Friday, March 01, 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.
Refer to the full report for the price target, fundamental analysis, and rating.
Full Year Loss Was Less Than Expected. GeoVax reported a FY2023 loss of $26.0 million or $(14.29) per share, adjusted for a 1-for-15 reverse split in January 2024. The loss for 4Q23 was $7.6 million or $(4.29) per share, compared with our estimated loss of $9.0 million. Cash on December 31 was $6.5 million. On its quarterly conference call, the company reviewed progress in its clinical programs and confirmed milestones for 2024.
Gedeptin Program Is Moving Forward. In July 2023, GeoVax reported initial data from the Phase 1/2 trial testing Gedeptin head and neck cancer. The data showed successful delivery of the PNP gene, with safety, tumor reduction, and stable disease. Enrollment was completed in 2Q23, with additional results expected in 1H24. Expansion of Phase 2 of trial is planned during 2024. Additional trials using Gedeptin as a neoadjuvant at earlier stages of disease or in combination with immune checkpoint inhibitors may be added.
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