April 2025 Update on GeoVax Labs, Inc. (GOVX-NASDAQ)
Crystal Research Associates has issued a 17-page Company Update on clinical-stage biotechnology company, GeoVax Labs, Inc. (GOVX-NASDAQ).
Snapshot of GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company advancing next-generation vaccines and immunotherapies for some of the world’s most serious infectious diseases and solid tumor cancers. The Company’s lead infectious disease candidate, GEO-CM04S1, is a novel COVID-19 vaccine designed to offer broader and more durable protection. GEO-CM04S1 is currently being evaluated in three Phase 2 clinical trials and is the focus of a BARDA-funded Phase 2b trial involving 10,000 participants, comparing its efficacy to an approved COVID-19 vaccine. The ongoing studies target immunocompromised individuals, such as those with hematologic cancers, patients with chronic lymphocytic leukemia (CLL), and healthy individuals previously vaccinated with mRNA-based vaccines. In oncology, GeoVax’s lead program is Gedeptin®, a gene-directed oncolytic therapy for solid tumors. Following a successful multicenter Phase 1/2 trial in advanced head and neck cancers, the Company is planning a follow-on Phase 2 trial evaluating Gedeptin® in combination with an immune checkpoint inhibitor in patients with first recurrent disease. In addition, GEO-MVA is advancing to a definitive clinical evaluation with the goal of becoming the first U.S.-provided vaccine against Mpox and smallpox. GeoVax holds worldwide rights to its product candidates and underlying technologies, supported by a strong intellectual property portfolio. The Company is led by a proven management team with decades of experience creating value across the life sciences sector.
Key Points
- On March 27, GeoVax announced year end 2024 financial results and provided a corporate update. The Company reported a 2025 net loss of $25.0 million, slightly improved from 2023’s $26.0 million net loss, driven by $4.0 million in BARDA-related revenue and increased R&D spending on GEO-CM04S1, with general and administrative expenses declining year-over-year.
- GeoVax was awarded nearly $400 million in June 2024 through BARDA’s Project NextGen to support a 10,000-patient Phase 2b trial of GEO-CM04S1, marking a major validation of its COVID-19 vaccine program. Managed by Allucent, the trial is expected to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine.
- The Company presented compelling data showing GEO-CM04S1’s ability to generate strong immune responses and protection against COVID-19, including in individuals previously vaccinated with mRNA vaccines—highlighting its potential as a next-generation booster.
- In oncology, GeoVax has plans for a Phase 2 trial of Gedeptin® for first recurrent head and neck cancer in combination with an immune checkpoint inhibitor. Planning with leading academic oncology centers is underway, while clinical trial material is being produced.
- In response to emerging health threats, including WHO’s Mpox emergency declaration, GeoVax is advancing GEO-MVA, its vaccine candidate targeting Mpox and smallpox, enhancing its pandemic preparedness portfolio. The Company is investing in domestic manufacturing capabilities for its MVA-based vaccines, aiming to strengthen U.S. national security and support rapid response to infectious disease outbreaks.
- GeoVax continues to strengthen its global intellectual property position, with over 130 granted or pending patent applications spread over twenty-three patent families.
- As of December 31, 2024, the Company reported cash balances of $5.5 million versus $6.5 million as of December 31, 2023.
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