As filed with the Securities and Exchange Commission on ~~July 24~~September 19, ~~2024~~2025.

Registration No. 333-~~_________~~

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

~~WASHINGTON~~Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER ~~THE SECURITIES ACT OF 1933~~

THE SECURITIES ACT OF 1933

SOLIGENIX, INC.

(Exact ~~name~~Name of ~~registrant~~Registrant as ~~specified~~Specified in ~~its~~Its ~~charter~~Charter)

Delaware		2834		41-1505029
(State or Other Jurisdiction of Incorporation or Organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

Delaware		2834		41-1505029
(State or other jurisdiction ofincorporation or organization)		(Primary Standard IndustrialClassification Code Number)		(I.R.S. EmployerIdentification No.)

Soligenix, Inc.

29 Emmons Drive, Suite B-10

Princeton, New Jersey 08540

(609) 538-8200

(Address, ~~including~~Including ~~zip~~Zip ~~code~~Code, and ~~telephone~~Telephone ~~number~~Number, ~~including~~Including ~~area~~Area ~~code~~Code, of Registrant’s Principal Executive Offices)

of registrant’s principal executive offices)

Christopher J. Schaber, Ph.D.

President and Chief Executive Officer

Soligenix, Inc.

29 Emmons Drive, Suite B-10

Princeton, New Jersey 08540

(609) 538-8200

(Name, ~~address~~Address, ~~including~~Including ~~zip~~Zip ~~code~~Code, and ~~telephone~~Telephone ~~number~~Number, Including Area Code, of Agent For Service)

~~including~~Copies ~~area code, of agent for service)~~to:

~~with copies to:~~

Driscoll R. Ugarte, Esq.Duane Morris LLPBoca Center Tower II5100 Town Center Circle, Suite 400Boca Raton, FL 33486-1008(561) 962-2100 Ron Ben-Bassat, Esq.Eric Victorson, Esq.Sullivan & Worcester LLP1251 Avenue of the AmericasNew York, NY 10020(212) 660-3000

~~Duane Morris LLP~~

~~5100~~Approximate ~~Town~~date ~~Center~~of ~~Circle,~~commencement ~~Suite 400~~of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

Boca Raton, Florida 33486

(561) 962-2100

Approximate date of commencement of proposed sale to the public: From time to time, at the discretion of the selling stockholders, after the effective date of this registration statement.

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

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 7(a)(2)(B) of the Securities Act. ☐

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

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The information in this preliminary prospectus is not complete and may be changed. The selling stockholders shall not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

Preliminary Prospectus Subject to Completion, Dated ~~July~~September 2419, ~~2024~~2025

Up to 12,~~054~~909,~~688~~090 Shares of Common Stock

~~Issuable~~Up ~~Upon~~to ~~the~~2,909,090 ~~Exercise~~Pre-Funded ofWarrants ~~Previously~~to ~~Issued~~Purchase up to 2,909,090 Shares of Common ~~Warrants~~Stock

~~This~~Up ~~prospectus relates~~ to ~~the resale from time to time by certain selling stockholders named herein (the “Selling Stockholders”) of up to 1~~2,~~054~~909,~~688~~090 ~~shares of common stock par value $0.001 per share (“~~Common ~~Stock”) of Soligenix, Inc. (the “Company,” “us” or “we”), issuable upon exercise of~~ Warrants to Purchase ~~Shares~~up ~~of Common Stock (the “July 2024 Warrants”). The July 2024 Warrants were issued pursuant~~ to ~~that certain Warrant Inducement Agreement dated as of July 9~~2, ~~2024~~909,090 byShares ~~and among the Company and the Selling Stockholders (the “Warrant Inducement Agreement”). The July 2024 Warrants entitle holders to purchase shares~~ of ~~our~~ Common Stock at an exercise price of $6.00 per share for a period of five years from issuance. Such shares of Common Stock underlying the July 2024 Warrants are collectively referred to herein as the “Resale Shares.” We are registering the Resale Shares on behalf of the Selling Stockholders, to be offered and sold from time to time, to satisfy certain registration rights that we have granted to the Selling Stockholders pursuant to the Warrant Inducement Agreement.

~~The~~Up ~~Selling Stockholders may resell or dispose of the Resale Shares~~ to ~~or through underwriters~~2, ~~broker-dealers~~909,090 ~~agents,~~shares ~~or through any other means described in the section~~ of ~~this~~Common ~~prospectus~~Stock ~~entitled~~Underlying ~~“Plan of Distribution.” The Selling Stockholders will bear~~ the ~~commissions~~Pre-Funded and discounts, if any, attributable to the sale or disposition of the Resale Shares. We will bear all costs, expenses and fees in connection with the registration of the Resale Shares. We will not receive any of the proceeds from the sale of the Resale Shares by the Selling Stockholders.Warrants

~~Our~~Up ~~Common~~to ~~Stock is listed on the Nasdaq Capital Market under the symbol “SNGX.” On July 19~~2, ~~2024~~909,090 ~~the~~shares ~~last reported sale price~~ of ~~our~~ Common Stock onUnderlying the ~~Nasdaq~~Common ~~Capital Market was $6.07 per share.~~Warrants

~~Investing~~We inare offering up to $8.0 million of shares of common stock together with common warrants to purchase up to 2,909,090 shares of common stock. Each share of our ~~securities~~common ~~involves~~stock, or pre-funded warrant in lieu thereof, is being sold together with a ~~high~~common ~~degree~~warrant to purchase 1.0 share of ~~risk~~our common stock. ~~You~~The ~~should~~shares ~~review~~of ~~carefully~~common ~~the~~stock ~~risks~~and common warrants are immediately separable and ~~uncertainties~~will ~~described~~be ~~under~~issued ~~the~~separately ~~heading~~in ~~“Risk~~this ~~Factors”~~offering, ~~beginning~~but onmust ~~page 7~~be ofpurchased together in this ~~prospectus~~offering.

~~Neither~~We ~~the~~have ~~Securities~~assumed ~~and~~a ~~Exchange~~public ~~Commission~~offering ~~nor~~price ~~any~~of ~~state~~$2.75 ~~securities~~per ~~commission~~share, ~~has~~the ~~approved~~last orreported ~~disapproved~~sale price of ~~these~~our ~~securities~~common orstock ~~determined~~on ifThe ~~this~~Nasdaq ~~prospectus~~Capital isMarket ~~truthful~~on orSeptember 15, ~~complete~~2025. ~~Any~~The ~~representation~~common warrants will have an assumed initial exercise price of $2.75 per share (assuming an exercise price equal to the ~~contrary~~last isreported sale price of our common stock on The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share) and will have a ~~criminal~~five-year ~~offense~~term. The actual public offering price will be determined between us, the Placement Agent (as defined below) and the investors in the offering, and may be at a discount to the current market price of our common stock. Therefore, the assumed public offering price used throughout this prospectus may not be indicative of the final offering price.

~~The~~We ~~date~~are also offering pre-funded warrants to purchase up to 2,909,090 shares of common stock to those purchasers whose purchase of shares of common stock in this ~~prospectus~~offering would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering, in lieu of shares of common stock that would result in beneficial ownership in excess of 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock. Each pre-funded warrant is ~~July 24~~exercisable for one share of our common stock and has an exercise price of $0.001 per share. Each pre-funded warrant is being offered together with the common warrants. The pre-funded warrants and common warrants are immediately separable and will be issued separately in this offering, ~~2024~~but must be purchased together in this offering. For each pre-funded warrant that we sell, the number of shares of common stock we are offering will be reduced on a one-for-one basis.

Pursuant to this prospectus, we are also offering the shares of common stock issuable upon the exercise of pre-funded warrants and common warrants offered hereby. These securities are being sold in this offering to certain purchasers under a securities purchase agreement dated , 2025 between us and such purchasers.

We have engaged A.G.P./Alliance Global Partners to act as our sole placement agent (the “Placement Agent” or “A.G.P.”) in connection with this offering. We have engaged the Placement Agent in connection with the securities offered by this prospectus. The Placement Agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of securities but has agreed to use its best efforts to sell the securities offered by this prospectus. We have agreed to pay the Placement Agent a fee based upon the aggregate gross proceeds raised in this offering as set forth in the table below.

The shares of our common stock, pre-funded warrants or common warrants being offered will be sold in a single closing. The shares issuable upon exercise of the pre-funded warrants or common warrants will be issued upon the exercise thereof. Because there is no minimum number of securities or minimum aggregate amount of proceeds for this offering to close, we may sell fewer than all of the securities offered hereby, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue the business goals outlined in this prospectus. Because there is no escrow account and there is no minimum offering amount, investors could be in a position where they have invested in our company, but we are unable to fulfill our objectives due to a lack of interest in this offering. Also, any proceeds from the sale of securities offered by us will be available for our immediate use, despite uncertainty about whether we would be able to use such funds to effectively implement our business plan. The offering of the shares of our common stock, pre-funded warrants or common warrants will terminate no later than October 28, 2025; however, the shares of our common stock underlying the pre-funded warrants and the common warrants will be offered on a continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”).

Our common stock is listed on The Nasdaq Capital Market under the symbol “SNGX.” The last reported sale price of our common stock on The Nasdaq Capital Market on September 15, 2025 was $2.75 per share. We do not intend to list the pre-funded warrants or the common warrants on any national securities exchange or other nationally recognized trading system.

An investment in our securities involves significant risks. You should carefully consider the risk factors beginning on page 8 of this prospectus before you make your decision to invest in our securities.

Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

	Per Share	Per Pre-Funded
	and	Warrant and
	Common	Accompanying
	Warrant	Common Warrant	Total
Public offering price	$	$	$
Placement Agent fees⁽¹⁾	$	$	$
Proceeds to us, before expenses⁽²⁾	$	$	$

(1)

We have agreed to pay the Placement Agent a cash placement commission equal to 6.5% of the aggregate proceeds from the sale of the shares of common stock, common warrants and pre-funded warrants sold in this offering; provided, however, in the case of certain identified investors, the Placement Agent fee will be 3.0% of the aggregate proceeds in this offering and in the case of aggregate proceeds received, if any, from our directors and officers, we will not pay any Placement Agent fee. Does not include certain expenses of the Placement Agent. See “Plan of Distribution” beginning on page 105 of this prospectus for additional information regarding compensation to be received by the Placement Agent.

(2)

The amount of proceeds, before expenses, to us does not give effect to any exercise of the pre-funded warrants or common warrants. Delivery of the shares of our common stock, pre-funded warrants or common warrants is expected to be made on or about , 2025.

Sole Placement Agent

A.G.P.

The date of this prospectus is , 2025.

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~~Table~~TABLE ofOF ~~Contents~~CONTENTS


	Page
PROSPECTUS SUMMARY	1
RISK FACTORS	8
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA AND MARKET INFORMATION	40
USE OF PROCEEDS	42
DIVIDEND POLICY	43
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS	43
CAPITALIZATION	45
DILUTION	47
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	49
BUSINESS	58
MANAGEMENT	85
EXECUTIVE COMPENSATION	91
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS	96
SECURITY OWNERSHIP OF MANAGEMENT AND OTHER BENEFICIAL OWNERS	97
DESCRIPTION OF CAPITAL STOCK	98
DESCRIPTION OF SECURITIES WE ARE OFFERING	102
PLAN OF DISTRIBUTION	105
LEGAL MATTERS	107
EXPERTS	107
WHERE YOU CAN FIND MORE INFORMATION	107
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS	F-1

ABOUT THIS PROSPECTUS		1
PROSPECTUS SUMMARY		2
RISK FACTORS		10
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA AND MARKET INFORMATION		34
USE OF PROCEEDS		36
DIVIDEND POLICY		36
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS		36
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		38
BUSINESS		49
MANAGEMENT		81
EXECUTIVE COMPENSATION		87
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS		92
SECURITY OWNERSHIP OF MANAGEMENT AND OTHER BENEFICIAL OWNERS		93
SELLING STOCKHOLDERS		94
PLAN OF DISTRIBUTION		97
DESCRIPTION OF CAPITAL STOCK		98
LEGAL MATTERS		102
EXPERTS		102
WHERE YOU CAN FIND MORE INFORMATION		103
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS		F-1

Neither we nor the Placement Agent have authorized anyone to give any information or to make any representations other than those contained in this prospectus. You must not rely on any information or representations not contained in this prospectus. This prospectus is an offer to sell only the securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date.

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ABOUT THIS PROSPECTUS

This prospectus is part of a resale registration statement on Form S-1 that we filed with the Securities and Exchange Commission (the “SEC”).

This prospectus includes important information about us, the securities being offered and other information you should know before investing in our securities. You should also read and consider information in the documents we have referred you to in the sections of this prospectus entitled “Where You Can Find More Information.”

You should rely only on the information contained in this prospectus (as supplemented and amended). We have not authorized anyone to provide you with different information. We take no responsibility for, and can provide no assurances as to the reliability of, any other information that others may give you. The information contained in this prospectus (and in any supplement or amendment to this prospectus) are accurate only as of their respective dates, regardless of the time of delivery of this prospectus, any applicable prospectus supplement, or any sale of a security. We urge you to read carefully this prospectus (as supplemented and amended), before deciding whether to invest in any of the Common Stock being offered.

This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the section entitled “Where You Can Find More Information.”

We further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to the registration statement were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

Except as otherwise indicated herein or as the context otherwise requires, references in this prospectus to “Soligenix,” “the Company,” “we,” “us,” “our” and similar references refer to Soligenix, Inc., a corporation organized under the laws of the State of Delaware, and its subsidiaries on a consolidated basis.

We are not making an offer or sale of our Common Stock in any jurisdiction where such offer or sale is not permitted. Neither we nor any of our representatives are making any representation to you regarding the legality of an investment in our Common Stock by you under applicable laws. We urge you to consult with your own advisors as to legal, tax, business, financial and related aspects of an investment in our Common Stock.

This prospectus includes trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included in this prospectus are the property of their respective owners.

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PROSPECTUS SUMMARY

This summary highlights certain information appearing elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our securities. You should read this entire prospectus carefully, including the information presented under the headings “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements and Industry Data and Market Information” in this prospectus and the historical financial statements and the notes thereto included elsewhere in this prospectus. You should pay special attention to the information contained under the caption titled “Risk Factors” in this prospectus, before deciding to buy our securities.

This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before deciding to invest in our securities. You should carefully read this entire prospectus before making an investment decision, including the information presented under the headings “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements and Industry Data and Market Information” in this prospectus and the historical financial statements and the notes thereto included elsewhere in this prospectus. You should pay special attention to the information contained under the caption titled “Risk Factors” in this prospectus, before deciding to buy our securities. In this prospectus, the terms “Soligenix,” “Soligenix, Inc.,” the “Company,” “we,” “our,” “ours” and “us” refer to Soligenix, Inc. and its subsidiaries.

Overview

We are a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. We maintain two active business segments: Specialized BioTherapeutics and Public Health Solutions.

Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy, utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early -stage disease, we ~~are~~began ~~targeting to begin~~ patient enrollment byduring December 2024 for the ~~end~~second ofPhase ~~2024~~3 ~~with~~study called “FLASH2” (Fluorescent Light Activated Synthetic Hypericin 2). We anticipate top-line results ~~anticipated~~ in the second half of 2026. Upon successful completion of the ~~second~~ Phase 3 ~~study, called “~~FLASH2” ~~(Fluorescent Light Activated Synthetic Hypericin 2)~~study, regulatory approval will be sought to support potential commercialization worldwide.

Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, and our first-in-class Innate Defense Regulator ~~(“IDR”)~~ technology, dusquetide ~~(SGX942 and SGX945)~~, for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer (SGX942) and aphthous ulcers in Behçet’s Disease (SGX945).

Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID 19 (caused by SARS-CoV 2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority, and the Defense Threat Reduction Agency.

Recent Developments

On ~~June~~August 2315, ~~2023~~2025, we received anotice ~~letter from~~ (the ~~Listing~~“Notice”) ~~Qualifications~~from ~~Department of~~ The Nasdaq Stock Market LLC (“Nasdaq”) ~~stating~~advising us that we were not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule ~~5450~~5550(ab)(1) requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the “~~Minimum~~Stockholders’ ~~Bid~~Equity ~~Price Rule~~Requirement”). ~~because~~In our ~~Common~~Quarterly ~~Stock~~Report ~~failed~~on toForm 10-Q ~~maintain~~for athe ~~minimum~~quarter ~~closing~~ended ~~bid~~June 30, ~~price~~2025, we reported stockholders’ equity of $1~~.00~~,828,951, which is below the Stockholders’ Equity Requirement for 30continued ~~consecutive~~listing. ~~trading~~This amount did not reflect common stock sales on July ~~days~~1, 2025, which generated total gross proceeds of approximately $1,439,300. Additionally, as of the date of the Notice, we did not meet either of the alternative Nasdaq continued listing standards under the Nasdaq Listing Rules, market value of listed securities of at least $35 million, or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

OnThe ~~December 21,~~Notice ~~2023,~~had weno ~~received~~immediate ~~written~~effect ~~notice~~on ~~from~~the ~~Nasdaq~~listing ~~stating~~of ~~that~~our wecommon ~~had~~stock ~~not complied with the Minimum Bid Price Rule~~ and ~~indicating that~~ our ~~Common~~common ~~Stock~~stock ~~would~~continues beto ~~suspended~~trade ~~from trading~~ on ~~Nasdaq~~The ~~unless we requested a hearing before a hearings panel by December 28, 2023. On March 26, 2024, we had an oral hearing with a~~ Nasdaq ~~Hearings~~Capital ~~Panel~~Market tounder ~~appeal~~ the ~~delisting~~symbol ~~determination~~“SNGX,” ~~which~~subject ~~stayed~~to ~~the trading suspension of~~ our ~~Common~~compliance ~~Stock~~with ~~pending a final written decision by~~ the ~~Nasdaq~~other ~~Hearings~~continued ~~Panel~~listing ~~and expiration of any additional extension period granted by the panel following the hearing~~requirements.

2Pursuant to the Notice, Nasdaq has given us 45 calendar days from the date of the Notice, or until September 29, 2025, to submit to Nasdaq a plan to regain compliance. If our plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Notice to evidence compliance.

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In order to regain compliance with the Shareholders’ Equity Requirement, we are offering the securities in this offering. We ~~effected~~estimate a(based ~~1-for-16~~upon ~~reverse~~assumptions ~~stock~~we ~~split~~believe onare ~~June~~ reasonable) that we will have more than the required $2.5, ~~2024~~million in ~~order~~shareholders’ equity as of the closing date provided we receive net proceeds of at least $3.4 million in this offering. There can be no assurance that we will be able to regain compliance with the ~~Minimum~~Shareholders’ ~~Bid~~Equity ~~Price~~Requirement, ~~Rule.~~or ~~Since~~that ~~the~~our ~~reverse~~common stock ~~split~~will remain listed on The Nasdaq Capital Market. See “Risks Related to this Offering — If we fail to meet Nasdaq’s listing requirements, we could be removed from The Nasdaq Capital Market, which would limit the ~~closing~~ability ~~price~~of ~~for~~broker-dealers to sell our securities and the ~~Common~~ability ~~Stock~~of ~~has~~shareholders ~~been~~to ~~above~~sell $1their securities in the secondary market and negatively impact our ability to raise capital.00” ~~per~~on ~~share~~page 34 of this prospectus.

OnCorporate July 24, 2024, we received a letter from the Nasdaq confirming that we had regained compliance with the Minimum Bid Price Rule. Accordingly, the Nasdaq Hearings Panel determined to continue the listing of our Common Stock and closed the matter.Information

AsWe ~~of July 19, 2024, there~~ were ~~2,280,108~~incorporated ~~shares~~in ofDelaware ~~Common~~in ~~Stock~~1987 ~~issued~~under ~~and outstanding. Of~~ the ~~outstanding~~name ~~shares,~~Biological 2Therapeutics,~~279,440~~ Inc. ~~shares~~In ~~of Common Stock were held by non-affiliates of the Company (assuming~~1987, ~~for~~we ~~this~~merged ~~purpose,~~with ~~that~~Biological ~~executive officers~~Therapeutics, ~~directors and holders of 10% or more of the Common Stock are affiliates). The closing price for the Common Stock on July~~ ~~19, 2024 was $6~~Inc.~~07 per share; consequently~~, ~~the~~a ~~market~~North ~~value~~Dakota ~~for our total listed securities and publicly held shares was $13~~corporation,~~840,256~~ ~~and~~pursuant ~~$13,836,201,~~to ~~respectively.~~which ~~As of March 31, 2024,~~ we ~~had~~changed ~~cash~~our ~~and~~name ~~cash~~to ~~equivalents of $7~~“Immunotherapeutics,~~091,548, working capital of $607,499 and total liabilities of $7,290,013, of which over 41~~ Inc.1%” ~~was~~We ~~owed~~changed ~~under~~ our ~~convertible~~name ~~debt~~to ~~facility~~“Endorex Corp.” Inin ~~the near term~~1996, ~~we will need~~ to ~~obtain~~“Endorex ~~significant~~Corporation” ~~capital~~in ~~through~~1998, ~~public~~to or“DOR ~~private equity offerings~~BioPharma, Inc.” ~~debt~~in ~~financings~~2001, ~~collaborations~~ and ~~licensing~~finally ~~arrangements or other sources~~ to ~~continue to fund our operations~~“Soligenix, Inc.” ~~However, there can be no assurance that we will be able to obtain such funding on terms acceptable to us, on a timely basis or at all, particularly~~ in ~~light of our current stock price and liquidity~~2009.

Our principal executive offices are located at 29 Emmons Drive, Suite B-10, Princeton, New Jersey 08540 and our telephone number is (609) 538-8200. Our corporate website address is www.soligenix.com. Our website and the information contained on, or that can be accessed through, our website will not be deemed to be incorporated by reference in, and are not considered part of, this prospectus. You should not rely on our website or any such information in making your decision whether to purchase our securities.

We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our common stock held by non-affiliates exceeds $250 million as of the prior June 30, or (2) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our common stock held by non-affiliates exceeds $700 million as of the prior June 30.

Our Product Candidates in Development

The following tables summarize our product candidates under development:

Specialized BioTherapeutics Product Candidates


Soligenix Product Candidate	Therapeutic Indication	Stage of Development

HyBryte™	Cutaneous T-Cell Lymphoma	Phase 2 trial completed; demonstrated significantly higher response rate compared to placebo; Phase 3 trial completed; demonstrated statistical significance in primary endpoint in March 2020 (Cycle 1) and demonstrated continued improvement in treatment response with extended treatment in April 2020 (Cycle 2) and October 2020 (Cycle 3); new drug application (“NDA”) submitted to FDA December 2022; FDA refusal to file letter received February 2023; second Phase 3 trial based upon EMA-accepted protocol began patient enrollment in December 2024 with top-line results anticipated in the second half of 2026; discussions continue with FDA on modifying the development path to adequately address FDA’s preference for a longer duration comparative study over a placebo-controlled trial

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Soligenix Product Candidate	Therapeutic Indication	Stage of Development

SGX302	Mild-to-Moderate Psoriasis	Positive proof-of-concept demonstrated in a small Phase 1/2 pilot study; Phase 2a protocol and Investigation New Drug (“IND”) clearance received from the FDA; Phase 2a study remains ongoing having demonstrated biological effect in Cohort 1 and clinically meaningful benefit in Cohort 2
SGX942†	Oral Mucositis in Head and Neck Cancer	Phase 2 trial completed; demonstrated significant response compared to placebo with positive long-term (12 month) safety also reported; Phase 3 clinical trial results announced December 2020: the primary endpoint of median duration of severe oral mucositis (“SOM”) did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group; analyzed full dataset from Phase 3 study and designing a second Phase 3 clinical trial; continued development contingent upon identification of partnership
SGX945	Aphthous Ulcers in Behçet’s Disease	Phase 2a protocol and Investigational New Drug clearance received from the FDA; Phase 2a study complete; biological efficacy and safety demonstrated

Public Health Solutions†
Soligenix Product
Candidate	Indication	Stage of Development
ThermoVax^®	Thermostability of vaccines for Ricin toxin, Ebola, and Marburg viruses	Pre-clinical
RiVax^®	Vaccine against Ricin Toxin Poisoning	Phase 1a, 1b, and 1c trials completed, safety and neutralizing antibodies for protection demonstrated
SGX943	Therapeutic against Emerging Infectious Diseases	Pre-clinical

†	Contingent upon continued government contract/grant funding or other funding source.

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~~Specialized~~The BioTherapeutics Product Candidates*Offering

Soligenix Product Candidate	Therapeutic Indication	Stage of Development
HyBryte™	Cutaneous T-Cell Lymphoma	Phase 2 trial completed; demonstrated significantly higher response rate compared to placebo; Phase 3 trial completed; demonstrated statistical significance in primary endpoint in March 2020 (Cycle 1) and demonstrated continued improvement in treatment response with extended treatment in April 2020 (Cycle 2) and October 2020 (Cycle 3); New drug application (“NDA”) submitted to the U.S. Food and Drug Administration (“FDA”) December 2022; FDA refusal to file letter received February 2023; second Phase 3 trial based upon EMA-accepted protocol targeted to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026; discussions continue with FDA on modifying the development path to adequately address FDA’s preference for a longer duration comparative study over a placebo-controlled trial

SGX302	Mild-to-Moderate Psoriasis	Positive proof-of-concept demonstrated in a small Phase 1/2 pilot study; Phase 2a protocol and Investigation New Drug (“IND”) clearance received from the FDA; Phase 2a study remains ongoing having demonstrated biological effect in Cohort 1 and clinically meaningful benefit in Cohort 2

SGX942†	Oral Mucositis in Head and NeckCancer	Phase 2 trial completed; demonstrated significant response compared to placebo with positive long-term (12 month) safety also reported; Phase 3 clinical trial results announced December 2020: the primary endpoint of median duration of severe oral mucositis (“SOM”) did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group; analyzed full dataset from Phase 3 study and designing a second Phase 3 clinical trial; continued development contingent upon identification of partnership


Securities we are offering		2,909,090 shares of common stock and common warrants to purchase an aggregate of 2,909,090 shares of our common stock, or pre-funded warrants to purchase 2,909,090 shares of common stock and common warrants to purchase 2,909,090 shares of common stock. The shares of common stock or pre-funded warrants, respectively, and common warrants are immediately separable and will be issued separately in this offering, but must initially be purchased together in this offering. Each common warrant has an assumed exercise price of $2.75 per share (assuming an exercise price equal to the last reported sale price of our common stock on The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share) and will have a five-year term. We are also registering 5,818,180 shares of our common stock issuable upon exercise of the common warrants and pre-funded warrants.
Pre-funded warrants we are offering		We are also offering to those purchasers whose purchase of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the closing of this offering, in lieu of purchasing common stock, pre-funded warrants to purchase up to an aggregate of 2,909,090 shares of our common stock. Each pre-funded warrant is exercisable for one share of our common stock. The purchase price of each pre- funded warrant is equal to the price at which a share of common stock is being sold to the public in this offering, minus $0.001, and the exercise price of each pre-funded warrant is $0.001 per share. The pre-funded warrants are exercisable immediately and may be exercised at any time until all of the pre-funded warrants are exercised in full. This offering also relates to the shares of common stock issuable upon exercise of any pre-funded warrants sold in this offering. For each pre-funded warrant that we sell, the number of shares of common stock that we are offering will be reduced on a one- for-one basis.
Common stock outstanding immediately before this offering		4,285,570 shares
Common stock outstanding immediately after this offering		7,194,660 shares, assuming no exercise of the common warrants issued in this offering.
Use of proceeds		We estimate that the net proceeds from this offering will be approximately $7.3 million, at an assumed public offering price of $2.75 per share (assuming a public offering price equal to the last sale price of our common stock as reported by The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share), after deducting the Placement Agent fee and estimated offering expenses payable by us. We intend to use the net proceeds from the sale of the securities offered by us pursuant to this prospectus to fund our research and development and commercialization activities, and for general corporate and working capital purposes, which may include, among other things, working capital, product development and/or commercialization, acquisitions, capital expenditures, repayment

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	of debt and other business opportunities. See the section titled “Use of Proceeds” on page 42 of this prospectus.
SGX945	Aphthous Ulcers in Behçet’s Disease	Phase 2a protocol and IND clearance received from the FDA; Phase 2a study to be initiated in the second half of 2024
Amendment to certain outstanding warrants	In connection with the offering pursuant to this prospectus, we may amend the terms of up to 1,467,581 issued and outstanding warrants to reduce the exercise price of such warrants to: (i) equal the exercise price of the common warrants sold in this offering; and (ii) extend the term during which the such warrants could remain exercisable to the term of the common warrants sold in this offering.
Risk Factors	See “Risk Factors” and other information appearing elsewhere in this prospectus for a discussion of factors you should carefully consider before deciding whether to invest in our securities.
Lock-up	We have agreed, subject to certain exceptions and without the approval of the Placement Agent and purchasers of our securities in this offering, not to (1) issue, enter into any agreement to issue or announce the issuance or proposed issuance of, any shares of common stock (or securities convertible into or exercisable for common stock) or file any registration statement, including any amendments or supplements for a period of 30 days following the closing of the offering of the shares and (2) enter into a variable rate transaction for a period of one year following the closing of this offering, other than the issuance of shares of our common stock in an “at the market” offering, including pursuant to that certain At Market Issuance Sales Agreement by and among the Company and the Placement Agent dated August 16, 2024, following 30 days from the closing of this offering. See “Plan of Distribution” for more information.
The Nasdaq Capital Market listing symbol	“SNGX.” There is no established trading market for the pre-funded warrants or the common warrants and we do not expect a market to develop. In addition, we do not intend to apply for the listing of the pre-funded warrants or the common warrants on any national securities exchange or other trading market. Without an active trading market, the liquidity of the pre-funded warrants and common warrants will be limited.

~~Public~~The ~~Health~~number ~~Solutions†~~of shares of common stock to be outstanding after this offering is based on 4,285,570 shares of common stock outstanding on September 15, 2025, does not give effect to the shares of common stock issuable upon exercise of the pre-funded warrants and common warrants issued in this offering and excludes:

Soligenix Product Candidate	Indication	Stage of Development
ThermoVax®	Thermostability of vaccines for Ricin toxin, Ebola, and Marburg viruses	Pre-clinical
RiVax®	Vaccine against Ricin Toxin Poisoning	Phase 1a, 1b, and 1c trials completed, safety and neutralizing antibodies for protection demonstrated
SGX943	Therapeutic against EmergingInfectious Diseases	Pre-clinical

●

1,467,581 shares of common stock issuable upon the exercise of outstanding warrants at a weighted average price of $11.01 per share, of which warrants to purchase 1,467,581 shares are exercisable as of September 15, 2025;

~~†Contingent~~● 300,467 shares of common stock issuable upon ~~continued~~the ~~government~~exercise ~~contract/grant~~of ~~funding~~outstanding oroptions ~~other~~at ~~funding~~a ~~source~~weighted average exercise price of $16.70 per share, of which options to purchase 112,332 shares of common stock are vested as of September 15, 2025; and

●

5,929,412 shares of common stock available for future issuance under our 2025 Equity Incentive Plan as of September 15, 2025.

Unless otherwise indicated, all information in this prospectus gives effect to the one-for-sixteen reverse stock split effectuated on June 5, 2024.

We were incorporated in Delaware in 1987 under the name Biological Therapeutics, Inc. In 1987, we merged with Biological Therapeutics, Inc., a North Dakota corporation, pursuant to which we changed our name to “Immunotherapeutics, Inc.” We changed our name to “Endorex Corp.” in 1996, to “Endorex Corporation” in 1998, to “DOR BioPharma, Inc.” in 2001, and finally to “Soligenix, Inc.” in 2009.

We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our Common Stock held by non-affiliates exceeds $250 million as of the prior June 30, or (2) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our Common Stock held by non-affiliates exceeds $700 million as of the prior June 30.

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THE OFFERING

Shares of Common Stock Offered By the Selling Stockholders:		Up to 1,054,688 Resale Shares

Common Stock outstanding prior to this offering:		2,280,108 shares of Common Stock

Terms of the offering:		The Selling Stockholders will determine when and how they will dispose of any Resale Shares.

Use of proceeds:		We will not receive any proceeds from the sale of the Resale Shares by the Selling Stockholders.

Risk factors:		Investing in our Common Stock involves significant risks. Before deciding whether to invest in our Common Stock, please read the information contained in this prospectus, including under the heading “Risk Factors” on page 7 of this prospectus.

Nasdaq Capital Market Symbol:		“SNGX”

Unless otherwise indicated, the number of shares of Common Stock to be outstanding after this offering is based on 2,280,108 shares of Common Stock outstanding as of July 19, 2024. The number of shares of Common Stock outstanding after this offering excludes:

● 1,054,688 shares of Common Stock issuable upon the exercise of outstanding July 2024 Warrants at a weighted average price of $6.00 per share, of which warrants to purchase 1,054,688 shares are exercisable as of July 19, 2024;

● 4,566 shares of Common Stock issuable upon the exercise of outstanding warrants (other than the July 2024 Warrants) at a weighted average price of $6.40 per share, of which warrants to purchase 4,566 shares are exercisable as of July 19, 2024;

● 56,699 shares of Common Stock issuable upon the exercise of outstanding options at a weighted average exercise price of $84.65 per share, of which options to purchase 23,959 shares of Common Stock are vested as of July 19, 2024;

● 5,051,513 shares of Common Stock available for future issuance under our 2015 Equity Incentive Plan as of July 19, 2024; and

● shares issuable upon the conversion of $2,059,309 of principal and $9,080 of accrued interest as of July 19, 2024 under convertible promissory notes, which may be converted at $27.20 per share.

Unless otherwise indicated, all information in this prospectus gives effect to the 1-for-16 reverse stock split effectuated on June 5, 2024.

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Summary of Risk Factors

Our business is subject to a number of risks and uncertainties that you should understand before making an investment decision. These risks include, but are not limited to, the following:

Risks Related to our Business

● We have ~~had~~incurred significant losses ~~and~~since ~~anticipate~~inception ~~future~~and ~~losses;~~expect ifto ~~additional~~continue ~~funding~~to ~~cannot~~incur belosses ~~obtained,~~for wethe ~~may~~foreseeable ~~reduce~~future, orwhich ~~discontinue~~together with our ~~product~~negative ~~development~~cash flows and ~~commercialization~~auditor’s ~~efforts~~going orconcern ~~not~~opinion beraise ~~able~~substantial doubt about our ability to ~~repay~~continue ~~certain~~as ~~convertible~~a ~~notes~~going concern without obtaining additional capital.

● ~~Our~~We ~~losses~~expect ~~from~~a ~~operations,~~number ~~negative~~of ~~cash~~factors ~~flows,~~to ~~and~~cause ~~shareholders’~~our ~~equity~~operating ofresults ~~approximately~~to ~~$768,000~~fluctuate ason ofa ~~March~~quarterly ~~31,~~and ~~2024~~annual ~~raise~~basis, ~~substantial~~which ~~doubt~~may ~~about~~make ~~our~~it ~~ability~~difficult to ~~continue~~predict asour afuture ~~going concern absent obtaining adequate new debt or equity financings~~performance.

● The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2023 contains an explanatory paragraph relating to our ability to continue as a going concern.

● If we are unable to develop our product candidates, our ability to generate revenues and viability as a company will be significantly impaired.

●

We have no approved products on the market and therefore do not expect to generate any revenues from product sales in the foreseeable future, if at all.

● Our ~~business~~biodefense isprograms ~~subject~~depend toheavily ~~extensive~~on ~~governmental~~uncertain ~~regulation,~~government ~~which~~funding ~~can~~and beface ~~costly~~unique regulatory, ~~time~~operational, ~~consuming~~ and ~~subjects~~market ~~us to unanticipated delays~~challenges.

● ~~There~~We ~~may~~rely beon ~~unforeseen~~third ~~challenges~~parties infor ~~developing~~the supply and manufacturing of our product candidates and for preclinical and clinical development, ~~including~~regulatory insupport, ~~the~~and ~~area~~strategic ofexecution, ~~biodefense~~and any delays, failures, or performance issues could adversely affect our development and commercialization efforts.

● WeEven ~~are~~if ~~dependent~~our onproduct ~~government~~candidates ~~funding~~are approved, ~~which~~they iswill ~~inherently~~be ~~uncertain,~~subject ~~for~~to ~~the~~extensive ~~success~~post-approval ofregulation ~~our~~and ~~public~~may ~~health~~not ~~business~~achieve ~~segment~~market ~~operations~~acceptance or commercial viability.

● The terms of our loan and security agreement with Pontifax Medison Finance require, and any future debt financing may require, us to meet certain operating covenants and place restrictions on our operating and financial flexibility.

● If the parties we depend on for supplying our drug substance raw materials and certain manufacturing-related services do not timely supply these products and services, it may delay or impair our ability to develop, manufacture and market our products.

● If we are not able to maintain or secure agreements with third parties for pre-clinical and clinical trials of our product candidates on acceptable terms, if these third parties do not perform their services as required, or if these third parties fail to timely transfer any regulatory information held by them to us, we may not be able to obtain regulatory approval for, or commercialize, our product candidates.

● The manufacturing of our products is a highly exacting process, and if we or one of our materials suppliers encounter problems manufacturing our products, our business could suffer.

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● We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

● Even if approved, our products will be subject to extensive post-approval regulation.

● Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market.

●

We do not have extensive sales and marketing experience and our lack of experience may restrict our success in commercializing some of our product candidates.

● Our products, if approved, may not be commercially viable due to change in health care practice and third party reimbursement limitations.

●

Our product candidates may cause serious adverse events or undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.

● If we fail to obtain or maintain orphan drug designation or exclusivity for our product candidates, our ~~competitors~~competitive ~~may~~position ~~sell products to treat the same conditions~~ and ~~our~~ revenue ~~will~~potential could be ~~reduced~~adversely affected.

● ~~Federal~~We ~~and/~~may not be able to retain rights licensed to us by third parties to commercialize key products or ~~state~~to ~~health~~develop ~~care~~the ~~reform~~third-party ~~initiatives~~relationships ~~could~~we ~~negatively~~need ~~affect~~to develop, manufacture and market our ~~business~~products.

● We may not be able to retain rights licensed to us by third parties to commercialize key products or to develop the third party relationships we need to develop, manufacture and market our products.

●

We may suffer product and other liability claims; we maintain only limited product liability insurance, which may not be sufficient.

● We may use hazardous chemicals in our business. Potential claims relating to improper handling, storage or disposal of these chemicals could affect us and be time consuming and costly.

●

We may not be able to compete with our larger and better-financed competitors in the biotechnology industry.

● Competition and technological change may make our product candidates and technologies less attractive or obsolete.

●

Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run our business.

● ~~Instability~~Changes ~~and~~in ~~volatility~~United inStates ~~the~~(“U.S.”) ~~financial~~and ~~markets~~international ~~could~~trade ~~have~~policies amay ~~negative~~adversely impact on our business, ~~financial condition, results of operations,~~ and ~~cash~~operating ~~flows~~results.

●

Adverse developments affecting financial institutions such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity.

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● We may not be able to utilize all of our net operating loss carryforwards.

● Global pathogens could have an impact on financial markets, materials sourcing, patients, governments and population (e.g. COVID-19).

Risks Related to our Intellectual Property

● WeIf ~~may be unable to commercialize our products if~~ we are unable to adequately protect or enforce our ~~proprietary~~intellectual property rights, ~~and~~or if we ~~may~~infringe bethe ~~liable~~rights ~~for~~of ~~significant~~others, ~~costs~~our ~~and~~ability ~~damages~~to ifcommercialize weour ~~face~~products acould ~~claim~~be ofimpaired, ~~intellectual~~and ~~property~~we ~~infringement~~may byface asignificant ~~third~~costs ~~party~~and legal exposure.

~~● We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.~~6

●Table ~~If we infringe the rights~~ of ~~third parties we could be prevented from selling products, forced to pay damages, and defend against litigation.~~Contents

Risks Related to Technology and ~~Intellectual Property~~Cybersecurity

●

Our strategy includes an increasing dependence on technology in our operations. If any of our key technology fails, our business could be adversely affected.

●

A cybersecurity incident could negatively impact our business and our relationships with our employees, service providers, patients, clinical study sites and government agencies.

Risks Related to Marketing Approval and Other Legal Compliance Matters

●

The marketing approval process is expensive, time consuming and uncertain and may prevent us from obtaining approvals for the commercialization of our current or future product candidates.

●

Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad.

●

Any product candidate for which we obtain marketing approval would remain subject to ongoing regulation and could be subject to restrictions or withdrawal from the market.

●

If we are not able to use accelerated development pathways, we may be required to conduct additional clinical trials beyond those that are contemplated, which would increase the expense of obtaining, and delay or prevent the receipt of, necessary marketing approvals.

●

The prices of prescription pharmaceuticals in the U.S. and foreign jurisdictions are subject to pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which could limit our ability to market those products and decrease our ability to generate revenue.

●

We may be subject to certain healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, fines, disgorgement, exclusion from participation in government healthcare programs, curtailment or restricting of our operations, and diminished profits and future earnings.

●

We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.

Risks Related to this Offering

● If we fail to regain compliance to meet Nasdaq’s listing requirements, we could be removed from The ~~price~~Nasdaq Capital Market, which would limit the ability of broker-dealers to sell our ~~Common~~securities ~~Stock~~and ~~may~~the beability ~~highly~~of ~~volatile~~shareholders to sell their securities in the secondary market and negatively impact our ability to raise capital.

● IfInvestors wewill ~~fail~~experience toimmediate ~~meet~~and ~~Nasdaq’s~~substantial ~~listing~~dilution ~~requirements,~~as wea ~~could~~result ~~be removed from The Nasdaq Capital Market, which would limit the ability~~ of ~~broker-dealers~~this tooffering ~~sell our securities~~ and ~~the~~may ~~ability~~suffer ofsubstantial ~~shareholders~~dilution related to ~~sell~~issued ~~their~~stock ~~securities~~warrants ~~in the secondary market~~ and ~~negatively impact our ability to raise capital~~options.

● ~~Investors~~Our shares of common stock are thinly traded, so stockholders may ~~suffer~~be ~~substantial~~unable ~~dilution~~to ~~related~~sell at or near ask prices or at all if they need to ~~issued~~sell ~~options~~shares ~~and~~to ~~convertible~~raise ~~promissory~~money ~~notes~~or otherwise desire to liquidate their shares.

● Our shares of Common Stock are thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares to raise money or otherwise desire to liquidate their shares.

● We do not currently intend to pay dividends on our Common Stock in the foreseeable future, and consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our Common Stock.

●

Upon our dissolution, our stockholders may not recoup all or any portion of their investment.

● The issuance of our ~~Common~~common ~~Stock~~stock pursuant to the terms of the asset purchase agreement with Hy Biopharma may cause dilution and the issuance of such shares of ~~Common~~common ~~Stock~~stock, or the perception that such issuances may occur, could cause the price of our ~~Common~~common ~~Stock~~stock to fall.

9● Our Board of Directors can, without stockholder approval, cause preferred stock to be issued on terms that adversely affect holders of our common stock.

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● Repayment of certain convertible notes, if they are not otherwise converted, will require a significant amount of cash, and we may not have sufficient cash flow from our business to make payments on our indebtedness.

● The issuance of shares of Common Stock upon conversion of certain convertible notes could substantially dilute shareholders’ investments and could impede our ability to obtain additional financing.

● Our Board of Directors can, without stockholder approval, cause preferred stock to be issued on terms that adversely affect holders of our Common Stock.

RISK FACTORS

Investing in our ~~securities~~common stock, pre-funded warrants and common warrants involves a high degree of risk. Before investing in our ~~securities~~common stock, pre-funded warrants and common warrants, you should consider carefully the risks and uncertainties discussed below. You ~~also~~ should carefully consider each of the following risks, together with all other information set forth in this prospectus, including our consolidated financial statements and the related notes, before deciding to buy our ~~securities.~~common ~~Any~~stock, ofpre-funded ~~these~~warrants ~~risks~~ and ~~uncertainties~~common ~~could~~warrants. ~~have~~If aany ~~material~~of ~~adverse~~the ~~effect~~following onrisks ~~our~~actually ~~business~~occurs, ~~financial~~our ~~condition,~~business ~~cash~~could ~~flows~~be ~~and results of operations~~harmed. IfIn that ~~occurs~~case, the trading price of our ~~Common~~common ~~Stock~~stock could decline ~~materially~~, and you ~~could~~may lose all or part of your investment.

The risks included in this prospectus are not the only risks we face. We may experience additional risks and uncertainties not currently known to us, or as a result of developments occurring in the future. Conditions that we currently deem to be immaterial may also materially and adversely affect our business, financial condition, cash flows and results of operations, and our ability to pay distributions to stockholders.

This prospectus also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including the risks faced by us described below and elsewhere in this prospectus. See “Cautionary Note Regarding Forward-Looking Statements and Industry Data and Market Information” for information relating to these forward-looking statements.

Risks Related to our Business

We have ~~had~~incurred significant losses since inception and ~~anticipate~~expect ~~future~~to ~~losses;~~continue ifto ~~additional~~incur ~~funding~~losses ~~cannot~~for bethe ~~obtained~~foreseeable future, wewhich ~~may~~together ~~reduce~~with orour ~~discontinue~~negative cash flows and auditor’s going concern opinion raise substantial doubt about our ~~product~~ability ~~development~~to ~~and~~continue ~~commercialization~~as ~~efforts~~a going concern without obtaining additional capital.

We have ~~experienced~~incurred significant losses since inception and, atexpect ~~March~~to continue incurring operating losses for the foreseeable future. As of June 3130, ~~2024~~2025, we had an accumulated deficit of approximately $~~227,619,503~~246.6 Wemillion, ~~expect~~cash toand ~~incur~~cash ~~additional~~equivalents ~~operating~~of ~~losses~~approximately in$5.1 ~~the~~million, ~~future~~ and ~~expect~~current ~~our~~liabilities ~~cumulative~~of ~~losses~~approximately to$3.6 ~~increase~~million. AsWe ofhave ~~March 31,~~not ~~2024,~~generated weany ~~had~~significant ~~$7,091,548~~revenues infrom ~~cash~~sales ~~and~~or ~~cash~~licensing ~~equivalents~~of ~~available~~our product candidates, ~~and~~which asare ofin ~~July 19,~~preclinical ~~2024~~or weclinical ~~had~~development ~~$12,281,699~~stages. inFrom ~~cash~~inception ~~and~~through ~~cash~~June 30, ~~equivalents~~2025, ~~available.~~we ~~Without~~have ~~additional~~spent ~~funding,~~approximately ~~based~~$128 onmillion developing our ~~projected~~current ~~budgetary~~product ~~needs~~candidates, and ~~funding~~we ~~from~~currently ~~existing~~anticipate ~~contracts~~spending ~~and~~approximately ~~grants~~$4.8 million over the next 12 ~~year,~~months weto ~~expect~~support tofurther bedevelopment ~~able~~activities, toof ~~maintain~~which ~~the~~only ~~current~~a ~~level~~small ofportion ~~our~~is ~~operations~~expected ~~through~~to ~~the~~be ~~1st~~reimbursed ~~half~~through ofexisting ~~2025~~government grants.

InWe ~~September 2014,~~rely weheavily ~~entered~~on ~~into~~government afunding, ~~contract~~including ~~with~~grants ~~the~~and ~~NIH~~contracts ~~for~~from ~~the~~agencies ~~development~~such ofas ~~RiVax® to~~the ~~protect~~NIH ~~against~~and ~~exposure~~NIAID, to ~~ricin~~support ~~toxin~~our ~~that~~operations. ~~would~~These ~~provide~~grants upand tocontracts ~~$24.7~~have ~~million~~contributed ofmeaningful funding inhistorically. ~~the~~However, ~~aggregate~~such ~~over~~funding ~~six years~~is ifsubject ~~options~~ to ~~extend~~uncertainty, ~~the~~periodic ~~contract are exercised by the NIH. In 2017~~renewal, weand ~~were~~potential ~~awarded~~termination ~~two~~at ~~separate grants from~~ the ~~NIH~~discretion of ~~approximately~~the $1funding agencies.5 ~~million~~As ~~each~~of toJune 30, ~~support~~2025, ~~our~~we ~~pivotal~~did ~~Phase~~not 3have ~~trials~~any ofawarded ~~HyBryte™~~grant ~~for~~funding ~~the~~available, ~~treatment~~and ofwe ~~CTCL~~have ~~and~~no ~~SGX942~~control ~~for~~over the ~~treatment~~level ofor ~~oral~~continuity ~~mucositis~~of ingovernment ~~head~~resources ~~and~~that ~~neck~~may ~~cancer.~~be Inallocated ~~December 2020, we were awarded Direct~~ to ~~Phase~~our IIprograms ~~SBIR~~in ~~grant~~the ~~from NIAID of approximately $1~~future.5 ~~million~~Failure to ~~support~~obtain ~~manufacture,~~government ~~formulation~~support ~~(including~~in ~~thermostabilization)~~the ~~and~~future ~~characterization~~could ofmaterially ~~COVID-19~~ and ~~EVD~~adversely ~~vaccine~~impact ~~candidates~~our ~~in conjunction with the CoVaccine HT™ adjuvant. Our~~ biodefense ~~grants~~programs ~~have~~and anoverall ~~overhead~~financial ~~component that allows us an~~ condition.

10Unless and until we are able to generate revenues from product sales or licensing activities, we will need to raise additional capital to fund our research and development programs, meet future clinical trial obligations, and support ongoing operations. There can be no assurance that such funding will be available on acceptable terms, or at all. If additional funds are raised through equity offerings, existing stockholders may experience dilution, and newly issued securities could have rights senior to those of our common stock. If we issue debt, we could face operational restrictions. If we are unable to secure adequate funding, we may be required to delay, scale back, or discontinue one or more of our development programs or operational initiatives.

Our recurring operating losses, negative cash flows, and accumulated shareholders’ deficit raise substantial doubt about our ability to continue as a going concern. We have concluded that substantial doubt exists regarding our ability to continue as a going concern for the 12 months following the date of issuance of the financial statements for the fiscal quarter ended June 30, 2025 that are included in this prospectus. As of such date, we believed we had sufficient resources to continue operating only into the fourth quarter of 2025. We do not have sufficient cash as of September 15, 2025 to support operations for the full 12-month period following such issuance.

To address these risks and alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we are pursuing various strategies, including:

●

Securing additional capital through public or private equity offerings or strategic transactions, such as partnerships or collaborations; and

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~~agency-approved percentage~~● ~~over~~Obtaining ~~our~~further ~~incurred~~proceeds ~~costs.~~from Wegovernment ~~estimate that the overhead component associated with our existing contracts and~~ grants ~~will fund some fixed costs for direct employees working on these contracts~~ and ~~grants as well as other administrative costs~~contracts. ~~As of March 31, 2024, we had approximately $700,000 in awarded grant funding available.~~

~~Our~~None ~~product~~of ~~candidates~~these ~~are~~alternatives ~~positioned for or~~ are currently ~~in clinical trials~~committed, and we ~~have~~cannot ~~not~~provide ~~yet~~assurance ~~generated~~that ~~any significant revenues from sales or licensing of these product candidates. From inception through March 31, 2024,~~ we ~~have~~will ~~expended~~succeed ~~approximately~~in ~~$120.1~~obtaining ~~million~~sufficient ~~developing~~funding ~~our~~or ~~current~~entering ~~product~~into ~~candidates~~strategic ~~for pre-clinical research and development and clinical trials~~arrangements. WeIf ~~currently~~these ~~expect~~efforts toare ~~spend~~unsuccessful ~~approximately~~or ~~$5.5 million for the year ending December 31~~delayed, ~~2024~~we inmay ~~connection~~not ~~with~~have the ~~development~~liquidity ofnecessary ~~our~~to ~~therapeutic~~sustain ~~and~~operations ~~vaccine~~beyond ~~products,~~the ~~licenses,~~fourth ~~employment~~quarter ~~agreements, and consulting agreements,~~ of ~~which approximately $0~~2025.~~3 million is expected to be reimbursed through our existing government grants.~~

WeFurther, ~~have no control over~~ the ~~resources~~report ~~and~~of ~~funding~~our ~~U.S.~~independent ~~government~~registered ~~agencies~~accounting ~~may~~firm ~~devote~~on to our ~~programs,~~audited ~~which~~financial ~~may~~statements ~~be subject to periodic renewal and which generally may be terminated by the government at any time~~ for ~~convenience. Any significant reductions in~~ the year ~~funding~~ended ofDecember 31, ~~U.S.~~2024, ~~government~~includes ~~agencies~~an orexplanatory inparagraph ~~the~~expressing ~~funding~~substantial ~~areas~~doubt ~~targeted~~about by our ~~business~~ability ~~could~~to ~~materially~~continue ~~and~~as ~~adversely~~a ~~affect~~going ~~our biodefense program and our results of operations and financial condition~~concern. If we ~~fail~~are unable to ~~satisfy~~resolve our ~~obligations~~liquidity ~~under~~issues ~~the~~or ~~government~~secure ~~contracts~~sufficient funding, ~~the~~we ~~applicable~~will ~~Federal~~likely ~~Acquisition~~need ~~Regulations allow the government~~ to ~~terminate~~significantly ~~the~~reduce ~~agreement~~our inoperations, ~~whole~~limit or incease ~~part~~product development efforts, and weour ~~may~~business, befinancial ~~required~~condition, toresults ~~perform~~of ~~corrective actions~~operations, ~~including~~and ~~but~~prospects ~~not~~would ~~limited~~be tomaterially ~~delivering~~and toadversely ~~the government any incomplete work~~affected. IfAdditionally, ~~U.S.~~ongoing ~~government~~market ~~agencies~~volatility doand ~~not~~geopolitical ~~exercise~~instability ~~future~~may ~~funding~~reduce ~~options~~access ~~under~~to ~~the contracts or grants~~capital, ~~terminate~~and the ~~funding~~perception orof ~~fail~~going toconcern ~~perform~~uncertainty ~~their~~may ~~responsibilities~~hinder ~~under the agreements or grants, it could materially impact~~ our ~~biodefense~~ability ~~program~~to ~~and~~establish ~~our~~or ~~financial~~maintain ~~results~~business relationships.

Unless and until we are able to generate sales or licensing revenue from one of our product candidates, we will require additional funding to meet these commitments, sustain our research and development efforts, provide for future clinical trials, and continue our operations. There can be no assurance we can raise such funds. If additional funds are raised through the issuance of equity securities, stockholders may experience dilution of their ownership interests, and the newly issued securities may have rights superior to those of the Common Stock. If additional funds are raised by the issuance of debt, we may be subject to limitations on our operations. If we cannot raise such additional funds, we may have to delay or stop some or all of our drug development programs.

Our losses from operations and negative cash flows as of March 31, 2024 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings.

We have concluded that substantial doubt exists about our ability to continue as a going concern for the 12 months following the issuance of the financial statements for the quarter ended March 31, 2024. As of March 31, 2024, we had cash and cash equivalents of $7,091,548 and current liabilities of $7,210,888. As of the issuance date of the financial statements for the quarter ended March 31, 2024, we believed that we have sufficient resources available to support our development activities and business operations and timely satisfy our obligations as they come due through the first half of 2025. We do not have sufficient cash and cash equivalents as of July 19, 2024 to support our operations for at least the 12 months following July 24, 2024.

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on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least 12 months following the issuance of the financial statements for the quarter ended March 31, 2024. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce our ability to access capital, which could negatively affect our liquidity and ability to continue as a going concern. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.

The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2023 contains an explanatory paragraph relating to our ability to continue as a going concern.

The auditor’s opinion on our audited financial statements for the year ended December 31, 2023 includes an explanatory paragraph stating that we have incurred recurring losses from operations that raise substantial doubt about our ability to continue as a going concern. While we believe that we will be able to obtain the capital we need to continue our operations, there can be no assurances that we will be successful in these efforts or will be able to resolve our liquidity issues or eliminate our operating losses. If we are unable to obtain sufficient funding, we would need to significantly reduce our operating plans and curtail some or all of our development efforts. Accordingly, our business, prospects, financial condition, and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.

If we are unable to develop our product candidates, our ability to generate revenues and viability as a company will be significantly impaired.

In order to generate revenues and profits, our organization must, along with corporate partners and collaborators, positively research, develop and commercialize our technologies or product candidates. Our current product candidates are in various stages of clinical and pre-clinical development and will require significant further funding, research, development, pre-clinical and/or clinical testing, regulatory approval and commercialization, and are subject to the risks of failure inherent in the development of products based on innovative or novel technologies. Specifically, each of the following is possible with respect to any of our product candidates:

●

we may not be able to maintain our current research and development schedules;

●

we may be unable to secure procurement contracts on beneficial economic terms or at all from the U.S. government or others for our biodefense products;

●

we may encounter problems in clinical trials; or

●

the technology or product may be found to be ineffective or unsafe, or may fail to obtain marketing approval.

If any of the risks set forth above occur, or if we are unable to obtain the necessary regulatory approvals as discussed below, we may be unable to develop our technologies and product candidates and our business will be seriously harmed. Furthermore, for reasons including those set forth below, we may be unable to commercialize or receive royalties from the sale of any other technology we develop, even if it is shown to be effective, if:

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commercialize or receive royalties from the sale of any other technology we develop, even if it is shown to be effective, if:

●

it is not economical or the market for the product does not develop or diminishes;

●

we are not able to enter into arrangements or collaborations to manufacture and/or market the product;

●

the product is not eligible for third-party reimbursement from government or private insurers;

●

others hold proprietary rights that preclude us from commercializing the product;

●

we are not able to manufacture the product reliably;

●

others have brought to market similar or superior products; or

●

the product has undesirable or unintended side effects that prevent or limit its commercial use.

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We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance.

We are a late-stage biopharmaceutical company. Our operations to date have been primarily limited to developing our technology and undertaking pre-clinical studies and clinical trials of our product candidates in our two active business segments, Specialized BioTherapeutics and Public Health Solutions. We have not yet obtained regulatory approvals for any of our product candidates. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had commercialized products. Our financial condition has varied significantly in the past and will continue to fluctuate from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include other factors described elsewhere in this prospectus and also include:

●

our ability to obtain additional funding to develop our product candidates;

● our ability to repay existing debt in accordance with its terms;

●

delays in the commencement, enrollment and timing of clinical trials;

●

the success of our product candidates through all phases of clinical development;

●

any delays in regulatory review and approval of product candidates in clinical development;

●

our ability to obtain and maintain regulatory approval for our product candidates in the U.S. and foreign jurisdictions;

●

potential side effects of our product candidates that could delay or prevent commercialization, limit the indications for any approved drug, require the establishment of risk evaluation and mitigation strategies, or cause an approved drug to be taken off the market;

●

our dependence on third-party contract manufacturing organizations to supply or manufacture our products;

13● our dependence on third-party contractors to conduct our clinical trials;

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● our dependence on contract research organizations to conduct our clinical trials;

●

our ability to establish or maintain collaborations, licensing or other arrangements;

●

market acceptance of our product candidates;

●

our ability to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations;

●

competition from existing products or new products that may emerge;

●

the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our products;

●

our ability to discover and develop additional product candidates;

●

our ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important to our business;

●

our ability to attract and retain key personnel to manage our business effectively;

●

our ability to build our finance infrastructure and improve our accounting systems and controls;

●

potential product liability claims;

●

potential liabilities associated with hazardous materials; and

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●

our ability to obtain and maintain adequate insurance policies.

Accordingly, the results of any quarterly or annual periods should not be relied upon as indications of future operating performance.

We have no approved products on the market and therefore do not expect to generate any revenues from product sales in the foreseeable future, if at all.

To date, we have no approved product on the market and have not generated any significant product revenues. We have funded our operations primarily from sales of our securities and from government contracts and grants. We have not received, and do not expect to receive for at least the next several years, if at all, any revenues from the commercialization of our product candidates. To obtain revenues from sales of our product candidates, we must succeed, either alone or with third parties, in developing, obtaining regulatory approval for, manufacturing and marketing drugs with commercial potential or successfully obtain government procurement or stockpiling agreements. We may never succeed in these activities, and we may not generate sufficient revenues to continue our business operations or achieve profitability.

Our business is subject to extensive governmental regulation, which can be costly, time consuming and subjects us to unanticipated delays.

Our business is subject to very stringent federal, foreign, state and local government laws and regulations, including the Federal Food, Drug and Cosmetic Act, the Environmental Protection Act, the Occupational Safety and Health Act, and state and local counterparts to these acts. These laws and regulations may be amended, additional laws and regulations may be enacted, and the policies of the FDA and other regulatory agencies may change.

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The regulatory process applicable to our products requires pre-clinical and clinical testing of any product to establish its safety and efficacy. This testing can take many years, is uncertain as to outcome, and requires the expenditure of substantial capital and other resources. We estimate that the clinical trials of our product candidates that we have planned will take at least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. Favorable results in early studies or trials, if any, may not be repeated in later studies or trials. Even if our clinical trials are initiated and completed as planned, we cannot be certain that the results will support our product candidate claims. Success in preclinical testing, Phase 1 and Phase 2 clinical trials does not ensure that later Phase 2 or Phase 3 clinical trials will be successful. In addition, we, the FDA or other regulatory authorities may suspend clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or the FDA or other regulatory authorities find deficiencies in our submissions or conduct of our trials.

We may not be able to obtain, or we may experience difficulties and delays in obtaining, necessary domestic and foreign governmental clearances and approvals to market a product (for example, the FDA may not recognize fast track designation upon an NDA submission, resulting in no priority review and subjecting us to longer potential review times than originally anticipated). Also, even if regulatory approval of a product is granted, that approval may entail limitations on the indicated uses for which the product may be marketed.

Following any regulatory approval, a marketed product and its manufacturer are subject to continual regulatory review. Later discovery of problems with a product or manufacturer may result in restrictions on such product or manufacturer. These restrictions may include product recalls and suspension or withdrawal of the marketing approval for the product. Furthermore, the advertising, promotion and export, among other things, of a product are subject to extensive regulation by governmental authorities in the U.S. and other countries. If we fail to comply with applicable regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and/or criminal prosecution.

~~There~~Our ~~may~~biodefense beprograms ~~unforeseen~~depend ~~challenges~~heavily inon ~~developing~~uncertain ~~our~~government ~~biodefense~~funding ~~products~~and face unique regulatory, operational, and market challenges.

~~For~~Our ~~development of~~ biodefense ~~vaccines~~product ~~and~~development ~~therapeutics,~~efforts ~~the FDA has instituted policies that~~ are ~~expected~~highly todependent ~~result~~on infinancial ~~accelerated~~support ~~approval.~~from ~~This includes approval for commercial use using the results of animal efficacy trials, rather than efficacy trials in humans, referred to as the Animal Rule~~U. ~~However, we will still have to establish that the vaccines we are developing are safe in humans at doses that are correlated with the beneficial effect in animals~~S. ~~Such~~government ~~clinical~~agencies, ~~trials~~which ~~will~~represent ~~also~~both ~~have to be completed in distinct populations that are subject to~~ the ~~countermeasures;~~primary ~~for~~source ~~instance,~~of ~~the~~funding ~~very young~~ and the ~~very~~principal ~~old,~~anticipated ~~and~~purchasers in pregnant women, if the countermeasure is to be licensed for civilian use. Other agencies will have an influence over the risk benefit scenarios for deploying the countermeasures and in establishing the number of ~~doses~~these ~~utilized in the Strategic National Stockpile~~products. WeThis ~~may~~reliance ~~not~~exposes beus ~~able~~ to ~~sufficiently~~significant ~~demonstrate the animal correlation to the satisfaction of the FDA~~risks, as ~~these~~government ~~correlates~~funding ~~are~~is ~~difficult~~inherently touncertain ~~establish~~ and ~~are~~subject often unclear. Invocation of the Animal Rule may raise issues of confidence in the model systems even if the models have been validated. For many of the biological threats, the animal models are not available and we may have to ~~develop~~annual ~~the~~budget ~~animal models~~appropriations, aadministrative ~~time-consuming research effort. There are few historical precedents~~decisions, orchanges recent precedents, for the development of new countermeasures for bioterrorism agents. Despite the Animal Rule, the FDA may require large clinical trials to establish safety and immunogenicity before licensure and it may require safety and immunogenicity trials in ~~additional populations. Approval of~~ biodefense ~~products may be subject to post-marketing studies~~priorities, and ~~could~~political ~~be restricted in use in only certain populations~~developments. ~~The~~We ~~government’s~~have ~~biodefense~~no ~~priorities~~control ~~can~~over ~~change, which could adversely affect~~ the ~~commercial~~level ~~opportunity for the products we are developing. Further, other countries have not, at this time, established criteria for review and approval~~ of ~~these~~resources ~~types~~government ofagencies ~~products~~may outside their normal review process, i.e., there is no Animal Rule equivalent, and consequently there can be no assurance that we will be able to make a submission for marketing approval in foreign countries based on such animal data.

Additionally, few facilities in the U.S. and internationally have the capability to test animals with ricin, or otherwise assist us in qualifying the requisite animal models. We have to compete with other biodefense 11

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~~companies~~commit ~~for~~to ~~access~~our programs, which are subject to ~~this~~periodic ~~limited~~renewal ~~pool~~and ofmay ~~highly~~be ~~specialized~~terminated ~~resources~~at any time for convenience. WeIf ~~therefore~~U.S. ~~may~~government ~~not~~agencies bedecide ~~able~~not to ~~secure~~exercise future funding options under existing contracts or grants, fail to ~~conduct~~perform ~~the~~their ~~testing~~responsibilities, inor aterminate ~~predictable~~funding ~~timeframe~~altogether, orour atbiodefense ~~all~~programs and financial results could be materially and adversely affected.

WeAdditionally, we are ~~dependent~~required onto comply with Federal Acquisition Regulations in the performance of our contracts. Failure to meet these obligations may result in corrective actions, loss of funding, or the obligation to return government property or deliver incomplete work. Even when funding is awarded, ~~which~~our continued receipt of support is ~~inherently~~conditioned ~~uncertain,~~on ~~for~~adherence to the ~~success~~terms of ~~our~~the ~~biodefense~~applicable ~~operations~~grant or contract, which may be complex and subject to interpretation.

WeBeyond ~~are~~funding ~~subject~~concerns, tothe ~~risks~~development ~~specifically~~and ~~associated~~approval ~~with~~of ~~operating in the~~ biodefense ~~industry,~~products ~~which~~present isunique aregulatory ~~new~~ and ~~unproven~~logistical ~~business area~~challenges. WeWhile dothe ~~not~~FDA ~~anticipate~~has ~~that~~instituted athe ~~significant~~Animal ~~commercial~~Rule to ~~market~~permit ~~will~~product ~~develop~~approval ~~for~~based ~~our~~on ~~biodefense~~animal ~~products.~~efficacy ~~Because~~studies wewhen ~~anticipate~~human ~~that~~trials ~~the~~are ~~principal~~not ~~potential~~feasible ~~purchasers~~or ~~of these products~~ethical, asdemonstrating ~~well~~sufficient asanimal-to-human ~~potential~~correlation ~~sources~~remains ofscientifically ~~research~~complex and ~~development funds, will be the U~~uncertain.S. ~~government~~We ~~and~~must ~~governmental~~also ~~agencies,~~show ~~the~~that ~~success of~~ our ~~biodefense~~products ~~division~~are ~~will~~safe ~~be dependent~~ in ~~large~~humans, ~~part~~and ~~upon~~in ~~government~~some ~~spending~~cases, ~~decisions.~~conduct ~~The~~trials ~~funding~~in ofspecific ~~government~~at-risk ~~programs~~populations, issuch ~~dependent~~as onchildren, ~~budgetary~~the ~~limitations~~elderly, ~~congressional~~or ~~appropriations~~pregnant ~~and~~women. ~~administrative~~Approval ~~allotment~~may ofstill ~~funds,~~be ~~all~~contingent ofupon ~~which~~additional ~~are~~post-marketing ~~inherently~~studies, ~~uncertain~~ and use may be ~~affected~~restricted byto ~~changes~~limited inpopulations ~~U.S.~~or ~~government~~emergency ~~policies~~stockpile ~~resulting~~deployment. ~~from~~Moreover, ~~various~~other ~~political~~countries ~~and~~have ~~military~~not ~~developments.~~established ~~Our~~equivalent ~~receipt~~regulatory offrameworks ~~government~~for ~~funding~~Animal isRule-based ~~also~~submissions, ~~dependent~~which onlimits our ability to ~~adhere~~pursue toforeign ~~the~~approvals ~~terms~~using ~~and provisions of~~ the ~~original~~same ~~grant and contract documents and other regulations~~data. We can provide no assurance that we will receive or continue to receive funding for grants and contracts we have been awarded. The loss of government funds could have a material adverse effect on our ability to progress our biodefense business.

The ~~terms~~development of ~~our~~effective ~~loan~~animal ~~and~~models ~~security~~for ~~agreement~~certain ~~with~~bioterrorism ~~Pontifax~~agents, ~~Medison~~such ~~Finance~~as ~~require~~ricin, is time- consuming and ~~any~~expensive, ~~future~~and ~~debt~~few ~~financing~~specialized ~~may~~facilities ~~require,~~exist usglobally to ~~meet~~conduct ~~certain~~the ~~operating~~necessary ~~covenants~~studies. ~~and~~We ~~place~~face ~~restrictions~~competition onfrom ~~our~~other ~~operating~~biodefense companies for access to these limited resources, which may delay or impede testing and ~~financial~~qualification ~~flexibility~~efforts.

~~In December 2020~~Finally, ~~we entered into a loan and security agreement with Pontifax Medison Finance (~~the ~~“Loan~~ ~~and~~biodefense ~~Security~~market ~~Agreement”),~~itself ~~that~~remains islargely ~~secured by a lien covering substantially all of our assets, other than our intellectual property and licenses for intellectual property~~unproven. ~~The~~We ~~Loan~~do ~~and~~not ~~Security~~expect ~~Agreement~~significant ~~contains~~commercial ~~customary~~demand ~~affirmative~~outside ~~and negative covenants and events~~ of ~~default.~~government ~~Affirmative covenants include~~procurement, ~~among others, covenants requiring us to protect~~ and ~~maintain~~shifts our intellectual property and comply with all applicable laws, deliver certain financial reports, and maintain insurance coverage. Negative covenants include, among others, covenants restricting us from transferring any material portion of our assets, incurring additional indebtedness, engaging in ~~mergers~~government orpolicy ~~acquisitions, changing foreign subsidiary voting rights, repurchasing shares, paying dividends~~ or ~~making~~strategic ~~other~~priorities distributions, making certain investments, and creating other liens on our assets, including our intellectual property, in each case subject to customary exceptions. If we raise any additional debt financing, the terms of such additional debt could ~~further~~reduce ~~restrict~~or ~~our~~eliminate ~~operating~~potential ~~and financial flexibility~~opportunities. These restrictions may include, among other things, limitations on borrowing and specific restrictions on the use of our assets, as well as prohibitions on our ability to create liens, pay dividends, redeem capital stock or make investments. If wegovernment ~~default~~support ~~under~~diminishes ~~the terms of the Loan and Security Agreement~~ or ~~any~~is ~~future debt facility~~withdrawn, ~~the~~we ~~lender~~ may ~~accelerate~~be ~~all~~unable ~~of our repayment obligations and take control of our pledged assets, potentially requiring us~~ to ~~renegotiate~~progress our ~~agreement~~biodefense ~~on terms less favorable to us or to immediately cease operations. Further~~initiatives, ifwhich ~~we are liquidated, the lender’s right to repayment would be senior to the rights of the holders of our Common Stock. The lender~~ could ~~declare~~have a ~~default upon the occurrence of any event that it interprets as a~~ material adverse ~~effect~~impact ason ~~defined under the Loan and Security Agreement or based upon~~ our ~~insolvency. Any declaration by the lender of an event of default could significantly harm our~~ business, ~~and~~operations, ~~prospects~~ and ~~could~~financial ~~cause the price of our Common Stock to decline~~condition.

IfWe ~~the~~rely ~~parties~~on wethird ~~depend~~parties on for ~~supplying~~the ~~our~~supply ~~drug substance raw materials~~ and ~~certain~~ manufacturing~~-related~~ ~~services~~of doour ~~not~~product ~~timely~~candidates, ~~supply~~and ~~these~~any ~~products~~delays, ~~and services~~failures, ~~it may delay~~ or ~~impair~~quality ~~our~~issues ~~ability~~could toadversely ~~develop,~~affect ~~manufacture and market~~ our ~~products.~~development Weand docommercialization ~~not have or anticipate having internal manufacturing capabilities~~efforts.

We ~~rely~~depend entirely on third-party suppliers for our drug substance raw materials and ~~third~~for ~~parties~~the ~~for~~performance ~~certain~~of critical manufacturing-related services. toWe ~~produce~~do ~~material~~not ~~that meets appropriate content~~have, ~~quality~~nor ~~and~~do ~~stability~~we ~~standards~~anticipate establishing, ~~which~~internal ~~material~~manufacturing ~~will~~capabilities. beThese ~~used~~third inparties ~~clinical~~must ~~trials~~produce ofmaterials ~~our~~that ~~products~~meet ~~and~~stringent quality, ~~after approval~~content, ~~for~~and ~~commercial~~stability ~~distribution.~~requirements Tonecessary ~~succeed,~~for our clinical trials ~~require adequate supplies of drug substance~~ and, ~~drug~~if ~~product~~approved, ~~which~~for ~~may~~commercial ~~be difficult or uneconomical to~~ distribution.

16The successful development and commercialization of our product candidates require uninterrupted access to sufficient quantities of drug substance and drug product that meet applicable regulatory standards. However, our suppliers and service providers may fail to:

●

produce our drug substance or product to the standards necessary for clinical or commercial use,

●

meet their contractual obligations,

●

maintain business operations over the long term, or

●

comply with FDA or foreign regulatory requirements, including current Good Manufacturing Practice (“cGMP”).

If any of these events occur, we may face delays in clinical trials, regulatory submissions, or product launches. Furthermore, should our relationships with key manufacturers or service providers be disrupted, we may not be able to secure suitable replacements in a timely or cost-effective manner, if at all. Even if we locate alternative providers, we may not be able to negotiate favorable terms, and qualifying new facilities with the FDA or foreign regulatory agencies can be time-consuming and costly.

Manufacturing our product candidates is a highly exacting process, and even minor deviations in production can result in failed batches, regulatory noncompliance, or product recalls. Regulatory authorities routinely inspect manufacturing facilities for cGMP compliance. Any failure by our suppliers to maintain these standards could result in clinical hold orders, delays in product

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~~procure~~development or ~~manufacture. We and our suppliers and vendors may not be able to (i) produce our drug substance or drug product to appropriate standards for use in clinical studies~~commercialization, ~~(ii) perform under any definitive manufacturing, supply~~ or ~~service~~denial ~~agreements with us~~ or ~~(iii) remain~~withdrawal ~~in business for a sufficient time to be able to develop, produce, secure regulatory approval~~ of ~~and market our~~ product ~~candidates~~approvals. IfThese werisks ~~do not maintain important manufacturing and service relationships, we may fail to find a replacement supplier or required vendor or develop our own manufacturing capabilities which~~ could ~~delay~~materially ~~or impair our ability to obtain regulatory approval for our products~~ and ~~substantially~~adversely ~~increase~~affect our ~~costs or deplete profit margins~~business, iffinancial ~~any. If we do find replacement manufacturers and vendors~~condition, ~~we may not be able to enter into agreements with them on terms~~ and ~~conditions~~results ~~favorable~~of ~~to us and, there could be a substantial delay before a new facility could be qualified and registered with the FDA and foreign regulatory authorities~~operations.

We rely on third parties for ~~pre-clinical~~preclinical and clinical ~~trials of our product candidates and~~development, inregulatory ~~some cases~~support, toand ~~maintain~~strategic ~~regulatory files for our product candidates. If we are not able to maintain or secure agreements with such third parties on acceptable terms~~execution, ifand ~~these third parties do not perform~~ their ~~services~~performance ~~as required,~~ or ifour ~~these~~resource ~~third~~allocation ~~parties~~decisions ~~fail~~could toadversely ~~timely~~affect ~~transfer~~our ~~any~~product ~~regulatory~~development ~~information~~efforts ~~held~~and bycommercial ~~them to us, we may not be able to obtain regulatory approval for, or commercialize, our product candidates~~potential.

We rely on academic institutions, hospitals, clinics, contract research organizations, and other third-party collaborators ~~for~~to conduct preclinical studies and clinical trials of our product candidates., ~~Although~~and wein ~~monitor,~~some ~~support~~cases, ~~and/or~~to ~~oversee~~maintain ~~our~~related ~~pre-clinical~~regulatory ~~and~~files. ~~clinical~~Because ~~trials, because~~ we do not conduct these ~~trials~~activities ~~ourselves~~internally, we have ~~less~~limited control over the execution, timing, and ~~cost~~costs of these studies, and ~~the~~less ~~ability~~influence toover ~~recruit~~patient ~~trial~~enrollment ~~subjects~~and ~~than~~data ifquality wethan ~~conducted these trials wholly by ourselves. If we are unable to maintain or enter into agreements with these third parties on acceptable terms, or~~ if ~~any such engagement is terminated,~~ we ~~may~~managed ~~be unable to enroll patients on a timely basis or otherwise conduct our trials in~~ the manner we anticipate. In addition, there is no guarantee that these third parties will devote adequate time and resources to our studies or perform as required by a contract or in accordance with regulatory requirements, including maintenance of clinical trial information regarding our product candidates. If these third parties fail to meet expected deadlines, fail to timely transfer to us any regulatory information, fail to adhere to protocols or fail to act in accordance with regulatory requirements or our agreements with them, or if they otherwise perform in a substandard manner or in a way that compromises the quality or accuracy of their activities or the data they obtain, then preclinical and/or clinical trials ~~of our product candidates may be extended, delayed or terminated, or our data may be rejected by the FDA or regulatory agencies~~ourselves.

~~The~~If ~~manufacturing~~we ofare ~~our~~unable ~~products~~to ismaintain aor ~~highly~~secure ~~exacting~~agreements ~~process~~with these third parties on commercially reasonable terms, ~~and~~or if any such agreements are terminated, we may face delays in trial initiation or ~~one~~completion. ofMoreover, there is no assurance that our ~~materials~~collaborators ~~suppliers~~will ~~encounter~~allocate ~~problems~~sufficient ~~manufacturing~~resources to our ~~products~~programs, perform in accordance with regulatory requirements, or adhere to protocols and deadlines. If they fail to transfer regulatory data to us on a timely basis, perform inadequately, or act in a way that compromises the integrity of clinical results, our ~~business~~ability to obtain regulatory approval or to commercialize our product candidates could ~~suffer~~be materially impaired.

~~The~~Additionally, ~~FDA~~our limited financial and ~~foreign~~human ~~regulators~~resources require ~~manufacturers~~us to ~~register~~make ~~manufacturing~~strategic ~~facilities.~~decisions ~~The~~regarding ~~FDA~~which ~~and~~programs ~~foreign regulators also inspect these facilities~~ to ~~confirm~~prioritize. ~~compliance~~As ~~with~~a ~~current~~result, ~~Good~~we ~~Manufacturing~~may ~~Practice~~delay ~~(“cGMP”)~~ or ~~similar~~forego ~~requirements~~pursuing ~~that~~product ~~the~~candidates ~~FDA~~ or ~~foreign~~indications ~~regulators~~that ~~establish.~~could ~~We,~~ultimately orprove ~~our~~to ~~materials~~have ~~suppliers,~~greater ~~may~~commercial ~~face~~value ~~manufacturing~~ or ~~quality~~development ~~control~~success. ~~problems~~If ~~causing~~we ~~product~~misjudge ~~production~~the ~~and~~market ~~shipment~~opportunity ~~delays~~ or atechnical ~~situation~~feasibility ~~where~~of wea orcandidate, ~~the~~we ~~supplier~~ may ~~not~~prematurely beenter ~~able~~into tosuboptimal ~~maintain~~strategic ~~compliance~~alliances ~~with~~or ~~the~~license ~~FDA’s cGMP requirements~~agreements, or ~~those of foreign regulators~~conversely, ~~necessary~~fail to ~~continue~~capitalize ~~manufacturing~~on ~~our~~valuable ~~drug~~opportunities ~~substance.~~that ~~Any~~would ~~failure~~have tobeen ~~comply~~more ~~with~~advantageous ~~cGMP requirements or other FDA or foreign regulatory requirements could adversely affect our clinical research activities and our ability~~ to ~~market and~~ develop ~~our products~~internally.

WeCollectively, ~~may~~these ~~use~~risks ~~our~~related ~~financial and human resources~~ to ~~pursue~~third-party areliance ~~particular~~and ~~research~~internal ~~program~~resource orallocation ~~product~~could ~~candidate~~significantly ~~and~~delay ~~fail~~development totimelines, ~~capitalize~~reduce onthe ~~programs~~likelihood orof ~~product~~regulatory ~~candidates~~approval, ~~that~~and ~~may~~limit beour ~~more~~ability ~~profitable~~to orbring ~~for~~commercially ~~which~~viable ~~there~~products isto ~~a greater likelihood of success~~market.

Because we have limited financial and human resources, we are currently focusing on the regulatory approval of certain product candidates. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on existing and future product candidates for specific indications may not yield any commercially

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viable products. 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 strategic alliance, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate in an area in which it would have been more advantageous to enter into a partnering arrangement.

Even if approved, our products will be subject to extensive post-approval regulation.

Once a product is approved, numerous post-approval requirements apply. Among other things, the holder of an approved NDA is subject to periodic and other FDA monitoring and reporting obligations, including obligations to monitor and report adverse events and instances of the failure of a product to meet the specifications in the NDA. Application holders must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling, or manufacturing process. Application holders must also submit advertising and other promotional material to the FDA and report on ongoing clinical trials.

Depending on the circumstances, failure to meet these post-approval requirements can result in criminal prosecution, fines, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, or refusal to allow us to enter into supply contracts, including government contracts. In addition, even if we comply with FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the FDA to modify or withdraw product approval.

Even if weour ~~obtain~~product ~~regulatory~~candidates ~~approval~~are toapproved, they may not achieve market ~~our~~acceptance ~~product~~or ~~candidates,~~commercial ~~our~~viability ~~product~~due ~~candidates~~to ~~may~~changing ~~not~~healthcare bepractices, ~~accepted~~payer bylimitations, ~~the~~and ~~market~~reimbursement challenges.

Even if ~~the~~we ~~FDA~~obtain ~~approves~~regulatory approval to market one or more of our product candidates, ~~physicians~~we ~~and patients~~ may ~~not~~be ~~accept~~unable itto orsuccessfully ~~use~~commercialize ~~it.~~them ~~Even~~due ~~if physicians and patients would like~~ to ~~use~~lack ~~our~~of ~~products, our products may not gain~~ market acceptance ~~among~~by healthcare ~~payors~~providers, ~~such as managed care formularies~~patients, ~~insurance~~and ~~companies~~third-party orpayors. ~~government~~Our ~~programs~~future ~~such~~revenue ~~as Medicare or Medicaid. Acceptance~~ and ~~use~~profitability ~~of our products will~~ depend ~~upon~~heavily aon ~~number~~the ofsuccessful ~~factors~~commercialization ~~including: perceptions by members~~ of ~~the~~our ~~health~~current ~~care~~product ~~community~~candidates, ~~including physicians~~which, ~~about~~if ~~the~~approved, ~~safety~~are ~~and~~expected ~~effectiveness~~to ofgenerate ~~our~~substantially ~~drug~~all ~~product; cost-effectiveness~~ of our product ~~relative~~revenue ~~to competing products; availability of reimbursement~~ for ~~our~~the ~~product~~foreseeable ~~from government or other healthcare payers; and effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any~~future.

The degree of market acceptance ~~of any product that we develop~~ will depend on anumerous ~~number of~~ factors, including:

● ~~cost-effectiveness~~the safety and efficacy of our products relative to competing treatments, including potential side effects;

● ~~the~~perceptions ~~safety~~among ~~and effectiveness of our products~~physicians, ~~including any significant potential side effects~~patients, asand ~~compared~~the tobroader ~~alternative~~medical ~~products or treatment methods~~community;

~~● the timing of market entry as compared to competitive products;~~13

● the rate of adoption of our products by doctors and nurses;

● product labeling or product insert required by the FDA for each of our products;

● reimbursement policies of government and third-party payors;

● effectiveness of our sales, marketing and distribution capabilities and the effectiveness of such capabilities of our collaborative partners, if any; and

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● ~~unfavorable~~the ~~publicity~~cost-effectiveness ~~concerning~~of our products orcompared ~~any~~to ~~similar products.~~alternatives;

~~Our~~● ~~product~~the ~~candidates,~~availability ~~if successfully developed, will compete with a number of products manufactured~~ and ~~marketed~~adequacy ~~by major pharmaceutical companies, biotechnology companies and manufacturers~~ of ~~generic~~reimbursement ~~drugs.~~from ~~Our products may also compete with new products currently under development by others. Physicians, patients,~~ third-party payors, ~~and~~including ~~the~~Medicare, ~~medical~~Medicaid, ~~community may not accept~~ and ~~utilize~~private ~~any of our product candidates. If our products do not achieve market acceptance, we will not be able to generate significant revenues or become profitable.~~insurers;

~~Because~~● ~~we expect sales of our current~~ product ~~candidates,~~labeling ~~if approved, to generate substantially all of our product revenues for the foreseeable future, the failure of these products to find market acceptance would harm our business~~ and ~~could~~restrictions ~~require~~imposed usby toregulatory ~~seek additional financing.~~authorities;

●

the strength of our sales, marketing, and distribution capabilities (and those of any collaborators); and

●

the timing of product launches relative to competing therapies, and any unfavorable publicity related to our products or similar products.

Failure to achieve meaningful market acceptance would significantly limit our ability to generate product revenue, and we may not be able to recover our investment in the development of these product candidates.

In addition, changes in healthcare delivery and reimbursement practices, both in the U.S. and internationally, could further hinder the commercial success of our products. U.S. federal and state governments, as well as private insurers, are continuing to pursue cost-containment initiatives, such as bundling payments, implementing price controls, and imposing tighter restrictions on reimbursement eligibility. The availability of appropriate billing codes and national or local coverage determinations will be critical to securing reimbursement. If our products are not covered under current Medicare or Medicaid policies — or if coverage decisions are deferred to local contractors — we may face significant delays or reductions in uptake.

Outside the U.S., many countries require government approval of drug pricing before commercial launch, and the rules governing pricing and reimbursement vary significantly. Any inability to secure favorable pricing and reimbursement in global markets would further restrict the commercial viability of our products.

Ongoing legislative proposals at both federal and state levels in the U.S. aim to impose new pricing controls or reform reimbursement models, adding additional uncertainty to the reimbursement environment. These dynamics could make it difficult for us to profitably commercialize our products even if they are successfully developed and approved, and could ultimately have a material adverse effect on our business, financial condition, and operating results.

We do not have extensive sales and marketing experience and our lack of experience may restrict our success in commercializing some of our product candidates.

We do not have extensive experience in marketing or selling pharmaceutical products whether in the U.S. or internationally. To obtain the expertise necessary to successfully market and sell any of our products, the development of our own commercial infrastructure and/or collaborative commercial arrangements and partnerships will be required. Our ability to make that investment and also execute our current operating plan is dependent on numerous factors, including, the performance of third -party collaborators with whom we may contract.

Our products, if approved, may not be commercially viable due to change in health care practice and third party reimbursement limitations.

Initiatives to reduce the federal deficit and to change health care delivery are increasing cost-containment efforts. We anticipate that Congress, state legislatures and the private sector will continue to review and assess alternative benefits, controls on health care spending through limitations on the growth of private health insurance premiums and Medicare and Medicaid spending, price controls on pharmaceuticals, and other fundamental changes to the health care delivery system. Any changes of this type could negatively impact the commercial viability of our products, if approved. Our ability to successfully commercialize our product candidates, if they are approved, will depend in part on the extent to which appropriate reimbursement codes and authorized cost reimbursement levels of these products and related treatment are obtained from governmental authorities, private health insurers and other organizations, such as health maintenance organizations. In the absence of national Medicare coverage determination, local contractors that administer the Medicare program may make their own coverage decisions. Any of our product candidates, if approved and when commercially available, may not be included within the then current Medicare coverage determination or the coverage determination of state Medicaid programs, private insurance companies or other health care providers. In addition, third-party payers are increasingly challenging the necessity and prices charged for medical products, treatments and services.

Serious adverse events or undesirable side effects from any of our product candidates could arise either during clinical development or, if approved, after the approved product has been marketed. The results of future clinical trials may show that our product candidates cause serious adverse events or undesirable side effects, which could interrupt, delay or halt clinical trials, resulting in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities.

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If any of our product candidates cause serious adverse events or undesirable side effects:

●

regulatory authorities may impose a clinical hold which could result in substantial delays and adversely impact our ability to continue development of the product;

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●

regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies;

●

we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;

●

we may be required to implement a risk minimization action plan, which could result in substantial cost increases and have a negative impact on our ability to commercialize the product;

●

we may be required to limit the patients who can receive the product;

●

we may be subject to limitations on how we promote the product;

●

sales of the product may decrease significantly;

●

regulatory authorities may require us to take our approved product off the market;

●

we may be subject to litigation or product liability claims; and

●

our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from the sale of our products.

If we fail to obtain or maintain orphan drug designation or exclusivity for our product candidates, our ~~competitors~~competitive ~~may~~position ~~sell products to treat the same conditions~~ and ~~our~~ revenue ~~will~~potential could be ~~reduced~~adversely affected.

~~Under~~Certain ~~the~~of ~~Orphan~~our ~~Drug~~product ~~Act~~candidates, ~~the~~such ~~FDA~~as ~~may~~HyBryte™, ~~designate~~have areceived ~~product as an~~ orphan drug ifdesignation ~~it is intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000~~ in the U.S., and/or ~~a patient population greater than 200~~Europe,~~000~~ inand ~~the~~we ~~U.S.~~may ~~where~~seek ~~there~~additional isorphan nodesignations ~~reasonable~~for ~~expectation~~other ~~that~~product ~~the~~candidates ~~cost of developing the drug will be recovered from sales~~ in the Ufuture.S. ~~In the EU, the EMA’s Committee for~~ Orphan ~~Medicinal Products grants orphan~~ drug designation toprovides ~~promote~~important ~~the~~financial ~~development~~incentives ofand ~~products~~regulatory ~~that~~benefits, ~~are~~including ~~intended~~tax ~~for~~credits, ~~the~~fee ~~diagnosis~~waivers, ~~prevention~~and, orif ~~treatment~~granted ofmarketing approval, a ~~life-threatening~~period orof ~~chronically~~market ~~debilitating~~exclusivity — ~~condition~~seven years ~~affecting not more than five~~ in ~~10,000 persons in~~ the EUU.S. ~~Additionally,~~and ~~designation~~ten years isin ~~granted for products intended for~~ the ~~diagnosis,~~European ~~prevention,~~Union. ~~or treatment of a life-threatening~~However, ~~seriously~~we ~~debilitating~~ or ~~serious~~our ~~and~~collaborators ~~chronic~~may ~~condition~~not ~~when, without incentives, it is unlikely that sales of the drug in the EU would~~ be ~~sufficient~~able to ~~justify~~obtain ~~the~~or ~~necessary~~maintain ~~investment~~orphan ~~in developing the~~ drug ordesignation ~~biological product~~ or ~~where~~exclusivity ~~there~~for isany nocurrent ~~satisfactory method of diagnosis, prevention,~~ or ~~treatment,~~future ~~or,~~product ~~if such a method exists, the medicine must be of significant benefit to those affected by the condition~~candidates.

In the U.S., ~~orphan~~the ~~drug~~Orphan ~~designation~~Drug ~~entitles~~Act defines a ~~party~~rare todisease ~~financial~~or ~~incentives~~condition ~~such~~ as ~~opportunities~~one ~~for~~affecting ~~grant~~fewer ~~funding~~than ~~towards clinical trial costs~~200,000 ~~tax~~individuals ~~advantages~~annually, ~~and~~or ~~user-fee~~where ~~waivers.~~there Inis ~~addition,~~no ifreasonable aexpectation ~~product~~that ~~receives~~ the ~~first~~cost ~~FDA~~of ~~approval~~development ~~for~~will ~~the~~be ~~indication~~recovered ~~for~~through ~~which~~U.S. itsales. ~~has~~In ~~orphan~~the ~~designation~~EU, ~~the~~a ~~product~~condition ismust ~~entitled~~affect tono ~~orphan~~more ~~drug~~than ~~exclusivity~~five in 10,000 ~~which~~individuals, ~~means~~or the ~~FDA~~product ~~may~~must ~~not~~demonstrate ~~approve~~significant ~~any~~benefit ~~other~~over ~~application~~existing totreatments. ~~market~~Even ~~the~~if ~~same~~we ~~drug~~meet ~~for~~these ~~the~~criteria ~~same~~and ~~indication~~receive ~~for~~orphan adrug ~~period of seven years~~designation, ~~except~~exclusivity inis ~~limited~~only ~~circumstances,~~granted ~~such~~upon asthe afirst ~~showing~~marketing ofapproval ~~clinical~~for ~~superiority~~the designated indication.

20Even if orphan drug exclusivity is obtained, it may not effectively protect our products from competition. Regulatory authorities, including the FDA and EMA, may approve different drugs for the same indication or even drugs with the same active moiety if they determine the competing product is clinically superior, meaning it is safer, more effective, or makes a major contribution to patient care. Additionally, exclusivity may be lost if the sponsor is unable to assure sufficient product supply or if the designation is found to be materially defective. In Europe, exclusivity can also be reduced to six years if the drug is deemed sufficiently profitable or if it no longer meets the criteria for orphan designation.

Furthermore, orphan drug protections exist within a complex and evolving regulatory framework. FDA policy changes, new legislation, judicial interpretation, or administrative actions may alter the standards for obtaining or retaining orphan drug status. We cannot predict how future regulatory or policy developments will affect the application or interpretation of orphan drug laws, either in the U.S. or abroad.

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~~over~~Lastly, in the ~~product~~EU, ~~with~~obtaining orphan ~~exclusivity~~designation orrequires ~~where~~demonstrating ~~the~~that ~~manufacturer~~there is ~~unable~~no tosatisfactory ~~assure~~method ~~sufficient~~of ~~product~~diagnosis, ~~quantity. In the EU~~prevention, ~~orphan~~or ~~drug~~treatment ~~designation~~currently ~~entitles~~authorized ain ~~party~~the toEU, ~~financial incentives such as reduction of fees~~ or ~~fee~~that ~~waivers~~the ~~and~~proposed ~~ten years~~product ofoffers ~~market~~substantial ~~exclusivity~~benefit ~~following~~over ~~drug~~existing ~~or biological product approval~~methods. ~~This~~We ~~period~~ may be ~~reduced~~unable to ~~six years~~meet ifthese ~~the~~standards ~~orphan~~for ~~drug~~our ~~designation criteria are no longer met, including where it is shown that the~~ product ~~is sufficiently profitable not to justify maintenance of market exclusivity~~candidates.

~~Even~~If ~~though~~ we ~~have~~fail ~~orphan drug designation for HyBryte™ in the U.S. and Europe, and RiVax® in the U.S., we may not be the first~~ to obtain ~~marketing~~or ~~approval~~maintain ~~for any particular~~ orphan ~~indication~~drug ~~due~~designation ~~to the uncertainties associated with developing drugs~~ or ~~biologic products. Further, even if we obtain orphan drug~~ exclusivity for aour product candidates, ~~that~~we ~~exclusivity~~could ~~may~~lose ~~not~~important ~~effectively~~commercial ~~protect~~and ~~the~~regulatory ~~product~~advantages. ~~from~~Competitors ~~competition~~may ~~because~~be ~~different~~able ~~drugs~~to ~~with~~market ~~different~~similar ~~active~~or ~~moieties~~superior ~~can~~products ~~be approved~~ for the same ~~condition.~~conditions, ~~Absent~~which ~~patent~~could orreduce ~~other~~our ~~intellectual~~potential ~~property~~market ~~protection~~share, ~~even~~impair ~~after~~our ancompetitive ~~orphan drug is approved~~position, ~~the~~and ~~FDA~~adversely oraffect ~~EMA~~our ~~may~~ability ~~subsequently~~to ~~approve~~achieve ~~the same drug with the same active moiety for the same condition if the FDA~~ or ~~EMA~~sustain ~~concludes that the later drug is safer, more effective, or makes a major contribution to patient care~~profitability.

~~Federal~~We ~~and/~~may not be able to retain rights licensed to us by third parties to commercialize key products or ~~state~~to ~~health~~develop ~~care~~the ~~reform~~third-party ~~initiatives~~relationships ~~could~~we ~~negatively~~need ~~affect~~to develop, manufacture and market our ~~business~~products.

The availability of reimbursement by governmental and other third-party payers affects the market for any pharmaceutical product. These third-party payers continually attempt to contain or reduce the costs of healthcare. There have been a number of legislative and regulatory proposals to change the healthcare system and further proposals are likely. Medicare’s policies may decrease the market for our products. Significant uncertainty exists with respect to the reimbursement status of newly approved healthcare products.

Third-party payers are increasingly challenging the price and cost-effectiveness of medical products and services. Once approved, we might not be able to sell our products profitably or recoup the value of our investment in product development if reimbursement is unavailable or limited in scope, particularly for product candidates addressing small patient populations. On July 15, 2008, the Medicare Improvements for Patients and Providers Act of 2008 became law with a number of Medicare and Medicaid reforms to establish a bundled Medicare payment rate that includes services and drug/labs that were separately billed at that time. Bundling initiatives that have been implemented in other healthcare settings have occasionally resulted in lower utilization of services that had not previously been a part of the bundled payment.

In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. We expect that there will continue to be a number of U.S. federal and state proposals to implement governmental pricing controls. While we cannot predict whether such legislative or regulatory proposals will be adopted, the adoption of such proposals could have a material adverse effect on our business, financial condition and profitability.

We may not be able to retain rights licensed to us by third parties to commercialize key products or to develop the third party relationships we need to develop, manufacture and market our products.

We currently rely on license agreements from New York University, Yeda Research and Development Company Ltd., the University of Texas Southwestern Medical Center, the University of British Columbia, and George B. McDonald, MD as well as sublicense agreement from VitriVax for the rights to commercialize key product candidates. We may not be able to retain the rights granted under these agreements or negotiate additional agreements on reasonable terms, if at all. Our existing license agreements impose, and we expect that future license agreements will impose, various diligence, milestone payment, royalty, and other obligations on us. If we fail to comply with our obligations under these agreements, or we are subject to a bankruptcy, we may be required to make certain payments to the licensor, we may lose the exclusivity of our license, or the licensor may have the right to terminate the license, in which event we would not be able to develop or market products covered by the license.

21Additionally, the milestone and other payments associated with these licenses will make it less profitable for us to develop our drug candidates. See “Business — Patents and Other Proprietary Rights” for a description of our license agreements.

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Additionally, the milestone and other payments associated with these licenses will make it less profitable for us to develop our drug candidates. See “Business – Patents and Other Proprietary Rights” for a description of our license agreements.

Licensing of intellectual property is of critical importance to our business and involves complex legal, business, and scientific issues. Disputes may arise regarding intellectual property subject to a licensing agreement, including but not limited to:

●

the scope of rights granted under the license agreement and other interpretation-related issues;

●

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

●

the sublicensing of patent and other rights;

●

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

●

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

●

the priority of invention of patented technology.

If disputes over intellectual property and other rights that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.

Additionally, the research resulting in certain of our licensed patent rights and technology was funded by the U.S. government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention for non-commercial purposes. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the U.S. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations and prospects.

Furthermore, we currently have very limited product development capabilities and no manufacturing, marketing or sales capabilities. For us to research, develop and test our product candidates, we need to contract or partner with outside researchers, in most cases with or through those parties that did the original research and from whom we have licensed the technologies. If products are successfully developed and approved for commercialization, then we will need to enter into additional collaboration and other agreements with third parties to manufacture and market our products. We may not be able to induce the third parties to enter into these agreements, and, even if we are able to do so, the terms of these agreements may not be favorable to us. Our inability to enter into these agreements could delay or preclude the development, manufacture and/or marketing of some of our product candidates or could significantly increase the costs of doing so. In the future, we may grant to our development partners rights to license and commercialize pharmaceutical and related products developed under the agreements with them, and these rights may limit our flexibility in considering alternatives for the commercialization of these products. Furthermore, third-party manufacturers or suppliers may not be able to meet our needs with respect to timing, quantity and quality for the products.16

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Additionally, if we do not enter into relationships with additional third parties for the marketing of our products, if and when they are approved and ready for commercialization, we would have to build our own sales force or enter into commercialization agreements with other companies. Development of an effective sales force in any part of the world would require significant financial resources, time and expertise. We may not be able to obtain the financing necessary to establish a sales force in a timely or cost effective manner, if at all, and any sales force we are able to establish may not be capable of generating demand for our product candidates, if they are approved.

We may suffer product and other liability claims; we maintain only limited product liability insurance, which may not be sufficient.

The clinical testing, manufacture and sale of our products involves an inherent risk that human subjects in clinical testing or consumers of our products may suffer serious bodily injury or death due to side effects, allergic reactions or other unintended negative reactions to our products. As a result, product and other liability claims may be brought against us. We currently have clinical trial and product liability insurance with aggregate limits of liability of $10 million, which may not be sufficient to cover our potential liabilities. Because liability insurance is expensive and difficult to obtain, we may not be able to maintain existing insurance or obtain additional liability insurance on acceptable terms or with adequate coverage against potential liabilities. Furthermore, if any claims are brought against us, even if we are fully covered by insurance, we may suffer harm such as adverse publicity.

We may use hazardous chemicals in our business. Potential claims relating to improper handling, storage or disposal of these chemicals could affect us and be time consuming and costly.

Our research and development processes and/or those of our third -party contractors involve the controlled use of hazardous materials and chemicals. These hazardous chemicals are reagents and solvents typically found in a chemistry laboratory. Our operations also may produce hazardous waste products. Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal of hazardous materials. While we attempt to comply with all environmental laws and regulations, including those relating to the outsourcing of the disposal of all hazardous chemicals and waste products, we cannot eliminate the risk of contamination from or discharge of hazardous materials and any resultant injury. In the event of such an accident, we could be held liable for any resulting damages and any liability could materially adversely affect our business, financial condition and results of operations.

Compliance with environmental laws and regulations may be expensive. Current or future environmental regulations may impair our research, development or production efforts. We might have to pay civil damages in the event of an improper or unauthorized release of, or exposure of individuals to, hazardous materials. We are not insured against these environmental risks. We may agree to indemnify our collaborators in some circumstances against damages and other liabilities arising out of development activities or products produced in connection with these collaborations.

In addition, the federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous or radioactive materials and waste products may require us to incur substantial compliance costs that could materially adversely affect our business, financial condition and results of operations.

We may not be able to compete with our larger and better financed competitors in the biotechnology industry.

The biotechnology industry is intensely competitive, subject to rapid change and sensitive to new product introductions or enhancements. Most of our existing competitors have greater financial resources, larger technical staffs, and larger research budgets than we have, as well as greater experience in developing products and conducting clinical trials. Our competition is particularly intense in the gastroenterology and transplant areas and is also intense in the therapeutic area of inflammatory bowel diseases. We face intense competition in the biodefense area from various public and private companies and universities as well as

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than we have, as well as greater experience in developing products and conducting clinical trials. Our competition is particularly intense in the gastroenterology and transplant areas and is also intense in the therapeutic area of inflammatory bowel diseases. We face intense competition in the biodefense area from various public and private companies and universities as well as governmental agencies, such as the U.S. Army, which may have their own proprietary technologies that may directly compete with our technologies. In addition, there may be other companies that are currently developing competitive technologies and products or that may in the future develop technologies and products that are comparable or superior to our technologies and products. We may not be able to compete with our existing and future competitors, which could lead to the failure of our business.

Additionally, if a competitor receives FDA approval before we do for a drug that is similar to one of our product candidates, FDA approval for our product candidate may be precluded or delayed due to periods of non-patent exclusivity and/or the listing with the FDA by the competitor of patents covering its newly-approved drug product. Periods of non-patent exclusivity for new versions of existing drugs such as our current product candidates can extend up to three and one-half years. See “Business –— The Drug Approval Process.”

These competitive factors could require us to conduct substantial new research and development activities to establish new product targets, which would be costly and time consuming. These activities would adversely affect our ability to commercialize products and achieve revenue and profits.

Competition and technological change may make our product candidates and technologies less attractive or obsolete.

We compete with established pharmaceutical and biotechnology companies that are pursuing other forms of treatment for the same indications we are pursuing and that have greater financial and other resources. Other companies may succeed in developing products earlier than us, obtaining FDA approval for products more rapidly, or developing products that are more effective than our product candidates. Research and development by others may render our technology or product candidates obsolete or noncompetitive, or result in treatments or cures superior to any therapy we develop. We face competition from companies that internally develop competing technology or acquire competing technology from universities and other research institutions. As these companies develop their technologies, they may develop competitive positions that may prevent, make futile, or limit our product commercialization efforts, which would result in a decrease in the revenue we would be able to derive from the sale of any products.

There can be no assurance that any of our product candidates will be accepted by the marketplace as readily as these or other competing treatments. Furthermore, if our competitors’ products are approved before ours, it could be more difficult for us to obtain approval from the FDA. Even if our products are successfully developed and approved for use by all governing regulatory bodies, there can be no assurance that physicians and patients will accept our product(s) as a treatment of choice.

Furthermore, the pharmaceutical research industry is diverse, complex, and rapidly changing. By its nature, the business risks associated therewith are numerous and significant. The effects of competition, intellectual property disputes, market acceptance, and FDA regulations preclude us from forecasting revenues or income with certainty or even confidence.

Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run our business.

We currently have 15 employees and we depend upon these employees, in particular Dr. Christopher Schaber, our President and Chief Executive Officer, to manage the day-to-day activities of our business. Because we have such limited personnel, the loss of any of them or our inability to attract and retain other qualified employees in a timely manner would likely have a negative impact on our operations. We may be unable to effectively manage and operate our business, and our business may suffer, if we lose the services of our employees.

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Instability and volatility in the financial markets could have a negative impact on our business, financial condition, results of operations, and cash flows.

During recent years, there has been substantial volatility in financial markets due at least in part to the uncertainty ~~with~~regarding ~~regard to~~ the global economic environment. In addition, there has been substantial uncertainty in the capital markets and access to additional financing is uncertain. Moreover, customer spending habits may be adversely affected by current and future economic conditions. These conditions could have an adverse effect on our industry and business, including our financial condition, results of operations, and cash flows.

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To the extent that we do not generate sufficient cash from operations, we may need to issue stock or incur indebtedness to finance our plans for growth. Recent turmoil in the credit markets and the potential impact on the liquidity of major financial institutions may have an adverse effect on our ability to fund our business strategy through borrowings, under either existing or newly created instruments in the public or private markets on terms we believe to be reasonable, if at all.

Changes in U.S. and international trade policies may adversely impact our business and operating results.

The U.S. government has recently made statements and taken certain actions that may lead to potential changes to U.S. and international trade policies, including imposing several rounds of tariffs and export control restrictions affecting certain products manufactured in other countries. It is unknown whether and to what extent new tariffs, export controls, or other new laws or regulations will be adopted, or the effect that any such actions would have on us or our business or industry.

Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may increase the cost of manufacturing our product candidates, affect the demand for our drug products (if and once approved), the competitive position of our product candidates, and import or export of raw materials and finished product candidate used in our and our collaborators’ preclinical studies and clinical trials. If any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated, such changes could have an adverse effect on our business, financial condition and results of operations.

Adverse developments affecting financial institutions such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity.

Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, or concerns or rumors about any events of these kinds, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (the “FDIC”) as receiver. Despite subsequent actions taken by the U.S. Department of the Treasury, the U.S. Federal Reserve and the FDIC to ensure that all depositors of SVB had access to all of their cash deposits following the closure of SVB, uncertainty and liquidity concerns in the broader financial services industry remain.

We maintain cash balances at a third-party financial institution in excess of the FDIC insurance limit. Our access to our cash and cash equivalents in amounts adequate to finance our operations could be significantly impaired to the extent the financial institution with which we maintain cash balances faces liquidity constraints or failures. Any material decline in our ability to access our cash and cash equivalents could adversely impact our ability to meet our operating expenses, result in breaches of our contractual obligations or result in significant disruptions to our business, any of which could have material adverse impacts on our operations and liquidity. There is no guarantee that the U.S. Department of Treasury, the U.S. Federal Reserve and the FDIC will provide access to uninsured funds in the future in the event of the closure of other banks or financial institutions in a timely fashion or at all.

We may not be able to utilize all of our net operating loss carryforwards.

The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused net operating loss (“NOL”) carryforwards to other New Jersey-based corporate taxpayers. We sold ~~2022~~2023, ~~2021~~2022 and ~~2020~~2021 New Jersey NOL carryforwards, resulting in the recognition of $1409,~~767,803~~114 and $1,~~154~~767,~~935~~803 of income tax benefit, net of transaction costs during the years ended December 31, ~~2023~~ 2024 and ~~2022~~2023, respectively. The Company sold its 2022 New Jersey NOLs and has recorded a receivable of $606,606 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, 2023. We have not yet ~~completed~~sold ~~the sale of~~ our ~~2023~~2024 New Jersey NOL carryforwards but may do so in the future. If there is an unfavorable change in the State of New Jersey’s Technology Business Tax Certificate Program (whether as a result of a change in law, policy or otherwise) that terminates the program or eliminates or reduces our ability to use or sell our NOL carryforwards or if we are unable to find a suitable buyer to utilize our New Jersey NOL carryforwards to the extent the NOLs expire before we are able to utilize them against our taxable income, our cash taxes may increase which may have an adverse effect on our financial condition.

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Global pathogens that could have an impact on financial markets, materials sourcing, patients, governments and population (e.g. COVID-19).

Global pathogens (e.g., SARS-CoV-2, the pathogen responsible for COVID-19) could cause an impact on financial markets and therefore repercussions to our operating business, including but not limited to, the sourcing of materials for our product candidates, manufacture of supplies for our preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for our trials due to such things as quarantines, our conduct of patient monitoring and clinical trial data retrieval at investigational study sites.

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manufacture of supplies for our preclinical and/or clinical studies, delays in clinical operations, which may include the availability or the continued availability of patients for our trials due to such things as quarantines, our conduct of patient monitoring and clinical trial data retrieval at investigational study sites.

The impacts of outbreaks are highly uncertain and cannot be predicted, and we cannot provide any assurance that any outbreak will not have a material adverse impact on our operations or future results or filings with regulatory health authorities. The extent of the impact to us, if any, will depend on future developments, including actions taken to contain the pathogen.

Risks Related to our Intellectual Property

WeIf ~~may~~we beare unable to ~~commercialize~~adequately ~~our~~protect ~~products~~or ifenforce weour ~~are~~intellectual ~~unable~~property torights, ~~protect~~or ~~our~~if ~~proprietary~~we ~~rights,~~infringe ~~and~~the werights ~~may~~of ~~be liable~~others, ~~for~~our ~~significant~~ability ~~costs~~to ~~and~~commercialize ~~damages~~our ifproducts wecould ~~face~~be aimpaired, ~~claim~~and ofwe ~~intellectual~~may ~~property~~face ~~infringement~~significant bycosts aand ~~third~~legal ~~party~~exposure.

Our ~~near~~success ~~and~~depends ~~long-term prospects depend~~ in part on our ability to obtain and maintain ~~patents,~~patent ~~protect~~protection ~~trade secrets~~ and ~~operate without infringing upon the proprietary rights of others. In the absence of patent and~~ trade secret ~~protection,~~rights ~~competitors~~for ~~may adversely affect~~ our ~~business~~product bycandidates ~~independently developing~~ and ~~marketing~~technologies, ~~substantially equivalent or superior products~~ and ~~technology,~~to ~~possibly~~operate atwithout ~~lower~~infringing ~~prices.~~the Weintellectual ~~could~~property ~~also~~rights ~~incur substantial costs in litigation and suffer diversion~~ of ~~attention~~others. ofIf ~~technical and management personnel if~~ we are ~~required~~unable to ~~defend~~secure ~~ourselves~~or inprotect ~~intellectual~~our ~~property~~proprietary ~~infringement~~rights, ~~suits~~or ~~brought~~if byour ~~third~~rights ~~parties~~are invalidated, ~~with or without merit~~circumvented, or ifchallenged weby ~~are~~third ~~required~~parties, toour ~~initiate~~ability ~~litigation against others~~ to ~~protect~~develop orand ~~assert~~commercialize our ~~intellectual~~products ~~property~~could ~~rights. Moreover, any such litigation may not~~ be ~~resolved~~materially ~~in our favor~~harmed.

Although we and our licensors have filed various patent applications covering ~~the uses of~~ our product candidates, ~~patents~~and ~~may~~technologies, ~~not~~there beis ~~issued~~no ~~from~~assurance ~~the~~that ~~patent~~patents ~~applications~~will ~~already~~be ~~filed~~issued or, ~~from~~if ~~applications~~issued, ~~that~~will weprovide ~~might~~meaningful ~~file~~protection. inThe ~~the~~scope, ~~future. Moreover~~validity, ~~the~~and ~~patent~~enforceability ~~position~~ of ~~companies~~patents ininvolve ~~the pharmaceutical industry generally involves~~ complex legal and factual ~~questions,~~issues ~~and~~that ~~has~~are ~~been~~frequently litigated in the ~~subject~~pharmaceutical ofand ~~much~~biotechnology ~~litigation~~industries. ~~Any~~Patents ~~patents~~that we own or license, ~~now or in the future,~~ may be challenged, invalidated, or circumvented., Toand ~~date,~~the nopatent ~~consistent~~applications ~~policy~~we ~~has~~have ~~been~~filed ~~developed~~may not result in ~~the~~issued patents. U.S. ~~Patent~~patent law remains subject to evolving judicial interpretation and ~~Trademark~~administrative ~~Office~~policy, ~~(the~~and ~~“PTO”)~~we ~~regarding~~may face interference proceedings to determine the ~~breadth~~priority of ~~claims~~inventions. ~~allowed~~Additionally, delays in ~~biotechnology~~publication ~~patents~~of patent applications and scientific discoveries may limit our ability to establish first inventorship.

InWe ~~addition,~~also ~~because~~rely ~~patent~~on ~~applications~~unpatented inproprietary ~~the~~technology, ~~U.S. are maintained in secrecy until patent applications publish or patents issue~~know-how, and ~~because~~trade ~~publication of discoveries in the scientific or patent literature often lags behind actual discoveries~~secrets, wewhich ~~cannot~~may be ~~certain~~difficult ~~that we and our licensors are the first creators of inventions covered by any licensed patent applications or patents or that we or they are the first~~ to ~~file~~protect. ~~The~~Disputes ~~PTO~~ may ~~commence~~arise ~~interference~~with ~~proceedings~~consultants, ~~involving~~employees, ~~patents~~ or ~~patent~~collaborators ~~applications,~~over inrights ~~which~~to ~~the~~inventions ~~question~~or ofproprietary ~~first inventorship is contested. Accordingly~~information, ~~the~~and ~~patents~~these ~~owned or licensed to us~~ may not be ~~valid~~resolved orin ~~may~~our ~~not~~favor. ~~afford~~Any usfailure ~~protection~~to ~~against~~adequately ~~competitors~~protect ~~with~~this ~~similar~~intellectual ~~technology,~~property ~~and~~could ~~the~~allow ~~patent~~competitors ~~applications licensed~~ to ususe ~~may~~our ~~not~~technologies ~~result~~without incompensation ~~the~~and ~~issuance~~reduce ofour ~~patents~~competitive advantage.

ItIn isaddition ~~also~~to ~~possible~~the ~~that~~risk ~~our~~of ~~owned~~losing ~~and~~protection, ~~licensed~~we ~~technologies~~ may ~~infringe~~be onsubject ~~patents~~to orclaims ~~other~~that ~~rights~~our ~~owned~~technologies, ~~by others~~products, ~~and~~or ~~licenses~~methods toinfringe ~~which~~on ~~may~~the ~~not~~proprietary berights ~~available~~of tothird usparties. WeIf ~~may~~we beare ~~unable~~found to ~~obtain~~infringe a ~~license~~valid ~~under such~~ patent onor ~~terms~~intellectual ~~favorable~~property ~~to us~~right, ifwe atcould ~~all.~~be Werequired ~~may have~~ to ~~alter our products or processes, pay licensing fees or cease activities altogether because of patent rights of third parties.~~:

In● ~~addition~~obtain tolicenses, ~~the products for~~ which ~~we have patents or have filed patent applications, we rely upon unpatented proprietary technology and~~ may not be ~~able~~available toon ~~meaningfully~~commercially ~~protect~~reasonable ~~our~~terms ~~rights~~or ~~with~~at ~~regard to that unpatented~~ all;

26● pay substantial damages, including treble damages if infringement is found to be willful;

●

stop selling the infringing products or using the infringing technology;

●

redesign our products or processes to avoid infringement; or

●

defend costly and time-consuming litigation or administrative proceedings.

Even if such claims are without merit, defending against them can result in significant financial and management resource diversion and reputational damage. An adverse outcome in litigation could result in injunctions, substantial monetary liability, and loss of valuable intellectual property rights.

Furthermore, litigation or administrative proceedings, such as those before the U.S. Patent and Trademark Office, are inherently unpredictable. They are expensive, time-consuming, and may require disclosure of confidential information, which could harm our competitive position. Public announcements regarding such proceedings — regardless of outcome — could negatively affect investor perception and the market price of our common stock.

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~~proprietary~~Overall, ~~technology.~~our ~~Furthermore,~~inability to ~~the~~protect ~~extent~~our ~~that~~own ~~consultants,~~intellectual ~~key~~property ~~employees~~rights, or ~~other~~avoid ~~third~~infringing ~~parties~~the ~~apply~~rights ~~technological~~of ~~information~~others, ~~developed~~could bymaterially ~~them~~impair orour byability ~~others~~ to ~~any~~develop ofand commercialize our ~~proposed~~product ~~projects,~~candidates ~~disputes~~and ~~may~~could ~~arise~~have asa tosignificant ~~the~~adverse ~~proprietary~~effect ~~rights~~on toour ~~this information~~business, ~~which~~financial ~~may~~condition, ~~not~~and beresults ~~resolved~~of ~~in our favor~~operations.

WeRisks ~~may~~Related ~~be involved in lawsuits~~ to ~~protect~~Technology ~~or enforce our patents, which could be expensive~~ and ~~time consuming.~~Cybersecurity

The pharmaceutical industry has been characterized by extensive litigation regarding patents and other intellectual property rights, and companies have employed intellectual property litigation to gain a competitive advantage. We may become subject to infringement claims or litigation arising out of patents and pending applications of our competitors, or additional interference proceedings declared by the PTO to determine the priority of inventions. The defense and prosecution of intellectual property suits, PTO proceedings, and related legal and administrative proceedings are costly and time-consuming to pursue, and their outcome is uncertain. Litigation may be necessary to enforce our issued patents, to protect our trade secrets and know-how, or to determine the enforceability, scope, and validity of the proprietary rights of others. An adverse determination in litigation or interference proceedings to which we may become a party could subject us to significant liabilities, require us to obtain licenses from third parties, or restrict or prevent us from selling our products in certain markets. Although patent and intellectual property disputes might be settled through licensing or similar arrangements, the costs associated with such arrangements may be substantial and could include our paying large fixed payments and ongoing royalties. Furthermore, the necessary licenses may not be available on satisfactory terms or at all.

Competitors may infringe our patents, and we may file infringement claims to counter infringement or unauthorized use. This can be expensive, particularly for a company of our size, and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover its technology. An adverse determination of any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly.

Also, a third party may assert that our patents are invalid and/or unenforceable. There are no unresolved communications, allegations, complaints or threats of litigation related to the possibility that our patents are invalid or unenforceable. Any litigation or claims against us, whether or not merited, may result in substantial costs, place a significant strain on our financial resources, divert the attention of management and harm our reputation. An adverse decision in litigation could result in inadequate protection for our product candidates and/or reduce the value of any license agreements we have with third parties.

Interference proceedings brought before the PTO may be necessary to determine priority of invention with respect to our patents or patent applications. During an interference proceeding, it may be determined that we do not have priority of invention for one or more aspects in our patents or patent applications and could result in the invalidation in part or whole of a patent or could put a patent application at risk of not issuing. Even if successful, an interference proceeding may result in substantial costs and distraction to our management.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or interference proceedings, there is a risk that some of our confidential information could be compromised by disclosure. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If investors perceive these results to be negative, the price of our Common Stock could be adversely affected.

If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against litigation.

If our products, methods, processes and other technologies infringe the proprietary rights of other parties, we could incur substantial costs and we may have to: obtain licenses, which may not be available on commercially reasonable terms, if at all; abandon an infringing product candidate; redesign our products or processes to

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avoid infringement; stop using the subject matter claimed in the patents held by others; pay damages; and/or defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.

Risks Related to Technology and Intellectual Property

Our strategy includes an increasing dependence on technology in our operations. If any of our key technology fails, our business could be adversely affected.

Our operations are increasingly dependent on technology. Our information technology systems are critical to our ability to develop our products and otherwise operating our business. Problems with the operation of the information or communication technology systems we use could adversely affect, or temporarily disable, all or a portion of our operations. Further, any systems failures could impede our ability to timely collect and report financial results in accordance with applicable laws.

A cybersecurity incident could negatively impact our business and our relationships with our employees, service providers, patients, clinical study sites and government agencies.

We use information technology and operational technology assets, including computer and information networks, in substantially all aspects of our business operations. We also use mobile devices, social networking and other online activities to connect with our employees, service providers, patients, clinical study sites and government agencies. Such uses give rise to cybersecurity risks, including security breach, espionage, system disruption, theft and inadvertent release of information. Our business involves the storage and transmission of numerous classes of sensitive and/or confidential information and intellectual property, including clinical trial participants’ personal information, private information about employees and financial and strategic information about us and our business partners. If we fail to assess and identify cybersecurity threats, we may become increasingly vulnerable to such threats. Additionally, while we have implemented measures to prevent security breaches and cyber incidents, our preventive measures and incident response efforts may not be entirely effective. Also, the regulatory environment surrounding information security and privacy is increasingly demanding, with the frequent imposition of new and constantly changing requirements. This changing regulatory landscape may cause increasingly complex compliance challenges, which may increase our compliance costs. Any failure to comply with these changing security and privacy laws and regulations could result in significant penalties, fines, legal challenges and reputational harm. The theft, destruction, loss, misappropriation, or release of sensitive and/or confidential information or intellectual property, or interference with our information technology systems or the technology systems of third parties on which we rely, could result in business disruption, negative publicity, brand damage, violation of privacy laws, loss of confidence, potential liability and competitive disadvantage.

Risks Related to ~~This~~Marketing ~~Offering~~Approval and Other Legal Compliance Matters

~~The~~Even ~~number~~if ofwe ~~shares~~complete ~~being~~the ~~registered~~necessary ~~for~~preclinical ~~resale~~studies and clinical trials, the marketing approval process is ~~significant~~expensive, intime ~~relation~~consuming toand uncertain and may prevent us or any future collaborators from obtaining approvals for the ~~number~~commercialization of our ~~outstanding~~current ~~shares~~or offuture ~~Common~~product ~~Stock~~candidates. As a result, we cannot predict when or if, and in which territories, we, or any future collaborators, will obtain marketing approval to commercialize a product candidate.

WeThe ~~have~~research, ~~filed~~testing, amanufacturing, ~~registration~~labeling, ~~statement~~approval, ofselling, ~~which~~marketing, ~~this~~promotion ~~prospectus~~and isdistribution aof ~~part~~biopharmaceutical products are subject to ~~register~~extensive regulation by the ~~shares~~FDA ~~offered~~and ~~hereunder~~comparable ~~for~~foreign ~~sale~~regulatory ~~into~~authorities such as the ~~public~~EMA, which regulations differ from country to country. We, and any future collaborators, are not permitted to market byour ~~the~~product ~~Selling~~candidates ~~Stockholders~~in the U.S. ~~These~~or ~~shares~~in ~~represent~~other acountries ~~large~~until ~~number~~we, ofor ~~shares~~they, receive approval of ~~our~~a ~~Common~~biologics ~~Stock~~license application (“BLA”), ~~and~~NDA ifor ~~sold~~marketing inauthorization from the ~~market~~FDA ~~all~~or atmarketing ~~once~~approval orfrom atapplicable ~~about~~regulatory authorities outside the ~~same~~U.S. ~~time,~~Product ~~could~~candidates ~~depress~~in the ~~market~~development ~~price~~phase are subject to the risks of failure inherent in drug development. We have not received marketing approval for any of our ~~Common~~product ~~Stock~~candidates ~~during~~in the ~~period~~U.S. or in any other jurisdiction. We have limited experience in filing and supporting the ~~registration~~applications ~~statement~~necessary ~~remains~~to ~~effective~~gain marketing approvals and ~~could~~expect ~~also~~to ~~affect~~rely ~~our~~on ~~ability~~third parties, including third-party clinical research and regulatory consultants, to ~~raise~~assist ~~equity~~us ~~capital~~in this process.

The process of obtaining marketing approvals, both in the U.S. and abroad, is lengthy, expensive and uncertain. It may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information, including manufacturing information, to regulatory authorities for each therapeutic indication

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to establish the product candidate’s safety and efficacy. The FDA or other regulatory authorities may determine that our product candidates are not safe and effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use.

We will need to carefully review the guidance and advice that FDA and other regulatory and scientific authorities in foreign jurisdictions, including the Committee for Medicinal Products for Human Use (“CHMP”), provide in any meetings we have with those authorities to discuss our clinical development programs. Sponsors are given opportunities to meet with the FDA and other regulatory bodies at certain points in their development programs. At the conclusion of these meetings, the FDA and comparable regulatory authorities provide responses to questions posed by the sponsor regarding the clinical development program. They will not indicate whether an application will be approved, but will provide guidance to the sponsor on various questions, including what types of studies and data are likely necessary to support review and potential approval of an NDA, BLA or marketing authorization. For example, the FDA may express support for the sponsor’s approach in the clinical development program but indicate that questions concerning whether the data support approval will be subject to review by the agency following its acceptance for filing of the NDA or BLA. While such guidance is not legally binding, our failure to carefully consider these recommendations for the design of a clinical program may put the program at significant risk of failure.

Further, the FDA or other comparable foreign regulatory authorities may determine that we must provide additional evidence of safety or efficacy before approving a BLA, NDA or marketing authorization for our product candidates. For example, the FDA reviews an application to determine whether there is “substantial evidence” to support a finding of efficacy for the proposed product for its intended use(s). The FDA has interpreted this evidentiary standard to generally require at least two adequate and well-controlled clinical trials to establish efficacy of a new product. Under certain circumstances, however, the FDA has indicated that a single trial with certain characteristics and additional confirmatory evidence may satisfy this standard. The FDA issued draft guidance in September 2023 that outlines considerations for relying on confirmatory evidence in lieu of a second clinical trial to demonstrate efficacy. In the event that we submit a BLA, NDA or marketing authorization on the basis of one clinical trial and confirmatory evidence, the FDA or other comparable foreign regulatory authorities could determine that such information is not sufficient to support approval of the application and the agencies could require us to conduct an additional trial in support of the BLA, NDA or marketing authorization. In addition, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may be impacted.

Further, in January 2022, the new Clinical Trials Regulation (EU) No 536/2014 became effective in the EU and replaced the prior Clinical Trials Directive 2001/20/EC. This regulation aims at simplifying and streamlining the authorization, conduct and transparency of clinical trials in the EU. Under the coordinated procedure for the approval of clinical trials, the sponsor of a clinical trial to be conducted in more than one EU member state will only be required to submit a single application for approval. The submission will be made through the Clinical Trials Information System, a clinical trials portal overseen by the EMA and available to clinical trial sponsors, competent authorities of the EU member states and the public. If we seek approval of our clinical trials in the EU pursuant to this regulation, there can be no assurance that we will be able to secure such an authorization for our product candidates.

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

Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we, or any future collaborators, ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

Further, under the Pediatric Research Equity Act, an NDA or BLA, or supplement to an NDA or BLA, for certain drugs and biological products must contain data to assess the safety and efficacy of the drug or biological product in all relevant pediatric

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subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective, unless the sponsor receives a deferral or waiver from the FDA. A deferral may be granted for several reasons, including a finding that the product or therapeutic candidate is ready for approval for use in adults before pediatric trials are complete or that additional safety or efficacy data needs to be collected before the pediatric trials begin. The applicable legislation in the EU also requires sponsors to either conduct clinical trials in a pediatric population in accordance with a Pediatric Investigation Plan approved by the Pediatric Committee of the EMA or to obtain a waiver or deferral from the conduct of these studies by this Committee. For any of our product candidates for which we are seeking marketing approval in the U.S. or Europe, we cannot guarantee that we will be able to obtain a waiver or alternatively complete any required studies and other requirements in a timely manner, or at all, which could result in associated reputational harm and subject us to enforcement action.

Any delay in obtaining or failure to obtain required approvals could negatively affect our ability or that of any future collaborators to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price.

Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad. Any approval we may be granted for our product candidates in the U.S. would not assure approval of our product candidates in foreign jurisdictions and any of our product candidates that may be approved for marketing in a foreign jurisdiction will be subject to risks associated with foreign operations.

In order to market and sell our products in the EU and other foreign jurisdictions, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain U.S. approval. The marketing approval process outside the U.S. generally includes similar risks as associated with obtaining FDA approval. We, and any future collaborators, may not obtain approvals from regulatory authorities outside the U.S. on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the U.S. does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. We may file for marketing approvals but not receive necessary approvals to commercialize our products in any market.

In many countries outside the U.S., a product candidate must also be approved for reimbursement before it can be sold in that country. In some cases, the price that we intend to charge for our products, if approved, is also subject to approval. Obtaining non-U.S. marketing approvals and compliance with non-U.S. regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our product candidates in certain countries. In addition, if we fail to obtain the non-U.S. approvals required to market our product candidates outside the U.S. or if we fail to comply with applicable non-U.S. regulatory requirements, our target markets will be reduced and our ability to realize the full market potential of our product candidates will be harmed and prospects may be adversely affected.

Additionally, we could face heightened risks with respect to obtaining marketing authorization in the United Kingdom (“UK”) as a result of the withdrawal of the UK from the EU, commonly referred to as “Brexit.” The UK is no longer part of the European Single Market and EU Customs Union. As of January 1, 2025, UK Medicines and Healthcare products Regulatory Agency (“MHRA”), is responsible for approving all medicinal products destined for the UK market (i.e., Great Britain and Northern Ireland). At the same time, a new international recognition procedure (“IPR”) will apply, which intends to facilitate approval of pharmaceutical products in the UK. The IRP is open to applicants that have already received an authorization for the same product from one of the MHRA’s specified Reference Regulators (“RRs”). The RRs notably include the EMA and regulators in the EU/European Economic Area (“EEA”), member states for approvals in the EU centralized procedure and mutual recognition procedure, as well as the FDA (for product approvals granted in the U.S.). Any delay in obtaining, or an inability to obtain, any approvals may force us or our collaborators to restrict or delay efforts to seek marketing approval in the UK for our product candidates, which could significantly and materially harm our business.

In addition, foreign regulatory authorities may change their approval policies and new regulations may be enacted. For instance, EU pharmaceutical legislation is currently undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020. The European Commission’s proposal for revision of several legislative instruments related to medicinal products (among other things, potentially reducing the duration of regulatory data protection and revising the eligibility for expedited pathways) was published in April 2023. The proposed revisions remain to be agreed and adopted by the European Parliament and European Council and the proposals may therefore be substantially revised before

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adoption, which is not anticipated before 2026. The revisions may however have a significant impact on the pharmaceutical industry and our business in the long term.

We expect that we will be subject to additional risks in commercializing any of our product candidates that receive marketing approval outside the U.S., including tariffs, trade barriers and regulatory requirements; economic weakness, including inflation, or political instability in particular foreign economies and markets (such as the war between Ukraine and Russia and the conflict in the Middle East); compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; and workforce uncertainty in countries where labor unrest is more common than in the U.S..

Any product candidate for which we obtain marketing approval would remain subject to ongoing regulation and could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements, when and if any of our product candidates are approved.

Any product candidate for which we obtain marketing approval will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to quality control and manufacturing, quality assurance and corresponding maintenance of records and documents, and requirements regarding the distribution of samples to physicians and recordkeeping. In addition, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine, including the requirement to implement a REMS. Accordingly, if we receive marketing approval for one or more of our product candidates, we will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control. If we fail to comply with these requirements, we could have the marketing approvals for our products withdrawn by regulatory authorities and our ability to market any products could be limited, which could adversely affect our ability to achieve or sustain profitability.

We must also comply with requirements concerning advertising and promotion for any product candidate for which we obtain marketing approval. Promotional communications with respect to prescription products are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling. The FDA and other agencies, including the Department of Justice, closely regulate and monitor the post-approval marketing and promotion of products to ensure that they are marketed and distributed only for the approved indications and in accordance with applicable laws.

In addition, later discovery of previously unknown adverse events or other problems with our products or their manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

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restrictions on such products, manufacturers or manufacturing processes;

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restrictions on the labeling or marketing of a product;

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restrictions on distribution or use of a product;

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requirements to conduct post-marketing studies or clinical trials;

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warning letters or untitled letters;

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withdrawal of the products from the market;

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refusal to approve pending applications or supplements to approved applications that we submit;

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recall of products;

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damage to relationships with collaborators;

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unfavorable press coverage and damage to our reputation;

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fines, restitution or disgorgement of profits or revenues;

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suspension or withdrawal of marketing approvals;

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refusal to permit the import or export of our products;

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product seizure;

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injunctions or the imposition of civil or criminal penalties; and

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litigation involving patients using our products.

Non-compliance with EU requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with the EU’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions. Further, the marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the EU and are also subject to EU member state laws. Direct-to-consumer advertising of prescription medicines is prohibited across the EU.

Accordingly, assuming we, or any future collaborators, receive marketing approval for one or more of our product candidates, we, and any future collaborators, and our and their contract manufacturers will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control. If we, and any future collaborators, are not able to comply with post-approval regulatory requirements, our or any future collaborators’ ability to market any future products could be limited, which could adversely affect our ability to achieve or sustain profitability. Further, the cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition.

We may seek certain designations for our product candidates, including Breakthrough Therapy, Regenerative Medicine Advanced Therapy (“RMAT”), Fast Track and Priority Review designations in the U.S., and the PRIority MEdicines (“PRIME”) designation in the EU, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.

We may seek certain designations for one or more of our product candidates that could expedite review and approval by the FDA. A Breakthrough Therapy and RMAT product is defined as a product that is intended, alone or in combination with one or more other products, to treat a serious condition, and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For products that have been designated as Breakthrough and RMAT therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens.

The FDA may also designate a product for Fast Track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. For Fast Track products, sponsors may have greater interactions with the FDA and the FDA may initiate review of sections of a Fast Track product’s application before the application is complete. This rolling review may be available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a Fast Track product may be effective.

We may also seek a Priority Review designation for one or more of our product candidates. If the FDA determines that a product candidate would provide a significant improvement in safety or efficacy, the FDA may designate the product candidate for priority review. A priority review designation means that the goal for the FDA to review an application is six months, rather than the standard review period of ten months.

These designations are within the discretion of the FDA. Accordingly, even if we believe that one of our product candidates meets the criteria for these designations, the FDA may disagree and instead determine not to make such designation. Further, even if we receive a designation, the receipt of such designation for a product candidate may not result in a faster development or regulatory review or approval process compared to products considered for approval under conventional FDA procedures and does not assure

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ultimate approval by the FDA. In addition, even if one or more of our product candidates qualifies for these designations, the FDA may, among other things, later decide that the product candidates no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. Further, obtaining any of these designations does not assure or increase the likelihood of the marketing approval by the FDA.

In the EU, we may seek PRIME designation for some of our product candidates in the future. PRIME is a voluntary program aimed at enhancing the EMA’s role to reinforce scientific and regulatory support in order to optimize development and enable accelerated assessment of new medicines that are of major public health interest with the potential to address unmet medical needs. The program focuses on medicines that target conditions for which there exists no satisfactory method of treatment in the EU or even if such a method exists, it may offer a major therapeutic advantage over existing treatments. PRIME is limited to medicines under development and not authorized in the EU and the applicant intends to apply for an initial marketing authorization application through the centralized procedure. To be accepted for PRIME, a product candidate must meet the eligibility criteria in respect of its major public health interest and therapeutic innovation based on information that is capable of substantiating the claims. The benefits of a PRIME designation include the appointment of a CHMP rapporteur to provide continued support and help to build knowledge ahead of a marketing authorization application, early dialogue and scientific advice at key development milestones, and the potential to qualify products for accelerated review, meaning reduction in the review time for an opinion on approvability to be issued earlier in the application process. PRIME enables an applicant to request parallel EMA scientific advice and health technology assessment advice to facilitate timely market access. Even if we receive PRIME designation for any of our product candidates, the designation may not result in a materially faster development process, review or approval compared to conventional EMA procedures. Further, obtaining PRIME designation does not assure or increase the likelihood of EMA’s grant of a marketing authorization.

We may seek approval of our product candidates from the FDA or comparable foreign regulatory authorities through the use of accelerated development pathways. If we are not able to use such pathways, we may be required to conduct additional clinical trials beyond those that are contemplated, which would increase the expense of obtaining, and delay or prevent the receipt of, necessary marketing approvals. Moreover, even if we receive accelerated approval from the FDA or comparable foreign regulatory authorities, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA or comparable foreign regulatory authorities may seek to withdraw accelerated approval.

Under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and implementing regulations, the FDA may grant accelerated approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit measurement of a therapeutic effect that is considered reasonably likely to predict the clinical benefit. Prior to seeking such accelerated approval, we will continue to seek feedback from the FDA or comparable foreign regulatory agencies and otherwise evaluate our, or their, ability to seek and receive such accelerated approval.

There can be no assurance that the FDA or foreign regulatory agencies will agree with our surrogate endpoints or intermediate clinical endpoints in any of our clinical trials, or that we will decide to pursue or submit any additional NDAs or BLAs seeking accelerated approval. Similarly, there can be no assurance that, after feedback from the FDA or comparable foreign regulatory agencies, we will continue to pursue or apply for accelerated approval. Furthermore, for any submission of an application for accelerated approval, there can be no assurance that such submission will be accepted for filing or that any expedited development, review or approval will be granted on a timely basis, or at all. Finally, there can be no assurance that we will satisfy all FDA requirements, including new provisions, that govern accelerated approval.

In the EU, a “conditional” marketing authorization may be granted in cases where all the required safety and efficacy data are not yet available. A conditional marketing authorization is subject to conditions to be fulfilled for generating missing data or ensuring increased safety measures. A conditional marketing authorization is valid for one year and has to be renewed annually until fulfillment of all relevant conditions. Once the applicable pending studies are provided, a conditional marketing authorization can become a “standard” marketing authorization. However, if the conditions are not fulfilled within the timeframe set by the EMA, the marketing authorization will cease to be renewed.

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Accordingly, a failure to obtain and maintain accelerated approval or any other form of expedited development, review or approval for our product candidates, or withdrawal of a product candidate, would result in a longer time period until commercialization of such product candidate, could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.

We may seek a priority review voucher (“PRV”), for our current and future product candidates. A BLA or NDA for our current and future product candidates will not, however, meet the eligibility criteria for a PRV, unless we secure the applicable designation and approval of the BLA or NDA for the product candidate.

Congress has authorized the FDA to award PRVs to sponsors of certain drugs for tropical diseases or rare pediatric diseases or to use as medical countermeasures that meet the criteria specified in the law. This provision is designed to encourage development of new drug and biological products for prevention and treatment of certain tropical diseases, rare pediatric diseases and illnesses related to public health emergencies. Specifically, under this program, a sponsor who receives approval for a new drug or biologic for a tropical diseases, rare pediatric diseases or illnesses related to a public health emergency may qualify for a PRV, which can be redeemed for priority review of a subsequent marketing application for a different product. The sponsor that receives a PRV may transfer, including by sale, the PRV to another sponsor and that PRV may be further transferred any number of times before it is used. A PRV entitles the holder to designate a single human drug application submitted under Section 505(b)(1) of the FDCA or Section 351 of the Public Health Service Act as qualifying for a priority review. An FDA priority review may expedite the review process of a marketing application reducing the review time from ten months after formal acceptance of the file to six months after formal acceptance of the file.

In order for a sponsor to receive a PRV in connection with approval of a BLA or NDA, the BLA or NDA must be for a product that does not include a previously approved active ingredient in addition to meeting other applicable requirements.

We and our contract manufacturers are subject to significant regulation. The manufacturing facilities on which we rely may not continue to meet regulatory requirements, which could materially harm our business.

All entities involved in the preparation of product candidates, including drug substance, drug product and device combinations that may be used in combination with our product candidates, for clinical trials or commercial sale, including any contract manufacturers, are subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMPs. These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants or to inadvertent changes in the properties or stability of our product candidates that may not be detectable in final product testing.

We or our contract manufacturers must supply all necessary documentation in support of a BLA or NDA on a timely basis and must adhere to the FDA’s current good laboratory practices and cGMP regulations enforced through its facilities inspection program. Our facilities and quality systems and the facilities and quality systems of some or all of our contract manufacturers must pass a pre-approval inspection for compliance with the applicable regulations as a condition of marketing approval of any product candidate. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of our product candidates or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If these facilities do not pass a pre-approval plant inspection, FDA approval of the products will not be granted.

The regulatory authorities also may, at any time following approval of a product for sale, audit our manufacturing facilities or those of our contract manufacturers. If any such inspection or audit identifies failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time-consuming for us or a third-party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility, which may lead to temporary or permanent supply shortages. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business.

If we or our third-party manufacturers fail to maintain regulatory compliance, the FDA can impose regulatory sanctions including, among other things, refusal to approve a pending application for a new product, or revocation of a pre-existing approval. Any such consequence would severely harm our business, financial condition and results of operations.

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Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, competing priorities or other disruptions to these agencies’ operations, and regulatory reform efforts, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the FDA have fluctuated in recent years as a result. Disruptions at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. In addition, government funding of the SEC and other government agencies, including government agencies and regulatory authorities outside the U.S., on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. Further, while the FDA’s review of NDAs and BLAs is funded by the user fee program established under the Prescription Drug User Fee Act (“PDUFA”), the Trump Administration has indicated that it will be reviewing that program and its implementation.

In addition, disruptions may result from events similar to the COVID-19 pandemic. During the COVID-19 pandemic, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications. In the event of a similar public health emergency in the future, the FDA may not be able to continue its current pace and review timelines could be extended. Regulatory authorities outside the U.S. facing similar circumstances may adopt similar restrictions or other policy measures in response to a similar public health emergency and may also experience delays in their regulatory activities.

Disruptions or competing priorities at the FDA and other agencies may also slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

If a prolonged government shutdown or other disruption occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Future shutdowns or other disruptions could also affect other government agencies such as the SEC, which may also impact our business by delaying review of our public filings, to the extent such review is necessary, and our ability to access the public markets.

Current and future legislation may increase the difficulty and cost for us to obtain reimbursement for any of our product candidates that do receive marketing approval.

In the U.S. and foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we may receive for any approved products. If reimbursement of our products is unavailable or limited in scope, our business could be materially harmed.

We expect that recent healthcare reforms, as well as other healthcare reform measures that may be adopted in the future, may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product and/or the level of reimbursement physicians receive for administering any approved product we might bring to market. Reductions in reimbursement levels may negatively impact the prices we receive or the frequency with which our products are prescribed or administered. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. Accordingly, such reforms, if enacted, could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain marketing approval and may affect our overall financial condition and ability to develop or commercialize product candidates.

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At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. This is increasingly true with respect to products approved pursuant to the accelerated approval pathway. State Medicaid programs and other payers are developing strategies and implementing significant coverage barriers, or refusing to cover these products outright, arguing that accelerated approval drugs have insufficient or limited evidence despite meeting the FDA’s standards for accelerated approval. In addition, regional healthcare organizations and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.

In the EU, similar political, economic and regulatory developments may affect our ability to profitably commercialize our product candidates, if approved. In markets outside of the U.S. and the EU, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. In many countries, including those of the EU, the pricing of prescription pharmaceuticals is subject to governmental control and access. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we or our collaborators may be required to conduct a clinical trial that compares the cost-effectiveness of our product to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be materially harmed.

The insurance coverage and reimbursement status of newly approved products is uncertain. Our product candidates, if approved, may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain coverage and adequate reimbursement for any of our product candidates for which we obtain approval could limit our ability to market those products and decrease our ability to generate revenue.

The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drugs and other medical products vary widely from country to country. In the U.S., healthcare reform legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a product before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenue we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more products or product candidates, even if any product candidates we may develop obtain marketing approval.

Our ability to successfully commercialize our products and product candidates also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. Sales of any product we successfully develop will depend substantially, both domestically and abroad, on the extent to which the costs of such product will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. If coverage and adequate reimbursement is not available, or is available only to limited levels or only after clearing significant barriers, such as the requirement to fail on other products before providing reimbursement, we may not be able to successfully

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commercialize any product we may successfully develop. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. In general, the prices of medicines under such systems are substantially lower than in the U.S. Other countries allow companies to fix their own prices for medicines, but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for any product we may successfully develop. Accordingly, in markets outside the U.S., the reimbursement for products may be reduced compared with the U.S. and may be insufficient to generate commercially reasonable revenues and profits.

There is also significant uncertainty related to the insurance coverage and reimbursement of newly approved products and coverage may be more limited than the purposes for which the medicine is approved by the FDA or comparable foreign regulatory authorities. In the U.S., the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare and Medicaid Services (“CMS”). CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. No uniform policy of coverage and reimbursement for products exists among third-party payors and coverage and reimbursement levels for products can differ significantly from payer to payer. As a result, the coverage determination process is often a time consuming and costly process that may require us to provide scientific and clinical support for the use of any product we may successfully develop to each payer separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

In the Europe and in the rest of the world, pricing and reimbursement schemes vary widely from country to country and may be more conservative than CMS. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors any product we may successfully develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize product candidates and our overall financial condition.

Further, some countries provide that products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug candidate to currently available therapies or so-called health technology assessments, in order to obtain reimbursement or pricing approval. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any products, if approved in those countries.

Finally, net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the U.S. Our inability to promptly obtain coverage and profitable reimbursement rates from third-party payors for any product we may successfully develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Increasingly, third-party payors are requiring that pharmaceutical companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will be available for any product candidate that we commercialize and, if reimbursement is available, the level of reimbursement. Reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. In order to obtain reimbursement, physicians may need to show that patients have superior treatment outcomes with our products compared to standard of care drugs, including lower-priced generic versions of standard of care drugs. We may experience pricing pressures in connection with the sale of any of our product candidates, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.

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Healthcare providers, third-party payors and others will play a primary role in the recommendation and prescription of any products for which we obtain marketing approval. Our future arrangements with healthcare providers and third-party payors will expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any products for which we obtain marketing approval. Potentially applicable U.S. federal and state healthcare laws and regulations include the following:

Anti-Kickback Statute. 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 either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs 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.

False Claims Laws. The federal false claims laws, including the civil False Claims Act, impose criminal and civil penalties, including those from civil whistleblower or qui tam actions against individuals or entities for 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. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti- Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

HIPAA. The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal and civil liability for executing or attempting to execute a scheme to defraud any healthcare benefit program. In addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, also imposes obligations on certain types of individuals and entities, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.

False Statements Statute. The federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services.

Transparency Requirements. The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Department of Health and Human Services (“HHS”) information related to physician and healthcare provider payments and other transfers of value and physician ownership and investment interests.

Analogous State and Foreign Laws. Analogous state laws and regulations, such as state anti-kickback and false claims laws, and transparency 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, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, in addition to requiring manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures. Many state 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. Foreign laws also govern the privacy and security of health information in many circumstances.

The provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is prohibited in the EU. Payments made to physicians in certain EU member states must be publicly disclosed. Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and/or the regulatory authorities of the individual EU member states. These requirements are provided in the national laws, industry codes or professional codes of conduct applicable in the EU member states. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

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Efforts to ensure that our business arrangements with third parties, and our business generally, will comply with applicable healthcare laws and regulations will involve 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 be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, corporate integrity or other similar forms of agreements or decrees, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, and reputational harm, any of which could substantially disrupt our operations. If any of the physicians or other providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

We are subject to data privacy and protection laws and regulations that apply to the collection, transmission, storage and use of personally-identifying information, which among other things, impose certain requirements relating to the privacy, security and transmission of personal information, including comprehensive regulatory systems in the U.S., EU and the UK. The legislative and regulatory landscape for privacy and data protection continues to evolve in jurisdictions worldwide, and there has been an increasing focus on privacy and data protection issues with the potential to affect our business. Failure to comply with any of these laws and regulations could result in enforcement action against us, including fines, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.

There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information that may impact certain of our business operations. For example, regulations promulgated pursuant to HIPAA establish privacy and security standards that limit the use and disclosure of individually identifiable health information, or protected health information, and require the implementation of administrative, physical, and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity, and availability of electronic protected health information. Determining whether protected health information has been handled in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation. These obligations may be applicable to some or all of our business activities now or in the future.

If we fail to comply with applicable privacy laws, including applicable HIPAA privacy and security standards, we could face civil and criminal penalties. Enforcement activity can result in financial liability and reputational harm, and responses to such enforcement activity can consume significant internal resources. We cannot be sure how these regulations will be interpreted, enforced or applied to our operations. In addition to the risks associated with enforcement activities and potential contractual liabilities, our ongoing efforts to comply with evolving laws and regulations at the federal and state level may be costly and require ongoing modifications to our policies, procedures and systems.

In addition to potential enforcement by the HHS, we could also be potentially subject to privacy enforcement from the Federal Trade Commission (the “FTC”). The FTC has been particularly focused on the unpermitted processing of health and genetic data through its recent enforcement actions and is expanding the types of privacy violations that it interprets to be “unfair” under Section 5 of the FTC Act, as well as the types of activities it views to trigger the Health Breach Notification Rule (which the FTC also has the authority to enforce). The agency is also in the process of developing rules related to commercial surveillance and data security. We will need to account for the FTC’s evolving rules and guidance for proper privacy and data security practices in order to mitigate risk for a potential enforcement action, which may be costly. Finally, both the FTC and HHS’s enforcement priorities (as well as those of other federal regulators) may be impacted by the change in administration and new leadership. These shifts in enforcement priorities may also impact our business.

There are also increased restrictions at the federal level relating to transferring sensitive data outside of the U.S. to certain foreign countries. Failure to comply with these rules can lead to a potential FTC enforcement action. These data transfer restrictions (and others that may pass in the future) may create operational challenges and legal risks for our business.

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There also are state privacy and security laws that also may be applicable to our business activities now or in the future. These laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products.

Similar to the laws in the U.S., there are significant privacy and data security laws that apply in Europe and other countries which we will need to navigate.

Data privacy remains an evolving landscape at both the domestic and international level, with new regulations coming into effect and continued legal challenges, and our efforts to comply with the evolving data protection rules may be unsuccessful. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices. We must devote significant resources to understanding and complying with this changing landscape. Failure to comply with laws regarding data protection would expose us to risk of enforcement actions taken by data protection authorities in the EEA and elsewhere and carries with it the potential for significant penalties if we are found to be non-compliant. Similarly, failure to comply with federal and state laws in the U.S. regarding privacy and security of personal information could expose us to penalties under such laws. Any such failure to comply with data protection and privacy laws could result in government-imposed fines or orders requiring that we change our practices, claims for damages or other liabilities, regulatory investigations and enforcement action, litigation and significant costs for remediation, any of which could adversely affect our business. Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our business, financial condition, results of operations or prospects.

We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.

We are subject to the Foreign Corrupt Practices Act, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, third-party intermediaries, joint venture partners and collaborators from authorizing, promising, offering or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector. We may have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. In addition, we may engage third-party intermediaries to promote our clinical research activities abroad and/or to obtain necessary permits, licenses, and other regulatory approvals. We can be held liable for the corrupt or other illegal activities of these third-party intermediaries, our employees, representatives, contractors, partners and agents, even if we do not explicitly authorize or have actual knowledge of such activities.

Noncompliance with anti-corruption and anti-money laundering laws could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, suspension and/or debarment from contracting with certain persons, the loss of export privileges, reputational harm, adverse media coverage and other collateral consequences. If any subpoenas, investigations or other enforcement actions are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, results of operations and financial condition could be materially harmed. In addition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense and compliance costs and other professional fees. In certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor which can result in added costs and administrative burdens.

Various laws, regulations and executive orders also restrict the use and dissemination outside of the U.S., or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. Further, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order, or use of medicinal products is prohibited in the EU. The provision of benefits or advantages to physicians is also governed by the national anti-bribery laws of EU member states and the U.K. Bribery Act 2010. Violations of these laws could result in substantial fines and imprisonment. Payments made to physicians in certain EU member states must be publicly disclosed. Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization, and/or the regulatory authorities of the individual EU member states. These requirements are provided in the national laws, industry codes, or professional codes of conduct applicable in the EU member states. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines, or imprisonment.

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If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could significantly harm our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. From time to time and in the future, our operations may involve the use of hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste products. Even if we contract with third parties for the disposal of these materials and waste products, we cannot completely eliminate the risk of contamination or injury resulting from these materials. In the event of contamination or injury resulting from the use or disposal of our hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

We maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, but this insurance may not provide adequate coverage against potential liabilities. However, we do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us.

In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. Current or future environmental laws and regulations may impair our research, development or production efforts, which could adversely affect our business, financial condition, results of operations or prospects. In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions.

Our employees, independent contractors, CROs, consultants, contract manufacturers, commercial partners, vendors and principal investigators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

We are exposed to the risk of fraud or other misconduct by our employees, independent contractors, CROs, consultants, contract manufacturers, commercial partners, vendors and, if we commence clinical trials, our principal investigators. Misconduct by these parties could include intentional failures to comply with FDA regulations or the regulations applicable in the EU and other jurisdictions, provide accurate information to the FDA, the European Commission and other regulatory authorities, comply with healthcare fraud and abuse laws and regulations in the U.S. and abroad, report financial information or data accurately, or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

Such misconduct also could involve the improper use of information obtained in the course of clinical trials or interactions with the FDA or other regulatory authorities, which could result in regulatory sanctions and cause serious harm to our reputation. Even with appropriate policies and procedures, it is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent such activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition, results of operations and prospects, including the imposition of significant fines or other sanctions.

Risks Related to this Offering

The price of our common stock may be highly volatile.

The market price of our securities, like that of many other research and development public pharmaceutical and biotechnology companies, has been highly volatile and the price of our common stock may be volatile in the future due to a wide variety of factors, including:

●

announcements by us or others of results of pre-clinical testing and clinical trials;

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●

announcements of technological innovations, more important bio-threats or new commercial therapeutic products by us, our collaborative partners or our present or potential competitors;

● failure of our ~~Common~~common ~~Stock~~stock to continue to be listed or quoted on a national exchange or market system, such as Nasdaq or the New York Stock Exchange;

●

our quarterly operating results and performance;

●

developments or disputes concerning patents or other proprietary rights;

●

mergers or acquisitions;

●

litigation and government proceedings;

●

adverse legislation;

●

changes in government regulations;

●

our available working capital;

●

economic and other external factors; and

●

general market conditions.

Since January 1, ~~2023~~2024, the closing stock price of our ~~Common~~common ~~Stock~~stock has fluctuated between a high of $~~122~~15.4004 per share to a low of $21.0012 per share. On ~~July~~September 1915, ~~2024~~2025, the last reported sale price of our ~~Common~~common ~~Stock~~stock on The Nasdaq Capital Market was $62.0775 per share. The fluctuation in the price of our ~~Common~~common ~~Stock~~stock has sometimes been unrelated or disproportionate to our operating performance. In addition, potential dilutive effects of future sales of shares of ~~Common~~common ~~Stock~~stock and warrants by us, as well as potential sale of ~~Common~~common ~~Stock~~stock by the holders of warrants, ~~options~~ and ~~convertible promissory notes~~options, could have an adverse effect on the market price of our shares.

If we fail to regain compliance to meet Nasdaq’s listing requirements, we could be removed from The Nasdaq Capital Market, which would limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market and negatively impact our ability to raise capital.

Companies trading on Nasdaq, such as our Company, must be reporting issuers under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and must meet the listing requirements in order to maintain the listing of ~~Common~~common ~~Stock~~stock on The Nasdaq Capital Market. If we do not meet these requirements, the market liquidity for our securities could be severely adversely affected by limiting the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market.

On August 15, 2025, we received the Notice from Nasdaq advising us that we were not in compliance with the Stockholders’ Equity Requirement. Pursuant to the Notice, Nasdaq has gave us 45 calendar days from the date of the Notice, or until September 29, 2025, to submit to Nasdaq a plan to regain compliance. If our plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Notice to evidence compliance.

In order to regain compliance with the Shareholders’ Equity Requirement, we are offering the securities in this offering. We estimate (based upon assumptions we believe are reasonable) that we will have more than the required $2.5 million in shareholders’ equity as of the closing date provided we receive net proceeds of at least $3.4 million in this offering. There can be no assurance that we will be able to regain compliance with the Shareholders’ Equity Requirement, or that our common stock will remain listed on The Nasdaq Capital Market.

If our common stock is delisted from Nasdaq, it will have material negative impact on the actual and potential liquidity of our securities, as well as material negative impact on our ability to raise future capital. If, for any reason, Nasdaq should delist our common stock from trading on its exchange and we are unable to obtain listing on another national securities exchange or take action

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~~If our Common Stock is delisted from Nasdaq, it will have material negative impact on the actual and potential liquidity of our securities, as well as material negative impact on our ability~~ to raise future capital. If, for any reason, Nasdaq should delist our Common Stock from trading on its exchange and we are unable to obtain listing on another national securities exchange or take action to restore our compliance with the Nasdaq continued listing requirements, a reduction in some or all of the following may occur, each of which could have a material adverse effect on our shareholders:

● the liquidity of our ~~Common~~common ~~Stock~~stock;

● the market price of our ~~Common~~common ~~Stock~~stock;

●

our ability to obtain financing for the continuation of our operations;

●

the number of institutional and general investors that will consider investing in our securities;

● the number of market makers in our ~~Common~~common ~~Stock~~stock;

● the availability of information concerning the trading prices and volume of our ~~Common~~common ~~Stock~~stock; and

● the number of broker-dealers willing to execute trades in shares of our ~~Common~~common ~~Stock~~stock.

~~Shareholders~~Investors will experience immediate and substantial dilution as a result of this offering and may suffer substantial dilution related to issued stock warrants, ~~options~~ and ~~convertible promissory notes~~options.

AsInvestors will incur immediate and substantial dilution as a result of ~~July~~this offering. After giving effect to our sale in this offering of common stock, pre-funded warrants and common warrants in the aggregate amount of $8.0 million at an assumed public offering price of $2.75 per share of common stock and accompanying common warrant (assuming a public offering price equal to the last sale price of our common stock as reported by The Nasdaq Capital Market on September 1915, ~~2024~~2025, wewhich ~~have~~was $2.75 per share), and $2.749 per pre-funded warrant and accompanying common warrant (assuming a ~~number~~public offering price equal to the last sale price of ~~agreements~~our orcommon ~~obligations~~stock ~~that~~as ~~may~~reported ~~result~~by The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share), and after deducting estimated offering expenses payable by us, investors in this offering can expect an immediate dilution toof ~~investors~~$1.34 ~~These~~per ~~include:~~share of common stock. See “Dilution.”

●As ~~1,054,688 shares~~ of ~~Common~~September 15, ~~Stock~~2025, ~~issuable~~we ~~upon~~have ~~the~~a ~~exercise~~number of ~~outstanding~~agreements ~~July~~or ~~2024~~obligations ~~Warrants~~that atmay aresult ~~weighted~~in ~~average~~dilution ~~price~~to ~~of $6~~investors.00 ~~per~~These ~~share, of which warrants to purchase 1,054,688 shares are exercisable as of July 19, 2024;~~include:

● 41,~~566~~467,581 shares of ~~Common~~common ~~Stock~~stock issuable upon the exercise of outstanding warrants ~~(other than the July 2024 Warrants)~~ at a weighted average price of $611.4001 per share, of which warrants to purchase 41,~~566~~467,581 shares are exercisable as of ~~July~~September 1915, ~~2024~~2025;

● ~~56,699~~options ~~shares~~to ofpurchase ~~Common~~approximately ~~Stock~~300,467 ~~issuable~~shares ~~upon the exercise~~ of ~~outstanding~~our ~~options~~common stock at a current weighted average exercise price of $8416.6570 ~~per share, of which options to purchase 23,959 shares of Common Stock are vested~~ as of ~~July~~September 1915, ~~2024~~2025; and

● 5,~~051~~929,~~688~~412 shares of ~~Common~~common ~~Stock~~stock available for future issuance under our ~~2015~~2025 Equity Incentive Plan as of ~~July~~September 1915, ~~2024; and~~2025.

●We ~~shares~~also ~~issuable~~have ~~upon~~an ~~the~~incentive ~~conversion~~compensation ofplan $2for our management,~~059,309~~ ofemployees ~~principal~~and consultants. We have granted, and $9expect to grant in the future,~~080~~ ofoptions ~~accrued~~to ~~interest~~purchase asshares of ~~July~~our 19common stock to our directors, ~~2024~~employees ~~under~~and ~~convertible~~consultants. ~~promissory~~To ~~notes,~~the ~~which~~extent ~~may~~that bewarrants or options are exercised or converted, atour ~~$27.20~~stockholders ~~per~~will ~~share~~experience dilution and our stock price may decrease.

~~We also have an incentive compensation plan for our management~~Additionally, ~~employees~~the ~~and consultants. We have granted~~sale, ~~and~~or ~~expect~~even tothe ~~grant~~possibility inof the ~~future~~sale, ~~options~~of tothe ~~purchase~~ shares of ~~our~~common ~~Common~~stock ~~Stock~~underlying tothese ~~our~~warrants ~~directors, employees~~ and ~~consultants.~~options Tocould ~~the~~have ~~extent~~an ~~that~~adverse ~~warrants,~~effect ~~options~~on orthe ~~convertible~~market ~~promissory~~price ~~notes~~for ~~are~~our ~~exercised~~securities or ~~converted,~~on our ~~stockholders~~ability ~~will~~to ~~experience~~obtain ~~dilution~~future ~~and our stock price may decrease~~financing.

30Our shares of common stock are thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares to raise money or otherwise desire to liquidate their shares.

Our common stock has from time to time been “thinly-traded,” meaning that the number of persons interested in purchasing our common stock at or near ask prices at any given time may be relatively small or non-existent. This situation is attributable to a number of factors, including the fact that we are a small company that is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of

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~~Additionally~~such persons, ~~the~~they ~~sale,~~tend to be risk-averse and would be reluctant to follow an unproven company such as ours or ~~even~~purchase or recommend the ~~possibility~~purchase of ~~the~~our ~~sale~~shares until such time as we become more seasoned and viable. As a consequence, ofthere ~~the~~may ~~shares~~be periods of ~~Common~~several days ~~Stock~~or ~~underlying~~more ~~these~~when ~~warrants~~trading activity in our shares is minimal or non-existent, ~~options~~as compared to a seasoned issuer which has a large and ~~convertible~~steady ~~promissory~~volume ~~notes~~of ~~could~~trading ~~have~~activity that will generally support continuous sales without an adverse effect on ~~the~~share ~~market~~ price. We cannot give stockholders any assurance that a broader or more active public trading market for our ~~securities~~common shares will develop or onbe ~~our~~sustained, ~~ability~~or tothat ~~obtain~~current ~~future~~trading ~~financing~~levels will be sustained.

~~Our~~We ~~shares~~do ofnot ~~Common~~currently ~~Stock~~intend ~~are~~to ~~thinly~~pay ~~traded,~~dividends soon ~~stockholders~~our ~~may~~common bestock ~~unable~~in tothe ~~sell~~foreseeable atfuture, orand ~~near~~consequently, ~~ask~~our ~~prices~~stockholders’ orability atto ~~all~~achieve ifa ~~they~~return ~~need~~on totheir ~~sell~~investment ~~shares~~will todepend ~~raise~~on ~~money~~appreciation orin ~~otherwise~~the ~~desire~~price toof ~~liquidate~~our ~~their~~common ~~shares~~stock.

~~Our~~We ~~Common~~have ~~Stock~~never ~~has~~declared ~~from~~or ~~time~~paid tocash ~~time~~dividends ~~been~~on ~~“thinly-traded,” meaning that the number of persons interested in purchasing~~ our ~~Common~~common ~~Stock~~stock atand ordo ~~near~~not ~~ask~~anticipate ~~prices~~paying at any ~~given~~cash ~~time~~dividends ~~may be relatively small or non-existent. This situation is attributable~~ to aholders ~~number~~ of ~~factors,~~our ~~including~~common ~~the fact that we are a small company that is relatively unknown to~~ stock ~~analysts, stock brokers, institutional investors and others~~ in the ~~investment~~foreseeable ~~community~~future. ~~that generate or influence sales volume~~Consequently, ~~and~~our ~~that~~stockholders ~~even~~must ifrely weon ~~came~~sales ~~to the attention~~ of ~~such~~their ~~persons,~~common ~~they~~stock ~~tend~~after toprice beappreciation, ~~risk-averse~~which ~~and~~may ~~would~~never beoccur, ~~reluctant to follow an unproven company such~~ as ~~ours or purchase or recommend~~ the ~~purchase~~only ofway ~~our~~to ~~shares~~realize ~~until~~any ~~such~~future ~~time~~gains ason wetheir ~~become more seasoned and viable~~investments. AsThere ais ~~consequence,~~no ~~there~~guarantee ~~may~~that beshares ~~periods~~ of ~~several days~~our orcommon ~~more~~stock ~~when~~will ~~trading~~appreciate ~~activity~~ in ~~our~~value ~~shares is minimal~~ or ~~non-existent,~~even asmaintain ~~compared~~the toprice aat ~~seasoned issuer~~ which ~~has~~our ~~a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give~~ stockholders ~~any~~have ~~assurance~~purchased ~~that~~their ~~a broader or more active public trading market for our common~~ shares ~~will develop or be sustained, or that current trading levels will be sustained~~.

We do not currently intend to pay dividends on our Common Stock in the foreseeable future, and consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our Common Stock.

We have never declared or paid cash dividends on our Common Stock and do not anticipate paying any cash dividends to holders of our Common Stock in the foreseeable future. Consequently, our stockholders must rely on sales of their Common Stock after price appreciation, which may never occur, as the only way to realize any future gains on their investments. There is no guarantee that shares of our Common Stock will appreciate in value or even maintain the price at which our stockholders have purchased their shares.

Upon our dissolution, our stockholders may not recoup all or any portion of their investment.

In the event of our liquidation, dissolution or winding-up, whether voluntary or involuntary, the proceeds and/or our assets remaining after giving effect to such transaction, and the payment of all of our debts and liabilities will be distributed to the holders of ~~Common~~common ~~Stock~~stock on a pro rata basis. There can be no assurance that we will have available assets to pay to the holders of ~~Common~~common ~~Stock~~stock, or any amounts, upon such a liquidation, dissolution or winding-up. In this event, our stockholders could lose some or all of their investment.

The issuance of our ~~Common~~common ~~Stock~~stock pursuant to the terms of the asset purchase agreement with Hy Biopharma Inc. may cause dilution and the issuance of such shares of ~~Common~~common ~~Stock~~stock, or the perception that such issuances may occur, could cause the price of our ~~Common~~common ~~Stock~~stock to fall.

On April 1, 2014, we entered into an option agreement pursuant to which Hy Biopharma Inc. (“Hy Biopharma”) granted us an option to purchase certain assets, properties and rights (the “Hypericin Assets”) related to the development of Hy Biopharma’s synthetic hypericin product candidate for the treatment of CTCL, which we refer to as HyBryte™, from Hy Biopharma. In exchange for the option, we paid $50,000 in cash and issued ~~288~~18 shares of ~~Common~~common ~~Stock~~stock in the aggregate to Hy Biopharma and its assignees. We subsequently exercised the option, and on September 3, 2014, we entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Hy Biopharma, pursuant to which we purchased the Hypericin Assets. Pursuant to the Asset Purchase Agreement, we initially paid $275,000 in cash and issued ~~12,328~~771 shares of ~~Common~~common ~~Stock~~stock in the aggregate to Hy Biopharma and its assignees, and the licensors of the license agreement acquired from Hy Biopharma. Also, on September 3, 2014, we entered into a Registration Rights Agreement with Hy Biopharma, pursuant to which we may be required to file a registration statement with the SEC. In March 2020, we issued ~~130~~8,~~413~~151 shares of ~~Common~~common ~~Stock~~stock at a value of $5,000,000 (based upon an effective per share price of $38614.40 as a result of HyBryte™ demonstrating statistically significant treatment response in the Phase 3 clinical trial. We will be required to issue up to $5.0 million worth of our common stock (subject to a cap equal to 19.9% of our issued and outstanding common stock) in the aggregate, if HyBryte™ is approved for the treatment of CTCL by either the FDA or the EMA.

31The number of shares that we may issue under the Asset Purchase Agreement will fluctuate based on the market price of our common stock. Depending on market liquidity at the time, the issuance of such shares may cause the trading price of our common stock to fall.

We may ultimately issue all, some or none of the additional shares of our common stock that may be issued pursuant to the Asset Purchase Agreement. We are required to register any shares issued pursuant to the Asset Purchase Agreement for resale under the Securities Act. After any such shares are registered, the holders will be able to sell all, some or none of those shares. Therefore, issuances by us under the Asset Purchase Agreement could result in substantial dilution to the interests of other holders of our common stock. Additionally, the issuance of a substantial number of shares of our common stock pursuant to the Asset Purchase Agreement, or the anticipation of such issuances, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

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asOur aBoard ~~result~~ of ~~HyBryte™~~Directors ~~demonstrating~~can, ~~statistically~~without ~~significant~~stockholder ~~treatment~~approval, ~~response~~cause inpreferred ~~the~~stock ~~Phase~~to ~~3 clinical trial. We will~~ be ~~required~~issued toon ~~issue~~terms upthat toadversely ~~$5.0~~affect ~~million~~holders ~~worth~~ of our ~~Common~~common ~~Stock (subject to a cap equal to 19~~stock.~~9% of our issued and outstanding Common Stock) in the aggregate, if HyBryte™ is approved for the treatment of CTCL by either the FDA or the EMA.~~

~~The~~Under ~~number~~our Certificate of ~~shares~~Incorporation, ~~that~~our weBoard ~~may~~of Directors is authorized to issue ~~under~~up ~~the~~to ~~Asset~~350,000 ~~Purchase~~shares ~~Agreement~~of ~~will~~preferred ~~fluctuate~~stock, ~~based~~of onwhich none are issued and outstanding as of the ~~market~~date of this prospectus. Also, our Board of Directors, without stockholder approval, may determine the price, rights, preferences, privileges and restrictions, including voting rights, of those shares. If our ~~Common~~Board ~~Stock~~of Directors causes shares of preferred stock to be issued, the rights of the holders of our common stock would likely be subordinate to those of preferred holders and therefore could be adversely affected. ~~Depending~~Our onBoard ~~market~~of ~~liquidity~~Directors’ atability to determine the ~~time~~terms of preferred stock and to cause its issuance, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, could have the ~~issuance~~effect of ~~such~~making it more difficult for a third-party to acquire a majority of our outstanding common stock. Preferred shares ~~may~~issued ~~cause~~by our Board of Directors could include voting rights or super voting rights, which could shift the ~~trading~~ability to control the Company to the holders of the preferred stock. Preferred stock could also have conversion rights into shares of our common stock at a discount to the market price of our ~~Common~~common ~~Stock~~stock, which could negatively affect the market for our common stock. In addition, preferred stock would have preference in the event of liquidation of the Company, which means that the holders of preferred stock would be entitled to ~~fall~~receive the net assets of the Company distributed in liquidation before the holders of our common stock receive any distribution of the liquidated assets.

WeOur ~~may~~management ~~ultimately~~will ~~issue~~have ~~all,~~broad ~~some~~discretion orover ~~none of~~ the ~~additional~~use ~~shares~~ of ~~our Common Stock that may be issued pursuant to~~ the ~~Asset~~net ~~Purchase~~proceeds ~~Agreement.~~from Wethis ~~are~~offering ~~required~~and towe ~~register~~may ~~any~~use ~~shares issued pursuant to~~ the ~~Asset~~net ~~Purchase~~proceeds Agreement for resale under the Securities Act. After any such shares are registered, the holders will be able to sell all, some or none of those shares. Therefore, issuances by us under the Asset Purchase Agreement could result in ~~substantial~~ways ~~dilution~~with towhich ~~the~~you ~~interests~~disagree ~~of other holders of our Common Stock. Additionally, the issuance of a substantial number of shares of our Common Stock pursuant to the Asset Purchase Agreement,~~ or ~~the~~which ~~anticipation~~do ofnot ~~such~~produce ~~issuances,~~beneficial ~~could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales~~results.

~~Repayment~~We ofcurrently ~~certain~~intend ~~convertible~~to ~~notes~~use the net proceeds from this offering, ifto ~~they~~fund ~~are~~our research and development and commercialization activities, and for general corporate and working capital purposes, which may include, among other things, working capital, product development and/or commercialization, acquisitions, capital expenditures, repayment of debt and other business opportunities (see “Use of Proceeds”). We have not ~~otherwise~~allocated ~~converted~~specific amounts of the net proceeds from this offering for any of the foregoing purposes. Accordingly, ~~will~~our ~~require~~management awill have significant ~~amount~~discretion and flexibility in applying the net proceeds of ~~cash~~this offering. You will be relying on the judgment of our management with regard to the use of these net proceeds, and weyou ~~may~~will not have ~~sufficient~~the ~~cash~~opportunity, ~~flow~~as ~~from~~part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that the net proceeds will be invested in a way that does not yield a favorable, or any, return for us or our ~~business~~stockholders. The failure of our management to ~~make~~use ~~payments~~such funds effectively could have a material adverse effect on our ~~indebtedness~~business, financial condition, and results of operation.

~~Our~~This ~~ability~~is toa ~~pay~~best ~~the~~efforts ~~principal~~offering; ofno ~~and/or~~minimum ~~interest~~amount onof ~~the~~securities ~~convertible notes issued pursuant to the loan and security agreement with Pontifax Medison Finance (the “Convertible Notes”) depends on our future performance, which~~ is ~~subject~~required to ~~economic,~~be ~~financial~~sold, ~~competitive~~ and ~~other~~we ~~factors beyond our control. Our business~~ may not ~~generate~~raise ~~cash flow from operations in~~ the ~~future~~amount ~~sufficient~~of ~~to service the Convertible Notes or other future indebtedness and make necessary~~ capital ~~expenditures. If~~ we ~~are~~believe ~~unable~~is ~~to generate such cash flow, we may be~~ required tofor adopt and implement one or more alternatives, such as selling assets, restructuring indebtedness or obtaining additional debt financing or equity financing on terms that may be onerous or highly dilutive. Our ability to refinance the Convertible Notes or other future indebtedness will depend on the capital markets and our ~~financial condition at such time~~business. ~~We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations, including the Convertible Notes.~~

The ~~issuance~~Placement Agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities in this offering. The Placement Agent has no obligation to buy any of ~~shares~~the securities from us or to arrange for the purchase or sale of ~~Common~~any ~~Stock~~specific ~~upon~~number ~~conversion~~or dollar amount of the ~~Convertible~~securities. ~~Notes could~~There is no required minimum number of securities that must be sold as a condition to completion of this offering. Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, Placement Agent fees and proceeds to us are not presently determinable and may be substantially ~~dilute~~less ~~shareholders’~~than ~~investments~~the maximum amounts set forth in this prospectus. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and ~~could~~investors ~~impede~~in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue the business goals outlined in this prospectus. Thus, we may not raise the amount of capital we believe is required for our ~~ability~~business and may need to ~~obtain~~raise additional ~~financing~~funds, which may not be available or available on terms acceptable to us. Despite this, any proceeds from the sale of securities offered by us will be available for our immediate use, and because there is no escrow account and no minimum offering amount in this offering, investors could be in a position where they have invested in us, but we are unable to fulfill our objectives due to a lack of interest in this offering.

~~The~~There ~~Convertible~~is Notes are convertible into shares of our Common Stock and give the holders an opportunity to profit from a rise in the market price of our Common Stock such that conversion or exercise thereof could result in dilution of the equity interests of our shareholders. As of July 19, 2024, there was $2,059,309 of principal and $9,080 of accrued interest outstanding under the Convertible Notes. We have no ~~control~~public ~~over whether the holders will exercise their right to convert their Convertible Notes. While the Convertible Notes are convertible at $27.20 per share, we cannot predict the~~ market ~~price~~for ~~of our Common Stock at any future date, and therefore, cannot predict whether~~ the ~~Convertible~~pre-funded ~~Notes will~~warrants ~~be converted. We also may choose to reduce the conversion price of the Convertible Notes, which would likely cause the Convertible Notes to be converted into a significant amount of our Common Stock~~ and ~~reduce~~common ~~our~~warrants ~~liabilities.~~being ~~The~~offered ~~existence and potentially dilutive impact of the Convertible Notes may prevent us from obtaining additional financing~~ in ~~the~~this ~~future on acceptable terms, or at all~~offering.

~~Our~~There ~~Board~~is ofno ~~Directors~~established ~~can~~public trading market for the pre-funded warrants or common warrants being offered in this offering, ~~without~~and ~~stockholder~~we ~~approval~~do not expect a market to develop. In addition, ~~cause~~we ~~preferred~~do ~~stock~~not intend to beapply ~~issued~~to list the warrants on ~~terms~~any ~~that~~securities ~~adversely~~exchange ~~affect~~or ~~holders~~nationally recognized trading system. Without an active market, the liquidity of ~~our~~the ~~Common~~pre-funded ~~Stock~~warrants and common warrants will be extremely limited.

Under our Certificate of Incorporation, our Board of Directors is authorized to issue up to 230,000 shares of preferred stock, of which none are issued and outstanding as of the date of this prospectus. Also, our Board of 38

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~~Directors,~~The ~~without~~warrants ~~stockholder~~offered approval, may determine the price, rights, preferences, privileges and restrictions, including voting rights, of those shares. If our Board of Directors causes shares of preferred stock to be issued, the rights of the holders of our Common Stock would likely be subordinate to those of preferred holders and therefore could be adversely affected. Our Board of Directors’ ability to determine the terms of preferred stock and to cause its issuance, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire a majority of our outstanding Common Stock. Preferred shares issued by ~~our~~this ~~Board~~prospectus ofmay ~~Directors~~not ~~could include voting rights or super voting rights, which could shift the ability to control the Company to the holders of the preferred stock. Preferred stock could also~~ have conversion rights into shares of our Common Stock at a discount to the market price of our Common Stock, which could negatively affect the market for our Common Stock. In addition, preferred stock would have preference in the event of liquidation of the Company, which means that the holders of preferred stock would be entitled to receive the net assets of the Company distributed in liquidation before the holders of our Common Stock receive any ~~distribution of the liquidated assets~~value.

The common warrants have an assumed exercise price of $2.75 per share (assuming an exercise price equal to the last reported sale price of our common stock on The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share) and will have a five-year term. In the event our common stock price does not exceed the exercise price of the common warrants during the period when the warrants are exercisable, the common warrants may not have any value.

If we do not maintain a current and effective registration statement relating to the common stock issuable upon exercise of the pre-funded warrants and common warrants being offered in this offering, holders will be able to exercise such warrants on a “cashless” basis and we may not receive any additional funds upon the exercise of such warrants.

If we do not maintain a current and effective registration statement relating to the common stock issuable upon exercise of the pre-funded warrants and common warrants being offered in this offering, such warrants may be exercised by way of a “cashless” exercise, meaning that the holder would not pay a cash purchase price upon exercise, but instead would receive upon such exercise the net number of shares of our common stock determined according to the formula set forth in the warrant. Accordingly, we may not receive any additional funds upon the exercise of such warrants.

3339

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA AND MARKET INFORMATION

INDUSTRY DATA AND MARKET INFORMATION

This prospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. These forward-looking statements are often identified by words such as “may,” “should,” “would,” “expect,” “intend,” “anticipate,” “believe,” “estimate,” “continue,” “plan,” “potential” and similar expressions. These statements involve estimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed for the reasons described in this prospectus. You should not place undue reliance on these forward-looking statements.

You should be aware that our actual results could differ materially from those contained in the forward- looking statements due to a number of factors, including:

●

uncertainty as to whether our product candidates will be sufficiently safe and effective to support regulatory approvals;

●

uncertainty inherent in developing therapeutics and vaccines, and manufacturing and conducting preclinical and clinical trials;

●

our ability to obtain future financing or funds when needed, either through the raising of capital, the incurrence of convertible or other indebtedness or through strategic financing or commercialization partnerships;

●

our ability to secure government grants or contracts to support our vaccine development;

●

our ability to maintain our listing on Nasdaq and meet Nasdaq’s listing requirements;

●

that product development and commercialization efforts will be reduced or discontinued due to difficulties or delays in clinical trials or a lack of progress or positive results from research and development efforts;

●

maintenance and progression of our business strategy;

●

the possibility that our products under development may not gain market acceptance;

●

our expectations about the potential market sizes and market participation potential for our product candidates may not be realized;

●

our expected revenues (including sales, milestone payments and royalty revenues) from our product candidates and any related commercial agreements of ours may not be realized;

●

the ability of our manufacturing partners to supply us or our commercial partners with clinical or commercial supplies of our products in a safe, timely and regulatory compliant manner and the ability of such partners to timely address any regulatory issues that have arisen or may arise in the future;

●

competition existing today or that may arise in the future, including the possibility that others may develop technologies or products superior to our products;

●

the effect that global pathogens could have on financial markets, materials sourcing, service providers, patients, clinical study sites, governments and population (e.g. COVID 19); and

34● other factors, including those “Risk Factors” beginning on page 8 of this prospectus.

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● other factors, including those “Risk Factors” beginning on page 7 of this prospectus.

You should also consider carefully the statements under the section titled “Risk Factors” in this prospectus, which address additional factors that could cause our actual results to differ from those set forth in the forward-looking statements and could materially and adversely affect our business, operating results and financial condition. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the applicable cautionary statements.

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The forward-looking statements speak only as of the date on which they are made, and, except to the extent required by federal securities laws, we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

Industry Data and Market Information

This prospectus contains estimates, projections and other statistical data made by independent parties and by us relating to market size and growth, the potential value of government procurement contracts, the incidence of certain medical conditions and other industry data. These data, to the extent they contain estimates or projections, involve a number of subjective assumptions and limitations, and you are cautioned not to give undue weight to such estimates or projections. Industry publications and other reports we have obtained from independent parties generally state that the data contained in these publications or other reports have been obtained in good faith or from sources considered to be reliable, but they do not guarantee the accuracy or completeness of such data. While we believe that the data from these industry publications and other reports are generally reliable, we have not independently verified the accuracy or completeness of such data in all instances. These and other factors could cause results to differ materially from those expressed in these publications and reports.

We have provided estimates of the potential worldwide market or value of potential government procurement contracts and grants for certain of our product candidates. These estimates are based on a number of factors, including our expectation as to the number of patients with a certain medical condition that would potentially benefit from a particular product candidate, the current costs of treating patients with the targeted medical condition, our expectation that we will be able to demonstrate to the FDA’s satisfaction in our clinical trials that the product candidate is safe and effective, our belief that our product candidate would, if approved, have an assumed treatment cost per patient, historic values of government procurement contracts for vaccines, and our expectation of the dosage of the product candidate. While we have determined these estimates based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized. Among these factors are the following: (1) there is no assurance that the product candidate will prove to be safe and effective or will ultimately be approved for sale by the FDA; (2) any FDA approval of the product candidate may contain restrictions on its use or require warning labels; (3) third -party payors may not be willing to provide reimbursement for the product candidate at the assumed price per patient; (4) the government may not be willing to procure our vaccine candidates in amounts or at costs similar to its historic procurement activities; (5) the dosage that ultimately may be approved may be different from the assumed dosage; and (6) doctors may not adopt the product candidate for use as quickly or as broadly as we have assumed. It is possible that the ultimate market for a product candidate or value of procurement contracts will differ significantly from our expectations due to these or other factors. As a result of these and other factors, investors should not place undue reliance on such estimates.

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USE OF PROCEEDS

~~This~~We ~~prospectus~~estimate ~~relates~~that tonet ~~the~~proceeds ~~Resale~~from ~~Shares~~this ~~that~~offering ~~may~~will be approximately $7.3 million (assuming the sale of the maximum number of securities offered hereby), based upon an assumed public offering price of $2.75 per share and ~~sold~~accompanying ~~from~~common ~~time~~warrant to(which ~~time~~is bythe last reported sale price of our common stock on the ~~Selling~~Nasdaq ~~Stockholders~~Capital Market on September 15, 2025), and $2.749 Weper ~~will~~pre-funded ~~not~~warrant ~~receive~~and ~~any~~accompanying ~~proceeds~~common ~~upon~~warrant (assuming a public offering price equal to the last sale price of ~~the~~our ~~Resale~~common ~~Shares~~stock as reported by ~~the~~The ~~Selling~~Nasdaq ~~Stockholders~~Capital ~~pursuant~~Market toon September 15, 2025, which was $2.75 per share), after deducting estimated Placement Agent fees and estimated offering expenses payable by us, and assuming no sale of any pre-funded warrants in this ~~prospectus;~~offering. ~~however~~However, webecause ~~may~~this ~~receive~~is ~~proceeds~~a ~~from~~reasonable ~~the~~best ~~exercise~~efforts offering with no minimum number of securities or amount of proceeds as a condition to closing, the ~~July 2024~~actual ~~Warrants~~offering amount, ifplacement ~~such~~agent ~~warrants~~fees, and net proceeds to us are ~~exercised.~~not ~~Assuming~~presently determinable and may be substantially less than the ~~exercise~~maximum amounts set forth on the cover page of this prospectus, and we may not sell all or any of the ~~July 2024~~securities ~~Warrants~~we ~~for~~are ~~cash~~offering. As a result, we ~~will~~may receive ~~gross~~significantly less in net proceeds. ofBased $6on the assumed offering price set forth above,~~328,128.~~ Wewe ~~will~~estimate ~~use~~that ~~the~~our net proceeds from the ~~exercise~~sale of 75%, 50%, and 25% of the ~~July 2024~~securities ~~Warrants~~offered toin ~~fund~~this ~~our~~offering ~~research~~would ~~and~~be ~~development~~approximately $5,300,000, $3,300,000, and ~~commercialization~~$1,300,000, ~~activities~~respectively, ~~and~~after ~~for~~deducting ~~general~~the ~~corporate~~estimated placement agent fees and ~~working~~estimated ~~capital~~offering ~~purposes,~~expenses ~~which~~payable ~~may~~by ~~include~~us, ~~among~~and ~~other~~assuming ~~things,~~no ~~working~~issuance ~~capital,~~of ~~product~~any ~~development~~pre-funded warrants and~~/or~~ ~~commercialization,~~assuming ~~acquisitions,~~no ~~capital~~exercise ~~expenditures,~~of ~~repayment~~the common warrants. We will only receive additional proceeds from the exercise of ~~debt~~the common warrants we are selling in this offering if the common warrants are exercised for cash. We cannot predict when or if these common warrants will be exercised. It is possible that these common warrants may expire and ~~other~~may ~~business~~never ~~opportunities~~be exercised.

Each $0.25 increase (decrease) in the assumed public offering price of $2.75 per share and accompanying common warrant (which is the last reported sale price of our common stock on the Nasdaq Capital Market on September 15, 2025), and $2.749 per pre-funded warrant and accompanying common warrant (assuming a public offering price equal to the last sale price of our common stock as reported by The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share), would increase (decrease) the net proceeds to us from this offering by $679,997, assuming the number of securities offered, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated offering expenses payable by us and assuming no exercise of the common warrants or pre-funded warrants. Each 100,000 share increase (decrease) in the number of securities offered by us in this offering would increase (decrease) the net proceeds to us from this offering by $257,123, assuming that the price per share and accompanying common warrant, and per pre-funded warrant and accompanying common warrant for the offering remains at $2.75 (which is the last reported sale price of our common stock on The Nasdaq Capital Market on September 15, 2025), and after deducting the estimated offering expenses payable by us and assuming no exercise of the common warrants or pre-funded warrants included in the securities in the offering.

These estimates exclude the proceeds, if any, from the exercise of common warrants offered hereby. If all of the common warrants offered hereby were to be exercised in cash at the assumed exercise price of $2.75 per share (assuming an exercise price equal to the last reported sale price of our common stock on The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share), we would receive additional gross proceeds of approximately $12 million. We cannot predict when or if these common warrants will be exercised. It is possible that these common warrants may expire and may never be exercised. Additionally, these common warrants contain a cashless exercise provision that permit exercise of such warrants on a cashless basis at any time when there is no effective registration statement under the Securities Act covering the issuance of the underlying shares.

We intend to use the net proceeds from the sale of the securities offered by us pursuant to this prospectus, if any, to fund our research and development and commercialization activities, and for general corporate and working capital purposes, which may include, among other things, working capital, product development and/or commercialization, acquisitions, capital expenditures, repayment of debt and other business opportunities. We have not determined the amount of net proceeds to be used specifically for such purposes and, as a result, management will retain broad discretion over the allocation of net proceeds. The occurrence of unforeseen events or changed business conditions could result in the application of the net proceeds from this offering in a manner other than as described in this prospectus. Pending their uses, we intend to invest the net proceeds of this offering in interest-bearing bank accounts or in short-term, interest-bearing, investment-grade securities.

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DIVIDEND POLICY

We have not paid cash dividends on our ~~Common~~common ~~Stock~~stock, and we do not anticipate that we will declare or pay dividends on our ~~Common~~common ~~Stock~~stock in the foreseeable future. Payment of dividends, if any, is within the sole discretion of our Board of Directors and will depend, among other factors, upon our earnings, capital requirements and our operating and financial condition. To the extent we have any earnings, we likely will retain earnings to pay down debt, or expand corporate operations and not use such earnings to pay dividends.

MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

Market Information

Our ~~Common~~common ~~Stock~~stock is traded on The Nasdaq Capital Market under the symbol “SNGX.” The following table sets forth the high and low sales prices per share of our ~~Common~~common ~~Stock~~stock for the periods indicated, as reported by The Nasdaq Capital Market.

		~~Price Range~~
Period		High		Low
	Price Range
Year Ended December 31, 2022:
Period	High		Low
First Quarter	$	218.40	$	139.20
Second Quarter	$	192.00	$	91.20
Third Quarter	$	240.00	$	103.20
Fourth Quarter	$	175.20	$	93.60
Year Ended December 31, 2023:
First Quarter	$	129.60	$	28.00
Second Quarter	$	67.20	$	10.24
Third Quarter	$	11.84	$	6.72
Fourth Quarter	$	32.00	$	6.08
Year Ending December 31, 2024:
Year Ended December 31, 2024:
First Quarter	$	19.20	$	8.96
Second Quarter	$	14.88	$	2.50
Third Quarter	$	14.83	$	1.83
Fourth Quarter	$	4.87	$	2.77
Year Ending December 31, 2025:
First Quarter	$	3.59	$	2.15
Second Quarter	$	2.21	$	1.31

Our stock is listed on The Nasdaq Capital Market under the symbol “SNGX”. The Nasdaq Capital Market prices set forth above represent inter-dealer quotations, without adjustment for retail mark-up, mark- down or commission, and may not represent the prices of actual transactions. On ~~July~~September 1915, ~~2024~~2025, the last reported price of our ~~Common~~common ~~Stock~~stock quoted on The Nasdaq Capital Market was $62.0775 per share.

Unregistered Sales of Equity Securities

We issued (1) a vendor 337 shares of fully vested ~~Common~~common ~~Stock~~stock with a fair value of $148.80 per share on February 7, 2022; (2) a vendor 401 shares of fully vested ~~Common~~common ~~Stock~~stock with a fair value of $124.80 per share on May 6, 2022; (3) a vendor 229 shares of fully vested ~~Common~~common ~~Stock~~stock with a fair value of $218.40 per share on August 5, 2022; (4) a vendor 105 shares of fully vested ~~Common~~common ~~Stock~~stock with a fair value of $115.20 per share on October 4, 2022; (5) a vendor 321 shares of fully vested common stock with a fair value of $156.00 per share on November 7, 2022; (6) a vender 3,125 shares of fully vested common stock with a fair value of $23.36 per share on April 27, 2023; (7) a vender 1,978 shares of fully vested common stock with a fair value of $25.28 per share on May 2, 2023; (8) a total of 9,139 shares of common stock to two lenders upon conversion of approximately $100,000 of principal under promissory notes at a conversion price of $10.88 on January 3, 2024; (9) a total of 27,651 shares of common stock to two lenders upon conversion of approximately $155,000 of principal under promissory notes at a conversion price of $5.60 on April 15, 2024; (10) a vendor 5,000 shares of fully vested common stock with a fair value of $3.16 per share on December 13, 2024; and (11) a vendor 12,346 shares of fully vested common stock with a fair value of $2.43 per share on March 14, 2025.

36The issuance of common stock as described above was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipients are knowledgeable, sophisticated and experienced in making investment decisions of this kind and received adequate information about us or had adequate access to information about us. The vendors represented to the Company that the vendors are not “consultants” for purposes of Nasdaq Listing Rule 5635(c).

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share on October 4, 2022; (5) a vendor 321 shares of fully vested Common Stock with a fair value of $156.00 per share on November 7, 2022; (6) issued a total of 9,139 shares of Common Stock to two lenders upon conversion of approximately $100,000 of principal under promissory notes at a conversion price of $10.88 on January 3, 2024; (7) issued a total of 27,651 shares of Common Stock to two lenders upon conversion of approximately $154,840 of principal under promissory notes at a conversion price of $5.60 on April 15, 2024 and (8) the July 2024 Warrants to the Selling Stockholders on July 10, 2024 in exchange for the Selling Stockholders agreeing to exercise for cash existing warrants to purchase 703,125 shares of our Common Stock at an exercise price of $6.00 per share (which includes the $0.125 charge for the July 2024 Warrants in compliance with the Nasdaq rules).

The issuance of Common Stock as described above was exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipients are knowledgeable, sophisticated and experienced in making investment decisions of this kind and received adequate information about us or had adequate access to information about us. The vendors represented to the Company that the vendors are not “consultants” for purposes of Nasdaq Listing Rule 5635(c).

Transfer Agent

Shares of our ~~Common~~common ~~Stock~~stock are issued in registered form. Equiniti Trust Company, LLC, 486201 ~~Wall~~15th ~~Street~~Avenue, ~~Floor~~ 23Brooklyn, ~~New York,~~ NY ~~10005~~11219 (Telephone: (718) 921-8200; Facsimile: (718) 765-8719) is the registrar and transfer agent for shares of our ~~Common~~common ~~Stock~~stock.

Holders of Common Stock

As of ~~July~~September 1915, ~~2024~~2025, there were ~~182~~186 holders of record of our ~~Common~~common ~~Stock~~stock. As of such date, 24,~~280~~285,~~108~~570 shares of our ~~Common~~common ~~Stock~~stock were issued and outstanding.

Equity Compensation Plan Information

In December 2005, our Board of Directors approved the 2005 Equity Incentive Plan (the “2005 Plan”), which was approved by stockholders on December 29, 2005. ~~The~~Our ~~maximum number of shares of our Common Stock available for issuance under the~~ 2005 ~~Equity Incentive~~ Plan isexpired ~~1,250~~in ~~shares. In April~~ 2015, ~~our~~and ~~Board~~thus ofno ~~Directors~~securities ~~approved~~remain ~~the 2015 Equity Incentive Plan, which was approved by stockholders on June 18, 2015. The maximum number of shares of Common Stock~~ available for future issuance under ~~the~~that ~~2015 Equity Incentive Plan is 6,000,000 shares~~plan.

~~The~~In ~~following~~April 2015, ~~table~~our ~~sets~~Board ~~forth~~of ~~certain~~Directors ~~information~~approved the 2015 Equity Incentive Plan (the “2015 Plan”), aswhich ofwas ~~December~~approved by stockholders on June 3118, ~~2023~~2015. On September 22, ~~with~~2022, ~~respect~~the stockholders approved an amendment to the ~~following~~2015 ~~compensation~~Plan ~~plans~~to ~~(including~~increase ~~individual~~the ~~compensation~~maximum ~~arrangements)~~number of shares of common stock available for issuance under ~~which~~the ~~our~~plan ~~equity~~from ~~securities~~2,000,000 ~~are~~to ~~authorized~~6,000,000 shares. As of December 31, 2024, there were 5,770,122 shares available for ~~issuance:~~future grants under the 2015 Plan; however, as of July 29, 2025 no future grants may be made under the 2015 Plan.

●In ~~all~~May 2025, ~~compensation~~our ~~plans~~Board ~~previously~~of Directors approved the 2025 Equity Incentive Plan (the “2025 Plan”), which was approved by stockholders on June 20, 2025. A maximum of 6,000,000 shares of common stock may be initially delivered in satisfaction of awards made under the 2025 Plan. The number of shares of common stock reserved for issuance will automatically increase (i) on January 1 of each calendar year, from January 1, 2026 through January 1, 2035, by the least of (a) four percent of the total number of shares of common stock outstanding on December 31st of the preceding calendar year, (b) 1,000,000 shares, or (c) a number determined by our ~~security~~Board ~~holders;~~of ~~and~~Directors that is less than (a) or (b). As of September 15, 2025, there are 5,929,412 shares available for future grants under the 2025 Plan.

●The ~~all~~following table sets forth certain information, as of December 31, 2024, with respect to the following compensation plans ~~not~~(including ~~previously~~individual ~~approved~~compensation byarrangements) under which our ~~security~~equity ~~holders.~~securities are authorized for issuance:


				Number of
				Securities
				Remaining
				Available
				for Future
	Number of			Issuance
	Securities to	Weighted-		Under Equity
	be Issued	Average		Compensation
	upon	Exercise		Plans
	Exercise of	Price of		(excluding
	Outstanding	Outstanding		securities
	Options,	Options,		reflected in
	Warrants and	Warrants and		the first
Plan Category	Rights	Rights		column)
Equity compensation plans approved by security holders⁽¹⁾	229,919	$	21.94	5,770,122
Equity compensation plans not approved by security holders	—		—	—
Total	229,919	$	21.94	5,770,122

(1)	Includes our 2005 Plan and our 2015 Plan.

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				Number of
				Securities
				Remaining
				Available for
				Future
	Number of			Issuance
	Securities to		Weighted-	Under Equity
	be Issued		Average	Compensation
	upon Exercise		Exercise	Plans
	of		Price of	(excluding
	Outstanding		Outstanding	securities
	Options,		Options,	reflected in
	Warrants and		Warrants and	the first
Plan Category	Rights		Rights	column)
Equity compensation plans approved by security holders (1)	56,609	$	90.58	5,943,590
Equity compensation plans not approved by security holders	—		—	—
Total	56,609	$	90.58	5,943,590

CAPITALIZATION

~~(1)~~The ~~Includes~~following ~~our~~table ~~2005~~sets ~~Equity~~forth ~~Incentive~~our ~~Plan~~cash and ~~our~~cash ~~2015~~equivalents, ~~Equity~~total ~~Incentive~~long-term ~~Plan.~~liabilities ~~Our 2005 Equity Incentive Plan expired in 2015~~ and ~~thus~~capitalization noas ~~securities~~of ~~remain~~June 30, ~~available~~2025 ~~for future issuance under that plan.~~on:

●

an actual basis;

●

on a pro forma basis to give effect to the issuance of 780,620 shares of common stock for approximately $1.4 million from June 30, 2025 through September 15, 2025; and

●

on a pro forma as adjusted basis, to give further effect to this sale by us of 2,909,090 shares of common stock and common warrants to purchase up to 2,909,090 shares of common stock in this offering at the assumed public offering price of $2.75 per share (assuming a public offering price equal to the last reported sale price of our common stock on The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share), after deducting the Placement Agent fees and other estimated offering expenses payable by us, and assuming no sale of pre-funded warrants, which, if sold, would reduce the number of shares of common stock that we are offering on a one-for-one basis, and no exercise of any common warrants issued in this offering.

You should read this capitalization table together with the section titled “Use of Proceeds” in this prospectus, and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the related notes included in this prospectus.

	At June 30, 2025
			Pro Forma		As Adjusted
	Actual		(unaudited)		(unaudited)
Cash and cash equivalents	$	5,097,670	$	6,520,914	$	13,820,914
Total current portion of liabilities		3,629,107		3,629,107		3,629,107
Total non-current liabilities, net of current portion		302,589		302,589		302,589
Stockholders’ equity:
Common stock, $.001 par value; 75,000,000 shares authorized; 3,504,950, 4,285,570 and 7,194,660 shares issued and outstanding at June 30, 2025 on an actual, pro forma and a pro forma as adjusted basis, respectively		3,505		4,286		7,195
Additional paid-in capital		241,403,653		242,826,116		250,123,207
Accumulated other comprehensive income		45,789		45,789		45,789
Accumulated deficit		(239,623,996)		(239,623,996)		(239,623,996)
Total stockholders’ equity		1,828,951		3,252,195		10,552,195
Total liabilities and shareholders’ equity	$	5,760,647	$	7,183,891	$	14,483,891

~~MANAGEMENT~~A $0.10 increase (decrease) in the assumed public offering price per share of common stock and common warrants of $2.75 (assuming a public offering price equal to the last reported sale price of our common stock on The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share) would increase (decrease) the pro forma as adjusted amount of additional paid-in capital, total stockholders’S ~~DISCUSSION~~equity ~~AND~~and ~~ANALYSIS~~total capitalization by $271,998 ($271,998), assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated placement agent fees and estimated offering expenses payable by us and assuming no exercise of common warrants or sale of pre-funded warrants. An increase (decrease) of 1,000,000 in the number of shares of common stock and accompanying common warrants offered by us would increase (decrease) the pro forma as adjusted amount of additional paid-in capital, total stockholders’ equity and total capitalization by $2,571,248 ($2,571,248), assuming no change in the public offering price per share of common stock and accompanying common warrant, and after deducting estimated placement agent fees and estimated offering expenses payable by us.

~~OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS~~45

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The number of shares of common stock to be outstanding after this offering set forth in the table above is based on 3,504,950 shares of common stock outstanding on June 30, 2025, does not give effect to the shares of common stock issuable upon exercise of the pre-funded warrants and common warrants issued in this offering and excludes:

●

300,467 shares of common stock issuable upon the exercise of outstanding options at a weighted average exercise price of $16.70 per share, of which options to purchase 112,332 shares of common stock are vested as of June 30, 2025; and

●5,929,412 shares of common stock available for future issuance under our 2025 Equity Incentive Plan as of June 30, 2025.

●

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DILUTION

Purchasers of common stock, or pre-funded warrants, and accompanying common warrants in this offering will experience immediate dilution to the extent of the difference between the public offering price per share of common stock in this offering and the net tangible book value per share of common stock immediately after this offering.

Our pro forma net tangible book value as of June 30, 2025 was $2,842,891, or $1.41 per share of common stock, based upon 4,285,570 shares outstanding as of September 15, 2025, after giving effect to the issuance of 780,620 shares of common stock for approximately $1.4 million from June 30, 2025 through September 15, 2025. Pro forma net tangible book value per share is determined by dividing the net of total tangible assets, which excludes intangible assets, less total liabilities, by the aggregate number of shares of common stock outstanding as of June 30, 2025, as adjusted for the issuance of 780,620 shares for approximately $1.4 million from June 30, 2025 through September 15, 2025. After giving effect to our sale in this offering of common stock, or pre-funded warrants, and accompanying common warrants in the aggregate amount of $8.0 million at an assumed public offering price of $2.75 per share (assuming a public offering price equal to the last reported sale price of our common stock on The Nasdaq Capital Market on September 15, 2025, which was $2.75 per share) of common stock, or pre-funded warrant, and accompanying common warrant, and after deducting the estimated offering expenses of $700,000 payable by us, our pro forma net tangible book value as of June 30, 2025 would have been $10,142,891, or $0.66 per share of common stock. This represents an immediate increase in pro forma net tangible book value of $0.75 per share to our existing stockholders and an immediate dilution of $1.34 per share of common stock issued to the new investors purchasing securities in this offering. The dilution figures assume no sale of pre-funded warrants, which, if sold, would reduce the number of shares of common stock that we are offering on a one-for-one basis, and excludes the proceeds, if any, from the exercise of any pre-funded warrants or common warrants issued in this offering.

The following table illustrates this dilution on a per-share basis:


Assumed public offering price per share of common stock and accompanying common warrant			$	2.75
Pro forma net tangible book value per share as of June 30, 2025	$	0.66
Pro forma increase per share attributable to new investors participating in this offering	$	0.75
Pro forma net tangible book value per share after this offering⁽¹⁾			$	1.41
Dilution in pro forma net tangible book value per share to new investors			$	1.34

(1)

A $0.50 increase or decrease in the assumed combined public offering price per share of common stock, or pre-funded warrant, and accompanying common warrant of $2.75, which was the last reported sale price of our common stock on Nasdaq on September 15, 2025, would increase (decrease) the as adjusted net tangible book value by $0.09 per share and the dilution to investors participating in this offering by $0.41 per share, assuming the number of shares of common stock, pre-funded warrants, and accompanying common warrants offered by us as set forth on the cover page of this prospectus, remains the same, and after deducting estimated Placement Agent fees and estimated expenses payable by us. An increase of 500,000 in the shares of common stock, pre-funded warrants, and accompanying common warrants offered by us, as set forth on the cover page of this prospectus, would increase the as adjusted net tangible book value by $0.08 per share and decrease the dilution to investors participating in this offering by $0.08 per share, assuming the assumed combined public offering price per share of common stock, or pre- funded warrant, and accompanying common warrant of $2.75, which was the last reported sale price of our common stock on Nasdaq on September 15, 2025, remains the same and after deducting estimated Placement Agent fees and estimated offering expenses payable by us. A decrease of 500,000 in the shares of common stock, pre-funded warrants, and accompanying common warrants offered by us, as set forth on the cover page of this prospectus, would decrease the as adjusted net tangible book value by $0.08 per share and increase the dilution to investors participating in this offering by $0.08 per share, assuming the assumed combined public offering price per share of common stock, or pre-funded warrant, and accompanying common warrant of $2.75, which was the last reported sale price of our common stock on Nasdaq on September 15, 2025, remains the same and after deducting estimated Placement Agent fees and estimated offering expenses payable by us.

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The above table excludes:

●

5,929,412 shares of common stock available for future issuance under our 2025 Plan as of June 30, 2025; and

●

2,909,090 shares issuable upon exercise of the common warrants to be issued to the purchasers in this offering.

To the extent that options or warrants are exercised, new options are issued under our equity plans, or we issue additional shares of common stock in the future, there may be further dilution to investors participating in this offering. In addition, we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

Because there is no minimum offering amount required as a condition to the closing of this offering, the dilution per share to purchasers in the offering may be more than that indicated above in the event that the actual number of shares sold, if any, is less than the maximum number of shares of our common stock we are offering.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis provides information that we believe is relevant to an assessment and understanding of our results of operations and financial condition. You should read this analysis in conjunction with our audited consolidated financial statements and related notes and our unaudited consolidated interim financial statements and their notes. This discussion and analysis contains statements of a forward-looking nature relating to future events or our future financial performance. These statements are only predictions, and actual events or results may differ materially. In evaluating such statements, you should carefully consider the various factors identified in this prospectus, which could cause actual results to differ materially from those expressed in, or implied by, any forward-looking statements, including those set forth in “Risk Factors” in this prospectus. See “Cautionary Note Regarding Forward-Looking Statements and Industry Data and Market Information.”

Our Business Overview

Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy, utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early -stage disease, we ~~are targeting~~began ~~to begin~~ patient enrollment byduring December 2024 for the ~~end~~second ofPhase ~~2024~~3 ~~with~~study called “FLASH2” (Fluorescent Light Activated Synthetic Hypericin 2). We anticipate top-line results ~~anticipated~~ in the second half of 2026. Upon successful completion of the ~~second~~ Phase 3 ~~study, called “~~FLASH2” ~~(Fluorescent Light Activated Synthetic Hypericin 2)~~study, regulatory approval will be sought to support potential commercialization worldwide.

Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, and our first-in-class ~~IDR~~Innate ~~technology,~~Defense ~~dusquetide~~Regulator (~~SGX942~~“IDR”) ~~and~~technology, ~~SGX945)~~dusquetide, for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer (SGX942) and aphthous ulcers in Behçet’s Disease (“BD”) (SGX945).

38Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID 19 (caused by SARS-CoV 2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases, the Biomedical Advanced Research and Development Authority, and the Defense Threat Reduction Agency.

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Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs, targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.

An outline of our business strategy follows:

● Following agreement from the EMA on the key design components for the second confirmatory Phase 3 placebo-controlled FLASH2 ~~(Florescent Light Activated Synthetic Hypericin 2)~~ clinical trial of HyBryte™ in CTCL and positive primary endpoint results from the first Phase 3 FLASH study, ~~initiate~~continue enrollment and execution of the FLASH2 study, while at the same time, continuing discussions with the United States (U.S.) Food and Drug Administration (“FDA”) on potential modifications to the development path to adequately address their feedback.

● ~~Expanding~~Expand development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof- of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients.

● Following feedback from the United Kingdom ~~(“UK”)~~ Medicines and Healthcare products Regulatory Agency ~~(“MHRA”)~~ that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment of oral mucositis would be required to support a marketing authorization;, design a second study and attempt to identify a potential partner(s) to continue this development program.

● Expanding development of dusquetide under the research name SGX945 into Behçet’s Disease with the conduct of a Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation.49

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●

Expand development of dusquetide under the research name SGX945 into BD by conducting a Phase 2 clinical trial, where previous studies with dusquetide in oral mucositis and BD have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation and BD.

●

Continue development of our heat stabilization platform technology, ThermoVax^®, in combination with programs for RiVax^® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and multivalent combinations), with U.S. government and non-governmental organization funding support.

●

Continue to apply for and secure additional government funding for each of our Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements.

●

Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives, including but not limited to merger/acquisition strategies.

●

Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development.

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Critical Accounting Policies

Our management’s discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with ~~accounting principles~~ generally accepted accounting principles in the U.S. The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in the notes to our financial statements, we believe that the following accounting policies are those most critical to the assumptions and estimates used in the preparation of our financial statements.

Revenue Recognition

Our revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when we incur reimbursable internal expenses that are related to the government contracts and grants.

We also record revenue from contracts with customers in accordance with Accounting Standards Codification Topic 606 (“ASC 606”), Revenue From Contracts with Customers. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as license revenues. Sales-based royalties under our license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, we have not recognized any royalty revenue.

Research and Development Costs

As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing open contract and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include fees paid to:

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services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include fees paid to:

●

contract research organizations (“CROs”) in connection with performing research activities on our behalf and conducting preclinical studies and clinical trials on our behalf;

●

investigative sites or other service providers in connection with clinical trials;

●

vendors in connection with preclinical and clinical development activities; and

●

vendors related to product manufacturing and distribution of preclinical and clinical supplies.

We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple CROs that conduct and manage preclinical studies and clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing fees, we estimate the time period over which services will be performed, enrollment of patients, number of sites active and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or amount of prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low in any particular period. To date, we have not made any material adjustments to our prior estimates of accrued research and development expenses.

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payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing fees, we estimate the time period over which services will be performed, enrollment of patients, number of sites active and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or amount of prepaid expense accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low in any particular period. During the year ended December 31, 2024, we made adjustments to estimated accrued clinical trial expenses for completed trials of approximately $1.4 million. These adjustments resulted in decreases to research and development expenses in the accompanying consolidated statements of operations during the year ended December 31, 2024.

Use of Estimates and Assumptions

The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions such as the fair value of stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates.

Recent Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update enhances the segment reporting requirements by increasing transparency and providing investors with additional insights into how an entity’s Chief Operating Decision Maker (“CODM”) evaluates segment performance and allocates resources.

The standard requires public entities to disclose significant segment expenses that are regularly reviewed by the CODM and included in the reported measure of segment profit or loss. Additionally, entities must provide a reconciliation of total segment amounts to consolidated financial statements, as well as enhanced qualitative disclosures regarding the methodology used to identify reportable segments and assess performance. The update applies to all public entities, including those with a single reportable segment, and expands segment disclosures in interim financial statements.

ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We have adopted ASU 2023-07 for the year ended December 31, 2024, and have updated our segment disclosures accordingly. The adoption of this standard did not impact the recognition or measurement of our financial statements but resulted in enhanced segment- related disclosures in the notes to the consolidated financial statements.

Changes in Results of Operations

Three and Six Months Ended ~~March~~June 3130, ~~2024~~2025 Compared to ~~March~~June 3130, ~~2023~~2024

For the three months ended ~~March~~June 3130, ~~2024~~ 2025, we had a net loss of $12,~~915~~701,~~327~~976 as compared to a net loss of $1,~~046~~644,~~109~~502 for the same prior year period, representing increased net loss of $~~869~~1,~~218 or 83%~~057,474. This increase in net loss was primarily due to ~~the~~an ~~recognition~~increase ofin anoperating expenses related to ongoing clinical trials and a decrease in other income ~~tax~~which ~~benefit~~was attributable to the change in the fair value of debt during the three months ended ~~March~~June 3130, ~~2023~~ 2024 with no corresponding ~~income~~change ~~tax~~in ~~benefit~~fair ~~recognized~~value during the three months ended ~~March~~June 3130, 2025. For the six months ended June 30, 2025, we had a net loss of $5,653,244 as compared to a net loss of $3,559,829 for the same prior year period, representing increased net loss of $2,093,415. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in other income which was attributable to the change in the fair value of debt during the six months ended June 30, 2024 with no corresponding change in fair value during the six months ended June 30, 2025.

Our revenues and associated costs incurred ~~relate~~related to government ~~contracts, grants and~~ subawards received to support the ~~development~~evaluation of ~~SGX943~~HyBryte™ for expanded treatment ofin ~~emerging~~patients ~~and/or~~with ~~antibiotic~~early-~~resistant~~stage ~~infectious~~CTCL. ~~diseases;~~For ~~development~~the ofthree months ~~CiVax™~~ended June 30, ~~our~~2025, ~~vaccine~~we ~~candidate~~had ~~for~~no ~~the~~revenue ~~prevention~~as compared to revenue of ~~COVID-19~~$2,342 ~~and~~for ~~evaluation~~the ofsame ~~HyBryte™~~prior ~~for~~year ~~expanded~~period, ~~treatment~~representing ina ~~patients~~decrease ~~with~~in ~~early~~revenue ~~stage~~of ~~CTCL~~$2,342. ~~For~~We also incurred costs related to those revenues for the three months ended ~~March~~June 3130, 2024 of $2,342. weFor ~~had~~the ~~revenues~~six months ofended ~~$117~~June 30,~~029~~ 2025, we had no revenue as compared to revenue of $~~257~~119,~~178~~371 for the same prior year period, representing a decrease in revenue of $~~140~~119,~~149 or 54%~~371. We also incurred costs related to those revenues for the ~~three~~six months ended ~~March~~June 3130, 2024 ~~and 2023~~ of $~~117~~119,~~029 and $226,040, respectively, representing a~~ 371.

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~~decrease~~Research ofand ~~$109,011~~development orexpenses ~~48%.~~were ~~Our~~$1,677,014 ~~gross profit~~ for the three months ended ~~March~~June 3130, ~~2024~~ ~~was~~2025 ~~zero~~as orcompared 0%to of$501,158 ~~total~~for ~~revenues,~~the assame ~~compared~~period toin a2024, ~~gross~~representing ~~profit~~an increase of $311,~~138~~175,856. orThe ~~12%~~increase ofwas ~~total~~primarily ~~revenues~~due ~~for~~to ~~the~~costs ~~same~~associated ~~period~~with our Phase 2 study in ~~2023,~~BD ~~representing~~and athe ~~decrease~~second ofconfirmatory ~~$31,138~~Phase or3 ~~100%.~~CTCL ~~The~~trial ~~decrease~~as well as increases in ~~revenue~~third-party manufacturing. Research and ~~gross~~development ~~profit~~expenses ~~during~~were $3,618,694 for the ~~three~~six months ended ~~March~~June 3130, ~~2024~~ ~~was~~2025 ~~primarily~~as ~~related~~compared to ~~the~~$1,596,198 ~~conclusion~~for ofthe ~~higher~~same ~~margin~~period ~~grants~~in ~~associated~~2024, ~~with~~representing ~~the~~an ~~development~~increase of ~~SGX943~~$2,022,496. ~~and~~The ~~CiVax™~~increase ~~and~~was aprimarily ~~decrease~~due into ~~revenue~~costs associated with ~~the~~our ~~zero~~Phase ~~margin~~2 ~~grant~~study ~~for~~in BD and the ~~HyBryte™~~second ~~investigator~~confirmatory ~~initiated~~Phase ~~study~~3 CTCL trial as well as increases in third-party manufacturing.

~~Research~~General and ~~development~~administrative expenses were $1,~~095~~086,~~040~~865 for the three months ended ~~March~~June 3130, ~~2024~~ 2025, as compared to $~~946~~1,~~451~~243,517 for the same period in ~~2023~~2024, representing ana ~~increase~~decrease of $~~148~~156,~~589 or 16%~~652. The ~~increase~~decrease in general and administrative expenses for the three months ended June 30, 2025 was primarily ~~due~~attributable to andecreases ~~increase~~in professional fees offset by increases in ~~preliminary~~various ~~costs~~taxes. ~~associated~~General ~~with~~and administrative expenses were $2,171,693 for the ~~anticipated~~six months ~~initiation~~ended ofJune 30, ~~our~~2025, ~~Phase~~as compared to $2,265,568 ~~study~~for the same period in ~~Behçet’s~~2024, ~~Disease~~representing a decrease of $93,875. The decrease in general and administrative expenses for the ~~second~~six months ~~confirmatory~~ended ~~Phase~~June 30, 32025 ~~CTCL~~was ~~trial~~primarily attributable to decreases in professional fees offset by increases in various taxes.

~~General~~Interest ~~and administrative expenses were $1~~income,~~022,051~~ net for the three months ended ~~March~~June 3130, ~~2024~~ 2025 was $69,823 as compared to $135,~~235,376~~925 for the same period in ~~2023~~2024, representing aan ~~decrease~~increase of $~~213~~33,~~325 or 17%~~898. The ~~decrease~~increase is primarily associated with a reduction in ~~general~~interest ~~and~~expense ~~administrative~~resulting ~~expenses~~from repayment of convertible debt. Interest income, net for the ~~three~~six months ended ~~March~~June 3130, ~~2024~~ 2025 was ~~primarily~~$145,851 ~~attributable~~as compared to a$64,767 ~~reduction~~for inthe ~~legal~~same ~~and~~period ~~professional~~in ~~fees~~2024, ~~associated~~representing ~~with~~an aincrease ~~reverse~~of ~~stock~~$81,084. ~~split~~The ofincrease ~~our~~is ~~issued~~primarily ~~and~~associated ~~outstanding~~with ~~shares~~a ofreduction ~~Common~~in ~~Stock~~interest ~~during~~expense ~~the~~resulting ~~three months~~from ~~ended~~repayment ~~March 31, 2023~~of convertible debt.

~~The~~Year ~~amendment~~Ended ~~to the convertible debt financing agreement with Pontifax Medison Finance (“Pontifax”)~~December ~~– see Note 4 to our quarterly financial statements found elsewhere in this prospectus –~~31, ~~resulted~~2024 inCompared ~~the extinguishment of the original convertible debt for accounting purposes. We elected~~ to ~~account~~December for the amended convertible debt using the fair value option, which requires us to record changes in fair value as a component of other income or expense. The fair value of the convertible debt as of March 31, ~~2024~~ was $2,996,136, which resulted in the recognition of $165,382 of other income from the change in the fair value of the convertible debt on our accompanying condensed consolidated statements of operations during the three months ended March 31, 2024. The fair value of the convertible debt was estimated using the Monte Carlo valuation method.2023

~~Interest~~For ~~expense~~the year ended December 31, 2024, we had a net loss of $8,266,576 as compared to a net loss of $6,140,730 for the ~~three~~prior ~~months~~year, representing increased net loss of $2,125,846 or 35%. The increase in net loss is primarily attributed to decreases in gross profit and income tax benefits as well as an increase in operating expenses, offset by increases in interest income, tax credits and the change in the fair value of debt. For the year ended ~~March~~December 31, 2024, ~~was~~we (had revenues of $28119,~~842)~~371 as compared to $~~103~~839,~~568~~359 for the ~~same period in 2023~~prior year, representing a decrease of $~~132~~719,~~410~~988 or ~~128~~86%. The decrease isin revenues was primarily a result of the conclusion of higher margin grants associated with the ~~reduction~~development of SGX943 and CiVax™ and a decrease in ~~interest~~revenue ~~resulting~~associated ~~from~~with the ~~repayment~~zero ofmargin ~~$6M~~grant offor the ~~convertible~~HyBryte™ ~~debt~~investigator ~~principal~~initiated ~~balance~~study.

~~Year~~We ~~Ended~~incurred costs related to contract and grant revenues in the year ended December 31, 2024 and 2023 ~~Compared~~of to$119,371 ~~2022~~and $742,048, respectively, representing a decrease of $622,677 or 84%. The decrease in costs was primarily the result of the conclusion of higher margin grants associated with the development of SGX943 and CiVax™ and a decrease in the zero margin grant for the HyBryte™ investigator initiated study.

~~For~~Our gross profit for the year ended December 31, ~~2023,~~ we2024 ~~had~~was a$0 ~~net~~or ~~loss~~0% of ~~$6,140,730~~total revenues as compared to a$97,311 ~~net~~or ~~loss~~12% of ~~$13,798,339~~total revenues for the prior year, representing ~~decreased~~a ~~net~~decrease ~~loss~~ of $797,~~657,609~~311 or 55100%. The decrease in ~~net~~gross ~~loss~~profit iswas primarily ~~attributed~~the toresult ~~decreases~~of inthe ~~operating~~conclusion ~~expenses~~of ~~and~~higher ~~interest~~margin ~~expense~~grants asassociated ~~well~~with ~~as an increase in other income. For~~ the ~~year~~ ~~ended~~development ~~December 31, 2023, we had revenues~~ of ~~$839,359~~SGX943 asand ~~compared~~CiVax™ toand ~~$948,911 for the prior year, representing~~ a decrease ~~of $109,552 or 12%. The decrease~~ in ~~revenues~~the ~~was~~zero ~~primarily~~margin agrant ~~result~~for of the ~~recognition~~HyBryte™ ofinvestigator ~~licensing~~initiated ~~revenue in 2022 partially offset by an increase in grant revenue during 2023~~study.

WeResearch ~~incurred~~and ~~costs~~development ~~related~~expenses toincreased ~~contract~~by ~~and~~$1,910,890 ~~grant~~or ~~revenues~~58% into ~~the~~$5,223,589 for year ended December 31, ~~2023~~ ~~and~~2024 ~~2022~~as ofcompared ~~$742,048~~to ~~and~~ $~~550~~3,~~822~~312,699 ~~respectively,~~for ~~representing~~the anprior year. The increase ofin ~~$191,226~~research orand ~~35%.~~development ~~The~~spending ~~increase~~for inthe year ~~costs~~ended December 31, 2024 was primarily related to preliminary costs associated with the ~~result~~initiation of anour ~~increase~~Phase in2 ~~costs~~study ~~relating~~in toBD and the ~~HyBryte™~~second ~~investigator-initiated~~confirmatory ~~study~~Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed clinical trials.

~~Our~~General ~~gross~~and ~~profit~~administrative expenses decreased by $266,644 or 6%, to $4,215,908 for the year ended December 31, ~~2023~~ ~~was $97~~2024,~~311~~ ~~or 12% of total revenues~~ as compared to $~~398~~4,~~089~~482,552 ~~or 42% of total revenues~~ for the prior year~~, representing a decrease of $300,778 or 76%~~. ~~The~~This decrease inis ~~gross profit was~~ primarily ~~the~~related ~~result~~to ofa ~~the~~reduction ~~recognition of higher margin licensing revenue~~ in ~~2022~~legal and ~~the~~consulting ~~lower margin grant revenue associated with the HyBryte™ investigator-initiated study during 2023~~expenses.

~~Research~~In ~~and~~April 2023, ~~development~~we ~~expenses~~entered ~~decreased~~into byan ~~$4,631,390~~amendment or(the ~~58%~~“2023 Amendment”) to ~~$3,312,699~~the ~~for year~~convertible ~~ended~~debt ~~December~~financing agreement with Pontifax Medison Finance (“Pontifax”) (see Note ~~31,~~5 — Debt). The 2023 asAmendment ~~compared~~resulted in the extinguishment of the original convertible debt for accounting purposes. We elected to ~~$7,944,089~~account for the ~~prior year~~amended convertible debt using the fair value option, which requires us to record changes in fair value as a component of other income or expense. The ~~decrease~~fair value of the convertible debt on the date of the amendment was approximately $3,304,000, which resulted in ~~research~~the ~~and~~recognition ~~development~~of ~~spending~~a ~~for~~loss on extinguishment of approximately $394,000 on our accompanying consolidated statements of operations during the year ended December 31, 2023. ~~was~~The ~~primarily~~fair ~~related~~value toof the ~~decrease~~convertible indebt ~~manufacturing~~as ~~and~~of ~~regulatory~~December 31, ~~costs~~2023 ~~associated~~was ~~with~~approximately $3,260,934, which resulted in the ~~HyBryte™~~recognition ~~NDA~~of ~~filing.~~$43,066 of other

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~~General~~income ~~and~~from ~~administrative~~the ~~expenses~~change ~~decreased~~in bythe ~~$2,210,352~~fair orvalue ~~33%,~~of tothe ~~$4,482,552~~convertible debt on our accompanying consolidated statements of operations for the year ended December 31, 2023,. asFor ~~compared~~2023 toand ~~$6,692,904~~through ~~for~~the 2024 Amendment (described below), the ~~prior year.~~fair ~~This~~value ~~decrease~~of isthe ~~primarily~~convertible ~~related~~debt towas aestimated ~~reduction~~using inthe ~~legal~~Monte ~~and~~Carlo ~~consulting~~valuation ~~expenses~~method.

~~The~~In ~~amendment~~October 2024, towe ~~the~~entered ~~convertible~~into ~~debt~~an ~~financing~~amendment ~~agreement with Pontifax Medison Finance~~ (the “~~Pontifax~~2024 Amendment”) – ~~see~~to ~~Note 5~~the toconvertible ~~our~~debt ~~audited~~financing ~~financial~~agreement ~~statements~~with ~~found~~Pontifax, ~~elsewhere~~as inamended. ~~this~~The ~~prospectus –,~~2024 Amendment resulted in ~~the~~a ~~extinguishment~~substantial modification of the ~~original convertible~~ debt for accounting purposes., Weas ~~elected~~defined, towhich ~~account~~is accounted for ~~the~~as ~~amended~~an ~~convertible~~extinguishment. ~~debt~~The ~~using~~difference between the fair value ~~option~~, ~~which~~or ~~requires~~net uscarrying toamount, ~~record~~of ~~changes~~the indebt ~~fair~~before ~~value~~the as2024 aAmendment ~~component~~and ofupon ~~other~~reacquisition ~~income~~was orde ~~expense~~minimus. ~~The~~Accordingly, ~~fair~~no ~~value~~gain ofor ~~the~~loss ~~convertible~~was ~~debt~~recognized onrelated to the ~~date~~extinguishment ofrelated to the ~~amendment~~2024 ~~was~~Amendment. ~~approximately $3~~Furthermore,~~304,000,~~ ~~which~~as ~~resulted~~the in2024 ~~the~~Amendment ~~recognition~~resulted ofin a ~~loss~~substantial onmodification, ~~extinguishment~~as ofdefined, ~~approximately~~we ~~$394,000~~elected onnot ~~our~~to ~~accompanying~~account ~~consolidated~~for ~~statements~~the ofconvertible ~~operations~~debt ~~during~~using the ~~year~~ ~~ended~~fair ~~December 31, 2023.~~value ~~The~~option ~~fair~~in ~~value~~accordance ofwith the ~~convertible~~applicable ~~debt~~guidance. asWe ofdetermined ~~December 31~~the embedded conversion feature, ~~2023~~ ~~was~~after ~~approximately~~the $32024 Amendment,~~260,934,~~ ~~which~~does ~~resulted~~not inrequire bifurcation and therefore the ~~recognition~~convertible ofdebt, ~~$43~~as amended,~~066~~ ofhas ~~other~~been ~~income~~recorded ~~from~~as ~~the~~a ~~change~~single liability classified instrument in ~~the~~accordance ~~fair~~with ~~value~~ASU 2020-06. As a result of ~~the~~this ~~convertible~~election, ~~debt~~we onrecognized ~~our~~a ~~accompanying~~gain ~~consolidated~~of ~~statements~~$260,933 of ~~operations~~other ~~during~~income from the ~~year~~ ~~ended~~change ~~December 31, 2023.~~in ~~The~~the fair value of the convertible debt ~~was~~on ~~estimated~~our ~~using~~accompanying ~~the~~2024 ~~Monte~~consolidated ~~Carlo~~statement ~~valuation~~of ~~method~~operations.

Total other ~~expense~~income for the year ended December 31, ~~2023~~ 2024 was $~~210~~763,~~593~~807 as compared to $~~714~~210,~~370~~593 of total other expense for the prior year, reflecting a decrease of $~~503~~974,~~777~~400 or 71463%. The decrease in total other expense was primarily associated with the reduction in interest resulting from the repayment of a portion of the convertible debt principal balance, ~~and~~ higher interest income earned on cash balances, an increase in tax credits, an increase in other income resulting from the change in the fair value of the convertible debt and approximately $394,000 of a loss on extinguishment of debt resulting from an amendment to the original convertible debt loan agreement was recognized in 2023.

The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused NOL carryforwards to other New Jersey-based corporate taxpayers. We sold ~~2022~~2023, ~~2021~~2022 and ~~2020~~2021 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $1409,~~767,803~~114 and $1,~~154~~767,~~935~~803 during the years ended December 31, ~~2023~~ 2024 and ~~2022~~2023, respectively. We sold our ~~2022~~2023 New Jersey NOLs and have recorded a receivable of $~~606~~409,~~606~~114 which is included in prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended December 31, ~~2023~~2024. We have not yet sold our ~~2023~~2024 New Jersey NOL carryforwards but may do so in the future. We will continue to explore opportunities to sell unused NOL carryforwards for the year ended December 31, ~~2023~~ 2024. However, there can be no assurance as to the continuation or magnitude of this program in future years.

Business Segments

We maintain two active business segments for the years ended December 31, ~~2023~~ 2024 and ~~2022~~2023: Specialized BioTherapeutics and Public Health Solutions.

The Specialized BioTherapeutics business segment had revenue of $~~395~~119,~~124~~371 for the year ended December 31, ~~2023~~ 2024 as compared to $31395,~~929~~124 for the year ended December 31, ~~2022~~ 2023, representing ana ~~increase~~decrease of $~~363~~275,~~195~~753 or ~~100~~70%. The ~~increase~~decrease was due to ~~increased~~decreased reimbursable development activity under the grant to support the investigator-initiated study of HyBryte™ for expanded treatment in patients with early -stage CTCL.

Revenues for the Public Health Solutions business segment for the year ended December 31, ~~2023~~ 2024 were $~~444,235~~0 as compared to $~~916~~444,~~982~~235 for the year ended December 31, ~~2022~~ 2023, representing a decrease of $~~472~~444,~~747~~235 or 52100%. The decrease in revenues was primarily the result of the ~~recognition of licensing revenue in 2022 and the~~ conclusion of the grant associated with the development of SGX943.

Loss from operations for the Public Health Solutions business segment for the year ended December 31, ~~2023~~ 2024 was $36254,~~531~~576 as compared to ~~income~~loss from operations of $2636,~~612~~531 for the year ended December 31, ~~2022~~ 2023, representing aan ~~decrease~~increase in loss of $63218,~~143~~045 or ~~237~~597%. The loss for the year ended December 31, ~~2023~~ 2024 is attributable to ~~the recognition of licensing revenue in 2022 and~~ additional expenses incurred due to the expiration of grants and contracts. Loss from operations for the Specialized BioTherapeutics business segment for the year ended December 31, ~~2023~~ 2024 was $24,~~812~~365,~~303~~034 as compared to $72,~~614~~812,~~988~~303 for the year ended December 31, ~~2022~~ 2023, representing an increase in loss of $1,552,731 or 55%. This increase in loss is primarily related to preliminary costs associated with the initiation of our Phase 2 study in BD and the second confirmatory Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed clinical trials.

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representing a decreased loss of $4,802,685 or 63%. This decreased loss is primarily attributed to the decrease in manufacturing and regulatory costs associated with the HyBryte™ NDA filing.

Financial Condition and Liquidity

Cash and Working Capital

As of ~~March~~June 3130, ~~2024~~ 2025, we had cash and cash equivalents of $75,~~091~~097,~~548~~670 as compared to $87,~~446~~819,~~158~~514 as of December 31, ~~2023~~ 2024, representing a decrease of $12,~~354~~721,~~610 or 16%~~844. As of ~~March~~June 3130, ~~2024~~ 2025, we had working capital of $~~607~~1,~~499~~691,345 as compared to working capital of $3,~~355~~980,~~212~~218 as of December 31, ~~2023~~ 2024, representing a decrease of $2,~~747~~288,~~713 or 82%~~873. The decrease in cash and cash equivalents was primarily related to cash used in operating activities ~~during~~and ~~the~~repayment ~~three months ended March 31, 2024. The decrease in working capital is primarily the result~~ of ~~the reclassification of approximately $1 million of the~~ convertible debt ~~balance~~offset ~~from~~by acash ~~non-current~~received ~~liability as of December 31, 2023 to a current liability as of March 31, 2024 (resulting~~ from ~~the~~financing ~~amendment to the loan and security agreement with Pontifax – see Note 4 to our quarterly financial statements found elsewhere in this prospectus), and cash used in operating~~ activities during the ~~three~~six months ended ~~March~~June 3130, ~~2024~~ 2025.

Based on our operating budget, current rate of cash outflows, cash on hand, and proceeds from government contract and grant programs, we believe that we have sufficient resources ~~available~~ to support ~~our~~ development activities, ~~and~~ business operations , and ~~timely~~meet ~~satisfy~~ our obligations ~~as they become due~~ through the first quarter of ~~2025~~2026. We doHowever, ~~not~~as ~~have~~of ~~sufficient~~the ~~cash~~date ~~and~~of ~~cash~~issuance ~~equivalents~~of asthe offinancial statements for the ~~date~~fiscal ofquarter ~~filing~~ended June 30, 2025 that are included in this ~~Quarterly~~prospectus, ~~Report~~we ondid ~~Form 10-Q~~not tohave ~~support~~sufficient ~~our~~cash and cash equivalents to fund operations for at least ~~the~~ 12 months following ~~the~~such date ~~the financial statements are issued~~. These ~~conditions~~factors raise substantial doubt about our ability to continue as a going concern ~~through 12 months after the date that the financial statements are issued~~.

To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations, securing additional proceeds from government contract and grant programs, securing additional proceeds available from the sale of shares of our Common Stock via an At Market Issuance Sales Agreement and potentially amending the loan agreement with Pontifax to reduce the conversion price in order to allow for conversion of a portion of the debt which will reduce our debt repayments; howeverplans, none of these alternatives are committed at this time. There can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that we will require or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as ~~a going concern. If none~~ of ~~these alternatives are available, or if available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for at least the 12~~June ~~months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require us to delay~~30, ~~limit~~2025, orinclude eliminate the development of business opportunities and our ability to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In addition, market instability, including as a result of geopolitical instability, may reduce our ability to access capital, which could negatively affect our liquidity and ability to continue as a going concern. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.securing:

●

additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations.

●

additional proceeds from government contract and grant programs.

●

additional proceeds from the sale of shares of our common stock via the At Market Issuance Sales Agreement with A.G.P. We sold the remaining capacity of our At-The-Market (“ATM”) facility as of July 1, 2025 under the prospectus dated August 16, 2024. From July 1, 2025 through August 7, 2025, we issued 780,620 shares of common stock pursuant to our ATM facility at a weighted average price of $1.84 per share for total gross proceeds of approximately $1,439,300.

There is no assurance that we will be successful in securing sufficient financing on acceptable terms, if at all, to continue operations, enter into strategic transactions that provide the necessary capital, or implement other strategies to mitigate the substantial doubt about our ability to continue as a going concern. If these alternatives are unavailable or not secured on satisfactory terms, we will not have sufficient cash resources or liquidity to fund our operations for at least 12 months after the date of issuance of the financial statements for the fiscal quarter ended June 30, 2025 that are included in this prospectus. Failure to obtain adequate capital when needed may force us to delay, reduce, or eliminate business development efforts, negatively impacting our ability to achieve our objectives, remain competitive, and maintain our financial condition and operating results. On July 1, 2025, we sold 772,900 shares of common stock pursuant to our ATM facility for total gross proceeds of approximately $1,429,100 and in doing so, as of July 1, 2025, we have no further capacity on the ATM facility.

Additionally, macroeconomic and geopolitical uncertainties may further restrict access to capital, exacerbating liquidity challenges. Furthermore, concerns regarding our ability to continue as a going concern could negatively impact relationships with business partners, vendors, and other stakeholders.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

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Our plans with respect to our liquidity management include, but are not limited to, the following:

● We have up to approximately $673,000 in active government grant funding still available as of March 31, 2024 to support our associated research programs through May 2026, provided the federal agencies do not elect to terminate the grants for convenience. We plan to submit additional contract and grant applications for further support of our programs with various funding agencies. However, there can be no assurance that we will obtain additional governmental grant funding;

● We ~~have~~will ~~continued~~continue to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expect to continue to do so for the foreseeable future;

~~● We will continue to pursue NOL sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if the program is available;~~54

● We plan to pursue potential partnerships for pipeline programs as well as continue to explore merger and acquisition strategies. However, there can be no assurances that we can consummate such transactions;

● We completed a public offering on April 22, 2024 of 204,694 shares of our Common Stock, pre-funded warrants to purchase 537,500 shares of our Common Stock and common warrants to purchase up to 742,194 shares of our Common Stock at a combined public offering price of $6.40. The pre-funded warrants have an exercise price of $0.02. The common warrants have an exercise price of $6.40 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to us from this offering were approximately $4.75 million before deducting commissions and other estimated offering expenses of $0.4 million ($4.3 net). We plan to use the proceeds for further support of our programs, as well as for working capital. See Note 8 to our quarterly financial statements found elsewhere in this prospectus; and

● We are currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that we can consummate such a transaction, or consummate a transaction at favorable pricing.

Expenditures

Under our budget and based upon our existing product development agreements and license agreements, we expect our total research and development expenditures for the next 12 months to be approximately $6.0 million before any contract or grant reimbursements, all of which relates to the Specialized BioTherapeutics business segment. We anticipate contract and grant reimbursements revenue in the next 12 months of approximately $0.3 million to offset research and development expenses in the Specialized BioTherapeutics business segment.

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~~The~~● ~~table~~We ~~below~~will ~~details~~continue ~~our~~to ~~costs~~pursue ~~for~~NOL ~~research~~sales ~~and~~in ~~development~~the bystate ~~program~~of ~~and~~New ~~amounts~~Jersey ~~reimbursed~~pursuant ~~for~~to ~~the~~its ~~three months~~Technology ~~ended~~Business ~~March 31~~Tax Certificate Transfer Program, ~~2024~~ ~~and~~if ~~2023:~~the program is available;


		2024		2023
Research & Development Expenses
RiVax® and ThermoVax® Vaccines	$	45,839	$	30,533
SGX942 (Dusquetide)		19,258		(318)
HyBryte™ (SGX301 or synthetic hypericin)		840,393		822,096
Other		189,550		94,140
Total	$	1,095,040	$	946,451
Reimbursed under Government Contracts and Grants
RiVax® and ThermoVax® Vaccines	$	—	$	—
CiVax™		—		35,247
SGX943		—		35,429
HyBryte™ (investigator-initiated study)		117,029		155,365
Total		117,029		226,040
Grand Total	$	1,212,069	$	1,172,491

●

We plan to pursue potential partnerships for pipeline programs as well as continue to explore merger and acquisition strategies. However, there can be no assurances that we can consummate such transactions;

●

We are currently evaluating additional equity/royalty/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that we can consummate such a transaction, or consummate a transaction at favorable pricing.

Research and Development Expenditures

Under our budget and based upon our existing product development agreements and license agreements, we expect our total research and development expenditures for the next 12 months to be approximately $4.8 million before any contract or grant reimbursements, all of which relates to the Specialized BioTherapeutics business segment. We do not anticipate any contract and grant reimbursements revenue in the next 12 months to offset research and development expenses in the Specialized BioTherapeutics business segment.

The table below details our costs for research and development by program and amounts reimbursed for the six months ended June 30, 2025 and 2024:


	2025		2024
Research & Development Expenses
RiVax^®and ThermoVax^®Vaccines	$	63,347	$	107,731
SGX942 (Dusquetide)		113,663		(194,846)
HyBryte™ (SGX301 or synthetic hypericin)		3,213,012		1,336,749
Other		228,672		346,564
Total	$	3,618,694	$	1,596,198
Reimbursed under Government Contracts and Grants
HyBryte™ (investigator-initiated study)		—		119,371
Total		—		119,371
Grand Total	$	3,618,694	$	1,715,569

The table below details our costs for research and development by program and amounts reimbursed for the years ended December 31, ~~2023~~ 2024 and ~~2022~~2023:


	2024	~~2023~~	2023	~~2022~~
Research & Development Expenses
RiVax® and ThermoVax® Vaccines	$	~~133~~253,~~186~~994	$	~~346~~133,~~894~~186
SGX942 (Dusquetide)		(28330,~~570~~257)		~~295~~(28,~~376~~570)
CiVax™		—		22,901
HyBryte™ (SGX301 or synthetic hypericin)		4,691,803		2,698,609
HyBryte™ (SGX301 or synthetic hypericin)		2,698,609		6,831,827
Other		608,049		509,474
Other		509,474		447,091
Total	$	5,223,589	$	3,312,699
Total	$	3,312,699	$	7,944,089
Reimbursed under Government Contracts and Grants
Reimbursed under Government Contracts and Grants
CiVax™		—		311,495
RiVax® and ThermoVax® Vaccines	$	—	$	22,161
SGX943		—		35,429
CiVax™		311,495		398,001
HyBryte™ (investigator-initiated study)		119,371		395,124
SGX943		35,429		98,731
Total		119,371		742,048
HyBryte™ (investigator-initiated study)		395,124		31,929
Grand Total	$	5,342,960	$	4,054,747
Total		742,048		550,822
Grand Total	$	4,054,747	$	8,494,911

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Contractual Obligations

We have ~~licensing fee~~ commitments of approximately $230,000 as of ~~March~~June 3130, ~~2024~~ 2025 over the next five years for several licensing agreements with partners and universities. Additionally, we ~~have~~are ~~collaboration~~party ~~and~~to ~~license~~other agreements, which ~~upon~~include ~~clinical~~cash ormilestone ~~commercialization success may require the payment of milestones of up to approximately $13.2 million~~payments, royalties onand ~~net~~other ~~sales~~fees ~~of covered products ranging from 2% to 3%~~payable, ~~sub-license~~which ~~IND~~are ~~milestones~~all oncontingent ~~covered~~upon ~~products~~clinical ofor upcommercialization ~~to approximately $200,000, sub-license income royalties on covered products up to 15% and sub-license global net sales royalties on covered products ranging from 1~~success.5% toThere ~~2.5%, if and when achieved. However, there~~ can be no assurance that clinical or commercialization success will occur.

WeIn ~~currently~~May 2025, ~~lease~~we ~~office~~entered ~~space~~into ~~which~~an ~~serves~~amendment asof our ~~corporate~~lease ~~headquarters~~for office space, ~~and~~resulting ~~both~~in the recognition of ~~our~~right-of-use ~~business~~assets ~~segments~~and ~~(Specialized~~lease ~~BioTherapeutics~~liabilities ~~and~~during ~~Public~~the ~~Health~~six months ~~Solutions)~~ended June 30, ~~operate~~2025 ~~from~~totaling ~~this space~~$360,604. Pursuant to anthe amendment ~~on June 21~~, ~~2022,~~ the lease has been extended tothrough October ~~2025~~2028. The current rent ofis $11,~~367~~625 per month ~~will~~through beOctober 2026. ~~maintained~~It ~~until~~increases ~~November 2024~~to ~~when~~$11,883 itin ~~will~~November 2026 beand ~~increased~~ to $1112,~~625~~142 ~~per~~in November ~~month~~2027 where it ~~will~~remains ~~remain~~ until expiration. ~~Our office space is sufficient for our current needs.~~

46In September 2014, we entered into an asset purchase agreement with Hy Biopharma Inc. (“Hy Biopharma”) pursuant to which we acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, we paid $275,000 in cash and issued 771 shares of common stock with a fair value based on our stock price on the date of grant of $3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in our research and development activities and do not have alternative future use.

In March 2020, we filed a prospectus supplement covering the offer and sale of up to 8,151 shares of our common stock which were issued to Hy Biopharma. We were required to issue the shares to Hy Biopharma as payment following the achievement of a milestone under the asset purchase agreement, specifically, the Phase 3 clinical trial of HyBryte™ being successful in the treatment of CTCL. The number of shares of our common stock issued to Hy Biopharma was calculated using an effective price of $614.40 per share, based upon a formula set forth in the asset purchase agreement.

Provided the sole remaining future success-oriented milestone of FDA approval is attained, we will be required to make an additional payment of $5 million, if and when achieved. Such payment will be payable in our restricted securities provided such number of shares does not exceed 19.9% ownership of our outstanding stock. As of June 30, 2025, no other milestone or royalty payments have been paid or accrued.

In May 2025, we entered into an amendment to Dr. Schaber’s employment agreement to increase the number of shares of common stock, from 2,084 to 200,000, issuable to Dr. Schaber immediately prior to the completion of a transaction, or series or a combination of related transactions, negotiated by our Board of Directors whereby, directly or indirectly, a majority of our capital stock or a majority of our assets are transferred from us and/or our stockholders to a third party.

In December 2020, we entered into a $20 million convertible debt financing agreement with Pontifax (the “Loan Agreement”). Under the terms of the Loan Agreement, we had access to up to $20 million in convertible debt financing which accrued interest at a rate of 8.47% on borrowed amounts and an interest rate of 1% on amounts available but not borrowed as an unused line of credit fee. Payments of interest only were due for the first two years and thereafter, the outstanding principal was to be repaid in quarterly installments, as defined.

Upon the closing of this transaction, we borrowed an initial amount of $10 million and made no further borrowings through the term of the agreement.

In April 2023, we entered into an amendment to the Loan Agreement (the “2023 Amendment”). The 2023 Amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The 2023 Amendment adjusted certain payment provisions, and provided for an adjustment to the conversion price provisions with respect to the remaining principal amount to (i) 90% of the closing price of our common stock on the day before the delivery of a conversion notice with respect to the first 36,790 shares of our common stock issuable upon conversion and to (ii) $27.20 with respect to all shares of our common stock issuable upon conversion thereafter.

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InThe ~~September 2014,~~2023 weAmendment ~~entered~~resulted ~~into~~in anthe ~~asset~~extinguishment ~~purchase~~of ~~agreement~~the ~~with~~original Hyconvertible ~~Biopharma~~debt ~~pursuant~~for toaccounting ~~which~~purposes. weWe ~~acquired~~elected ~~certain~~to ~~intangible~~account ~~assets,~~for ~~properties~~the ~~and~~amended ~~rights~~convertible ofdebt Hyusing ~~Biopharma related to~~ the ~~development~~fair ofvalue ~~Hy BioPharma’s synthetic hypericin product~~option. As ~~consideration~~a ~~for the assets acquired~~result, we ~~initially~~recognized ~~paid~~ $~~275~~260,~~000~~933 inof ~~cash~~other ~~and~~income ~~issued~~from ~~12,328~~the ~~shares~~change ofin ~~Common~~the ~~Stock with a~~ fair value ~~based~~of ~~upon~~the ~~our~~convertible ~~stock~~debt ~~price~~in onour ~~the~~accompanying ~~date~~condensed ofconsolidated ~~grant~~statements of ~~$3.75~~operations ~~million.~~during ~~These~~the ~~amounts~~six months ~~were~~ended ~~charged~~June 30, to2024. ~~research~~The ~~and~~fair ~~development~~value ~~expense~~of ~~during~~ the ~~third~~convertible ~~quarter~~debt ofwas ~~2014~~estimated asusing the ~~assets~~Monte ~~will~~Carlo bevaluation ~~used in our research and development activities and do not have alternative future use pursuant to GAAP~~method.

InDuring ~~January~~the six ~~2020,~~months ~~our~~ended ~~Board~~June 30, of2024, ~~Directors~~Pontifax ~~authorized~~delivered ~~an amendment~~ to ~~Dr. Schaber’s~~us ~~employment~~notices ~~agreement to increase the number~~ of ~~shares~~conversion ofelecting ~~Common Stock from 334~~ to ~~33,334,~~convert ~~issuable~~a toportion ~~Dr. Schaber~~of ~~immediately prior to~~ the ~~completion~~then ofoutstanding aprincipal ~~transaction,~~balance orinto ~~series~~shares ~~or a combination~~ of ~~related transactions, negotiated by~~ our ~~Board~~common ofstock. ~~Directors whereby~~Accordingly, ~~directly~~we orissued ~~indirectly~~36,790 ashares ~~majority~~ of our ~~capital~~common stock orresulting in a ~~majority~~reduction of ~~our~~the ~~assets~~outstanding ~~are~~principal ~~transferred~~balance ~~from~~totaling ~~us and/or our stockholders to a third party~~$254,256.

In ~~March~~October ~~2020~~2024, we ~~filed~~entered ainto ~~prospectus~~an ~~supplement~~amendment ~~covering~~ (the ~~offer~~“2024 ~~and~~Amendment”) ~~sale~~to ofthe upLoan ~~to 130~~Agreement,~~413~~ ~~shares~~as ofamended. ~~our~~The ~~Common~~2024 ~~Stock~~Amendment ~~which~~reduced ~~were~~the ~~issued~~conversion price with respect to Hythe ~~Biopharma.~~remaining Weprincipal ~~were~~amount ~~required~~outstanding to ~~issue~~(i) $3.81 for the first 501,648 shares toof Hyour ~~Biopharma~~common asstock ~~payment~~issuable ~~following~~upon ~~the~~conversion ~~achievement~~and of(ii) $4.23 awith ~~milestone~~respect ~~under~~to ~~the~~all ~~asset~~shares ~~purchase~~of ~~agreement,~~our ~~specifically,~~common ~~the~~stock ~~Phase~~issuable 3upon ~~clinical~~conversion ~~trial~~thereafter. The remaining terms of ~~HyBryte™~~the ~~being~~agreement ~~successful~~remained in ~~the~~effect ~~treatment~~with ofminimal, ~~CTCL~~non-material modifications to those terms. ~~The~~Pursuant ~~number~~to ofapplicable ~~shares~~accounting ofstandards, ~~our~~after ~~common~~the ~~stock~~2024 ~~issued~~amendment, we elected not to Hyaccount ~~Biopharma~~for ~~was~~the ~~calculated~~amended ~~using~~convertible andebt ~~effective~~under ~~price~~the offair ~~$38~~value option.40 ~~per share~~Accordingly, ~~based~~there ~~upon~~was ano ~~formula~~further ~~set~~recognition ~~forth~~for the impact of changes in ~~the~~fair ~~asset~~value ~~purchase~~in ~~agreement~~our financial statements.

~~Provided~~In ~~the~~February 2025, ~~final~~we ~~success-oriented~~fully ~~milestone~~repaid ofall ~~FDA~~outstanding ~~approval~~obligations isand ~~attained,~~terminated wethe ~~will~~Loan beAgreement. ~~required~~As ~~to make~~ a ~~payment~~result, ofall uprelated toliens ~~$5 million, if~~ and ~~when~~security ~~achieved.~~interests ~~The~~securing ~~potential future payment will be payable in~~ our ~~Common~~obligations ~~Stock,~~were ~~not to exceed 19~~released.9% ofWe ~~our~~did ~~outstanding~~not ~~stock.~~incur Asany ofprepayment ~~March 31, 2024,~~penalties nofor ~~other~~the ~~milestone~~early ~~or royalty payments have been paid or accrued~~repayment.

In December 2020, we entered into a $20 million convertible debt financing agreement with Pontifax, the healthcare-dedicated venture and debt fund of the Pontifax life science funds. Under the terms of the agreement with Pontifax, we had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and had an interest-only period through December 2022 with a rate of 8.47% on borrowed amounts and a 1% rate on amounts available but not borrowed as an unused line of credit fee. After the interest-only period, the outstanding principal was to be repaid in quarterly payments of $1 million each commencing in the first quarter of 2023. The agreement is secured by a lien covering substantially all of our assets, other than intellectual property.

Upon the closing of this transaction, we borrowed the first tranche of $10 million. We did not utilize our option to draw the second or third tranche of $5 million each, which expired on December 15, 2021 and March 15, 2022, respectively.

In April 2023, we entered into an amendment to the convertible debt financing agreement with Pontifax. The amendment required the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The amendment also provided for a new interest only period from the date of the amendment through June 30, 2024, reduced quarterly principal repayments from $1 million to $750,000 and eliminated the minimum cash covenant. Further, the Amendment reduced the conversion price with respect to the remaining principal amount under the agreement to (i) 90% of the closing price of our Common Stock on the day before the delivery of the conversion notice with respect to the first 36,790 shares of our Common Stock issuable upon conversion and to (ii) $27.20 with respect to all shares of our Common Stock issuable upon conversion in excess of the first 36,790 shares so issued. The remaining terms of the agreement remain in effect without modification.

On January 3, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining principal balance into shares of the Company’s Common Stock. Upon conversion, the Company issued 146,199 shares of the Company’s Common Stock at $0.68 per share, reducing the remaining principal

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balance by $99,416. Pontifax may elect to convert the remaining outstanding loan drawn under the first tranche into additional shares of the Company’s Common Stock at any time prior to repayment. The Company also has the ability to force the conversion of the loan into shares of its Common Stock, subject to certain conditions.

The amendment to the convertible debt financing agreement with Pontifax resulted in the extinguishment of the original convertible debt for accounting purposes. We elected to account for the amended convertible debt using the fair value option, which requires us to record changes in fair value as a component of other income or expense. The fair value of the convertible debt as of March 31, 2024 was $2,996,136, which resulted in the recognition of $165,382 of other income from the change in the fair value of the convertible debt on our accompanying condensed consolidated statements of operations during the three months ended March 31, 2024. The fair value of the convertible debt was estimated using the Monte Carlo valuation method.

Interest expense incurred during the three months ended March 31, 2024 and 2023 was $61,239 and $187,964, respectively. Interest expense paid during the three months ended March 31, 2024 and 2023 was $64,047 and $213,490, respectively.

Contingencies

We follow subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain conditions may exist as of the date the financial statements are issued, which may result in a loss to us but which will only be resolved when one or more future events occur or fail to occur. We assess such contingent liabilities, and such assessment inherently involves an exercise of judgment. A liability is only recorded if we determine that it is both probable and reasonably estimable.

4857

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BUSINESS

Our Business Overview

Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy, utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With successful completion of the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early -stage disease, we ~~are targeting~~began ~~to begin~~ patient enrollment byduring December 2024 for the ~~end~~second ofPhase ~~2024~~3 ~~with~~study called “FLASH2” (Fluorescent Light Activated Synthetic Hypericin 2). We anticipate top-line results ~~anticipated~~ in the second half of 2026. Upon successful completion of the ~~second~~ Phase 3 ~~study, called “~~FLASH2” ~~(Fluorescent Light Activated Synthetic Hypericin 2)~~study, regulatory approval will be sought to support potential commercialization worldwide.

Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our vaccine programs, targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID- 19 (caused by SARS-CoV- 2). The development of ~~the~~our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority, and the Defense Threat Reduction Agency.

An outline of our business strategy follows:

● Following agreement from the EMA on the key design components for the second confirmatory Phase 3 placebo-controlled FLASH2 ~~(Florescent Light Activated Synthetic Hypericin 2)~~ clinical trial of HyBryte™ in CTCL and positive primary endpoint results from the first Phase 3 FLASH study, ~~initiate~~continue enrollment and execution of the FLASH2 study, while at the same time, continuing discussions with the United States (“U.S.”) Food and Drug Administration (“FDA”) on potential modifications to the development path to adequately address their feedback.

● Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment of oral mucositis would be required to support a marketing authorization;, design a second study and attempt to identify a potential partner(s) to continue this development program.

● ~~Expanding~~Expand development of dusquetide under the research name SGX945 into ~~Behçet’s~~BD ~~Disease~~by ~~with~~conducting ~~the conduct of~~ a Phase 2a2 clinical trial, where previous studies with dusquetide in oral mucositis and BD have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation and BD.

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in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation.

●

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●

Continue to apply for and secure additional government funding for each of our Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements.

●

Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives, including but not limited to merger/acquisition strategies.

●

Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development.

Corporate Information

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Our Product Candidates in Development

The following tables summarize our product candidates under development:

Specialized BioTherapeutics Product Candidates


Specialized BioTherapeutics Product Candidates
Soligenix Product
Candidate	Therapeutic Indication	Stage of Development
HyBryte™	Cutaneous T-Cell Lymphoma	Phase 2 trial completed; demonstrated significantly higher response rate compared to placebo; Phase 3 trial completed; demonstrated statistical significance in primary endpoint in March 2020 (Cycle 1) and demonstrated continued improvement in treatment response with extended treatment in April 2020 (Cycle 2) and October 2020 (Cycle 3); new drug application (“NDA”) submitted to FDA December 2022; FDA refusal to file letter received February 2023; second Phase 3 trial based upon EMA-accepted protocol began patient enrollment in December 2024 with top-line results anticipated in the second half of 2026; discussions continue with FDA on modifying the development path to adequately address FDA’s preference for a longer duration comparative study over a placebo-controlled trial

Soligenix Product Candidate	Therapeutic Indication	Stage of Development
HyBryte™	Cutaneous T-Cell Lymphoma	Phase 2 trial completed; demonstrated significantly higher response rate compared to placebo; Phase 3 trial completed; demonstrated statistical significance in primary endpoint in March 2020 (Cycle 1) and demonstrated continued improvement in treatment response with extended treatment in April 2020 (Cycle 2) and October 2020 (Cycle 3); NDA submitted to FDA December 2022; FDA RTF letter received February 2023; second Phase 3 trial based upon EMA-accepted protocol targeted to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026; discussions continue with FDA on modifying the development path to adequately address FDA’s preference for a longer duration comparative study over a placebo-controlled trial.

SGX302	Mild-to-Moderate Psoriasis	Positive proof-of-concept demonstrated in a small Phase 1/2 pilot study; Phase 2a protocol and Investigation New Drug (“IND”) clearance received from the FDA; Phase 2a study remains ongoing having demonstrated biological effect in Cohort 1 and clinically meaningful benefit in Cohort 2

SGX942†	Oral Mucositis in Head and Neck Cancer	Phase 2 trial completed; demonstrated significant response compared to placebo with positive long-term (12 month) safety also reported; Phase 3 clinical trial results announced December 2020: the primary endpoint of median duration of severe oral mucositis (“SOM”) did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group; analyzed full dataset from Phase 3 study and designing a second Phase 3 clinical trial; continued development contingent upon identification of partnership

SGX945	Aphthous Ulcers in Behçet’s Disease	Phase 2a protocol and IND clearance received from the FDA; Phase 2a study to be initiated in the second half of 2024

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Public Health Solutions†

Soligenix Product
Candidate	Therapeutic Indication	Stage of Development
SGX302	Mild-to-Moderate Psoriasis	Positive proof-of-concept demonstrated in a small Phase 1/2 pilot study; Phase 2a protocol and Investigation New Drug (“IND”) clearance received from the FDA; Phase 2a study remains ongoing having demonstrated biological effect in Cohort 1 and clinically meaningful benefit in Cohort 2
SGX942†	Oral Mucositis in Head and Neck Cancer	Phase 2 trial completed; demonstrated significant response compared to placebo with positive long-term (12 month) safety also reported; Phase 3 clinical trial results
		announced December 2020: the primary endpoint of median duration of severe oral mucositis (“SOM”) did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group; analyzed full dataset from Phase 3 study and designing a second Phase 3 clinical trial; continued development contingent upon identification of partnership
SGX945	Aphthous Ulcers in Behçet’s Disease	Phase 2a protocol and Investigational New Drug (“IND”) received from the FDA; Phase 2a study complete; biological efficacy and safety demonstrated

Soligenix Product Candidate	Indication	Stage of Development
ThermoVax®	Thermostability of vaccines for Ricin toxin, Ebola, and Marburg viruses	Pre-clinical

RiVax®	Vaccine against Ricin Toxin Poisoning	Phase 1a, 1b, and 1c trials completed, safety and neutralizing antibodies for protection demonstrated

SGX943	Therapeutic against Emerging Infectious Diseases	Pre-clinical

†Contingent upon continued government contract/grant funding or other funding source.

Public Health Solutions†
Soligenix Product
Candidate	Indication	Stage of Development
ThermoVax^®	Thermostability of vaccines for Ricin toxin, Ebola, and Marburg viruses	Pre-clinical
RiVax^®	Vaccine against Ricin Toxin Poisoning	Phase 1a, 1b, and 1c trials completed, safety and neutralizing antibodies for protection demonstrated
SGX943	Therapeutic against Emerging Infectious Diseases	Pre-clinical

†	Contingent upon continued government contract/grant funding or other funding source.

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Specialized BioTherapeutics Overview

Synthetic Hypericin

Synthetic Hypericin is a potent photosensitizer that is topically applied to skin lesions, taken up by cutaneous T-cells and then activated by safe visible light. Hypericin is also found in several species of Hypericum plants, although the active moiety used in HyBryte™ and SGX302 is chemically synthesized by a proprietary manufacturing process and not extracted from plants. Importantly, hypericin is optimally activated with visible light thereby avoiding the negative consequences of ultraviolet (“UV”) light. Other light therapies using UVA or UVB light can result in serious adverse effects including secondary skin cancers.

Combined with photoactivation, in clinical trials synthetic hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In both settings, it appears that the mode of action is an induction of cell death in a concentration as well as a light dose-dependent fashion. These effects appear to result, in part, from the generation of singlet oxygen during photoactivation of hypericin.

Synthetic hypericin is one of the most efficient known generators of singlet oxygen, the key component for phototherapy. The generation of singlet oxygen induces necrosis and apoptosis in cells. The use of topical synthetic hypericin coupled with directed visible light results in generation of singlet oxygen only at the treated site. We believe that the use of visible light (as opposed to cancer-causing UV light) is a major advance in photodynamic therapy. In a small published Phase 1/2 proof of concept pilot clinical study using synthetic hypericin twice weekly for six weeks, statistically significant efficacy was demonstrated in patients with CTCL (58.3% response, p=0.04) and psoriasis (80% response, p<0.02). Subsequently, a published Phase 3 study in CTCL has further confirmed the biological efficacy of synthetic hypericin (termed HyBryte™ in the context of CTCL). A confirmatory, placebo-controlled study based upon an EMA-accepted protocol is enrolling with top-line results expected in the 2nd half of 2026.

HyBryte™ –— for Treating Cutaneous T-Cell Lymphoma

HyBryte™ is a novel, first-in-class, Photodynamic Therapy (“PDT”), that utilizes safe visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a photosensitizer which is topically applied to skin lesions and then activated by visible fluorescent light 16 to 24 hours later.

Based on the positive and previously published Phase 1/2 results, we initiated our Phase 3 clinical study of HyBryte™ for the treatment of CTCL during December 2015 and completed the trial in 2020. This trial, referred to as the “FLASH” (Fluorescent Light Activated Synthetic Hypericin) study, aimed to evaluate the response to HyBryte™ as a skin directed therapy to treat early -stage CTCL. We completed the study with approximately 35 CTCL centers across the U.S. participating in this trial. The Phase 3 protocol was a highly powered, double-blind, randomized, placebo-controlled, multicenter trial that enrolled 169 subjects (166 evaluable). The trial consisted of three treatment cycles, each of eight weeks duration. Treatments were administered twice weekly for the first six weeks and treatment response was determined at the end of the eighth week. In the first treatment cycle, approximately 66% of subjects received HyBryte™ and 33% received placebo treatment of their index lesions. In the second cycle, all subjects received HyBryte™ treatment of their index lesions, and in the third cycle, all subjects received HyBryte™ treatment of all of their lesions. The majority of subjects enrolled elected to continue into the third optional, open-label cycle of the study. Subjects were followed for an additional six months after their last evaluation visit. The primary efficacy endpoint was assessed on the percentage of patients in each of the two treatment groups (i.e., HyBryte™ and placebo) achieving a partial or complete response of the treated lesions, defined as a ≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (“CAILS”) score for three index lesions at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline. Secondary endpoints for the trial included the duration of responses, the extent of the regression of the tumors, and the safety of the treatment. We continue to work closely with the Cutaneous Lymphoma Foundation, as well as the National Organization for Rare Disorders.

52Over the course of 2020, the Phase 3 FLASH study data was announced. The study enrolled 169 patients (166 evaluable) randomized 2:1 to receive either HyBryte™ (116 patients) or placebo (50 patients) and demonstrated a statistically significant treatment response (p=0.04) in the CAILS primary endpoint assessment at 8 weeks for Cycle 1. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their index lesions compared to only 4% of patients in the placebo group at 8 weeks. HyBryte™ treatment in the first cycle was safe and well tolerated.

Analysis of the second open-label treatment cycle (Cycle 2) showed that continued treatment with HyBryte™ twice weekly for an additional 6 weeks (12 weeks total) increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001

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~~CTCL~~compared ~~centers~~to ~~across the U.S. participating in this trial. The Phase 3 protocol was a highly powered, double~~6-~~blind,~~weeks ~~randomized, placebo-controlled, multicenter trial that enrolled 169 subjects (166 evaluable~~treatment). The ~~trial~~response ~~consisted~~rate ofin ~~three~~patients ~~treatment~~receiving ~~cycles,~~a ~~each~~total of ~~eight~~12 weeks ~~duration. Treatments were administered twice weekly for the first six weeks and treatment response was determined at the end~~ of ~~the eighth week. In the first~~ treatment ~~cycle,~~increased ~~approximately~~two ~~66% of subjects received HyBryte™~~ and ~~33%~~a received placebo treatment of their index lesions. In the second cycle, all subjects received HyBryte™ treatment of their index lesions, and in the third cycle, all subjects received HyBryte™ treatment of all of their lesions. The majority of subjects enrolled elected to continue into the third optional, openhalf-~~label cycle of the study~~fold. ~~Subjects~~Treatment responses were ~~followed~~assessed ~~for~~at anWeek ~~additional~~8 ~~six months~~ (after ~~their~~6 ~~last~~weeks ~~evaluation visit. The primary efficacy endpoint was assessed on the percentage~~ of ~~patients in each of the two~~ treatment) ~~groups (i.e., HyBryte™~~ and placebo) achieving a partial or complete response of the treated lesions, defined as a ≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (“CAILS”) score for three index lesions at ~~the~~Week ~~Cycle~~16 ~~1 evaluation visit~~ (~~Week~~after 8)12 ~~compared~~weeks ~~to the total CAILS score at baseline. Secondary endpoints for the trial included the duration~~ of ~~responses, the extent of the regression of the tumors, and the safety of the~~ treatment). WeThe ~~continue~~data continued to ~~work~~indicate ~~closely~~that ~~with~~HyBryte™ ~~the~~was ~~Cutaneous~~safe ~~Lymphoma~~and ~~Foundation, as~~ well ~~as the National Organization for Rare Disorders~~tolerated.

~~Positive~~Analysis ~~primary~~of ~~endpoint~~the ~~analysis~~optional ~~for~~third ~~the~~open-label ~~Phase~~treatment cycle (Cycle 3) ~~study~~focused ~~for~~on safety and all patients could elect to receive HyBryte™ ~~was~~treatment ~~completed~~of all their lesions for an additional 6 weeks or up to 18 weeks in ~~March 2020~~total. ~~The~~Of ~~study~~note, ~~enrolled~~66% ~~169~~of patients ~~(166~~elected ~~evaluable)~~to ~~randomized~~continue ~~2:1~~with tothis ~~receive~~optional ~~either~~safety cycle of the study. Of the subset of patients that received HyBryte™ ~~(116~~throughout ~~patients)~~all orthree ~~placebo~~cycles of treatment (5018 ~~patients~~weeks), ~~and~~49% of them demonstrated a ~~statistically significant~~ treatment response (p=0.~~04)~~046 invs. ~~the~~patients ~~CAILS~~completing ~~primary~~12 ~~endpoint~~weeks ~~assessment~~of atHyBryte™ 8treatment ~~weeks~~in ~~for~~Cycle 2; p<0.0001 vs. patients receiving placebo in Cycle 1). AMoreover, ~~total~~in ofa ~~16%~~subset of ~~the~~ patients ~~receiving~~evaluated in this cycle, it was demonstrated that HyBryte™ ~~achieved~~is atnot ~~least~~systemically aavailable, ~~50%~~consistent ~~reduction~~with inthe ~~their~~general ~~index~~safety ~~lesions~~of ~~compared~~this totopical ~~only~~product 4%observed ofto ~~patients~~date. inAt the ~~placebo~~end ~~group~~of atCycle 83, ~~weeks.~~ HyBryte™ ~~treatment~~continued into ~~the~~be ~~first~~well ~~cycle~~tolerated ~~was~~despite ~~safe~~extended and ~~well~~increased ~~tolerated~~use of the product to treat multiple lesions.

Analysis of the second open-label treatment cycle (Cycle 2) was completed in April 2020, showing that continued treatment with HyBryte™ twice weekly for an additional 6 weeks (12 weeks total) increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment). After the subsequent additional 6-week treatment, the response rate in patients receiving a total of 12 weeks treatment increased two and a half-fold. Treatment responses were assessed at Week 8 (after 6 weeks of treatment) and at Week 16 (after 12 weeks of treatment). A positive response was defined as an improvement of at least 50% in the CAILS score for the three index lesions evaluated in both Cycles 1 and 2. The data continued to indicate that HyBryte™ was safe and well tolerated.

Analysis of the optional third open-label treatment cycle (Cycle 3) was completed in October 2020. Cycle 3 was focused on safety and all patients could elect to receive HyBryte™ treatment of all their lesions for an additional 6 weeks or up to 18 weeks in total. Of note, 66% of patients elected to continue with this optional safety cycle of the study. Of the subset of patients that received HyBryte™ throughout all three cycles of treatment (18 weeks), 49% of them demonstrated a treatment response (p=0.046 vs. patients completing 12 weeks of HyBryte™ treatment in Cycle 2; p<0.0001 vs. patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

In addition, continued analysis of results from the protocol mandated efficacy cycles (Cycles 1 and 2) of the study revealed that 12 weeks of treatment (Cycle 2) with HyBryte™ is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions when compared to Cycle 1 placebo lesion responses, further demonstrating the unique benefits of the more deeply penetrating visible light activation of hypericin.

Following the first Phase 3 study of HyBryte™ for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the confirmatory Phase 3 trial will be a randomized, double-blind, placebo-controlled, multicenter study treating approximately 80 subjects with early -stage CTCL. It will evaluate the efficacy and safety of HyBryte™ topically applied to CTCL lesions twice weekly for 18 weeks, with each application followed 21 (±3) hours later by the administration of safe, visible light at a wavelength of 500 to 650 nm. All of the patient’s lesions that are readily available for exposure to the visible light source will be treated and three to five index lesions of each patient will be prospectively identified and indexed for the modified composite assessment of index lesions severity (“mCAILS”) evaluation prior to randomization (baseline). The primary efficacy endpoint will be assessed on the percent of patients in each of the two treatment groups (i.e., HyBryte™ and placebo) achieving a Partial or Complete Response (yes/ no) of the treated lesions defined as a ≥ 50% reduction in the total mCAILS score for the three to five index lesions following 18 weeks of treatment compared to the total mCAILS score at baseline. Other secondary measures will assess treatment response (including duration), degree of improvement, time to relapse and safety. Following treatment, all patients will be followed every four weeks for a total of 12 weeks (through Week 30). The Data Monitoring Committee will conduct one (1) interim analysis when approximately 60% of the total subjects have completed the primary endpoint evaluation. The primary efficacy endpoint and the key safety endpoints will be analyzed. A sample size recalculation may be performed after examining the assumptions or the trial halted for either futility, safety concerns, or overwhelming efficacy. We, the participating clinical investigators, and any other personnel involved in trial conduct will remain blinded to study treatment until completion of the trial.

53HyBryte™ has received Orphan Drug designation as well as Fast Track designation from the FDA. The Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven-year term of market exclusivity for HyBryte™ upon final FDA approval, Orphan Drug designation also positions us to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees for the potential submission of an NDA for HyBryte™, and certain tax credits. In addition, Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast Track designation is designed to facilitate the development and expedite the review of new drugs. For instance, we were eligible to submit a NDA for HyBryte™ on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for Fast Track development programs ordinarily will be eligible for priority review. HyBryte™ for the treatment of CTCL also was granted Orphan Drug designation from the EMA Committee for Orphan Medical Products and Promising Innovative Medicine (“PIM”) designation from the MHRA, as well as Innovation Passport under the Innovative Licensing and Access Pathway (“ILAP”) in the UK.

In May 2021, HyBryte™ was awarded an “Innovation Passport” for the treatment of early-stage CTCL in adults under the UK’s ILAP. The decision to award the Innovation Passport to the HyBryte™ program was made by the Innovative Licensing and Access Pathway Steering Group, which is comprised of representatives from MHRA, the National Institute for Health and Care Excellence (“NICE”), and the Scottish Medicines Consortium (“SMC”). ILAP was launched at the start of 2021 to accelerate the development and access to promising medicines, thereby facilitating patient access to new medicines. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with the MHRA, NICE, and SMC. The

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~~nm.~~innovation ~~The~~passport ~~light~~designation ~~will~~is ~~be administered starting at 6 J/cm2 twice weekly. This will be increased upwards by 2 J/cm2 until: 1)~~ the ~~patient~~first ~~experiences~~step ain ~~Grade 1 erythema, 2)~~ the ~~patient~~ILAP ~~reaches~~process ~~the~~and ~~maximum~~triggers ~~dose of 30 J/cm2, or 3)~~ the ~~patient~~MHRA ~~cannot~~and ~~tolerate~~its ~~the~~partner ~~treatment~~agencies ~~time, whichever comes first. All of the patient’s lesions that are readily available for exposure~~ to ~~the~~create ~~visible~~a ~~light~~target ~~source~~development ~~will~~profile ~~be treated and three~~ to ~~five~~chart ~~index~~out ~~lesions~~a ofroadmap ~~each~~for ~~patient~~regulatory ~~will be prospectively identified~~ and ~~indexed~~development ~~for~~milestones ~~the~~with ~~modified composite assessment of index lesions severity (“mCAILS”) evaluation prior to randomization (baseline). The primary efficacy endpoint will be assessed on~~ the ~~percent~~ ofgoal ~~patients in each~~ of ~~the~~early ~~two~~patient ~~treatment~~access ~~groups (i.e., HyBryte™ and placebo) achieving a Partial or Complete Response (yes/no) of the treated lesions defined as a ≥ 50% reduction~~ in the ~~total mCAILS score for the three to five index lesions following 18 weeks of treatment compared to the total mCAILS score at baseline~~UK. Other ~~secondary~~benefits ~~measures will assess treatment response (including duration), degree~~ of ~~improvement,~~ILAP ~~time~~include ~~to relapse and safety. Following treatment, all patients will be followed every four weeks for~~ a ~~total~~150-day ofaccelerated 12 weeks (through Week 30). The Data Monitoring Committee will conduct one (1) interim analysis when approximately 60% of the total subjects have completed the primary endpoint evaluation. The primary efficacy endpoint and the key safety endpoints will be analyzed. A sample size recalculation may be performed after examining the assumptions or the trial halted for either futilityassessment, ~~safety~~rolling ~~concerns,~~review ~~or overwhelming efficacy. The Company, participating clinical investigators,~~ and ~~any~~a ~~personnel~~continuous ~~involved~~benefit inrisk ~~trial conduct will remain blinded to study treatment until completion of the trial~~assessment.

HyBryte™ has received Orphan Drug designation as well as Fast Track designation from the FDA. The Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven-year term of market exclusivity for HyBryte™ upon final FDA approval, Orphan Drug designation also positions us to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees for the potential submission of a NDA for HyBryte™, and certain tax credits. In addition, Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast Track designation is designed to facilitate the development and expedite the review of new drugs. For instance, we were eligible to submit a NDA for HyBryte™ on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for Fast Track development programs ordinarily will be eligible for priority review. HyBryte™ for the treatment of CTCL also was granted Orphan Drug designation from the EMA Committee for Orphan Medical Products and Promising Innovative Medicine (“PIM”) designation from the MHRA, as well as Innovation Passport under the Innovative Licensing and Access Pathway (“ILAP”) in the UK.

During January 2021, we signed an exclusive Supply, Distribution and Services Agreement with The Daavlin Distributing Co. (“Daavlin”), securing long-term supply and distribution of a commercially ready light device, which is an integral component of the regulatory and commercial strategy for HyBryte™ for the treatment of CTCL. Pursuant to the agreement, Daavlin will exclusively manufacture the proprietary light device for use with HyBryte™ for the treatment of CTCL. Upon approval of HyBryte™ by the FDA, we will promote HyBryte™ and the companion light device, and facilitate the direct purchase of the device from Daavlin. Daavlin will exclusively distribute and sell the HyBryte™ light device to us, physicians and patients.

In April 2021, the FDA conditionally accepted HyBryte™ as the proposed brand name for SGX301 or synthetic hypericin, in the treatment of early stage CTCL. The name HyBryte™ was developed in compliance with the FDA’s Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. The FDA’s conditional approval validates HyBryte™ as a proprietary name that is consistent with the FDA’s goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the HyBryte™ proprietary name is conditioned on FDA approval of the product candidate, SGX301.

In May 2021, HyBryte™ was awarded an "Innovation Passport" for the treatment of early stage CTCL in adults under the UK’s ILAP. The decision to award the Innovation Passport to the HyBryte™ program was made by the Innovative Licensing and Access Pathway Steering Group, which is comprised of representatives from MHRA, the National Institute for Health and Care Excellence (“NICE”), and the Scottish Medicines Consortium

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(“SMC”). ILAP was launched at the start of 2021 to accelerate the development and access to promising medicines, thereby facilitating patient access to new medicines. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with the MHRA, NICE, and SMC. The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day accelerated assessment, rolling review and a continuous benefit risk assessment.

As a result of discussions with the FDA regarding the HyBryte™ NDA submission and due to disruptions caused by the global COVID-19 pandemic resulting in delays by the commercial active pharmaceutical ingredient (“API”) contract manufacturer affecting the timing of availability of the pre-requisite amount of accrued stability data required to file the NDA, we filed the NDA with the FDA in December of 2022. We did not pursue a rolling NDA submission, so that we could provide additional supportive data in the NDA filing.

In June 2021, we received a Paediatric Investigation Plan (“PIP”) waiver from the EMA for HyBryte™. As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a PIP outlining their strategies for investigation of the new medicinal products in the pediatric population. In some instances, a waiver negating the need for a PIP for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate, as is the case for HyBryte™ in CTCL which is extremely rare in children.

In September 2021, we were granted orphan drug designation for the active ingredient hypericin for the treatment of T-cell lymphoma, extending the target population beyond CTCL as previously granted by the FDA.

In July 2022, the results of our successful Phase 3 FLASH study evaluating HyBryte™ for the treatment of CTCL were published in the Journal of the American Medical Association (JAMA) Dermatology.

In July 2022, we received agreement from the FDA on an initial pediatric study plan (“iPSP”) for HyBryte™ for the treatment of CTCL. The agreed iPSP stipulates that we intend to request a full waiver of pediatric studies upon submission of the NDA. Agreement with FDA on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.

In September 2022, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte™ for expanded treatment in patients with early -stage CTCL. The grant, totaling $2.6 million over four years, was awarded to a prestigious academic institution that was a leading enroller in the published positive Phase 3 FLASH study in the treatment of early -stage CTCL.

In December 2022, we submitted the HyBryte™ NDA for the treatment of CTCL with the FDA.

In February 2023, we received a refusal to file (“RTF”) letter from the FDA for the HyBryte™ NDA. Upon preliminary review, the FDA determined that the NDA was not sufficiently complete to permit substantive review.

In April 2023, the ~~United~~U.S. ~~States~~ Adopted Names (“USAN”) Council approved the use of the nonproprietary name of “hypericin sodium” for the novel active ingredient in both HyBryte™ (research name SGX301) for the treatment of CTCL and SGX302 for the treatment of mild-to-moderate psoriasis.

In April 2023, we had a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter received from the FDA and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to be deemed acceptable to file, in order to advance HyBryte™ towards marketing approval and U.S. commercialization. In order to accept an NDA filing for HyBryte™, the FDA is requiring positive results from a second, Phase 3 pivotal study in addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. Based on this feedback, we have decided to collaboratively engage in discussions with the FDA in order to define the protocol and evaluate the feasibility of conducting the additional clinical trial.

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In May 2023, we were granted a follow-on Type A meeting with the FDA to initiate formal discussions regarding the protocol design of a second, Phase 3 pivotal study evaluating HyBryte™ in the treatment of CTCL in support of potential FDA marketing approval. While discussions have been collaborative, the FDA has expressed a preference for a longer duration comparative study over a placebo-controlled trial. Given the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, we determined to initiate the FLASH2 study in support of worldwide potential approval. At the same time, we will continue discussions with the FDA on modifying the development path to adequately address their feedback.

In August 2023, patient enrollment was opened for the investigator-initiated study (“IIS”). IIS is supported by an Orphan Products Development grant of $2.6 million over four years awarded by the FDA to ~~Ellen~~a ~~Kim,~~prestigious ~~MD,~~academic ~~Director,~~institution ~~Penn~~that ~~Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who~~ was a leading enroller in the published positive Phase 3 FLASH study in the treatment of early -stage CTCL. The IIS will evaluate the expanded treatment, including up to 12 months of treatment, with HyBryte™ in patients with early -stage CTCL.

In March 2024, we received agreement from the EMA on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early -stage disease. This confirmatory 18-week study, is expected to enroll approximately 80 patients in across the ~~US and Europe~~U.S. and isEurope, ~~targeted~~began ~~to begin~~ patient enrollment byin ~~the end of~~ December 2024, with top-line results anticipated in the second half of 2026.

In June 2024, we announced positive clinical results from a comparability study evaluating HyBryte™ versus Valchlor® (mechlorethamine gel) in the treatment of early stage CTCL. The open-label study enrolled 10 patients (5 patients per group) with treatment success defined as a ≥50% improvement in a patient’s cumulative mCAILS score after 12 weeks of topical treatment compared to Baseline. The study demonstrated that HyBryte™ treatment resulted in 60% of patients achieving a 50% or better improvement in their mCAILS score versus 20% of Valchlor® patients. When comparing the tolerance of the topical therapies in this trial, it is notable that all patients tolerated HyBryte™ well and had no adverse events “Related” to the therapy. In contrast, 60% of the Valchlor® treated patients had at least one adverse event “Related” to the therapy. These adverse events in the Valchlor® group included rashes, application site sensitivity, allergic contact dermatitis, and dermatitis, with one patient requiring steroid treatment, one requiring temporary interruption of Valchlor® treatment, and one requiring permanent discontinuation of Valchlor®. No such instances were reported in the HyBryte™ group.63

In July 2024, we announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for up to 12 months in patients with early stage CTCL. To date, the trial sponsored by Dr. Ellen Kim, has enrolled and treated six patients with HyBryte™ over a time period ranging up to 44 weeks. Patients have responded positively to HyBryte™ therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving “Treatment Success”, as predefined in the study’s protocol as ≥50% improvement in their cumulative mCAILS score compared to Baseline. Of the three Treatment Successes, two were achieved within the first 12 weeks of treatment and the third within 18 weeks. Of the remaining three patients, two have only recently started HyBryte™ therapy and have not yet reached their first efficacy evaluation visit (i.e., at Week 6) and the other had a substantial improvement documented at the Week 18 visit, but has not yet achieved the success threshold. In addition, HyBryte™ appears to be safe and well tolerated in all patients, with no treatment-related adverse events reported to date.

We estimate the potential worldwide market for HyBryte™ is in excess of $250 million for the treatment of CTCL. This potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.

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In September 2024, the European Patent Office granted the patent entitled “Systems and Methods for Producing Synthetic Hypericin”. The newly issued patent’s claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. Synthetic hypericin is the active pharmaceutical ingredient in HyBryte™, our photodynamic therapy for the treatment of CTCL, set to initiate a confirmatory Phase 3 clinical trial before the end of the year. This new European granted patent (EP3423428) is a related patent to U.S. Pat. No. 10,053,413, previously issued in the U.S. Both patents are expected to expire in 2036, and form part of a larger patent family, including previously granted U.S. patents covering methods of use (U.S. Pat. No. 7,122,518) and methods of synthesis (U.S. Pat. No. 8,629,302), as well as other granted patents throughout the world.

In October 2024, we established a partnership agreement with Sterling Pharma Solutions Limited (“Sterling”) to optimize and implement a commercially viable, scalable production technology for synthetic hypericin. We are currently working to transfer and optimize the manufacturing processes and analytics to enable GMP manufacturing for clinical trials with the intent of establishing a long-term commercial manufacturing collaboration.

In October 2024, the Hong Kong Patent Office granted the patent entitled “Systems and Methods for Producing Synthetic Hypericin”. The newly issued patent’s claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process. Synthetic hypericin is the active pharmaceutical ingredient in HyBryte™, our photodynamic therapy for the treatment of CTCL, for which a confirmatory Phase 3 clinical trial has been initiated. This new granted patent (HK1260757) is a related patent to U.S. Pat. Nos. 10,053,413 and 10,526,268, previously issued in the U.S., and is in the same family as another patent granted in Europe. These patents are expected to expire in 2036, and form part of a larger collection of different patent families, including previously granted foreign patents covering liquid formulations and methods of use (EP Pat. No. 2,571,507) and issued U.S. patents for methods of synthesis (U.S. Pat. No. 8,629,302), as well as other granted patents throughout the world.

In December 2024, we announced positive clinical results from a comparability study evaluating HyBryte™ versus Valchlor® (mechlorethamine gel) in the treatment of early-stage CTCL. The open-label study has demonstrated continued improvement in HyBryte™ treated patients and their individual lesions even after stopping treatment. The study, which enrolled 10 patients randomized 1:1 with 12 weeks of treatment and 4 weeks of follow-up post-treatment, was previously reported to demonstrate a positive difference in the overall per patient treatment response rate (60% in the HyBryte™ group vs. 20% in the Valchlor® group) at the end of treatment. After the 4-week follow-up period (Week 16), the majority (3 of 5) of HyBryte™ patients continued to demonstrate improvement with at least a further 10% improvement (absolute difference) at Week 16 relative to the primary outcome measure at Week 12, including one of the HyBryte™ patients achieving a “complete response”. In contrast, of the four patients that completed the Valchlor® arm of the study, none achieved this level of improvement by Week 16. For patients, a treatment response was defined as a ≥50% improvement in their cumulative mCAILS score over 3 to 5 lesions. Treatment response was also assessed on individual lesions. There was a similar continued improvement in the lesion responses over time, with the plaque lesions of particular interest given their increasing association with risk of overall disease progression and long-term mortality. At the 12-week (end of treatment) timepoint, the HyBryte™ treated plaque lesions were statistically significantly improved compared to the Valchlor® treated plaques (63%, [10/16] treatment success with HyBryte™ vs. 17%, [2/12] with Valchlor®, p=0.02). By Week 16, the response rates in lesions treated with HyBryte™ were statistically significant responses for all lesions (72% HyBryte™ vs 28% Valchlor®, p=0.02) and specifically for plaque lesions (75% responding plaque lesions with HyBryte™ treatment vs. 17% with Valchlor®, p=0.006) relative to the Valchlor® group. No safety concerns with HyBryte™ were raised during the follow-up period.

In December 2024, we opened patient enrollment for our confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) in the treatment of CTCL.

In April 2025, we announced positive interim results from the ongoing open-label, IIS evaluating extended HyBryte™ treatment for up to 54 weeks in patients with early-stage CTCL. Following 18 weeks of treatment, 75% of patients achieved “Treatment Success,” reinforcing HyBryte™ as a potentially safe and fast-acting therapy for this chronic and underserved cancer. To date, nine patients have been enrolled and treated with HyBryte™ over a time period of up to 54 weeks in the IIS, with all data for the Week 18 timepoint now complete. Consistent with the Phase 3 trials, Treatment Success is predefined as a greater than or equal to 50% improvement in the cumulative mCAILS score compared to Baseline. Of the eight patients who could be evaluated through Week 18, six (75%) had a Treatment Success. The 18-week treatment window is the same window that is being evaluated in the FLASH2 double-blind, placebo-controlled, randomized study that is currently enrolling patients. This rapid response is a distinct advantage of HyBryte™ therapy, with many other therapies used in CTCL taking up to six to 12 months to generate a clinically meaningful treatment response. Of these eight evaluable patients through Week 18, four have gone on to complete the 54- week treatment with an average maximum improvement in mCAILS score of 85%, three are still on treatment and one dropped out (due to logistical issues). HyBryte™ appears to be safe and well tolerated in all patients. The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous

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Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH study for the treatment of early-stage CTCL.

In July 2025, we successfully completed the transfer of the manufacturing process for our synthetic hypericin active ingredient under our partnership agreement with Sterling. The transfer from Europe to the U.S. included the optimization and implementation of a commercially viable, scalable production process for this important active ingredient, which is used in the topical drug product formulations HyBryte™ and SGX302, being developed for the treatment of CTCL and psoriasis, respectively. Together with Sterling, we have enabled current Good Manufacturing Practice requirements for clinical trials with the intent of establishing a long-term commercial manufacturing collaboration.

Cutaneous T-Cell Lymphoma

CTCL is a class of non-Hodgkin’s lymphoma (“NHL”), a type of cancer of the white blood cells that are an integral part of the immune system. ~~Unlike most NHLs, which generally involve B-cell lymphocytes (involved in producing antibodies),~~ CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. ~~These skin-trafficking malignant T-cells migrate to the skin,~~ causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mycosis fungoides (“MF”) is the most common form of CTCL. It generally presents with skin involvement only, manifested as scaly, erythematous patches. Advanced disease with diffuse lymph node and visceral organ involvement is usually associated with a poorer response rate to standard therapies. A relatively uncommon sub-group of CTCL patients present with extensive skin involvement and circulating malignant cerebriform T-cells, referred to as Sézary syndrome. These patients have substantially graver prognoses (expected five-year survival rate of 24%), than those with MF (expected five-year survival rate of 88%).

CTCL mortality is related to stage of disease, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no FDA- approved drug for front-line treatment of early -stage CTCL. Treatment of early -stage disease generally involves skin-directed therapies. One of the most common unapproved therapies used for early -stage disease is oral 5 or 8-methoxypsoralen (“Psoralen”) given with ultraviolet A (“UVA”) light, referred to as PUVA, which is approved for dermatological conditions such as disabling psoriasis not adequately responsive to other forms of therapy, idiopathic vitiligo and skin manifestations of CTCL in persons who have not been responsive to other forms of treatment. Psoralen is a mutagenic chemical that interferes with DNA causing mutations and other malignancies. Moreover, UVA is a carcinogenic light source that when combined with the Psoralen, results in serious adverse effects including secondary skin cancers; therefore, the FDA requires a Black Box warning for PUVA.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the ~~United~~U.S. ~~States~~ and Europe (European Union and United Kingdom). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS prevalence estimates, with approximately 3,800 new cases annually). We estimate, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the U.S., with approximately 2,800 new cases seen annually.

SGX302 –— for Treating Mild-to-Moderate Psoriasis

SGX302 (synthetic hypericin) is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the dysregulated T-cells found in psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using UV light associated with more severe potential long-term toxicities. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin (much more than UV light) potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL. Further, this treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UVA or UVB exposure. The use of SGX302 coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis.

In September 2021, following the validation of synthetic hypericin’s biologic activity in the positive Phase 3 FLASH study in CTCL, as well as positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, we decided to expand this novel therapy into a Phase 2a clinical trial in mild-to-moderate psoriasis.65

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Independent ~~June 2022,~~on weUVA ~~received~~or ~~FDA~~UVB ~~IND clearance for our Phase 2a clinical trial (protocol number HPN-PSR-01) titled, "Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis~~exposure." ~~In December 2022, we initiated patient enrollment for the Phase 2a study (protocol number HPN-PSR-01) evaluating SGX302 in the treatment of mild-to-moderate psoriasis.~~ The ~~Phase~~use ~~2a clinical trial (protocol number HPN-PSR-01) will target enrollment~~ of upSGX302 tocoupled ~~42 patients ages 18 years or older~~ with ~~mild to moderate~~safe, ~~stable~~visible ~~psoriasis~~light ~~covering~~also 2avoids tothe ~~30%~~risk of ~~the~~serious ~~body.~~infections ~~In both Parts A~~ and B,cancer ~~all~~associated ~~patients will apply the study drug twice per week and activate the drug~~ with ~~visible light 24 ± 6 hours later using~~ the ~~supplied~~systemic ~~visible~~immunosuppressive ~~light devices and according to the manufacturer’s instructions. Patients will undergo~~ treatments ~~for~~used ~~a total of 18 weeks and, on completion, will be followed for a four-week follow-up period~~ in ~~which patients will not receive other~~ psoriasis ~~treatments~~. In Part A, five to ten patients will be assigned open-label SGX302 (0.25% hypericin) at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment.

~~Active~~In ~~dermatologic~~September 2021, ~~assessment~~following ofthe ~~treated~~validation ~~lesions~~of ~~for~~synthetic ~~adverse~~hypericin’s ~~events~~biologic ~~will~~activity bein ~~performed~~the ~~immediately~~positive ~~before~~Phase ~~and~~3 ~~during~~FLASH ~~light~~study ~~treatments.~~in ~~Patients~~CTCL, ~~will~~as bewell ~~assessed~~as ~~for~~positive ~~overall~~proof-of-concept ~~disease~~demonstrated ~~status~~in ~~through~~a ~~four~~small ~~weeks~~Phase of1/2 ~~follow-up.~~pilot ~~Efficacy~~study ~~endpoints~~in ~~will~~mild-to-moderate ~~include~~psoriasis ~~the~~patients, ~~extent~~we ofdecided ~~lesion~~to ~~clearance~~expand ~~and~~this ~~patient~~novel ~~reported~~therapy ~~quality~~into ofa ~~life~~Phase ~~indices.~~2a ~~Routine~~clinical ~~safety~~trial ~~data~~in ~~also~~mild-to-moderate ~~will be collected~~psoriasis.

In ~~October~~June 2022, we ~~announced~~received ~~the~~FDA ~~formation~~IND ofclearance afor ~~Medical~~our ~~Advisory~~Phase ~~Board~~2a toclinical ~~provide~~trial ~~medical/clinical~~(protocol ~~strategic~~number ~~guidance~~HPN- PSR-01) titled, “Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate ~~advance~~Psoriasis.” In December 2022, we initiated patient enrollment for the Phase 2a ~~clinical~~study ~~development~~(protocol ofnumber HPN-PSR-01) evaluating SGX302 ~~for~~in the treatment of mild-to-moderate psoriasis. The Phase 2a clinical trial (protocol number HPN-PSR-01) will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of the body. In both Parts A and B, all patients will apply the study drug twice per week and activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer’s instructions. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a four-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, five to ten patients will be assigned open-label SGX302 (0.25% hypericin) at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment. Active dermatologic assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients will be assessed for overall disease status through four weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety data also will be collected.

In July 2023, we expanded the Phase 2a trial of SGX302 after demonstration of biological effect in the initial five subjects (Cohort 1). The study is expected to enroll at least an additional ten subjects, exploring the use of SGX302 in the standard of care psoriasis setting, prior to undertaking the larger phase of the study.

In January 2024, positive preliminary results of clinical success were demonstrated in the Cohort 2 subjects enrolled in the ongoing Phase 2a study. In the four evaluable patients from Cohort 2 (one patient withdrew early in the treatment course for personal reasons unrelated to the study), two reached a disease status of “Almost Clear” represented by an Investigator Global Assessment score of 1, which is considered the standard clinical measure for treatment success in psoriasis. In addition, the Psoriasis Activity and Severity Index score, another well-characterized measure of treatment success, for patients in Cohort 2 had a mean drop of approximately 50% over the 18-week treatment. SGX302 therapy was well tolerated by all patients with no drug related adverse events identified.

We estimate the potential worldwide market for SGX302 is in excess of $1 billion for the treatment of mild-to-moderate psoriasis. This potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.

Psoriasis

Psoriasis is a chronic, non-communicable, itchy and often painful inflammatory skin condition for which there is no cure. Psoriasis has a significantly detrimental impact on patients’ quality of life, and is associated with cardiovascular, arthritic, and metabolic diseases, as well as psychological conditions such as anxiety, depression and suicide. Many factors contribute to development of psoriasis including both genetic and environmental factors (e.g., skin trauma, infections, and medications). The lesions develop because of rapidly proliferating skin cells, driven by autoimmune T-cell mediated inflammation. Of the various types of psoriasis, plaque psoriasis is the most common and is characterized by dry, red raised plaques that are covered by silvery-white scales occurring most commonly on the elbows, knees, scalp, and lower back. Approximately 80% of patients have mild-to-moderate disease. Mild psoriasis is generally characterized by the involvement of less than 3% of the body surface area (“BSA”), while moderate psoriasis will typically involve 3-10% BSA and severe psoriasis greater than 10% BSA. Between 20% and 30% of individuals with psoriasis will go on to develop chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability. Studies have also associated psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL. Although psoriasis can occur at any age, most patients present with the condition before age 35.

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chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability. Studies have also associated psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL. Although psoriasis can occur at any age, most patients present with the condition before age 35.

Treatment of psoriasis is based on its severity at the time of presentation with the goal of controlling symptoms. It varies from topical options including PDT to reduce pain and itching, and potentially reduce the inflammation driving plaque formation, to systemic treatments for more severe disease. Most common systemic treatments and even current topical photo/photodynamic therapy such as UV A and B, carry a risk of increased skin cancer.

Psoriasis is the most common immune-mediated inflammatory skin disease. According to the World Health Organization (“WHO”) Global Report on Psoriasis 2016, the prevalence of psoriasis is between 1.5% and 5% in most developed countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published studies and reports and an interpolation of data that psoriasis affects 3% of the U.S. population or more than 7.5 million people. Current estimates have as many as 60-125 million people worldwide living with the condition. The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027.66

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Psoriasis is the most common immune-mediated inflammatory skin disease. According to the World Health Organization (“WHO”) Global Report on Psoriasis 2016, the prevalence of psoriasis is between 1.5% and 5% in most developed countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published studies and reports and an interpolation of data that psoriasis affects 3% of the U.S. population or more than 7.5 million people. Current estimates have as many as 60 – 125 million people worldwide living with the condition. The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027.

Dusquetide

Dusquetide (research name: SGX94) is an IDR that regulates the innate immune system to simultaneously reduce inflammation, eliminate infection and enhance tissue healing. Dusquetide is based on a new class of short, synthetic peptides known as IDRs. It has a novel mechanism of action in that it modulates the body’s reaction to both injury and infection and is both simultaneously anti-inflammatory and anti-infective. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens including both antibiotic sensitive and resistant strains, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- or radiation-therapy. IDRs represent a novel approach to the control of infection and tissue damage via highly selective binding to an intracellular adaptor protein, sequestosome-1, also known as p62, which has a pivotal function in signal transduction during activation and control of the innate defense system. Preclinical data indicate that IDRs may be active in models of a wide range of therapeutic indications including life-threatening bacterial infections as well as the severe side-effects of chemo- and radiation-therapy. Additionally, due to selective binding to p62, dusquetide may have potential anti-tumor action.

Dusquetide has demonstrated efficacy in numerous animal disease models including mucositis, oncology, colitis, skin infection and other bacterial infections and has been evaluated in a double-blind, placebo-controlled Phase 1 clinical trial in 84 healthy volunteers with both single ascending dose and multiple ascending dose components. Dusquetide was shown to have a good safety profile and be well-tolerated in all dose groups when administered by IV over 7 days and was consistent with safety results seen in pre- clinical studies. We believe that market opportunities for dusquetide include, but are not limited to, oral and gastrointestinal mucositis, oncology (e.g., breast cancer), acute Gram-positive bacterial infections (e.g., methicillin resistant Staphylococcus aureus (“MRSA”)), acute Gram-negative infections (e.g., acinetobacter, melioidosis), and acute radiation syndrome.

SGX942 –— for Treating Oral Mucositis in Head and Neck Cancer

SGX942 is our product candidate containing our IDR technology, dusquetide, targeting the treatment of oral mucositis in head and neck cancer patients. Oral mucositis in this patient population is an area of unmet medical need where there are currently no approved drug therapies. Accordingly, we received Fast Track designation for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients from the FDA. In addition, dusquetide has been granted PIM designation in the UK by the MHRA for the treatment of SOM in head and neck cancer patients receiving chemoradiation therapy.

59In a Phase 2 proof-of-concept clinical study that enrolled 111 patients, SGX942, at a dose of 1.5 mg/kg, successfully reduced the median duration of SOM by 50%, from 18 days to 9 days (p=0.099) in all patients and by 67%, from 30 days to 10 days (p=0.040) in patients receiving the most aggressive chemoradiation therapy for treatment of their head and neck cancer. The p-values met the prospectively defined statistical threshold of p<0.1 in the study protocol. A less severe occurrence of oral mucositis, ulcerative oral mucositis (defined as oral mucositis with a WHO score ≥2 corresponding to the occurrence of overt ulceration in the mouth), was also monitored during the study. In the patients receiving the most aggressive chemoradiation therapy, the median duration of oral mucositis was found to decrease from 65 days in the placebo treated patients to 51 days in the patients treated with SGX942 1.5 mg/kg (p=0.099).

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We initiated a Phase 2 clinical study of SGX942 for the treatment of oral mucositis in head and neck cancer patients in December of 2013. We completed enrollment in this trial and released positive results in December 2015. In this Phase 2 proof-of-concept clinical study that enrolled 111 patients, SGX942, at a dose of 1.5 mg/kg, successfully reduced the median duration of SOM by 50%, from 18 days to 9 days (p=0.099) in all patients and by 67%, from 30 days to 10 days (p=0.040) in patients receiving the most aggressive chemoradiation therapy for treatment of their head and neck cancer. The p-values met the prospectively defined statistical threshold of p<0.1 in the study protocol. A less severe occurrence of oral mucositis, ulcerative oral mucositis (defined as oral mucositis with a WHO score ≥2 corresponding to the occurrence of overt ulceration in the mouth), was also monitored during the study. In the patients receiving the most aggressive chemoradiation therapy, the median duration of oral mucositis was found to decrease from 65 days in the placebo treated patients to 51 days in the patients treated with SGX942 1.5 mg/kg (p=0.099).

In addition to identifying the best dose of 1.5 mg/kg, this study achieved all objectives, including increased incidence of “complete response” of tumor at the one month follow-up visit (47% in placebo vs. 63% in SGX942 at 1.5 mg/kg). Decreases in mortality and decreases in infection rate were also observed with SGX942 treatment, consistent with the preclinical results observed in animal models. Data from this Phase 2 trial are published in the Journal of Biotechnology.

SGX942 was found to be generally safe and well tolerated, consistent with the safety profile observed in the prior Phase 1 study conducted in 84 healthy volunteers. The long-term (12 month) follow-up data was consistent with the preliminary positive safety and efficacy findings. While the placebo population experienced the expected 12-month survival rate of approximately 80%, as defined in the Surveillance, Epidemiology, and End Results statistics 1975-2012 from the National Cancer Institute, the SGX942 1.5 mg/kg treatment group reported a 12-month survival rate of 93% (7% mortality in the SGX942 1.5 mg/kg group compared to 19% in the placebo group). Similarly, tumor resolution (complete response) at 12 months was better in the SGX942 1.5 mg/kg treatment group relative to the placebo population (80% in the 1.5 mg/kg group compared to 74% in the placebo group). The long-term follow-up results from the Phase 2 study are published in Biotechnology Reports.

In September 2016, we and SciClone Pharmaceuticals, Inc. (“SciClone”) entered into an exclusive license agreement, pursuant to which we granted rights to SciClone to develop, promote, market, distribute and sell SGX942 in defined territories. Under the terms of the license agreement, SciClone will be responsible for all aspects of development, product registration and commercialization in the territories, having access to data generated by us. In exchange for exclusive rights, SciClone will pay us royalties on net sales, and we will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights.67

Based on the positive and previously published Phase 2 results (Study IDR-OM-01), in July 2017, we initiated a Phase 3 clinical trial referred to as the “DOM–INNATE” (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) study. Approximately 50 U.S. and European oncology centers participated in this trial. The Phase 3 protocol (Study IDR-OM-02) was a highly powered, double-blind, randomized, placebo-controlled, multinational trial that sought to enroll approximately 260 subjects with squamous cell carcinoma of the oral cavity and oropharynx who were scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects were randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of chemoradiation therapy (“CRT”). The primary endpoint for the study was the median duration of SOM, which was assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO Grading system. SOM is defined as a WHO Grade of ≥3. Subjects are followed for an additional 12 months after the completion of treatment.

In April 2019, the Paediatric Committee of the EMA approved our PIP for SGX942, a prerequisite for filing a Marketing Authorization Application (“MAA”) for any new medicinal product in Europe. The EMA also agreed that we may defer conducting the PIP until successful completion of our pivotal Phase 3 clinical trial of SGX942, which allowed us to file the adult indication MAA prior to completion of the PIP.

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Intreatment ~~June 2020,~~group ~~the~~reported ~~pivotal~~a ~~Phase 3 DOM–INNATE study (Study IDR~~12-~~OM-02)~~month ~~completed~~survival ~~enrollment~~rate of ~~268~~93% ~~subjects.~~(7% Inmortality ~~December 2020,~~in the ~~results of our Phase 3 clinical trial for~~ SGX942 ~~showed that the primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p≤0~~1.~~05);~~5 ~~although~~mg/kg ~~biological~~group ~~activity~~compared ~~was~~to ~~observed with a 56~~19% ~~reduction~~ in the ~~median duration of SOM from 18 days in the~~ placebo group ~~to 8 days in the SGX942 treatment group~~). ~~Despite this clinically meaningful improvement~~Similarly, ~~the~~tumor ~~variability~~resolution in(complete ~~the~~response) ~~distribution~~at of12 months ~~the data yielded a p-value that~~ was ~~not~~better ~~statistically significant. Other secondary endpoints supported the biological activity of dusquetide, including a statistically significant 50% reduction~~ in the ~~median~~SGX942 ~~duration~~1.5 ofmg/kg ~~SOM in the per-protocol population, which decreased from 18 days in the placebo group to 9 days in the SGX942~~ treatment group ~~(p=0.049),~~relative ~~consistent~~to ~~with~~ the ~~findings~~placebo inpopulation ~~the Phase 2 trial~~ (~~Study IDR-OM-01). Similarly, incidence of SOM also followed this biological trend as seen in the Phase 2 study, decreasing by 16~~80% in the ~~SGX942~~1.5 ~~treatment~~mg/kg group ~~relative~~compared to ~~the~~74% ~~placebo group~~ in the ~~per-protocol~~placebo ~~population~~group). The ~~per~~long-~~protocol~~term ~~population~~follow-up ~~was~~results ~~defined~~from as the ~~population~~Phase ~~receiving~~2 ~~a minimum of 55 Gy radiation and at least 10 doses of~~ study ~~drug~~are ~~(placebo~~published ~~or SGX942) throughout the intended treatment period, with no major protocol deviations (e.g. breaks~~ in ~~study~~Biotechnology ~~drug administration longer than 8 days between successive doses)~~Reports.

Based on the positive and previously published Phase 2 results, we conducted a Phase 3 clinical trial referred to as the “DOM-INNATE” (Dusquetide treatment in Oral Mucositis — by modulating INNATE immunity) study. The Phase 3 protocol was a double-blind, randomized, placebo-controlled, multinational trial that sought to enroll approximately 260 subjects with squamous cell carcinoma of the oral cavity and oropharynx who were scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0 – 2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80 – 100 mg/m2 every third week. Subjects were randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of chemoradiation therapy (“CRT”). The primary endpoint for the study was the median duration of SOM, which was assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO Grading system. SOM is defined as a WHO Grade of ≥3. Subjects are followed for an additional 12 months after the completion of treatment.

The results of the study showed that the primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group. Despite this clinically meaningful improvement, the variability in the distribution of the data yielded a p-value that was not statistically significant. Other secondary endpoints supported the biological activity of dusquetide, including a statistically significant 50% reduction in the median duration of SOM in the per-protocol population, which decreased from 18 days in the placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial (Study IDR-OM-01). Similarly, incidence of SOM also followed this biological trend as seen in the Phase 2 study, decreasing by 16% in the SGX942 treatment group relative to the placebo group in the per-protocol population. The per-protocol population was defined as the population receiving a minimum of 55 Gy radiation and at least 10 doses of study drug (placebo or SGX942) throughout the intended treatment period, with no major protocol deviations (e.g. breaks in study drug administration longer than 8 days between successive doses).

Following analysis of the full dataset, including the 12-month long-term follow-up safety data in late 2021, we held a meeting with the MHRA to review the study results and to obtain further clarity on the future of the oral mucositis development program. The meeting was informative with the outcome being that based on the SGX942 biologic activity observed and the consistency in response between the Phase 2 and Phase 3 trials, the Phase 3 DOM-INNATE study could serve as the first of two Phase 3 studies required to support potential marketing authorization, assuming the second Phase 3 clinical trial achieves the required level of statistical significance in its primary endpoint. With the benefit of a robust preclinical and clinical data package for SGX942, we now will analyze the data to design a second Phase 3 study and will look to identify a potential partner(s) to continue this development program.

In January 2022, dusquetide proved effective at reducing tumor size in nonclinical xenograft models. Recent studies, recapitulating results from previously published studies, have confirmed the efficacy of dusquetide as a stand-alone and combination anti-tumor therapy, with radiation, chemotherapy and targeted therapy, in the context of the MCF-7 breast cancer cell line. Of note, these results are consistent with a potential direct anti-tumor effect identified with SGX942 and is another important consideration in the oral mucositis treatment space.

In June 2022, an article was published describing the binding of our IDR, dusquetide, to the p62 protein. Dusquetide binds to p62 or SQSTM-1, a scaffold protein implicated in a number of intracellular signaling networks implicated in tumor cell survival, including autophagy. This publication elaborates on the direct interaction of dusquetide with p62, as well as some of the direct downstream consequences of that interaction, consistent with its observed anti-infective, anti-tumor and anti-inflammatory activities. This information advances the understanding of dusquetide’s novel mechanism of action and supports the development of analogs related to dusquetide.

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We estimate the potential worldwide market for SGX942 is in excess of $500 million for the treatment of oral mucositis. This potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.

Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. We estimate, based upon our review of historic studies and reports, and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the U.S. per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

61The mechanisms of mucositis have been extensively studied and have been linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is regarded as a secondary consequence of dysregulated local inflammation triggered by therapy- induced cell death, rather than as the primary cause of the lesions.

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nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

We estimate, based upon our review of historic studies and reports, and an interpolation of data on the incidence of oral mucositis, that oral mucositis is a subpopulation of approximately 90,000 patients in the U.S., with a comparable number in Europe. Oral mucositis almost always occurs in patients with head and neck cancer treated with radiation therapy (greater than 80% incidence of severe mucositis) and is common in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

SGX945 –— for Treating Aphthous Ulcers in Behçet’s Disease

SGX945 is our product candidate containing our IDR technology, dusquetide, targeting the treatment of aphthous Ulcers in ~~Behçet’s Disease~~BD. ~~Behçet’s~~BD ~~Disease~~ is an orphan disease and an area of unmet medical need.

In November 2023, the FDA cleared the IND application for a Phase 2a clinical trial entitled, “Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behçet’s Disease.” The study is designed to evaluate the safety and potential efficacy of SGX945 (dusquetide) in the resolution of aphthous flares in ~~Behçet’s Disease and is expected to begin patient enrollment in the second half of 2024~~BD.

In January 2024, SGX945 received Fast Track designation for the treatment of oral lesions of ~~Behçet’s~~BD ~~Disease~~ from the FDA.

In February 2024, we announced the formation of a Medical Advisory Board to provide medical/ clinical strategic guidance to advance the clinical development of SGX945 for the treatment of ~~Behçet’s Disease~~BD.

WeIn ~~estimate~~November 2024, ~~the~~we ~~potential~~opened ~~worldwide~~patient ~~market~~enrollment for ~~SGX945 is in excess of $200 million for~~ the ~~treatment~~Phase of2 ~~aphthous~~study ~~ulcers~~(protocol innumber ~~Behçet’s Disease. This potential market information is a forward~~DUS-~~looking~~AUBD-01) ~~statement,~~evaluating ~~and~~SGX945 ~~investors~~(dusquetide) ~~are~~in ~~urged~~the ~~not~~treatment ~~to place undue reliance on this statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there are a number~~ of ~~factors that could cause our expectations to change or not be realized~~BD.

~~Behçet’s~~In ~~Disease~~July 2025, we announced completion of the Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of BD and achievement of the study objective of demonstrating biological efficacy and safety.

~~Behçet’s~~In ~~Disease~~August 2025, ~~(“BD”)~~dusquetide ~~is commonly known as an inflammatory disorder of~~ (the ~~blood~~active ~~vessels~~ingredient ~~(vasculitis). Often first diagnosed~~ in ~~young adults, its effects and severity will wax and wane over time. Major signs and symptoms usually include mouth sores (approximately 95% of patients~~SGX945), ~~skin~~received ~~rashes~~Orphan ~~and~~Drug ~~lesions~~designation ~~(approximately~~for ~~50%~~the oftreatment ~~patients), genital sores (approximately 50%~~ of ~~patients),~~BD ~~leg~~from ~~ulcers (approximately 40% of patients) and eye inflammation (approximately 15% of patients). It is a painful disease, directly impacting~~ the ~~patient’s quality of life and ability to productively engage in life activities, including work~~FDA.

BDWe isestimate ~~thought~~the topotential beworldwide anmarket ~~auto-immune~~for ~~disease~~SGX945 ~~with~~is ~~both~~in ~~genetic~~excess ~~and~~of ~~environmental~~$200 ~~factors.~~million Itfor isthe ~~most~~treatment ~~common~~of ~~along~~aphthous ~~the~~ulcers ~~“silk~~in ~~road”~~BD. inThis ~~the~~potential ~~Middle~~market ~~East~~information ~~and~~is ~~East~~a ~~Asia~~forward-looking statement, ~~including~~and ~~Turkey,~~investors ~~Iran,~~are ~~Japan~~urged ~~and~~not ~~China~~to place undue reliance on this statement. ~~There~~While ~~are~~we ~~approximately~~have ~~18,000~~determined ~~known~~this ~~cases~~potential ofmarket BDsize inbased ~~the~~on ~~U.S.~~assumptions ~~and~~that ~~80,000~~we inbelieve ~~Europe.~~are ~~There~~reasonable, there are asa ~~many~~number asof ~~1,000,000~~factors ~~people~~that ~~worldwide~~could ~~living~~cause ~~with~~our BDexpectations to change or not be realized.

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~~ulcers~~Behçet’s and leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that become more concerning with more chronic use. Genital ulcers are often associated with significant genital scarring while leg ulcers can result in a post-thrombotic syndrome. Other treatments for BD flares involve suppressing the immune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and kidney problems, low blood counts and high blood pressure. Finally, anti-inflammatory drugs are also used, including anti-TNF medications. The only approved drug in BD is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers. Unfortunately, apremilast is associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and headache.Disease

BD is commonly known as an inflammatory disorder of the blood vessels (vasculitis). Often first diagnosed in young adults, its effects and severity will wax and wane over time. Major signs and symptoms usually include mouth sores (approximately 95% of patients), skin rashes and lesions (approximately 50% of patients), genital sores (approximately 50% of patients), leg ulcers (approximately 40% of patients) and eye inflammation (approximately 15% of patients). It is a painful disease, directly impacting the patient’s quality of life and ability to productively engage in life activities, including work.

BD is thought to be an auto-immune disease with both genetic and environmental factors. It is most common along the “silk road” in the Middle East and East Asia, including Turkey, Iran, Japan and China. There are approximately 18,000 known cases of BD in the U.S. and over 50,000 in Europe. There are as many as 1,000,000 people worldwide living with BD.

There is no cure for BD, rather treatments are prescribed to manage symptoms. Treatments may include both maintenance therapies and those specifically addressing mucocutaneous flares (e.g., mouth ulcers, genital ulcers and leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that become more concerning with more chronic use. Genital ulcers are often associated with significant genital scarring while leg ulcers can result in a post- thrombotic syndrome. Other treatments for BD flares involve suppressing the immune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and kidney problems, low blood counts and high blood pressure. Finally, anti-inflammatory drugs are also used, including anti-TNF medications. The only approved drug in BD is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers. Unfortunately, apremilast is associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and headache.

Public Health Solutions Overview

ThermoVax® –— Thermostability Platform Technology

ThermoVax^® is a novel method for thermostabilizing vaccines with a variety of adjuvants, resulting in a single vial which can be reconstituted with water for injection immediately prior to use. One of the adjuvants utilized in ThermoVax® is aluminum salts (known colloquially as “Alum”). Alum is the most widely employed adjuvant technology in the vaccine industry.

The value of ThermoVax® lies in its potential ability to eliminate the need for cold chain production, transportation, and storage for Alum-adjuvanted vaccines. This would relieve the high costs of producing and maintaining vaccines under refrigerated conditions. Based on historical reports from WHO and other scientific reports, we believe that a meaningful proportion of vaccine doses globally are wasted due to excursions from required cold chain temperature ranges. This is due to the fact that many vaccines need to be maintained either between 2 and 8 degrees Celsius (“C”), frozen below -20 degrees C, or frozen below -60 degrees C, and even brief excursions from these temperature ranges usually necessitate the destruction of the product or the initiation of costly stability programs specific for the vaccine lots in question. ~~ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines for ricin exposure in emergency settings.~~

ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines for ricin exposure in emergency settings. ThermoVax® development, specifically in the context of an Alum adjuvant, was supported pursuant to ~~our~~a previous $9.4 million NIAID grant ~~enabling~~which enabled development of thermo-stable ricin (RiVax®) and anthrax vaccines. Proof-of-concept preclinical studies with ThermoVax® indicate that it is able to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. These studies were conducted with our Alum-adjuvanted ricin toxin vaccine, RiVax® and our Alum-adjuvanted anthrax vaccine. Each vaccine was manufactured under precise lyophilization conditions using excipients that aid in maintaining native protein structure of the key antigen. When RiVax® was kept at 40 degrees C (104 degrees Fahrenheit (“F”)) for up to one year, all of the animals vaccinated with the lyophilized RiVax® vaccine developed potent and high titer neutralizing antibodies. In contrast, animals that were vaccinated with the liquid RiVax® vaccine kept at 40 degrees C did not develop neutralizing antibodies and were not protected against ricin exposure. The ricin A chain is extremely sensitive to temperature and rapidly loses the ability to induce neutralizing antibodies when exposed to temperatures higher than 8 degrees C. When the anthrax vaccine was kept for up to 16 weeks at 70 degrees C, it was able to develop a potent antibody response, unlike the liquid formulation kept at the same temperature. Moreover, we also have demonstrated the compatibility of our thermostabilization technology with other secondary adjuvants such as TLR-4 agonists.

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We also entered into a collaboration agreement with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (“JABSOM”), University of Hawai’i at Manoa (“UH Manoa”) and Hawaii Biotech, Inc. (“HBI”) to develop a heat stable subunit Ebola vaccine. Dr. Lehrer, a co-inventor of the Ebola vaccine with HBI, has shown proof of concept efficacy with subunit Ebola vaccines in non-human primates (“NHP”). The most advanced Ebola vaccines involve the use of vesicular stomatitis virus and adenovirus vectors — live, viral vectors which complicate the manufacturing, stability and storage requirements. Dr. Lehrer’s vaccine candidate is based on highly purified recombinant protein antigens, circumventing many of these manufacturing difficulties. Dr. Lehrer and HBI have developed a robust manufacturing process for the required proteins. Application of ThermoVax® may allow for a product that can avoid the need for cold chain distribution and storage, yielding a vaccine ideal for use in both the developed and developing world. This agreement has expired in accordance with its terms.

In December 2010, we executed a worldwide exclusive license agreement with the University of Colorado (“UC”) for certain patents relating to ThermoVax® in all fields of use. In April 2018, the UC delivered a notice of termination of our license agreement based upon our failure to achieve one of the development milestones: initiation of the Phase 1 clinical trial of the heat stabilization technology by March 31, 2018. After negotiating with the UC, we and the UC agreed to extend the termination date to October 31, 2018 in order to allow us time to agree upon a potential agreement that would allow us to keep the rights to, and to continue to develop, the heat stabilization technology or a product candidate containing the heat stabilization technology in our field of use.

During September 2017, we were awarded funding of approximately $700,000 over five years under a NIAID Research Project (R01) grant awarded to UH Manoa for the development of a trivalent thermostabilized filovirus vaccine (including protection against Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus). Previous collaborations demonstrated the feasibility of developing a heat stable subunit Ebola vaccine. Under the terms of the subaward, we will continue to support vaccine formulation development with our proprietary vaccine thermostabilization technology, ThermoVax®. Ultimately, the objective is to produce a thermostable trivalent filovirus vaccine for protection against Ebola and related diseases, allowing worldwide distribution without the need for cold storage. Based on current U.S. government needs, efforts have been expanded to focus on a monovalent or bivalent vaccine to specifically address Marburg marburgvirus.

In October 2018, in a series of related transactions, (a) we and the UC agreed to terminate the original license agreement, (b) the UC and VitriVax, Inc. (“VitriVax”) executed a worldwide exclusive license agreement for the heat stabilization technology for all fields of use, and (c) we and VitriVax executed a worldwide exclusive sublicense agreement, which was amended and restated in October 2020, for the heat stabilization technology for use in the fields of ricin and Ebola vaccines. We paid a $100,000 sublicense fee on the effective date of the sublicense agreement. Under the amended sublicense agreement to maintain the sublicense we are obliged to pay a minimum annual royalty of $20,000 until first commercial sale of a sublicensed product, upon which point, we shall pay an earned royalty of 2% of net sales subject to a minimum royalty of $50,000 each year. We are also required to pay royalty on any sub-sublicense income based on a declining percentage of all sub-sublicense income calculated within the contractual period until reaching a minimum of 15% after two years. In addition, we are required to pay VitriVax milestone fees of: (a) $25,000 upon initiation of a Phase 2 clinical trial of the sublicensed product, (b) $100,000 upon initiation of a Phase 3 clinical trial of the sublicensed product, (c) $100,000 upon regulatory approval of a sublicensed product, and (d) $1 million upon achieving $10 million in aggregate net sales of a sublicensed product in the U.S. or equivalent. To date none of these milestones have been met.

In March 2020, we entered into a research collaboration with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa to further expand the filovirus collaboration to investigation of potential coronavirus vaccines, including for SARS-CoV-2 (causing COVID-19). This research collaboration will utilize the technology platform developed in the search for filovirus vaccines and will use well-defined surface glycoprotein(s) from one or more coronaviruses, which are expected to be protective for COVID-19.

During April 2020, we obtained an exclusive worldwide license for CoVaccine HT™, a novel vaccine adjuvant, from SERB Pharmaceuticals (formerly BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation) (“SERB”), for the fields of coronavirus infection (including SARS-CoV-2, the cause of COVID-19), and pandemic flu. CoVaccine HT™ is a novel adjuvant, which has been shown to enhance both cell-mediated and antibody-mediated immunity. We and our collaborators, including UH Manoa and Dr. Axel Lehrer, have successfully demonstrated the utility of CoVaccine HT™ in the development of our heat stable filovirus vaccine program, with vaccine candidates against Ebola and Marburg virus disease. Given this previous success, CoVaccine HT™ will potentially be an important component of our vaccine technology platform currently being assessed for use against coronaviruses including SARS-CoV-2, the cause of COVID-19. The license agreement was executed between us and SERB, which owns the CoVaccine HT™ intellectual property.

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program, with vaccine candidates against Ebola and Marburg virus disease. Given this previous success, CoVaccine HT™ will potentially be an important component of our vaccine technology platform currently being assessed for use against coronaviruses including SARS-CoV-2, the cause of COVID-19. The license agreement was executed between us and SERB, which owns the CoVaccine HT™ intellectual property.

In September 2020, the Journal of Pharmaceutical Sciences published a scientific article detailing the thermostabilization of the filovirus GP proteins and key assays describing their stability.

During October 2020, Frontiers in Immunology published a scientific article describing CiVax™, a prototype COVID-19 vaccine, using the novel CoVaccine HT™ adjuvant and demonstrating significant immunogenicity, including strong total and neutralizing antibody responses, with a balanced Th1 response, as well as enhancement of cell mediated immunity. These are all considered to be critical attributes of a potential COVID-19 vaccine.

InDuring ~~December~~August ~~2020~~2021, ~~NIAID~~positive ~~awarded~~data usdemonstrated the efficacy of multiple filovirus vaccine candidates in NHP, including thermostabilized multivalent vaccines in a ~~Direct~~single tovial ~~Phase~~platform IIpresentation. ~~Small~~Collaborators ~~Business~~at ~~Innovation~~UH ~~Research~~Manoa ~~(“SBIR”)~~describe ~~grant~~the potent efficacy of ~~approximately~~vaccine ~~$1.5~~candidates ~~million~~protecting toagainst ~~support~~three ~~manufacture~~life-threatening filoviruses, ~~formulation~~Zaire ~~(including~~ebolavirus, ~~thermostabilization)~~Sudan ebolavirus and ~~characterization~~Marburg ofMarburgvirus ~~COVID-19~~in ~~and~~an article titled “Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from Ebola, ~~Virus~~Sudan, ~~Disease~~and ~~(“EVD~~Marburg Viruses”), published in Frontiers in Immunology. These vaccine candidates incontain ~~conjunction~~highly purified protein antigens combined with the novel CoVaccine HT™ adjuvant., ~~This~~in ~~award~~both ~~also~~monovalent is(single ~~supporting~~antigen) ~~immune~~and ~~characterization~~bivalent of(two ~~this~~antigen) ~~novel~~formulations. Most recently, ~~emulsified~~efforts to formulate all three antigens and adjuvant ~~that~~into a thermostable single-vial vaccine platform has ~~unique~~also ~~potency~~been ~~and~~shown ~~compatibility~~to protect 75% of vaccinated NHPs against subsequent Sudan ebolavirus challenge, with ~~lyophilization~~further ~~strategies~~development to ~~enable~~test ~~thermostabilization~~efficacy ofagainst ~~subunit~~other ~~vaccines~~filovirus infections ongoing.

During August 2021, positive data demonstrated the efficacy of multiple filovirus vaccine candidates in NHP, including thermostabilized multivalent vaccines in a single vial platform presentation. Collaborators at UH Manoa describe the potent efficacy of vaccine candidates protecting against three life-threatening filoviruses, Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus in an article titled "Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from Ebola, Sudan, and Marburg Viruses", published in Frontiers in Immunology. These vaccine candidates contain highly purified protein antigens combined with the novel CoVaccine HT™ adjuvant, in both monovalent (single antigen) and bivalent (two antigen) formulations. Most recently, efforts to formulate all three antigens and adjuvant into a thermostable single-vial vaccine platform has also been shown to protect 75% of vaccinated NHPs against subsequent Sudan ebolavirus challenge, with further development to test efficacy against other filovirus infections ongoing.

During August 2021, Vaccine published a scientific article describing the formulation of single-vial platform presentations of monovalent (single antigen), bivalent (two antigens) and trivalent (three antigens) combinations of filovirus vaccine candidates.

During September 2021, an accelerated preprint was posted on bioRxiv of pre-clinical immunogenicity studies for CiVax™ (heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses, including against the Beta, Gamma and Delta variants of concern. The scientific article was subsequently published on March 9, 2022 in ACS Infectious Diseases. The work is part of an ongoing collaboration with Axel Lehrer, PhD, Associate Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa. Development continues under a non-dilutive $1.5M grant from the NIAID awarded to us in December 2020.

In December 2021, 100% protection of NHPs against lethal Sudan ebolavirus challenge was achieved using a bivalent, thermostabilized vaccine formulated in a single vial, reconstituted only with water immediately prior to use. This milestone is part of an ongoing collaboration with UH Manoa and further demonstrates the broad applicability of the vaccine platform, and its potential role in the U.S. government’s initiative for pandemic preparedness.

In May 2022, the U.S. Patent and Trademark Office issued a Notice of Allowance for the patent application titled “Composition and Methods of Manufacturing Trivalent Filovirus Vaccines.” The allowed claims are directed to unique, proprietary composition and ~~methods directed to combinations of glycoprotein antigens with nano-emulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization. The described vaccine~~

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methods directed to combinations of glycoprotein antigens with nano-emulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization. The described vaccine platform has previously been successfully applied to filovirus vaccines (as mono-, bi- and tri-valent candidates for Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus) as well as SARS-CoV-2 vaccine. No currently licensed lyophilized vaccine that contains an adjuvant is presented in a single vial format and there are few reports of successfully using nano-emulsions in lyophilized formulations. Previous work has demonstrated the use of a single vial platform to co-lyophilize antigen(s) and a nano-emulsion adjuvant, CoVaccine HT™, maintaining key adjuvant stability characteristics including particle size and colloidal stability, as well as maintaining immunogenicity. This most recent milestone confirms that, in the context of lethal challenge with Sudan ebolavirus, complete protection is maintained with the thermostabilized formulation.

In June 2022, 100% protection of NHPs against lethal Marburg marburgvirus challenge was achieved using a bivalent, thermostabilized vaccine formulated in a single vial, reconstituted only with sterile water immediately prior to use. This important milestone is part of an ongoing collaboration with UH Manoa, demonstrating the successful presentation of one or more antigen(s) within the same formulation while maintaining full potency and thermostability. It further demonstrates the broad applicability of the heat stable vaccine platform, and its potential role in the U.S. government’s initiative for pandemic preparedness.

In September 2023, positive data demonstrated two-year stability of thermostabilized bivalent and trivalent filovirus vaccine candidates at temperatures of 40 degrees C (104 degrees F) when formulated in a single vial, needing reconstitution only with sterile water immediately prior to use. This important milestone is part of an ongoing collaboration with UH Manoa, demonstrating the successful presentation of one or more antigen(s) within the same formulation while maintaining full potency and thermostability. It further demonstrates the broad applicability of the heat stable vaccine platform, and its potential role in the U.S. government’s initiative for pandemic preparedness.

In January 2024, Vaccine published the preclinical efficacy results of our novel, single-vial, thermostabilized bivalent filovirus vaccine providing 100% protection against both Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV) infections. The manuscript was entitled “Thermostable bivalent filovirus vaccine protects against severe and lethal Sudan ebolavirus and marburgvirus infection”.

In April 2024, we received orphan drug designation for the active ingredient in SuVax™, the subunit protein vaccine of recombinantly expressed SUDV glycoprotein, for the prevention and post-exposure prophylaxis against SUDV infection.

In April 2024, we received orphan drug designation for the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed MARV glycoprotein, for the prevention and post-exposure prophylaxis against MARV infection.

In April 2024, we received notice of intent to grant additional patents based on our patent application titled “Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines” in the United Kingdom and South Africa, with other international jurisdictions pending.

~~RiVax~~In March 2025, we announced a publication describing the preclinical efficacy of CiVax™, a thermostabilized subunit vaccine against SARS-CoV-2. Using custom-developed immunoassays, the combination of a primary adenovirus vaccine (COVID-19 Vaccine AstraZeneca) coupled with a CiVax™ booster was shown to induce broader protection against COVID-19 variants in non-human primates than a 2-shot mRNA series (such as the Moderna vaccine Spikefax® or the Pfizer vaccine Cominarty®) in humans. In collaboration with Axel Lehrer, –PhD, ~~for~~Professor ~~Protection~~at ~~Against~~the ~~Ricin~~Department ~~Toxin~~of ~~Exposure~~Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawai’i at Manoa, the manuscript entitled “Use of a Multiplex Immunoassay Platform to Investigate Multifaceted Antibody Responses in SARS-CoV-2 Vaccinees with and Without Prior Infection”, has been published in COVID.

RiVax® is— ~~our~~for ~~proprietary~~Protection ~~vaccine~~Against ~~candidate~~Ricin ~~being~~Toxin developed to protect against exposure to ricin toxin and if approved, would be the first ricin vaccine. The immunogen in RiVax® induces a protective immune response in animal models of ricin exposure and functionally active antibodies in humans. The immunogen consists of a genetically inactivated ricin A chain subunit that is enzymatically inactive and lacks residual toxicity of the holotoxin. RiVax® has demonstrated statistically significant (p < 0.0001) preclinical survival results, providing 100% protection against acute lethality in an aerosol exposure non-human primate model (Roy et al, 2015, Thermostable ricin vaccine protects rhesus macaques against aerosolized ricin: Epitope-specific neutralizing antibodies correlate with protection, PNAS USA 112:3782-3787), and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Results of the first Phase 1 human trial of RiVax® established that the immunogen was safe and induced antibodies that we believe may protect humans from ricin exposure. The antibodies generated from vaccination, concentrated and purified, were capable of Exposure

66RiVax® is our proprietary vaccine candidate being developed to protect against exposure to ricin toxin and if approved, would be the first ricin vaccine. The immunogen in RiVax® induces a protective immune response in animal models of ricin exposure and functionally active antibodies in humans. The immunogen consists of a genetically inactivated ricin A chain subunit that is enzymatically inactive and lacks residual toxicity of the holotoxin. RiVax® has demonstrated statistically significant (p < 0.0001) preclinical survival results, providing 100% protection against acute lethality in an aerosol exposure non-human primate model (Roy et al, 2015, Thermostable ricin vaccine protects rhesus macaques against aerosolized ricin: Epitope- specific neutralizing antibodies correlate with protection, PNAS USA 112:3782-3787), and has also been shown to be well tolerated and immunogenic in two Phase 1

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clinical trials in healthy volunteers. Results of the first Phase 1 human trial of RiVax® established that the immunogen was safe and induced antibodies that we believe may protect humans from ricin exposure. The antibodies generated from vaccination, concentrated and purified, were capable of conferring immunity passively to recipient animals, indicating that the vaccine was capable of inducing functionally active antibodies in humans. The outcome of this study was published in the Proceedings of the National Academy of Sciences (Vitetta et al., 2006, A Pilot Clinical Trial of a Recombinant Ricin Vaccine in Normal Humans, PNAS, 103:2268-2273). The second trial that was completed in September 2012 and was sponsored by University of Texas Southwestern Medical Center (“UTSW”) evaluated a more potent formulation of RiVax® that contained an Alum adjuvant. The results of the Phase 1b study indicated that Alum-adjuvanted RiVax® was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax®. The outcomes of this second study were published in the Clinical and Vaccine Immunology.

We have adapted the original manufacturing process for the immunogen contained in RiVax^® for thermostability and large scale manufacturing and recent studies have confirmed that the thermostabilized RiVax^® formulation enhances the stability of the RiVax^® antigen, enabling storage for at least 1 year at temperatures up to 40 degrees C (104 degrees F). The program will pursue approval via the FDA “Animal Rule” since it is not possible to test the efficacy of the vaccine in a clinical study which would expose humans to ricin. Uniform, easily measured and species-neutral immune correlates of protection that can be measured in humans and animals, and are indicative of animal survival to subsequent ricin challenge, are central to the application of the “Animal Rule.” Recent work has identified such potential correlates of immune protection in animals and work to qualify and validate these approaches is continuing, with the goal of utilizing these assays in a planned Phase 1/2 clinical trial with the thermostable RiVax^®formulation. During September 2018, we published an extended stability study of RiVax^®, showing up to 100% protection in mice after 12 months storage at 40 degrees C (104 degrees F) as well as identification of a potential in vitro stability indicating assay, critical to adequately confirming the long-term shelf life of the vaccine. We have entered into a collaboration with IDT Biologika GmbH (“IDT”) to scale-up the formulation/filling process and continue development and validation of analytical methods established at IDT to advance the program. We also initiated a development agreement with Emergent BioSolutions, Inc. (“EBS”) to implement a commercially viable, scalable production technology for the RiVax® drug substance protein antigen.

The development of RiVax® has been sponsored through a series of overlapping challenge grants, UC1, and cooperative grants, U01, from the NIH, granted to us and to UTSW where the vaccine originated. The second clinical trial was supported by a grant from the FDA’s Office of Orphan Products to UTSW. To date, we and UTSW have collectively received approximately $25 million in grant funding from the NIH for the development of RiVax®. In September 2014, we entered into a contract with the NIH for the development of RiVax® pursuant to which we were awarded an additional $21.2 million of funding in the aggregate. The development agreements with EBS and IDT were specifically funded under this NIH contract. No funds are remaining from any of these grants.

In 2017, NIAID exercised options to fund additional animal efficacy studies and good manufacturing practices compliant RiVax® bulk drug substance and finished drug product manufacturing, which is required for the conduct of future preclinical and clinical safety and efficacy studies. The exercised options provide us with approximately $4.5 million in additional non-dilutive funding, bringing the total amount awarded to date under this contract to $21.2 million, which expired in February 2021. The total award of up to $21.2 million supported the preclinical, manufacturing and clinical development activities necessary to advance heat stable RiVax® with the FDA. In addition to this funding for the development of RiVax®, biomarkers for RiVax® testing have been successfully identified, facilitating potential approval under the FDA Animal Rule.

During December 2019, we initiated a third Phase 1 double-blind, placebo-controlled, randomized study in eight healthy adult volunteer subjects designed to evaluate the safety and immunogenicity of RiVax® utilizing ThermoVax®. During January 2020, we suspended the study after Emergent Manufacturing Operations Baltimore LLC (“EMOB”), the manufacturer of the drug substance, notified us that, after releasing the final drug product to us, EMOB identified that the active drug substance tested outside the established specification parameters. Two subjects had received doses as part of the study before the manufacturer provided this notice. Those two subjects were monitored with no safety issues noted and data was captured in accordance with the study protocol. They did not receive further doses of study drug.

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During April 2020, we received notification from NIAID that they would not be exercising the final contract option to support the conduct of a Phase 1/2 clinical study in healthy volunteers. As a result, the total contract award will not exceed $21.2 million. This contract expired in February 2021.

In November 2021, an article was published on pre-clinical immunogenicity studies for RiVax® demonstrating enduring protection for at least 12 months post-vaccination. These results, coupled with the previous demonstration of efficacy in mice and NHPs as well as long-term thermostability (at least 1 year at 40 degrees C or 104 degrees F), reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require stringent cold chain handling.

RiVax® has been granted Orphan Drug designation as well as Fast Track designation by the FDA for the prevention of ricin intoxication. In addition, RiVax® has also been granted Orphan Drug designation in the European Union (“EU”) from the EMA Committee for Orphan Medical Products.

Assuming development efforts are successful for RiVax®, we believe potential government procurement contract(s) could reach as much as $200 million. This potential procurement contract information is a forward-looking statement, and investors are urged not to place undue reliance on this statement. While we have determined this potential procurement contract value based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.

As a new chemical entity, an FDA approved RiVax® vaccine has the potential to qualify for a biodefense Priority Review Voucher (“PRV”). Approved under the 21st Century Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context. PRVs are transferable and can be sold, with sales in recent years of approximately $100 million. When redeemed, PRVs entitle the user to an accelerated review period of nine months, saving a median of seven months review time as calculated in 2009. However, FDA must be advised 90 days in advance of the use of the PRV and the use of a PRV is associated with an additional user fee ($1.3 million for fiscal year 2024).

In July 2022, we signed a worldwide exclusive agreement to license and supply our ricin antigen, used in our RiVax® vaccine, to SERB, for development of a novel therapeutic treatment against ricin toxin poisoning. In pursuit of a ricin antidote, SERB will leverage its unique broad-spectrum polyclonal antibody platform, gained in its acquisition of BTG Specialty Pharmaceuticals. This specialized manufacturing process generates binding fragments from antibodies that are specific to a given antigen, helping to ensure potency and purity. This platform is currently used to manufacture two of SERB’s currently marketed products, CroFab® and DigiFab®.

In December 2022, we published a paper demonstrating statistically significant correlates of protection predicting survival after lethal aerosolized ricin challenge in non-human primates. The article titled “Serum antibody profiling identifies vaccine-induced correlates of protection against aerosolized ricin toxin in rhesus macaques” was published in the journal npj Vaccines.

~~Ricin~~RiVax® ~~Toxin~~has been granted Orphan Drug designation as well as Fast Track designation by the FDA for the prevention of ricin intoxication. In addition, RiVax® has also been granted Orphan Drug designation in the European Union (“EU”) from the EMA Committee for Orphan Medical Products.

~~Ricin~~Assuming ~~toxin~~development ~~can~~efforts beare ~~cheaply~~successful ~~and~~for ~~easily produced~~RiVax®, iswe ~~stable~~believe ~~over long periods of time, is toxic by several routes of exposure and thus has the~~ potential togovernment beprocurement ~~used as a biological weapon against military and/or civilian targets. As a bioterrorism agent, ricin~~ contract(s) could bereach ~~disseminated~~ as anmuch ~~aerosol, by injection, or~~ as a$200 ~~food supply contaminant~~million. ~~The~~This potential ~~use~~procurement ofcontract ~~ricin~~information ~~toxin~~is as a ~~biological~~forward- ~~weapon~~looking ~~of mass destruction has been highlighted in a Federal Bureau of Investigation Bioterror report released in November 2007 titled Terrorism 2002-2005~~statement, ~~which states that “Ricin~~ and ~~the~~investors ~~bacterial agent anthrax~~ are ~~emerging~~urged asnot ~~the most prevalent agents involved in WMD investigations.” Al Qaeda in the Arabian Peninsula had threatened the use of ricin toxin~~ to ~~poison~~place ~~food~~undue ~~and~~reliance ~~water~~on ~~supplies~~this ~~and in connection with explosive devices~~statement. ~~Domestically,~~While ~~the~~we ~~threat~~have ~~from~~determined ~~ricin~~this ~~remains~~potential aprocurement ~~concern~~contract ~~for~~value ~~security~~based ~~agencies.~~on Inassumptions ~~April 2013,~~that ~~letters~~we ~~addressed~~believe toare ~~the U.S. President~~reasonable, athere ~~Senator~~are ~~and~~ a ~~judge~~number ~~tested~~of ~~positive~~factors ~~for~~that ~~ricin.~~could Ascause ~~recently~~our asexpectations ~~September 2020, ricin-laced letters addressed~~ to ~~the~~change ~~White~~or ~~House~~not ~~and~~be realized.

68As a new chemical entity, an FDA approved RiVax® vaccine has the potential to qualify for a biodefense Priority Review Voucher (“PRV”). Approved under the 21st Century Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context. PRVs are transferable

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~~others~~and ~~addressed~~can be sold, with sales in recent years of approximately $100 million. When redeemed, PRVs entitle the user to ~~Texas~~an ~~law~~accelerated ~~enforcement~~review ~~agencies~~period ~~were~~of ~~intercepted~~nine months, ~~before~~saving ~~delivery~~a ~~raising~~median ~~fresh~~of ~~concerns~~seven months ~~about~~review time as calculated in 2009. However, FDA must be advised 90 days in advance of the ~~deadly~~use ~~toxin~~of the PRV and the use of a PRV is associated with an additional user fee ($2.50 million for fiscal year 2025).

Ricin Toxin

Ricin toxin can be cheaply and easily produced, is stable over long periods of time, is toxic by several routes of exposure and thus has the potential to be used as a biological weapon against military and/or civilian targets. As a bioterrorism agent, ricin could be disseminated as an aerosol, by injection, or as a food supply contaminant. The potential use of ricin toxin as a biological weapon of mass destruction (“WMD”) has been highlighted in a Federal Bureau of Investigation Bioterror report released in November 2007 titled Terrorism 2002 – 2005, which states that “Ricin and the bacterial agent anthrax are emerging as the most prevalent agents involved in WMD investigations.” Al Qaeda in the Arabian Peninsula had threatened the use of ricin toxin to poison food and water supplies and in connection with explosive devices. Domestically, the threat from ricin remains a concern for security agencies. In April 2013, letters addressed to the U.S. President, a Senator and a judge tested positive for ricin. As recently as September 2020, ricin-laced letters addressed to the White House and others addressed to Texas law enforcement agencies were intercepted before delivery raising fresh concerns about the deadly toxin.

The Centers for Disease Control and Prevention has classified ricin toxin as a Category B biological agent. Ricin works by first binding to glycoproteins found on the exterior of a cell, and then entering the cell and inhibiting protein synthesis leading to cell death. Once exposed to ricin toxin, there is no effective therapy available to reverse the course of the toxin. The recent ricin threat to government officials has heightened the awareness of this toxic threat. Currently, there is no FDA approved vaccine to protect against the possibility of ricin toxin being used in a terrorist attack, or its use as a weapon on the battlefield nor is there a known antidote for ricin toxin exposure.

SGX943 – for Treating Emerging and/or Antibiotic-Resistant Infectious Diseases

SGX943 is an IDR, containing the same active ingredient as SGX942. Dusquetide is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. Extensive in vivo preclinical studies have demonstrated enhanced clearance of bacterial infection with SGX943 administration. SGX943 has shown efficacy against both Gram-negative and Gram-positive bacterial infections in preclinical models, independent of whether the bacteria is antibiotic-resistant or antibiotic-sensitive.

The innate immune system is responsible for rapid and non-specific responses to combat bacterial infection. Augmenting these responses represents an alternative approach to treating bacterial infections. In animal models, IDRs are efficacious against both antibiotic-sensitive and antibiotic-resistant infections, both Gram-positive and Gram-negative bacteria, and are active irrespective of whether the bacteria occupy a primarily extracellular or intracellular niche. IDRs are also effective as stand-alone agents or in conjunction with antibiotics. An IDR for the treatment of serious bacterial infections encompasses a number of clinical advantages including:

● Treatment when antibiotics are contraindicated, such as:

o before the infectious organism and/or its antibiotic susceptibility is known; or

o in at-risk populations prior to infection.

● An ability to be used as an additive, complementary treatment with antibiotics, thereby:

o enhancing efficacy of sub-optimal antibiotic regimens (e.g., partially antibiotic-resistant infections);

o enhancing clearance of infection, thereby minimizing the generation of antibiotic resistance (e.g., in treating melioidosis); and

o reducing the required antibiotic dose, again potentially minimizing the generation of antibiotic resistance.

● An ability to modulate the deleterious consequences of inflammation in response to the infection, including the inflammation caused by antibiotic-driven bacterial lysis.

● Being unlikely to generate bacterial resistance since the IDR acts on the host, and not the pathogen.

Importantly, systemic inflammation and multi-organ failure is the ultimate common outcome of not only emerging and/or antibiotic-resistant infectious diseases, but also of most biothreat agents (e.g., Burkholderia pseudomallei), indicating that dusquetide would be applicable not only to antibiotic-resistant infection, but also

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to biothreat agents, especially where the pathogen is not known and/or has been engineered for enhanced antibiotic resistance.

The Drug Approval Process

The FDA and comparable regulatory agencies in state, local and foreign jurisdictions impose substantial requirements on the clinical development, manufacture and marketing of new drug and biologic products. The FDA, through regulations that implement the Federal Food, Drug, and Cosmetic Act, as amended (“FDCA”), and other laws and comparable regulations for other agencies, regulate research and development activities and the testing, manufacture, labeling, storage, shipping, approval, recordkeeping, advertising, promotion, sale, export, import and distribution of such products. The regulatory approval process is generally lengthy, expensive and uncertain. Failure to comply with applicable FDA and other regulatory requirements can result in sanctions being imposed on us or the manufacturers of our products, including holds on clinical research, civil or criminal fines or other penalties, product recalls, or seizures, or total or partial suspension of production or injunctions, refusals to permit products to be imported into or exported out of the U.S., refusals of the FDA to grant approval of drugs or to allow us to enter into government supply contracts, withdrawals of previously approved marketing applications and criminal prosecutions.

Before human clinical testing in the U.S. of a new drug compound or biological product can commence, an ~~Investigational New Drug (“~~IND”), application is required to be submitted to the FDA. The IND application includes results of pre- clinical animal studies evaluating the safety and efficacy of the drug and a detailed description of the clinical investigations to be undertaken.

Clinical trials are normally done in three phases, although the phases may overlap. Phase 1 trials are smaller trials concerned primarily with metabolism and pharmacologic actions of the drug and with the safety of the product. Phase 2 trials are designed primarily to demonstrate effectiveness and safety in treating the disease or condition for which the product is indicated. These trials typically explore various doses and regimens. Phase 3 trials are expanded clinical trials intended to gather additional information on safety and effectiveness needed to clarify the product’s benefit-risk relationship and generate information for proper labeling of the drug, among other things. The FDA receives reports on the progress of each phase of clinical testing and may require the modification, suspension or termination of clinical trials if an unwarranted risk is presented to patients. When data is required from long-term use of a drug following its approval and initial marketing, the FDA can require Phase 4, or post-marketing, studies to be conducted.

With certain exceptions, once successful clinical testing is completed, the sponsor can submit a NDA, for approval of a drug, or a Biologic License Application (“BLA”), for biologics such as vaccines, which will be reviewed, and if successful, approved by the FDA, allowing the product to be marketed. The process of completing clinical trials for a new drug is likely to take a number of years and require the expenditure of substantial resources. Furthermore, the FDA or any foreign health authority may not grant an approval on a timely basis, if at all. The FDA may deny the approval of a NDA or BLA, in its sole discretion, if it determines that its regulatory criteria have not been satisfied or may require additional testing or information. Among the conditions for marketing approval is the requirement that the prospective manufacturer’s quality control and manufacturing procedures conform to good manufacturing practice regulations. In complying with standards contained in these regulations, manufacturers must continue to expend time, money and effort in the area of production, quality control and quality assurance to ensure full technical compliance. Manufacturing facilities, both foreign and domestic, also are subject to inspections by, or under the authority of, the FDA and by other federal, state, local or foreign agencies.

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~~the~~on ~~FDA~~a ~~can~~timely ~~revoke~~basis, ~~approval~~ if ~~later~~at ~~testing does not reproduce previous findings~~all. The FDA may ~~also~~deny ~~condition~~the approval of a ~~product~~NDA onor ~~the~~BLA, ~~sponsor~~in ~~agreeing~~its tosole ~~certain~~discretion, ~~mitigation~~if ~~strategies~~it determines that ~~can~~its ~~limit~~regulatory ~~the~~criteria ~~unfettered~~have ~~marketing~~not ofbeen asatisfied ~~drug.~~or ~~Also,~~may ~~the~~require ~~FDA~~additional testing or ~~foreign~~information. ~~regulatory~~Among ~~authority~~the ~~will~~conditions ~~require~~for ~~post-~~marketing ~~reporting~~approval tois ~~monitor~~ the ~~side~~requirement ~~effects~~that of the ~~drug.~~prospective ~~Results~~manufacturer’s ofquality ~~post-marketing~~control ~~programs~~and ~~may~~manufacturing ~~limit~~procedures orconform ~~expand~~to ~~the~~good ~~further~~manufacturing ~~marketing~~practice ofregulations. ~~the~~In ~~product.~~complying ~~Further,~~with ifstandards ~~there~~contained ~~are~~in ~~any~~these ~~modifications~~regulations, manufacturers must continue to ~~the~~expend ~~drug~~time, ~~including~~money ~~any~~and ~~change~~effort in ~~indication,~~the ~~manufacturing~~area ~~process~~of production, ~~labeling~~quality orcontrol ~~manufacturing~~and ~~facility,~~quality anassurance ~~application~~to ~~seeking~~ensure ~~approval~~full oftechnical ~~such~~compliance. ~~changes~~Manufacturing ~~will~~facilities, ~~likely~~both beforeign ~~required~~and todomestic, bealso ~~submitted~~are subject to inspections by, or under the authority of, the FDA and by other federal, state, local or foreign ~~regulatory authority~~agencies.

Even after initial FDA or foreign health authority approval has been obtained, further studies, including Phase 4 post-marketing studies, may be required to provide additional data on safety and will be required to gain approval for the marketing of a product as a treatment for clinical indications other than those for which the product was initially tested. For certain drugs intended to treat serious, life- threatening conditions that show great promise in earlier testing, the FDA can also grant conditional approval. However, drug developers are required to study the drug further and verify clinical benefit as part of the conditional approval provision, and the FDA can revoke approval if later testing does not reproduce previous findings. The FDA may also condition approval of a product on the sponsor agreeing to certain mitigation strategies that can limit the unfettered marketing of a drug. Also, the FDA or foreign regulatory authority will require post-marketing reporting to monitor the side effects of the drug. Results of post- marketing programs may limit or expand the further marketing of the product. Further, if there are any modifications to the drug, including any change in indication, manufacturing process, labeling or manufacturing facility, an application seeking approval of such changes will likely be required to be submitted to the FDA or foreign regulatory authority.

In the U.S., the FDCA, the Public Health Service Act, the Federal Trade Commission Act, and other federal and state statutes and regulations govern, or influence the research, testing, manufacture, safety, labeling, storage, record keeping, approval, advertising and promotion of drug, biological, medical device and food products. Noncompliance with applicable requirements can result in, among other things, fines, recall or seizure of products, refusal to permit products to be imported into the U.S., refusal of the government to approve product approval applications or to allow us to enter into government supply contracts, withdrawal of previously approved applications and criminal prosecution. The FDA may also assess civil penalties for violations of the FDCA involving medical devices.

For biodefense development, such as with RiVax®, the FDA has instituted policies that are expected to result in shorter pathways to market. This potentially includes approval for commercial use utilizing the results of animal efficacy trials, rather than efficacy trials in humans. However, we will still have to establish that the vaccine and countermeasures it is developing are safe in humans at doses that are correlated with the beneficial effect in animals. Such clinical trials will also have to be completed in distinct populations that are subject to the countermeasures; for instance, the very young and the very old, and in pregnant women, if the countermeasure is to be licensed for civilian use. Other agencies will have an influence over the benefit- risk scenarios for deploying the countermeasures and in establishing the number of doses utilized in the Strategic National Stockpile. We may not be able to sufficiently demonstrate the animal correlation to the satisfaction of the FDA, as these correlates are difficult to establish and are often unclear. Invocation of the animal rule may raise issues of confidence in the model systems even if the models have been validated. For many of the biological threats, the animal models are not available and we may have to develop the animal models, a time-consuming research effort. There are few historical precedents, or recent precedents, for the development of new countermeasure for bioterrorism agents. Despite the animal rule, the FDA may require large clinical trials to establish safety and immunogenicity before licensure and it may require safety and immunogenicity trials in additional populations. Approval of biodefense products may be subject to post-marketing studies, and could be restricted in use in only certain populations.

Vaccines are approved under the BLA process that exists under the Public Health Service Act. In addition to the greater technical challenges associated with developing biologics, the potential for generic competition is lower for a BLA product than a small molecule product subject to a NDA under the Federal Food, Drug and Cosmetic Act. Under the Patient Protection and Affordable Care Act enacted in 2010, a “generic” version of a biologic is known as a biosimilar and the barriers to entry –— whether legal, scientific, or logistical –— for a biosimilar version of a biologic approved under a BLA are higher.

Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs or biologics intended to treat a rare disease or condition –— generally a disease or condition that affects fewer than 200,000 individuals in the U.S. Orphan drug designation must be requested before submitting a NDA or BLA. After the FDA grants orphan drug designation, the generic identity of the drug or biologic and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. The first NDA or BLA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for that product, for that indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug or biologic for the same disease, except in limited circumstances, such as a showing of clinical superiority to the product with orphan

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particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for that product, for that indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug or biologic for the same disease, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent the 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 NDA or BLA application user fee.

Fast Track Designation and Accelerated Approval

The FDA is required to facilitate the development, and expedite the review, of drugs or biologics that are intended for the treatment of a serious or life-threatening disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for the condition. Under the fast track program, the sponsor of a new drug or biologic candidate may request that the FDA designate the candidate for a specific indication as a fast track drug or biologic concurrent with, or after, the filing of the IND for the candidate. The FDA must determine if the drug or biologic candidate qualifies for fast track designation within 60 days of receipt of the sponsor’s request. Unique to a fast track product, the FDA may initiate review of sections of a fast track product’s NDA or BLA before the application is complete. This rolling review is available if the applicant provides, and the FDA approves, a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA’s time period goal for reviewing an application does not begin until the last section of the NDA or BLA is submitted. Additionally, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.

Any product submitted to the FDA for marketing, including under a fast track program, may be eligible for other types of FDA programs intended to expedite development and review, such as accelerated approval. Drug or biological products studied for their safety and effectiveness in treating serious or life- threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval, which means the FDA may approve the product based upon 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.

In clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a direct measurement of how a patient feels, functions, or survives. Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A drug or biologic candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, will allow the FDA to withdraw the drug or biologic from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA.

Pediatric Information

Under the Pediatric Research Equity Act (“PREA”), NDAs or BLAs or supplements to NDAs or BLAs must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant full or partial waivers, or deferrals, for submission of data. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has been granted.

Paediatric Investigation Plan

As part of the regulatory process for the registration of new medicines with the EMA and the MHRA, pharmaceutical companies are required to provide a PIP outlining ~~the~~our ~~Company’s~~ strategy for investigation of the new medicinal products in the paediatric population. In some instances, a waiver negating the need for a PIP for certain conditions may be granted by the EMA or MHRA when development of a medicine for use in children is not feasible or appropriate.

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PIP for certain conditions may be granted by the EMA or MHRA when development of a medicine for use in children is not feasible or appropriate.

Innovative Licensing and Access Pathway

The ILAP was launched in the UK at the start of 2021 to accelerate the development and access to promising medicines, thereby facilitating patient access to new medicines. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with the MHRA and other stakeholders including the NICE, and the SMC. The decision to award the Innovation Passport is made by an ILAP Steering Group, which is comprised of representatives from MHRA, NICE, and SMC. The Innovation Passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day accelerated assessment, rolling review and a continuous benefit risk assessment.

Early Access to Medicines Scheme

Launched in April 2014 in the ~~United~~UK ~~Kingdom~~ by the MHRA, the Early Access to Medicines Scheme (“EAMS”) offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines earlier than they would normally be accessible. PIM designation is the first phase of EAMS and is awarded following an assessment of early nonclinical and clinical data by the MHRA. The criteria product candidates must meet to obtain PIM designation are:

● Criterion 1 –— The condition should be life-threatening or seriously debilitating with a high unmet medical need (i.e., there is no method of treatment, diagnosis or prevention available or existing methods have serious limitations).

● Criterion 2 –— The medicinal product is likely to offer major advantage over methods currently used in the UK.

● Criterion 3 –— The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance. A positive benefit risk balance should be based on preliminary scientific evidence that the safety profile of the medicinal product is likely to be manageable and acceptable in relation to the estimated benefits.

False Claims Laws

The federal False Claims Act 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 government. 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.

Anti-Kickback Laws

The federal Anti-Kickback Statute prohibits, among other things, any person or entity, 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 purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term remuneration has been interpreted broadly to include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary managers on the other.

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United States Healthcare Reform

Federal Physician Payments Sunshine 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 (with certain exceptions) to report information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members.

In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. The Health Insurance Portability and Accountability Act (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates” – independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

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Technology for Economic and Clinical Health Act (“HITECH”), and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates” — independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Third-Party Suppliers and Manufacturers

Drug substance and drug product manufacturing is outsourced to qualified suppliers. We do not have manufacturing capabilities/infrastructure and do not intend to develop the capacity to manufacture drug products substances. We have agreements with third-party manufacturers to supply bulk drug substances for our product candidates and with third parties to formulate, package and distribute our product candidates. Our employees include professionals with expertise in pharmaceutical manufacturing development, quality assurance and third-party supplier management who oversee work conducted by third-party companies. We believe that we have on hand or can easily obtain sufficient amounts of product candidates to complete our currently contemplated clinical trials. All of the drug substances used in our product candidates currently are manufactured by single suppliers. While we have not experienced any supply disruptions, the number of manufacturers of the drug substances is limited. In the event it is necessary or advisable to acquire supplies from alternative suppliers, assuming commercially reasonable terms could be reached, the challenge would be the efficient transfer of technology and know-how from current manufactures to the new supplier. Formulation and distribution of our finished product candidates also currently are conducted by single suppliers but we believe that alternative sources for these services are readily available on commercially reasonable terms, subject to the efficient transfer of technology and know-how from current suppliers to the new supplier.

All of the current agreements for the supply of bulk drug substances for our product candidates and for the formulation or distribution of our product candidates relate solely to the development (including preclinical and clinical) of our product candidates. Under these contracts, our product candidates are manufactured upon our order of a specific quantity. In the event that we obtain marketing approval for a product candidate, we will qualify secondary suppliers for all key manufacturing activities supporting the marketing application.

Marketing and Collaboration

We do not currently have any sales and marketing capability, other than to potentially market our biodefense vaccine products directly to government agencies. With respect to other commercialization efforts, we currently intend to seek distribution and other collaboration arrangements for the sales and marketing of any product candidate that is approved, while also evaluating the potential to commercialize on our own in orphan disease indications. From time to time, we have had and are having strategic discussions with potential collaboration partners for our biodefense vaccine product candidates, although no assurance can be given that we will be able to enter into one or more collaboration agreements for our product candidate on acceptable terms, if at all. We believe that both military and civilian health authorities of the U.S. and other countries will increase their stockpiling of therapeutics and vaccines to treat and prevent diseases and conditions that could ensue following a bioterrorism attack.

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indications. From time to time, we have had and are having strategic discussions with potential collaboration partners for our biodefense vaccine product candidates, although no assurance can be given that we will be able to enter into one or more collaboration agreements for our product candidate on acceptable terms, if at all. We believe that both military and civilian health authorities of the U.S. and other countries will increase their stockpiling of therapeutics and vaccines to treat and prevent diseases and conditions that could ensue following a bioterrorism attack.

On August 25, 2013, we entered into an agreement with SciClone, pursuant to which SciClone provided us with access to its oral mucositis clinical and regulatory data library in exchange for exclusive commercialization rights for SGX942 in the People’s Republic of China, including Hong Kong and Macau, subject to the negotiation of economic terms. SciClone’s data library was generated from two sequential Phase 2 clinical studies conducted in 2010 and 2012 evaluating SciClone’s compound, SCV-07, for the treatment of oral mucositis caused by chemoradiation therapy in head and neck cancer patients, before SciClone terminated its program. By analyzing data available from the placebo subjects in the SciClone trials, we acquired valuable insight into disease progression, along with quantitative understanding of its incidence and severity in the head and neck cancer patient population. This information assisted us with the design of the SGX942 Phase 2 clinical trial, in which positive preliminary results were announced in December 2015.

On September 9, 2016, we and SciClone entered into an exclusive license agreement, pursuant to which we granted rights to SciClone to develop, promote, market, distribute and sell SGX942 in the People’s Republic of China, including Hong Kong and Macau, as well as Taiwan, South Korea and Vietnam. Under the terms of the license agreement, SciClone will be responsible for all aspects of development, product registration and commercialization in the territories, having access to data generated by us. In exchange for exclusive rights, SciClone will pay us royalties on net sales, and we will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights. We also entered into a Common Stock purchase agreement with SciClone pursuant to which we sold 23,530 shares of our Common Stock to SciClone for approximately $127.50 per share, for an aggregate price of $3 million.

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aspects of development, product registration and commercialization in the territories, having access to data generated by us. In exchange for exclusive rights, SciClone will pay us royalties on net sales, and we will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights. We also entered into a common stock purchase agreement with SciClone pursuant to which we sold 1,471 shares of our common stock to SciClone for approximately $2,040.00 per share, for an aggregate price of $3 million.

Competition

Our competitors are pharmaceutical and biotechnology companies, most of whom have considerably greater financial, technical, and marketing resources than we do. Universities and other research institutions, including the U.S. Army Medical Research Institute of Infectious Diseases, also compete in the development of treatment technologies, and we face competition from other companies to acquire rights to those technologies.

HyBryte™ Competition

There is currently no approved cure for CTCL and treatments are prescribed to manage symptoms. The FDA has approved several treatments for later stages (IIB-IV) of CTCL and/or in conditions that are unresponsive to prior treatment. Three are targeted therapies (Targretin®-caps, Ontak® and Adcetris®), two are histone deacetylases inhibitors (Zolina® and Istodax®) and the remaining two are topical therapies (Valchor® and Targretin®-gel). There are currently no FDA approved therapies for the treatment of front- line, early stage (I-IIA) CTCL; however certain topical chemotherapies and topical, radiation, photodynamic and other therapies which are approved for indications other than CTCL are prescribed off-label for the treatment of early stage CTCL. These include narrow-band ultraviolet B (NB-UVB) light therapy and psoralen combined with ultraviolet A UVA light therapy (“PUVA”); however, PUVA treatments are usually limited to three times per week and 200 times in total due to the potentially carcinogenic side effect, while NB UVB is known to be effective against patches but less so against plaque lesions, common in early stage CTCL. There are other drugs currently in development that may have the potential to be used in early stage (I-IIA) CTCL, primarily in early Phase 1 and 2 clinical studies. Other treatments for later stage disease are not considered direct competitors.

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SGX302 Competition

There is currently no approved cure for psoriasis and treatments are prescribed to manage symptoms. The FDA has approved several topical and systemic treatments for psoriasis. Systemic therapies dominate the treatment of severe and increasingly the more severe moderate patients, and include biologics aimed at reducing systemic inflammation. Skin directed therapy remains the primary treatment for mild-to-moderate disease. Current therapies for mild-to-moderate disease include psoralen activated by ultraviolet A (“PUVA”, a photodynamic therapy), emollients, topical steroids, vitamin D preparations including retinoids (e.g., Sorilux®, Dovonex®, Cacitrene®), coal tar, salicylic acid, calcineurin inhibitors (e.g., Prograf®, Elidel®, Zorac®, Tazorac®) and dithranols (e.g., Drithocreme®). Other phototherapy approaches include the use of both broad-band and narrow-band ultraviolet B light. There are also a number of ongoing Phase 2 and 3 clinical trials in mild to moderate psoriasis.

Compared to PUVA, photoactivated hypericin uses non-carcinogenic and more penetrative visible light (unlike ultraviolet light used with PUVA) and a non-mutagenic compound hypericin (unlike psoralen used with PUVA), and is more highly targeted and more commensurate with long-term treatment. Compared to other skin-directed therapies, photoactivated hypericin has demonstrated a comparatively low local irritancy/adverse event rate with minimal long-term skin effects. Compared to systemic therapies, commonly used in more severe patients only, photoactivated hypericin does not cause immunosuppression.

SGX94/942/945 Competition

Because SGX94 (dusquetide) uses a novel mechanism of action in combating bacterial infections, there are no direct competitors at this time. Bacterial infections are routinely treated with antibiotics and SGX94 treatment is anticipated to be utilized primarily where antibiotics are insufficient (e.g., due to antibiotic resistance) or contra-indicated (e.g., in situations where the development of antibiotic resistance is a significant concern). Many groups are working on the antibiotic resistance problem and research into the innate immune system is intensifying, making emerging competition likely (from companies such as Celtaxsys Inc., Innaxon Therapeutics and Innate Pharma SA).

There is currently one drug approved for the treatment of oral mucositis in hematological cancer (palifermin). There are currently no approved drugs for treatment of oral mucositis in cancers with solid tumors (e.g., head and neck cancer). There are several drugs in clinical development for oral mucositis – three in Phase 3 (brilacidin by Innovation Pharmaceuticals, Inc., a mucobuccal tablet by Monopar Therapeutics LLC and GC4419 by Galera Therapeutics, Inc.). There are various natural products in small and/or open label studies (including sage, turmeric, honey and olive oil). In addition, there are medical devices approved for the treatment of oral mucositis including MuGard®, GelClair®, Episil®, and Caphosol®. These devices attempt to create a protective barrier around the oral ulceration with no biologic activity in treating the underlying disease.

There is currently no approved cure for BD and treatments are prescribed to manage symptoms. Treatments may include both maintenance therapies and those specifically addressing mucocutaneous flares (e.g., mouth ulcers, genital ulcers and leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that become more concerning with more chronic use. Other treatments for BD flares involve suppressing the immune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and kidney problems, low blood counts and high blood pressure. For skin and mucosal manifestations of BD, anti-inflammatory drugs are also used, including colchicine, azathioprine, anti-TNF, anti-interferon alpha, anti-IL-17 and anti-IL-23 medications. The only approved drug in BD is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers. Apremilast is associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and headache.79

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clinical development for oral mucositis — three in Phase 3 (brilacidin by Innovation Pharmaceuticals, Inc., a mucobuccal tablet by Monopar Therapeutics LLC and GC4419 by Galera Therapeutics, Inc.). There are various natural products in small and/or open label studies (including sage, turmeric, honey and olive oil). In addition, there are medical devices approved for the treatment of oral mucositis including MuGard®, GelClair®, Episil®, and Caphosol®. These devices attempt to create a protective barrier around the oral ulceration with no biologic activity in treating the underlying disease.

There is currently no approved cure for BD and treatments are prescribed to manage symptoms. Treatments may include both maintenance therapies and those specifically addressing mucocutaneous flares (e.g., mouth ulcers, genital ulcers and leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that become more concerning with more chronic use. Other treatments for BD flares involve suppressing the immune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and kidney problems, low blood counts and high blood pressure. For skin and mucosal manifestations of BD, anti- inflammatory drugs are also used, including colchicine, azathioprine, anti-TNF, anti-interferon alpha, anti- IL-17 and anti-IL-23 medications. The only approved drug in BD is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers. Apremilast is associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and headache.

ThermoVax^®Competition

Multiple groups and companies are working to address the unmet need of vaccine thermostability using a variety of technologies. In addition, other organizations, such as the Bill and Melinda Gates Foundation and PATH, have programs designed to advance technologies to address this need.

Several stabilization technologies currently being developed involve mixing vaccine antigen +/- adjuvant with various proprietary excipients or co-factors that either serve to stabilize the vaccine or biological product in a liquid or dried (lyophilized) form. Examples of these approaches include the use of various plant- derived sugars and macromolecules being developed by companies such as iosBio. Variation Biotechnologies, Inc. (“VBI”) is developing a lipid system (resembling liposomes) to stabilize viral antigens, including virus- like particles (“VLPs”), and for potential application to a conventional influenza vaccine among others.

Additionally, companies like ~~Altimmune, Inc., and~~ Panacea Biotec Ltd., ~~and Compass Biotech Inc.~~ are developing proprietary vaccines with the application of some form of stabilization technology.

Public Health Solutions Competition

We face competition in the area of biodefense product development from various public and private companies, universities and governmental agencies, such as the U.S. Army, some of whom may have their own proprietary technologies which may directly compete with our technologies.

The U.S. Army Medical Research Institute of Infectious Diseases, the DoD’s lead laboratory for medical research to counter biological threats is also developing a ricin vaccine candidate, RVEc™. RVEc™ has been shown to be fully protective in mice exposed to lethal doses of ricin toxin by the aerosol route. Further studies, in both rabbits and nonhuman primates, were conducted to evaluate RVEc™’s safety as well as its immunogenicity, with positive results observed. No further data has been released in recent years. A monoclonal antibody is also being developed by Mapp Biopharmaceutical Inc. as a ricin therapeutic, with administration 4 hours after exposure demonstrating efficacy while administration 12 hours after ricin exposure was not protective in animal models.

There are no approved vaccines to prevent infection and/or mitigate exposure to Sudan ebolavirus or Marburg marburgvirus. There are other vaccine candidates in development, primarily using viral-vectored vaccine platforms. These platforms may be contra-indicated in the immune-compromised, pregnant individuals or children. They may also have limited efficacy on repeat administration.

Patents and Other Proprietary Rights

Our goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods and other proprietary technologies, preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the U.S. and in other countries. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our product candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the U.S. and elsewhere in the world.

We also depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our advisors, consultants and other contractors, none of which is patentable. To help protect our proprietary knowledge and experience that is not patentable, and for inventions for which patents may be difficult to enforce, we rely on trade secret protection and confidentiality agreements to protect our interests. To this end, we require all employees, consultants, advisors and other contractors to enter into confidentiality agreements, which prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.80

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the U.S. and in other countries. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our product candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the U.S. and elsewhere in the world.

In 2014, we acquired a novel PDT that utilizes safe visible light for activation, which we refer to as HyBryte™. The active ingredient in HyBryte™ is synthetic hypericin, a photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. As part of the acquisition, we acquired a license agreement relating to the use of photo-activated hypericin, composition of matter patent for HyBryte™ (U.S. patent 8,629,302) and additional issued and pending applications, both in the U.S. and abroad. U.S. patent 8,629,302 is expected to expire in September 2030. In August 2018, we were granted a U.S. patent (No. 10,053,513) titled “Systems and Methods for Producing Synthetic Hypericin.” This newly issued patent, expected to expire in 2036, broadens the production around synthetic hypericin. Our proprietary formulation of synthetic hypericin also has been granted a European patent for the treatment of psoriasis, EP 2571507, and complements the method of treatment claims covered by the previously issued U.S. patent 6001882, Photoactivated hypericin and the use thereof. Further, on January 7, 2020, we also were granted a U.S. patent (No. 10,526,268) titled “Systems and Methods for Producing Synthetic Hypericin”, which further expanded protection for the composition of purified synthetic hypericin. This patent is also expected to expire in 2036. Patent protection is also pursued worldwide with similar patents and expiry dates.

In addition to issued and pending patents, we also have “Orphan Drug” designations for HyBryte™ in the U.S. and the EU for CTCL, as well as for RiVax^® in the U.S. and EU. Our Orphan Drug designations provide for seven years of post-approval marketing exclusivity in the U.S. and ten years exclusivity in Europe. We have pending patent applications for this indication that, if granted, may extend our anticipated marketing exclusivity beyond the U.S. seven year or EU ten year post-approval exclusivity provided by Orphan Drug legislation.

In 2013, we expanded our patent portfolio to include innate defense regulation through the acquisition of the novel drug technology, known as SGX94. By binding to the pivotal regulatory protein p62, also known as sequestosome-1, SGX94 regulates the innate immune system to reduce inflammation, eliminate infection and enhance healing. As part of the acquisition, we acquired all rights, including composition of matter patents for SGX94 as well as other analogs and crystal structures of SGX94 with its protein target p62, including U.S. patent 8,124,721 (expiring 2028), 9,416,157 (expiring 2028) and 8,791,061 (expiring 2029), both in the U.S. and abroad. SGX94 was developed pursuant to discoveries made by Professors B. Brett Finlay and Robert Hancock of University of British Columbia (“UBC”). We also have rights to the background technology patents (U.S. patent numbers 7,~~507,787 [expiring 2024], 7,~~687,454 [expiring 2026] and 11,311,598 [expiring 2034]). The U.S. Patent Office has also granted patents titled “Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis.” The issued patents (U.S. patent numbers 9,850.279 and 10,253,068, both expiring in 2034) claim therapeutic use of dusquetide and related IDR analogs, and adds to composition of matter claims for dusquetide and related analogs that have been granted in the U.S. and worldwide.

ThermoVax® is the subject of U.S. patents 8,444,991 (expiring February 2030) and 8,808,710 (expiring March 2028) both issued on May 21, 2013 titled “Method of Preparing an Immunologically-Active Adjuvant- Bound Dried Vaccine Composition” and licensed to us by VitriVax, Inc. ThermoVax® is also U.S. patent application number 15/694.023 filed September 17, 2017 titled “Thermostable Vaccine Compositions and Methods of Preparing Same” and jointly invented by the UC and ~~the Company~~us. The patent application and the corresponding foreign filings are pending or granted and they address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation. The license agreement covers thermostable alum-adjuvanted vaccines for ricin toxin and Ebola virus. An additional patent, covering vaccine combinations such as ricin toxin and anthrax, was filed in 2015 and granted on May 21, 2019 in the U.S. (No. 10,293,041, titled “Multivalent Stable Vaccine Composition and Methods of Making Same”) and is expected to expire in 2035. A patent for unique, proprietary compositions and methods directed to combinations of glycoprotein antigens with nano-emulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization was filed in 2020, granted in 2022 and expiring in 2040 (No. 11,433,129 titled “Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines.”) Patent protection is also pursued worldwide with similar patents and expiry dates.

Additional vaccine thermostabilization patents specific for anti-viral vaccines, including filovirus and coronavirus have been filed but are not yet granted. If granted, expiry dates would range from 2040 to 2041. Patent protection is also pursued worldwide with similar patents and expiry dates.81

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HyBryte™ License Agreement

In September 2014, we acquired a worldwide exclusive license agreement with New York University and Yeda Research and Development Company Ltd. for the rights to a novel PDT that utilizes safe visible light for activation, which we refer to as HyBryte™. To maintain this license, we are obligated to pay $25,000 in annual license fees. In addition, we will pay the licensors: (a) a royalty amount equal to 3% of all net sales of HyBryte™ made directly by us and/or any affiliates; (b) a royalty amount equal to 2.5% of all net sales of HyBryte™ made by our sublicensees, subject to stated maximums and (c) 20% of all payments, not based on net sales, received by us from our sublicensees. This license may be terminated by either party upon notice of a material breach by the other party that is not cured within the applicable cure period. The exclusive license includes rights to several issued U.S. patents, including U.S. patent numbers 6,867,235 and 7,122,518, among other domestic and foreign patent applications. U.S. Patent numbers 6,867,235 and 7,122,518 expired in January 2020 and ~~is expected to expire in~~ November 2023, respectively.

We acquired the license agreement for HyBryte™ and related intangible assets, including U.S. patent 8,629,302, properties and rights pursuant to an asset purchase agreement with Hy Biopharma Inc. (“Hy Biopharma”). As consideration for the assets acquired, we initially paid $275,000 in cash and issued ~~12,328~~771 shares of ~~Common~~common ~~Stock~~stock with a market value of $3,750,000, and in March 2020 we issued 8,151 shares of ~~Common~~common ~~Stock~~stock at a value of $5,000,000 (based upon an effective per share price of $614.40) as a result of HyBryte™ demonstrating statistical significant treatment response in the Phase 3 clinical trial. Provided the final success-orientated milestone is attained, we will be required to make a payment of up to $5 million, if and when achieved, payable in our ~~Common~~common ~~Stock~~stock.

SGX94 License Agreements

On December 18, 2012, we acquired a first in class drug technology, known as SGX94 (dusquetide), representing a novel approach to modulation of the innate immune system. SGX94 is an IDR that regulates the innate immune system to reduce inflammation, eliminate infection and enhance tissue healing by binding to the pivotal regulatory protein p62, also known as sequestosome-1. As part of the acquisition, we acquired all rights, including composition of matter patents, preclinical and Phase 1 clinical study datasets for SGX94. We also assumed a license agreement with UBC to advance the research and development of the SGX94 technology. The license agreement with UBC provides us with exclusive worldwide rights to manufacture, distribute, market sell and/or license or sublicense products derived or developed from this technology. Under the license agreement we are obligated to pay UBC (i) an annual license maintenance fee of CAD $1,000, and (ii) milestone payments which could reach up to CAD $1.2 million. This license agreement (a) will automatically terminate if we file, or become subject to an involuntary filing, for bankruptcy, and (b) may be terminated by UBC in the event of, among other things, our insolvency, dissolution, grant of a security interest in the technology licensed to us pursuant to the license agreement, or material breach of or failure to perform material obligations under the license agreement or other research agreements between us and UBC.

ThermoVax^®License Agreement

On December 21, 2010, we executed a worldwide exclusive license agreement with the UC for ThermoVax®, which is the subject of U.S. patent number 8,444,991 issued on May 21, 2013 titled “Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition.” This patent and its corresponding foreign filings are licensed to us by the UC and they address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation. U.S. Patent 8,444,991 is expected to expire in December 2031. The license agreement also covers thermostable vaccines for biodefense as well as other potential vaccine indications. In addition, we, in conjunction with UC, filed domestic and foreign patent applications claiming priority back to a provisional application filed on May 17, 2011 titled: “Thermostable Vaccine Compositions and Methods of Preparing Same.” In April 2018, the UC delivered a notice of termination of our license agreement based upon our failure to achieve one of the development milestones: initiation of the Phase 1 clinical trial of the heat stabilization technology by March 31, 2018. After negotiating with the UC, we and the UC agreed to extend the termination date to October 31, 2018 in order to allow us time to agree upon a potential agreement that would allow us to keep the rights to, and to continue to develop, the heat stabilization technology or a product candidate containing the heat stabilization technology in our field of use.

79On October 31, 2018, in a series of related transactions, (a) we and the UC agreed to terminate the original license agreement, (b) the UC and VitriVax executed a worldwide exclusive license agreement for the heat stabilization technology for all fields of use,

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~~that~~and ~~would~~(c) we ~~allow~~and usVitriVax executed a worldwide exclusive sublicense agreement, which was amended and restated in October 2020, for the heat stabilization technology for use in the fields of ricin and Ebola vaccines. We paid a $100,000 sublicense fee on the effective date of the sublicense agreement. Under the amended sublicense agreement to ~~keep~~maintain the ~~rights~~sublicense we are obliged to pay a minimum annual royalty of $20,000 ~~and~~until first commercial sale of a sublicensed product, upon which point, we will be required to ~~continue~~pay an earned royalty of 2% of net sales subject to ~~develop~~a minimum royalty of $50,000 each year. We are also required to pay royalties on any sub-sublicense income based on a declining percentage of all sub-sublicense income calculated within the ~~heat~~contractual ~~stabilization~~period ~~technology~~until orreaching a minimum of 15% after two years. In addition, we are required to pay VitriVax milestone fees of: (a) $25,000 upon initiation of a Phase 2 clinical trial of the sublicensed product, ~~candidate~~(b) $100,000 ~~containing~~upon initiation of a Phase 3 clinical trial of the ~~heat~~sublicensed ~~stabilization~~product, ~~technology~~(c) $100,000 upon regulatory approval of a sublicensed product, and (d) $1 million upon achieving $10 million in ~~our~~aggregate ~~field~~net sales of ~~use~~a sublicensed product in the U.S. or equivalent. To date none of these milestones have been met.

On October 31, 2018, in a series of related transactions, (a) we and the UC agreed to terminate the original license agreement, (b) the UC and VitriVax executed a worldwide exclusive license agreement for the heat stabilization technology for all fields of use, and (c) we and VitriVax executed a worldwide exclusive sublicense agreement, which was amended and restated in October 2020, for the heat stabilization technology for use in the fields of ricin and Ebola vaccines. We paid a $100,000 sublicense fee on the effective date of the sublicense agreement. Under the amended sublicense agreement to maintain the sublicense we are obliged to pay a minimum annual royalty of $20,000 until first commercial sale of a sublicensed product, upon which point, we will be required to pay an earned royalty of 2% of net sales subject to a minimum royalty of $50,000 each year. We are also required to pay royalties on any sub-sublicense income based on a declining percentage of all sub-sublicense income calculated within the contractual period until reaching a minimum of 15% after two years. In addition, we are required to pay VitriVax milestone fees of: (a) $25,000 upon initiation of a Phase 2 clinical trial of the sublicensed product, (b) $100,000 upon initiation of a Phase 3 clinical trial of the sublicensed product, (c) $100,000 upon regulatory approval of a sublicensed product, and (d) $1 million upon achieving $10 million in aggregate net sales of a sublicensed product in the U.S. or equivalent. To date none of these milestones have been met.

RiVax^®License Agreement

In June 2003, we executed a worldwide exclusive option to license patent applications with UTSW for the nasal, pulmonary and oral uses of a non-toxic ricin vaccine. In June 2004, we entered into a license agreement with UTSW for the injectable rights to the ricin vaccine and, in October 2004, we negotiated the remaining oral rights to the ricin vaccine. To maintain this license, we are obligated to pay $50,000 in annual license fees. Through this license, we have rights to the issued patent number 7,175,848 titled “Ricin A chain mutants lacking enzymatic activity as vaccines to protect against aerosolized ricin.” This patent includes methods of use and composition claims for RiVax^®.

CoVaccine HT™ License Agreement

In April 2020, we executed an agreement for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant, from BTG, a division of Boston Scientific Corporation (NYSE: BSX), for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic flu. The agreement was executed with Protherics Medicines Development, one of the companies that make up the BTG specialty pharmaceuticals business, which owns the CoVaccine HT™ intellectual property.

Research and Development Expenditures

We spent approximately $1.17 million and $0.95 million ~~for~~in the three months ended ~~March~~June 3130, ~~2024~~ 2025 and ~~2023~~2024, respectively; $3.6 million and $1.6 million in the six months ended June 30, 2025 and ~~approximately~~2024, respectively; and $35.32 million and $73.93 million in the years ended December 31, ~~2023~~ 2024 and ~~2022~~2023, respectively,; on research and development. The amounts we spent on research and development per product during the three months ended ~~March~~June 3130, ~~2024~~ 2025 and ~~2023~~2024 and the years ended December 31, ~~2023~~ 2024 and ~~2022~~2023 are set forth in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” inbeginning on page 49 on this prospectus.

Human Capital

We are committed to a work environment that is welcoming, inclusive and encouraging. To achieve our plans and goals, it is imperative that we attract and retain top talent. In order to do so, we aim to have a safe and encouraging workplace, with opportunities for our employees to grow and develop professionally, supported by strong compensation, benefits, and other incentives. In addition to competitive base salaries, we offer every full-time employee a cash target bonus, a comprehensive benefits package and equity compensation.

80As of June 30, 2025, we employed a total of 15 persons, including 2 part-time employees and 13 full- time employees, five of whom are MDs/PhDs. In addition to our employees, we contract with third-parties for the conduct of certain clinical development, manufacturing, accounting and administrative activities. We anticipate increasing the number of our employees. We have no collective bargaining agreements with our employees, and none are represented by labor unions. We consider our relationships with our employees to be good.

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As of March 31, 2024, we employed a total of 15 persons, including 2 part-time employees and 13 full-time employees, five of whom are MDs/PhDs. In addition to our employees, we contract with third-parties for the conduct of certain clinical development, manufacturing, accounting and administrative activities. We anticipate increasing the number of our employees. We have no collective bargaining agreements with our employees, and none are represented by labor unions. We consider our relationships with our employees to be good.

Throughout the COVID 19 pandemic, many of our employees have worked remotely. In September 2021 our employees returned to the Company’s facilities in-person and have maintained a hybrid work schedule with both in-office and remote hours.

Properties

We currently lease approximately 6,200 square feet of office space at 29 Emmons Drive, Suite B-10 in Princeton, New Jersey pursuant to a lease which expires in October 2025. This office space currently serves as our corporate headquarters, and both of our business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. ~~Pursuant to an amendment on June 21, 2022, the lease has been extended from November 2022 to October 2025.~~ The current rent is approximately $11,~~367~~625 per month. ~~and~~Pursuant ~~will~~to ~~remain~~an soamendment ~~through~~on ~~October~~May ~~2024.~~12, ~~The~~2025, ~~rent for~~ the lease ~~period~~has ~~starting~~been ~~November 2024~~extended isfrom ~~approximately $11,625 per~~November ~~month.~~2025 Our office space is sufficient for our current needs. We may add new space or expand existing space as we add employees, and we believe that suitable additional or substitute space will be available as needed to ~~accommodate any such expansion of our operations.~~

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October 2028. The current rent is approximately $11,625 per month and will remain so until October 2026. The rent for lease periods starting November 2026 and November 2027 is approximately $11,833 and $12,142, respectively.

Our office space is sufficient for our current needs. We may add new space or expand existing space as we add employees, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.

Legal Proceedings

From time to time, we are a party to claims and legal proceedings arising in the ordinary course of business. Our management evaluates our exposure to these claims and proceedings individually and in the aggregate and allocates additional monies for potential losses on such litigation if it is possible to estimate the amount of loss and if the amount of the loss is probable.

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MANAGEMENT

The table below contains information regarding the current members of the Board of Directors and executive officers. The ages of individuals are provided as of ~~July~~September 1915, ~~2024~~2025.

Name	Age	Position
Christopher J. Schaber, PhD	5758	Chairman of the Board, Chief Executive Officer and President
Gregg A. Lapointe, CPA, MBA	6566	Director
Diane L Parks, MBA	7172	Director
Robert J. Rubin, MD	7879	Director
Jerome B. Zeldis, MD, PhD	7475	Director
Jonathan Guarino, CPA, CGMA	5253	Chief Financial Officer, Senior Vice President and Corporate Secretary
Oreola Donini, PhD	5253	Chief Scientific Officer and Senior Vice President
Richard Straube, MD	7273	Chief Medical Officer ~~and Senior Vice President~~(consulting)

Christopher J. Schaber, PhD has over 35 years of experience in the pharmaceutical and biotechnology industry. Dr. Schaber has been our President and Chief Executive Officer and a director since August 2006. He was appointed Chairman of the Board in October 2009. He also has served on the board of directors of the Biotechnology Council of New Jersey (“BioNJ”) since January 2009 and the Alliance for Biosecurity since October 2014, and has been a member of the corporate council of the National Organization for Rare Disorders (“NORD”) since October 2009. He also serves on the scientific advisory board for private start-up medical device company, Simphotek, Inc. Prior to joining Soligenix, Dr. Schaber served from 1998 to 2006 as Executive Vice President and Chief Operating Officer of Discovery Laboratories, Inc., where he was responsible for overall pipeline development and key areas of commercial operations, including regulatory affairs, quality control and assurance, manufacturing and distribution, pre-clinical and clinical research, and medical affairs, as well as coordination of commercial launch preparation activities. From 1996 to 1998, Dr. Schaber was a co-founder of Acute Therapeutics, Inc., and served as its Vice President of Regulatory Compliance and Drug Development. From 1994 to 1996, Dr. Schaber was employed by Ohmeda PPD, Inc., as Worldwide Director of Regulatory Affairs and Operations. From 1989 to 1994, Dr. Schaber held a variety of regulatory, development and operations positions with The Liposome Company, Inc., and Elkins-Sinn Inc., a division of Wyeth-Ayerst Laboratories. Dr. Schaber received his BA degree from Western Maryland College, his MS degree in Pharmaceutics from Temple University School of Pharmacy and his PhD degree in Pharmaceutical Sciences from the Union Graduate School. During his career, Dr. Schaber has played a significant role in raising in excess of $350 million through both public offerings and private placements, as well as approximately $100 million in non-dilutive funding awards from state and federal governmental agencies. Dr. Schaber was selected to serve as a member of our Board of Directors because of his extensive experience in drug development and pharmaceutical operations, including his experience as a senior executive officer with our company and Discovery Laboratories, Inc., and as a member of the board of directors of BioNJ and Simphotek; because of his proven ability to raise funds and provide access to capital; and because of his advanced degrees in science and business.

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pipeline development and key areas of commercial operations, including regulatory affairs, quality control and assurance, manufacturing and distribution, pre-clinical and clinical research, and medical affairs, as well as coordination of commercial launch preparation activities. From 1996 to 1998, Dr. Schaber was a co-founder of Acute Therapeutics, Inc., and served as its Vice President of Regulatory Compliance and Drug Development. From 1994 to 1996, Dr. Schaber was employed by Ohmeda PPD, Inc., as Worldwide Director of Regulatory Affairs and Operations. From 1989 to 1994, Dr. Schaber held a variety of regulatory, development and operations positions with The Liposome Company, Inc., and Elkins-Sinn Inc., a division of Wyeth-Ayerst Laboratories. Dr. Schaber received his BA degree from Western Maryland College, his MS degree in Pharmaceutics from Temple University School of Pharmacy and his PhD degree in Pharmaceutical Sciences from the Union Graduate School. During his career, Dr. Schaber has played a significant role in raising in excess of $350 million through both public offerings and private placements, as well as approximately $100 million in non-dilutive funding awards from state and federal governmental agencies. Dr. Schaber was selected to serve as a member of our Board of Directors because of his extensive experience in drug development and pharmaceutical operations, including his experience as a senior executive officer with our Company and Discovery Laboratories, Inc., and as a member of the board of directors of BioNJ and Simphotek; because of his proven ability to raise funds and provide access to capital; and because of his advanced degrees in science and business.

Gregg A. Lapointe, CPA, MBA has been a director since March 2009. Mr. Lapointe is currently CEO of Cerium Pharmaceuticals, Inc. and serves on the board of directors of Rigel Pharmaceuticals, Inc., and Astria Therapeutics, Inc. Mr. Lapointe has previously served on the board of directors of ImmunoCellular Therapeutics Ltd., Raptor Pharmaceuticals, Inc., SciClone Pharmaceuticals, Inc., the Pharmaceuticals Research and Manufacturers of America (PhRMA), Questcor Pharmaceuticals, Inc. and the board of trustees of the Keck Graduate Institute of Applied Life Sciences. He previously served in varying roles for Sigma-Tau Pharmaceuticals, Inc. (now known as Leadiant Biosciences, Inc.), a private biopharmaceutical company, from September 2001 through February 2012, including Chief Operating Officer from November 2003 to April 2008 and Chief Executive Officer from April 2008 to February 2012. From May, 1996 to August 2001, he served as Vice President of Operations and Vice President, Controller of AstenJohnson, Inc. (formerly JWI Inc.). Prior to that, Mr. Lapointe spent several years in the Canadian medical products industry in both distribution and manufacturing. Mr. Lapointe began his career at Price Waterhouse. Mr. Lapointe received his B.A. degree in Commerce from Concordia University in Montreal, Canada, a graduate diploma in Accountancy from McGill University and his M.B.A. degree from Duke University. He is a C.P.A. in the state of Illinois. Mr. Lapointe was selected to serve as a member of our Board of Directors because of his significant experience in the areas of global strategic planning and implementation, business development, corporate finance, and acquisitions, and his experience as an executive officer and board member in the pharmaceutical and medical products industries.

Diane L. Parks, MBA has been a director since July 2019. From February 2016 until July 2018, she served as Head of U.S. Commercial and Senior Vice President of Marketing, Sales & Market Research at Kite Pharma, Inc., a privately-held biopharma company developing cancer immunotherapy products with a primary focus on genetically engineered autologous T cell therapy with chimeric antigen receptors. From October 2014 to October 2015, Ms. Parks served as Vice President of Global Marketing at Pharmacyclics LLC, a privately-held biopharmaceutical company primarily focused on the development of cancer therapies. Prior to Pharmacyclics LLC, Ms. Parks held senior leadership roles as Vice President of Sales for Amgen, Inc., a publicly-traded biopharmaceutical company, representing oncology and nephrology products, and Senior Vice President of Specialty Biotherapeutics and Managed Care at Genentech, Inc., a biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions that was acquired by Roche Holding AG in 2009. At Genentech, she led the launches of multiple products as well as commercial development of Lucentis® and Rituxan®. Since May 2019, she has been a member of the board of directors of Calliditas Therapeutics AB, a biopharmaceutical company, the shares of which are traded on the Nasdaq Stockholm Exchange, that is developing and commercializing pharmaceutical products for patients with significant unmet medical needs in niche indications. She is also a member of the board of directors of Kura Oncology, a biopharmaceutical company, the shares of which are traded on US Nasdaq, that is developing a pipeline of precision medicines for the treatment of solid tumors and

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company developing cancer immunotherapy products with a primary focus on genetically engineered autologous T cell therapy with chimeric antigen receptors. From October 2014 to October 2015, Ms. Parks served as Vice President of Global Marketing at Pharmacyclics LLC, a privately-held biopharmaceutical company primarily focused on the development of cancer therapies. Prior to Pharmacyclics LLC, Ms. Parks held senior leadership roles as Vice President of Sales for Amgen, Inc., a publicly-traded biopharmaceutical company, representing oncology and nephrology products, and Senior Vice President of Specialty Biotherapeutics and Managed Care at Genentech, Inc., a biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions that was acquired by Roche Holding AG in 2009. At Genentech, she led the launches of multiple products as well as commercial development of Lucentis® and Rituxan®. Since May 2019, she has been a member of the board of directors of Calliditas Therapeutics AB, a biopharmaceutical company, the shares of which are traded on the Nasdaq Stockholm Exchange, that is developing and commercializing pharmaceutical products for patients with significant unmet medical needs in niche indications. She is also a member of the board of directors of Kura Oncology, a biopharmaceutical company, the shares of which are traded on US Nasdaq, that is developing a pipeline of precision medicines for the treatment of solid tumors and blood cancers. Since October 2019 Ms. Parks has been a member of the board of directors for TriSalus Life Sciences, an early stage company focused on improving patient outcomes in pancreatic and other highly intractable solid tumors. Ms. Parks holds a BS from Kansas State University and a master’s of business administration in marketing from Georgia State University. She has been a commercial leader in the biotech and pharma industry for over 30 years. Ms. Parks was selected to serve as a member of our Board of Directors because of her over 30 years’ experience as a businesswoman and commercial executive with an extensive record of driving profitable growth for large pharmaceutical and biotech companies.

Robert J. Rubin, MD has been a director since October 2009. Dr. Rubin was a clinical professor of medicine at Georgetown University from 1995 until 2012 when he was appointed a Distinguished Professor of Medicine. From 1987 to 2001, he was President of the Lewin Group (purchased by Quintiles Transnational Corp. in 1996), an international health policy and management consulting firm. From 1994 to 1996, Dr. Rubin served as Medical Director of ValueRx, a pharmaceutical benefits company. From 1992 to 1996, Dr. Rubin served as President of Lewin-VHI, a health care consulting company. From 1987 to 1992, he served as President of Lewin-ICF, a health care consulting company. From 1984 to 1987, Dr. Rubin served as a principal of ICF, Inc., a health care consulting company. From 1981 to 1984, Dr. Rubin served as the Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services and as an Assistant Surgeon General in the U.S. Public Health Service. Dr. Rubin has served on the Board of BioTelemetry, Inc. (formerly known as CardioNet, Inc.) from 2007 to February 2021. He is currently on the Board of Cerium Pharmaceuticals where he is also the acting Chief Medical Officer since July 2022. He is a board certified nephrologist and internist. Dr. Rubin received an undergraduate degree in Political Science from Williams College and his medical degree from Cornell University Medical College. Dr. Rubin was selected to serve as a member of our Board of Directors because of his vast experience in the health care industry, including his experience as a nephrologist, internist, clinical professor of medicine and Assistant Surgeon General, and his business experience in the pharmaceutical industry.

Jerome B. Zeldis, MD, PhD has been a director since June 2011. In March 2023 Dr. Zeldis retired as Executive Vice President, Research and Development of Neximmune. He was the Chief Medical Officer and President of Clinical Research, Drug Safety and Regulatory of Sorrento Therapeutics, Inc. and Celularity, Inc. Previously, Dr. Zeldis was Chief Executive Officer of Celgene Global Health and Chief Medical Officer of Celgene Corporation, a publicly traded, fully integrated biopharmaceutical company. He was employed by Celgene ~~Corporation~~ from 1997 to 2016. From September 1994 to February 1997, Dr. Zeldis worked at Sandoz Research Institute and the Janssen Research Institute in both clinical research and medical development. He has been a board member of several biotechnology companies and is currently on the boards of Metastat, Inc

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