GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company, announced its 2025 year-end financial results and key operational accomplishments, highlighting significant progress with its lead vaccine candidate GEO-MVA. The company plans to initiate a pivotal Phase 3 clinical trial for GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine targeting mpox and smallpox, in the second half of this year. This trial is supported by regulatory alignment with the European Medicines Agency (EMA) and key manufacturing milestones.
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 aims to address the documented global shortage of orthopoxvirus vaccines and diversify supply beyond a single foreign manufacturer.
In 2025, GeoVax achieved formal Scientific Advice from the EMA, supporting a streamlined development pathway that allows a single Phase 3 immuno-bridging study without prior Phase 1 or 2 trials. The company also completed cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, ensuring readiness for clinical supply and potential commercialization.
GeoVax's pipeline also includes GEO-CM04S1, a next-generation COVID-19 vaccine candidate advancing through Phase 2 trials in immunocompromised populations, with data readouts expected in 2026. Interim findings in a chronic lymphocytic leukemia (CLL) study showed superior immune responses versus an mRNA comparator. Additionally, Gedeptin®, an oncology therapy, completed Phase 1/2 evaluation in advanced head and neck cancer, with a planned 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 decreased to $2.5 million from $4.0 million, primarily due to the termination of the BARDA/RRPV Project NextGen contract in April 2025. Research and development expenses fell to $18.1 million from $23.7 million, reflecting lower costs related to 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 and investor relations costs. Cash and cash equivalents stood at $3.1 million as of December 31, 2025, down from $5.5 million a year earlier.
The company remains focused on executing key GEO-MVA clinical and regulatory milestones, strengthening strategic partnerships, and selectively advancing other programs. For more information, visit GeoVax's website. Further financial details are available in the company's Annual Report on Form 10-K filed with the SEC.
