individuals ~~negative~~and ~~consequences,~~a ~~including~~strengthened ~~adverse~~individual ~~publicity~~data rights regime, ~~judicial~~shortened ortimelines ~~administrative~~for ~~enforcement~~data breach notifications, ~~warning~~limitations ~~letters~~on ~~from~~retention ~~the~~of ~~FDA~~information, ~~mandated~~increased ~~corrective~~requirements ~~advertising~~pertaining orto ~~communications~~special ~~with~~categories ~~doctors~~of data, such as health data, and ~~civil~~additional orobligations ~~criminal~~when ~~penalties,~~we ~~among~~contract ~~others.~~with ~~Newly~~third-party ~~discovered~~processors orin ~~developed~~connection ~~safety~~with orthe ~~effectiveness~~processing ~~data~~of ~~may~~the ~~require~~personal ~~changes~~data. toThe aGDPR ~~product's~~also ~~approved~~imposes ~~labeling,~~strict ~~including~~rules on the ~~addition~~transfer of ~~new~~personal ~~warnings~~data out of the EU to the U.S. and ~~contraindications~~other third countries. In addition, ~~and~~the ~~also~~GDPR provides that EU member states may ~~require~~make their own further laws and regulations limiting the ~~implementation~~processing of ~~other~~personal ~~risk~~data, ~~management~~including ~~measures~~genetic, biometric or health data.

~~Also,~~ITEM 1A. ~~new~~RISK government requirements, including those resulting from new legislation, may be established, or the FDA's policies may change, which could delay or prevent regulatory approval of our products under developmentFACTORS.

UYou should carefully consider the risks described below, as well as general economic and business risks and the other information in this Annual Report on Form 10‑K.S The occurrence of any of the events or circumstances described below or other adverse events could have a material adverse effect on our business, results of operations and financial condition and could cause the trading price of our common stock to decline. ~~Marketing~~Additional ~~Exclusivity~~risks or uncertainties not presently known to us or that we currently deem immaterial may also harm our business.

~~The~~Risks ~~Biologics~~Related ~~Price Competition and Innovation Act (“BPCIA”) amended the PHSA~~ to ~~authorize~~Our ~~the~~Financial ~~FDA to approve similar versions of innovative biologics, commonly known as biosimilars. A competitor seeking approval of a biosimilar~~ Position

30We have incurred losses since inception and we expect to incur significant net losses in the foreseeable future.

~~Table~~We generated negative cash flows from operations and have incurred net operating losses each year since we started business. For the year ended December 31, 2024, we incurred net losses of $26.90 ~~Contents~~million and our net cash used in operating activities was $19.5 million. As of December 31, 2024, our accumulated deficit was $149.8 million. We expect to continue to incur net losses and negative cash flow from operating activities for at least the next twelve months. As our focus on development of our product candidates has increased, losses have resulted primarily from expenses associated with research and development and clinical trial-related activities, as well as general and administrative expenses. While we have implemented and continue to implement cost reduction measures where possible, we nonetheless expect to continue operating in a loss position on a consolidated basis and expect that recurring operating expenses will be at higher levels for the year ending December 31, 2024. Further, we anticipate that our expenses will increase substantially if and as we:

~~must~~● ~~file~~Continue anour ~~application~~current toresearch ~~establish~~and ~~its~~development ~~molecule as highly similar to an approved innovator biologic~~programs, ~~among~~including ~~other~~conducting requirements. This abbreviated approval pathway is intended to permit a biosimilar to come to market more quickly and less expensively by relying to some extent on the data generated by the reference product’s sponsorlaboratory, ~~and~~preclinical ~~the FDA’s previous review~~ and ~~approval~~greenhouse ofstudies the reference product. Under the BPCIA, a biosimilar sponsor’s ability to seek or obtain approval through the abbreviated pathway is limited by periods of exclusivity granted by the FDA to the holder of the reference product’s BLA. In general, no biosimilar application may be accepted by the FDA for ~~review until 4 years after the date the reference~~ product ~~was first licensed by the FDA, and no biosimilar application, once accepted, may receive final approval until 12 years after the reference product was first licensed by the FDA~~candidates.

~~Depending~~● ~~upon~~Initiate ~~the~~clinical ~~timing,~~or ~~duration~~field ~~and~~trials ~~specifics~~for ~~of the FDA approval of the use of our~~ product candidates~~, some of our U~~.S. patents, if granted, may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act permits 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 product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The USPTO, 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 currently owned or licensed patents 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.

~~Pediatric~~● ~~exclusivity~~Seek isto ~~another type of regulatory market exclusivity in the United States. Pediatric exclusivity~~identify, ~~if granted~~assess, ~~adds~~acquire ~~six~~or ~~months~~develop toadditional ~~existing~~research ~~exclusivity~~programs ~~periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection~~ or ~~patent~~product ~~term, may be granted based on the voluntary completion of a pediatric trial in accordance with an FDA-issued "Written Request" for such a trial~~candidates.

~~Other U.S. Healthcare Laws and Compliance Requirements~~ 31

In Table the U.S., our activities are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the Centers for Medicare and Medicaid Services (“CMS”), other divisions of the Department of Health and Human Services (“HHS”) (e.g., the Office of Inspector General, the U.S. Department of Justice (“DOJ”), and individual U.S. Attorney offices within the DOJ, and state and local governments). For example, our business practices, including any future sales, marketing and scientific/educational grant programs may be required to comply with the anti-fraud and abuse provisions of the Social Security Act, the false claims laws, the patient data privacy and security provisions of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), transparency requirements, and similar state, local and foreign laws, each as amended.Contents

~~The~~● ~~federal Anti-Kickback Statute prohibits~~Maintain, ~~among~~expand ~~other things, any person or entity, from knowingly~~ and ~~willfully~~protect ~~offering,~~our ~~paying,~~intellectual ~~soliciting~~property or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item, good, facility or service reimbursable under Medicare, Medicaid or other federal healthcare programsportfolio. The term remuneration has been interpreted broadly to include anything of value. The federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, formulary managers, and other individuals and entities on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. The exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection.

~~Practices~~● ~~that~~Seek ~~involve~~marketing ~~remuneration~~approvals ~~that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify~~ for anany ~~exception~~product orcandidates ~~safe~~that harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Our practices may ~~not~~successfully incomplete ~~all cases meet all of the criteria for protection under a statutory exception or regulatory safe harbor~~development.

31● Establish a sales, marketing and distribution infrastructure to commercialize any products that may obtain marketing approval.

~~Table~~● ofFurther ~~Contents~~develop and refine the manufacturing process for our product candidates.

~~Additionally,~~● ~~the~~Change intent standard under the federal Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, collectively, the Affordable Care Act, to a stricter standard such that a person or ~~entity~~add noadditional ~~longer~~manufacturers ~~needs to have actual knowledge of the federal Anti-Kickback Statute~~ or ~~specific~~suppliers ~~intent to violate it in order to have committed a violation. Rather, if "one purpose"~~ of ~~the~~biological ~~remuneration~~materials ~~is to induce referrals, the federal Anti-Kickback Statute is violated. In addition, the Affordable Care Act codified case law that a claim that includes items~~ or ~~services~~product ~~resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (discussed below)~~candidates.

~~The~~● ~~civil~~Validate ~~monetary penalties statute imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented~~ a ~~claim~~commercial-scale ~~to,~~manufacturing ~~among~~facility ~~others,~~compliant awith ~~federal healthcare program that the person knows or should know is for a medical or other item or service that was not provided as claimed or is false or fraudulent~~cGMP.

~~The~~● ~~federal~~Further ~~civil~~develop ~~False~~our ~~Claims~~genome ~~Act~~editing prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to, or approval by, the federal government or knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal governmenttechnology. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes "any request or demand" for money or property presented to the U.S. government. Several pharmaceutical and other healthcare companies are being investigated or, in the past, have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of the companies' marketing of the product for unapproved, and thus non-reimbursable, uses.

~~HIPAA~~● ~~created~~Acquire ~~additional federal criminal statutes that prohibit knowingly and willfully executing,~~ or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private thirdin-~~party~~license ~~payors~~other and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or servicestechnologies.

~~Also,~~● ~~many~~Seek ~~states have similar fraud and abuse statutes or regulations that apply~~ to ~~items~~attract and ~~services~~retain ~~reimbursed~~new ~~under Medicaid~~ and ~~other~~existing ~~state programs, or, in several states, apply regardless of the payor~~personnel.

We● ~~may~~Expand ~~be subject to data privacy and security regulations by both the federal government and the states in which we conduct~~ our ~~business~~facilities. HIPAA, and its implementing regulations, imposes requirements on covered entity health care providers, health plans, and health care clearinghouses, as well as their “business associates” – certain persons or covered entities that create, receive, maintain, or transmit protected health information in connection with providing a specified service or performing a function on behalf of a covered entity. Although we are not directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we may obtain health information from third parties that are subject to privacy and security requirements under HIPAA, and other privacy and data security and consumer protection laws, and we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly receive individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA, and subject to other civil and/or criminal penalties if we obtain, use, or disclose information in a manner not permitted by other privacy and data security and consumer protection laws. In addition, state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Many of the state laws enable a state attorney general to bring actions and provide private rights of action to consumers as enforcement mechanisms. There is also heightened sensitivity around certain types of health data, which may be subject to additional protections. The landscape of federal and state laws regulating personal data is constantly evolving, and compliance with these laws requires a flexible privacy framework and substantial resources, and compliance efforts will likely be an increasing and substantial cost in the future. Failure to comply with these laws and regulations could result in government enforcement actions and create liability for us (which could include civil and/or criminal penalties), private litigation, and/or adverse publicity. Federal regulators, state attorneys general, and plaintiffs’ attorneys have been active in this space.

~~The~~Our ~~Federal~~ability ~~Trade~~to ~~Commission~~generate ~~(“FTC”)~~sufficient ~~also~~revenue ~~sets~~from ~~expectations~~any ~~for~~of ~~failing~~our products, product candidates or technologies to ~~take~~achieve ~~appropriate~~profitability ~~steps~~will depend on a number of factors including, but not limited to, ~~keep~~the ~~consumers’~~success ~~personal~~of ~~information~~our ~~secure~~research and development programs, orour ~~failing~~ability to ~~provide~~achieve aregulatory ~~level~~approvals, market conditions, costs and effectiveness of ~~security~~manufacturing, ~~commensurate~~sales, tomarketing ~~promises~~and ~~made~~distribution operations related to ~~individual~~such ~~about~~product candidate, and the ~~security~~terms of ~~their~~any ~~personal~~collaboration ~~information~~or ~~(such~~other asstrategic inarrangement awe ~~privacy~~may ~~notice)~~have ~~may~~with ~~constitute~~respect ~~unfair~~to orsuch ~~deceptive~~product ~~acts~~candidate orand ~~practices~~levels of reimbursement from third-party payors.

32We may never achieve or sustain profitability.

~~Table~~We do not know when or whether we will become profitable. We have no products approved for commercial sale and have not generated revenue from operations. To become and remain profitable, we must succeed in developing and obtaining regulatory approval for and commercializing one or more of ~~Contents~~our product candidates. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates, discovering and developing additional product candidates, obtaining regulatory approval for any product candidates that successfully complete clinical trials, establishing commercialization capabilities for any approved products and achieving market acceptance for any approved products. We may never succeed in these activities. Even if we succeed in these activities, we may never generate revenue in an amount sufficient to achieve profitability.

inBecause ~~violation~~ of ~~Section 5(a) of~~ the ~~Federal~~numerous ~~Trade~~risks ~~Commission~~and ~~Act~~uncertainties ~~(“FTC~~associated ~~Act”).~~with ~~The~~biotechnology ~~FTC~~product ~~expects~~development aand ~~company’s~~commercialization, ~~data~~we ~~security~~are ~~measures~~unable to beaccurately ~~reasonable~~predict whether and ~~appropriate~~when inwe ~~light~~will ofachieve ~~the~~profitability. ~~sensitivity~~If ~~and~~we ~~volume~~are ofrequired ~~consumer~~by ~~information~~the ~~it holds~~FDA, the ~~size~~European ~~and~~Medicines ~~complexity~~Agency of(the ~~its~~“EMA”) ~~business,~~or ~~and~~any ~~the~~comparable ~~cost~~regulatory ofauthority ~~available tools~~ to ~~improve~~perform ~~security~~preclinical ~~and~~studies ~~reduce~~or ~~vulnerabilities.~~clinical ~~Individually~~trials ~~identifiable~~in ~~health~~addition ~~information~~to isthose ~~considered~~we ~~sensitive~~currently ~~data~~expect ~~that merits stronger safeguards. With respect~~ to ~~privacy~~conduct, ~~the~~or ~~FTC~~if ~~also~~there ~~sets~~are ~~expectations~~any ~~that~~delays ~~companies~~or ~~honor~~complications ~~the~~in ~~privacy~~completing ~~promises~~preclinical ~~made~~studies toof ~~individuals~~our ~~about~~product ~~how~~candidates ~~the~~or, ~~company~~if ~~handles~~preclinical ~~consumers’~~studies ~~personal~~are ~~information; any failure to honor promises~~successful, ~~such as the statements made~~ in asubmitting ~~privacy~~an ~~policy~~IND or onClinical aTrial ~~website,~~Application ~~may~~to ~~also~~the ~~constitute~~FDA ~~unfair~~and orcomparable ~~deceptive~~regulatory ~~acts~~authorities, orand ~~practices~~if inclinical ~~violation~~trials ofare ~~the~~successful, ~~FTC Act. While we do not intend to engage~~ in ~~unfair~~submitting ora ~~deceptive~~BLA ~~acts~~ or ~~practices,~~Marketing ~~the~~Authorization ~~FTC~~Application ~~has~~to the ~~power~~FDA toand ~~enforce~~comparable ~~promises~~regulatory ~~as it interprets them~~authorities, ~~and~~manufacturing ~~events~~clinical ~~that~~trial wesupplies ~~cannot~~and ~~fully~~completing ~~control,~~clinical ~~such as data breaches~~trials, ~~may~~our beexpenses ~~result~~could inincrease ~~FTC~~substantially ~~enforcement.~~and ~~Enforcement~~our byability ~~the~~to ~~FTC~~achieve ~~under~~profitability ~~the~~could ~~FTC~~be ~~Act~~further ~~can result in civil penalties or enforcement actions~~delayed.

~~Additionally,~~Even ~~the~~if ~~federal~~we ~~Physician~~achieve ~~Payments~~profitability, ~~Sunshine~~we ~~Act~~may ~~within~~not ~~the~~be ~~Affordable~~able ~~Care~~to ~~Act,~~sustain ~~and~~profitability ~~its~~in ~~implementing~~subsequent ~~regulations,~~periods. ~~require~~After ~~that~~we ~~certain~~achieve ~~manufacturers of drugs~~profitability, ~~devices,~~if ~~biological and medical supplies for which payment is available under Medicare~~ever, ~~Medicaid~~we orexpect ~~the~~to ~~Children's~~continue ~~Health~~to ~~Insurance~~engage ~~Program~~in ~~(with~~substantial ~~certain~~research ~~exceptions)~~and ~~annually~~development ~~report~~activities ~~information~~and to ~~CMS~~incur ~~related~~substantial toexpenses ~~certain payments or other transfers of value made or distributed~~ to ~~physicians~~develop and ~~teaching~~commercialize ~~hospitals,~~additional orproduct tocandidates. ~~entities~~In oraddition, ~~individuals~~we atmay ~~the~~encounter ~~request~~unforeseen ofexpenses, ordifficulties, ~~designated on behalf of~~complications, ~~physicians~~delays and ~~teaching~~other ~~hospitals~~unknown ~~and~~factors ~~certain~~that ~~ownership~~may ~~and~~adversely ~~investment~~affect ~~interests~~our ~~held~~revenues, byexpenses ~~physicians~~ and ~~their immediate family members~~profitability.

InOur ~~order~~failure to ~~distribute~~achieve ~~products~~or ~~commercially,~~sustain weprofitability ~~must~~would ~~comply~~depress ~~with~~our ~~state~~market ~~laws~~value ~~that require the registration of manufacturers~~ and ~~wholesale~~could ~~distributors~~impair ofour ~~drug~~ability ~~and~~to ~~biological~~execute ~~products~~our inbusiness ~~a state~~plan, ~~including,~~raise ~~in certain states~~capital, ~~manufacturers~~develop ~~and~~additional ~~distributors~~product ~~who~~candidates ~~ship products into the state even if such manufacturers~~ or ~~distributors~~continue ~~have~~our ~~no place of business within the state~~operations. ~~Some~~A ~~states~~decline ~~also impose requirements on manufacturers and distributors to establish the pedigree of product~~ in the ~~chain~~value of ~~distribution,~~our ~~including~~company ~~some~~could ~~states~~cause ~~that~~our ~~require~~shareholders ~~manufacturers and others~~ to ~~adopt~~lose ~~new~~all ~~technology~~or ~~capable~~part of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practicesinvestment. ~~All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.~~

If our operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including without limitation, civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private "qui tam" actions brought by individual whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. 32

~~Coverage,~~ Table ~~Pricing~~of ~~and Reimbursement~~Contents

~~Significant~~We ~~uncertainty~~will ~~exists~~need assubstantial toadditional ~~the~~funding ~~coverage~~to ~~and~~develop ~~reimbursement~~our ~~status of any~~ product candidates ~~for~~and ~~which~~conduct weour ~~obtain~~future ~~regulatory~~operations ~~approval. In the U.S.~~ and ~~markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the extent~~ to ~~which~~repay ~~third-party~~our ~~payors~~outstanding ~~provide~~debt ~~coverage, and establish adequate reimbursement levels for such products~~obligations. InWe ~~the~~cannot U.S., third-party payors include federal and state healthcare programs, private managed care providers, health insurers and other organizations. The process for determining whether a third-party payor will provide coverage for a product may be ~~separate~~certain ~~from the process for setting the price of a product or for establishing the reimbursement rate~~ that ~~such~~additional acapital ~~payor~~ will ~~pay~~be ~~for~~available ~~the~~on ~~product.~~terms ~~Third-party~~acceptable ~~payors may limit coverage~~ to ~~specific products on an approved list~~us, or ~~also~~at ~~known as a formulary, which might not include~~ all ~~of the FDA-approved products for a particular indication~~. Third-party payors are increasingly challenging the price, examining the medical necessity and reviewing the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy. We may need to conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor's decision to provide coverage for a

33We have an ongoing need to raise additional cash from outside sources to continue funding our operations, including our continuing substantial research and development expenses. We do not currently believe that our cash balance will be sufficient to fund the development and marketing efforts required to reach profitability without raising additional capital from accessible sources of financing in the near future. Our future capital requirements will depend on many factors, including:

~~Table~~● ofOur ~~Contents~~ability to raise capital to fund our operations on terms acceptable to us, or at all.

~~product~~● ~~does~~Our ~~not~~perceived ~~imply~~capital ~~that~~needs anwith ~~adequate~~respect ~~reimbursement~~to ~~rate~~our ~~will~~development ~~be approved. Further~~programs, ~~one~~and ~~payor's~~any ~~determination~~delays toin ~~provide~~or ~~coverage~~adverse ~~for~~events aand ~~product~~excessive ~~does~~costs ~~not~~of ~~assure~~such ~~that~~programs ~~other~~beyond ~~payors~~what ~~will~~we ~~also~~currently ~~provide coverage for the product~~anticipate. ~~Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.~~

~~Different~~● ~~pricing~~Our ~~and~~ability ~~reimbursement~~to ~~schemes~~establish ~~exist in other countries. In the European Union (the “EU”), governments influence the price of pharmaceutical products through their pricing~~ and ~~reimbursement~~maintain ~~rules~~collaborative and ~~control~~other ofarrangements ~~national~~with ~~health~~third ~~care~~parties ~~systems~~to ~~that~~assist ~~fund~~in abringing ~~large~~our ~~part~~product ofcandidates ~~the cost of those products~~ to ~~consumers.~~market ~~Some jurisdictions operate positive~~ and ~~negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require~~ the ~~completion of clinical trials that compare the~~ cost~~-effectiveness~~ of asuch ~~particular~~arrangements ~~product~~at candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on health care costs has become very intense. As a result, increasingly high barriers are being erected to the ~~entry of new products~~time. ~~In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.~~

● The ~~marketability~~cost of ~~any~~manufacturing our product candidates ~~for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. In addition~~, ~~emphasis~~including oncompliance ~~managed~~with ~~care~~GMP inapplicable ~~the U.S. has increased and we expect will continue~~ to ~~increase~~our ~~the~~product ~~pressure on healthcare pricing~~candidates. ~~Coverage policies and third-party reimbursement rates may change at any time.~~

~~Even~~● ifExpenses ~~favorable~~related ~~coverage~~to ~~and~~the ~~reimbursement~~establishment ~~status~~of issales ~~attained~~and ~~for~~marketing ~~one~~capabilities ~~or more products~~ for ~~which~~product wecandidates ~~receive~~awaiting ~~regulatory~~ approval, ~~less~~or ~~favorable~~products ~~coverage~~that ~~policies~~have ~~and~~been ~~reimbursement rates may be implemented in the future~~approved.

~~Healthcare~~● ~~Reform~~Competing technological and market developments.

In● ~~the~~Our ~~U.S.~~ability ~~and some foreign jurisdictions, there have been, and continue~~ to ~~be,~~introduce ~~several legislative~~ and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect the ability to profitably sell ~~product~~new ~~candidates for which marketing approval is obtained~~products. Among policy makers and payors in the U.S. and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the U.S., the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.

~~For~~The ~~example,~~amount ~~the~~and ~~Affordable~~timing ~~Care~~of ~~Act~~our ~~has~~future ~~substantially~~funding ~~changed~~requirements ~~healthcare~~will ~~financing~~depend ~~and~~on ~~delivery~~many byfactors, ~~both~~including ~~governmental and private insurers. Among~~ the ~~Affordable~~pace ~~Care~~and ~~Act~~results ~~provisions~~ of ~~importance~~our toclinical ~~the pharmaceutical~~ and ~~biotechnology~~preclinical ~~industries,~~development ~~in addition to those otherwise described above, are the following:~~efforts.

•We ~~Created~~have ansecured ~~annual,~~capital ~~nondeductible~~historically ~~fee~~from onequity ~~any~~offerings ~~entity~~and ~~that~~debt ~~manufactures~~financing. orTo ~~imports~~obtain ~~certain~~additional ~~specified~~capital, ~~branded~~we ~~prescription~~may ~~drugs~~pursue debt and/or ~~biologic~~equity ~~agents~~offering ~~apportioned~~programs, ~~among~~strategic ~~these~~corporate ~~entities~~partnerships, ~~according~~state toand ~~their~~federal ~~market~~development ~~share~~programs, inlicensing ~~some~~arrangements, ~~government~~and ~~healthcare~~sales ~~programs~~of assets. We cannot be certain that ~~began~~additional incapital ~~2011~~will be available on terms acceptable to us, or at all.

•Depending ~~Increased~~on the ~~statutory~~type ~~minimum~~and ~~rebates~~the aterms ~~manufacturer~~of ~~must~~any ~~pay~~financing ~~under~~we pursue, stockholders’ rights and the ~~Medicaid~~value ~~Drug~~of ~~Rebate~~their ~~Program,~~investment ~~retroactive~~in toour ~~January~~common 1stock could be reduced. Additional financing could involve one or more types of securities including common stock, ~~2010~~preferred stock, convertible debt or warrants to 23acquire common stock.1% ~~and~~These ~~13%~~securities ofcould be issued at or below the ~~average~~then ~~manufacturer~~prevailing market price ~~(“AMP”)~~ for ~~most~~our ~~branded~~common ~~and~~stock. ~~generic~~In ~~drugs~~addition, ~~respectively~~if we issue secured debt securities, the holders of the debt would have a claim to our assets that would be prior to the rights of stockholders until the debt is paid. Interest on debt or other securities would increase costs and ~~capped~~negatively impact operating results. If the ~~total~~issuance ~~rebate~~of ~~amount~~new ~~for~~securities ~~innovator~~results ~~drugs~~in atdiminished ~~100%~~rights to holders of our common stock, the ~~AMP~~market price of our common stock could be negatively impacted.

•If ~~Created~~we aare ~~new~~unable ~~Medicare~~to ~~Part~~raise Dsubstantial ~~coverage~~additional ~~gap~~capital ~~discount~~on ~~program~~acceptable terms, inor ~~which~~at ~~manufacturers must now agree to offer 70% point-of-sale discounts~~all, ~~off~~we ~~negotiated~~may ~~prices~~be offorced ~~applicable brand drugs~~ to ~~eligible beneficiaries during their coverage gap period~~delay, asreduce aor ~~condition~~eliminate ~~for~~some ~~the~~or ~~manufacturers'~~all ~~outpatient~~of ~~drugs~~our toresearch beprograms, ~~covered~~product ~~under~~development ~~Medicare~~activities ~~Part~~and Dcommercialization efforts.

•The ~~Extended~~process ~~manufacturers'~~of ~~Medicaid~~identifying ~~rebate~~product ~~liability~~candidates and conducting preclinical and clinical trials is time consuming, expensive, uncertain and can take years to ~~covered~~complete. ~~drugs~~We ~~dispensed~~expect our expenses to ~~individuals~~increase ~~who~~in ~~are~~connection ~~enrolled~~with our ongoing activities, particularly as we identify, continue the research and development of, initiate clinical or field trials of, and seek marketing approval for, product candidates. In addition, if any therapeutic product candidate that we develop alone or with collaborators obtains marketing approval, we may incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution efforts. Accordingly, we will need to obtain substantial additional funding in ~~Medicaid~~connection ~~managed~~with ~~care~~our ~~organizations~~continuing operations. If we are unable to raise sufficient capital when needed, we may be forced to delay, reduce or eliminate current or future research programs, product development activities and/or commercialization efforts.

•Adequate ~~Expanded~~additional ~~eligibility~~financing ~~criteria~~may ~~for~~not ~~Medicaid~~be ~~programs~~available ~~by,~~to ~~among~~us ~~other~~on ~~things~~acceptable terms, ~~allowing~~or ~~states~~at all. If we are unable to ~~offer~~obtain ~~Medicaid~~sufficient ~~coverage~~funding on a timely basis or on favorable terms, we may be required to ~~additional~~significantly ~~individuals~~delay, reduce or eliminate one or more of our research or product development programs and/or ~~added~~commercialization ~~new~~efforts. ~~mandatory~~We ~~eligibility~~may ~~categories~~also ~~for~~be ~~individuals~~unable ~~with~~to ~~income~~expand atour operations or ~~below~~otherwise ~~133%~~capitalize on business opportunities as desired. Any of ~~the~~these ~~federal~~events ~~poverty~~could ~~level,~~materially ~~thereby~~adversely ~~potentially~~affect ~~increasing~~our ~~manufacturers'~~financial ~~Medicaid~~condition ~~rebate~~and ~~liability~~business prospects.

~~• Expanded the list of entities eligible for discounts under the 340B Drug Discount Program.~~ 33

34 Table of Contents

~~Table~~Our offinancial ~~Contents~~situation creates doubt whether we will continue as a going concern.

•We ~~Created~~have not generated any revenues to date. For the years ended December 31, 2024 and 2023, we had a ~~Patient-Centered~~net ~~Outcomes~~loss ~~Research~~of ~~Institute~~$26.90 million and $20.95 million, respectively. There can be no assurances that we will be able to ~~oversee,~~achieve ~~identify~~a ~~priorities~~level inof revenues adequate to generate sufficient cash flow from operations or obtain funding from additional financing through private placements, public offerings and/or ~~conduct~~bank ~~comparative~~financing ~~clinical~~necessary ~~effectiveness~~to ~~research~~support our working capital requirements. No assurance can be given that additional financing will be available, ~~along~~or ~~with~~if ~~funding~~available, ~~for~~will ~~such~~be ~~research~~on acceptable terms. These conditions raise substantial doubt about our ability to continue as a going concern.

•Risks ~~Expanded~~Related ~~healthcare~~to ~~fraud~~our ~~and abuse laws, including the Foreign Corrupt Practices Act (the “FCPA”), and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance.~~Business

•We ~~Created~~have a ~~new~~limited ~~methodology~~operating byhistory, which ~~rebates~~makes ~~owed~~it bydifficult ~~manufacturers~~to ~~under~~evaluate ~~the~~our ~~Medicaid~~current ~~Drug~~business ~~Rebate~~and ~~Program~~future ~~are~~prospects ~~calculated~~and ~~for~~may ~~drugs~~increase ~~that~~the ~~are~~risk ~~inhaled,~~of ~~infused,~~your ~~instilled, implanted, or injected~~investment.

•We ~~Required~~are ~~reporting~~a company with a limited operating history. We began principal business operations in 2012 and spent the first three years of ~~certain~~our ~~financial~~history ~~arrangements~~developing ~~with~~and ~~physicians~~refining our core technology, and ~~teaching~~only ~~hospitals~~since then have we focused our efforts on advancing the development of product candidates.

•Investment ~~Required~~in ~~annual~~biopharmaceutical ~~reporting~~product ofdevelopment ~~certain~~is ~~information~~a ~~regarding~~highly ~~drug~~speculative ~~samples~~endeavor and entails substantial upfront capital expenditures. There is significant risk that ~~manufacturers~~any product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, obtain any required regulatory approvals or become commercially viable. Our platforms and ~~distributors~~the ~~provide~~technologies we are using are new and unproven. We have not yet demonstrated an ability to obtain ~~physicians~~any required marketing approvals, conduct sales, marketing and distribution activities, or arrange for a third party to do any of the foregoing on our behalf.

•Consequently, ~~Established~~any predictions made about our future success or viability may not be as accurate as they could be if we had a ~~Center~~history ~~for~~of ~~Medicare~~successfully developing and ~~Medicaid~~commercializing ~~Innovation~~products. atOur ~~CMS~~limited tooperating ~~test~~history, ~~innovative~~particularly ~~payment~~in light of the rapidly evolving nature of the biopharmaceutical industries and ~~service~~the ~~delivery~~genome ~~models~~editing field, may make it difficult to ~~lower~~evaluate ~~Medicare~~our technology and ~~Medicaid~~business ~~spending~~prospects or to predict our future performance.

•As ~~Created~~a company, we have never commercialized a ~~licensure~~product. ~~framework~~We ~~for~~currently ~~follow~~have onno ~~biologic~~active ~~products~~sales force or commercial infrastructure. We may lack the necessary expertise, personnel and resources to successfully commercialize our product candidates.

~~There~~We currently have ~~been~~no ~~legal~~active ~~challenges~~sales ~~and~~force ~~legislative~~or ~~changes~~commercial toinfrastructure. ~~certain~~As ~~aspects~~a ofcompany, ~~the~~we ~~Affordable~~have ~~Care~~never ~~Act~~commercialized a product for any indication. ~~For~~Even ~~example,~~if inwe ~~December~~receive ~~2017,~~regulatory ~~Congress~~approval ~~repealed,~~for ~~effective~~one ~~January~~or 1,more ~~2019,~~of our product candidates from the ~~tax~~FDA ~~penalty~~or ~~for~~comparable anregulatory ~~individual's~~authorities, ~~failure~~we towill ~~maintain~~need ~~Affordable~~to ~~Care~~develop ~~Act-mandated~~robust ~~health~~internal ~~insurance~~sales, ~~commonly~~marketing ~~known~~and asdistribution ~~the~~capabilities ~~"individual~~to ~~mandate",~~commercialize assuch ~~part~~products, ofwhich ~~the~~will ~~Tax~~be ~~Cuts~~expensive and ~~Jobs~~time-consuming, ~~Act~~or ofenter ~~2017~~into ~~(the~~collaborations ~~“Tax~~with ~~Act”)~~third parties to perform these services.

There are costs and risks involved with establishing our own sales, marketing and distribution capabilities. For example, recruiting and training a sales force is expensive and time-consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel. We must also compete with other biotechnology companies to recruit, hire, train and retain marketing and sales personnel.

~~Congress~~Alternatively, iswe ~~continuing~~may wish to ~~consider~~establish ~~legislation~~collaborations ~~that~~with ~~would~~third ~~alter~~parties ~~other~~to ~~aspects~~maximize of the ~~Affordable~~potential ~~Care~~of ~~Act.~~our ~~The~~product ~~ultimate~~candidates' ~~content,~~jurisdictions ~~timing~~in orwhich ~~effect~~a ofproduct ~~any~~candidate ~~healthcare~~has ~~reform~~been ~~legislation on the U~~approved.S. ~~healthcare~~The biotechnology industry is ~~unclear. It~~characterized isby ~~unclear~~intense ~~how~~competition. ~~efforts~~Therefore, towe ~~modify~~may ornot ~~challenge~~be ~~the~~successful ~~Affordable~~in ~~Care~~entering ~~Act~~into orsuch ~~its~~commercialization ~~implementing~~arrangements ~~regulations,~~with orthird ~~portions~~parties ~~thereof,~~on ~~will~~favorable ~~affect~~terms, ~~our~~or ~~business~~at all. ~~Additional~~ ~~legislative~~In ~~and regulatory changes~~addition, ~~and~~we ~~further~~may ~~judicial~~have ~~challenges,~~limited ~~related~~control toover ~~the Affordable Care Act remain possible. Any~~ such ~~changes~~third orparties, ~~challenges~~and ~~could~~any ~~have~~of athem ~~material~~may ~~adverse~~fail ~~effect~~to ondevote ~~our~~the ~~industry~~necessary ~~generally~~resources and onattention ~~our~~to ~~ability~~sell, tomarket ~~successfully~~and ~~commercialize~~distribute our ~~product~~products ~~candidates~~effectively.

We anticipate that the Affordable Care Act, if substantially maintained in its current form, will continue to result in additional downward pressure on coverage and the price that we receive for any approved product, and could seriously harm our business. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates. 34

~~Further~~ Table ~~legislation or regulation could be adopted that could harm our business, financial condition and results~~ of operations. Other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. For example, in August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years 2012 through 2021, triggering the legislation's automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year, which went into effect beginning on April 1, 2013, and, due to subsequent legislation, will stay in effect through 2030, with the exception of a temporary suspension from May 1, 2020, through May 31, 2022, due to the COVID-19 pandemic. The law provides for 1% Medicare sequestration in the second quarter of 2022 and allows the full 2% sequestration thereafter until 2030. To offset the temporary suspension during the COVID-19 pandemic, in 2030, the sequestration will be 2.25% for the first half of the year, and 3% in the second half of the year. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.Contents

~~Additionally,~~There ~~there~~can ~~has~~be ~~been~~no ~~increasing~~assurance ~~legislative,~~that ~~regulatory~~we ~~and~~will ~~enforcement~~be ~~interest~~able into develop the ~~U.S.~~necessary ~~with~~commercial ~~respect~~infrastructure and capabilities to ~~specialty~~successfully ~~and~~commercialize ~~other~~our ~~drug~~product ~~pricing~~candidates ~~practices~~or be able to establish or maintain relationships with third parties necessary to perform these services. ~~Among~~As ~~other~~a ~~things~~result, ~~there~~we ~~have~~may ~~been~~not ~~several~~successfully ~~U.S.~~commercialize ~~Congressional~~any ~~inquiries~~product ~~and~~in ~~federal~~any jurisdiction.

35We must maintain quality controls and compliance with manufacturing standards.

~~Table~~The manufacture of ~~Contents~~our product candidates is, and the manufacture of any future drug and/or cell-related therapeutic products would be, subject to periodic inspection by regulatory authorities and distribution partners. The manufacture of drug and device products for human use is subject to regulation and inspection from time to time by the FDA for compliance with the FDA’s cGMP, Quality System Regulations (“QSRs”), as well as equivalent requirements and inspections by state and non-U.S. regulatory authorities. There can be no assurance that the FDA or other authorities will not, during the course of an inspection of existing or new facilities, identify what they consider to be deficiencies in our compliance with QSRs or other requirements and request, or seek remedial action.

~~and~~Failure ~~state legislative and regulatory activity designed~~ to, ~~among~~comply ~~other~~with ~~things,~~such ~~bring~~regulations ~~more~~or ~~transparency~~a topotential ~~drug~~delay ~~pricing,~~in ~~reduce~~attaining ~~the~~compliance ~~cost~~may ofadversely ~~prescription~~affect ~~drugs~~our ~~under~~manufacturing ~~Medicare~~activities and ~~other~~could ~~government~~result ~~programs~~in, ~~examine~~among ~~the~~other ~~relationship between pricing and manufacturer patient programs~~things, ~~and reform government program reimbursement methodologies for drugs. For example~~injunctions, atcivil ~~the federal level~~penalties, inFDA ~~September~~refusal ~~2018,~~to ~~CMS~~grant ~~announced~~pre- ~~that~~market itapprovals ~~will~~or ~~allow~~clearances ~~Medicare~~of ~~Advantage~~future ~~Plans~~or ~~the~~pending ~~option~~product tosubmissions, ~~use~~fines, ~~step~~recalls ~~therapy~~or ~~for~~seizures ~~Part~~of Bproducts, ~~drugs~~total ~~beginning~~or ~~January~~partial 1,suspensions ~~2019.~~of ~~Congress~~production and ~~the~~criminal Uprosecution.S. ~~President's~~There ~~administration~~can ~~have~~be ~~each~~no ~~indicated~~assurance that itafter ~~will~~such ~~continue~~occurrences towe ~~seek~~will ~~new~~be ~~legislative~~able ~~and/or administrative measures~~ to ~~control~~obtain ~~drug~~additional ~~costs.~~necessary ~~Individual~~regulatory ~~states~~approvals inor ~~the~~clearances ~~United~~on ~~States~~a ~~have~~timely ~~also~~basis, ~~become~~if ~~increasingly~~at ~~active~~all. Delays in ~~passing~~receipt ~~legislation~~of ~~and~~or ~~implementing~~failure ~~regulations designed~~ to ~~control~~receive ~~pharmaceutical~~such ~~product~~approvals ~~pricing, including those regarding price~~ or ~~patient reimbursement constraints~~clearances, ~~discounts,~~or ~~restrictions~~the onloss ~~certain~~of ~~product~~previously ~~access,~~received ~~and~~approvals ~~marketing~~or ~~cost~~clearances ~~disclosure~~could ~~and~~have ~~transparency~~a ~~measures,~~substantial ~~and,~~negative ineffect ~~some~~on ~~cases,~~our ~~importation~~results ~~from~~of ~~other~~operations ~~countries~~ and ~~bulk~~financial ~~purchasing~~condition.

~~The~~Serious ~~Foreign~~adverse ~~Corrupt~~events, ~~Practices~~including ~~Act~~patient deaths in our clinical trials could delay or prevent regulatory approval and impact our business.

~~The~~Our ~~FCPA~~product ~~prohibits~~candidates ~~any~~are ~~U.S.~~in ~~individual~~clinical ~~or business from paying~~development, ~~offering~~and, oras ~~authorizing~~with ~~payment~~any orinvestigational ~~offering of anything of value~~therapy, ~~directly~~there oris ~~indirectly,~~a torisk ~~any~~of ~~foreign~~adverse ~~official~~events, ~~political~~including ~~party~~serious oradverse ~~candidate~~events ~~for~~(SAEs) ~~the purpose of influencing any act~~ or ~~decision~~deaths. ofWhile ~~the~~such ~~foreign~~events ~~entity~~are innot ~~order~~uncommon ~~to assist the individual or business~~ in ~~obtaining~~clinical ortrials ~~retaining~~involving ~~business.~~advanced ~~The~~tumors ~~FCPA~~such ~~also~~as ~~obligates~~NSCLC, ~~companies~~regulatory ~~whose~~agencies ~~securities~~such ~~are~~as ~~listed in~~ the FDA ~~U.S.~~or toEMA ~~comply~~may ~~with~~require ~~accounting~~us ~~provisions requiring the company~~ to ~~maintain~~conduct ~~books~~additional ~~and~~studies, ~~records~~place ~~that~~a ~~accurately~~clinical ~~and fairly reflect all transactions of the corporation~~hold, ~~including~~or ~~international~~request ~~subsidiaries,~~modifications ~~and~~ to ~~devise~~our ~~and maintain an adequate system of internal accounting controls for international operations~~protocols.

~~Additional~~If ~~Regulation~~safety concerns arise, our ability to obtain regulatory approval may be delayed or denied, negatively impacting our business, financial condition, and prospects. Additionally, public perception and investor confidence in our company and product candidates could be adversely affected.

InWe ~~addition~~continue to ~~the~~monitor ~~foregoing,~~all ~~state~~adverse ~~and~~events ~~federal~~closely ~~laws regarding environmental protection~~ and ~~hazardous~~work ~~substances,~~with ~~including~~regulators the Occupational Safety and Health Act, the Resource Conservancy and Recovery Act and the Toxic Substances Control Act, affect our business. These and other laws govern our use. The General Data Protection Regulation (the “GDPR”) applies extraterritorially, and we may be subject to ~~the~~assess ~~GDPR because of our data processing activities that involve~~ the ~~personal~~risk-benefit ~~data~~profile of ~~individuals located in the EU, such as in connection with~~ our EUinvestigational ~~clinical trials~~therapies. Failure to comply with the requirements of the GDPR and the applicable national data protection laws of the EU member states may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties. GDPR regulations may impose additional responsibility and liability in relation to the personal data that we process, and we may be required to put in place additional mechanisms to ensure compliance with the new data protection rules.

~~The~~Our ~~GDPR~~future ~~imposes~~success ~~strict~~depends ~~obligations and restrictions~~ on ~~the~~our ability to ~~collect,~~retain analyze and transfer personal data. In particular, these obligations and restrictions concern the consent of the individuals to whom the personal data relates, the information provided to the individuals, the sharing of personal data with third parties, the transfer of personal data out of the EU, security breach notifications, security and confidentiality of the personal data and imposition of substantial potential fines for violations of the data protection obligations. Specifically regarding the transfer of personal data outside of the EU, while there are legal mechanisms available to lawfully transfer personal data outside of the EU, including to the United States, there are certain unsettled legal issues regarding such data transfers, the resolution of which may adversely affect our ~~ability~~Chief toExecutive transfer personal data or otherwise may cause us to incur significant costs to come into compliance with applicable data transfer impact assessments and implementation of legal data transfer mechanisms. On July 16Officer, ~~2020, the European Court of Justice ruled the EU-US Privacy Shield to be an invalid data transfer mechanism~~ and ~~confirmed~~other ~~that~~key ~~the~~executives ~~Model Clauses remain valid,~~ and ~~in June 2021, the European Commission published updated versions of the Model Clauses, which must be incorporated into new and existing agreements within prescribed timeframes in order~~ to ~~continue to lawfully transfer personal data outside of the EU. Data protection authorities from the different EU member states~~attract, asretain ~~well as in the United Kingdom~~ and ~~Switzerland,~~motivate ~~have~~qualified promulgated national privacy laws that impose additional requirements, which add to the complexity of processing and transferring EU personal data, with the United Kingdom and Switzerland following the EU with the publication of new Model Clauses to be incorporated in all applicable contracts within a specified timeframe in order to legitimize data transfers from those jurisdictionspersonnel. Our ability to continue to transfer personal data outside of the EU, United Kingdom, or Switzerland may become significantly more costly and may subject us to increased scrutiny and liability under the GDPR or similar local laws, and we may experience operating disruptions if we are unable to conduct these transfers in the future.

36We are highly dependent on the research and development experience, technical skills, leadership and continued service of certain members of our management and scientific teams, including Pietro Bersani, our Chief Executive Officer; Brian Hungerford, our Chief Financial Officer; Leonardo Mirandola, our Chief Scientific Officer and Scott Dahlbeck, our Chief of Staff.

~~Table~~Although we have employment agreements with our executive officers, these agreements do not prevent them from terminating their employment with us at any time. The loss of ~~Contents~~the services of any of these persons could impede the achievement of our research, development and commercialization objectives.

~~California~~Recruiting ~~Consumer~~and ~~Privacy~~retaining ~~Act~~qualified scientific, clinical, manufacturing and, if we retain commercialization responsibility for any product candidate we develop alone or with collaborators, sales and marketing personnel, will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms or at all given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategies. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.

The ~~California~~inability Consumer Privacy Act (“CCPA”) creates new individual privacy rights for consumers (as that word is broadly defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA requires covered companies to ~~provide new disclosures to California consumers~~recruit, ~~provide such consumers new ways to opt-out of certain sales of personal information~~integrate, ~~and~~motivate ~~allow for a new cause of action for data breaches. The CCPA~~ and ~~its~~retain ~~implementing~~additional ~~regulations~~skilled have already been amended multiple times since their enactment. In November 2020, California voters approved the California Privacy Rights Act (“CPRA”) ballot initiative which introduced significant amendments to the CCPA and ~~established~~qualified ~~and funded a dedicated California privacy regulator~~personnel, the California Privacy Protection Agency (“CPPA”). The amendments introduced by the CPRA go into effect on January 1, 2023, and new implementing regulations are expected to be introduced by the CPPA. Failure to comply with the CCPA may result in, among other things, significant civil penalties and injunctive relief, or ~~potential statutory or actual damages. In addition, California residents have~~ the ~~right~~loss toof ~~bring~~services ~~a private right~~ of ~~action in connection with~~ certain ~~types of incidents. These claims may result in significant liability and potential damages. We implemented processes to manage compliance with the CCPA and continue to assess the impact of the CPRA~~executives, ~~and~~key ~~other state legislation~~employees, onconsultants ~~our~~or ~~business as additional information and guidance becomes available. Similarly~~advisors, ~~there~~may ~~are~~impede ~~a number of legislative proposals in~~ the ~~United~~progress ~~States, at both the federal and state level, that could impose new obligations or limitations in the area~~ of ~~consumer protection. These laws and regulations are evolving and may impose limitations on~~ our ~~business activities. The obligations to comply with new privacy laws may require us~~research, ~~among~~development ~~other things, to update our notices~~ and ~~develop~~commercialization ~~new~~objectives ~~processes internally~~ and ~~with~~have ~~our~~a ~~service~~material ~~providers~~adverse toeffect ~~facilitate consumer rights requests, and such laws may impose restrictions~~ on our ~~processing of personal information that may impact the way we operate our~~ business. ~~We may be subject to fines, penalties, or private actions in the event of non-compliance with such laws.~~

~~Human~~We ~~Capital~~will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

~~Our~~We ~~Employees.~~will Asneed ofto ~~December~~significantly ~~31,~~expand ~~2023,~~our organization. If we ~~had~~are anot ~~total~~able ofto ~~35 employees~~effectively ~~all~~manage ~~located~~this inexpansion, ~~the~~that ~~United~~may ~~States~~impact ofour ~~America.~~future ~~Our~~financial ~~highly~~performance, ~~qualified~~our ~~and~~ability ~~experienced~~to ~~team~~develop ~~includes~~and ~~scientists,~~commercialize ~~physicians,~~product ~~laboratory~~candidates ~~technicians,~~alone ~~finance~~or ~~professionals~~with collaborators, and ~~administrative~~our ~~professionals.~~ability Weto ~~also~~compete ~~utilize~~effectively. aIn ~~number~~addition, ofwe ~~consultants~~may ~~for~~have ~~financial~~difficulty ~~reporting~~identifying, ~~clinical,~~hiring ~~regulatory,~~ and ~~SEC~~integrating ~~compliance~~new personnel if we are unable to effectively manage expansion.

WeMany ~~believe~~of the biotechnology companies that we ~~maintain~~compete aagainst ~~satisfactory~~for ~~working~~qualified ~~relationship~~personnel ~~with~~and ~~our~~consultants ~~employees~~have greater financial and other resources, different risk profiles and a longer history than we ~~have~~do. ~~not~~If ~~experienced~~we ~~any~~are ~~significant~~unable ~~labor~~to ~~disputes~~continue orto ~~any~~attract ~~difficulty~~and inretain ~~recruiting~~high-quality ~~staff~~personnel ~~for~~and ~~our~~consultants, ~~operations.~~the ~~None~~rate ofand ~~our~~success ~~employees~~at iswhich ~~represented~~we bycan aidentify ~~labor~~and ~~union~~develop product candidates, enter into collaborative arrangements and otherwise operate our business will be limited.

Employee Engagement, Talent Development & Benefits. We believe that our future success largely depends upon our continued ability to attract and retain highly skilled employees. We provide our employees with competitive salaries and bonuses, and opportunities for equity ownership. 35

~~Diversity,~~ Table ~~Inclusion, and Culture. Much~~ of our success is rooted in the diversity of our teams and our commitment to inclusion. We value diversity at all levels and continue to focus on extending our diversity and inclusion initiatives across our entire workforce. We believe that our business benefits from the different perspectives a diverse workforce brings, and we pride ourselves on having a strong, inclusive and positive culture based on our shared mission and values.Contents

~~Overseas~~Future ~~Government~~growth ~~Regulation~~would impose significant additional responsibilities on our management, including the need to identify, recruit, maintain, motivate and integrate additional employees, consultants and contractors. Management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expected expansion of our operations or recruit and train additional qualified personnel.

InMoreover, ~~addition to regulations in~~ the ~~U.S.,~~expected wephysical ~~will~~expansion ~~be subject to a variety~~ of ~~regulations~~our inoperations ~~other~~may ~~jurisdictions~~lead ~~governing,~~to ~~among~~significant ~~other~~costs ~~things, clinical trials~~ and ~~any~~may ~~commercial~~divert ~~sales and distribution of~~ our ~~products.~~management ~~Whether~~and orbusiness ~~not~~development weresources ~~obtain~~from ~~FDA~~other ~~approval of a product~~projects, wesuch ~~must~~as ~~obtain~~ the ~~requisite~~development ~~approvals from regulatory authorities in foreign countries prior to the commencement~~ of ~~clinical trials or marketing of the~~ product ~~in those countries~~candidates. ~~Certain~~If ~~countries~~we ~~outside~~are ofnot ~~the~~able ~~U.S.~~to ~~have~~effectively amanage ~~similar process that requires~~ the ~~submission~~expansion of aour ~~clinical trial application much like the IND prior to the commencement of human clinical trials. In the EU~~operations, ~~for~~it ~~example,~~may aresult ~~clinical~~in ~~trial~~weaknesses ~~application~~in ~~must~~our ~~be submitted to each country's national health authority and an independent ethics committee~~infrastructure, increase ~~much~~our ~~like~~expenses ~~the~~more ~~FDA~~than ~~and IRB~~expected, ~~respectively.~~give ~~Once~~rise ~~the~~to ~~clinical~~operational ~~trial application is approved in accordance with a country's requirements~~mistakes, ~~clinical~~loss ~~trial~~of ~~development~~business ~~may proceed. Because biologically sourced raw materials are subject to unique contamination risks~~opportunities, ~~their~~loss ~~use~~of ~~may~~employees beand ~~restricted~~reduced ~~in some countries~~productivity.

37Our governing documents designate the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of state law actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.

~~Table~~Our Fourth Amended and Restated Certificate of ~~Contents~~Incorporation dictates that the Delaware Court of Chancery is the sole and exclusive forum for certain state law based actions including certain derivative actions or proceedings brought on behalf of us; an action asserting a breach of fiduciary duty owed by an officer, a director, employee or to our shareholders; any claim arising under Delaware corporate law; and any action asserting a claim governed by the internal affairs doctrine.

~~The~~This ~~requirements~~exclusive ~~and~~forum ~~process~~provision ~~governing~~does ~~the~~not ~~conduct~~apply ofto ~~clinical~~suits ~~trials,~~brought ~~product~~to ~~licensing,~~enforce ~~pricing~~any ~~and~~liability ~~reimbursement~~or ~~vary~~duty ~~from~~created ~~country~~by tothe ~~country.~~Securities InAct ~~all~~or ~~cases,~~ the ~~clinical~~Exchange ~~trials~~Act ~~must~~or beother ~~conducted~~federal insecurities ~~accordance~~laws ~~with~~for ~~GCP~~which ~~and~~there ~~the~~is ~~applicable~~exclusive ~~regulatory~~federal ~~requirements~~or ~~and~~concurrent ~~the~~federal ~~ethical~~and ~~principles~~state ~~that have their origin in the Declaration of Helsinki~~jurisdiction.

ToThis ~~obtain~~choice ~~regulatory~~of ~~approval~~forum ofprovision anmay ~~investigational~~limit ~~drug~~our stockholders’ ability to bring a claim in a judicial forum that it finds favorable for disputes with us or ~~biological~~our ~~product~~directors, ~~under~~officers, EUemployees ~~regulatory~~or ~~systems~~agents, wewhich ~~must~~may ~~submit~~discourage such lawsuits against us and our directors, officers, employees and agents even though an action, if successful, might benefit our stockholders. Stockholders who do bring a ~~marketing~~claim ~~authorization~~in ~~application~~the Court of Chancery could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware. The ~~application~~Court ~~used~~of Chancery may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to ~~file~~bring the ~~BLA~~action, inand ~~the~~such Ujudgments or results may be more favorable to us than to our stockholders.S. isAlternatively, ~~similar~~if a court were to ~~that~~find ~~required~~this provision inapplicable to, or unenforceable in ~~the~~respect EUof, ~~with~~one or more of the ~~exception~~specified types of actions or proceedings, ~~among~~we may incur additional costs associated with resolving such matters in other ~~things~~jurisdictions, ~~country-specific~~which ~~document~~could ~~requirements~~have a material adverse effect on our business, financial condition or results of operations.

~~For~~We ~~other~~are ~~countries~~an ~~outside~~emerging ofgrowth ~~the EU~~company, ~~such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing~~ and ~~reimbursement~~we ~~vary~~cannot ~~from country to country. In all cases, again, the clinical trials must~~ be ~~conducted~~certain inif ~~accordance with GCP and~~ the ~~applicable~~reduced ~~regulatory~~reporting requirements ~~and~~applicable ~~the~~to ~~ethical~~emerging ~~principles~~growth ~~that~~companies ~~have~~make ~~their~~our ~~origin~~shares inless ~~the~~attractive ~~Declaration~~to ~~of Helsinki~~investors.

IfWe weare oran ~~our~~“emerging ~~potential~~growth ~~collaborators~~company,” ~~fail~~as todefined ~~comply~~in ~~with~~the ~~applicable~~JOBS ~~foreign~~Act. ~~regulatory~~For ~~requirements~~as long as we continue to be an emerging growth company, we may betake ~~subject~~advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, ~~among~~including, ~~other~~but ~~things~~not limited to, ~~fines~~(i) not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, ~~suspension~~(ii) orreduced ~~withdrawal~~disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements and (iii) exemptions from the requirements of ~~regulatory~~holding ~~approvals~~a nonbinding advisory vote on executive compensation. In addition, ~~product~~as ~~recalls~~an emerging growth company, ~~seizure~~we are required to provide only two years of ~~products~~audited financial statements and two years of selected financial data in our initial registration statement, ~~operating~~compared ~~restrictions~~to three and ~~criminal~~five ~~prosecution~~years, respectively, for comparable data reported by other public companies.

~~EU General Data Protection Regulation~~ 36

In Table ~~addition to EU regulations related to the approval and commercialization~~ of our products, we may be subject to the EU's General Data Protection Regulation, or the GDPR. The GDPR imposes stringent requirements for controllers and processors of personal data of persons in the EU, including, for example, more robust disclosures to individuals and a strengthened individual data rights regime, shortened timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to special categories of data, such as health data, and additional obligations when we contract with third-party processors in connection with the processing of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the EU to the U.S. and other third countries. In addition, the GDPR provides that EU member states may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric or health data.Contents

We could be an emerging growth company for up to five years from our initial public offering (“IPO”), although circumstances could cause us to lose that status earlier, including if the market value of our shares held by non-affiliates equals or exceeds $700 million as of any June 30 (the end of our second fiscal quarter) before that time or if we have total annual gross revenues of $1.07 billion or more during any fiscal year before that time, in which cases we would no longer be an emerging growth company as of the following December 31 (our fiscal year end); or, if we issue more than $1.0 billion in non-convertible debt during any three-year period before that time, we would cease to be an emerging growth company immediately. Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.

~~ITEM~~We 1Acannot predict if investors will find our securities less attractive because we may rely on these exemptions. ~~RISK~~If ~~FACTORS~~some investors find our securities less attractive as a result, there may be a less active trading market for our securities and the price of our securities may be more volatile. When these exemptions cease to apply, we expect to incur additional expenses and devote increased management effort towards ensuring compliance with them, and we cannot predict or estimate the amount or timing of such additional costs.

~~You~~We ~~should~~may ~~carefully~~be ~~consider~~subject the risks described below, as well as general economic and business risks and the other information in this Annual Report on Form 10-K. The occurrence of any of the events or circumstances described below or other adverse events could have a material adverse effect on our business, results of operations and financial condition and could cause the trading price of our common stock to ~~decline.~~securities ~~Additional~~laws ~~risks~~claims orregarding ~~uncertainties~~past ~~not presently known to us or that we currently deem immaterial may also harm our business~~disclosures.

~~Risks~~We ~~Related~~may be subject to ~~Our~~additional ~~Financial~~claims ~~Position~~for rescission (under which a successful claimant would have the right to receive the total amount paid for his or her shares, plus interest and less any income earned on the shares, in exchange for surrender of the shares), damages (under which a successful claimant would have the right to receive the total amount paid for his or her shares, plus interest and less any income earned on the shares, in exchange for surrender of the shares) or other securities law claims resulting from our failure to timely disclose that the Company had received communications from the FDA on June 16 and June 17, 2021 that the FDA was placing the Company’s IND applications that the Company submitted to the FDA on May 14 and May 17, 2021 for the ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates, respectively, on clinical hold (the “June 16 and 17, 2021 FDA Communications”).

On July 2, 2021, we consummated a public offering of $40 million of our common stock. Neither the Registration Statement on Form S-1 with respect to this offering that was filed on June 25, 2021, nor the final prospectus dated June 29, 2021, with respect to this offering contained any disclosure with respect to the June 16 and 17, 2021 FDA Communications. Our Form S-1 and final prospectus for the offering stated the following with respect to our ALEXIS-PRO-1 and ALEXIS-ISO-1 product candidates: “These products are in the pre-IND stage of the FDA clinical trial process. We ~~have~~are ~~incurred~~currently ~~losses~~going ~~since~~through ~~inception~~the IND enabling trials process for these product candidates and we expect that first in human dosing in Phase I of clinical trials will commence in the third quarter of 2021.”Anyone who purchased shares of our common stock in the offering and anyone who purchased or sold shares of our common stock in the public market after June 16, 2021 could claim that they were misled by our failure to ~~incur~~disclose ~~significant~~the ~~net~~clinical ~~losses~~hold on studies under the INDs for these product candidates and that they suffered damages. On March 7, 2022, certain shareholders who had purchased shares of our common stock in our public offering that closed on July 2, 2021, filed a complaint against us and certain of our current and former officers and directors for alleged violations of Sections 11, 12, and 15 of the ~~foreseeable~~Securities ~~future~~Act of 1933 in connection with the purchase of common stock in the offering. The plaintiffs sought unspecified damages; rescission to the extent they still hold Kiromic securities, or if sold, rescissory damages; reasonable costs and expenses, including attorneys’ and experts’ fees; and other unspecified equitable and injunctive relief. We subsequently reached agreement with the plaintiffs on all settlement materials and terms including with respect to payment of up to $2,300,000 and, on September 29, 2023, counsel for plaintiffs submitted the proposed settlement materials to the Court for approval. Of this amount, insurance covered $570,000, resulting in a net settlement of $1,730,000 covered by the Company.

We ~~generated~~face ~~negative~~risks cash flows from operations and have incurred net operating losses each year since we started business. For the year ended December 31, 2023, we incurred net losses of $20,949,300 and our net cash used in operating activities was $21,225,300. As of December 31, 2023, our accumulated deficit was $122,896,800. We expect to continue to incur net losses and negative cash flow from operating activities for at least the next twelve months. As our focus on development of our product candidates has increased, losses have resulted primarily from expenses associated with ~~research~~increased ~~and~~political ~~development and clinical trial-related activities, as well as general and administrative expenses~~uncertainty. While we have implemented and continue to implement cost reduction measures where possible, we nonetheless expect to continue operating in a loss position on a consolidated basis and expect that recurring operating expenses will be at higher levels for the year ending December 31, 2024. Further, we anticipate that our expenses will increase substantially if and as we:

●The ~~Continue~~recent ~~our~~invasion ~~current~~of ~~research~~Ukraine by Russia and ~~development~~the ~~programs~~sanctions, bans and other measures taken by governments, organizations and companies against Russia and certain Russian citizens in response thereto has increased the political uncertainty in Europe and has strained the relations between Russia and a significant number of governments, including ~~conducting~~the ~~laboratory~~U.S. The duration and outcome of this conflict, ~~preclinical~~any retaliatory actions taken by Russia and ~~greenhouse~~the ~~studies~~impact ~~for~~on ~~product~~regional ~~candidates~~or global economies is unknown but could have a material adverse effect on our business, financial condition and results of our operations.

~~● Initiate clinical or field trials for product candidates.~~ 37

● Table ~~Seek~~of ~~to identify, assess, acquire or develop additional research programs or product candidates.~~Contents

38In the U.S., the change in the U.S. government to the Trump administration has resulted in uncertainty regarding potential changes in regulations, fiscal policy, social programs, domestic and foreign relations and international trade policies. In addition, potential changes in relationships among the U.S. and China and other countries including Taiwan could have significant impacts on global trade and regional economic conditions, among other things. In addition, changes in the relationships between the U.S. and its neighbors, such as Mexico, could have significant, potentially negative, impacts on commerce. Further, anti-American sentiment could harm the reputation and success of U.S. companies doing business abroad.

~~Table~~Our ability to respond to these developments or comply with any resulting new legal or regulatory requirements, including those involving economic and trade sanctions, could reduce our sales, increase our costs of ~~Contents~~doing business, reduce our financial flexibility and otherwise have a material adverse effect on our business, financial condition and results of our operations.

●Risks ~~Maintain,~~Related ~~expand~~to ~~and protect~~ our ~~intellectual~~Product ~~property portfolio.~~Candidates

●Our ~~Seek~~tumor-specific ~~marketing~~cancer ~~approvals~~immunotherapy ~~for~~approach ~~any~~is ~~product~~based ~~candidates~~on novel ideas and technologies that are unproven and may ~~successfully~~not ~~complete~~result in marketable products, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval.

●We ~~Establish~~are using our proprietary technologies to develop tumor-specific immunotherapy product candidates to treat cancer. Our foundational science and product development approach are based on our ability to predict the presence of a ~~sales~~patient’s TSIA’s and develop a TSIA-directed therapy that will elicit a meaningful specific immune-system cell response (T or NK cells). We believe that this approach may offer an improved therapeutic effect by driving an intense, ~~marketing~~focused attack selectively upon a patient’s tumor. However, this approach to treating cancer is novel and ~~distribution~~the ~~infrastructure~~scientific research that forms the basis of our efforts to ~~commercialize~~predict ~~any~~the ~~products~~presence of TSIA and to develop a CAR that ~~may~~targets ~~obtain~~TSIA-directed ~~marketing~~cancer ~~approval~~immunotherapy candidates is both preliminary and limited.

●Our ~~Further~~tumor-specific ~~develop~~immunotherapy ~~and~~product ~~refine~~candidates ~~the~~have ~~manufacturing~~experienced limited testing in humans. We are currently in the process of validating different tumor-specific immunotherapy product candidates. When we validate adequate biomarkers for ~~our~~these product candidates, we will commence preclinical animal studies, and the results of our preclinical animal studies may not translate into humans. For example, our prediction model may fail to accurately predict the presence of TSIAs, resulting in little or no T cell activity, or our therapy may fail to elicit a significant or durable enough T or NK cell response to effectively destroy a tumor.

●As ~~Change~~such, orwe ~~add~~cannot ~~additional~~assure ~~manufacturers~~you orthat ~~suppliers~~even ofif ~~biological~~we ~~materials~~are orable ~~product~~to develop cancer immunotherapy candidates capable of recognizing TSIA and eliciting a T cell response, that such therapy would safely and effectively treat cancers. We may spend substantial funds attempting to develop this approach and never succeed in developing a marketable therapeutic.

●Furthermore, ~~Validate~~no regulatory authority has granted approval for a ~~commercial~~cancer immunotherapy based on a heterologous prime-~~scale~~boost ~~manufacturing~~approach. ~~facility~~As ~~compliant~~such, we believe that the FDA has limited experience with ~~cGMP~~evaluating our approach, which may increase the complexity, uncertainty and length of the regulatory approval process for our product candidates. We may never receive approval to market and commercialize any product candidate. Even if we obtain regulatory approval, the approval may be for targets, disease indications, lines of therapy or patient populations that are not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings.

●We ~~Further~~face ~~develop~~substantial ~~our~~competition ~~genome~~from ~~editing~~other ~~technology~~pharmaceutical and biotechnology companies, which may result in others discovering, developing, or commercializing products before, or more successfully, than we do.

●The ~~Acquire~~development orand ~~in-license~~commercialization ~~other~~of ~~technologies~~new drug products is highly competitive. Our future success depends on our ability to demonstrate and maintain a competitive advantage with respect to the design, development, and commercialization of our product candidates. Our objective is to design, develop and commercialize new products with superior efficacy, convenience, tolerability, and safety. In many cases, the products that we intend to commercialize, if successfully commercialized, will compete with existing market-leading products.

●Many ~~Seek~~of toour ~~attract~~potential competitors have significantly greater financial, manufacturing, marketing, drug development, technical and ~~retain~~human ~~new~~resources than we do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and ~~existing~~manufacturing ~~personnel~~pharmaceutical products.

~~● Expand our facilities.~~ 38

~~Our~~ Table ~~ability to generate sufficient revenue from any~~ of our products, product candidates or technologies to achieve profitability will depend on a number of factors including, but not limited to, the success of our research and development programs, our ability to achieve regulatory approvals, market conditions, costs and effectiveness of manufacturing, sales, marketing and distribution operations related to such product candidate, and the terms of any collaboration or other strategic arrangement we may have with respect to such product candidate and levels of reimbursement from third-party payors.Contents

WeLarge and established companies compete in the same market as our product candidates. These companies compete with us with their greater experience and resources to support their research and development efforts, conduct testing and clinical trials, obtain regulatory approvals to market products, manufacture such products on a broad scale and market approved products. These companies also compete with us by having significantly greater research and marketing capabilities than we do and may ~~never~~also ~~achieve~~have products that have been approved or ~~sustain~~are ~~profitability~~in late stages of development and have collaborative arrangements in our target markets with leading companies and research institutions. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the products that we develop obsolete. We also face competition from smaller companies who, like us, rely on investors to fund research and development and compete for co-development and licensing opportunities from large and established pharmaceutical companies.

We domay ~~not~~expend ~~know~~our ~~when~~limited orresources ~~whether~~pursuing weparticular ~~will~~research ~~become~~programs profitable. We have no products approved for commercial sale and have not generated revenue from operations. To become and remain profitable, we must succeed in developing, obtaining regulatory approval for and commercializing one or ~~more of our~~ product candidates. ~~This~~that ~~will~~may ~~require us to~~ be less successful inor aprofitable ~~range~~than ofother ~~challenging~~programs ~~activities,~~or ~~including completing preclinical studies and clinical trials of our~~ product candidates, discovering and developing additional product candidates, obtaining regulatory approval for any product candidates that successfully complete clinical trials, establishing commercialization capabilities for any approved products and achieving market acceptance for any approved products. ~~We may never succeed in these activities. Even if we succeed in these activities, we may never generate revenue in an amount sufficient to achieve profitability.~~

~~Because~~Research ofprograms ~~the~~to ~~numerous~~identify ~~risks~~new ~~and~~product ~~uncertainties~~candidates ~~associated~~and ~~with biotechnology~~ product development ~~and~~platforms ~~commercialization,~~require wesubstantial ~~are~~technical, ~~unable~~financial, ~~to accurately predict whether~~ and ~~when~~human weresources. ~~will~~We ~~achieve~~may ~~profitability.~~focus Ifour weefforts ~~are~~and ~~required~~resources byon ~~the~~potential ~~FDA~~programs, ~~the~~product ~~European~~candidates ~~Medicines~~or ~~Agency~~product ~~(the~~development ~~“EMA”)~~platforms orthat ~~any~~ultimately ~~comparable~~prove ~~regulatory authority~~ to ~~perform~~be ~~preclinical~~unsuccessful. ~~studies~~Clinical ~~or clinical~~ trials inof ~~addition to those we currently expect to conduct, or if there are~~ any ~~delays or complications in completing preclinical studies~~ of our product candidates ~~or,~~is ifnot ~~preclinical~~assured ~~studies~~despite ~~are~~the ~~successful,~~expenditure inof ~~submitting~~significant anresources ~~IND~~in orpursuit ~~Clinical~~of ~~Trial~~their ~~Application to the FDA and comparable regulatory authorities~~development, and ifour ~~clinical~~spending ~~trials~~on ~~are~~current ~~successful, in submitting a BLA or Marketing Authorization Application to the FDA~~ and ~~comparable~~future ~~regulatory~~research ~~authorities, manufacturing clinical trial supplies~~ and ~~completing~~development ~~clinical trials~~programs, ~~our~~product ~~expenses~~candidates ~~could increase substantially~~ and ~~our~~product ~~ability~~development toplatforms ~~achieve~~may ~~profitability~~not ~~could~~yield beany ~~further~~commercially ~~delayed~~viable products.

~~Even~~Additionally, if we ~~achieve~~do ~~profitability, we may~~ not beaccurately ~~able~~evaluate tothe ~~sustain~~commercial ~~profitability~~potential inor ~~subsequent~~target ~~periods.~~market ~~After~~for wea ~~achieve~~particular ~~profitability,~~product ~~if ever~~candidate, we ~~expect~~may torelinquish ~~continue~~valuable rights to ~~engage~~that inproduct ~~substantial~~candidate ~~research~~through ~~and~~collaboration, ~~development~~licensing ~~activities~~or ~~and~~other tostrategic ~~incur~~arrangements ~~substantial~~in ~~expenses~~cases toin ~~develop~~which ~~and~~it ~~commercialize~~would ~~additional~~have ~~product~~been ~~candidates.~~more Inadvantageous ~~addition,~~for weus ~~may~~to ~~encounter~~retain ~~unforeseen~~sole ~~expenses,~~development ~~difficulties, complications, delays~~ and ~~other~~commercialization ~~unknown~~rights ~~factors~~to ~~that~~such ~~may~~product ~~adversely affect our revenues, expenses and profitability~~candidate.

~~Our~~If ~~failure~~we toexperience ~~achieve~~delays or ~~sustain~~difficulties ~~profitability~~in ~~would~~patient ~~depress~~enrollment ~~our~~for ~~market~~clinical ~~value and could impair our ability to execute our business plan~~trials, ~~raise capital, develop additional product candidates or continue~~ our ~~operations.~~research Aand ~~decline~~development inefforts and the ~~value~~receipt of ~~our~~necessary ~~company~~regulatory approvals could ~~cause~~be ~~our~~significantly ~~shareholders~~delayed ~~to lose all~~ or ~~part of their investment~~prevented.

39Commencement and successful and timely completion of clinical trials require us to enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, the EMA or comparable regulatory authorities. Any delay or difficulty in patient enrollment could significantly delay or otherwise hinder our research and development efforts and delay or prevent receipt of necessary regulatory approvals. Despite diligent planning of our clinical trials and analysis of their feasibility regarding patient recruitment, we may experience difficulties, delays or inability in patient enrollment in our clinical trials for a variety of reasons, including:

~~Table~~● The size and nature of ~~Contents~~the patient population.

We● ~~will~~The ~~need~~severity ~~substantial additional funding to develop our product candidates~~ and ~~conduct~~incidence ~~our~~of ~~future~~the ~~operations~~disease ~~and~~under ~~to repay our outstanding debt obligations~~investigation. ~~We cannot be certain that additional capital will be available on terms acceptable to us, or at all.~~

● The eligibility criteria for the study in question, including any misjudgment of, and resultant adjustment to, the appropriate ranges applicable to the exclusion and inclusion criteria.

We● ~~have~~The ansize ~~ongoing~~of need to raise additional cash from outside sources to continue funding our operations, including our continuing substantial research and development expenses. We do not currently believe that our cash balance will be sufficient to fund the ~~development~~study ~~and~~population ~~marketing efforts~~ required tofor ~~reach~~analysis ~~profitability without raising additional capital from accessible sources~~ of ~~financing in~~ the ~~near~~trial’s ~~future. Our~~primary ~~future capital requirements will depend on many factors, including:~~endpoints.

● ~~Our~~The ability to ~~raise~~recruit ~~capital~~clinical totrial ~~fund~~investigators ~~our~~with ~~operations~~the onappropriate ~~terms~~competencies ~~acceptable~~and ~~to us, or at all~~experience.

● ~~Our~~The ~~perceived~~number ~~capital~~of ~~needs~~clinical ~~with~~trial ~~respect~~sites ~~to our development programs,~~ and ~~any~~the ~~delays~~proximity ~~in, adverse events and excessive costs~~ of ~~such~~prospective ~~programs~~patients ~~beyond~~to ~~what~~those ~~we currently anticipate~~sites.

● ~~Our~~The ~~ability~~design toof ~~establish~~the ~~and~~trial ~~maintain collaborative~~ and ~~other~~the ~~arrangements~~complexity ~~with~~for ~~third~~patients ~~parties to assist in bringing our product candidates to market~~ and ~~the~~clinical ~~cost of such arrangements at the time~~sites.

● The ~~cost~~nature, ofseverity ~~manufacturing~~and ~~our~~frequency ~~product~~of ~~candidates,~~adverse ~~including~~side ~~compliance~~effects associated with ~~GMP applicable to~~ our product candidates.

● ~~Expenses~~The ~~related~~screening toprocedures and the ~~establishment~~rate of ~~sales~~patients ~~and~~failing ~~marketing~~screening ~~capabilities for product candidates awaiting approval or products that have been approved~~procedures.

● ~~Competing~~The ~~technological~~ability ~~and~~to ~~market~~provide ~~developments~~appropriate screening assays.

● ~~Our~~The ~~ability~~risk tothat ~~introduce~~patients’ ~~and~~general ~~sell~~health ~~new~~conditions ~~products~~do not allow the conduct of study/screening procedures (for example, tumor biopsy).

~~The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical and preclinical development efforts.~~ 39

We Table have secured capital historically from equity offerings and debt financing. To obtain additional capital, we may pursue debt and/or equity offering programs, strategic corporate partnerships, state and federal development programs, licensing arrangements, and sales of ~~assets. We cannot be certain that additional capital will be available on terms acceptable to us, or at all.~~Contents

~~Depending~~● onThe ~~the~~ability type and the terms of any financing we pursue, stockholders’ rights and the value of their investment in our common stock could be reduced. A financing could involve one or more types of securities including common stock, preferred stock, convertible debt or warrants to ~~acquire~~manufacture ~~common~~patient ~~stock.~~products ~~These~~appropriately ~~securities could be issued at or below the then prevailing market price~~ (for ~~our common stock. In addition~~example, ifat wea ~~issue~~sufficient ~~secured~~high ~~debt securities~~dose, ~~the holders of the debt would have a claim to our assets that would be prior to the rights of stockholders until the debt is paid. Interest on debt~~ or ~~other~~with ~~securities~~sufficiently ~~would~~active ~~increase~~T ~~costs and negatively impact operating results~~cells). ~~If the issuance of new securities results in diminished rights to holders of our common stock, the market price of our common stock could be negatively impacted.~~

If● weThe ~~are~~efforts ~~unable~~ to ~~raise~~facilitate ~~substantial~~timely ~~additional~~enrollment ~~capital~~in onclinical ~~acceptable~~trials ~~terms,~~and orthe ateffectiveness ~~all, we may be forced to delay, reduce or eliminate some or all~~ of ~~our~~recruiting ~~research programs, product development activities and commercialization efforts~~publicity.

● The ~~process~~patient ofreferral ~~identifying~~practices ~~product~~of ~~candidates~~physicians ~~and~~within ~~conducting~~the ~~preclinical~~same ~~and~~hospital ~~clinical~~as ~~trials~~well ~~is time consuming, expensive, uncertain and takes years to complete. We expect our expenses to increase in connection with our ongoing activities, particularly~~ as wewithin ~~identify,~~other ~~continue~~hospitals ~~the research and development of, initiate clinical~~ or ~~field~~private ~~trials of, and seek marketing approval for, product candidates~~practices. In addition, if any therapeutic product candidate that we develop alone or with collaborators obtains marketing approval, we may incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution efforts. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise sufficient capital when needed, we may be forced to delay, reduce or eliminate current or future research programs, product development activities and/or commercialization efforts.

~~Adequate~~● ~~additional~~Competing ~~financing~~clinical ~~may~~trials ~~not~~for besimilar ~~available to us on acceptable terms~~therapies, orother atnew ~~all. If we are unable to obtain sufficient funding on a timely basis or on favorable terms~~therapeutics, wenew ~~may~~combination ~~be required to significantly delay~~treatments, ~~reduce~~new ormedicinal ~~eliminate one or more of our research or product development programs and/or commercialization efforts~~products. ~~We may also be unable to expand~~

40● Approval of new indications for existing therapies or approval of new therapies in general or changes in standard of care.

~~Table~~● Clinicians’ and patients’ perceptions as to the potential advantages and side effects of ~~Contents~~the product candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved or become standard of care for the indications we are investigating.

~~our~~● ~~operations~~The orability ~~otherwise~~to ~~capitalize~~obtain onand ~~business~~maintain ~~opportunities~~patient ~~as desired~~consents. ~~Any of these events could materially adversely affect our financial condition and business prospects.~~

~~Our~~● ~~financial~~Inability ~~situation~~of ~~creates~~clinical ~~doubt~~sites ~~whether~~to weenroll ~~will~~patients ~~continue~~as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies, such as athe ~~going~~COVID-19 ~~concern~~pandemic.

WeFurther, ~~have~~challenges ~~not~~in ~~generated~~recruiting ~~any~~and ~~revenues~~enrolling tosuitable ~~date.~~patients ~~For~~to ~~the~~participate ~~years~~in ~~ended~~clinical ~~December~~trials ~~31,~~could ~~2023~~increase ~~and 2022~~costs, weaffect ~~had~~the atiming ~~net loss of $20,949,300~~ and ~~$34,731,000,~~outcome ~~respectively. There can be no assurances that we will be able to achieve a level~~ of ~~revenues~~our ~~adequate~~planned toclinical ~~generate~~trials ~~sufficient cash flow from operations or obtain funding from additional financing through private placements, public offerings~~ and~~/or~~ ~~bank~~result ~~financing~~in ~~necessary~~delays to ~~support~~ our ~~working~~current ~~capital~~development ~~requirements.~~plan Nofor ~~assurance can be given that additional financing will be available, or if available, will be on acceptable terms. These conditions raise substantial doubt about~~ our ~~ability~~product ~~to continue as a going concern~~candidates.

~~Risks~~Delays ~~Related~~in tothe commencement and completion of clinical trials could increase costs and delay or prevent regulatory approval and commercialization of our ~~Business~~product candidates.

We ~~have~~cannot aguarantee ~~limited~~that ~~operating~~clinical ~~history~~trials of our product candidates will be conducted as planned or completed on schedule, ~~which~~if ~~makes~~at itall. ~~difficult~~A tofailure ~~evaluate~~of ~~our~~one ~~current~~or ~~business~~more ~~and~~clinical ~~future~~trials ~~prospects~~can occur at any stage of the clinical trial process, and other events may ~~increase~~cause ~~the~~us ~~risk~~to oftemporarily ~~your~~or ~~investment~~permanently stop a clinical trial. Events that may prevent successful or timely commencement and completion of clinical development include:

We● ~~are~~Negative apreclinical ~~company with a limited operating history~~data. We began principal business operations in 2012 and spent the first three years of our history developing and refining our core technology, and only since then have we focused our efforts on advancing the development of product candidates.

~~Investment~~● Delays in ~~biopharmaceutical~~receiving ~~product~~the development is a highly speculative endeavor and entails substantial upfront capital expenditures. There is significant risk that any product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, obtain any required regulatory ~~approvals~~clearance orfrom ~~become commercially viable. Our platforms and~~ the ~~technologies~~appropriate weregulatory ~~are~~authorities ~~using~~to ~~are~~commence ~~new and unproven. We have not yet commenced human~~ clinical trials ~~for any of our product candidates, nor have we demonstrated an ability to initiate~~ or ~~successfully~~amend ~~complete any~~ clinical ~~trials~~trial protocols, ~~obtain~~including any ~~required~~objections ~~marketing~~to ~~approvals,~~our ~~manufacture~~INDs ~~products, conduct sales, marketing and distribution activities,~~ or ~~arrange~~protocol ~~for~~amendments afrom ~~third~~regulatory ~~party to do any of the foregoing on our behalf~~authorities.

~~Consequently,~~● ~~any~~Delays ~~predictions~~in ~~made~~reaching, ~~about our future success~~ or ~~viability may not be as accurate as they could be if we had~~ a ~~history~~failure ofto ~~successfully developing and commercializing products. Our limited operating history~~reach, ~~particularly~~a inconsensus ~~light~~with ofregulatory ~~the~~authorities ~~rapidly~~on ~~evolving~~study ~~nature of the biopharmaceutical industries and the genome editing field, may make it difficult to evaluate our technology and business prospects or to predict our future performance~~design.

As● aDelays ~~company~~in reaching, weor ~~have~~a ~~never~~failure ~~commercialized~~to areach, ~~product.~~an Weagreement ~~currently~~on ~~have~~acceptable noterms ~~active~~with ~~sales~~prospective ~~force~~independent orclinical ~~commercial~~investigators, ~~infrastructure.~~CROs Weand ~~may~~clinical ~~lack~~trial sites, the ~~necessary~~terms ~~expertise,~~of ~~personnel~~which ~~and~~can ~~resources~~be subject to ~~successfully~~extensive ~~commercialize~~negotiation ~~our~~and ~~product~~may ~~candidates~~vary significantly among different investigators, CROs and clinical trial sites.

We● ~~currently~~Difficulties ~~have~~in noobtaining ~~active~~required ~~sales~~IRB ~~force~~ or ~~commercial~~ethics ~~infrastructure.~~committee ~~As a company, we have never commercialized a product for any indication. Even if we receive regulatory~~ approval ~~for~~at ~~one~~each orclinical ~~more~~trial of our product candidates from the FDA or comparable regulatory authorities, we will need to develop robust internal sales, marketing and distribution capabilities to commercialize such products, which will be expensive and time-consuming, or enter into collaborations with third parties to perform these servicessite.

~~There~~● ~~are~~Challenges ~~costs~~in ~~and risks involved with establishing our own sales, marketing and distribution capabilities. For example,~~ recruiting and ~~training~~enrolling asuitable ~~sales~~patients ~~force~~that ismeet ~~expensive and time-consuming and could delay any product launch. If~~ the ~~commercial~~study ~~launch~~criteria of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel. We must also compete with other biotechnology companies to ~~recruit,~~participate ~~hire,~~in ~~train~~clinical ~~and retain marketing and sales personnel~~trials.

~~Alternatively,~~● weThe ~~may~~inability ~~wish~~ to ~~establish~~enroll ~~collaborations~~a ~~with~~sufficient ~~third~~number ~~parties to maximize the potential~~ of ~~our~~patients ~~product candidates jurisdictions~~ in ~~which~~clinical atrials product candidate has been approved. The biotechnology industry is characterized by intense competition. Therefore, we may not be successful in entering into such commercialization arrangements with third parties on favorable terms, or at all. In addition, we may have limited control over such third parties, and any of them may fail to ~~devote~~ensure ~~the~~adequate ~~necessary~~statistical ~~resources~~power ~~and attention~~ to ~~sell,~~detect ~~market~~statistically ~~and~~significant ~~distribute~~treatment ~~our products effectively~~effects.

41● Imposition of a clinical hold by regulatory authorities or IRBs for any reason, including safety concerns and non-compliance with regulatory requirements.

~~Table~~● ofFailure ~~Contents~~by independent clinical investigators, CROs, other third parties or us to adhere to clinical trial requirements.

~~There~~● ~~can~~Failure beto noperform ~~assurance~~in ~~that~~accordance wewith ~~will be able to develop~~ the ~~necessary~~FDA’s ~~commercial~~GCPs ~~infrastructure and capabilities to successfully commercialize our product candidates~~ or beapplicable ~~able~~regulatory toguidelines ~~establish or maintain relationships with third parties necessary to perform these services. As a result, we may not successfully commercialize any product~~ in ~~any~~other ~~jurisdiction~~jurisdictions.

~~We must maintain quality controls and compliance with manufacturing standards.~~ 40

~~The~~ Table ~~manufacture~~ of our product candidates is, and the manufacture of any future drug and/or cell-related therapeutic products would be, subject to periodic inspection by regulatory authorities and distribution partners. The manufacture of drug and device products for human use is subject to regulation and inspection from time to time by the FDA for compliance with the FDA’s cGMP, Quality System Regulations (“QSRs”), as well as equivalent requirements and inspections by state and non-U.S. regulatory authorities. There can be no assurance that the FDA or other authorities will not, during the course of an inspection of existing or new facilities, identify what they consider to be deficiencies in our compliance with QSRs or other requirements and request, or seek remedial action.Contents

~~Failure~~● toThe ~~comply~~inability ~~with such regulations or a potential delay in attaining compliance may adversely affect our manufacturing activities and could result in, among other things, injunctions, civil penalties, FDA refusal~~ to ~~grant~~manufacture ~~pre-~~adequate ~~market~~quantities ~~approvals or clearances~~ of ~~future~~a ~~or pending~~ product ~~submissions,~~candidate ~~fines, recalls~~ or ~~seizures~~other ofmaterials ~~products,~~necessary ~~total~~in oraccordance ~~partial~~with ~~suspensions~~cGMPs ~~of production~~ and ~~criminal~~current ~~prosecution.~~cGTPs ~~There can be no assurance that after such occurrences we will be able~~ to ~~obtain~~conduct ~~additional~~clinical ~~necessary regulatory approvals or clearances on a timely basis, if at all~~trials. Delays in receipt of or failure to receive such approvals or clearances, or the loss of previously received approvals or clearances could have a substantial negative effect on our results of operations and financial condition.

~~Our~~● ~~future~~Lower ~~success~~than ~~depends~~anticipated onpatient ~~our~~retention ~~ability to retain our Chief Executive Officer, and other key executives and to attract, retain and motivate qualified personnel~~rates.

We● ~~are~~Difficulties ~~highly~~in ~~dependent~~maintaining oncontact ~~the~~with ~~research~~patients ~~and~~after ~~development experience~~treatment, ~~technical~~resulting ~~skills,~~in ~~leadership~~incomplete and continued service of certain members of our management and scientific teams, including Pietro Bersani, our Chief Executive Officer, Brian Hungerford, our Chief Financial Officer, Leonardo Mirandola, our Chief Scientific Officer and Scott Dahlbeck, our Chief of Staff Officerdata.

~~Although~~● weAmbiguous ~~have~~or ~~employment~~negative ~~agreements~~interim ~~with our executive officers, these agreements do not prevent them from terminating their employment with us at any time~~results. ~~The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.~~

~~Recruiting~~● ~~and~~Our ~~retaining~~independent ~~qualified scientific,~~ clinical, ~~manufacturing and~~investigators, ifCROs weor ~~retain~~clinical ~~commercialization~~trial ~~responsibility~~sites ~~for~~failing ~~any~~to ~~product~~comply ~~candidate~~with weregulatory ~~develop~~requirements ~~alone~~ or ~~with~~meet ~~collaborators,~~their ~~sales~~contractual ~~and~~obligations ~~marketing personnel, will also be critical~~ to ~~our~~us ~~success.~~in Wea ~~may~~timely ~~not~~manner, ~~be able to attract and retain these personnel on acceptable terms~~ or at all, ~~given~~deviating from the ~~competition~~protocol ~~among~~or ~~numerous~~dropping ~~pharmaceutical~~out ~~and biotechnology companies for similar personnel. We also experience competition for the hiring~~ of ~~scientific~~a ~~and~~ clinical ~~personnel from universities and research institutions~~trial. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategies. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.

~~The~~● ~~inability~~Unforeseen tosafety ~~recruit~~issues, ~~integrate,~~including ~~motivate~~occurrence ~~and~~of ~~retain~~adverse ~~additional~~events ~~skilled~~associated ~~and~~with ~~qualified personnel, or~~ the ~~loss~~product ofcandidate ~~services~~that ofare ~~certain~~viewed ~~executives,~~to ~~key~~outweigh ~~employees, consultants or advisors, may impede~~ the ~~progress~~product ofcandidate’s ~~our~~potential ~~research, development and commercialization objectives and have a material adverse effect on our business~~benefits.

We● ~~will~~Changes ~~need~~in toregulatory ~~expand~~requirements ~~our organization,~~ and weguidance ~~may~~that ~~experience~~require ~~difficulties~~amending inor ~~managing~~submitting ~~this~~new ~~growth,~~clinical ~~which could disrupt our operations~~protocols.

We● ~~will~~Lack ~~need~~of toadequate ~~significantly~~funding ~~expand our organization. If we are not able~~ to ~~effectively~~continue ~~manage~~the ~~this~~clinical ~~expansion, that may impact our future financial performance, our ability to develop and commercialize product candidates alone or with collaborators, and our ability to compete effectively~~trial. ~~In addition, we may have difficulty identifying, hiring and integrating new personnel if we are unable to effectively manage expansion.~~

~~Many~~Results offrom ~~the~~preclinical ~~biotechnology~~studies ~~companies~~and ~~that~~early-stage weclinical ~~compete~~trials ~~against~~may ~~for~~not ~~qualified~~be ~~personnel~~predictive ~~and~~of ~~consultants~~results ~~have~~from ~~greater~~late-stage ~~financial~~or ~~and~~ other ~~resources,~~clinical ~~different risk profiles and a longer history than we do~~trials. ~~If we are unable to continue to attract~~

42Positive and promising results from preclinical studies and early-stage clinical trials may not be predictive of results from late-stage clinical trials or from clinical trials of the same product candidates. The primary objectives of our current Phase 1 clinical trials are to establish safety and tolerability and to determine the recommended Phase 2 dose. Results from those and future early-stage clinical trials may not be representative of results from later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Late-stage clinical trials could differ in significant ways from early-stage clinical trials, including changes to inclusion and exclusion criteria, efficacy endpoints, dosing regimen and statistical design. In particular, we expect there may be greater variability in results for products processed and administered on a patient-by-patient basis, as for our cellular therapy product candidates, than for “OTS” products, like many other drugs. Many companies in the biotechnology industry have suffered significant setbacks in late-stage clinical trials after achieving encouraging or positive results in early-stage development. There can be no assurance that we will not face similar setbacks. Therefore, despite positive results observed in early-stage clinical trials, our product candidates may fail to demonstrate sufficient efficacy in our pivotal or confirmatory clinical trials.

~~Table~~Interim ofor “top-line” data ~~Contents~~that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.

~~and~~From ~~retain~~time ~~high~~to time, we may announce or publish preliminary interim or “top-~~quality~~line” data ~~personnel~~from ~~and~~clinical ~~consultants,~~trials. Positive preliminary data may not be predictive of such trial’s subsequent or overall results. Preliminary data are subject to the ~~rate~~risk ~~and~~that ~~success~~one ator ~~which~~more weof ~~can~~the ~~identify~~outcomes ~~and~~may ~~develop~~materially ~~product~~change ~~candidates~~as more data become available. Additionally, ~~enter~~preliminary ~~into~~data ~~collaborative~~are ~~arrangements~~subject ~~and~~to ~~otherwise~~the ~~operate~~risk ~~our~~that ~~business~~one ~~will~~or bemore ~~limited~~of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.

~~Future~~Therefore, ~~growth~~positive ~~would~~preliminary ~~impose~~results ~~significant~~in ~~additional~~any ~~responsibilities~~ongoing onclinical ~~our~~trial ~~management,~~may ~~including~~not be predictive of such results in the ~~need~~completed totrial. ~~identify,~~We ~~recruit~~also make assumptions, ~~maintain~~estimations, ~~motivate~~calculations and ~~integrate~~conclusions ~~additional~~as ~~employees,~~part ~~consultants~~of ~~and~~our ~~contractors.~~analyses ~~Management~~of data, and we may ~~need~~not have received or had the opportunity to ~~divert~~fully evaluate all data. As a ~~disproportionate~~result, ~~amount~~preliminary ofdata ~~its~~that ~~attention~~we ~~away~~report may differ from ~~our~~future ~~day-to-day~~results ~~activities~~from ~~and~~the ~~devote~~same aclinical ~~substantial~~trials, ~~amount~~or ofdifferent ~~time~~conclusions toor ~~managing~~considerations ~~these~~may ~~growth~~qualify ~~activities~~such results, once additional data have been received and fully evaluated. ~~Due~~Preliminary todata ~~our~~also ~~limited~~remain ~~financial~~subject ~~resources~~to audit and verification procedures that may result in the ~~limited~~final ~~experience~~data ofbeing ~~our~~materially ~~management~~different ~~team~~from inthe ~~managing~~preliminary adata ~~company~~we ~~with~~previously ~~such~~published. ~~anticipated~~As ~~growth~~a result, wepreliminary ~~may~~data ~~not~~should be ~~able~~viewed towith ~~effectively~~caution ~~manage~~until the ~~expected~~final ~~expansion~~data ofare ~~our~~available. ~~operations~~Material oradverse ~~recruit~~changes ~~and~~in ~~train~~the ~~additional~~final ~~qualified~~data ~~personnel~~compared to preliminary data could significantly harm our business prospects.

Moreover, the expected physical expansion of our operations may lead to significant costs and may divert our management and business development resources from other projects, such as the development of product candidates. If we are not able to effectively manage the expansion of our operations, it may result in weaknesses in our infrastructure, increase our expenses more than expected, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity. 41

~~Our~~ Table ~~governing documents designate the Court~~ of Chancery of the State of Delaware as the sole and exclusive forum for certain types of state law actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.Contents

~~Our~~Product ~~Fourth~~liability ~~Amended~~lawsuits ~~and~~against ~~Restated~~us ~~Certificate~~could ofcause ~~Incorporation~~us ~~dictates~~to ~~that~~incur ~~the~~substantial ~~Delaware~~liabilities ~~Court of Chancery is the sole~~ and ~~exclusive~~could ~~forum~~limit ~~for~~commercialization ~~certain state law based actions including certain derivative actions or proceedings brought on behalf~~ of ~~us;~~any anproducts ~~action~~that ~~asserting~~we adevelop ~~breach~~alone ~~of fiduciary duty owed by an officer, a director, employee~~ or towith ~~our shareholders; any claim arising under Delaware corporate law; and any action asserting a claim governed by the internal affairs doctrine~~collaborators.

~~This~~We ~~exclusive~~face ~~forum~~an ~~provision~~inherent ~~does~~risk ~~not~~of ~~apply~~product toliability ~~suits~~and ~~brought~~professional indemnity exposure related to ~~enforce~~the ~~any~~testing ~~liability~~in orclinical ~~duty~~trials ~~created~~of byour ~~the~~product ~~Securities~~candidates. ~~Act~~We orwill ~~the~~face ~~Exchange~~an ~~Act~~even orgreater ~~other~~liability ~~federal~~risk ~~securities~~if ~~laws~~we ~~for~~commercially ~~which~~sell ~~there~~any isproducts ~~exclusive~~that ~~federal~~we or ~~concurrent~~our ~~federal~~collaborators ~~and~~may ~~state~~develop ~~jurisdiction~~for human use.

~~This~~Manufacturing ~~choice~~defects, oferrors ~~forum provision may limit our stockholders’ ability to bring a claim~~ in aproduct ~~judicial~~distribution ~~forum that it finds favorable for disputes with us~~ or ~~our~~storage ~~directors~~processes, ~~officers,~~improper ~~employees~~administration or ~~agents,~~application ~~which may discourage such lawsuits against us~~ and ~~our~~known ~~directors,~~or ~~officers,~~unknown ~~employees~~side ~~and~~effects ~~agents even though an action, if successful, might benefit our stockholders. Stockholders who do bring a claim in the Court~~ of ~~Chancery~~product ~~could~~usage ~~face~~may ~~additional~~result ~~litigation costs~~ in ~~pursuing~~liability ~~any~~claims ~~such~~against ~~claim,~~us ~~particularly~~or ifthird ~~they~~parties dowith ~~not~~which ~~reside~~we inhave ~~or near Delaware~~relationships. ~~The~~These ~~Court~~actions ofcould ~~Chancery~~include ~~may~~claims ~~also~~resulting ~~reach~~from ~~different~~acts ~~judgments~~by orour ~~results than would other courts~~collaborators, ~~including~~licensees ~~courts~~and ~~where~~subcontractors aover ~~stockholder~~which ~~considering~~we anhave ~~action~~little ~~may be located~~ or ~~would~~no ~~otherwise~~control. ~~choose~~For ~~to bring the action~~example, ~~and~~our ~~such~~liability ~~judgments~~could orbe ~~results~~sought ~~may~~by bepatients ~~more~~participating ~~favorable~~in toclinical ustrials ~~than~~for topotential ~~our~~therapeutic ~~stockholders.~~product ~~Alternatively,~~candidates ifas a ~~court~~result ~~were~~of tounexpected ~~find~~side ~~this provision inapplicable to~~effects, orimproper ~~unenforceable~~product inadministration ~~respect of, one~~ or ~~more of~~ the ~~specified~~deterioration ~~types~~ of ~~actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could have~~ a ~~material~~patient’s ~~adverse effect on our business~~condition, ~~financial~~patient ~~condition~~injury or ~~results~~even ~~of operations~~death.

WeCriminal ~~are~~or ancivil ~~emerging~~proceedings ~~growth~~might ~~company~~be filed against us by patients, regulatory authorities, biopharmaceutical companies and any other third party using or marketing any product candidates or products that we ~~cannot~~develop bealone ~~certain~~or ifwith ~~the~~collaborators. ~~reduced~~On ~~reporting~~occasion, ~~requirements~~large ~~applicable~~judgments tohave ~~emerging~~been ~~growth~~awarded ~~companies~~in ~~make~~class ~~our~~action ~~shares~~lawsuits ~~less~~based ~~attractive~~on toproducts ~~investors~~that had unanticipated adverse effects. If we cannot successfully defend ourselves against claims that product candidates or products we develop alone or with collaborators caused harm, we could incur substantial liabilities.

WeClinical ~~are~~development andoes ~~“emerging~~not ~~growth~~always ~~company,”~~fully ascharacterize ~~defined in~~ the ~~JOBS~~safety ~~Act.~~and ~~For~~efficacy asprofile ~~long~~of asa wenew ~~continue to be an emerging growth company~~medicine, weand ~~may~~it ~~take~~is ~~advantage~~always ofpossible ~~exemptions from various reporting requirements~~ that ~~are~~a ~~applicable~~drug toor ~~other public companies that are not emerging growth companies~~biologic, ~~including,~~even ~~but~~after ~~not~~regulatory ~~limited to~~approval, ~~(i)~~may ~~not~~exhibit ~~being~~unforeseen ~~required~~side toeffects. ~~comply~~If ~~with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, (ii) reduced disclosure obligations regarding executive compensation in this prospectus and~~ our ~~periodic~~product ~~reports~~candidates ~~and~~were ~~proxy~~to ~~statements~~cause ~~and~~adverse ~~(iii)~~side ~~exemptions~~effects ~~from~~during ~~the~~clinical ~~requirements~~trials ofor ~~holding~~after ~~a nonbinding advisory vote on executive compensation. In addition~~approval, ~~as an emerging growth company,~~ we ~~are~~may ~~required~~be toexposed ~~provide only two years of audited financial statements and two years of selected financial data in our initial registration statement, compared~~ to ~~three~~substantial ~~and five years, respectively, for comparable data reported by other public companies~~liabilities.

WeProduct ~~could~~liability beinsurance ancoverage ~~emerging~~may ~~growth~~not ~~company~~be ~~for~~adequate up to ~~five~~cover ~~years~~all ~~from~~liabilities ~~our~~that ~~initial~~we ~~public~~may ~~offering~~incur. ~~(“IPO”),~~We ~~although~~anticipate ~~circumstances~~that ~~could~~we ~~cause~~will usneed to ~~lose~~increase ~~that status earlier, including if the market value of~~ our ~~shares~~insurance ~~held~~coverage bywhen ~~non-affiliates~~we ~~equals~~begin orclinical ~~exceeds~~trials ~~$700~~and ~~million~~if ~~as of any June 30 (the end of~~ our ~~second~~collaborators ~~fiscal quarter) before that time~~ or ifourselves wesuccessfully ~~have~~commercialize ~~total~~any products.

43Our product candidates are complex and difficult to manufacture. We could experience manufacturing problems that result in delays in our development or commercialization programs.

~~Table~~Our product candidates are cellular products or biologics and the process of ~~Contents~~manufacturing our products is complex, highly regulated and subject to multiple risks. The manufacture of our cellular product candidates involves complex processes which include, for example, harvesting white blood cells from healthy donors, transporting them from blood banks to our cGMP facility for donor GDT expansion, engineering, and cryopreservation, and finally shipping of the T cell product back to the patient for treatment. As a result of these complexities, the cost to manufacture cellular products per dose is generally higher than traditional small molecule chemical compounds or biologics, and the manufacturing process is less reliable, more variable and is more difficult to reproduce. Our manufacturing process may be susceptible to product loss or failure due to logistical issues associated with the collection of patients’ blood cells, shipping such material to the manufacturing site, shipping the final product back to the patient, and infusing the patient with the product. Product loss or failure may also be caused by manufacturing issues associated with the variability in patient starting material especially from heavily treated cancer patients, interruptions in the manufacturing process, contamination, equipment failure, assay failures, improper installation or operation of equipment, vendor or operator error, inconsistency in cell growth, and variability in product characteristics. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. If for any reason we lose a patient’s starting material, or any intermediate product at any point in the process, or if any product does not meet the preset specifications, the manufacturing process for that patient will need to be restarted, sometimes including re-collection of blood cells from the patient, and the resulting delay may adversely affect that patient’s outcome. It may even happen that failed product manufacture may prevent a patient from getting a T cell product. If microbial, environmental or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. If such contaminations or other product quality issues are not discovered and if as a result thereof patients are exposed to a health risk, we may be held liable. Our insurance may not cover those cases, or the financial coverage may not be sufficient.

annual gross revenues of $1.07 billion or more during any fiscal year before that time, in which cases we would no longer be an emerging growth company as of the following December 31 (our fiscal year end); or, if we issue more than $1.0 billion in non-convertible debt during any three-year period before that time, we would cease to be an emerging growth company immediately. Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company,” which would allow us to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. 42

We Table cannot predict if investors will find our securities less attractive because we may rely on these exemptions. If some investors find our securities less attractive as a result, there may be a less active trading market for our securities and the price of our securities may be more volatile. When these exemptions cease to apply, we expect to incur additional expenses and devote increased management effort towards ensuring compliance with them, and we cannot predict or estimate the amount or timing of such additional costs.Contents

WeAs ~~may~~product becandidates ~~subject~~are developed through preclinical to ~~securities~~late-stage ~~laws~~clinical ~~claims~~trials ~~regarding~~towards ~~past~~approval ~~disclosures~~and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials or otherwise necessitate the conduct of additional studies, including bridging clinical trials, which can be costly and time-consuming.

WeIn ~~may~~addition, bethe ~~subject~~manufacturing toprocess ~~additional~~and ~~claims~~facilities for ~~rescission~~any ~~(under~~products ~~which~~that awe ~~successful~~may ~~claimant~~develop ~~would~~is ~~have~~subject ~~the right~~ to ~~receive~~FDA ~~the~~and ~~total~~comparable ~~amount~~regulatory ~~paid~~authority ~~for~~approval ~~his or her shares~~processes, ~~plus interest~~ and ~~less~~we ~~any~~will ~~income~~need ~~earned~~to onmeet ~~the~~all ~~shares,~~applicable inregulatory ~~exchange~~authority ~~for~~requirements, ~~surrender~~including ofcGMP ~~the~~and ~~shares)~~cGTP requirements, ~~damages~~on ~~(under~~an ~~which~~ongoing abasis, ~~successful~~including ~~claimant~~requirements ~~would~~pertaining ~~have the right~~ to ~~receive~~quality ~~the~~control, ~~total~~quality ~~amount paid for his or her shares~~assurance, ~~plus interest~~ and ~~less any income earned on~~ the ~~shares,~~maintenance ~~in exchange for surrender~~ of ~~the~~records ~~shares)~~and ordocumentation. ~~other~~The ~~securities~~FDA ~~law~~and ~~claims~~comparable ~~resulting~~regulatory ~~from~~authorities ~~our~~enforce ~~failure~~these torequirements ~~timely~~through ~~disclose~~facility ~~that~~inspections. ~~the~~Manufacturing ~~Company~~facilities ~~had~~must ~~received~~be ~~communications~~approved ~~from~~by the FDA onpursuant ~~June~~to 16inspections ~~and June 17, 2021~~ that ~~the~~will ~~FDA~~be ~~was~~conducted ~~placing~~after ~~the~~we ~~Company’s~~submit ~~IND~~our marketing applications. ~~that~~Manufacturers ~~the~~are ~~Company~~also ~~submitted~~subject to ~~the~~continuing FDA onand ~~May~~comparable 14regulatory ~~and~~authority ~~May~~inspections ~~17,~~following ~~2021~~marketing ~~for~~approval. ~~the~~Further, ~~ALEXIS-PRO-1~~we ~~and~~must ~~ALEXIS-ISO-1~~supply ~~product~~all ~~candidates~~necessary chemistry, ~~respectively~~manufacturing, onand ~~clinical~~control ~~hold~~documentation ~~(the~~in ~~“June~~support 16of ~~and~~a ~~17,~~BLA ~~2021~~on ~~FDA~~a ~~Communications”)~~timely basis.

OnAny ~~July~~failure 2,to ~~2021,~~follow wecGMP ~~consummated~~and acGTP ~~public~~or ~~offering~~other ofregulatory ~~$40~~requirements ~~million~~or ofany ~~our~~delay, ~~common~~interruption ~~stock.~~or ~~Neither~~other ~~the~~issues ~~Registration Statement on Form S-1 with respect to this offering~~ that ~~was~~arise ~~filed~~in ~~on June 25, 2021, nor~~ the ~~final prospectus dated June 29~~manufacture, ~~2021,~~fill ~~with respect to this offering contained any disclosure with respect to the June 16~~ and 17finish, ~~2021~~packaging, ~~FDA~~or ~~Communications.~~storage ~~Our~~of ~~Form S-1 and final prospectus for the offering stated the following with respect to~~ our ~~ALEXIS-PRO-1 and ALEXIS-ISO-1~~ product candidates: ~~“These~~as ~~products~~a ~~are~~result inof ~~the~~a ~~pre-IND~~failure ~~stage~~ of ~~the~~our ~~FDA~~facilities ~~clinical~~or ~~trial process. We are currently going through~~ the ~~IND~~facilities ~~enabling~~or ~~trials~~operations ~~process for these product candidates and we expect that first in human dosing in Phase I~~ of ~~clinical trials will commence in the~~ third ~~quarter~~parties ofto ~~2021.”Anyone~~comply ~~who~~with ~~purchased~~regulatory ~~shares~~requirements ~~of our common stock in the offering and anyone who purchased~~ or ~~sold~~pass ~~shares~~any ofregulatory ~~our~~authority ~~common~~inspection ~~stock in the public market after June 16, 2021~~ could ~~claim~~significantly ~~that~~impair ~~they were misled by~~ our ~~failure~~ability to ~~disclose~~develop ~~the~~and ~~clinical~~commercialize ~~hold~~our ~~on studies under the INDs for these~~ product candidates ~~and that they suffered damages. On March 7~~, ~~2022,~~including ~~certain~~leading ~~shareholders~~to ~~who~~significant ~~had~~delays ~~purchased shares of our common stock~~ in the ~~Company’s~~availability ~~public~~of ~~offering~~drug ~~that~~product ~~closed~~for ~~on July 2, 2021, filed a complaint against the Company and certain~~ our ~~current~~clinical ~~and~~trials ~~former~~or ~~officers and directors for alleged violations of Sections 11, 12, and 15 of~~ the ~~Securities~~termination ~~Act~~ of ~~1933~~or inhold ~~connection~~on ~~with~~a ~~the~~clinical ~~purchase~~trial, ofor ~~common stock in~~ the ~~offering.~~delay ~~The plaintiffs seek unspecified damages; rescission to the extent they still hold Kiromic securities,~~ or ifprevention sold, rescissory damages; reasonable costs and expenses, including attorneys’ and experts’ fees; and other unspecified equitable and injunctive relief. We expect to vigorously defend against this action. We have evaluated that it is reasonably possible that other unasserted claims in future litigation and losses may occur. However, we are unable to estimate any possible range of ~~loss~~a ~~attributed~~filing ~~to other unasserted claims at this time. Even if we are successful in defending against this litigation~~ or ~~any~~approval ~~other~~of ~~unasserted~~marketing ~~claims,~~applications ~~securities~~for ~~litigation~~our isproduct ~~costly to defend and would likely divert management’s attention away from the business~~candidates.

~~The~~If ~~existence~~we are unable to obtain sufficient quantities of ~~pending~~raw materials and ~~potential~~supplies, ~~securities~~at ~~law~~acceptable ~~claims~~prices ~~may~~and ~~adversely~~on ~~affect~~a ~~our~~timely ~~ability~~basis, toit ~~raise~~could ~~capital~~harm our business.

We ~~face~~are ~~risks~~dependent ~~associated~~on ~~with~~third ~~increased~~parties ~~political~~for ~~uncertainty~~the supply of various biological materials, such as cells, cytokines and antibodies, and the manufacture of product supplies, such as media, plasmids, mRNA and viral vectors, that are necessary to produce our product candidates. The supply of these materials could be reduced or interrupted at any time. In such case, identifying and engaging an alternative supplier or manufacturer could result in delay, and we may not be able to find other acceptable suppliers or manufacturers on acceptable terms, or at all.

~~The~~Changing ~~recent~~suppliers ~~invasion~~or ofmanufacturers ~~Ukraine~~may byinvolve ~~Russia~~substantial costs and ~~the~~is ~~sanctions,~~likely ~~bans~~to result in a delay in our desired clinical and ~~other~~commercial ~~measures~~timelines. ~~taken~~If bywe ~~governments~~change suppliers or manufacturers for commercial production, ~~organizations~~applicable ~~and~~regulatory ~~companies~~agencies ~~against~~may ~~Russia~~require ~~and~~us ~~certain~~to ~~Russian~~conduct ~~citizens~~additional instudies ~~response~~or ~~thereto~~trials. ~~has~~If ~~increased~~key ~~the~~suppliers ~~political~~or ~~uncertainty~~manufacturers inare ~~Europe~~lost, ~~and~~or ~~has~~if ~~strained~~the supply of the ~~relations~~materials ~~between~~is ~~Russia~~diminished or discontinued, we or our collaborators may not be able to develop, manufacture and market product candidates in a ~~significant~~timely ~~number~~and ofcompetitive ~~governments~~manner, ~~including~~or ~~the~~at Uall.S. ~~The~~If ~~duration~~any ~~and~~of ~~outcome~~our ofproduct ~~this~~candidates ~~conflict~~receives approval, ~~any~~we ~~retaliatory~~will ~~actions~~likely ~~taken~~need byto ~~Russia~~seek ~~and~~alternative ~~the~~sources ~~impact~~of onsupply ~~regional~~of raw materials or ~~global~~manufactured ~~economies~~product issupplies ~~unknown~~and ~~but~~there ~~could~~can ~~have~~be ano ~~material~~assurance ~~adverse~~that ~~effect~~we will be able to establish such relationships to provide such supplies on ~~our~~commercially ~~business,~~reasonable ~~financial~~terms ~~condition~~or ~~and~~at ~~results~~acceptable ofquality ~~our~~levels, ~~operations~~if at all.

44If we are unable to identify and procure additional sources of supply that fit our required needs, we could face substantial delays or incur additional costs in procuring such materials.

~~Table~~The ofmarket ~~Contents~~opportunities for our product candidates may be smaller than we estimate.

InOur ~~the~~projections ~~U.S.,~~of both the ~~change~~number inof people who have the ~~U.S.~~cancers ~~government~~we toare targeting, as well as the ~~Biden~~subset ~~administration~~of ~~has~~people ~~resulted~~with these cancers who are in ~~uncertainty~~a ~~regarding~~position to receive our product candidates, and who have the potential ~~changes~~to inbenefit ~~regulations~~from treatment with our product candidates, ~~fiscal~~are ~~policy~~based on our beliefs and estimates that have been derived from a variety of sources, ~~social~~including ~~programs~~scientific literature, ~~domestic~~surveys ~~and~~of ~~foreign~~clinics, ~~relations~~patient foundations, or market research by third parties, and ~~international~~may ~~trade~~prove ~~policies~~to be incorrect. InThese ~~addition,~~estimates ~~potential~~may ~~changes~~be ininaccurate ~~relationships~~or ~~among~~based ~~the~~on Uimprecise data.S. ~~and~~We ~~China~~do ~~and~~not ~~other~~have ~~countries~~verifiable ~~including~~internal ~~Taiwan~~marketing ~~could~~data ~~have~~regarding ~~significant~~the ~~impacts~~potential onsize ~~global~~of ~~trade~~the ~~and~~commercial ~~regional~~market ~~economic~~for ~~conditions~~our product candidates, ~~among~~nor ~~other~~have ~~things.~~we Inobtained ~~addition,~~current ~~changes~~independent inmarketing surveys to verify the ~~relationships~~potential ~~between~~size of the Ucommercial markets for our current product candidates or any future product candidates.S. Since our current product candidates and ~~its~~any ~~neighbors,~~future ~~such~~product ascandidates ~~Mexico~~will represent novel approaches to treating various conditions, ~~could~~it ~~have~~may ~~significant~~be difficult, ~~potentially~~in ~~negative~~any event, ~~impacts~~to onaccurately ~~commerce~~estimate the potential revenues from these product candidates. ~~Further,~~The ~~anti-American~~number ~~sentiment~~of ~~could~~patients ~~harm~~in the ~~reputation~~addressable ~~and~~markets ~~success~~may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our product candidates or new patients may become increasingly difficult to identify or gain access to, all of ~~U.S.~~which ~~companies~~could ~~doing~~materially adversely affect our business, ~~abroad~~financial condition, results of operations and prospects.

Our ability to respond to these developments or comply with any resulting new legal or regulatory requirements, including those involving economic and trade sanctions, could reduce our sales, increase our costs of doing business, reduce our financial flexibility and otherwise have a material adverse effect on our business, financial condition and results of our operations. 43

~~Risks~~ Table ~~Related~~of ~~to our Product Candidates~~Contents

~~Our~~Risks ~~tumor-specific~~Related ~~cancer immunotherapy approach is based on novel ideas and technologies that are unproven and may not result in marketable products, which exposes us~~ to ~~unforeseen~~Government ~~risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval.~~Regulation

WeThe ~~are~~FDA ~~using~~regulatory ~~our~~approval ~~proprietary~~process ~~technologies~~is tolengthy ~~develop~~and ~~tumor~~time-~~specific~~consuming, ~~immunotherapy product candidates to treat cancer. Our foundational science~~ and ~~product~~we ~~development~~may ~~approach~~experience ~~are~~significant ~~based~~delays onin ~~our ability to predict~~ the ~~presence~~clinical ofdevelopment ~~a patient’s TSIA’s~~ and ~~develop~~regulatory aapproval TSIA-directed therapy that will elicit a meaningful specific immune-system cell response (T or NK cells). We believe that this approach may offer an improved therapeutic effect by driving an intense, focused attack selectively upon a patient’s tumor. However, this approach to treating cancer is novel and the scientific research that forms the basis of our ~~efforts~~product ~~to predict the presence of TSIA and to develop a CAR that targets TSIA-directed cancer immunotherapy~~ candidates ~~is both preliminary and limited~~.

~~Our~~The ~~tumor-specific~~research, ~~immunotherapy~~testing, ~~product~~manufacturing, ~~candidates~~labeling, ~~have~~approval, ~~experienced~~sale, ~~limited~~import, ~~testing~~export, marketing, and distribution of drug products, including biologics, are subject to extensive regulation by the FDA and other regulatory authorities in ~~humans~~the United States. We are ~~currently~~not permitted to market any biological drug product in the ~~process~~U.S. ofuntil ~~validating~~we ~~different~~receive ~~tumor-specific~~approval ~~immunotherapy~~of ~~product~~a ~~candidates~~BLA from the FDA. ~~When~~We wehave ~~validate~~not ~~adequate~~previously ~~biomarkers~~submitted ~~for~~a ~~these~~BLA ~~product~~to ~~candidates~~the FDA, weor ~~will~~similar ~~commence~~approval filings to comparable foreign authorities. A BLA must include extensive preclinical ~~animal~~and ~~studies,~~clinical data and ~~the~~supporting ~~results~~information ofto ~~our~~establish ~~preclinical~~the ~~animal~~product ~~studies~~candidate’s ~~may~~safety ~~not~~and ~~translate~~effectiveness ~~into~~for ~~humans~~each desired indication. ~~For~~The ~~example,~~BLA ~~our~~must ~~prediction~~also ~~model~~include ~~may~~significant ~~fail~~information toregarding ~~accurately~~the ~~predict~~chemistry, manufacturing and controls for the ~~presence~~product. ofWe ~~TSIAs,~~have ~~resulting~~not inreceived ~~little~~approval orfrom noregulatory Tauthorities ~~cell~~to ~~activity~~market any product candidate in any jurisdiction, orand it is possible that neither our ~~therapy~~current product candidates nor any product candidates that we may ~~fail~~seek to ~~elicit~~develop ain ~~significant~~the orfuture ~~durable~~will ~~enough~~ever Tobtain orthe NKappropriate ~~cell~~regulatory ~~response~~approvals tonecessary ~~effectively~~for ~~destroy~~us ato ~~tumor~~commence product sales.

AsThe ~~such~~pathway to regulatory approval is time consuming and unpredictable, weinvolves ~~cannot~~substantial ~~assure~~costs ~~you~~and ~~that~~consumes ~~even~~management iftime weand ~~are~~attention. ~~able~~It is not possible to ~~develop~~predict ~~cancer~~the ~~immunotherapy~~timing ~~candidates~~or ~~capable~~success of ~~recognizing~~obtaining ~~TSIA~~regulatory approvals with any degree of certainty, and ~~eliciting~~as a Tresult, ~~cell~~it ~~response,~~is ~~that~~difficult ~~such~~to ~~therapy~~forecast ~~would~~our ~~safely~~future ~~and~~financial ~~effectively~~results ~~treat~~or ~~cancers~~prospects. WeAny ~~may~~unexpected ~~spend~~development ~~substantial~~in ~~funds~~the ~~attempting~~regulatory approval process, including delays or denials of regulatory approvals or significant modifications to ~~develop~~our ~~this~~product ~~approach~~candidates required by our regulators, could materially and ~~never~~adversely ~~succeed~~affect inour ~~developing~~business, aresults ~~marketable~~of ~~therapeutic~~operations and financial condition, and could substantially harm our stock price.

~~Furthermore,~~We noexpect ~~regulatory~~the ~~authority~~novel ~~has~~nature ~~granted~~of ~~approval~~our ~~for~~product acandidates ~~cancer~~to ~~immunotherapy~~create ~~based~~further onchallenges ain ~~heterologous~~obtaining ~~prime-boost~~regulatory ~~approach~~approval. AsFor ~~such~~example, ~~we believe that~~ the FDA has limited experience with ~~evaluating~~commercial ~~our~~development ~~approach,~~of ~~which~~T ~~may~~cell ~~increase~~therapies ~~the~~for ~~complexity,~~cancer. ~~uncertainty~~We ~~and~~may ~~length~~also ofrequest ~~the~~ regulatory approval ~~process~~of ~~for~~future ~~our~~CAR-based product candidates. Weby ~~may~~target, ~~never~~regardless ~~receive~~of ~~approval~~cancer totype ~~market~~or ~~and~~origin, ~~commercialize~~which ~~any~~the ~~product~~FDA ~~candidate.~~may ~~Even~~have difficulty accepting if weour ~~obtain~~clinical ~~regulatory~~trials ~~approval,~~only ~~the~~involved ~~approval~~cancers of certain origins. The FDA may bealso ~~for~~require ~~targets~~a panel of experts, ~~disease~~referred ~~indications~~to as an Advisory Committee, ~~lines~~to deliberate on the adequacy of ~~therapy~~the orsafety ~~patient~~and ~~populations~~efficacy ~~that~~data ~~are~~to ~~not~~support aslicensure. ~~broad~~The asopinion weof ~~intended~~the orAdvisory ~~desired~~Committee, oralthough ~~may~~not ~~require~~binding, ~~labeling~~may ~~that~~have ~~includes~~a significant ~~use~~impact oron ~~distribution~~our ~~restrictions~~ability orto ~~safety~~obtain ~~warnings~~licensure of the product candidates based on the completed clinical trials, as the FDA often adheres to the Advisory Committee’s recommendations.

WeAccordingly, ~~face~~the ~~substantial~~regulatory ~~competition~~approval ~~from~~pathway ~~other~~for ~~pharmaceutical~~our ~~and~~product ~~biotechnology~~candidates ~~companies, which~~ may ~~result~~be ~~in others discovering~~uncertain, ~~developing~~complex, orexpensive ~~commercializing~~and ~~products before~~lengthy, orand ~~more~~approval ~~successfully,~~may ~~than~~not webe doobtained.

~~The~~Clinical ~~development~~testing ~~and~~is ~~commercialization~~expensive, oftime ~~new~~consuming ~~drug~~and ~~products~~uncertain isas ~~highly~~to ~~competitive~~the outcome. ~~Our~~We ~~future~~cannot ~~success~~guarantee ~~depends~~that onclinical ~~our~~trials ~~ability~~will tobe ~~demonstrate~~conducted ~~and~~as ~~maintain~~planned aor ~~competitive~~completed ~~advantage~~on ~~with respect to the design~~schedule, ~~development,~~if ~~and~~at ~~commercialization of our product candidates~~all. ~~Our~~A ~~objective~~failure isof toone ~~design,~~or ~~develop~~more ~~and~~clinical ~~commercialize~~trials ~~new~~can ~~products~~occur ~~with~~at ~~superior~~any ~~efficacy,~~stage ~~convenience,~~of ~~tolerability, and safety~~testing. InEvents ~~many cases, the products~~ that wemay ~~intend~~prevent tosuccessful ~~commercialize,~~or iftimely ~~successfully~~completion ~~commercialized,~~of ~~will~~clinical ~~compete~~development ~~with existing market-leading products.~~include:

~~Many~~● ofDelays ~~our~~or ~~potential~~failure ~~competitors have significantly greater financial, manufacturing, marketing, drug development, technical and human resources than we do. Large pharmaceutical companies,~~ in ~~particular,~~reaching ~~have~~a ~~extensive~~consensus ~~experience~~with ~~in clinical testing, obtaining~~ regulatory ~~approvals,~~agencies ~~recruiting~~on ~~patients~~trial ~~and manufacturing pharmaceutical products~~design.

45● Delays or failures in obtaining regulatory authorization to begin a trial, if applicable.

~~Table~~● The availability of ~~Contents~~financial resources to commence and complete the planned trials.

~~Large~~● ~~and~~Delays ~~established~~or ~~companies~~failures ~~compete~~ in ~~the~~reaching ~~same~~agreement ~~market~~on asacceptable ~~our~~terms ~~product candidates. These companies compete~~ with usprospective ~~with~~CROs ~~their greater experience~~ and ~~resources to support their research and development efforts, conduct testing and~~ clinical ~~trials,~~trial ~~obtain regulatory approvals to market products~~sites, ~~manufacture~~the ~~such~~terms products on a broad scale and market approved products. These companies also compete with us by having significantly greater research and marketing capabilities than we do and may also have products that have been approved or are in late stages of ~~development~~which ~~and~~can ~~have~~be ~~collaborative~~subject ~~arrangements~~to inextensive ~~our~~negotiation ~~target markets with leading companies~~ and ~~research institutions. Established pharmaceutical companies~~ may ~~also~~vary ~~invest~~significantly ~~heavily~~among todifferent ~~accelerate~~CROs ~~discovery~~ and ~~development~~trial ~~of novel compounds or to in-license novel compounds that could make the products that we develop obsolete~~sites. We also face competition from smaller companies who, like us, rely on investors to fund research and development and compete for co-development and licensing opportunities from large and established pharmaceutical companies.

We● ~~may~~Delays ~~expend our limited resources pursuing particular research programs~~ or ~~product~~failures ~~candidates~~in ~~that~~obtaining ~~may~~approval beat ~~less~~each ~~successful~~clinical ortrial ~~profitable~~site ~~than~~by ~~other~~an ~~programs~~independent ~~or product candidates~~IRB.

~~Research~~● ~~programs~~Delays to identify new product candidates and product development platforms require substantial technical, financial, and human resources. We may focus our efforts and resources on potential programs, product candidates or ~~product~~failures ~~development~~in ~~platforms~~recruiting ~~that~~suitable ~~ultimately~~patients ~~prove~~ to beparticipate ~~unsuccessful. Clinical trials of any of our product candidates is not assured despite the expenditure of significant resources~~ in ~~pursuit~~a ~~of their development, and our spending on current and future research and development programs, product candidates and product development platforms may not yield any commercially viable products~~trial.

Additionally, if we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. 44

If Table ~~we experience delays or difficulties in patient enrollment for clinical trials, our research and development efforts and the receipt~~ of ~~necessary regulatory approvals could be significantly delayed or prevented.~~Contents

~~Commencement~~● ~~and~~Withdrawal ~~successful and timely completion~~ of clinical ~~trials~~trial ~~require~~sites usfrom toour ~~enroll~~clinical atrials ~~sufficient~~because ~~number~~ of ~~eligible~~changing ~~patients~~standards toof ~~participate in these trials as required by the FDA~~care, the ~~EMA~~ineligibility ~~or comparable regulatory authorities. Any delay or difficulty in patient enrollment could significantly delay or otherwise hinder our research and development efforts and delay or prevent receipt~~ of ~~necessary~~a ~~regulatory~~site ~~approvals.~~to ~~Despite diligent planning of our clinical trials and analysis of their feasibility regarding patient recruitment~~participate, ~~we may experience difficulties, delays~~ or ~~inability~~other inunforeseen ~~patient enrollment in our clinical trials for a variety of reasons, including:~~circumstances.

● ~~The~~Imposition ~~size~~of ~~and~~a ~~nature~~clinical hold by regulatory agencies for any reason, including safety concerns raised by other clinical trials of similar product candidates that may reflect an unacceptable risk with the patient population, technology platform, product stability or after an inspection of clinical operations or trial sites.

● ~~The~~Failure ~~severity~~to ~~and~~perform ~~incidence~~clinical oftrials in accordance with the ~~disease~~GCP ~~under~~or ~~investigation~~applicable regulatory guidelines in other countries.

● ~~The~~Withdrawal ~~eligibility criteria for the study in question, including any misjudgment~~ of, ~~and~~patients ~~resultant~~from ~~adjustment to,~~ the ~~appropriate~~clinical ~~ranges~~study ~~applicable~~before toan ~~the~~efficacy ~~exclusion~~assessment ~~and~~can ~~inclusion~~be ~~criteria~~made.

● ~~The~~Clinical ~~size~~trial ofsites ~~the~~deviating ~~study~~from ~~population required for analysis of the~~ trial’s ~~primary endpoints~~protocol.

● ~~The~~Addressing ~~ability~~any topatient ~~recruit~~safety ~~clinical~~concerns ~~trial~~that ~~investigators~~arise ~~with~~during the ~~appropriate~~course ~~competencies~~of ~~and~~a ~~experience~~trial.

● ~~The~~Adding ~~number~~new of clinical trial sites ~~and the proximity of prospective patients to those sites~~.

● ~~The~~Manufacturing ~~design~~sufficient quantities of ~~the~~qualified ~~trial~~materials under cGMPs and ~~the~~applying ~~complexity~~them on a patient-by-patient basis for ~~patients~~use ~~and~~in clinical ~~sites~~trials.

● ~~The~~Our ~~nature,~~preclinical ~~severity~~tests or clinical trials may produce negative or inconclusive results, and ~~frequency~~we ofmay ~~adverse~~decide, ~~side~~or ~~effects~~regulators ~~associated~~or ~~with~~funders ~~our~~may ~~product~~require ~~candidates~~us, to conduct additional preclinical testing or clinical trials or to abandon projects that we expected to be promising.

● ~~The~~Our ~~screening~~third-party ~~procedures~~contractors ~~and~~(such ~~the~~as ~~rate~~CROs, ofproduct ~~patients~~manufacturers, ~~failing~~or ~~screening~~investigators) ~~procedures~~may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner.

● ~~The~~Fraudulent ~~ability~~activity by a clinical researcher, if discovered, could preclude the submission of clinical data prepared by that researcher, lead to ~~provide~~the ~~appropriate~~suspension ~~screening~~or ~~assays~~substantive scientific review or one or more of our marketing applications by regulatory agencies.

● The ~~risk~~cost ~~that~~of ~~patients’~~our ~~general~~clinical ~~health~~trials ~~conditions~~may dobe ~~not~~greater ~~allow~~than ~~the~~we ~~conduct of study/screening procedures (for example, tumor biopsy)~~anticipate.

46● The regulatory requirements for product approval may not be explicit, may evolve over time and may diverge by jurisdiction.

~~Table~~● Evolution in the standard of ~~Contents~~care that requires amendments to ongoing clinical trials and/or the conduct of additional preclinical studies or clinical trials.

● ~~The~~Changes ~~ability~~in toregulatory ~~manufacture~~requirements ~~patient~~and ~~products~~guidance ~~appropriately~~that ~~(for~~require ~~example,~~amending ~~at a sufficient high dose,~~ or ~~with~~submitting ~~sufficiently~~new ~~active~~clinical ~~T cells)~~protocols.

●We ~~The~~could ~~efforts~~also toencounter ~~facilitate~~delays ~~timely~~if ~~enrollment~~physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles. Further, a clinical trial may be suspended or terminated by us, the ~~effectiveness~~IRBs for the institutions in which such trials are being conducted or by the FDA or other regulatory authorities due to a number of ~~recruiting~~factors, ~~publicity~~including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions, lack of adequate funding to continue the clinical trial, or based on a recommendation by the SMC. The FDA’s review of our data of our ongoing clinical trials may, depending on the data, also result in the delay, suspension or termination of one or more clinical trials, which would also delay or prevent the initiation of our other planned clinical trials. If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.

●Many ~~The~~of ~~patient~~the ~~referral~~factors ~~practices~~that ofcause, ~~physicians~~or ~~within~~lead to, a delay in the ~~same~~commencement ~~hospital~~or ascompletion ~~well~~of asclinical ~~within~~trials ~~other~~may ~~hospitals~~ultimately orlead ~~private~~to ~~practices~~the denial of regulatory approval of our product candidates.

~~● Competing clinical trials for similar therapies, other new therapeutics, new combination treatments, new medicinal products.~~ 45

● Table ~~Approval~~ of ~~new indications for existing therapies or approval of new therapies in general or changes in standard of care.~~Contents

●We ~~Clinicians’~~may ~~and~~find ~~patients’~~it ~~perceptions~~difficult as to ~~the~~enroll ~~potential~~patients ~~advantages and side effects of the product candidate being studied~~ in ~~relation~~our toclinical ~~other available therapies~~trials, ~~including~~which ~~any~~could ~~new~~delay ~~drugs~~ or ~~treatments~~prevent ~~that~~clinical ~~may~~trials ~~be approved or become standard~~ of ~~care~~our ~~for~~product ~~the indications we are investigating~~candidates.

●Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The ~~ability~~timing of our clinical trials depends on the speed at which we can recruit patients to ~~obtain~~participate ~~and~~in ~~maintain~~testing our product candidates. If patients are unwilling to participate in our trials because of restrictions on travel or healthcare institution policies, negative publicity from adverse events in the biotechnology industries, public perception of vaccine safety issues or for other reasons, including competitive clinical trials for similar patient ~~consents~~populations, the timeline for recruiting patients, conducting studies and obtaining regulatory approval of potential products may be delayed. These delays could result in increased costs, delays in advancing our product development, delays in testing the effectiveness of our technology or termination of the clinical trials altogether.

●We ~~Inability~~may ofnot ~~clinical~~be ~~sites~~able to identify, recruit and enroll ~~patients~~a assufficient ~~healthcare~~number ~~capacities~~of ~~are~~patients, or those with required or desired characteristics to ~~cope~~achieve ~~with~~diversity ~~natural~~in ~~disasters~~a trial, ~~epidemics~~to orcomplete ~~other~~our ~~health~~clinical ~~system~~trials ~~emergencies,~~in ~~such~~a astimely ~~the~~manner. ~~COVID-19~~Patient ~~pandemic.~~enrollment is affected by several factors, including:

~~Further,~~● ~~challenges~~Severity inof ~~recruiting and enrolling suitable patients to participate in clinical trials could increase costs, affect~~ the ~~timing~~disease ~~and~~under ~~outcome of our planned clinical trials and result in delays to our current development plan for our product candidates~~investigation.

~~Delays~~● inDesign ~~the commencement and completion~~ of ~~clinical~~the ~~trials~~trial ~~could increase costs and delay or prevent regulatory approval and commercialization of our product candidates~~protocol.

We● ~~cannot~~Size ~~guarantee that clinical trials~~ of ~~our product candidates will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of~~ the ~~clinical~~patient ~~trial process, and other events may cause us to temporarily or permanently stop a clinical trial~~population. ~~Events that may prevent successful or timely commencement and completion of clinical development include:~~

● ~~Negative~~Eligibility ~~preclinical~~criteria ~~data~~for the trial in question.

● ~~Delays~~Perceived inrisks ~~receiving~~and ~~the~~benefits ~~required~~of ~~regulatory clearance from~~ the ~~appropriate~~product ~~regulatory~~candidate ~~authorities~~being ~~to commence clinical trials or amend clinical trial protocols, including any objections to our INDs or protocol amendments from regulatory authorities~~tested.

● ~~Delays~~Willingness ~~in reaching,~~ or aavailability ~~failure~~of patients to ~~reach,~~participate ain ~~consensus~~our ~~with~~clinical ~~regulatory authorities on study design~~trials.

● ~~Delays~~Proximity inand ~~reaching,~~availability orof ~~a failure to reach, an agreement on acceptable terms with prospective independent~~ clinical ~~investigators, CROs and clinical~~ trial sites, ~~the~~for ~~terms~~prospective ~~of which can be subject to extensive negotiation and may vary significantly among different investigators, CROs and clinical trial sites~~patients.

● ~~Difficulties~~Our inability ~~obtaining~~to ~~required~~recruit ~~IRB~~clinical ortrial ~~ethics~~investigators ~~committee~~with ~~approval~~appropriate atcompetencies ~~each~~and ~~clinical trial site~~experience.

● ~~Challenges~~Availability inof ~~recruiting~~competing vaccines and/or ~~enrolling~~therapies ~~suitable~~and ~~patients~~related ~~that meet the study criteria to participate in~~ clinical trials.

● ~~The~~Efforts ~~inability~~ to ~~enroll~~facilitate atimely ~~sufficient~~enrollment ~~number of patients~~ in clinical trials ~~to ensure adequate statistical power to detect statistically significant treatment effects~~.

● ~~Imposition~~Our ofability ato ~~clinical~~obtain ~~hold by regulatory authorities or IRBs for any reason, including safety concerns~~ and ~~non-compliance~~maintain ~~with~~patient ~~regulatory requirements~~consents.

● ~~Failure~~Patient byreferral ~~independent~~practices ~~clinical~~of ~~investigators, CROs, other third parties or us to adhere to clinical trial requirements~~physicians.

● ~~Failure~~Ability to ~~perform~~monitor inpatients ~~accordance~~adequately ~~with~~during ~~the~~and ~~FDA’s~~after ~~GCPs or applicable regulatory guidelines in other jurisdictions~~treatment.

47We may not be able to initiate or continue clinical trials if we cannot enroll a sufficient number of eligible patients to participate in the clinical trials required by regulatory agencies.

~~Table~~Even if we enroll a sufficient number of ~~Contents~~eligible patients to initiate our clinical trials, we may be unable to maintain participation of these patients throughout the course of the clinical trial as required by the clinical trial protocol, in which event we may be unable to use the research results from those patients.

●If ~~The~~we ~~inability~~have todifficulty ~~manufacture~~enrolling ~~adequate~~and ~~quantities~~maintaining the enrollment of a ~~product~~sufficient ~~candidate~~number orof ~~other~~patients ~~materials~~to ~~necessary~~conduct inour ~~accordance~~clinical ~~with~~trials ~~cGMPs~~as ~~and~~planned, ~~current~~we ~~cGTPs~~may need to ~~conduct~~delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business.

●Our ~~Lower~~product ~~than~~candidates ~~anticipated~~may ~~patient~~cause ~~retention~~undesirable ~~rates~~side effects or have other properties that delay or prevent their regulatory approval or limit their commercial potential.

●Significant ~~Difficulties~~adverse events caused by our product candidates or even competing products in ~~maintaining~~development ~~contact~~that ~~with~~utilize ~~patients~~a ~~after~~common ~~treatment~~mechanism of action could cause us, ~~resulting~~an IRB or ethics committee, and/or regulatory authorities to interrupt, delay or halt clinical trials and could result in ~~incomplete~~clinical ~~data~~trial challenges such as difficulties in patient recruitment, retention, and adherence, the denial of regulatory approval by the FDA or other regulatory authorities and potential product liability claims. Serious adverse events deemed to be caused by our product candidates could have a material adverse effect on the development of our product candidates and our business as a whole.

~~● Ambiguous or negative interim results.~~ 46

● Table Our independent clinical investigators, CROs or clinical trial sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of ~~a clinical trial.~~Contents

●Our ~~Unforeseen~~understanding ~~safety~~of ~~issues~~the relationship between our product candidates and these events, ~~including~~as ~~occurrence~~well as our understanding of adverse events ~~associated~~reported ~~with~~in ~~the~~future clinical trials of other product ~~candidate~~candidates, ~~that~~may ~~are~~change ~~viewed~~as towe ~~outweigh~~gather more information, and additional unexpected adverse events may be observed. In addition, the ~~product~~side ~~candidate’s~~effect profile of pharmaceutical drugs cannot be fully established based on preapproval clinical trials involving a limited number of patients. Routine review and analysis of post-marketing safety surveillance and clinical trials will provide additional information, for example, potential ~~benefits~~evidence of rare, population-specific or long-term adverse reactions, and may adversely affect the commercialization of the product, and even lead to the suspension or revocation of product marketing authorization.

●If ~~Changes~~we inor ~~regulatory~~others ~~requirements~~identify ~~and~~undesirable ~~guidance~~side ~~that~~effects ~~require~~caused ~~amending~~by our product candidates either before or ~~submitting~~after ~~new~~receipt ~~clinical~~of ~~protocols.~~marketing approval, a number of potentially significant negative consequences could result, including:

● ~~Lack~~Our ofclinical ~~adequate~~trials ~~funding~~may tobe ~~continue~~put ~~the~~on ~~clinical trial~~hold.

~~Results~~● ~~from~~We ~~preclinical studies and early-stage clinical trials~~ may ~~not~~ be ~~predictive~~unable ofto ~~results~~obtain ~~from~~regulatory ~~late-stage~~approval orfor ~~other~~our ~~clinical~~product ~~trials~~candidates.

~~Positive~~● ~~and~~Regulatory ~~promising~~authorities ~~results from preclinical studies and early-stage clinical trials~~ may ~~not~~withdraw beapprovals ~~predictive~~ of ~~results from late-stage clinical trials or from clinical trials of the same product candidates. The primary objectives of~~ our current Phase 1 clinical trials are to establish safety and tolerability and to determine the recommended Phase 2 dose. Results from those and future early-stage clinical trials may not be representative of results from later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Late-stage clinical trials could differ in significant ways from early-stage clinical trials, including changes to inclusion and exclusion criteria, efficacy endpoints, dosing regimen and statistical design. In particular, we expect there may be greater variability in results for products ~~processed and administered on a patient-by-patient basis, as for our cellular therapy product candidates, than for “OTS” products, like many other drugs~~. Many companies in the biotechnology industry have suffered significant setbacks in late-stage clinical trials after achieving encouraging or positive results in early-stage development. There can be no assurance that we will not face similar setbacks. Therefore, despite positive results observed in early-stage clinical trials, our product candidates may fail to demonstrate sufficient efficacy in our pivotal or confirmatory clinical trials.

~~Preliminary~~● ~~interim~~Regulatory ~~or “top-line” data~~authorities ~~that we announce or publish from time to time~~ may ~~change~~require asadditional ~~more~~warnings ~~data~~on ~~become available and are subject to audit and verification procedures that could result in material changes in~~ the ~~final data~~label.

~~From~~● ~~time~~A tomedication ~~time,~~guide weoutlining ~~may~~the ~~announce~~risks ~~or publish preliminary interim or “top-line” data from clinical trials. Positive preliminary data may not be predictive~~ of such ~~trial’s~~side ~~subsequent~~effects orfor ~~overall~~distribution ~~results. Preliminary data are subject~~ to ~~the~~patients ~~risk that one or more of the outcomes~~ may ~~materially~~be ~~change as more data become available~~required. ~~Additionally, preliminary data are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.~~

~~Therefore,~~● ~~positive~~We ~~preliminary~~could ~~results in any ongoing clinical trial may not~~ be ~~predictive~~sued ~~of such results in the completed trial. We also make assumptions, estimations, calculations~~ and ~~conclusions~~held asliable ~~part~~for ofharm ~~our~~caused ~~analyses of data, and we may not have received or had the opportunity~~ to ~~fully evaluate all data~~patients. As a result, preliminary data that we report may differ from future results from the same clinical trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Preliminary 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, preliminary data should be viewed with caution until the final data are available. Material adverse changes in the final data compared to preliminary data could significantly harm our business prospects.

● Our reputation may suffer.

48Any of these events could prevent us from achieving or maintaining marketing approvals for and market acceptance of our product candidates and could have a material adverse effect on our business and financial results.

~~Table~~We ofexpect ~~Contents~~the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to competition sooner than anticipated.

~~Product~~The ~~liability~~BPCIA ~~lawsuits~~was ~~against~~enacted usas ~~could~~part ~~cause~~of usthe Affordable Care Act to ~~incur~~establish ~~substantial~~an ~~liabilities~~abbreviated pathway for the approval of biosimilar and ~~could~~interchangeable ~~limit~~biological ~~commercialization~~products. The regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an approved biologic. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the reference product was approved under a BLA. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain when such processes intended to implement the BPCIA may be fully adopted by the FDA, any ~~products~~such ~~that~~processes wecould ~~develop~~have ~~alone~~a ormaterial ~~with~~adverse ~~collaborators~~effect on the future commercial prospects for our biological products.

We ~~face~~believe anthat ~~inherent~~if ~~risk~~any of the product ~~liability~~candidates ~~and~~we ~~professional~~develop ~~indemnity~~that ~~exposure~~are ~~related~~approved toin the ~~testing~~U.S. inas ~~clinical~~a ~~trials~~biological product under a BLA, the BLA should qualify for the 12-year period of ~~our~~exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider the subject product candidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. WeMoreover, ~~will~~the ~~face~~extent anto ~~even~~which ~~greater~~a ~~liability~~biosimilar, ~~risk~~once ifapproved, wewill ~~commercially~~be ~~sell~~substituted for any one of the reference products in a way that weis orsimilar ~~our~~to ~~collaborators~~traditional ~~may~~generic ~~develop~~substitution for ~~human~~non-biological ~~use~~products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

Manufacturing defects, errors in product distribution or storage processes, improper administration or application and known or unknown side effects of product usage may result in liability claims against us or third parties with which we have relationships. These actions could include claims resulting from acts by our collaborators, licensees and subcontractors over which we have little or no control. For example, our liability could be sought by patients participating in clinical trials for potential therapeutic product candidates as a result of unexpected side effects, improper product administration or the deterioration of a patient’s condition, patient injury or even death. 47

~~Criminal~~ Table orof civil proceedings might be filed against us by patients, regulatory authorities, biopharmaceutical companies and any other third party using or marketing any product candidates or products that we develop alone or with collaborators. On occasion, large judgments have been awarded in class action lawsuits based on products that had unanticipated adverse effects. If we cannot successfully defend ourselves against claims that product candidates or products we develop alone or with collaborators caused harm, we could incur substantial liabilities.Contents

~~Clinical~~The ~~development~~regulatory ~~does~~landscape ~~not~~that ~~always~~will ~~fully~~govern ~~characterize~~our ~~the~~product ~~safety~~candidates ~~and~~is ~~efficacy~~uncertain; ~~profile~~regulations ofrelating ato ~~new~~more ~~medicine,~~established ~~and~~gene ittherapy isand ~~always~~cell ~~possible~~therapy ~~that~~products aare ~~drug~~still ~~or biologic~~developing, ~~even~~and ~~after~~changes in regulatory ~~approval,~~requirements ~~may~~could ~~exhibit~~result ~~unforeseen~~in ~~side~~delays ~~effects.~~or Ifdiscontinuation of development of our product candidates ~~were to cause adverse side effects during clinical trials~~ or ~~after~~unexpected ~~approval,~~costs wein ~~may~~obtaining beregulatory ~~exposed to substantial liabilities~~approval.

~~Product~~Because ~~liability~~we ~~insurance~~are ~~coverage~~developing ~~may~~novel ~~not~~CAR-T cell immunotherapy product candidates that are unique biological entities, the regulatory requirements that we will be ~~adequate~~subject to ~~cover~~are ~~all~~not ~~liabilities~~entirely clear. Even with respect to more established products that wefit into the categories of gene therapies or cell therapies, the regulatory landscape is still developing. For example, regulatory requirements governing gene therapy products and cell therapy products have changed frequently and may ~~incur~~continue to change in the future. WeMoreover, ~~anticipate~~there ~~that~~is wesubstantial, ~~will~~and ~~need~~sometimes uncoordinated, overlap in those responsible for regulation of existing gene therapy products and cell therapy products. For example, in the U.S., the FDA has established the Office of Tissues and Advanced Therapies, formerly known as the Office of Cellular, Tissue and Gene Therapies, within its Center for Biologics Evaluation and Research to ~~increase~~consolidate ~~our~~the ~~insurance~~review ~~coverage~~of ~~when~~gene wetherapy ~~begin~~and related products, and the Cellular, Tissue and Gene Therapies Advisory Committee to advise the Center for Biologics Evaluation and Research on its review. Gene therapy clinical trials are also subject to review and oversight by an IBC, a local institutional committee that reviews and oversees basic and clinical research conducted at the institution participating in the clinical trial. Although the FDA decides whether individual gene therapy protocols may proceed, review process and determinations of other reviewing bodies can impede or delay the initiation of a clinical study, even if ~~our~~the ~~collaborators~~FDA has reviewed the study and approved its initiation. Conversely, the FDA can place an IND application on clinical hold even if such other entities have provided a favorable review. Furthermore, each clinical trial must be reviewed and approved by an independent IRB at or ~~ourselves~~servicing ~~successfully~~each ~~commercialize~~institution ~~any~~at which a clinical trial will be conducted. In addition, adverse developments in clinical trials of gene therapy products conducted by others may cause the FDA or other regulatory bodies to change the requirements for approval of any of our product candidates.

~~Our~~Complex regulatory environments exist in other jurisdictions in which we might consider seeking regulatory approvals for our product candidates, ~~are~~further ~~complex~~complicating the regulatory landscape. For example, in the EU a special committee called the Committee for Advanced Therapies was established within the EMA in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products to assess the quality, safety and ~~difficult~~efficacy of advanced-therapy medicinal products, and to ~~manufacture~~follow scientific developments in the field. WeAdvanced-therapy ~~could~~medicinal ~~experience~~products ~~manufacturing~~include ~~problems~~gene ~~that~~therapy ~~result~~products inas ~~delays~~well inas ~~our~~somatic ~~development~~cell ortherapy ~~commercialization~~products ~~programs~~and tissue engineered products.

~~Our~~These ~~product~~various ~~candidates~~regulatory ~~are~~review ~~cellular~~committees ~~products or biologics~~ and ~~the~~advisory ~~process~~groups ~~of manufacturing our products is complex, highly regulated~~ and ~~subject~~new toor ~~multiple~~revised ~~risks.~~guidelines ~~The~~that ~~manufacture~~they ofpromulgate ~~our cellular product candidates involves complex processes which include, for example, harvesting white blood cells~~ from ~~healthy~~time ~~donors, transporting them from blood banks~~ to ~~our~~time ~~cGMP~~may ~~facility~~lengthen ~~for donor GDT expansion, engineering, and cryopreservation, and finally shipping of~~ the Tregulatory ~~cell~~review product back to the patient for treatment. As a result of the complexities, the cost to manufacture cellular products per dose is generally higher than traditional small molecule chemical compounds or biologics, and the manufacturing process ~~is less reliable~~, ~~more~~require ~~variable~~us ~~and is more difficult~~ to ~~reproduce.~~perform ~~Our~~additional ~~manufacturing process may be susceptible to product loss or failure due to logistical issues associated with the collection of patients’ blood cells~~studies, ~~shipping~~increase ~~such~~our ~~material~~development ~~to the manufacturing site~~costs, ~~shipping~~lead ~~the final product back~~ to ~~the~~changes ~~patient, and infusing the patient with the product. Product loss or failure may also be caused by manufacturing issues associated with the variability~~ in ~~patient~~regulatory ~~starting~~positions ~~material~~and ~~especially from heavily treated cancer patients~~interpretations, ~~interruptions~~delay ~~in the manufacturing process, contamination, equipment failure, assay failures, improper installation~~ or ~~operation~~prevent ofapproval ~~equipment, vendor or operator error, inconsistency in cell growth,~~ and ~~variability~~commercialization inof ~~product~~our ~~characteristics. Even minor deviations from normal manufacturing processes could result in reduced production yields,~~ product ~~defects,~~candidates ~~and other supply disruptions. If for any reason we lose a patient’s starting material,~~ or ~~any~~lead ~~intermediate~~to ~~product~~significant atpost-approval ~~any~~limitations ~~point in the process,~~ or ifrestrictions. ~~any~~Because ~~product does not meet~~ the ~~preset~~regulatory ~~specifications,~~landscape ~~the manufacturing process~~ for ~~that~~our ~~patient will need to be restarted, sometimes including re~~CAR-collection of blood cells from the patient, and the resulting delay may adversely affect that patient’s outcome. It may even happen, that failed product manufacture may prevent a patient from getting a T cell ~~product.~~immunotherapy ~~If microbial, environmental or other contaminations are discovered in our~~ product candidates oris ~~in the manufacturing facilities in which our product candidates are made~~new, ~~such~~we ~~manufacturing facilities~~ may ~~need~~face toeven bemore ~~closed~~cumbersome ~~for an extended period of time to investigate~~ and ~~remedy~~complex ~~the~~regulations ~~contamination.~~than Ifthose ~~such~~emerging ~~contaminations~~for orgene ~~other~~therapy ~~product~~products ~~quality issues are not discovered~~ and ifcell astherapy ~~a result thereof patients are exposed to a health risk, we may be held liable~~products. ~~Our insurance may not cover those cases, or the financial coverage may not be sufficient.~~

~~Because~~Furthermore, ~~our~~even ~~cellular~~if our product candidates ~~are~~obtain ~~manufactured~~required ~~specifically~~regulatory ~~for~~approvals, ~~each~~such ~~individual~~approvals ~~patient,~~may welater ~~will~~ be ~~required~~withdrawn toas ~~maintain~~ a ~~chain~~result of ~~identity~~changes ~~with~~in ~~respect~~regulations toor the ~~patient’s~~interpretation ~~cellular~~of ~~material~~regulations asby itapplicable ~~moves~~regulatory ~~from the patient to the manufacturing~~ agencies.

49Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential product to market could decrease our ability to generate sufficient product revenue to maintain our business.

~~Table~~The FDA may disagree with our regulatory plan and we may fail to obtain regulatory approval of ~~Contents~~our product candidates.

~~facility,~~If ~~through~~our ~~the~~planned ~~manufacturing~~Phase ~~process,~~1 clinical trials for Deltacel is completed and, ~~back~~assuming positive data, we expect to ~~the~~advance ~~patient~~to potential registrational trials. ~~Maintaining~~The ~~such~~general aapproach ~~chain~~for FDA approval of ~~identity~~a isnew ~~difficult~~biologic ~~and~~or ~~complex,~~drug ~~and~~is ~~failure~~for tothe dosponsor soto ~~could~~provide ~~result~~dispositive indata ~~adverse~~from ~~patient~~two ~~outcomes~~well-controlled, ~~loss~~Phase 3 clinical trials of ~~product,~~the relevant biologic or ~~regulatory~~drug ~~action~~in ~~including~~the ~~withdrawal~~relevant ofpatient ~~our~~population. ~~products~~Phase ~~from~~3 ~~the~~clinical ~~market.~~trials ~~Further,~~typically asinvolve ~~product~~hundreds ~~candidates~~of ~~are~~patients, ~~developed~~have ~~through~~significant ~~preclinical~~costs and take years to ~~late-stage~~complete. If the results from our clinical trials ~~towards~~are ~~approval~~sufficiently ~~and commercialization~~compelling, itwe isintend ~~common~~to ~~that~~discuss ~~various~~with ~~aspects~~the FDA submission of a BLA for the ~~development~~relevant ~~program~~product candidate. However, ~~such~~we asdo ~~manufacturing~~not ~~methods,~~have ~~are~~any ~~altered~~agreement ~~along~~or guidance from the ~~way~~FDA tothat ~~optimize~~our ~~processes~~regulatory ~~and~~development ~~results.~~plans ~~Such~~will ~~changes~~be ~~carry~~sufficient for submission of a BLA. For example, the ~~risk~~FDA may require that ~~they~~we ~~will~~conduct ~~not~~a ~~achieve~~comparative ~~these~~trial ~~intended~~against ~~objectives,~~an ~~and~~approved ~~any~~therapy ofincluding ~~these~~potentially ~~changes~~an ~~could~~approved ~~cause~~autologous ~~our~~T ~~product~~cell ~~candidates~~therapy, towhich ~~perform~~would ~~differently~~significantly delay our development timelines and ~~affect~~require ~~the~~substantially ~~results~~more ofresources. ~~planned~~In ~~clinical~~addition, ~~trials~~the orFDA ~~other~~may ~~future~~only ~~clinical~~allow ~~trials~~us orto ~~otherwise~~evaluate ~~necessitate~~patients ~~the~~that ~~conduct~~have offailed ~~additional~~or ~~studies,~~who ~~including~~are ~~bridging~~ineligible ~~clinical~~for ~~trials~~autologous therapy, which ~~can~~are beextremely ~~costly~~difficult patients to treat and ~~time-consuming~~patients with advanced and aggressive cancer, and our product candidates may fail to improve outcomes for such patients.

In addition, the manufacturing process and facilities for any products that we may develop is subject to FDA and comparable regulatory authority approval processes, and we will need to meet all applicable regulatory authority requirements, including cGMP and cGTP requirements, on an ongoing basis, including requirements pertaining to quality control, quality assurance, and the maintenance of records and documentation. The FDA and comparable regulatory authorities enforce these requirements through facility inspections. Manufacturing facilities must be approved by the FDA pursuant to inspections that will be conducted after we submit our marketing applications. Manufacturers are also subject to continuing FDA and comparable regulatory authority inspections following marketing approval. Further, we must supply all necessary chemistry, manufacturing, and control documentation in support of a BLA on a timely basis. 48

~~Any~~ Table ~~failure to follow cGMP and cGTP or other regulatory requirements or any delay, interruption or other issues that arise in the manufacture, fill and finish, packaging, or storage~~ of our product candidates as a result of a failure of our facilities or the facilities or operations of third parties to comply with regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop and commercialize our product candidates, including leading to significant delays in the availability of drug product for our clinical trials or the termination of or hold on a clinical trial, or the delay or prevention of a filing or approval of marketing applications for our product candidates.Contents

IfThe weFDA ~~are~~may ~~unable~~grant toaccelerated ~~obtain~~approval ~~sufficient~~for ~~quantities~~our ofproduct ~~raw~~candidates ~~materials~~ and, ~~supplies~~as a condition for accelerated approval, atthe ~~acceptable~~FDA ~~prices~~may require a sponsor of a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biologic may be subject to withdrawal procedures by the FDA that are more accelerated than those available for regular approvals. We believe that an accelerated approval strategy is warranted given the limited alternatives for patients that our initial product candidates target, but the FDA may ultimately require a ~~timely~~Phase ~~basis~~3 clinical trial prior to approval, itparticularly ~~could~~since ~~harm~~our product candidates represent a novel treatment. In addition, the standard of care may change with the approval of new products in the same indications that we are studying. This may result in the FDA or other regulatory agencies requesting additional studies to show that our ~~business~~product candidate is superior to the new products.

WeOur ~~are~~clinical ~~dependent~~trial onresults ~~third~~may ~~parties~~also ~~for~~not ~~the~~support ~~supply~~approval. ofIn ~~various biological materials~~addition, ~~such as cells, cytokines and antibodies, and the manufacture of product supplies, such as media, plasmids, mRNA and viral vectors, that are necessary to produce~~ our product candidates. ~~The supply of these materials~~ could befail ~~reduced or interrupted at any time. In such case, identifying and engaging an alternative supplier or manufacturer could result in delay, and we may not be able~~ to ~~find~~receive ~~other~~regulatory ~~acceptable~~approval ~~suppliers~~for ormany ~~manufacturers on acceptable terms~~reasons, orincluding atthe ~~all.~~following:

~~Changing~~● ~~suppliers~~The orFDA ~~manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines. If we change suppliers~~ or ~~manufacturers~~comparable ~~for~~foreign ~~commercial production, applicable~~ regulatory ~~agencies~~authorities may ~~require~~disagree uswith ~~to conduct additional studies or trials. If key suppliers or manufacturers are lost, or if~~ the ~~supply~~design ~~of the materials is diminished~~ or ~~discontinued,~~implementation ~~we or our collaborators may not be able to develop, manufacture and market product candidates in a timely and competitive manner, or at all. If any~~ of our ~~product~~clinical candidates receives approval, we will likely need to seek alternative sources of supply of raw materials or manufactured product supplies and there can be no assurance that we will be able to establish such relationships to provide such supplies on commercially reasonable terms or at acceptable quality levels, if at alltrials.

If● weWe ~~are~~may be unable to ~~identify~~demonstrate ~~and~~to ~~procure~~the ~~additional~~satisfaction ~~sources~~ of ~~supply~~the ~~that~~FDA ~~fit~~or ~~our~~comparable ~~required~~foreign ~~needs,~~regulatory weauthorities ~~could~~that ~~face~~our ~~substantial~~product ~~delays~~candidates orare ~~incur~~safe ~~additional~~and ~~costs~~effective infor ~~procuring~~any ~~such~~of ~~materials~~their proposed indications.

● The ~~market~~results ~~opportunities~~of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for ~~our~~approval, ~~product~~including ~~candidates~~due ~~may~~to bethe ~~smaller~~heterogeneity ~~than~~of wepatient ~~estimate~~populations.

~~Our~~● ~~projections~~We of both the number of people who have the cancers we are targeting, as well as the subset of people with these cancers who are in a position to receive our product candidates, and who have the potential to benefit from treatment with our product candidates, are based on our beliefs and estimates that have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations, or market research by third parties, and may ~~prove to~~ be ~~incorrect.~~unable These estimates may be inaccurate or based on imprecise data. We do not have verifiable internal marketing data regarding the potential size of the commercial market for our product candidates, nor have we obtained current independent marketing surveys to ~~verify~~demonstrate ~~the~~that ~~potential size of the commercial markets for~~ our ~~current~~ product candidates’ orclinical ~~any future product candidates. Since our current product candidates~~ and ~~any~~other ~~future~~benefits ~~product~~outweigh ~~candidates~~their ~~will~~safety ~~represent novel approaches to treating various conditions, it may be difficult, in any event, to accurately estimate the potential~~ risks.

50● The FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials.

~~Table~~● The data collected from clinical trials of ~~Contents~~our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the U.S. or elsewhere.

~~revenues~~● ~~from~~The ~~these~~FDA ~~product~~or ~~candidates.~~comparable ~~The~~foreign ~~number~~regulatory ofauthorities ~~patients~~will inreview ~~the~~our ~~addressable~~manufacturing ~~markets~~process ~~may~~and ~~turn~~inspect ~~out~~our tocommercial bemanufacturing ~~lower~~facility ~~than~~and ~~expected, patients~~ may not beapprove ~~otherwise amenable to treatment with~~ our ~~product~~manufacturing ~~candidates~~process or ~~new patients may become increasingly difficult to identify or gain access to, all of which could materially adversely affect our business, financial condition, results of operations and prospects~~facility.

~~Risks~~● ~~Related~~The toapproval ~~Government~~policies ~~Regulation~~or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

~~The~~We ~~FDA~~may ~~regulatory~~seek Orphan ~~approval~~Drug ~~process~~Designation is(ODD) ~~lengthy~~for ~~and~~some ~~time-consuming~~of our product candidates across various indications, ~~and~~but we may ~~experience~~be ~~significant~~unable ~~delays~~to inobtain such designations or to maintain the ~~clinical~~benefits ~~development~~associated ~~and~~with ~~regulatory~~orphan ~~approval~~drug ofdesignation, including market exclusivity, which may cause our ~~product~~revenue, ~~candidates~~if any, to be reduced.

~~The~~We ~~research,~~may ~~testing,~~seek ~~manufacturing,~~ODD for ~~labeling,~~at ~~approval,~~least ~~sale,~~one ~~import, export, marketing, and distribution~~ of ~~drug~~our ~~products,~~product ~~including~~candidates ~~biologics,~~in ~~are~~specific ~~subject~~orphan toindications ~~extensive~~in ~~regulation~~which bythere ~~the~~is ~~FDA~~a ~~and~~medically ~~other~~plausible ~~regulatory~~basis ~~authorities~~for in the ~~United~~use ~~States.~~of Wethese ~~are~~products. ~~not~~Even ~~permitted~~if towe ~~market~~obtain ~~any~~ODD, ~~biological~~exclusive ~~drug~~marketing ~~product~~rights in the U.S. ~~until~~may be limited if we ~~receive~~seek approval offor aan ~~BLA~~indication ~~from~~broader than the ~~FDA.~~orphan Wedesignated ~~have~~indication ~~not~~and ~~previously~~may ~~submitted~~be alost ~~BLA~~if to the FDA, orlater ~~similar~~determines ~~approval~~that ~~filings~~the torequest ~~comparable~~for ~~foreign~~designation ~~authorities.~~was Amaterially ~~BLA~~defective ~~must~~or ~~include~~if ~~extensive~~we ~~preclinical~~are ~~and~~unable ~~clinical~~to ~~data~~assure ~~and~~sufficient ~~supporting~~quantities ~~information~~of ~~to establish~~ the product ~~candidate’s~~to ~~safety~~meet ~~and effectiveness for each desired indication. The BLA must also include significant information regarding~~ the ~~chemistry,~~needs ~~manufacturing~~of ~~and~~patients ~~controls~~with ~~for~~ the ~~product.~~rare Wedisease ~~have~~or ~~not~~condition, ~~received~~or ~~approval~~if ~~from~~a ~~regulatory~~subsequent ~~authorities~~applicant todemonstrates ~~market~~clinical ~~any~~superiority ~~product~~over ~~candidate~~our ~~in any jurisdiction~~products, ~~and~~if itapproved. isIn ~~possible~~addition, ~~that~~although ~~neither~~we ~~our~~may ~~current~~seek ~~product~~ODD ~~candidates~~for ~~nor~~other ~~any~~ product candidates, ~~that~~ we may ~~seek~~never toreceive ~~develop~~such ~~in the future will ever obtain the appropriate regulatory approvals necessary for us to commence product sales~~designations.

The pathway to regulatory approvals is time consuming and unpredictable, involves substantial costs and consumes management time and attention. It is not possible to predict the timing or success of obtaining regulatory approvals with any degree of certainty, and as a result, it is difficult to forecast our future financial results or prospects. Any unexpected development in the regulatory approval process, including delays or denials of regulatory approvals or significant modifications to our product candidates required by our regulators, could materially and adversely affect our business, results of operations and financial condition, and could substantially harm our stock price. 49

We Table ~~expect the novel nature~~ of our product candidates to create further challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercial development of T cell therapies for cancer. We may also request regulatory approval of future CAR-based product candidates by target, regardless of cancer type or origin, which the FDA may have difficulty accepting if our clinical trials only involved cancers of certain origins. The FDA may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to support licensure. The opinion of the Advisory Committee, although not binding, may have a significant impact on our ability to obtain licensure of the product candidates based on the completed clinical trials, as the FDA often adheres to the Advisory Committee’s recommendations.Contents

~~Accordingly,~~Obtaining ~~the~~and maintaining regulatory approval ~~pathway~~of ~~for~~ our product candidates ~~may~~in beone ~~uncertain,~~jurisdiction ~~complex,~~does ~~expensive~~not ~~and~~mean ~~lengthy,~~that ~~and~~we will be successful in obtaining regulatory approval ~~may~~of ~~not~~our beproduct ~~obtained~~candidates in other jurisdictions.

~~Clinical~~Obtaining ~~testing~~and ismaintaining ~~expensive,~~regulatory ~~time~~approval ~~consuming~~of ~~and~~our ~~uncertain~~product ascandidates toin ~~outcome.~~one Wejurisdiction ~~cannot~~does not guarantee that ~~clinical~~we ~~trials~~ will be ~~conducted~~able asto ~~planned~~obtain or ~~completed~~maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on ~~schedule~~the regulatory approval process in others. For example, even if atthe ~~all.~~FDA Agrants ~~failure~~marketing approval of ~~one~~a orproduct ~~more~~candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the U.S., including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the U.S., a product candidate must be approved for reimbursement before it can ~~occur~~be atapproved ~~any~~for ~~stage~~sale ofin ~~testing~~that jurisdiction. ~~Events~~In some cases, the price that ~~may~~we ~~prevent~~intend ~~successful~~to orcharge ~~timely~~for ~~completion~~our ofproducts ~~clinical~~is ~~development~~also ~~include:~~subject to approval.

●We ~~Delays~~may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the U.S. have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or ~~failure~~prevent the introduction of our products in ~~reaching~~certain acountries. ~~consensus~~If we fail to comply with the regulatory ~~agencies~~requirements onin ~~trial~~international ~~design~~markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

●Even ~~Delays~~if orwe ~~failures~~receive inregulatory ~~obtaining~~approval ~~regulatory~~for ~~authorization~~our product candidates, such products will be subject to ~~begin~~ongoing aregulatory ~~trial~~obligations and continued regulatory review, which may result in significant additional expense and other restrictions, and we may be subject to penalties if ~~applicable~~we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

●Any ~~The~~regulatory ~~availability~~approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to conditions of ~~financial~~approval. ~~resources~~We may also be required to ~~commence~~conduct post-marketing testing, including Phase 4 clinical trials, and ~~complete~~surveillance to monitor the ~~planned~~safety and efficacy of the product potentially over many years. If the FDA or other regulatory authority approves any of our product candidates, the manufacturing processes, labeling, packaging, distribution, import, export, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP and GTP, and compliance with cGMP, GTP, and GCP for any clinical trials that we conduct post-approval. Any such restrictions may result in significant additional expense or could limit sales of the approved product. If we, or any of the third parties on which we rely, fail to meet those requirements, the FDA or comparable regulatory authorities outside the United States could initiate enforcement action. Other consequences include the issuance of fines, warning letters, untitled letters or holds on clinical trials, product seizure or detention or refusal to permit the import or export of our product candidates, and permanent injunctions and consent decrees, including the imposition of civil or criminal penalties, among other consequences, that could significantly impair our ability to successfully commercialize a given product.

●Later ~~Delays~~discovery orof ~~failures~~previously inunknown ~~reaching~~problems ~~agreement on acceptable terms~~ with ~~prospective~~an ~~CROs~~approved ~~and~~product, ~~clinical~~including ~~trial~~adverse ~~sites,~~events ~~the~~of ~~terms~~unanticipated ofseverity ~~which~~or ~~can~~frequency, beor ~~subject~~with tomanufacturing ~~extensive~~operations ~~negotiation~~or ~~and~~processes, may ~~vary~~result ~~significantly~~in, among ~~different~~other ~~CROs and trial sites.~~things:

● ~~Delays~~Restrictions on the marketing or ~~failures~~manufacturing inof ~~obtaining~~the ~~approval~~product, atwithdrawal ~~each~~of ~~clinical~~the ~~trial~~product ~~site~~from bythe anmarket ~~independent~~or ~~IRB~~voluntary or mandatory product recalls.

● ~~Delays~~Fines or ~~failures~~warning inletters, ~~recruiting~~or ~~suitable~~clinical ~~patients~~holds toon ~~participate~~clinical intrials ainvolving ~~trial~~related product candidates.

51● Refusal by the FDA or other regulatory authorities to approve pending applications or supplements to approved applications submitted by us or suspension or revocation of product license approvals.

~~Table~~● Product seizure or detention or refusal to permit the import or export of ~~Contents~~products.

● ~~Withdrawal~~Injunctions or the imposition of ~~clinical~~civil, ~~trial~~criminal ~~sites~~and/or administrative penalties, damages, monetary fines, disgorgement, exclusion from ~~our~~participation ~~clinical~~in ~~trials~~governmental reimbursement programs, ~~including~~such as aMedicare, ~~result~~Medicaid ofand ~~changing~~other ~~standards~~federal ofhealth care orprograms ~~the~~and ~~ineligibility~~curtailment ofor arestructuring ~~site~~of toour ~~participate~~operations.

● Imposition of a clinical hold by regulatory agencies for any reason, including safety concerns raised by other clinical trials of similar product candidates that may reflect an unacceptable risk with the patient population, technology platform, product stability or after an inspection of clinical operations or trial sites. 50

● Table ~~Failure~~of ~~to perform clinical trials in accordance with the GCP or applicable regulatory guidelines in other countries.~~Contents

●In ~~Having~~addition, ~~patients~~applicable ~~complete~~regulatory apolicies ~~trial~~of governmental authorities, ~~including~~such ~~having~~as ~~patients~~the ~~enrolled~~FDA, inmay ~~clinical~~change ~~trials~~and ~~dropping~~additional ~~out~~government ofregulations may be enacted that could affect any regulatory approval that we may receive for our product candidates. We cannot predict the ~~trial~~likelihood, ~~before~~nature or extent of government regulation that may arise from future legislation or administrative action, either in the ~~product~~United ~~candidate~~States isor ~~manufactured~~abroad. ~~and~~If ~~returned~~we are slow or unable to adapt to changes in existing requirements or the ~~site~~adoption of new requirements or policies, or ~~return~~not ~~for~~able ~~post-treatment~~to ~~follow-up~~maintain regulatory compliance, we may lose any marketing approval that may have been obtained and we may not achieve or sustain profitability, which would adversely affect our business.

●Healthcare ~~Clinical~~reform ~~trial~~measures ~~sites~~may ~~deviating~~have ~~from~~a ~~trial~~material ~~protocol~~adverse effect on or ~~dropping~~prevent ~~out~~our ofproduct acandidates’ ~~trial~~commercial success.

●There ~~Addressing~~have ~~any~~been, ~~patient~~and ~~safety~~we ~~concerns~~expect there will continue to be, a number of legislative and regulatory changes to health care systems in the United States and abroad that ~~arise~~could ~~during~~impact our ability to sell our products profitably. The United States government and other governments have shown significant interest in pursuing healthcare reform. For example, in 2010, the ~~course~~Affordable Care Act was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers in the United States. Healthcare reform measures like the Affordable Care Act may adversely impact the pricing of ahealthcare ~~trial~~products and services in the United States or internationally and the amount of reimbursement available from governmental agencies or other third-party payors. Certain provisions of the ACA have been subject to judicial challenges, as well as efforts to modify them or alter their interpretation or implementation. It is unclear how efforts to challenge or modify the ACA or its implementing regulations, or portions thereof, will affect our business.

●In ~~Adding~~addition, ~~new~~other ~~clinical~~legislative ~~trial~~changes ~~sites~~have been proposed and adopted in the United States since the Affordable Care Act was enacted and we expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could result in (1) more rigorous coverage criteria and (2) additional downward pressure on the price that we receive for our product candidates, if commercialized, and could seriously harm our future revenues. Any reduction in reimbursement from Medicare, Medicaid, or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenues, attain profitability, or successfully commercialize our product candidates.

●Risks ~~Manufacturing~~Related ~~sufficient~~to ~~quantities~~Our ofReliance ~~qualified materials under cGMPs and applying them~~ on aThird ~~patient-by-patient basis for use in clinical trials~~Parties.

●We ~~Our~~expect ~~preclinical~~to ~~tests~~depend oron ~~clinical~~collaborations ~~trials~~with ~~may~~third ~~produce~~parties ~~negative~~for orcertain ~~inconclusive results~~research, development and wecommercialization ~~may decide~~activities, orand ~~regulators~~if orany ~~funders~~such ~~may~~collaborations ~~require~~are usnot successful, toit ~~conduct~~may ~~additional~~harm ~~preclinical~~our ~~testing~~business orand ~~clinical trials or to abandon projects that we expected to be promising~~prospects.

●Working ~~Our~~with ~~third-party~~collaborators ~~contractors~~poses ~~(such~~several assignificant ~~CROs~~risks, ~~product~~including ~~manufacturers,~~the ~~or investigators) may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner.~~following:

● ~~Fraudulent~~Limited ~~activity~~availability byof aresource ~~clinical~~allocation ~~researcher,~~and ifother ~~discovered,~~developmental ~~could~~decisions ~~preclude~~made ~~the~~by ~~submission~~our ofcollaborators ~~clinical~~about ~~data~~the ~~prepared~~product bycandidates or technologies that ~~researcher,~~we ~~lead~~seek to develop with them may result in the ~~suspension~~delay or ~~substantive~~termination ~~scientific~~of ~~review~~research programs, studies or ~~one~~trials, repetition of or ~~more~~initiation of ~~our~~new studies or trials or provision of insufficient funding or resources for the completion of studies or trials or the successful marketing ~~applications~~and bydistribution ~~regulatory~~of ~~agencies~~any product candidates that may receive approval.

● ~~The~~Collaborators ~~cost~~could ofindependently develop, or develop with third parties, product candidates or technologies that compete directly or indirectly with our ~~clinical~~product ~~trials~~candidates ~~may~~or technologies if the collaborators believe that competitive products or technologies are more likely to be ~~greater~~successfully ~~than~~developed weor ~~anticipate~~can be commercialized under terms that are more economically attractive than ours.

● ~~The~~Collaborators ~~regulatory~~may ~~requirements~~not ~~for~~properly ~~product~~obtain, ~~approval~~maintain, ~~may~~enforce ~~not~~or bedefend ~~explicit,~~our ~~may~~intellectual ~~evolve~~property ~~over~~or ~~time~~proprietary ~~and~~rights or may ~~diverge~~use byour ~~jurisdiction~~proprietary information in such a way that could jeopardize or invalidate our proprietary information or expose us to potential litigation.

● ~~Evolution~~Disputes inmay ~~the~~arise ~~standard~~between ofus ~~care~~and ~~that~~our ~~require~~collaborators ~~amendments~~that toresult ~~ongoing~~in ~~clinical~~the ~~trials~~delay ~~and/~~or termination of the ~~conduct~~research, ofdevelopment ~~additional~~or ~~preclinical~~commercialization ~~studies~~activities or ~~clinical~~that ~~trials~~result in costly litigation or arbitration that diverts management attention and resources.

~~● Changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.~~ 51

We Table ~~could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials~~ of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles. Further, a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such trials are being conducted or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions, lack of adequate funding to continue the clinical trial, or based on a recommendation by the Data Safety Monitoring Committee. The FDA’s review of our data of our ongoing clinical trials may, depending on the data, also result in the delay, suspension or termination of one or more clinical trials, which would also delay or prevent the initiation of our other planned clinical trials. If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.Contents

~~Many~~Our ofability ~~the~~to ~~factors~~generate ~~that~~revenues ~~cause,~~from orthese ~~lead~~arrangements will depend on our collaborators’ abilities to, asuccessfully ~~delay~~perform the functions assigned to them in these arrangements. If our collaborations do not result in the ~~commencement~~successful development and commercialization of product candidates or ~~completion~~technologies, or if one of ~~clinical~~our ~~trials~~collaborators terminates its agreement with us, we may ~~ultimately~~not ~~lead~~receive toany ~~the~~future ~~denial~~funding ofor ~~regulatory~~milestone ~~approval~~or ofroyalty ~~our~~payments ~~product~~under ~~candidates.~~the collaboration.

52If we do not receive the funding we expect under these agreements, our development of product candidates or technologies could be delayed, and we may need additional resources to develop such product candidates or technologies. In addition, if one of our collaborators terminates its agreement with us, we may find it more difficult to find a suitable replacement collaborator or attract new collaborators and may need to raise additional capital to pursue further development or commercialization of the applicable product candidates or technologies.

~~Table~~These events could delay development programs and negatively impact the perception of ~~Contents~~our company in business and financial communities. Failure to develop or maintain relationships with any current collaborators could result in the loss of opportunity to work with that collaborator or reputational damage that could impact our relationships with other collaborators in the relatively small industry communities in which we operate.

WeMoreover, ~~may~~all ~~find~~of itthe ~~difficult~~risks relating to ~~enroll~~product ~~patients~~development, regulatory approval and commercialization described in this prospectus apply to the activities of our ~~clinical~~collaborators. ~~trials~~If our existing collaboration agreements or any collaborative or strategic relationships we may establish in the future are not effective and successful, ~~which~~it ~~could~~may damage our reputation and business prospects, delay or prevent ~~clinical~~the ~~trials~~development ofand ~~our~~commercialization of product candidates and inhibit or preclude our ability to realize any revenues.

~~Identifying~~Our ~~and~~relationships ~~qualifying~~with ~~patients~~healthcare toprofessionals, ~~participate in~~ clinical ~~trials~~investigators, ofCROs ~~our~~and ~~product~~third ~~candidates~~party ispayors ~~critical~~in toconnection ~~our~~with ~~success. The timing of~~ our ~~clinical~~current ~~trials~~and ~~depends~~future onbusiness ~~the~~activities ~~speed~~may atbe ~~which~~subject ~~we can recruit patients~~ to ~~participate~~federal inand ~~testing~~state ~~our~~healthcare ~~product~~fraud ~~candidates.~~and Ifabuse ~~patients~~laws, ~~are~~false ~~unwilling~~claims tolaws, ~~participate~~transparency inlaws, ~~our~~government ~~trials~~price ~~because~~reporting, ofand ~~restrictions~~health oninformation ~~travel~~privacy orand ~~healthcare~~security ~~institution policies~~laws, ~~negative~~which ~~publicity~~could ~~from~~expose ~~adverse~~us ~~events in the biotechnology industries~~to, ~~public~~among ~~perception of vaccine safety issues or for~~ other ~~reasons~~things, ~~including~~criminal ~~competitive~~sanctions, ~~clinical~~civil ~~trials for similar patient populations~~penalties, ~~the~~contractual ~~timeline for recruiting patients~~damages, ~~conducting~~exclusion ~~studies~~from ~~and~~governmental ~~obtaining~~healthcare ~~regulatory approval of potential products may be delayed. These delays could result in increased costs~~programs, ~~delays~~reputational ~~in advancing our product development~~harm, ~~delays~~administrative inburdens ~~testing~~and ~~the~~diminished ~~effectiveness~~profits ofand ~~our~~future ~~technology or termination of the clinical trials altogether~~earnings.

WeHealthcare ~~may~~providers ~~not~~and bethird-party ~~able~~payors toplay ~~identify,~~a ~~recruit~~primary ~~and~~role ~~enroll~~in athe ~~sufficient~~recommendation ~~number~~and prescription of ~~patients,~~any orproduct ~~those~~candidates for which we obtain marketing approval. Our current and future arrangements with ~~required~~healthcare orprofessionals, ~~desired~~clinical ~~characteristics~~investigators, CROs, third-party payors and customers may expose us to ~~achieve~~broadly ~~diversity~~applicable infraud aand ~~trial~~abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, tosell ~~complete~~and distribute our ~~clinical~~products ~~trials~~for inwhich awe ~~timely~~obtain ~~manner~~marketing approval. ~~Patient~~Restrictions ~~enrollment~~under isapplicable ~~affected~~federal byand ~~several~~state ~~factors,~~healthcare ~~including~~laws and regulations include the following:

● ~~Severity~~The federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the ~~disease~~purchase, order or recommendation of, any good or service, for which payment may be made under ~~investigation~~a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act.

● ~~Design~~The offederal false claims and civil monetary penalties laws, including the ~~trial~~civil ~~protocol~~False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government.

● ~~Size~~The federal HIPPA prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the ~~patient~~statute ~~population~~or specific intent to violate it in order to have committed a violation.

● ~~Eligibility~~HIPAA ~~criteria~~and ~~for~~its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the ~~trial~~privacy, insecurity ~~question~~and transmission of individually identifiable health information.

~~● Perceived risks and benefits of the product candidate being tested.~~ 52

● Table ~~Willingness or availability~~ of ~~patients to participate in our clinical trials (including due to the COVID-19 pandemic).~~Contents

● ~~Proximity~~The ~~and~~federal ~~availability~~Physician Payments Sunshine Act requires applicable manufacturers of ~~clinical~~covered ~~trial~~drugs, ~~sites~~devices, biologics and medical supplies for ~~prospective~~which ~~patients~~payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value to physicians, as defined by such law, certain other healthcare providers starting in 2022 and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members. The information reported is publicly available on a searchable website, with disclosure required annually.

● ~~Our~~Analogous ~~ability~~state toand ~~recruit~~foreign ~~clinical~~laws ~~trial~~and ~~investigators~~regulations, ~~with~~such ~~appropriate~~as ~~competencies~~state anti-kickback and ~~experience~~false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.

●Some ~~Availability~~state oflaws ~~competing~~require ~~vaccines~~biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and~~/or~~ ~~therapies~~the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related ~~clinical~~to ~~trials~~payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Some state laws require biotechnology companies to report information on the pricing of certain drug products.

●State ~~Efforts~~and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. For instance, the collection and use of health data in the EU is governed by the GDPR, which extends the geographical scope of EU data protection law to ~~facilitate~~non-EU ~~timely~~entities ~~enrollment~~under certain conditions, tightens existing EU data protection principles, creates new obligations for companies and new rights for individuals. Failure to comply with the GDPR may result in ~~clinical~~substantial ~~trials~~fines and other administrative penalties. The GDPR may increase our responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with the GDPR. This may be onerous and if our efforts to comply with GDPR or other applicable EU laws and regulations are not successful, it could adversely affect our business in the EU. Moreover, the United Kingdom leaving the EU has created uncertainty with regard to data protection regulation in the United Kingdom. The European Commission has adopted an Adequacy Decision concerning the level of data protection in the UK. Personal data may now flow freely from the EEA to the UK, however, the European Commission may suspend the Adequacy Decision if it considers that the UK no longer provides for an adequate level of data protection. In California, the CCPA creates individual privacy rights for consumers and increases the privacy and security obligations of entities handling certain personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability, and similar laws have been proposed at the federal level and in other states.

●Efforts ~~Our~~to ~~ability~~ensure that our current and future business arrangements with third parties will comply with applicable healthcare laws and regulations will involve on-going substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to ~~obtain~~be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant penalties, including civil, criminal and ~~maintain~~administrative ~~patient~~penalties, ~~consents~~damages, fines, disgorgement, individual imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of our operations.

●Defending ~~Patient~~against ~~referral~~any ~~practices~~such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be materially impacted. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business is found to not be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

~~● Ability to monitor patients adequately during and after treatment.~~ 53

We Table ~~may not be able to initiate or continue clinical trials if we cannot enroll a sufficient number~~ of ~~eligible patients to participate in the clinical trials required by regulatory agencies.~~Contents

~~Even~~Risks ifRelated ~~we enroll a sufficient number of eligible patients~~ to ~~initiate~~Intellectual our clinical trials, we may be unable to maintain participation of these patients throughout the course of the clinical trial as required by the clinical trial protocol, in which event we may be unable to use the research results from those patients. Property

IfPatents ~~we have difficulty enrolling~~ and ~~maintaining~~patent ~~the~~applications ~~enrollment~~involve ofhighly acomplex ~~sufficient~~legal ~~number~~and offactual ~~patients~~questions, ~~to conduct our clinical trials as planned~~which, weif ~~may~~determined ~~need~~adversely to ~~delay~~us, ~~limit~~could ornegatively ~~terminate~~impact ~~ongoing or planned clinical trials, any of which would have an adverse effect on~~ our business position.

~~Our~~The ~~product~~patent ~~candidates~~positions of biopharmaceutical and biotechnology companies and other actors in our fields of business can be highly uncertain and typically involve complex scientific, legal and factual analyses. In particular, the interpretation and breadth of claims allowed in some patents covering biopharmaceutical compositions may ~~cause~~be ~~undesirable~~uncertain ~~side~~and ~~effects~~difficult orto ~~have~~determine and ~~other~~are ~~properties~~often affected materially by the facts and circumstances that ~~delay~~pertain orto ~~prevent~~the ~~their~~patented ~~regulatory~~compositions ~~approval~~and orthe ~~limit~~related ~~their~~patent ~~commercial~~claims. ~~potential~~The standards of the USPTO and its foreign counterparts are sometimes uncertain and could change in the future.

~~Significant~~Consequently, ~~adverse~~the ~~events~~issuance ~~caused~~and byscope ~~our~~of ~~product~~patents ~~candidates~~cannot orbe ~~even~~predicted ~~competing~~with ~~products~~certainty. inPatents, ~~development~~if ~~that~~issued, ~~utilize~~may abe ~~common~~challenged, ~~mechanism~~invalidated ofor ~~action~~designed ~~could~~around. ~~cause~~U.S. ~~us,~~patents anand ~~IRB~~patent orapplications ~~ethics~~may ~~committee,~~also ~~and/or~~be ~~regulatory~~subject ~~authorities~~ to ~~interrupt,~~interference ~~delay~~ or ~~halt~~derivation ~~clinical~~proceedings, ~~trials~~ and ~~could~~U.S. ~~result~~patents inmay ~~clinical~~be ~~trial~~subject ~~challenges~~to ~~such~~reexamination, aspost-grant ~~difficulties~~review inand/ ~~patient~~or ~~recruitment,~~inter ~~retention,~~parties ~~and~~review proceedings in the USPTO.

53International patents may also be subject to opposition or comparable proceedings in the corresponding international patent office, which could result in either loss of the patent or denial of the patent application, or loss or reduction in the scope of one or more of the claims of the patent or patent application. In addition, such interference, derivation, reexamination, post-grant review, inter parties review and opposition proceedings may be costly. Accordingly, rights under any issued patents may not provide us with sufficient protection against competitive products or processes.

~~Table~~Furthermore, even if not challenged, our patents and patent applications may not adequately protect our technology and any product candidates or products that we develop alone or with collaborators or prevent others from designing their products to avoid being covered by our claims. If the breadth or strength of ~~Contents~~protection provided by the patents and patent applications that we hold with respect to our product candidates or potential products is threatened, it could dissuade companies from collaborating with us to develop and could threaten our or their ability to successfully commercialize, such product candidates or potential products.

~~adherence~~In addition, ~~the~~changes ~~denial~~in, or different interpretations of, ~~regulatory~~patent ~~approval~~laws byin the ~~FDA~~U.S. orand other ~~regulatory~~countries ~~authorities~~may ~~and~~permit ~~potential~~others ~~product~~to ~~liability~~use ~~claims.~~our ~~Serious~~discoveries ~~adverse~~or ~~events deemed~~ to bedevelop ~~caused~~and bycommercialize our technology and product candidates ~~could~~or ~~have~~products awithout ~~material~~providing ~~adverse~~any ~~effect~~compensation onto us or may limit the ~~development~~scope of ~~our~~patent ~~product~~protection ~~candidates~~that ~~and~~we ~~our~~are ~~business~~able to obtain. The laws of some countries do not protect intellectual property rights to the same extent as a

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