GeoVax Labs, Inc. reported its third quarter 2025 financial results while highlighting substantial advancements across its vaccine and immunotherapy portfolio. The clinical-stage biotechnology company is accelerating development of multiple programs addressing critical public health threats, including the ongoing global mpox emergency and the need for more effective vaccines for immunocompromised populations.
The company's GEO-MVA vaccine program for mpox and smallpox has gained momentum following the World Health Organization's reaffirmation of mpox as a global public health emergency. Favorable scientific advice from the European Medicines Agency has supported a streamlined regulatory pathway for GEO-MVA, positioning GeoVax to become a diversified supplier addressing the increasing mpox threat. A new research collaboration with the University of Queensland and UniQuest will evaluate needle-free delivery using Vaxxas' high-density microarray patch platform, targeting improved thermostability, self-administration, and dose-sparing performance critical for pandemic preparedness.
In its COVID-19 vaccine program, GeoVax presented compelling data from Phase 2 trials of GEO-CM04S1, its multi-antigen vaccine designed for immunocompromised populations. Data presented at the 6th ESCMID Conference on Vaccines in Lisbon and the iwCLL 2025 Workshop in Krakow demonstrated robust T-cell and cross-variant antibody responses in chronic lymphocytic leukemia and hematologic cancer patients, exceeding the immune activity of standard mRNA vaccines. The CLL trial met its primary immunogenicity endpoint, prompting discontinuation of the comparator mRNA arm, while showing no serious adverse events attributed to the vaccine.
The company's oncology program with Gedeptin is expanding into new solid tumor indications following publication of KEYNOTE-689 Phase 3 results confirming the role of perioperative checkpoint inhibition in head and neck cancer. GeoVax announced plans for a Phase 2 trial evaluating Gedeptin combined with pembrolizumab and fludarabine in first-line, resectable head and neck squamous cell carcinoma, with initiation targeted for the second half of 2026. Preclinical studies are also expanding into triple-negative breast and cutaneous cancers in collaboration with Emory University's Winship Cancer Institute.
GeoVax's U.S.-based MVA platform aligns with bipartisan calls for domestic manufacturing and pandemic preparedness investments, as echoed in recent ASPR, BARDA, and State Department initiatives. The company's continuous avian cell line manufacturing process supports legislative goals to modernize domestic biomanufacturing and reduce dependency on foreign vaccine suppliers. Ongoing engagements with global health organizations including CEPI, Africa CDC, WHO, and UNICEF reinforce the company's commitment to biodefense and equitable access.
For the three-month period ended September 30, 2025, GeoVax reported a net loss of $6,318,914, or $0.31 per share, compared to $5,815,468, or $0.91 per share, for the comparable period in 2024. Research and development expenses decreased to $5,043,504 from $7,402,884 in the prior year period, primarily due to discontinued costs associated with termination of the BARDA/RRPV contract and lower costs for GEO-CM04S1 clinical trials. The company reported cash balances of $5,008,997 at September 30, 2025, compared to $5,506,941 at December 31, 2024. Further information is available in the company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and on their investor relations website at https://geovax.com/investors.
