GeoVax Labs, Inc. (Nasdaq: GOVX) reported financial results for the year ended December 31, 2025, and provided a business update highlighting progress in its lead program, GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine candidate targeting mpox and smallpox. The company announced plans to initiate a pivotal Phase 3 immuno-bridging study during the second half of 2026, following regulatory alignment with the European Medicines Agency (EMA).
According to the company, GEO-MVA is being developed on an expedited pathway to address a documented global supply constraint in orthopoxvirus vaccines and to support public health preparedness and biosecurity, including diversification of supply beyond a single foreign manufacturer. The EMA's scientific advice supports a streamlined development approach, including a single Phase 3 study without prior Phase 1 or 2 trials. GeoVax has completed cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, establishing readiness for clinical supply and potential commercialization.
David Dodd, Chairman and CEO of GeoVax, stated, “We believe GEO-MVA represents a critically important opportunity to eliminate the current global supply constraint in orthopoxvirus vaccines, while supporting broader public health preparedness and biosecurity objectives.” He added that the Phase 3 study is the next key step toward regulatory approval and access.
GeoVax also provided updates on other pipeline programs. GEO-CM04S1, a COVID-19 vaccine candidate, is advancing through multiple Phase 2 trials in immunocompromised populations, with data readouts expected in 2026. The oncology program, Gedeptin, completed Phase 1/2 evaluation in advanced head and neck cancer, and the company plans a Phase 2 trial for first-line treatment in 2027.
Financially, GeoVax reported a net loss of $21.5 million for 2025, compared to $25.0 million in 2024. Revenue from government contracts was $2.5 million, down from $4.0 million, primarily due to the termination of the BARDA/RRPV Project NextGen contract in April 2025. Research and development expenses decreased to $18.1 million from $23.7 million, while general and administrative expenses increased to $6.0 million from $5.4 million. Cash and cash equivalents stood at $3.1 million as of December 31, 2025, down from $5.5 million at the end of 2024.
The company emphasized that GEO-MVA is uniquely positioned amid recurring global mpox outbreaks, depleted government stockpiles, and policy-driven demand for diversified vaccine supply. GeoVax is actively engaging with international regulatory and governmental stakeholders to align with public health preparedness and biosecurity procurement frameworks. For more information, visit GeoVax's website.
