Crystal Research Associates has issued a 19-page Quarterly Update on clinical-stage biotechnology company, GeoVax Labs, Inc. (GOVX-NASDAQ).
Snapshot of GeoVax
GeoVax Labs, Inc. (“GeoVax” or “the Company”) is a clinical-stage biotechnology company developing preventive and therapeutic human vaccines and immunotherapies against infectious diseases and cancer. The Company recently significantly expanded its clinical stage portfolio through the in-licensing of two Phase 2 products/programs within SARS-CoV-2 and Head & Neck Cancer immunotherapy. Its proprietary GV-MVA-VLP™ vector vaccine technology utilizes a Modified Vaccinia Ankara (MVA) vector, a large virus capable of carrying several vaccine antigens, which are expressed as non-infectious virus-like particles (VLPs) in the individual receiving the vaccine (in vivo). VLPs mimic a natural infection, stimulating both the humoral (antibody) and cellular (T-cells) arms of the immune system to recognize, prevent, and control the target infection through durable immune responses. In addition to the GV-MVA-VLP™ technology, the recent license of the SARS-CoV-2 vaccine (GEO-CM04S1) provides the Company a complementary technology, sMVA (synthetic MVA), and the license of Gedeptin® adds the GDEPT (Gene Directed Enzyme Prodrug Therapy) technology to GeoVax’s technology platform portfolio. GeoVax is capitalizing on these technologies and its vaccine/immunotherapy design expertise to address the need for a broadly effective COVID-19 vaccine. The Company is also developing vaccines against Zika virus (ZIKV), hemorrhagic fever (HF) viruses (Ebola, Sudan, Marburg, and Lassa Fever), and malaria, while also applying its MVA-VLP™ technology to cancer immunotherapy (immuno-oncology).
Key Points
- On August 3, 2022, GeoVax announced financial results for the second quarter ended June 30, 2022 and provided a corporate update. The Company reported a net loss of $2,241,699 ($0.21 per share) for the three months ended June 30, 2022 versus a net loss of $1,314,033 ($0.18 per share) for the same period in 2021. For the six months ended June 30, 2022, GeoVax’s net loss was $4,669,214 ($0.47 per share) versus a net loss of $2,876,811 ($0.49 per share) in 2021.
- GeoVax is focused on two Phase II clinical trials supporting GEO-CMO4S1 to induce immunity to SARS-CoV-2 by stimulating the immune system to produce antibodies against SARS-CoV-2 to block the virus from entering healthy cells, while the immune system can grow new disease fighting T-cells to recognize and destroy infected cells. If effective, GEO-CM04S1 would reduce the need for repeated booster vaccine doses. GeoVax is also assessing GEO-CM02 as a single-dose universal coronavirus vaccine.
- For Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), GeoVax seeks to complete patient enrollment in the Phase 1/2 trial towards early 2023, followed by completion of patient evaluations, perhaps by the end of 2023 or 2024. The Company is optimistic about the promise of this drug, where it has received orphan drug designation and has previously provided encouraging potential for such patients.
- MVA is the vaccine used and stockpiled for immunization against Monkeypox. It is also the vaccine vector used in GeoVax’s vaccines targeting COVID-19, Hemorrhagic fever viruses, HIV, Zika, and GeoVax’s MVA-VLP-MUC1 cancer immunotherapy. Prior peer-reviewed publications have shown prevention of Monkeypox in non-human primate models by GeoVax’s MVA-based HIV vaccines. Evaluation is underway of GEO-CM04S1 in preventing Monkeypox, with results demonstrating potential successful protection, validating GEO-CM04S1’s possible projection against both COVID-19 and Monkeypox.
- The Company continues to strengthen its intellectual property portfolio with over 70 granted or pending patent applications across 20 patent families.
- In May 2022, GeoVax added to its cash resources through a follow-on offering and private placement of common stock and warrants with net proceeds of approximately $18.5 million, supplementing the $9.2 million raised in January 2022. GeoVax’s cash balances at June 30, 2022 was $30.9 million.
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