Crystal Research Associates has issued a 4-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 infectious disease vaccine 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 soon, 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 June 16, 2025, GeoVax announced that the European Medicines Agency (EMA) has endorsed GeoVax’s plan to bypass Phase 1 and 2 trials, allowing the Company’s GEO-MVA Mpox/smallpox vaccine to proceed directly to a single Phase 3 immuno-bridging trial using non-inferiority endpoints.
- A successful Phase 3 trial could support a centralized Marketing Authorization Application (MAA) in Europe, while also unlocking access to global health procurement channels including WHO, UNICEF, and GAVI.
- EMA guidance enhances prospects for U.S. and other national Strategic National Stockpile (SNS) inclusions, as well as providing an expansion of overall global MVA-vaccine supply for endemic outbreaks. GEO-MVA is aligned with BARDA’s Rapid Response Partnership Vehicle (RRPV) and national goals around domestic vaccine manufacturing and pandemic preparedness.
- GEO-MVA is working to transition from legacy egg-based production to the AGE1 continuous cell line platform—offering faster, lower-cost, and scalable bioreactor-based manufacturing in the U.S. and internationally.
- The WHO has recently issued a fourth declaration of Mpox as a Public Health Emergency of International Concern (PHEIC), and GEO-MVA would provide a critical alternative to the sole current supplier, Bavarian Nordic, which has faced production and supply limitations.
- GEO-MVA targets a $465M+ preparedness market with global potential of $10B+ across stockpile and endemic use. GeoVax is the only U.S.-based developer of an MVA-based vaccine for Mpox/smallpox.
- GeoVax holds a portfolio of 135+ granted or pending patents. The Company is further leveraging AI to support trial design, manufacturing, and regulatory planning across its broader pipeline.
- As of March 31, 2025, the Company reported $7.4 million in cash and expects to initiate clinical trials of GEO-MVA later in 2025.
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