Thursday, November 09, 2023
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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GeoVax Announces 2024 Milestones and 3Q23 Financial Results. GeoVax reported a 3Q23 loss of $8.4 million or $(0.32) per share. The company reviewed the progress made during the quarter, including completion of enrollment for the Phase 2 trial testing CM04S1 as a booster in healthy patients, presentation of data from the Phase 1/2 data for Gedeptin showing safety and tumor reduction, and addition of 3 new clinical sites for the Phase 2 trial for CM04S1 in immunocompromised patients.
CM04S1 Has Made Progress In Three Trials. Enrollment has been completed in the Phase 2 trial testing CM04S1 as a booster for healthy patients that had received the Pfizer or Moderna mRNA vaccines. An announcement of the top-line data is expected shortly. As discussed in our Research Note on September 25, a publication of data from the Phase 2 trial in immuno-compromised patients showed both humoral and cellular immune responses in patients that have difficulty responding to vaccination. Three new clinical sites were also added to the trial. An Investigator Initiated Trial (IIT) in chronic lymphocytic leukemia (CLL) is expected to announce interim data in the coming months.
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