Wednesday, November 13, 2024
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor 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®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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3Q24 Report Reviews Progress During The Quarter. GeoVax reported a loss of $5.8 million or $(0.91) per share. The quarter included first revenues from its BARDA contract for the Project NextGen Phase 2b trial testing CM04S1 as a preventive vaccine for COVID-19. The company gave updates and data timeframes for clinical trials with CM04S1, MVA, and Gedeptin. During the quarter, it raised $13.5 million and ended with a cash balance of $8.6 million on September 30, 2024.
Gedeptin Trial Design Announced. GeoVax announced that the Phase 2 trial in head and neck squamous cell carcinoma (HNSCC) will test Gedeptin in combination with an immune checkpoint inhibitor (ICI) in recurrent patients before surgery. A single-cycle of Gedeptin will be given with a standard dose of Keytruda (pembrolizumab), followed by a second cycle of Keytruda alone, then surgery. Endpoints will include standard measures of response, tumor shrinkage, and survival that would make the data comparable to other treatments. The trial is expected to begin in 1H25.
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