GOVX

New in FY2025

• These disclosures reflect the Company ’ s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future.
• References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.
• We incurred a net loss of approximately $21.5 million for the year ended December 31, 2025.
• As of the date of this Annual Report, we believe that our existing cash and cash equivalents are sufficient to fund our operations into mid-second quarter of 2026.
• These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern.
• We may pursue additional support from the federal government for our vaccine and immunotherapy development programs; however, as we progress to the later stages of our development activities, government financial support may be more difficult to obtain, may be terminated prior to the receipt of all funds, or may not be available at all.
• Additionally, even if we secure funding, such funding may be revoked if the agreements underlying the funding are terminated.
• For example, in April 2025, we received formal notice from ATI that BARDA elected to terminate the ATI-RRPV Contract for convenience, consistent with its terms.
• To the extent that we raise additional funds by issuance of equity securities, our stockholders would experience dilution, and debt financing, if available, may involve restrictive covenants and substantial fixed payments or may otherwise further constrain our financial flexibility.
• In addition, the rapid evolution and increased adoption of artificial intelligence and machine learning technologies may intensify our information security risks.
• Since its enactment, there have also been judicial and Congressional challenges to certain aspects of the Affordable Care Act, as well as efforts to repeal or replace certain aspects of the statute.
• Additionally, laws such as the Inflation Reduction Act have granted the Centers for Medicare and Medicaid Services the ability to negotiate drug prices for certain prescription drugs.
• In particular, the patent landscape in the COVID-19 vaccine space is crowded, and a large number of patent applications have been filed by numerous entities since January 2020, including for the use of certain SARS-CoV-2 antigens and antigenic combinations, including from Pfizer, Moderna, Janssen Pharmaceuticals, Inc., Sementis LTD., VaxBio, Inc., Oxford University, BioNTech, Ichan School of Medicine at Mount Sinai, Diosynvax LTD., The University of Alberta, University of Texas, and Tonix Pharmaceuticals.
• When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a nonexclusive license authorizing the government to use the invention for non-commercial purposes.
• Changes to the Biologics Price Competition and Innovation Act ’ s exclusivity provisions could affect our market exclusivity.
• In addition to our patents, we intend to rely on the regulatory exclusivity provisions of the Biologics Price Competition and Innovation Act (BPCIA) to protect our market in the United States.
• According to the BPCIA, new reference biologics are entitled to 4 years of data exclusivity and 12 years of market exclusivity in the United States from the date of first FDA licensure.
• According to the BPCIA, the FDA is prohibited from 1) accepting applications for an abbreviated pathway Section 351(k) biosimilar follow-on product for a period of 4 years, and 2) approve an abbreviated pathway Section 351(k) biosimilar follow-on product for a period of 12 years.
• Since the passage of the BPCIA, various bills have been introduced in the United States Congress to reduce these exclusivity periods.
• Any congressional changes to these exclusivity periods could harm our competitive position and our ability to prevent competitive biosimilar follow-on products from entering the market.
• The sale of additional equity securities, or the issuance of additional equity securities under our stock incentive plans, could result in significant additional dilution to our stockholders.
• There are warrants currently exercisable for approximately 5.4 million shares with a weighted average exercise price of $1.94 per share.
• The exercise of these warrants will cause us to issue additional shares of our Common Stock and will dilute the percentage ownership of our stockholders.
• Our common stock currently is listed for quotation on the Nasdaq Capital Market .
• We are required to meet specified financial requirements in order to maintain such listing, including a requirement that the bid price for our common stock remain above $1.00, and that the market value of our publicly held securities be at least $1 million.
• In addition, Nasdaq has recently proposed a new $5 million market value of listed securities requirement that we would not currently satisfy and therefore could cause our common stock be delisted by Nasdaq on an imminent basis, if approved by the SEC.
• Nasdaq Listing Rule 5550(a)(2) requires listed companies to maintain a minimum bid price of $1.00 for continued inclusion on the Nasdaq Capital Market.
• If the trading price of our common stock were to fall below $1.00 per share, we would not be compliant this requirement.
• In such event, we would be subject to delisting, and because we consummated a reverse stock split in January 2026, we would be ineligible for any compliance period under recently implemented Nasdaq listing rules if this event occurred prior to the one-year anniversary of such reverse stock split.
• As a result, such a decline in the price of our common stock, if it were to occur, would be expected to result in the prompt delisting of our common stock from the Nasdaq Capital Market.
• In addition, Nasdaq Listing Rules 5550(a)(5) and 5550(b)(1) require that the market value of our publicly held common stock (which is our only outstanding class of capital stock) to be at least $1 million and that our stockholders’ equity as reported in our most recent quarterly balance sheet to be at least $2.5 million.
• If the market value of our publicly held common stock declines below $1 million or our stockholders’ equity falls below $2.5 million, we would also be subject to Nasdaq delisting proceedings on that basis.
• Nasdaq’s staff also maintains discretionary authority under its listing rules to delist companies whose capital structure or public offerings raise public interest and investor protection concerns, including as a result of highly dilutive issuances, and it is possible that Nasdaq could assert that past offerings that we have consummated, or future offerings we may consummate, raise such concerns.
• In addition, to raise the significant amount of capital that we expect to need to fund our strategic plan, potential investors may require us to accept terms (such as board representation rights in excess of an investor’s beneficial ownership of our common stock) that could conflict with Nasdaq listing standards and result in us being delisted.
• In addition to the foregoing requirements, Nasdaq has recently proposed a new listing requirement that would require each Nasdaq listed issuer to maintain a minimum market value of listed securities of at least $5 million.
• Under this proposal, if the value of an issuer’s listed securities, as measured by each applicable trading day’s closing price, continues to be less than $5 million for a period of 30 consecutive trading days, the issuer’s securities would immediately be delisted, with no compliance or cure period.
• The proposed rule would also preclude an issuer’s ability to seek stay of delisting during any appeals process and would preclude Nasdaq hearings panels from reversing the delisting determination to situations where there was an error and the company never actually failed to satisfy the requirement.
• The panel would also not be able to consider any facts indicating that issuer subsequently regained compliance with the requirement or grant an issuer any additional time to regain compliance.
• The proposed rule is subject to review and approval by the SEC, and it is unknown whether the SEC will approve the proposal.
• If approved by the SEC, the rule could become effective on an imminent basis.

and 5 more.

Gone since FY2024

• We incurred a net loss of approximately $25 million for the year ended December 31, 2024.
• We may pursue additional support from the federal government for our vaccine and immunotherapy development programs; however, as we progress to the later stages of our development activities, government financial support may be more difficult to obtain, or may not be available at all.
• We will need to raise additional funds to significantly advance our vaccine development programs and to continue our operations.
• In order to meet our operating cash flow needs we plan to seek sources of non-dilutive capital through government grant programs and clinical trial support.
• To the extent that we raise additional funds by issuance of equity securities, our stockholders would experience dilution, and debt financings, if available, may involve restrictive covenants and substantial fixed payments or may otherwise further constrain our financial flexibility.
• Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could have a material adverse effect on our business, operating results, financial condition and prospects.
• A significant portion of the funding to further develop GEO-CM04S1, our next-generation COVID-19 vaccine candidate, is currently expected to come from the U.S. government.
• If the government were to eliminate, reduce, or delay funding available to us under the ATI-RRPV Contract, this could have a significant negative impact on our revenues and cash flows, and we may be forced to suspend or terminate the continued development of the product candidate or obtain alternative sources of funding.
• We anticipate that a significant portion of the funding for the continued development of GEO-CM04S1, our next generation self-COVID-19 vaccine candidate, will stem from the ATI-RRPV Contract.
• As awarded, the ATI-RRPV Contract currently makes available an aggregate amount of up to $26.2 million (which may increase to as much as $45 million), for reimbursement of costs incurred for manufacturing of clinical materials and support for a 10,000 patient Phase 2b clinical trial, including regulatory activities.
• BARDA has made a separate award of $343 million to Allucent, a global CRO, to execute the clinical trial as part of BARDA’s Clinical Studies Network.
• As of December 31, 2024, we have recognized approximately $4.0 million in revenue pursuant to the ATI-RRPV Contract based on costs incurred.
• As a standard government contract, BARDA is entitled to terminate the ATI-RRPV Contract for convenience at any time, in whole or in part, and is not required to provide continued funding beyond reimbursement of amounts currently incurred and obligated by us as a result of contract performance.
• Further, BARDA may suspend or terminate the ATI-RRPV Contract should we fail to achieve key milestones or fail to comply with the operating procedures and processes approved by BARDA and its audit agency.
• There can be no assurance that we will be able to achieve these milestones or continue to comply with these procedures and protocols, and there can also be no assurance that BARDA will not terminate or suspend the ATI-RRPV Contract.
• If the ATI-RRPV Contract is terminated or suspended, or if there is any government decision not to continue funding or reduction or delay in funding under the ATI-RRPV Contract, our revenues and cash flows would be significantly and negatively impacted and we may be forced to seek alternative sources of funding, which may not be available on non-dilutive terms, terms favorable to us, or at all.
• If alternative sources of funding are not available, we may be forced to suspend or terminate development activities for GEO-CM04S1, which could materially harm our business.
• Since its enactment, there have also been judicial and Congressional challenges to certain aspects of the Affordable Care Act, as well as efforts by the former Trump administration to repeal or replace certain aspects of the statute.
• In particular, the patent landscape in the COVID-19 vaccine space is crowded, and a large number of patent applications have been filed by numerous entities since January 2020, including for the use of certain SARS-CoV-2 antigens and antigenic combinations, including from Moderna, Janssen Pharmaceuticals, Inc., Sementis LTD., VaxBio, Inc., Oxford University, BioNTech, Ichan School of Medicine at Mount Sinai, Diosynvax LTD., The University of Alberta, University of Texas, and Tonix Pharmaceuticals.
• When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a nonexclusive license authorizing the government to use the invention for noncommercial purposes.
• The sale of additional equity securities could result in significant additional dilution to our stockholders.
• There are pre-funded warrants currently exercisable for approximately 2.1 million shares and other warrants currently exercisable for approximately 10.1 million shares with a weighted average exercise price of $2.61 per share.
• The exercise of these warrants will cause us to issue additional shares of our Common Stock and will dilute the percentage ownership of our shareholders.
• If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our Common Stock and related warrants could be delisted from the exchange.
• Our Common Stock (GOVX) and related warrants (GOVXW) are currently listed on Nasdaq.
• In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders’ equity, minimum share price, and certain corporate governance requirements.
• There can be no assurances that we will be able to continue to comply with the applicable listing standards.