Crystal Research Associates has issued a 17-page Quarterly Update on clinical-stage biotechnology company, GeoVax Labs, Inc. (GOVX-NASDAQ).
Snapshot of GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing multi-antigen vaccines for infectious diseases and gene-directed therapies for solid tumors. Its lead program, GEO-CM04S1, is an MVA-based COVID-19 vaccine designed to provide broader, more durable protection, particularly for immunocompromised patients who remain underserved by current mRNA vaccines. GEO-CM04S1 is in multiple Phase 2 trials as a primary vaccine in immunocompromised patients (including those with hematologic malignancies or post-transplant status) and as a booster in both patients with chronic lymphocytic leukemia (CLL) and healthy adults previously vaccinated with mRNA vaccines. In oncology, the Company’s lead asset is Gedeptin®, a gene-directed enzyme prodrug therapy that has completed a multicenter Phase 1/2 trial in advanced head and neck cancers, with a Phase 2 neoadjuvant trial (AdPNP-203) in preparation that will evaluate intra-tumoral Gedeptin with intravenous fludarabine and neoadjuvant pembrolizumab, alongside expanded preclinical work in additional solid tumors. GeoVax is also advancing GEO-MVA, a Mpox and smallpox vaccine candidate that, based on favorable European Medicines Agency advice, is expected to move directly into a single Phase 3 immunobridging trial. Supported by worldwide rights, a growing intellectual property portfolio, and scalable manufacturing plans, including a shift from egg-based to modern cell line platforms, GeoVax is led by an experienced management team focused on high-impact vaccines and immunotherapies for urgent, underserved medical needs.
Key Points
- On November 13, 2025, GeoVax reported a Q3 2025 net loss of $6.3 million ($0.31 per share) versus $5.8 million ($0.91 per share) in Q3 2024. The Company ended the quarter with $5.0 million in cash.
- Phase 2 trials of GEO-CM04S1 in immunocompromised and CLL patients continue to show strong T-cell and antibody responses, no serious vaccine-related adverse events, and achievement of the CLL trial’s primary immunogenicity endpoint.
- GEO-MVA advanced along an EMA-endorsed pathway in which a single Phase 3 immunobridging trial is expected to support centralized EU marketing authorization, with WHO’s reaffirmation of Mpox as a global emergency and reinforcing the need for additional MVA-based vaccine supply.
- Gedeptin® is being advanced into AdPNP-203, a Phase 2 neoadjuvant trial in resectable head and neck squamous cell carcinoma (Gedeptin + fludarabine + neoadjuvant pembrolizumab), with preclinical work expanding into triple-negative breast and cutaneous malignancies.
- GeoVax reinforced its role as a U.S.-based “Made-in-America” MVA vaccine developer, highlighting continuous avian cell-line manufacturing, alignment with U.S. biodefense and onshoring priorities, and active engagement with U.S. and global health agencies.
- The Company’s IP portfolio includes a June 2025 U.S. patent on a novel MVA-based malaria vaccine construct and more than 135 patents across 23 families supporting its multi-antigen infectious disease and oncology platform.
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