GeoVax Labs, Inc. (Nasdaq: GOVX) announced its financial results and key operational accomplishments for the year ended December 31, 2025, highlighting significant progress in advancing GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate targeting mpox and smallpox. The company plans to initiate a pivotal Phase 3 immuno-bridging study in the second half of 2026, following regulatory alignment with the European Medicines Agency (EMA) and completion of cGMP manufacturing and fill-finish of clinical-grade GEO-MVA.
David Dodd, Chairman and CEO of GeoVax, stated, "During 2025, we made significant progress advancing GEO-MVA toward late-stage clinical development, supported by regulatory alignment with the EMA and key manufacturing milestones. 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." The company's priority program aims to address documented global supply constraints and diversify supply beyond a single foreign manufacturer, positioning GEO-MVA for potential regulatory approval and commercialization.
In addition to GEO-MVA, GeoVax is advancing its pipeline in infectious diseases and oncology. GEO-CM04S1, a COVID-19 vaccine candidate, is progressing through multiple Phase 2 trials targeting immunocompromised populations, with data readouts expected in 2026. The company's oncology program, Gedeptin, completed a Phase 1/2 trial in advanced head and neck cancer and entered an exclusive license agreement with Emory University for combination use with immune checkpoint inhibitors, with a planned Phase 2 trial 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 in 2024, 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, reflecting lower costs associated with the terminated BARDA contract and reduced spending on GEO-CM04S1 and Gedeptin programs. General and administrative expenses increased to $6.0 million from $5.4 million, driven by higher personnel costs and investor relations activities. Cash and cash equivalents stood at $3.1 million as of December 31, 2025, compared to $5.5 million at the end of 2024.
GeoVax believes GEO-MVA is uniquely positioned at the intersection of recurring global mpox outbreaks, depleted government stockpiles, and policy-driven demand for diversified vaccine supply. The company is actively engaging with international regulatory and governmental stakeholders to align GEO-MVA with public health preparedness and biosecurity procurement frameworks. For more information, visit GeoVax's website.
