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

GeoVax Labs, Inc. reported its 2025 year-end financial results while highlighting significant progress toward late-stage clinical development of its GEO-MVA vaccine candidate for mpox and smallpox. The company announced plans to initiate a pivotal Phase 3 immuno-bridging study during the second half of 2026, representing a critical step toward potential regulatory approval and addressing documented global supply constraints in orthopoxvirus vaccines. David Dodd, Chairman and Chief Executive Officer of GeoVax, emphasized that GEO-MVA represents a critically important opportunity to eliminate current global supply limitations while supporting broader public health preparedness and biosecurity objectives.

The company's primary near-term strategic focus remains the advancement of GEO-MVA, a Modified Vaccinia Ankara-based vaccine candidate being developed on an expedited regulatory pathway. During 2025, GeoVax achieved several key milestones including regulatory alignment with the European Medicines Agency (EMA), which supported a streamlined development pathway requiring only a single Phase 3 study without prior Phase 1 or Phase 2 trials. The company also completed cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, establishing readiness for clinical supply and potential commercialization. GeoVax believes GEO-MVA 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.

Beyond its priority program, 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, supporting continued development. 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. The company is planning a Phase 2 trial for first-line treatment in locally advanced head and neck squamous cell carcinoma in 2027.

Financially, GeoVax reported a net loss of $21.5 million for the year ended December 31, 2025, compared to $25.0 million for the prior year. The company reported $2.5 million of government contract revenues associated with the BARDA/RRPV Project NextGen award, though it 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 for 2025 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, primarily 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 at https://www.sec.gov.