GeoVax Labs, Inc.

GeoVax Labs, Inc. is a clinical-stage biotechnology company that develops human vaccines and immunotherapies for infectious diseases and solid tumor cancers using proprietary platforms. The company's main near-term development focus is GEO-MVA, a Modified Vaccinia Ankara (MVA) vaccine candidate for mpox, smallpox, and other poxviruses. GEO-MVA is on an expedited regulatory pathway in Europe to address global supply constraints for orthopoxvirus vaccines. The company plans to start a pivotal Phase 3 clinical trial for GEO-MVA in the second half of 2026. GeoVax's lead oncology program is Gedeptin®, an oncolytic solid tumor gene-directed therapy. Gedeptin® recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial for Gedeptin® combined with an immune checkpoint inhibitor (ICI) as a first-line treatment for patients with squamous cell head and neck cancer eligible for curative surgery is planned to begin in the first half of 2027. The company is also developing GEO-CM04S1, a multi-antigen COVID-19 vaccine. GEO-CM04S1 is being evaluated in two Phase 2 clinical trials: one as a primary vaccine for immunocompromised patients, and another as a booster vaccine in patients with chronic lymphocytic leukemia (CLL), where an interim Data Safety Monitoring Board (DSMB) review showed superior immune responses compared to an mRNA vaccine. An additional clinical trial evaluating GEO-CM04S1 as a booster in healthy adults who previously received an mRNA vaccine has completed enrollment, with data readouts expected in the first half of 2026.