GeoVax Advances Mpox/Smallpox Vaccine Toward Phase 3 Trial Amid Global Supply Concerns

GeoVax Labs, Inc. reported its 2025 financial results while detailing significant progress toward late-stage development of its GEO-MVA vaccine candidate for mpox and smallpox. The company plans to initiate a pivotal Phase 3 immuno-bridging study in the second half of 2026, representing a critical step toward regulatory approval and addressing documented global supply constraints in orthopoxvirus vaccines.

David Dodd, Chairman and Chief Executive Officer of GeoVax, stated that GEO-MVA represents a critically important opportunity to eliminate current global supply constraints while supporting broader public health preparedness and biosecurity objectives. The company believes the vaccine is uniquely positioned at the intersection of recurring global mpox outbreaks, depleted government stockpiles following recent outbreaks, and policy-driven demand for diversified and domestic vaccine supply.

During 2025, GeoVax achieved several key milestones advancing GEO-MVA toward late-stage development. The company received formal Scientific Advice from the European Medicines Agency supporting a streamlined and accelerated development pathway, including a single Phase 3 study without the need for prior Phase 1 or Phase 2 trials. Manufacturing progress included completion of cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, establishing readiness for clinical supply and potential commercialization.

Beyond GEO-MVA, GeoVax continues to advance a diversified pipeline spanning infectious diseases and oncology. The company’s GEO-CM04S1 COVID-19 vaccine is advancing through multiple Phase 2 clinical trials targeting immunocompromised populations, with data readouts expected in 2026. Interim DSMB findings in the CLL study indicated superior immune responses versus mRNA comparator. In oncology, Gedeptin completed Phase 1/2 clinical evaluation in advanced head and neck cancer and entered into an exclusive license agreement with Emory University to support combination use with immune checkpoint inhibitors.

Financial results for 2025 showed a net loss of $21.5 million, or $22.40 per share, compared to $25.0 million, or $120.46 per share, for 2024. Revenue for 2025 was $2.5 million from government contract revenues associated with the BARDA/RRPV Project NextGen award, though the company received notification in April 2025 that BARDA determined to terminate the contract for convenience to the government. Research and development expenses decreased to $18.1 million from $23.7 million in 2024, primarily due to discontinued costs associated with termination of the BARDA/RRPV contract and lower costs for GEO-CM04S1 clinical trials and manufacturing. General and administrative expenses increased to $6.0 million from $5.4 million due to higher personnel costs, investor relations consulting, and other programmatic expenses.

The company reported cash balances of $3.1 million on December 31, 2025, compared to $5.5 million on December 31, 2024. Further information is included in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission available at https://www.sec.gov/edgar/searchedgar/companysearch. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities.

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