GOVX 10-K & 10-Q changes, risk factors and insider trading

Ownership of our securities involves a high degree of risk. You should carefully review and consider the risks, uncertainties and other factors described below before you decide whether to own our securities. 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. Any of these factors could materially and adversely affect our business, financial condition, operating results and prospects and could negatively impact the market price of our common stock, and you may lose some or all of your investment. The risks and uncertainties described below are not the only ones facing our Company. Additional risks and uncertainties that we are unaware of, or that we currently deem immaterial, may also impair our business operations. 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. You should also refer to the other information contained in this Form 10-K, including our financial statements and the related notes.

To date, we have financed our operations principally through the sale of our equity securities and through government grants and clinical trial support. We will require substantial additional financing at various intervals for our operations, including clinical trials, operating expenses, intellectual property protection and enforcement, for pursuit of regulatory approvals, and for establishing or contracting out manufacturing, marketing and sales functions. There is no assurance that such additional funding will be available on terms acceptable to us or at all. 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. If we are not able to secure the significant funding that is required to maintain and continue our operations at current levels, or at levels that may be required in the future, we may be required to delay clinical studies or clinical trials, curtail operations, or obtain funds through collaborative arrangements that may require us to relinquish rights to some of our products or potential markets. 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. Therefore, it will be necessary for us to look to other sources of funding to finance our development activities. 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.

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. We may also plan additional offerings of our equity securities, debt, or convertible debt instruments. To the extent that we raise additional funds by issuance of equity securities, our stockholders would experience dilution, and debt financings,financing, 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.

We rely upon a combination of information technology systems and traditional recordkeeping to operate our business. In the ordinary course of business, we collect, store, and transmit confidential information (including, but not limited to, personal information and intellectual property). We have also outsourced elements of our operations to third parties, including elements of our information technology systems and, as a result, we manage a number of independent vendor relationships with third parties who may or could have access to our confidential information. Our information technology and information security systems and records are potentially vulnerable to security breaches, service interruptions, or data loss from inadvertent or intentional actions by our employees or vendors. Our information technology and information security systems and records are also potentially vulnerable to malicious attacks by third parties. Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of expertise and motives (including, but not limited to, financial crime, industrial espionage, and market manipulation). 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 by the former Trump administration to repeal or replace certain aspects of the statute. We continue to evaluate the effect that the Affordable Care Act and subsequent changes to the statute has on our business. Changes in legislation, regulation or policy increase the likelihood that we will fail to appropriately adapt to changes in our compliance obligations, particularly when such changes happen abruptly, such as following a change in government. It is uncertain the extent to which any such changes may impact our business or financial condition.

There has also been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products. There have been several Congressional inquiries and proposed bills, as well as state efforts, designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. In June 2017, the FDA issued a Drug Competition Action plan intended to lower prescription drug prices by encouraging competition from generic versions of existing products. In July 2018, the FDA issued a Biosimilar Action Plan, intended to similarly promote competition to prescription biologics from biosimilars. 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.

Future or existing patents issued to third parties may contain patent claims that cover our products or their use or manufacture. 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. If a third party were to assert an infringement claim against us in the future with respect to our current products or with respect to products that we may develop or license, such litigation or interference proceedings could force us to:

In addition, the research resulting in certain of our in-licensed patent rights and technology was funded in part by the United States government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a nonexclusive license authorizing the government to use the invention for noncommercialnon-commercial purposes. These rights may permit the government to disclose our confidential information to third parties and to exercise march-in rights to use or allow third parties to use our licensed technology. The United States government also has the right to take title to these inventions if the applicable licensor fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to United States industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the United States. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations, and prospects.

In order to meet our operating cash flow needs, we may plan additional offerings of our equity securities, debt, or convertible debt instruments. 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. The incurrence of indebtedness could result in debt service obligations and operating and financing covenants that would restrict our operations. We cannot assure investors that financing will be available in amounts or on terms acceptable to us, if at all.

We are obligated to issue additional shares of our Common Stock in connection with our outstanding warrants if the warrant holders choose to exercise them. There are pre-funded warrants currently exercisable for approximately 2.1 million shares and other warrants currently exercisable for approximately 10.15.4 million shares with a weighted average exercise price of $2.61$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 shareholders.stockholders.

Our programs are in various stages of development,development. theKey mostupdates significantfor ofour whichlead programs are summarizedoutlined below along with recent developments:

We receivehave received payments from government entities under non-refundable grants in support of our vaccine development programs. We record revenue associated with these grants when the reimbursable costs are incurred and we have complied with all conditions necessary to receive the grant funds. From time to time, we may enter into collaborative research and development agreements for specific vaccine development approaches and/or disease indications whereby we receive third-party funding for preclinical research under certain of these arrangements. Each agreement is evaluated in accordance with the process defined by ASU 2014-09 and revenue is recognized accordingly.

Our research and development expenses were $23,713,602$18,121,519 for the year ended December 31, 2024,2025, as compared to $20,720,766$23,713,602 for 2023,2024, representing ana increasedecrease of $2,992,836$5,592,083 (14%24%). The increaseoverall duringdecrease 2024primarily relates to program-specificdiscontinued costs associated with termination of the ATI-RRPV Contract, Gedeptinas andwell GEO-MVA, partially offset byas lower costs for the GEO-CM04S1 clinical trials notand coveredmanufacturing bycosts associated with the ATI-RRPV Contract. The majority of the higher program costs relate to the ATI-RRPV ContractGEO-CM04S1 and includeGedeptin costs of manufacturing materials for use in our clinical trials, analytical expenses, third-party contracted research and consulting costs.programs. Research and development expense for 20242025 and 20232024 includes stock-based compensation expense of $222,202$513,867 and $291,094,$222,202, respectively, associated with employee stock options.

Our general and administrative expenses were $5,385,254$6,006,673 for the year ended December 31, 2024,2025, as compared to $6,022,173$5,385,254 for 2023,2024, representing aan decreaseincrease of $636,919$621,419 (11%12%). The decreaseoverall during 2024increase relates primarily to lowerhigher personnel costs, investor relations consulting and other programmatic expenses, patent costs, and stock-based compensation expense, consulting costs, patent costs and franchise tax cost.expense. General and administrative expense for 20242025 and 20232024 includes stock-based compensation expense of $306,442$601,287 and $783,863,$306,442, respectively, associated with employee and consultant stock options and stock awards.

Interest income was $173,359$174,276 and $776,177$173,359 for the years ended December 31, 20242025 and 2023,2024, respectively. The variances between years are primarily attributable to the cash available for investment and to interest rate fluctuations. Interest expense was $21,375$-0- and $-0-,$21,375 for the years ended December 31, 20242025 and 2023,2024, respectively, associated with certain notes payable issued during May 2024 and repaid in Augustduring 2024.

Financing Activities – Net cash provided by financing activities was $19,080,381 for 2025, consisting of primarily of net proceeds from offerings of our common stock and the exercise of warrants. Net cash provided by financing activities was $23,750,516 for 2024, consisting of primarily of net proceeds from offerings of our common stock and the exercise of warrants. Net cash provided by financing activities was $4,062,442 for 2023, consisting of net proceeds from the exercise of warrants.

DuringOn 2024,March 25, 2025, we closed foura registered direct offeringsoffering of our common stock and warrants,warrants. asNet wellproceeds asafter establisheddeducting placement agent fees and expenses and other offering expenses were approximately $4.1 million. During the first quarter of 2025, we also sold shares of our common stock pursuant to the ATM Program (seefor footnote 6 to the consolidated financial statements included in this Annual Report). Netnet proceeds to us from these offerings, after deducting commissions to the placement agent and sales agent, as applicable, and other related offering expenses, wereof approximately $21.4$3.8 million. We also received approximately $2.4 million upon the exercise of warrants.

During the first quarter of 2025,2026, we receivedalso approximatelysold $3.8 million of net proceeds from salesshares of our common stock throughpursuant to the ATM Program. Additionally, on March 25, 2025, we closed a registered direct offering of our common stock and warrantsProgram for net proceeds of approximately $4.1 million.$71,000.

As of the date of this Annual Report, we believe that our existing cash and cash equivalents are sufficient to fund our operations into the thirdmid-second quarter of 2025.2026. We plan to pursue additional cash resources through public or private equity or debt financings, government grants/contracts, arrangements with strategic partners, or from other sources.

ForExcept as set forth below, information regarding factors that could affect our results of operations, financial condition or liquidity, seehave thenot riskmaterially factorschanged discussedfrom those previously disclosed under “Risk Factors” in Item 1A of our most recent Annual Report on Form 10-K. See also “Forward-Looking Statements,” included in Part I - Item 2 of this Quarterly Report on Form 10-Q. As a smaller reporting company (as defined in Rule 12b-2 of the Exchange Act), we are not required to provide the information called for by this Item 1A concerning any material changes from the risk factors previously disclosed in our most recent Annual Report on Form 10‑K.

Information included in this Quarterly Report contains 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 (the “Exchange Act”). Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning future events and results. We generally use the words “believes,” “expects,”, “looks forward to”, “may”, “estimates”, “continues”, “should”, “could”, “target”, “potential”, “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. All statements in this Quarterly Report, other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenues, future governmental grants, projected costs, prospects, plans, intentions, expectations and objectives could be forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. We operate in a highly competitive, highly regulated and rapidly changing environment and our business is constantly evolving. Therefore, it is likely that new risks will emerge, and that the nature and elements of existing risks will change, over time. It is not possible for management to predict all such risk factors or changes therein, or to assess either the impact of all such risk factors on our business. We assume no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Quarterly Report.

We expect our research and development expenditures to increase as we advance our existing and future product candidates into and through clinical trials and pursue regulatory approval, especially with regard to the ongoingplanned GEO-MVA and planned GEO-CM04S1, Gedeptin and GEO-MVA clinical programs. We do not provide forward-looking estimates of costs and time to complete our research programs due to the many uncertainties associated with biotechnology research and development. Due to these uncertainties, our future expenditures are likely to be highly volatile in future periods depending on the outcomes of the trials and studies. As we obtain data from preclinical studies and clinical trials, we may elect to discontinue or delay certain development programs to focus our resources on more promising product candidates. Completion of preclinical studies and human clinical trials may take several years or more, but the length of time can vary substantially depending upon several factors. The duration and the cost of future clinical trials may vary significantly over the life of the project because of differences arising during development of the human clinical trial protocols, including the length of time required to enroll suitable patient subjects, the number of patients that ultimately participate in the clinical trial, the duration of patient follow-up, and the number of clinical sites included in the clinical trials.

The following table summarizes our results of operations for the three-month and six-month periods ended MarchJune 31,30, 2026 and 2025:

During the three-month periodand six-month periods ended MarchJune 31,30, 2025, we reported $1,636,863$852,282 and $2,489,145, respectively, of revenues associated with the Company’s contract with the Biomedical Advanced Research and Development Authority (BARDA), to support advancement of GEO-CM04S1 into a Phase 2b study. In April 2025, we were notified that BARDA elected to terminate the contract for convenience, consistent with its terms. There wereare therefore no revenues reported during the March 2026 period.2026.

Our research and development expenses were $3,903,463$3,110,508 and $7,013,971 for the three-month periodand six-month periods ended MarchJune 31,30, 2026, as compared to $5,354,588$4,728,998 and $10,083,586 for the comparable 2025 period,periods, representing a decreasedecreases of $1,451,12534.2% (27%).and 30.4%, respectively. The overall decrease primarily relates to discontinued costs associated with termination of the BARDA Contract,contract, as well as lower costs for the GEO-CM04S1 clinical trials and manufacturing costs associated with Gedeptin program. Research and development expenseexpenses for 2026the three-month and 2025six-month includesperiods of 2026 include stock-based compensation expense of $108,177$107,671 and $130,316,$215,848, respectively; as compared to $130,323 and $260,639, respectively, associatedfor withthe employeecomparable stock2025 options.periods.

Our general and administrative expenses were $1,369,418$1,331,564 and $2,700,982 for the three-month periodand six-month periods ended MarchJune 31,30, 2026, as compared to $1,687,445$1,542,190 and $3,229,635 for the comparable 2025 period,periods, representing a decreasedecreases of $318,02713.7% (19%).and 16.4%, respectively. The decrease during 2026 relates primarily to lower investor relations consulting and other programmatic costs and stock-based compensation expense. General and administrative expenseexpenses for 2026the three-month and 2025six-month includesperiods of 2026 include stock-based compensation expense of $111,140$56,075 and $162,428,$167,215, respectively; as compared to $162,417 and $324,845, respectively, associatedfor withthe employeecomparable andperiods consultantof stock options and stock awards.2025.

Interest income for the three-month and six-month periods ended MarchJune 31,30, 2026 and 2025 was $10,960$15,494 and $47,519,$26,454, respectively, withas thecompared differenceto $49,123 and $96,642, respectively, for comparable periods of 2025. The overall decrease during 2026 is attributable to fluctuatingthe average cash balances andavailable interestfor rates.investment.

The following tables summarize our liquidity and capital resources as of MarchJune 31,30, 2026 and December 31, 2025, and our cash flows for the three-monthsix-month periods ended MarchJune 31,30, 2026 and 2025:

Operating Activities – Net cash used in operating activities of $3,537,721$7,195,824 for the three-month periodsix-months ended MarchJune 31,30, 2026, was due to our net loss of $5,261,921,$9,688,499, offset by non-cash items such as depreciation and amortization expense and stock-based compensation expense, and by changes in our working capital accounts. Net cash used in operating activities of $5,965,680$10,300,078 for the three-monthsix periodmonths ended MarchJune 31,30, 2025, was primarily due to our net loss of $5,357,651,$10,727,434, offset by non-cash items such as depreciation and amortization expense and stock-based compensation expense, and by changes in our working capital accounts.

Investing Activities – There were no cash flows from investing activities for the three-monthsix periodmonths ended MarchJune 31,30, 2026. Net cash used in investing activities was $16,894$27,612 for the three-monthsix periodmonths ended MarchJune 31,30, 2025 and relates to purchases of laboratory equipment.

Financing Activities – Net cash provided by financing activities was $1,723,742$7,253,505 for the three-monthsix periodmonths ended MarchJune 31,30, 2026, and relates to offerings of our common stock and warrants. Net cash provided by financing activities was $7,914,402$7,914,611 for the three-monthsix periodmonths ended MarchJune 31,30, 2025, and relates to offerings of our common stock and warrants.

As of the date of this Quarterly Report, we believe that our existing cash and cash equivalents are sufficient to fund our operations into JuneSeptember 2026. We plan to pursue additional cash resources through public or private equity or debt financings, government grants/contracts, arrangements with strategic partners, or from other sources.