GeoVax Labs, Inc.

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and solid tumor cancers using novel proprietary platforms. The company operates in the biotechnology industry, which is characterized by rapid technological change, evolving industry standards, emerging competition, and new product introductions. The market for vaccines that protect against or treat human infectious diseases is intensely competitive and subject to rapid and significant technological change. GeoVax's primary near-term strategic development priority is the advancement of GEO-MVA, a Modified Vaccinia Ankara (MVA) vaccine candidate for mpox, smallpox, and other poxviruses, which is being advanced on an expedited regulatory pathway in Europe and is intended to address a significant global supply constraint for orthopoxvirus vaccines. The company also develops Gedeptin, a novel oncolytic solid tumor gene-directed therapy, and GEO-CM04S1, a next-generation multi-antigen COVID-19 vaccine.

GeoVax faces intense competition from large pharmaceutical companies including Sanofi, GSK, Merck, Mitsubishi Tanabe, Takeda, and Pfizer; mid-size pharmaceutical companies and emerging biotechnology companies including Dynavax, Novavax, Moderna, BioNTech and Bavarian Nordic; and academic and not-for-profit vaccine researchers and developers including the NIH. More than forty COVID-19 vaccines are currently authorized for use in one or more countries around the world, including three in the U.S. (from Pfizer/BioNTech, Moderna, and Novavax). A number of companies are developing various types of therapeutic vaccines or other immunotherapy approaches to treat cancer including Advaxis, Immune Design, Oncothyreon, Bavarian Nordic, Roche Pharmaceuticals, Merck, Bristol Myers Squibb, and AstraZeneca. For hemorrhagic fever viruses, competitors include NewLink Genetics and Merck, Johnson & Johnson, Novavax, Inovio and GlaxoSmithKline. GeoVax believes GEO-MVA is well-positioned to support both civilian public health needs and broader preparedness and biodefense objectives, and that its MVA platform offers potential advantages including a large genetic coding capacity, ability to effectively induce durable T-cell responses, and a strong safety profile due to its inability to replicate in human cells.

GeoVax generates revenue through government grants and contracts and other collaborative arrangements in support of its product development activities. The company has not generated any revenue to date from the sale of the products it is developing. Its corporate strategy is to advance, protect, and strategically leverage its proprietary vaccine and immunotherapy platforms to develop differentiated preventive and therapeutic solutions for infectious diseases and solid tumors. The company aims to efficiently progress its product candidates through clinical development and pursue regulatory approval and commercialization through internal development and selective external licensing and partnership arrangements. GeoVax also works collaboratively with academic, governmental, and industry partners to validate its technologies, support development efforts and enhance the strategic value of its pipeline.

GeoVax's primary near-term strategic development priority is GEO-MVA, an MVA vaccine candidate for mpox and smallpox. GEO-MVA is being advanced on an expedited regulatory pathway in Europe, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026. The company has received formal Scientific Advice from the European Medicines Agency (EMA) confirming alignment with its proposed immuno-bridging strategy, supporting progression directly to a single pivotal Phase 3 immuno-bridging clinical trial, and indicating that Phase 1 and Phase 2 studies could be omitted, subject to the absence of unexpected findings. A cGMP clinical drug substance batch of GEO-MVA has been successfully produced to support clinical development. The company believes GEO-MVA represents its most near-term opportunity to achieve regulatory approval and potential commercialization.

The company's lead clinical program in oncology is Gedeptin, a novel oncolytic solid tumor gene-directed therapy which recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial evaluating Gedeptin in combination with an immune checkpoint inhibitor (ICI) as first-line treatment of patients with squamous cell head and neck cancer eligible for curative surgery is planned to initiate during the first half of 2027. In February 2026, GeoVax entered into an exclusive worldwide license agreement with Emory University for intellectual property covering the use of Gedeptin in combination with ICIs. The FDA has granted Gedeptin orphan drug designation for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers. The company is also developing GEO-CM04S1, a next-generation multi-antigen COVID-19 vaccine currently being evaluated in two Phase 2 clinical trials: as a primary vaccine for immunocompromised patients, including those with hematologic cancers, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL), where an interim Data Safety Monitoring Board (DSMB) review demonstrated superior immune responses versus an mRNA vaccine. An additional clinical trial evaluating GEO-CM04S1 as a more robust booster vaccine in healthy adults who previously received an mRNA vaccine has completed enrollment with data readouts anticipated in the first half of 2026. In June 2024, GeoVax received an award through the Rapid Response Partnership Vehicle (RRPV) funded by BARDA to advance development of GEO-CM04S1 in a Phase 2b clinical trial, but on April 11, 2025, received written notification from ATI directing the company to immediately cease all work related to the ATI-RRPV contract, and BARDA determined to terminate the contract for convenience. GeoVax is also developing preclinical hemorrhagic fever virus vaccines (Ebola Zaire, Ebola Sudan, Marburg) utilizing its GV-MVA-VLP platform, with initial studies showing significant levels of protection in animal models.

During the fiscal year, GeoVax completed several capital-raising transactions. On March 25, 2025, the company closed a registered direct offering of its common stock and warrants with net proceeds of approximately $4.1 million ¹. On July 2, 2025, the company closed a public offering of its common stock and warrants with net proceeds of approximately $5.5 million ². On September 30, 2025, the company closed a registered direct offering of its common stock and warrants with net proceeds of approximately $2.3 million ³. On December 22, 2025, the company closed a public offering of its common stock and warrants with net proceeds of approximately $3.0 million ⁴. During 2025, the company also sold shares of its common stock pursuant to an At-the-Market (ATM) Program for net proceeds of approximately $4.1 million ⁵. In September 2023, GeoVax entered into a commercial, multi-product license agreement for ProBioGen's AGE1.DR.piX suspension avian cell line to support scalable manufacturing of MVA-based vaccines. The company has completed cGMP manufacture and fill-finish of clinical-grade GEO-MVA material to support planned late-stage clinical development activities. In December 2025, GeoVax announced the formation of an expanded Scientific Advisory Board focused on infectious diseases and vaccine development. In February 2026, the company announced the expansion of its Oncology Scientific Advisory Board to support the advancement of Gedeptin.

For the year ended December 31, 2025, GeoVax reported revenue from government contract of $2,489,145 ⁶, compared to $3,954,576 ⁷ in 2024. The company reported a net loss of $21,464,771 ⁸ for 2025, compared to a net loss of $24,992,296 ⁹ in 2024. Research and development expenses were $18,121,519 ¹⁰ in 2025, compared to $23,713,602 ¹¹ in 2024, representing a decrease of $5,592,083 ¹² or 24% ¹³. General and administrative expenses were $6,006,673 ¹⁴ in 2025, compared to $5,385,254 ¹⁵ in 2024, representing an increase of $621,419 ¹⁶ or 12% ¹⁷. Loss from operations was $21,639,047 ¹⁸ in 2025, compared to $25,144,280 ¹⁹ in 2024. Interest income was $174,276 ²⁰ in 2025, compared to $173,359 ²¹ in 2024. The company had no interest expense in 2025, compared to $21,375 ²² in 2024. Cash and cash equivalents as of December 31, 2025 were $3,085,741 ²³, compared to $5,506,941 ²⁴ as of December 31, 2024. Net cash used in operating activities was $21,473,969 ²⁵ in 2025, compared to $24,675,511 ²⁶ in 2024. Net cash provided by financing activities was $19,080,381 ²⁷ in 2025, compared to $23,750,516 ²⁸ in 2024.

GeoVax's primary near-term growth vector is the advancement of GEO-MVA, an MVA vaccine candidate for mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026 ²⁹. The company has received formal Scientific Advice from the EMA confirming alignment with its proposed immuno-bridging strategy, supporting progression directly to a single pivotal Phase 3 immuno-bridging clinical trial, and indicating that Phase 1 and Phase 2 studies could be omitted, subject to the absence of unexpected findings. GeoVax believes GEO-MVA is well-positioned to address a documented global supply constraint for orthopoxvirus vaccines, as current MVA-based mpox/smallpox vaccine supply is concentrated with a single foreign manufacturer. The company believes GEO-MVA represents its most near-term opportunity to achieve regulatory approval and potential commercialization, and that it is well-positioned to support both civilian public health needs and broader preparedness and biodefense objectives, including replenishing the U.S. Strategic National Stockpile.

Another growth vector is the advancement of Gedeptin, a novel oncolytic solid tumor gene-directed therapy. A Phase 2 clinical trial evaluating Gedeptin in combination with an immune checkpoint inhibitor (ICI) as first-line treatment of patients with squamous cell head and neck cancer eligible for curative surgery is planned to initiate during the first half of 2027 ³⁰. The trial is designed to assess major pathological response (MPR) as well as associated immunologic and biomarker outcomes following two pre-surgical cycles of therapy, and event-free survival over a one-year period. In February 2026, GeoVax entered into an exclusive worldwide license agreement with Emory University for intellectual property covering the use of Gedeptin in combination with ICIs, strengthening its intellectual property position around Gedeptin-based combination therapies. The company believes Gedeptin's localized tumor-debulking and immune-sensitizing mechanism may complement checkpoint inhibition by increasing antigen release and immune recognition within the tumor microenvironment.

GeoVax expects its research and development expenditures to increase as it advances its existing and future product candidates into and through clinical trials and pursues regulatory approval, especially with regard to the ongoing and planned GEO-CM04S1, Gedeptin and GEO-MVA clinical programs. The company expects its general and administrative expenses will increase in the future as it supports expanded research and development activities, prepares for potential commercialization of its current and future product candidates, and maintains compliance with requirements of Nasdaq and the SEC. Research and development costs are charged to expense as incurred. The company does not provide specific margin or cost targets.

GeoVax's manufacturing strategy relies primarily on established third-party contract manufacturing organizations (CMOs) rather than on the construction and operation of wholly owned manufacturing facilities. The company currently engages qualified third-party manufacturers to produce clinical trial material in compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements of FDA and, where applicable, the EMA. GeoVax has completed cGMP manufacture and fill-finish of clinical-grade GEO-MVA material to support planned late-stage clinical development activities. The company is advancing a transition toward a continuous, cell-line-based manufacturing process for MVA-based vaccines and immunotherapies, having entered into a commercial, multi-product license agreement for ProBioGen's AGE1.DR.piX suspension avian cell line in September 2023. GeoVax is also modernizing the Gedeptin manufacturing platform by switching to the CAP Ad suspension cell line for manufacturing. The company currently has nineteen full-time employees ³¹ and believes its current facilities are adequate to meet its immediate needs.

GeoVax's research and development expenditures were $18.1 million ³² during the year ended December 31, 2025, and $23.7 million ³³ during the year ended December 31, 2024. The company expects research and development costs to increase as its vaccines continue through the process of obtaining regulatory approval. Capital expenditure plans are not specifically quantified in the filing beyond purchases of laboratory equipment totaling $27,612 ³⁴ in 2025 and $20,653 ³⁵ in 2024. The company has not formulated any plans for marketing and sales of any vaccine candidate it may successfully develop. GeoVax has never declared or paid cash dividends on its common stock and does not anticipate paying any dividends on its common stock in the foreseeable future. The company has not disclosed any share repurchase authorization amounts.

GeoVax faces significant headwinds related to its capital requirements and going concern status. The company has a history of operating losses, having incurred a net loss of approximately $21.5 million ³⁶ for the year ended December 31, 2025, and expects losses to continue for the foreseeable future. The company has received a going concern opinion from its independent registered public accounting firm, reflecting substantial doubt about its ability to continue as a going concern. As of the date of the Annual Report, the company believes its existing cash and cash equivalents are sufficient to fund its operations into mid-second quarter of 2026 ³⁷. The company will require substantial additional financing at various intervals for its operations, including clinical trials, operating expenses, intellectual property protection and enforcement, 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 the company or at all.

GeoVax faces regulatory and legal uncertainties that could result in significant costs or otherwise harm its business. The company must comply with extensive domestic and international regulation, and satisfaction of regulatory requirements, including FDA requirements, typically takes many years and requires the expenditure of substantial resources. Federal agency priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles, and the current U.S. presidential administration has committed to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agencies, such as HHS and the FDA. The company also faces intense competition and rapid technological change that could result in products that are superior to, or earlier to the market than, the products it will be commercializing or developing. Additionally, the company's products are based on new medical technology and are inherently risky, with the possibility that the products will not be effective, will be unsafe, or will otherwise fail to receive the necessary regulatory approvals.

GeoVax faces material risks related to its capital requirements and going concern status. The company has a history of operating losses, having incurred a net loss of approximately $21.5 million ³⁸ for the year ended December 31, 2025, and expects losses to continue for the foreseeable future. The company has received a going concern opinion from its independent registered public accounting firm, reflecting substantial doubt about its ability to continue as a going concern. As of the date of the Annual Report, the company believes its existing cash and cash equivalents are sufficient to fund its operations into mid-second quarter of 2026 ³⁹. The company will require substantial additional financing and there is no assurance that such funding will be available on acceptable terms. Additionally, the company's products are in varying stages of development and have not been proven in human clinical trials or approved by any government agency for sale. The company faces intense competition from large pharmaceutical companies and biotechnology firms with substantially greater resources. The company also faces risks related to its reliance on third-party manufacturers and clinical investigators, and the potential for delays in clinical trials. Furthermore, the company's success depends on its ability to obtain, maintain, protect, and enforce its intellectual property rights, and the company could lose its license rights to important intellectual property if it does not fulfill its contractual obligations to its licensors. The company's common stock is subject to potential delisting from the Nasdaq Capital Market if it fails to meet continued listing requirements, including a minimum bid price of $1.00 per share and a minimum market value of publicly held securities of at least $1 million ⁴⁰.

Management's message emphasizes that GeoVax's primary near-term strategic development priority is the advancement of GEO-MVA, an MVA vaccine candidate for mpox and smallpox, which is being advanced on an expedited regulatory pathway in Europe and is intended to address a documented global supply constraint for orthopoxvirus vaccines. Management states that the advancement of GEO-MVA represents the company's most near-term opportunity to achieve regulatory approval and potential commercialization, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026 ⁴¹. Management also highlights the planned Phase 2 clinical trial evaluating Gedeptin in combination with an immune checkpoint inhibitor as first-line treatment of patients with squamous cell head and neck cancer eligible for curative surgery, anticipated to begin in the first half of 2027 ⁴². The strategic priorities emphasized are: advancing GEO-MVA through an expedited regulatory pathway to address global supply constraints for orthopoxvirus vaccines; progressing Gedeptin into a Phase 2 combination trial with ICIs; and continuing development of GEO-CM04S1 as a next-generation COVID-19 vaccine for immunocompromised populations. Management notes that the company's corporate strategy is to advance, protect, and strategically leverage its proprietary vaccine and immunotherapy platforms to develop differentiated preventive and therapeutic solutions for infectious diseases and solid tumors, and to efficiently progress product candidates through clinical development and pursue regulatory approval and commercialization through internal development and selective external licensing and partnership arrangements.