Crystal Research Associates has issued an 18-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 novel therapies and vaccines for cancers and many of the world’s most threatening infectious diseases. The Company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. GEO-CM04S1 is currently being evaluated in two Phase 2 clinical trials: (1) as a COVID-19 vaccine for immunocompromised patients; and (2) as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who has driven significant value creation across multiple life science companies over the past several decades.
Key Points
- On May 4, 2023, GeoVax announced financial results for the quarter ended March 31, 2023 and provided a corporate update. The Company reported a net loss for the three months ended March 31, 2023 of $4 million or $0.15 per share versus $2.4 million or $0.34 per share, for the three months ended March 31, 2022.
- During the quarter, GeoVax remained focused on advancing its ongoing clinical trials for its Gedeptin® cancer therapy targeting advanced head and neck cancers and GEO-CM04S1, the Company’s next-generation SARS-CoV-2 (COVID-19) vaccine. The Company’s Gedeptin® trial has expanded to additional NCI-designated Cancer Centers, allowing GeoVax to accelerate its patient enrollment efforts. The Company expects to complete enrollment for this trial in the very near future. Positive initial data was recently presented for GEO-CM04S1 during the World Vaccine Congress.
- GeoVax expanded its license agreement with City of Hope (COH), granting the Company added rights. The original agreement provided GeoVax with exclusive global rights to essential patents, including the use of COH’s proprietary synthetic MVA (sMVA) process for developing COVID-19 vaccines, such as GEO-CM04S1. The amended license extends GeoVax’s rights to include developing and commercializing products targeting orthopoxviruses, in addition to SARS-CoV-2. Orthopoxviruses comprise a range of viruses, including Mpox (monkeypox), smallpox, and other human disease-causing viruses.
- During the quarter, significant progress was made in developing a high-yield, high-capacity, continuous avian cell line system for manufacturing GeoVax’s MVA-based vaccines and immunotherapies, such as GEO-CM04S1. This could provide GeoVax with the ability to respond to large-scale world needs in a timely manner.
- GeoVax’s intellectual property portfolio contains over 115 granted or pending patent applications across 24 patent families. Within the quarter, the U.S. Patent and Trademark Office granted a Notice of Allowance for Patent Application No. 17/000,768, titled “Method for Generating a ZIKV Immune Response Utilizing a Recombinant Modified Vaccinia Ankara Vector Encoding the NS1 Protein”.
- At March 31, 2023, GeoVax’s reported cash balance was $23.8 million versus $27.6 million at December 31, 2022. The Company remains well capitalized to complete its current Phase 2 clinical programs, including expanding the Gedeptin® multi-site trial in addition to expanding the GEO-CM04S1 COVID-19 vaccine trial among immunocompromised patients to additional sites.
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