GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, reported its financial results for the year ended December 31, 2025, and provided a business update. The company highlighted significant progress in advancing its lead candidate, GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine targeting mpox and smallpox, toward late-stage clinical development.
GeoVax received formal Scientific Advice from the European Medicines Agency (EMA) supporting a streamlined development pathway for GEO-MVA, including a single Phase 3 immuno-bridging study without prior Phase 1 or 2 trials. This regulatory alignment is a critical step toward potential approval. The company completed cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, establishing readiness for clinical supply and potential commercialization. GeoVax plans to initiate the pivotal Phase 3 trial in the second half of 2026.
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 is positioning GEO-MVA to address recurring global mpox outbreaks, depleted government stockpiles, and policy-driven demand for diversified vaccine supply.
Beyond GEO-MVA, GeoVax is advancing its pipeline. GEO-CM04S1, a next-generation COVID-19 vaccine, is progressing through multiple Phase 2 trials targeting immunocompromised populations, with data readouts expected in 2026. Interim findings from a study in chronic lymphocytic leukemia patients showed superior immune responses compared to 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 GeoVax entered into an exclusive license agreement with Emory University to support combination use with immune checkpoint inhibitors. A Phase 2 trial for first-line treatment is planned for 2027.
For full-year 2025, GeoVax reported a net loss of $21.5 million, or $22.40 per share, compared to a net loss of $25.0 million, or $120.46 per share, 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 award in April 2025. Research and development expenses decreased to $18.1 million from $23.7 million, largely due to discontinued costs from the BARDA contract and lower expenses for GEO-CM04S1 and Gedeptin programs. General and administrative expenses rose 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.
The company's focus remains on executing key clinical and regulatory milestones for GEO-MVA, strengthening strategic partnerships, and selectively advancing other programs. GeoVax continues to engage with international regulatory and governmental stakeholders to align GEO-MVA with public health preparedness and biosecurity procurement frameworks. For more information, visit www.geovax.com.
