GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, reported its financial results for the year ended December 31, 2025, and provided a business update on 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 clinical trial 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, “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 primary near-term strategic focus is advancing GEO-MVA through an expedited regulatory pathway, as the program is its most direct path to potential regulatory approval and commercialization. GeoVax aims to diversify vaccine supply beyond a single foreign manufacturer, addressing documented global shortages.
During 2025, GeoVax received formal Scientific Advice from the EMA supporting a streamlined development pathway, including a single Phase 3 immuno-bridging study without prior Phase 1 or Phase 2 trials. The company also completed manufacturing of clinical-grade GEO-MVA, ensuring readiness for clinical supply and potential commercialization. These milestones position GEO-MVA at the intersection of recurring global mpox outbreaks, depleted government stockpiles, and policy-driven demand for diversified vaccine supply.
Beyond GEO-MVA, GeoVax continues to advance its pipeline. The GEO-CM04S1 COVID-19 vaccine is progressing through multiple Phase 2 trials targeting immunocompromised populations, with data readouts expected in 2026. Interim DSMB findings in a chronic lymphocytic leukemia (CLL) study indicated superior immune responses versus an mRNA comparator. In oncology, Gedeptin, a gene-directed enzyme prodrug therapy, completed a Phase 1/2 trial in advanced head and neck cancer, and the company entered an exclusive license agreement with Emory University to explore combination use with immune checkpoint inhibitors, with a Phase 2 trial planned for 2027.
Financially, GeoVax reported a net loss of $21.5 million for 2025, compared to $25.0 million in 2024. Revenue from government contracts, primarily associated with the BARDA/RRPV Project NextGen award, was $2.5 million, down from $4.0 million in 2024. In April 2025, BARDA terminated the contract for convenience. Research and development expenses decreased to $18.1 million from $23.7 million, mainly due to discontinued costs from the BARDA contract and lower costs for GEO-CM04S1 and Gedeptin programs. General and administrative expenses rose to $6.0 million from $5.4 million, driven by higher personnel and investor relations costs. Cash and cash equivalents stood at $3.1 million as of December 31, 2025, compared to $5.5 million a year earlier.
Looking ahead, GeoVax’s priority is executing key clinical and regulatory milestones for GEO-MVA, strengthening strategic partnerships, and selectively advancing other programs. The company expects GEO-MVA to play a central role in global orthopoxvirus preparedness strategies and is actively engaging with international regulatory and governmental stakeholders. For more information, visit www.geovax.com.
