Crystal Research Associates has issued a 15-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. The Company’s 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/COH04S1) provides the Company a complementary technology, sMVA (synthetic MVA), and the license of Gedeptin® adds the GDEPT (Gene Directed Enzyme Prodrug Therapy) technology to the GeoVax 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 March 9, 2022, GeoVax announced financial results from the fiscal year ended December 31, 2021 and provided a corporate update. For the year ended December 31, 2021, GeoVax reported a net loss of $18.6 million versus $3.0 million for the year ended December 31, 2020.
- During the quarter, GeoVax announced the initiation of vaccine dosing in the Phase 2 portion of its Phase 1/2 clinical trial of COH04S1, a multi-antigenic SARS-CoV-2 investigational vaccine, targeting both the spike (S) and nucleocapsid (N) proteins, to evaluate its use as a universal booster to current FDA-approved vaccines. COH04S1 is uniquely different from the many vaccines that have been developed because it targets both the spike and nucleocapsid proteins, in contrast to the current U.S. FDA-approved COVID-19 vaccines, which only target the spike protein.
- By inducing immune responses to both the S and N antigens, the COH04S1 vaccine may offer greater protection against the significant sequence variation observed with the S antigen, particularly with the newly identified Omicron VOC. The COH04S1 vaccine’s MVA backbone may also be more effective at inducing SARS-CoV-2 cellular immunity, since MVA strongly induces T cell responses, even in immunocompromised individuals.
- Patient enrollment continues for a Phase 1/2 trial of Gedeptin® therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. In January 2022, GeoVax announced the engagement of CATO SMS to manage the clinical trial.
- GeoVax continues to strengthen its intellectual property portfolio, with over 70 granted or pending patent applications across 20 patent families.
- At December 31, 2021, GeoVax’s cash balance was $11.4 million. During the first quarter of 2022, the Company further supplemented its cash resources with net proceeds of $9.4 million from a private placement of its common stock and warrants.
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