Crystal Research Associates has issued a 20-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 February 29, 2024, GeoVax announced financial results for the year ended December 31, 2023, and provided a corporate update. Net loss for the year ended December 31, 2023, was $26.0 million ($14.29/share) versus $14.0 million ($12.39/share) for the year ended December 31, 2022.
- GeoVax completed enrollment for its Phase 2 clinical trial during 2023 investigating GEO-CM04S1 as a universal booster for mRNA COVID vaccines. Concurrently, the Company expanded its Phase 2 trial to encompass multiple sites targeting immunocompromised/stem cell transplant patients, aiming to assess GEO-CM04S1 as a primary vaccine, directly comparing its efficacy to mRNA vaccines. Additionally, GeoVax initiated a third Phase 2 trial focusing on evaluating GEO-CM04S1 among immunocompromised/chronic lymphocytic leukemia (CLL) patients. This trial seeks to assess the vaccine’s efficacy as a booster for patients initially vaccinated with an mRNA vaccine in direct comparison to mRNA vaccination.
- During 2023, the Company completed patient enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients with results demonstrating safety and consistent reduction in treated tumors. The data presented at the AACR-AHNS Head and Neck Cancer Conference emphasized the safety and feasibility of Gedeptin therapy, providing insights into its potential as a treatment option for patients with limited therapeutic alternatives. The initial Phase 1/2 trial aims to guide future studies, potentially expanding the application of Gedeptin in other solid tumor areas and in combination with immune checkpoint inhibitors. The Company expects to report additional results from the Gedeptin Phase 1/2 clinical trial during the first half of 2024, with plans for an expanded Phase 2 clinical trial.
- Relative to its MVA vaccine against Mpox and smallpox, GeoVax expects to report its regulatory path and plans related to advancing this product towards registration. Furthermore, the Company anticipates providing further updates related to its advanced MVA manufacturing process to enable GeoVax to effectively produce and distribute MVA-based vaccines in response to real-time market needs worldwide.
- GeoVax continues to announce actions which strengthened its global intellectual property position, with the Company now holding over 115 granted or pending patent applications spread over twenty-four patent families.
- As of December 31, 2023, the Company’s reported cash balance was $6.5 million versus $27.6 on December 31, 2022.
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