Crystal Research Associates has issued a 15-page Company Update on clinical-stage biotechnology company, GeoVax Labs, Inc. (GOVX-NASDAQ).
Snapshot of GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing next-generation vaccines and immunotherapies for serious infectious diseases and solid tumor cancers. Its lead candidate, GEO-CM04S1, is a multi-antigen COVID-19 vaccine designed to provide broader, longer-lasting protection—especially for immunocompromised individuals. Currently in three Phase 2 trials, GEO-CM04S1 is being studied in healthy adults, Chronic Lymphocytic Leukemia (CLL) patients, and those undergoing stem cell transplant or CAR-T therapy. Although the BARDA-funded Phase 2b trial under Project NextGen ended due to external shifts, GeoVax continues to advance the program, driven by strong interim data and unmet global need. In oncology, GeoVax is advancing Gedeptin®, a gene-directed therapy for solid tumors, into a planned Phase 2 trial for recurrent head and neck cancer, alongside preclinical studies in other tumor types. GEO-MVA, the Company’s Mpox and smallpox vaccine candidate, is expected to enter clinical trials in late 2025, addressing global biosecurity risks and vaccine access gaps. Backed by global rights, a robust intellectual property (IP) portfolio, and scalable manufacturing capabilities, GeoVax is supported by an experienced management team with proven success in product development and commercialization.
Key Points
- On May 1, GeoVax announced its Q1 2025 results, reporting a net loss of $5.4 million for the quarter ended March 31, 2025, compared to a $5.9 million loss in the same period of 2024.
- In April 2025, BARDA issued a stop-work order on GeoVax’s planned Phase 2b trial under Project NextGen due to shifting priorities. The award, granted in June 2024, was intended to evaluate GEO-CM04S1 in 10,000 participants. While the program was discontinued, the award affirmed external confidence in GEO-CM04S1’s promise as a next-generation COVID-19 booster, particularly for immunocompromised individuals. Notably, GEO-CM04S1 was the only dual-antigen COVID-19 vaccine selected under the initiative—highlighting its distinct positioning and public health relevance. It should also be noted that the BARDA termination has no impact on GeoVax’s ongoing clinical trials of GEO-CM04S1, primarily addressing immunocompromised patient populations.
- In oncology, GeoVax is preparing a Phase 2 trial of Gedeptin® for recurrent head and neck cancer, in combination with an immune checkpoint inhibitor, with planning and clinical material production underway.
- GeoVax is also advancing GEO-MVA, its Mpox and smallpox vaccine candidate, with clinical trials expected to begin in late 2025. Developed in response to rising health threats, including WHO’s Mpox emergency declaration, GEO-MVA is designed to enhance global pandemic preparedness and provide a U.S.-sourced alternative amid limited international supply. The Company is also investing in domestic manufacturing to support rapid response and strengthen national biosecurity.
- GeoVax is leveraging AI to optimize clinical development, streamline manufacturing, and improve regulatory and supply chain efficiency. These tools are being used to enhance protocol design, accelerate trial analytics, and optimize manufacturing forecasting.
- GeoVax holds more than 130 granted or pending patents across 23 families, providing broad protection for its pipeline and platform technologies.
- As of March 31, 2025, the Company reported cash balances of $7.4 million, up from $5.5 million as of December 31, 2024.
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