GeoVax Labs, Inc. (Nasdaq: GOVX) reported its financial results for the year ended December 31, 2025, and provided a business update highlighting progress with its lead vaccine candidate GEO-MVA against mpox and smallpox. The company announced that it 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 vaccine.
GEO-MVA is a Modified Vaccinia Ankara (MVA)-based vaccine designed to address the global supply shortage of orthopoxvirus vaccines. The EMA's Scientific Advice supports a streamlined development pathway, allowing a single Phase 3 study without prior Phase 1 or 2 trials, which could accelerate time to market. The company believes GEO-MVA is uniquely positioned amid recurring mpox outbreaks, depleted government stockpiles, and policy-driven demand for diversified vaccine supply.
Beyond GEO-MVA, GeoVax is advancing GEO-CM04S1, a next-generation COVID-19 vaccine targeting immunocompromised populations, with data readouts expected in 2026. The company also progressed its oncology program Gedeptin®, completing a Phase 1/2 trial in advanced head and neck cancer and planning a Phase 2 combination study with immune checkpoint inhibitors 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 decreased to $2.5 million from $4.0 million, primarily due to the termination of the BARDA/RRPV Project NextGen award in April 2025. Research and development expenses fell to $18.1 million from $23.7 million, reflecting discontinued costs from the BARDA contract and reduced spending on COVID-19 and oncology programs. General and administrative expenses rose to $6.0 million from $5.4 million, driven by higher personnel and consulting costs. 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's Chairman and CEO David Dodd emphasized the importance of GEO-MVA in eliminating global supply constraints and supporting public health preparedness. With the Phase 3 trial initiation later this year, GeoVax aims to secure regulatory approval and access, providing a critically needed MVA vaccine source. The company continues to evaluate strategic partnerships and funding opportunities to support its pipeline.
