Crystal Research Associates has issued a 16-page Quarterly Update on clinical-stage biotechnology company, GeoVax Labs, Inc. (GOVX-NASDAQ).
Snapshot of GeoVax
GeoVax Labs, Inc. (“GeoVax” or “the Company”) is a clinical-stage biotechnology company developing novel therapies and vaccines for cancers and many of the world’s most threatening infectious diseases. The Company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, currently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate, GEO-CM04S1, is a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. GEO-CM04S1 is being evaluated in three Phase 2 clinical trials: (1) as a primary COVID-19 vaccine for immunocompromised patients versus mRNA vaccines; (2) as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines; and (3) most recently, as a more robust, durable booster versus mRNA vaccines in patients with chronic lymphocytic leukemia (CLL). GeoVax has a leadership team who has driven significant value creation across multiple life science companies over the past several decades.
Key Points
- On May 14, 2024, GeoVax announced first quarter 2024 financial results and provided a corporate update. Net loss for the three months ended March 31, 2024, was $5,580,132, or $2.47 per share versus $4,037,916, or $2.30 per share, for the three months ended March 31, 2023.
- During the quarter, the Company announced a significant milestone with the release of the first lot of GEO-CM04S1, the Company’s next-generation COVID-19 vaccine, produced using a validated chicken embryonic fibroblast (CEF) based production system. This marks the successful transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope to the experienced Contract Development and Manufacturing Organization (CDMO) ABL Europe, a subsidiary of Oxford Biomedica, the Company’s Current Good Manufacturing Practice (CGMP) manufacturing partner.
- The Company completed patient enrollment for Phase 1/2 trial evaluating Gedeptin® in advanced head and neck cancer and anticipates trial completion by third quarter, engaging in protocol discussions for follow-up Phase 2/3 trial targeting advanced head and neck cancer patients with limited treatment options. Additionally, GeoVax expects to disclose its plans for evaluating Gedeptin as combination therapy alongside immune checkpoint inhibitors.
- Regarding its MVA vaccine for Mpox and Smallpox, GeoVax expects to outline its regulatory strategy and advancement plans toward registration. Updates are expected for the Company’s advanced MVA manufacturing process, designed to facilitate the timely production and distribution of GeoVax’s MVA-based vaccines to meet market demands effectively.
- GeoVax continues to announce actions which strengthen its global intellectual property position, with the Company now holding over 115 granted or pending patent applications spread over twenty-four patent families.
- GeoVax reported cash balances of $768,859 at March 31, 2024 versus $6,452,589 at December 31, 2023. The Company is currently undergoing advanced discussions with Biomedical Advanced Research and Development Authority (BARDA) related to Project NextGen, which could be a significant fundraising catalyst for the Company should this come to be.
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