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 three Phase 2 clinical trials: (1) as a primary COVID-19 vaccine for immunocompromised patients versus mRNA vaccines; (2) as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines; and (3) most recently, as a more robust, durable booster versus mRNA vaccines in patients with chronic lymphocytic leukemia (CLL). GeoVax has a leadership team who has driven significant value creation across multiple life science companies over the past several decades.
Key Points
- On November 8, 2023, GeoVax announced financial results for the quarter ended September 30, 2023 and provided a corporate update. Net loss for the three months ended September 30, 2023, was $8.4 million ($0.32 per share) versus $4.0 million ($0.17 per share) for the comparable period in 2022. For the nine months ended September 30, 2023, the Company’s net loss was $18.4 million ($0.69 per share) versus a net loss of $8.6 million ($0.63 per share) in 2022.
- The Company continues to make advancements in its next-generation COVID-19 vaccine clinical programs as well as its cancer therapy program, along with advanced manufacturing developments, with new patents issued during the quarter for GeoVax’s Ebola, Marburg, Malaria, and HIV vaccines.
- During the quarter, the Company completed enrollment for Phase 2 clinical trial evaluating GEO-CM04S1 (the Company’s next-generation COVID-19 vaccine) as a booster for healthy patients who previously received the Pfizer or Moderna mRNA vaccine in September 2023. An initial data readout is expected soon. As well, in October, GeoVax began the planned site expansion to accelerate patient enrollment for its Phase 2 trial evaluating GEO-CM04S1 as a primary COVID-19 vaccine for immunocompromised patients versus mRNA vaccines.
- In July 2023, clinical data on Gedeptin (targeting advanced head and neck cancers) was presented at the AACR-AHNS Head and Neck Cancer Conference in an abstract titled, Phase 1/2 study of Ad/PNB with Fludarabine for the Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC). The FDA-funded study revealed that Gedeptin administration is safe and feasible.
In September 2023, GeoVax and ProBioGen announced the signing of a landmark multi-product commercial license agreement for ProBioGen’s AGE1.CR.PIX® suspension cell line. The agreement enhances the manufacturing capabilities of GeoVax’s entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio with respect to both scale and flexibility. - GeoVax’s intellectual property portfolio contains over 115 granted or pending patent applications across 24 patent families, having recently secured multiple positive patent decisions covering notice of allowances for Ebola, Marburg, Malaria and HIV vaccines.
- As of September 30, 2023, GeoVax’s cash balances was $12.7 million versus $27.6 million at December 31, 2023. GeoVax is funded into 2024 and anticipates further strengthening its balance sheet through supportive stock activities, business development initiatives, and non-dilutive opportunities related to government and NGO funding.
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