Decoy Therapeutics Inc. DCOY US Equity☆

10-K

Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

For the fiscal year ended December 31, 2025

OR

For the Transition Period from to

Commission File Number: 001-36812

Decoy Therapeutics Inc.

(Exact name of Registrant as Specified in Its Charter)

2450 Holcombe Blvd., Suite X, Houston, TX77021

(Address of principal executive offices)(Zip Code)

Registrant's Telephone Number, Including Area Code: (713) 913-5608

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

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, par value $ 0.0001 DCOY The Nasdaq Stock Market LLC

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

None.

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

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act.

Yes ☐ No ☒

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

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

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

Large Accelerated Filer ☐ Accelerated Filer ☐

Non-accelerated Filer ☒ Smaller Reporting Company ☒

Emerging Growth Company ☐

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

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐

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

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

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

As of June 30, 2025 (the last business day of the registrant's most recently completed second fiscal quarter, the aggregate market value of the common stock of the registrant held by non-affiliates of the registrant was $1,896,114 based on the last reported sale price of the registrant's common stock on the Nasdaq Capital Market on June 30, 2025.

As of March 17, 2026, there were 531,968 shares of common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Table of Contents

Portions of the proxy statement for the 2026 annual meeting of stockholders are incorporated by reference into Part III of the Annual Report to the extent described.

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DECOY THERAPEUTICS INC.

TABLE OF CONTENTS

Page

Special Note Regarding Forward Looking Statements 5

Summary of Selected Risks associated with our Business 7

PART I. 9

Item 1. Business 9

Item 1A. Risk Factors 47

Item 1B. Unresolved Staff Comments 73

Item 1C Cybersecurity 73

Item 2. Properties 74

Item 3. Legal Proceedings 74

Item 4. Mine Safety Disclosures 74

Item 6. Reserved 75

Item 7A. Quantitative and Qualitative Disclosure About Market Risk 82

Item 8. Financial Statements and Supplementary Data 83

Index to Financial Statements 83

Report of Independent Registered Public Accounting Firm 84

Consolidated Balance Sheets 86

Consolidated Statements of Operations 87

Consolidated Statements of Cash Flows 88

Consolidated Statement of Stockholders' Equity (Deficit) 89

Notes to Consolidated Financial Statements 90

Item 9A. Controls and Procedures 106

Item 9B. Other Information 106

Item 10. Directors, Executive Officers and Corporate Governance 107

Item 11. Executive Compensation 107

Item 14. Principal Accounting Fees and Services 107

Item 15. Exhibits, Financial Statement Schedules 108

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EXPLANATORY NOTE

On August 15, 2025, the Company filed a Certificate of Amendment to the Company’s restated certificate of incorporation, as amended, with the Secretary of State of the State of Delaware to effect a 1-for-15 reverse stock split of the Company’s issued and outstanding shares of common stock, par value $0.0001 per share which became effective on that date. All historical share and per share amounts reflected throughout this report have been adjusted to reflect the 2025 Reverse Stock Split (as defined below).

On March 5, 2026, the Company filed a Certificate of Amendment to the Company’s amended and restated certificate of incorporation, as amended, with the Secretary of State of the State of Delaware to effect a 1-for-12 reverse stock split of the Company's issued and outstanding shares of Common Stock, par value $0.0001 per share, which became effective as of March 6, 2026. All historical share and per share amounts reflected throughout this report have been adjusted to reflect the 2026 Reverse Stock Split (as defined below).

On March 13, 2026, the Company received a formal decision letter from the Nasdaq Hearings Panel granting the Company's request to continue its listing on The Nasdaq Stock Market. Previously, the Company had appealed a delisting determination issued by Nasdaq due to the Company's failure to maintain compliance with the Bid Price Rule set forth in Nasdaq Listing Rule 5550(a)(2). Pursuant to the Panel's decision, the continued listing of the Company's securities is subject to the condition that the Company must demonstrate compliance with the Bid Price Rule on or before March 20, 2026. In connection with its compliance plan, the Company completed a reverse stock split on March 6, 2026 and achieved a closing bid price of $7.47 on March 20, 2026 to regain compliance.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements made in this Annual Report on Form 10-K are forward-looking and involve risks and uncertainties. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements give our current expectations or forecasts of future events and are not statements of historical or current facts. These statements include, among others, statements about:

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our ability to continue as a going concern and support our operations;

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our expectations regarding the timing, likelihood, expected benefits of, and potential value created by, the recently completed merger transaction between us and Legacy Decoy;

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the plans, strategies and objectives of management for future operations, including the execution of integration plans and the anticipated timing of filings, commencement of preclinical studies or clinical trials of our current and future program candidates, including statements regarding the timing of our planned regulatory communications, submissions and approvals, and release of data from such studies or trials;

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our financial performance;

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our ability to maintain the listing of our shares of common stock on The Nasdaq Stock Market (“Nasdaq”), the potential liquidity and trading of such shares of common stock and our ability to maintain continued listing with the Nasdaq listing standards;

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our ability to successfully manage our cash and cash equivalents and any anticipated proceeds from financing transactions;

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our ability to acquire sufficient sources of funding if and when needed;

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our estimates and expectations as to expenses, ongoing losses, future revenue, cash flow, capital requirements and our need for or ability to obtain additional funding before we can expect to generate any revenue from product sales

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our belief regarding the sufficiency of our cash resources to support our operations;

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our liquidity position and the expected sufficiency of such position for anticipated operating and capital requirements;

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our plans to develop and commercialize potential product candidates, including planned preclinical, clinical, regulatory, commercialization and manufacturing activities;

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our expectations regarding the scope of any approved indication for any product candidate, if approved;

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the attraction and retention of highly qualified personnel;

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the ability to protect and enhance our products and intellectual property;

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developments and projections relating to our competitors or industry;

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our relationships and actions with third parties;

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future regulatory, judicial and legislative changes in our industry; and

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any other statements of expectations, plans, intentions or beliefs, and any statements of assumptions underlying any of the foregoing.

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

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

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the risk that the recently contemplated merger transaction with Legacy Decoy may not enhance stockholder value and may adversely affect our operating results, business or investor perceptions;

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our ability to raise additional funds when necessary, and/or on acceptable terms;

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the adequacy of our capital to support our future operations;

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our ability to obtain and maintain regulatory approvals for our potential product candidates;

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the potential impact of changes and disruptions at the FDA, including a reduction in the FDA’s workforce and/or decreased funding for the FDA, on our business;

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our ability to identify patients that can be treated by our potential product candidates and to enroll these patients in our clinical trials;

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our ability to successfully commercialize our potential product candidates, if approved.

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our ability to leverage technology to identify and develop future potential product candidates;

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fluctuations in our operating results; and

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other factors described in our filings with the SEC.

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

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

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SUMMARY OF SELECTED RISKS ASSOCIATED WITH OUR BUSINESS

Our business is subject to numerous risks and uncertainties, including those discussed at length in the section titled “Risk Factors.” These risks include, among others, the following:

Risks Related to our Business

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Our common stock may be subject to delisting from Nasdaq.

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Our financial condition raises substantial doubt regarding our ability to continue as a going concern.

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We have never generated revenue from product sales, and all of our potential product candidates are currently in the preclinical stage, and we may continue to incur significant losses for the foreseeable future and never generate revenue from product sales.

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Because we have yet to generate revenue from product sales on which to evaluate our potential for future success and to determine if we will be able to execute our business plan, it is difficult to evaluate our prospects and the likelihood of success or failure of our business.

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Because early-stage drug development requires major capital investment, as we continue to incur operating losses, we will need to raise additional capital or form strategic partnerships to support our research and development activities in the future.

Risks Related to the Discovery, Development and Commercialization of Potential Product Candidates

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If any strategic alliances on which we depend are unsuccessful or are terminated, we may be unable to develop or commercialize certain potential product candidates and we may be unable to generate revenues from our development programs.

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Since we expect to rely on third parties to conduct, supervise and monitor any future clinical trials, if those third parties fail to perform in a satisfactory manner and one that meets applicable regulatory, scientific and safety requirements, it may materially harm our business.

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Because the approach we are taking to discover and develop drugs is novel, including the use of artificial intelligence, it may never lead to marketable products, and we are subject to unique risks related to evolving AI regulations in the U.S. and internationally, third-party technology dependencies, intellectual property concerns, and cybersecurity threats associated with our use of AI technology.

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Even if FDA grants breakthrough therapy designation for one or more of our potential product candidates, the designation may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our potential product candidates will receive marketing approval, and FDA may rescind the designation if it determines the product candidate no longer meets the qualifying criteria for breakthrough therapy.

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If we do not succeed in our efforts to identify or discover additional potential product candidates, your investment may be lost.

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Our potential product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial viability of an approved label, or result in significant negative consequences following marketing approval, if any.

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Difficulty in enrolling patients is a common hurdle faced by early-stage biotechnology companies and could, and often does, delay or prevent clinical trials of potential product candidates.

Risks Related to Our Operations and Industry

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Our reliance on patents, trade secrets and confidentiality agreements may not adequately protect our intellectual property, and third parties may challenge the validity or enforceability of our patents or design around our claims.

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Our trade secrets and confidential proprietary information may be disclosed, and competitors may gain access to our trade secrets or independently develop substantially equivalent information and techniques.

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Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

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

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We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful.

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If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our potential product candidates, we may be unable to generate any revenues from product sales.

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If we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel, or experience increases in our compensation costs, our business may materially suffer.

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If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.

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We may face potential product liability, and if successful claims are brought against us, we may incur substantial liability and costs which could be greater than our insurance coverage or overall resources.

Risks Related to Ownership of our Common Stock

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The price of our common stock may fluctuate substantially.

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Future sales of a significant number of our shares of common stock in the public markets, or the perception that such sales could occur, could depress the market price of our shares of our common stock or cause our stock price to decline.

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We do not currently intend to pay dividends on our common stock, and any return to investors is expected to come, if at all, only from potential increases in the price of our common stock.

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If we were deemed to be an investment company under the Investment Company Act of 1940, as amended (the “1940 Act”), applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business, financial condition and results of operations.

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We are a “smaller reporting company” and are able to avail ourselves of reduced disclosure requirements applicable to smaller reporting companies, which could make our common stock less attractive to investors.

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Our certificate of incorporation, our bylaws, and Delaware law may have anti-takeover effects that could discourage, delay, or prevent a change in control, which may cause our stock price to decline.

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Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management is required to devote substantial time to compliance matters.

General Risk Factors

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If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline.

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If we fail to comply with the rules under the Sarbanes-Oxley Act related to accounting controls and procedures in the future, or, if we discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult.

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Changes in tax laws or exposure to additional income tax liabilities could have a material impact on our business, results of operations, financial condition and cash flows.

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Additional indirect taxes in various jurisdictions could materially adversely affect our business, financial condition, results of operations, and prospects.

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Part I

Item 1. Business

Unless the context otherwise requires, “Company,” “we,” “us,” and “our” refer to the combined organization, Decoy Therapeutics Inc. (“Decoy”, formerly known as Salarius Pharmaceuticals, Inc. (“Salarius”)), and, where appropriate, its consolidated subsidiaries. References to “Legacy Decoy” refer to Decoy Therapeutics Inc. prior to the Merger (as defined below), which became a wholly owned subsidiary of the Company as a result of the Merger. References to “Notes” refer to the Notes to Consolidated Financial Statements included herein (refer to Item 8).

Overview

We are a pre-clinical stage biotechnology company focused on advancing our pipeline of peptide conjugate therapeutics engineered through our proprietary IMP3ACTTM platform. Our IMP3ACTTM platform represents a paradigm shift in peptide conjugate drug discovery and manufacturing, leveraging machine learning ("ML") and artificial intelligence ("AI") tools alongside high-speed synthesis techniques to rapidly engineer, optimize and manufacture peptide conjugates that target serious unmet medical needs. Peptide conjugates are emerging as a major therapeutic drug modality, with the potential to transform multiple therapeutic areas. Utilizing our novel IMP3ACT platform that increases the drug development speed and reduce the complexity of variant synthesis, we aim to build a robust portfolio of novel peptide conjugate therapeutics, initially focusing on infectious diseases and oncology, with the goal of becoming a fully integrated biopharmaceutical company at the forefront of this field. Through this approach, we intend to revolutionize the design, development, and commercialization of peptide conjugate therapeutics. We have no products approved for commercial sales and have not generated any revenue from product sales.

Prior to January 8, 2026, we were known as Salarius Pharmaceuticals, Inc. (“Salarius”). In November 2025, Salarius completed a Merger (as defined below) with Legacy Decoy and conducted financings to raise capital for its business (together, along with future steps set forth elsewhere in this 10-K annual report, the “Decoy Transaction”). We refer herein to the post-transaction entity as the “Combined Company.” In connection with the Decoy Transaction, on January 8, 2026, Salarius filed an amendment to its amended and restated certificate of incorporation to change its name to Decoy Therapeutics Inc. (the “Name Change”). Prior to the Name Change, the Combined Company’s shares of common stock traded on the Nasdaq Capital Market (“Nasdaq”) under the symbol “SLRX.” Following the Name Change, the Combined Company’s shares of common stock now trade on the Nasdaq under the symbol “DCOY.”

The Merger (as defined below) combines our complementary approaches to create a comprehensive drug development platform. The Decoy IMP3ACT platform is generating a pipeline of Designable Multi-Antivirals ("D-MAV") candidates across respiratory viruses, designed to be extended, not rebuilt, when the next threat emerges. Additionally,two small molecule drugs that address gene dysregulation: (1) SP-3164, a targeted protein degrader, and (2) seclidemstat (“SP-2577”), a targeted protein inhibitor are legacy Salarius clinical candidates. We supported The University of Texas MD Anderson Cancer Center (“MDACC”) in MDACC’s sponsored clinical trial evaluating SP-2577 in combination with azacytidine in adult patients with myelodysplastic syndromes and chronic myelomonocytic leukemia through December, 2025. No further enrollment is planned. We intend to seek strategic alternatives for this program including potential out-licensing.

We plan to integrate SP-3164 to expand our opportunities in creating a novel class of peptide conjugates called peptide-based proteolysis targeting chimeras (“P-PROTACs”). We believe the synergies from the Merger are evident in our combined approach to drug development, integrating expertise in peptide conjugates with our small molecule assets. This combination enables us to address a wider range of diseases and potentially “undruggable” targets.

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Recent Developments

Nasdaq Listing

On December 31, 2025, the Company received written notice from Nasdaq that it was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the closing bid price of the Company’s common stock for the last 30 consecutive business days was below the $1.00 per share minimum bid price requirement (the “Minimum Bid Price Requirement”). The Company appealed the delisting determination by requesting a hearing before a Nasdaq Hearings Panel (the “Hearings Panel”). The company presented its appeal to the Hearings Panel in early February 2026 and submitted a plan to regain compliance by March 20, 2026, including conducting a reverse stock split.

On March 13, 2026, the Company received a written notice from the Hearings Panel notifying the Company that it has been granted until March 20, 2026 to regain compliance with the Minimum Bid Price Requirement. Pursuant to the Hearings Panel's decision, the continued listing of the Company's securities is subject to the condition that the Company must demonstrate compliance with the Minimum Bid Price Requirement on or before March 20, 2026. In connection with its compliance plan, the Company completed the 2026 Reverse Stock Split (as defined below) on March 6, 2026, and subsequently achieved a closing bid price of $7.47 on March 20, 2026, thereby demonstrating compliance with the Minimum Bid Price Requirement.

Closing of Decoy Merger

On January 10, 2025, the Company entered into an Agreement and Plan of Merger, as amended by the First Amendment on March 28, 2025, by the Second Amendment on June 10, 2025, by the Third Amendment on July 18, 2025, by the Fourth Amendment on July 29, 2025, and by the Fifth Amendment dated September 17, 2025 (as amended, collectively, the “Merger Agreement”) with Decoy Therapeutics MergerSub I, Inc. (“MergerSub I”), Decoy Therapeutics MergerSub II, LLC (“MergerSub II”), and Legacy Decoy. On November 12, 2025, pursuant to the Merger Agreement, MergerSub I merged with and into Legacy Decoy, and immediately thereafter Legacy Decoy merged with and into MergerSub II (the “Merger”), resulting in the Legacy Decoy business becoming a wholly owned subsidiary of the Company.

In connection with the Merger, the Company issued 877.709 shares of the Series A Preferred Stock and 796.306 shares of the Series B Preferred Stock to former Legacy Decoy stockholders and debtholders and reserved 45.098 shares of Series A Preferred Stock for assumed in-the-money options and warrants of Legacy Decoy. In connection with the adjustment to the conversion ratio in the certificate of designations for the Series A and Series B Preferred Stock triggered by the offering, the number of Company common shares underlying the issued and reserved shares of Series A and Series B Preferred Stock is 401,126. The shares of Series A Preferred Stock and Series B Preferred Stock are not convertible into common stock until such time as the Company’s stockholders approve such conversion in accordance with Nasdaq Rule 5635 and the approval of the Company’s initial listing application with Nasdaq. When converted, the conversion ratio pursuant to which the new common shares will be issued has been adjusted pursuant to the 2026 Reverse Stock Split (as defined below) ratio of 1-for-12.

Management and Director Changes

In connection with the Merger closing on November 12, 2025, Mr. Frederick E. Pierce was appointed Chief Executive Officer and Director; Dr. Barbara Hibner was appointed Chief Scientific Officer; and Mr. Peter Marschel was appointed Chief Business Officer. Mr. Mark Rosenblum will continue to serve as Executive Vice President and Chief Financial Officer (including as principal financial officer and principal accounting officer).

November 2025 Financing

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On November 11, 2025, we entered into an underwriting agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co. Inc., as the sole underwriter (the “Representative”), relating to the issuance and sale in a public offering (the “November 2025 Offering”) of: (i) 209,528 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”), (ii) pre-funded warrants to purchase up to 179,361 shares of Common Stock, (iii) Series A warrants to purchase up to 388,889 shares of Common Stock, (iv) Series B warrants to purchase up to 388,889 shares of Common Stock, and (v) up to 699,999 additional shares of Common Stock, Series A warrants to purchase up to an additional 699,999 shares of Common Stock and Series B warrants to purchase up to an additional 699,999 shares of Common Stock that may be purchased pursuant to a 45-day option to purchase additional securities granted to the Representative by the Company. The Representative exercised this option on November 11, 2025 for 55,477 shares of Common Stock, Series A warrants to purchase up to 58,333 shares of Common Stock and Series B warrants to purchase up to 58,333 shares of Common Stock. The combined public offering price of each share of Common Stock, together with the accompanying Series A warrants and Series B warrants, was $18, less underwriting discounts and commissions. The combined public offering price of each pre-funded warrant, together with the accompanying Series A warrants and Series B warrants, was $17.9988, less underwriting discounts and commissions. Subject to limited exceptions, a warrant holder may not exercise any portion of its warrants to the extent that the holder would beneficially own more than 4.99% (or, at the election of the holder prior to the date of issuance, 9.99%) of the Company’s outstanding Common Stock after exercise.

The November 2025 Offering, including the additional shares of Common Stock, Series A warrants and Series B warrants sold pursuant to the exercise of the Representative’s option, closed on November 12, 2025.

The net proceeds from the Offering, including the additional shares of Common Stock, Series A warrants and Series B warrants sold pursuant to the exercise of the Representative’s option, after deducting underwriting discounts and commissions and other estimated Offering expenses payable by the Company and excluding any net proceeds from the exercise of the Series A warrants, Series B warrants and pre-funded warrants, were approximately $6.3 million.

In connection with the November 2025 Offering, the Company and Equiniti Trust Company, LLC entered into a Warrant Agency Agreement pursuant to which Equiniti agreed to act as warrant agent with respect to the Series A warrants, the Series B warrants and the pre-funded warrants.

On November 12, 2025, pursuant to the Underwriting Agreement, the Company issued warrants to the Representative to purchase up to 22,218 shares of Common Stock at an exercise price of $27.90, subject to adjustments (the “Representative Warrants”). The Representative Warrants are exercisable at any time and from time to time, in whole or in part, until November 11, 2030, and have substantially similar terms to the Series A warrants.

All securities issued in the November 2025 Offering (including the shares of Common Stock issuable from time to time upon exercise of the warrants and the Representative Warrants) were offered pursuant to a registration statement on Form S-1, as amended, which became effective on November 10, 2025.

Reverse Stock Splits

On August 15, 2025, the Company filed a Certificate of Amendment to the Company’s restated certificate of incorporation, as amended, with the Secretary of State of the State of Delaware to effect a 1-for-15 reverse stock split of the Company’s issued and outstanding shares of common stock, par value $0.0001 per share (the “2025 Reverse Stock Split”) which became effective on that date. All historical share and per share amounts reflected throughout this report have been adjusted to reflect the 2025 Reverse Stock Split.

On March 5, 2026, the Company filed a Certificate of Amendment to the Company’s amended and restated certificate of incorporation, as amended, with the Secretary of State of the State of Delaware to effect a 1-for-12 reverse stock split of the Company's issued and outstanding shares of Common Stock, par value $0.0001 per share (the “2026

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Reverse Stock Split”) which became effective as of March 6, 2026. All historical share and per share amounts reflected throughout this report have been adjusted to reflect the 2026 Reverse Stock Split.

Strategy

Decoy focuses on viral diseases that drive widespread health, economic and societal disruption, shaping programs not only around scientific potential, but around affordability, reimbursement, and the ability to reach patients at scale.

Our IMP3ACT platform creates peptides that target what enveloped viruses share, integrating AI-enabled peptide design with rapid synthesis to advance candidates faster than traditional approaches. What that means in practice:

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AI-accelerated design that learns and improves with each candidate

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Research synthesis timelines measured in days, not months

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A proprietary data advantage that compounds across programs

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Built-in adaptability to novel and emerging viral threats

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Faster time to market, and potential for follow-on indications

We select D-MAV targets based on the following criteria:

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Potential for a therapeutic that can address multiple disease indications with one drug.

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The presence of a natural “starting peptide” that our platform can rapidly optimize into a promising therapeutic.

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Potential to create a peptide conjugate therapeutic with a novel and differentiated value proposition that meets a significant unmet medical need.

We believe this target selection strategy will maximize return on investment from the IMP3ACT platform by efficiently advancing paradigm-creating D-MAVs, changing the way we protect against and treat viral diseases.

Our goal is to become a fully integrated biopharmaceutical company with a pipeline of novel therapeutics. We intend to achieve this through the following strategic objectives:

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Achieve clinical proof-of-concept by bringing our lead pan-Coronavirus antiviral forward through a Phase 2 human challenge trial. Despite COVID-19 moving to an endemic phase, significant global unmet medical need remains among immune-suppressed populations. To date, this program has been largely supported by non-dilutive funds, and we believe the program will continue to attract such funds to advance this program clinically.

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Bring forward one additional transformative program to IND-enabling status within two years, leveraging our platform's speed and efficiency to advance potentially transformative peptide conjugate therapeutics meeting our target selection criteria.

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Build a platform manufacturing capability: We intend to pursue collaborations with major commercial peptide manufacturing organizations, allowing rapid scale-up of novel D-MAV drug candidates for pre-clinical and clinical studies in a repeatable, cost-effective manner.

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Continue to access non-dilutive funding. To date, we have attracted significant non-dilutive funding from The Gates Foundation, BARDA, Google, and the IMI-Care Consortium, and expect to continue to seek such funds.

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Pursue value-enhancing partnerships. We believe we can rapidly create and validate novel therapeutic assets, and aim to attract capital and capabilities in later-stage development and commercialization through selective partnerships.

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Maintain Pandemic Readiness: preserve the pandemic “Call-Option” embedded with the IMP3ACT Platform. Our platform is well-positioned to rapidly advance antiviral therapeutics in response to novel viral pathogens, especially in viral families considered most likely sources of such pathogens (e.g., avian influenza). We will continue to work with governmental and non-governmental organizations to provide funding for developing D-MAVs against global threats. Given financial returns from therapeutic assets like mRNA vaccines and Paxlovid during COVID-19, we consider this capability a valuable ‘Call Option’ on the next epidemic or pandemic.

Program Development

We intend to leverage the proprietary compound SP-3164, which binds to the E3 ligase complex CRLCBRN, together with our peptide engineering platform to create ‘peptide-based Proteolysis Targeting Chimeras’ (“PROTACs”, “P-PROTACS”).

PROTACs are typically bifunctional molecules: one side binds to a targeted protein while the other binds to an E3 ligase, with a linker between the two. When both are brought together, the targeted protein is ubiquitinated (“tagged”) by the E3 ligase and marked for destruction via proteasomal degradation. SP-3164, a novel immunomodulatory drug molecule, has advantageous properties including potent cereblon binding, low molecular weight, high oral bioavailability, and well-characterized binding mechanisms. Using IMP3ACT platform-engineered peptides instead of small molecules to target disease-causing proteins offers several advantages: peptides can be precisely engineered to bind specifically to one protein or a pre-determined set (e.g., across mutated Ras proteins), whereas small molecules typically bind to many “off-target” proteins, decreasing selectivity and increasing toxicity. Peptides can bind to the active enzymatic site or be engineered to bind to other sites under lower selective mutational pressure, reducing resistance mechanisms. We believe using peptides instead of small molecules vastly expands protein targeting opportunities and dramatically shortens P-PROTAC candidate development timelines.

The PROTAC mechanism is “event-driven”-one PROTAC molecule can induce degradation of multiple copies of the protein target. Even small concentrations can be highly effective, potentially avoiding toxicity from high drug concentrations. By degrading rather than inhibiting the protein target, both enzymatic and other functions are disrupted, with effects lasting until the cell synthesizes new proteins-dramatically expanding duration of action. P-PROTACs are an exploratory arm of the IMP3ACT platform, applying D-MAV design principles to intracellular viral and host protein targets, including those considered undruggable. Early investigative programs are underway, deepening the D-MAV antiviral thesis into a new modality.

Drug Development Programs

We are developing D-MAVs (designable multi-antivirals) targeting the conserved fusion mechanism shared across enveloped virus families. We have demonstrated multi-virus in vitro and in vivo activity. The same platform and design tools will support early investigative antiviral P-PROTAC candidates.

•

COV: Pan-Coronavirus Prophylactic for Immunocompromised Patients. Our lead program, a nasally inhaled pan-Coronavirus prophylactic, has demonstrated in vitro activity against all human-infecting Coronaviruses tested, including representatives of all variant strains of concern of COVID-19 that have emerged as of the date of this report. This program has primarily been funded by grants from The Gates

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Foundation, the Center for the Biologic Advanced Research and Development Authority’s Blue Knight Program (“BARDA”), and support from the IMI Care Consortium, Google, and NVIDIA computing programs. The Company plans to file an Investigational New Drug ( “IND”) application with the United States Food and Drug Administration ( “FDA”) or the European equivalent clinical trial application (“CTA”) during the first half of 2027 and to continue to pursue non-dilutive funding and a development partner for clinical development.

•

TRI: Broad Respiratory Antiviral (Flu/COVID-19/RSV). We aim to exploit structural similarities across these three viral families to create a peptide conjugate antiviral broadly applicable to most influenza-like-illnesses (“ILI”), which drive an estimated 15 to 20 million medical visits annually in the United States alone. Building on our work creating peptide conjugate antivirals with broad activity in the Coronavirus and Paramyxovirus (RSV) viral families, we believe this program could represent a fundamental shift in respiratory virus treatment.

Our Exploratory Stage Program

P-TAC: Exploratory P-PROTAC Conjugates: We aim to explore the use of SP-3164 as the E3 ligase binding component in peptide based PROTACs, using engineered peptides to target intracellular proteins involved in viral replication and latent virus activation.

Legacy Small Molecule Program

SP-2577: SP-2577 is a legacy small molecule LSD-1 inhibitor program from pre-Merger Salarius’ portfolio. As a legacy product, it does not utilize Legacy Decoy’s integrated technology. We intend to continue monitoring The University of Texas MD Anderson Cancer Center (“MDACC”) in its sponsored investigator-initiated clinical trial evaluating seclidemstat (SP-2577) in combination with azacytidine in adult patients with myelodysplastic syndromes and chronic myelomonocytic leukemia. In July 2024, the FDA placed the trial on partial clinical hold following a serious grade 4 adverse event. In February 2025, we announced that MDACC had addressed the FDA’s questions and the partial clinical hold was lifted, with patient enrollment resumed. Enrollment for this clinical trial ended in January of 2026; we intend to seek strategic alternatives for this program including potential out-licensing.

Grant Agreements

The grant agreement between Legacy Decoy and The Gates Foundation (the “Gates Grant Agreement”) was entered into on September 9, 2021 and subsequently amended on August 29, 2023 and February 26, 2025, entitling us to approximately $5 million in the aggregate. We have received approximately $4.4 million in multiple tranches as we reached specific research milestones, and expect to receive the final tranche of approximately $600,000 in the first half of 2026. The use of grant funds is governed by a budget approved in conjunction with The Gates Foundation, and material deviations (i.e., 10%) require their approval. The expiration date is December 31, 2026. The Gates Foundation may modify, suspend, discontinue, or terminate the Gates Grant Agreement if: (a) not reasonably satisfied with our progress; (b) significant changes to leadership or other factors threaten the project’s success; (c) a change in control occurs; (d) a change in our tax status; or (e) we fail to comply with the agreement. Any unused funds must be returned promptly upon expiration or termination.

We have received multiple awards from the BLUE KNIGHTTM Resident QuickFire Challenge (the “QFC”) and entered into letter agreements with Johnson & Johnson Innovation LLC (“JJI”) on January 31, 2023, July 28, 2023, and March 11, 2024 to investigate various ancillary program elements. We have supplied final reports for all three grants in accordance with the letter agreements.

Market Opportunity for Our Current Drug Development Programs

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We see opportunities in each of the four main areas of our drug discovery program efforts:

COV: Pan-Coronavirus Inhibitor for Immunocompromised Patients

According to the December 2024 World Health Organization publication on COVID-19, SARS-CoV-2 continues to infect and cause severe acute disease and post COVID-19 condition (long COVID).[1]Current tools include mRNA vaccines and Paxlovid, which are effective at avoiding severe outcomes in high-risk patients. However, Paxlovid cannot be used prophylactically and has a significant Drug-Drug Interaction[2](“DDI”) profile, leaving a treatment gap for immune-suppressed patients or those with high-risk comorbidities who do not respond significantly to vaccines. Early pandemic antibody prophylactics like Evusheld became obsolete due to rapid SARS-CoV-2 evolution. The recently authorized prophylactic antibody Pemgarda is at risk of losing efficacy as the virus continues to mutate-the most recent variants have approximately 150 mutations compared to the original viral sample.

We commissioned market research in 2022[3] that indicated important unmet medical needs in COVID-19 treatment and prevention:

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Prophylaxis for current and future variants in high-risk patients: Health care providers (“HCPs”) are concerned about preventing severe cases in at-risk patients, particularly critical if new variants arise.

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Easy-to-use route of administration: Key opinion leaders noted the need for non-injectable preventative products to enable broad availability and avoid high-risk patients visiting healthcare facilities for administration.

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Effective treatments with better Drug-Drug Interaction ("DDI") profile: DDIs, such as those with Paxlovid, are a concern for HCPs, especially given that high-risk patients tend to have comorbidities and are likely on other treatments.

This market research, which included HCP and payer studies across the United States and European Union, indicated that 20 million or more patients in the U.S. and Europe are at ‘highest risk’ from COVID-19 and other respiratory viral infections, with favorable reimbursement outlook for therapeutics filling treatment gaps.

Our lead program is a broad-acting antiviral nasal spray to prevent or mitigate COVID-19 infections in high-risk, immunocompromised populations with limited treatment options. This agent has shown in vitro activity against all human-infecting Coronaviruses, including all COVID-19 variants to date, would be conveniently self-administered, and is expected to provide 8-24 hours of antiviral activity with low cost of goods.

We expect multiple potential attractive development and commercialization options for an inhaled pan-Coronavirus fusion inhibitor, including:

•

Pre- and post-exposure prophylaxis (“PrEP”/”PEP”) for highly immunocompromised populations facing elevated risks from severe immune deficiencies associated with hematological malignancies and immunosuppressive medical treatments in hematopoietic stem cell transplantation and solid organ transplants, with potential for label expansion. Market research suggests over 5 million such patients in the U.S. and EU, with an estimated net price of up to $500 per 30-day supply in the U.S. feasible.

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Post-infection treatment as an alternative to Paxlovid with a superior DDI profile. Morningstar projects full year 2024 revenues exceeding $5 billion[1] for Paxlovid, despite notable DDIs with widely prescribed drugs such as statins (over 90 million Americans) and calcium channel blockers (more than 20 million Americans). Many high-risk patients cannot take Paxlovid due to DDI concerns. Paxlovid’s U.S. list price is $1,390 for a 5-day course[2] as of October 18, 2023.

We also believe there may be additional opportunities for a pan-Coronavirus fusion inhibitor to generate revenue from public health authority stockpiling of drug for pandemic preparedness and military readiness purposes.

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Our plan is to initially develop this agent as a pre- and post-exposure prophylactic for targeted immunocompromised subsets, such as patients with hematological malignancies and post-transplant patients, who have high unmet medical need and can be accessed in the U.S. by a small, specialized sales force focusing on cancer treatment and transplant centers. We then plan to expand to additional indications.

We recognize the rapid evolution of the COVID landscape and will continue to engage key opinion leaders, health care providers, payers, and patient market research and potentially adjust our plans based on those findings.

[1] https://www.who.int/publications/m/item/covid-19-epidemiological-update---24-december-2024

[2] https://paxlovid.pfizerpro.com/drug-interactions

[3] Primary market research performed by Bionest Partners in Oct/Nov 2022: 13 HCPs, 13 Payers in the US, DE, FR, IT, and the U.K.

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TRI: Broad Respiratory Antiviral (Flu/COVID/RSV)

We are engineering a groundbreaking approach to combat Flu/COVID/RSV infections with a single D-MAV antiviral potentially effective against all three major respiratory viruses, including pandemic flu strains if possible.

By addressing three viral families with a single therapy, we aim to revolutionize respiratory illness management. Respiratory tract infections represent a significant unmet medical need. The seasonal convergence of influenza, respiratory syncytial virus (“RSV”), and COVID-19 (the “tripledemic”) has intensified the burden of these infections, which are often vectors to dangerous lower respiratory infections. Despite vaccine availability, with decreasing uptake, hospitalizations and fatalities from respiratory viruses continue to strain healthcare resources.

Our single therapy with broad activity approach potentially offers several key advantages:

•

A single therapy with proven efficacy against all three viruses could potentially eliminate the need for multiple treatments, streamlining patient care and reducing complexity for healthcare providers.

•

Our therapy is expected to be self-administered, offering convenience and autonomy to patients.

•

Peptide conjugates to date have a favorable safety and tolerability profile.

Given the expected ease of use and safety profile, we intend to pursue a commercialization approach that will make this product, if approved, broadly accessible to symptomatic patients, leveraging emerging channels such as telehealth, digital patient engagement, and at-home delivery.

In the United States, the combined impact of influenza, RSV, and COVID-19 results in an estimated 15 to 20 million medical visits annually among patients aged 18 and older. This significant healthcare utilization underscores the burden of respiratory tract infections on the healthcare system.

Expanding the market to include individuals with symptomatic illness who may not physically visit a doctor's office approximately doubles the number of eligible adult patients. With the increasing adoption of telehealth services and the advancement of wearables signaling very early respiratory infections, there is a tangible opportunity to expand the market for respiratory tract infection treatments beyond patients who traditionally seek in-person medical care.

Given these factors, we believe our ‘tripledemic’ D-MAV antiviral program could represent the cornerstone of a significant global franchise.

Our IMP3ACT Platform

Overview of Peptides and Peptide Conjugate Therapeutics

A key advantage of D-MAVs engineered by our IMP3ACT Platform is ‘polypharmacology,' in which a single molecule can activate or inhibit multiple targets/receptors in an additive or synergistic manner to achieve superior or multi-indication efficacy.

The success of multi-targeting peptide conjugates is due to careful peptide design based on structural similarity between viruses, an advantage difficult to match with other modalities, and in contrast to the often unpredictable off-target effects of small molecules.

An FDA-approved polypharmacology example is Eli Lilly’s blockbuster ZepBoundTM, a single peptide conjugate demonstrating agonism of both GLP-1R and gastric inhibitory peptide receptor. Another example is our lead program, a D-MAV demonstrating activity against multiple human infecting coronaviruses.

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Peptides are short chains of amino acids linked by peptide (amide) bonds, typically less than 50 amino acids long, playing vital roles in biological processes.[4] Secondary interactions cause peptides to fold into complex 3-dimensional structures, including the common α-helical coil. α-helical peptides and proteins are ubiquitous in biology, and α-helices often interact chemically with other α-helices driving protein-protein and protein-nucleic acid interactions, making α-helical peptides effective therapeutic bases.

Peptides have important advantages compared to small molecules and antibody-based therapeutics[5]:

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High potency and specificity: Peptides bind a larger surface area of the target than small molecules, providing high selectivity with tight binding.

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Excellent safety profile with predictable metabolism: Small molecules easily diffuse across cell membranes and often have off-target toxicities. Peptides typically do not passively diffuse and are usually metabolized into non-toxic compounds.

•

High tissue penetration vs. antibodies: Antibody-based therapeutics are very large (~30x the size of peptides) and have difficulty diffusing deep into tissues from blood vessels.

•

Simpler manufacturing, lower cost of goods: Peptides are manufactured using synthetic chemistry, whereas antibody-based therapeutics require complex, intensively regulated biological processes.

Small peptides as drugs, however, have an intrinsic limitation; they are subject to rapid enzymatic digestion and clearance from the GI tract or in the bloodstream, limiting their half-life and oral bioavailability.

Peptide conjugates solve this problem by chemically linking a peptide, typically via a polyethylene glycol (PEG) structure, to additional molecules (e.g., another peptide, nucleic acid, or fatty acid), enhancing drug-like properties by improving enzymatic stability, half-life, and bioavailability while maintaining low immunogenicity.

The IMP3ACT Platform

The Immediate Peptide/PPMO/P-PROTAC Alpha-helical Conjugate Technology (“IMP3ACT”) platform leverages peptide ‘coiled-coils’ chemistry and physics to design α-helical peptides through computational and ML tools. Starting from naturally existing peptide ligands, we optimize their structure and transform them into multimeric conjugates by chemically linking peptides to lipids and other anchor moieties, enhancing drug-like properties with extended pharmacokinetics. Our technology has produced single peptide conjugates active against multiple human coronaviruses, including all SARS-CoV-2 major variants to date, and a second conjugate active against RSV A, RSV B, and hPIV3. By integrating ML algorithms to assist in peptide design and synthesis, our platform accelerates creation of lead molecules for preclinical evaluations, simultaneously optimizing for enhanced affinity, binding specificity, protease resistance, pharmacokinetic properties, and manufacturability.

Our IMP3ACT platform may achieve peptide conjugate manufacturing readiness faster than conventional processes, reducing costs and accelerating delivery of broad-spectrum drug candidates to IND. The modular nature means each new drug candidate improves the overall platform, and success likelihood should grow as the ML/AI models learn. By employing solid phase peptide synthesis in an “All-in-One” manufacturing approach, we optimize assembly of complex peptide-linker-functionalized compounds, enhancing platform speed, efficiency, and predictive value.

The Design-Build-Test-Learn Engine

We have integrated advancements in data science, peptide conjugate chemistry, and manufacturing processes to create our IMP3ACT platform. The core is the Design-Build-Test-Learn Cycle: “Design” utilizes AI in silico approaches to analyze protein and genomics datasets and make structure-function predictions; “Build” implements fast-flow synthesizers generating peptide candidates faster than industry standard; “Test” incorporates experimental testing via reliable assays to characterize peptide-candidates; and "Learn" capitalizes on experimental data to redesign improved in silico candidates.

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This integrated, multiparameter approach streamlines drug discovery, making it faster and more efficient with greater attention to drug-like and commercialization properties. Continuing to iterate on our Design-Build-Test-Learn loop will generate valuable proprietary data driving in silico models to generate design solutions otherwise unavailable from computational approaches. Our hypothesis is that the key to ML/AI-driven drug design value-creation is well-structured, useful, proprietary data and knowledge on which tools to use-not the computational models themselves. Our platform strategy will help us become leaders in designing and developing α-helical D-MAV peptide-conjugate therapeutics.

Starting from Existing Peptide Ligands

A key platform strategy element is starting from naturally existing peptides, leveraging ‘nature’s starting points’ to improve program timelines and reduce risk. We can rapidly synthesize a D-MAV incorporating a naturally existing peptide sequence that is immediately active against the target in question. We believe this is an excellent starting point for the Design-Build-Test-Learn loop because it significantly decreases the size of the peptide conjugate design space, making it computationally tractable to rapidly optimize for drug-like properties.

Our in silico engine uses ML, AI, and physics-based computational tools to identify helical motifs within metagenomics data shared across targets. This enables rapid design of polypharmacologic peptide conjugates where one drug can interact with multiple targets, unlocking broad activity across several indications from a single conjugate. These ML-driven α-helical drug candidates can inhibit a wide range of viruses by targeting shared viral fusion machinery, critical for enveloped virus entry and replication. We will leverage the virally trained α-helical database to explore targeting intracellular viral targets with innovatively designed P-PROTACs incorporating the Salarius molecular degrader, SP-3164.

Multiparameter Optimization of Drug Properties

The IMP3ACT Platform acts as an iterative feedback loop and incorporates data from multiple in vitro experiments to improve candidate peptide design parameters. The platform is designed to optimize against multiple parameters simultaneously. Traditional drug development relied on ‘one step at a time’ optimization, often leading to restricted chemical design space where important downstream attributes like pharmacokinetic behavior cannot be easily enhanced. By using all experimental data relevant to making a drug to train the ML engine, more drug-like peptide conjugates with optimized functionality and commercialization potential may be designed. This multiparameter optimization reduces costs and significantly decreases probability of pre-clinical or clinical failures by avoiding ‘dead end’ development paths.

Rapid synthesis

We use fast-flow automated process coupled with a proprietary “All-in-One” method (patent pending) to synthesize multiple peptide-conjugates on lab-based machines. The yield (5-100 mg depending on desired scale) and purity is sufficient for multiple in vitro tests including physicochemical properties and biological function. This innovation dramatically decreases cycle time to learn structure-activity relationships for different peptide designs and enables construction of a multiparameter structure-activity-drug-like proprietary database on α-helical peptides.

Compared to standard industrial solid phase synthesis, fast-flow synthesis leverages a heated reactor to accelerate speed, allowing amide bond formation creation in just 7 seconds per amino acid, compared to around 1 hour per cycle traditionally. Fast-flow synthesis can be automated to eliminate human intervention and errors and work in high throughput fashion. Mijalis et al demonstrated fast-flow machines can generate peptides 45 times faster than standard batch synthesis (40 minutes versus 30 hours[6]) with better crude peptide output and yields. This automated approach enables rapid peptide conjugate production while maintaining high quality, shortening overall time to optimize clinical drug candidates.

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We have invented a multi-arm linker compatible with solid phase peptide synthesis methods that can build complex biomacromolecules containing branched peptides and other functionalities in one synthetic run. These molecules can be differentially functionalized while attached to solid phase resin; our proprietary “All-In-One” manufacturing. When the desired molecule is built, the intact, desired compound can be cleaved from the resin, purified, and isolated for formulation and administration.

Using fast-flow synthesis with this process, the research scale synthesis of a peptide conjugate is reduced from several months (typical at a standard CDMO) to days or hours. Our IMP3ACT platform is a unique lead optimization engine that can rapidly design from natural peptide ligands and identify optimized drug-like lead molecules. Additionally, we are currently evaluating the use of our “All-In-One” process at commercial scale for further time savings in the transition from preclinical to GLP and cGMP scale-up.

Testing

We focus on using in silico and empirical assays with predictive value. In the design engine, in silico tools have been validated against actual data (e.g., binding affinity, solubility, protease resistance, manufacturability) to ensure reliability. The screening cascade for each program relies on predictive assays to streamline decision making. Where possible, human organoid and epithelial tissue models are incorporated to improve predictive power, as rodent models have moderate predictive value and translation to human tissues is difficult, especially for intranasal or inhaled programs. Organoid models are also significantly less expensive and easier to scale than animal models.

The human airway epithelial (“HAE”) model is a cell culture system grown at an air-liquid interface (“ALI”). This in vitro culture system mimics human airway epithelium more closely than traditional submerged cell cultures. In the ALI setup, the basal surface of human airway cells contacts a liquid culture medium while the apical surface is exposed to air, promoting differentiation into a mucociliary phenotype characteristic of human respiratory tract pseudostratified epithelium. The ALI culture system is used for studying respiratory epithelium cell biology, modeling respiratory diseases, and studying drug effects.

SARS-CoV-2 HAE-ALI experiments demonstrate this model recapitulates human data: infection kinetics peak between days 4 and 8 in HAE-ALI culture, consistent with human SARS-CoV-2 viral kinetics in the nasal epithelium.[7]Multiple coronaviruses have been tested, with growth kinetics and cellular effects correlating to human experience across seasonal versus pandemic viruses. Both influenza and RSV have been modeled in HAE for testing infectivity and therapeutic efficacy.

Additional preclinical work will include quantitative pharmacology and model-based approaches in conjunction with toxicology information in both human model systems and animal studies to project human starting doses for Phase 1 studies.

Scale-Up Manufacturing

We are working internally and with multiple Contract Manufacturing Organizations (“CMOs”) to develop and scale-up proprietary GMP-compatible manufacturing processes. The efficiency of our IMP3ACT platform enables D-MAV manufacturing readiness faster than conventional processes, reducing costs and accelerating delivery of broad-spectrum drug candidates.

By employing solid phase peptide synthesis in an “All-in-One” manufacturing approach, we optimize assembly of complex peptide-linker-functionalized compounds. We are working with a major peptide manufacturer to scale the process to quantities useful for preclinical development through early-stage clinical trials; we anticipate new intellectual property from this collaboration. Our goal is preclinical manufacturing readiness within significantly shorter timelines than traditional processes, aiming to meet or exceed the 100-day goal for vaccine manufacturing-moving from initial natural peptide ligand to drug lead in a single quarter.

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Formulation Flexibility

Traditionally peptides as drugs have suffered from very low bioavailability, limiting delivery to intravenous or subcutaneous routes. We are exploring multiple self-administered routes including:

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Intranasal, including nose-to-brain delivery;

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Inhaled/pulmonary delivery (local and systemic applications);

•

Subcutaneous patches for extended systemic release; and

•

Oral.

We are engineering D-MAVS to possess physicochemical and pharmaceutical properties enabling each delivery route, including solubility, chemical stability, protease resistance, and excipient compatibility. Results indicate our peptide conjugates can be formulated into both liquid and dry powder dosage forms that are room temperature stable and suitable for various delivery devices.

Competitive Strengths of the IMP3ACT Platform

We believe the IMP3ACT platform has several key advantages compared to other drug-discovery approaches:

•

Proprietary Data: Continuing to run our Design-Build-Test-Learn loop results in an expanding proprietary data set giving the IMP3ACT platform a differentiated, difficult-to-duplicate capability to design novel therapeutic candidates against α-helical targets in viruses.

•

Faster & Lower Cost Discovery: Our ML/AI engine applies computational tools to model structures, energy costs, binding affinities and specificity, protease resistance, and manufacturability to design lead-quality molecules in a fraction of the time, making significantly fewer candidate molecules than required in traditional drug discovery methods.

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Streamlined & Repeatable Manufacturing: We are working to scale-up the “All-in-one” manufacturing process to repeatably utilize the same CMC processes for each new drug candidate. We have applied for the FDA Emerging Technology program based on the Food and Drug Omnibus Reform Act of 2022. Our goal is to manufacture 30g of active pharmaceutical ingredient (“API”) of a new therapeutic candidate-typically enough through preclinical activities-in 30 days.

•

Low Commercial Cost of Goods: Our manufacturing process is fully chemically synthetic and runs on standard peptide synthesis machinery, avoiding the bioprocess and regulatory complexities of recombinant biological processes. We expect very low COGS at commercial scale-for example, targeting total COGS of less than $1/dose in our lead pan-Coronavirus inhibitor program.

•

Flexible Formulation: We intend to formulate peptide-conjugate therapeutics in a variety of self-administered formats, including nasal and oral inhalation and extended-release dermal patches, optimizing delivery route for indication and market.

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Increased Probability of Success: Multi-parameter optimization from the beginning of design and discovery should help avoid “dead-ends” which result in expensive, time-consuming drug development failures.

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Drug Development Programs

Through our IMP3ACT platform, we aim to create a diverse and expanding development portfolio of antiviral and GPCR-targeted peptide conjugates. Our initial programs are outlined below.

Pan-Coronavirus Prophylactic for Immunocompromised Patients

We are developing this program for prophylactic prevention of SARS-CoV-2 infection in immunocompromised patients, currently in late lead optimization stage. This program is supported through IND-enabling studies by grants from the Gates Foundation and Blue Knight Program totaling $6.5 million. We intend to seek additional non-dilutive funding through Phase 2a proof-of-concept (antiviral challenge) studies and a development partner.

The SARS-CoV-2 pandemic demonstrated that vaccines and antiviral therapeutics are complementary tools. Rapid COVID-19 vaccine development saved millions of lives. However, continued SARS-CoV-2 immune escape variant evolution, growing ‘vaccine hesitancy,’ and immune-suppressed sub-groups at risk regardless of vaccination status are treatment gaps only antiviral therapeutics can fill.

Our target product profile for this program, developed in conjunction with the Gates Foundation, is:

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Prevention of infection by all SARS-CoV-2 variants and other human infecting coronaviruses including MERS-CoV;

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Convenient self-administration via intranasal spray;

•

Over 8 hours of protection from a single dose; and

•

Cost of goods of less than $1 per dose.

We have demonstrated through in vitro pseudotype, live virus, HAE assays and in vivo Syrian hamster models that multiple D-MAVs inhibit viral infection and demonstrate multifold decrease in viral infectious particles when delivered before (pre-exposure prophylaxis or PrEP) or after (post exposure prophylaxis or PEP) viral challenge. DCOY101 and its analogs have demonstrated infection inhibition in cell-based assays against all major SARS-CoV-2 variants of concern and other human-infecting coronaviruses, including SARS-CoV-1, Middle Eastern Respiratory Syndrome (“MERS”), and the “cold-causing” coronaviruses OC43 and NL63, as expected due to strong similarity of fusion region structure across coronaviruses.

The initial indication will be PrEP and PEP prevention of COVID-19 in immunocompromised patients. The Company plans to file an IND application with the FDA or the European equivalent CTA during the first half of 2027, then initiate a Phase I clinical trial in adult healthy volunteers followed by a proof-of-concept Phase 2a human “challenge” study in which healthy volunteers are infected with SARS-CoV-2 under controlled conditions[8]. We expect to partner this program after demonstrating human proof-of-concept.

Immunocompromised Populations

SARS-CoV-2 initially infects ciliated cells in the nasopharynx; most people have mild to moderate illness with viral replication restricted to the upper airways. However, COVID-19 can progress to life-threatening pneumonia in people with predispositions including hypertension, heart failure, cardiac arrhythmia, diabetes, kidney failure, chronic pulmonary disease, old age, and/or compromised immune systems. Severe illness typically begins one week after symptom onset, potentially leading to Acute Respiratory Distress Syndrome (ARDS). COVID-19 can also lead to disease beyond the respiratory tract, including gastrointestinal, acute cardiac, kidney, and liver injury. COVID-19 can lead to Long COVID (Post COVID Condition or “PCC”), a multisystemic condition persisting for weeks to years. The

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risk of Long COVID increases with each infection; approximately 6% of symptomatic infections resulted in PCC despite vaccination.[9]

Immunocompromised patients face several distinct challenges:

•

Patients post-hematopoietic stem cell transplants or CAR-T therapy are at higher risk of severe COVID-19 within 100 days of treatment, even with rigorous infection control and social avoidance practices.

•

Patients with cancer have an impaired immune response to COVID-19 vaccination and are thus at significant risk from SARS-CoV-2 infection.

•

Prolonged SARS-CoV-2 infection has been observed in patients with lymphoid or hematological malignancies.

•

COVID-19 infections may lead to disruptions of care, for example an interruption in cancer treatment or a delay in a transplant procedure, that can have significant life-altering consequences for patients.

Chronic, persistent SARS-CoV-2 infections in immunocompromised patients are also of public health concern, as continued viral evolution within these patients may be a key source of novel variants of concern.

SARS-CoV-2 Burden of Disease Post-Pandemic

SARS-CoV-2 continues to cause significant morbidity and mortality. Between September 2023 and March 2024, approximately 561,000 people were hospitalized in the U.S. from COVID-19, resulting in approximately 42,000 deaths.[10] By comparison, during the 2023-2024 flu season, there were 470,000 influenza-associated hospitalizations and 28,000 deaths. This suggests COVID-19 prevalence may equal or exceed influenza for the foreseeable future.

Current Treatment Landscape and Opportunity

We are not aware of any antiviral that can prevent SARS-CoV-2 infection. The prophylactic monoclonal antibody Pemivibart was recently authorized under emergency use for immunocompromised patients, but given continued SARS-CoV-2 evolution, it is unclear how long this antibody will remain effective.

Therefore, immunocompromised patients, including those facing transplants or cancer treatments, are at particularly high risk of significant morbidity and mortality upon infection with few options. There is a clear unmet medical need for additional safe, novel prophylactic treatments that can act across multiple SARS-CoV-2 variants.

Our Solution - a pan-Coronavirus D-MAV

We are designing and synthesizing α-helical peptides simultaneously optimized for binding affinity, broad activity against human coronaviruses, potency in cell-based antiviral assays, physicochemical features important for pharmacokinetic durability, formulation, and manufacturability. These peptides are linked via a PEG-based linker to a cholesterol molecule, demonstrated in scientific literature to significantly improve peptide conjugate pharmacokinetic properties.

Mechanism of Action

Viral fusion is required for enveloped viruses to enter human host cells and initiate viral replication. Without fusion, infection will not occur. Treatment with a fusion inhibitor interrupts the infectious cycle, decreasing viral replication. Our pan-Coronavirus peptide conjugates recognize the HRN helical region of the coronavirus spike protein and bind to it, precluding natural binding of spike HRC to HRN and preventing fusion and viral entry.

The basic viral fusion “machinery” structure is highly conserved across enveloped viruses, comprising 11 viral families and 250+ human-infecting viruses[11], presenting opportunity to apply fusion inhibition to other viruses and viral families.

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Summary of Proof-of-Concept Preclinical Data

In vitro cell-based assays:

We demonstrated that a single D-MAV targeting fusion machinery can inhibit viral infection for multiple SARS-CoV-2 variants in pseudotype and live virus infection assays. We have also shown activity against 5/6 other human-infecting coronaviruses: SARS-CoV-1, MERS, OC43, NL63, and 229E. The final human-infecting coronavirus, HKU1, is difficult to culture in vitro and so has not been tested to date.

Figure 1: In Vitro Antiviral Activity of pan-Coronavirus Peptide Conjugates

Human Airway Epithelial Model:

The HAE-ALI system is a HAE cell culture grown at an air-liquid interface (“ALI”), designed to mimic human airway epithelium more closely than traditional submerged cell cultures. In the ALI setup, the basal surface of the human airway (nasal, bronchial, or alveolar) cells is in contact with a liquid culture medium, while the apical surface is exposed to air. This configuration supports cellular differentiation into a mucociliary phenotype characteristic of human respiratory tract pseudostratified epithelium. The ALI culture system is physiologically relevant for studying respiratory epithelium, modeling respiratory diseases, and studying drug efficacy.

[1] https://www.morningstar.com/news/business-wire/20241029363831/pfizer-reports-strong-third-quarter-2024-results-and-raises-2024-guidance

[2] https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-price-covid-19-drug-paxlovid-1400-five-daycourse-wsj-2023-10-18/

[3] Susini, C. & Buscail, L. Rationale for the use of somatostatin analogs as antitumor agents. Ann. Oncol. 17: 1733-1742 (2006).

[4] Insel, PA et. al. GPCRomics: GPCR Expression in Cancer Cells and Tumors Identifies New, Potential Biomarkers and Therapeutic Targets. Front Pharmacol. 9:431 (2018).

[5] PLoS ONE 17(3): e0255753. https://doi.org/10.1371/journal.pone.0255753

[6] Mijalis AJ, et. al. A fully automated flow-based approach for accelerated peptide synthesis. Nat Chem Biol. 13(5):464-466 (2017).

[7] Lindeboom, R.G.H., Worlock, K.B., Dratva, L.M. et al. Human SARS-CoV-2 challenge uncovers local and systemic response dynamics. Nature 631, 189-198 (2024). https://doi.org/10.1038/s41586-024-07575-x

[8] Nature Medicine (2022) 28:1031-1041.

[9] Wulf Hanson, S. et al. JAMA. (2022) 328(16):1604-1615

[10] https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_weeklyhospitaladmissions100k_00

[11] https://en.wikipedia.org/wiki/Viral_envelope

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DCOY101 D-MAV Inhibits Infection in a Human SARS-CoV-2 HAE-ALI Infection Model:

DCOY101 prevented infection in the HAE model with dose response across 25 nM, 125 nM, and 625 nM. The compound was delivered apically at the same time as viral challenge (prophylactic treatment). DCOY101 demonstrated a dose-dependent decrease in viral load at 48 and 72 hours post-infection, reducing viral load by ~4 logs compared to vehicle. Remdesivir was used as a positive control, demonstrating significant inhibition as expected based on previous prophylactic HAE-ALI results[1], though delivered basolaterally at an 8x higher dose than DCOY101.

Figure 2: Activity of DCOY101 in the Human Airway Epithelial Model

The dose-responsive antiviral efficacy shown in the above graph is due to DCOY101’s anti-fusion mechanism, not cellular toxicity. Toxic effects were measured with five different endpoint assays showing no impact on cellular junctions/epithelial layer integrity, no lactate dehydrogenase increase, no inflammatory response induction, and no mucociliary clearance impact after treatment with DCOY101.

In vivo Efficacy Evaluations:

Administration of DCOY101+ reduced pathological body weight loss and decreased viral infectious genomes and live virus particles in vivo in intranasal prophylactic (dosing before viral exposure) and post-exposure prophylactic (dosing after exposure but before symptoms) Syrian hamster models of SARS-CoV-2 delta variant infection.

Syrian Golden hamsters are susceptible to SARS-CoV-2 infection and will become sick, though typically clearing infection by day 7. SARS-CoV-2 infects the hamster nose and causes lung lesions by day 4. Hamsters lose weight, thought to be equivalent to human symptoms.

In the first study (Pre-Exposure Prophylaxis or PrEP), hamsters were dosed intranasally at different dose levels once daily, starting two days before viral challenge and continuing until day 7. By day 7, vehicle-treated animals lost 5-10% body weight as they stopped eating due to illness. Animals treated with DCOY101 maintained or gained weight at the highest dose level, indicating protection from viral effects. Viral load showed significant reduction at all dose levels tested, measured by RT-qPCR on a log scale.

[1] Antiviral Research (2021) 192:105122.

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Figure 3: DCOY101 Prevents SARS-CoV-2 Infection in the PrEP Syrian Hamster Model

In the second study (PEP), hamsters were dosed intranasally beginning at various timepoints after viral challenge (2, 12, 24, and 36 hours post-challenge). Control animals began losing weight between 24 and 48 hours. Animals treated with DCOY101 maintained weight throughout the study across all timepoints tested, even when dosing started 36 hours after virus-within the symptomatic timeframe. This result suggests our pan-Coronavirus intranasal D-MAV could also have therapeutic activity.

Figure 4: DCOY101 Prevents SARS-CoV-2 Infection up to 36 hours Post Exposure

Preclinical Research Plans

We have demonstrated in vitro activity across human-infecting coronaviruses with significant antiviral activity. SARS-CoV-2 infection can be significantly inhibited with prophylactic DCOY101 treatment in the human organoid HAE-ALI model and in vivo in pre-exposure and PEP hamster models.

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Lead Optimization:

The IMP3ACT Platform acts as an iterative feedback loop incorporating data from in vitro experiments to improve candidate peptide design. Typical data includes SPR binding potency, cell-based activity via pseudotype or live virus assays, and molecular parameters. By incorporating experimental data, more potent and drug-like peptide binders can be designed with multiple parameter optimization simultaneously. This ML/AI-enhanced design approach reduces combinatorial research costs and allows lower-cost manufacturing due to improvements in synthesis speed and scale. The platform achieves manufacturing readiness within significantly shorter timelines, aiming to meet or exceed a 100-day goal for vaccine manufacture.

Use of Physiologically Relevant Human Tissue Models:

The HAE model uses primary differentiated human biopsy tissue with appropriate architecture and cellular complexity, allowing infections from standard respiratory viruses including RSV, SARS-CoV-2, and influenza.[1] SARS-CoV-2 replication kinetics in HAE-ALI cultures is similar to that observed in humans. We believe this human-based model will be useful to optimize pharmacokinetic properties, with human nasal tissue providing the most predictive tool versus rodent models. This medium-throughput system allows careful evaluation of tissue residence time and formulation excipient effects.

CMC

Drug Substance: Continuous Manufacturing - IMP3ACT Platform:

We use a proprietary patent pending manufacturing technology which, by thoughtful design and differentiation of chemically active sites, allows complete manufacture of the target compound from beginning to end without intermediate isolation or purification. Both the peptide component and the final cholesterol linker/anchor are assembled in one continuous operation, with the compound isolated only after the target is fully assembled.

The advantages of the continuous manufacturing process are several:

1. A single continuous operation to produce a very complex molecule.

2. Overall improvement of synthesis speed

•

Continuous manufacturing process time to final product is approximately 5-6 days, versus approximately 8 weeks for similar compounds requiring numerous isolations and purifications.

3. In-process analytical and quality checks can be performed to check on progress of the assembly of the target molecule.

•

High quality of process output is assured by continuous monitoring of combined unit operations.

4. Simplicity of overall process.

•

Instead of as many as roughly 70-unit operations and numerous purifications, this continuous process requires only material inputs and a single isolation and purification.

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Drug Substance: Distributed Manufacturing - IMP3ACT platform

We project that IMP3ACT, described above, can become a modular, distributed manufacturing platform if the following process development criteria are met:

1. Experience with multiple product manufactures enables continuous processing from start to finish to be optimized to maximize yield and purity of the final product.

2. This experience leads to an understanding of the critical process parameters, variables and attributes affecting product quality which can be applied to efficient continuous processing.

3. Robust and predictive in-process controls are developed.

4. Process concentrations are high.

5. Final purification and isolation of the agent produced can be made efficient and robust; and

6. The above criteria having been met, modular, portable standalone manufacturing skids with modest utility requirements are assembled and shown to be viable for the process.

This type of modular, distributed manufacturing has been demonstrated for vaccine production “in-country” where the vaccines are urgently required. We propose developing a similar modular, portable continuous manufacturing platform for use “in-country” where viral outbreaks occur. We intend this process to be straightforward enough that deep chemical processing knowledge is not required to produce needed medicines.

Drug Product

For drug product development, we are developing and optimizing multiple nasal candidate formulations containing our D-MAVs, including liquid and dry powder. We have demonstrated suitability of our peptide conjugates in shelf-stable aqueous nasal formulations containing typical pharmaceutical excipients and identified multiple lead formulation candidates. We have demonstrated delivery at therapeutic doses via conventional nasal spray devices such as the VP7 Spray Pump and Unidose Liquid Nasal Spray devices from Aptar Pharma Inc. (“Aptar”). We are also developing dry powder formulations for nasal delivery via the Unidose Powder Nasal Spray device available from Aptar.

Clinical Development Plan

We expect to file an IND application with the FDA or the European equivalent CTA for our optimized pan-Coronavirus peptide conjugate within the first half of 2027 and initiate a Phase 1 trial shortly thereafter. Our planned Phase 1 trial is expected to be randomized, placebo-controlled with single ascending daily intranasal dose and multiple ascending dose in up to 40 healthy volunteers (part A), followed by a 12-healthy volunteer cohort given daily intranasal dose for 28 days (part B).

Primary endpoints are expected to determine safety and tolerability of the optimized clinical candidate administered daily as an intranasal spray. Secondary endpoints will include evaluation of pharmacokinetic profiles in the nose and oropharyngeal cavity over 12 hours, device delivery characterization, mucociliary clearance, and nasal residence time.

We anticipate taking two dose levels into a Phase 2 proof-of-concept human challenge trial with up to 250 healthy volunteers, who are administered SARS-CoV-2 under carefully controlled and monitored conditions to establish the PK/efficacy relationship and proof of concept.

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Other Indications for our pan-Coronavirus Antiviral

We believe there may be opportunities to develop DCOY101+ in additional indications, including:

•

Inhaled COVID-19 Therapeutic: DCOY101 has demonstrated activity in hamsters against SARS-CoV-2 infection even when administered up to 36 hours after viral challenge, when significant symptoms have emerged. DCOY101+ may have utility as a COVID-19 treatment alternative to Paxlovid with a significantly superior DDI profile, benefiting immunocompromised, high-risk, and elderly patients already taking drugs contraindicated to Paxlovid.

•

Middle Eastern Respiratory Syndrome (“MERS”) Therapeutic: DCOY101+ has shown activity against MERS-CoV coronavirus in live virus cell-based assays. MERS symptoms range from mild respiratory illness to severe disease with approximately 35% case fatality rate-much higher than SARS-CoV-2.

•

Broad Respiratory Antiviral (Flu/COVID-19/RSV): Influenza, RSV, and SARS-CoV-2 continue to pose significant global health threats. There is urgent need for potent, versatile antiviral agents targeting multiple viral strains. A single peptide-conjugate therapeutic active against major respiratory viruses from these three viral families with an excellent safety profile could fill a significant unmet medical need, particularly in immunocompromised patients and children.

Clinical Rationale and Disease Description

Globally, acute lower respiratory tract infections (“LRTI”) are among the top three causes of death and disability in children and adults, causing nearly 4 million deaths annually and leading deaths in children under 5.[2] Viruses are estimated causative in up to 50% of respiratory infections, with influenza, RSV, and coronaviruses identified often.

Current Treatment Landscape and Opportunity

Current medical approaches include vaccination and antiviral treatment where applicable. Vaccination coverage appears to be decreasing globally. Influenza vaccination among healthcare professionals increased during COVID-19 up to ~90% but has since decreased to 81% in 2022-23. By late 2023, only 14% of American adults got the latest SARS-CoV-2 vaccine, despite vaccinated individuals being 54% less likely to get COVID-19. RSV vaccine uptake appears substantially less than flu rates.

Antiviral medications for influenza (Tamiflu, Relenza, Repivab) and COVID-19 (Paxlovid) exist, but influenza drugs are subject to resistance and Paxlovid is underutilized due to DDI concerns. Society's reluctance to maintain vaccinations can have significant public health repercussions, including increased disease burden, outbreak risks, and resistant strain transmission.

Our D-MAV therapeutic that treats LRIs from three major respiratory endemic and epidemic viruses would be unprecedented and could fill a significant medical need given the morbidity and mortality associated with LRIs globally.

Our Solution

We intend to explore combining fusion inhibitory peptides for SARS-CoV-2 (coronaviruses), RSV (paramyxoviruses), and flu (orthomyxoviruses) in a single molecule, investigating several approaches to optimize breadth of activity.

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Mechanism of Action

Figure 5: Conservation of the 6-helix bundle across class I fusion proteins from 3 viral families

Figure 5 adapted from Igoneta, S. et. al., Proc Natl Acad Sci U S A. 2011 Dec 13;108(50):19967-72. doi: 10.1073/pnas.1108910108.

We target the conserved fusion machinery common to influenza A&B, paramyxoviruses (RSV A&B, hMPV, hPIV, measles), and coronaviruses (SARS-CoV-2, OC43, NL63). We believe a single molecule targeting all three major respiratory viral families is possible, given the highly conserved protein structure of the 6-helix post-fusion bundle common to these viruses as shown in Figure 5. By focusing on this shared mechanism, our project aims to pioneer a versatile D-MAV antiviral agent significantly impacting global health by mitigating the LRTI threat.

Summary of Proof-of-Concept Preclinical Data

Significant progress has been made with our leading antiviral peptide conjugate series, DCOY101+, showing strong in vitro effectiveness against all tested SARS-CoV-2 variants and other human coronaviruses including MERS, SARS-CoV-1, OC43, and NL63 (see Fig. 1, 2). In vivo, DCOY101+ has demonstrated antiviral effects and maintained therapeutic levels for over 8 hours when administered intranasally in Syrian golden hamsters (Figures 3, 4).

Recently, our rapid discovery engine has produced broad-spectrum paramyxovirus inhibitors with promising in vitro proof-of-concept results against RSV-A, RSV-B, and HPIV3 (Fig. 6). Synthesis of these novel D-MAVs was completed in just four days with the “All-in-one” synthesis process.

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Figure 6: Activity of our Peptide Conjugate Antivirals Against 3 viruses from the Paramyxovirus Family

On March 26, 2025, we announced that these antiviral drug candidates also showed promising in silico activity against the measles and Nipah viruses based on molecular dynamics modeling. AlphaFold2 multimer predicted that the possibility of expected six helical bundle formation with measles or Nipah HR1 domains is very high. Molecular Dynamics simulations and MMGBSA calculations showed the rationally designed fusion inhibitor can bind to measles or Nipah HR1 domains with similar affinity to the native complex, and approximately the same as its calculated binding energy to hPIV3, RSV A, and RSV B (which have demonstrated in vitro activity with EC50 <1 uM). We believe there is reasonable probability the fusion inhibitor will show similar activity against measles and Nipah in vitro, though this cannot be confirmed until relevant experiments are performed.

We have demonstrated D-MAV with broad-based antiviral POC against two of the three respiratory viral families targeted. Based on in silico tools, we believe it will be possible to design a single molecule also targeting influenza.

Clinical Development Plan

We intend to follow a similar clinical program structure as our pan-Coronavirus prophylactic. Phase 1 would focus on safety and tolerability of an inhaled formulation. Phase 2 would include a healthy volunteer human challenge trial using multiple arms to interrogate all three viral families (flu A, RSV, SARS-CoV-2) to determine PK/efficacy relationship and establish human dose levels and proof of concept.

Potential Future Indications

Upon establishing proof of concept as outlined above, we believe there would be several attractive commercial indications for this candidate, including:

•

Therapeutic treatment of early LRTIs in immunocompromised patients via inhaled administration (mortality rates can be as high as 50%[1] in some severely immunocompromised populations);

•

Prophylactic use in highly immunocompromised patient populations, including immunocompromised pediatric populations;

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Therapeutic use in large populations that are susceptible to LRTIs, including people who are 65+ or who are suffering from high-risk conditions such as Type II diabetes, chronic kidney disease, congestive heart failure, and chronic obstructive pulmonary disease; and

•

Broad use among otherwise healthy populations during seasonal surges in ‘influenza-like illness.’

Competitors and Competitive Advantage

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and emphasis on proprietary products. While we believe our technologies, knowledge, experience, and scientific resources provide competitive advantages, we face potential competition from major pharmaceutical, specialty pharmaceutical, and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions. Any potential product candidates we successfully develop and commercialize will compete with existing and new therapies.

Our potential competitors include large pharmaceutical and biotechnology companies, as well as specialty and generic or biosimilar drug companies. Many have significantly greater financial and human resources and expertise in R&D, manufacturing, preclinical testing, clinical trials, regulatory approvals, and marketing. Smaller companies may also prove significant competitors through collaborations with established companies. These competitors compete with us in recruiting qualified personnel, establishing clinical trial sites, and acquiring complementary products or technologies.

Each of our pipeline candidates faces a unique but, in our view, favorable competitive landscape because of our emphasis on unique value propositions. Specifically:

•

COVID-19 Prevention & Treatment for Immune-Suppressed Patients: Despite being four years from the COVID-19 pandemic, there are still limited prophylactic options for people with highly suppressed immune function. mRNA vaccines are less effective for immune-suppressed patients[1]. Vaccine efficacy remains at risk from viral evolution, and uptake continues to decline.[2]Long-lasting antibody prophylactics like Evusheld rapidly became obsolete due to viral evolution,[3] and this is likely for pemivibart. Our therapeutic candidate is effective against all SARS-CoV-2 variants and expected to continue effective based on limited evolution in the targeted genome portion. With convenient administration and no requirement for functional immune system, we believe this therapeutic will deliver a unique solution for highly immune-suppressed patients.

•

Broad Respiratory Antiviral (COVID-19/Flu/RSV): There is significant competition in each area, both from commercialized drugs and pipeline candidates. While vaccines exist, usage continues to be low. We believe our strategy of treating all three viruses-and potentially additional human Coronaviruses and Paramyxoviruses causing influenza-like symptoms-with a single therapeutic will deliver a unique value proposition during seasonal ILI surges. A therapeutic that can safely treat a large percentage of ILI-causing viruses would be uniquely useful for healthcare providers.

Intellectual Property

We strive to protect our proprietary technology, inventions, improvements, platforms, program candidates, therapeutic candidates, methods of use, and manufacturing processes by obtaining, maintaining, defending, and enforcing patent and other intellectual property rights in the United States and foreign jurisdictions. We also rely on trade secrets and confidentiality agreements to protect information and know-how not amenable to, or not appropriate for, patent protection.