GeoVax Labs, Inc., a biotechnology company developing immunotherapies and vaccines for cancers and infectious diseases, reported progress across multiple clinical programs in its third quarter 2024 financial results and business update.
The company is preparing to initiate a 10,000-participant Phase 2b clinical trial of its next-generation COVID-19 vaccine, GEO-CM04S1, as part of the U.S. government’s Project NextGen program. GeoVax is collaborating with BARDA and its CRO partner Allucent to activate clinical trial sites. The study will compare GEO-CM04S1 to an FDA-approved mRNA COVID-19 vaccine.
GeoVax expects to report interim results in Q4 2024 from two ongoing Phase 2 trials of GEO-CM04S1 – one in immunocompromised patients with chronic lymphocytic leukemia and another as a booster in healthy adults. A third Phase 2 trial in stem cell transplant patients is continuing enrollment.
For its cancer immunotherapy program, GeoVax is preparing to launch a Phase 2 trial in the first half of 2025 evaluating Gedeptin in combination with an immune checkpoint inhibitor for first recurrent head and neck cancer. The trial will enroll approximately 36 patients to assess efficacy.
The company is also advancing its Mpox and smallpox vaccine candidate, GEO-MVA. A cGMP clinical batch is expected to be produced in Q4 2024, supporting GeoVax’s goal of creating the first U.S.-based Mpox vaccine source.
GeoVax reported a net loss of $5.8 million for Q3 2024, compared to $8.4 million in Q3 2023. The company recognized $2.8 million in government contract revenue related to the BARDA Project NextGen award. Research and development expenses increased to $7.4 million, primarily due to manufacturing and clinical trial costs for GEO-CM04S1.
As of September 30, 2024, GeoVax had a cash balance of $8.6 million, up from $6.5 million at the end of 2023. The company completed additional funding during the quarter to support its clinical programs.
GeoVax Chairman and CEO David Dodd stated, ‘2024 has shaped up to be a year of steady progress and execution across our development programs. We believe we are well-positioned to advance our priority programs in support of developing innovative solid tumor therapies and infectious disease vaccines.’
The company’s progress in multiple clinical-stage programs for COVID-19, cancer, and other infectious diseases demonstrates its continued efforts to develop novel vaccines and therapies to address significant unmet medical needs. The major government-supported trial of GEO-CM04S1 and advancement of cancer immunotherapies could position GeoVax for important clinical readouts in the coming year.
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