Tuesday, April 15, 2025
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.
Refer to the full report for the price target, fundamental analysis, and rating.
GeoVax Has Received A Stop Work Order For The Phase 2b Trial. GeoVax has received a Stop Work order for its BARDA-sponsored Phase 2b trial testing of CM04S1 for COVID-19. We have known about other Project NextGen-funded COVID-19 trials that were halted, but hoped the CM04S1 program would continue.
Background On The Phase 2 Trial. In June 2024, BARDA (an office within HHS) selected CM04S1 for a Phase 2b trial to test efficacy, immunogenicity, and safety for protection against COVID-19 as part of Project NexGen. We had expected GeoVax to receive about $25 million for its work on trial design and supplies to be received over several years. During FY2024, GeoVax received payments of $4.0 million.
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