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 focused on developing innovative vaccines for some of the world’s most serious infectious diseases and therapies for solid tumor cancers. The Company’s flagship program, GEO-CM04S1, is a next-generation COVID-19 vaccine. GeoVax recently secured a BARDA-funded contract to conduct a 10,000-participant Phase 2b clinical trial to assess the efficacy of GEO-CM04S1 compared to an approved COVID-19 vaccine. Additionally, GEO-CM04S1 is currently being tested in three Phase 2 clinical trials: (1) as a primary vaccine for immunocompromised patients, including those with hematologic cancers who may not benefit sufficiently from existing COVID-19 vaccines, (2) as a booster for patients with chronic lymphocytic leukemia (CLL), and (3) as a more robust, durable COVID-19 booster for healthy individuals who have previously received mRNA vaccines. In the oncology field, GeoVax’s lead program is the evaluation of Gedeptin®, a novel oncolytic gene-directed therapy for solid tumors, which recently completed a multicenter Phase 1/2 trial targeting advanced head and neck cancers; plans are underway for a follow-on Phase 2 trial in first recurrent head and neck cancer evaluating Gedeptin in combination with an immune checkpoint inhibitor. GeoVax additionally has a solid intellectual property portfolio, holding global rights to its technologies and product candidates. The Company’s leadership team has a proven track record of creating significant value across multiple life science companies over the past few decades.
Key Points
- On November 12, GeoVax announced third quarter 2024 financial results and provided a corporate update. Net loss for the three-month period ended September 30, 2024, was $5.8 million or $0.91 per share versus $8.4 million or $4.75 per share, for the comparable period in 2023.
- GeoVax’s $400 million contract from BARDA is to support a 10,000-participant Phase 2b trial for its GEO-CM04S1 COVID-19 vaccine. The trial, managed by Allucent, will evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine.
- On November 19, GeoVax announced that a DSMB interim review of its Phase 2 trial as a COVID-19 booster vaccine for patients with chronic lymphocytic leukemia (CLL) supported continued enrollment in the GEO-CM04S1 arm. While the mRNA control arm did not meet the primary endpoint, GEO-CM04S1 shows promise as a COVID-19 booster for CLL patients, delivering robust T-cell and antibody responses for durable immunity in immunocompromised groups.
- GeoVax has announced plans for a Phase 2 trial of Gedeptin for first recurrent head and neck cancer in combination with an immune checkpoint inhibitor. The trial is anticipated to begin in mid-2025.
- The development of the GEO-MVA vaccine, targeting Mpox and smallpox, continues with successful cGMP production milestones. The vaccine aims to become the first U.S.-based supplier in a market supported by WHO and CDC recommendations, addressing critical global supply needs.
- The Company continues to strengthen its global intellectual property position, with over 120 granted or pending patent applications spread over twenty-four patent families.
- GeoVax’s collaborations with WHO, BARDA, and other stakeholders are expected to continue to drive global distribution, anticipating revenue growth from its cancer and infectious disease portfolio through clinical milestones and partnerships.
- As of September 30, 2024, GeoVax reported cash balances of $8.5 million, up from $6.5 million as of December 31, 2023.
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