GeoVax Advances Vaccine Programs Amid Global Health Crises While Reporting Q3 2025 Financial Results

GeoVax Labs, Inc. accelerated development of its GEO-MVA vaccine program in response to the World Health Organization's reaffirmation of mpox as a global public health emergency, with Clade I outbreaks continuing across Africa, Europe, and the United States. The company received favorable scientific advice from the European Medicines Agency supporting a streamlined regulatory pathway for GEO-MVA, positioning the company to become a critically important diversified supplier of MVA vaccine addressing the increasing mpox threat. A new research collaboration with the University of Queensland and UniQuest will evaluate needle-free delivery using Vaxxas' high-density microarray patch platform, targeting improved thermostability, self-administration, and dose-sparing performance critical for pandemic preparedness and global vaccine equity.

The company's GEO-CM04S1 multi-antigen COVID-19 vaccine program demonstrated strong immunogenicity data and success in chronic lymphocytic leukemia trials. At the 6th ESCMID Conference on Vaccines in Lisbon, Portugal and iwCLL 2025 Workshop in Krakow, Poland, GeoVax presented data confirming the differentiated performance of GEO-CM04S1 with no serious adverse events attributed to the vaccine, robust T-cell and cross-variant antibody responses in CLL and hematologic cancer patients that exceeded standard-of-care mRNA vaccines, and achievement of the primary immunogenicity endpoint prompting discontinuation of the comparator mRNA arm. The program showed sustained cellular responses across multiple timepoints, indicating long-term protection potential for immunocompromised patients, with plans to incorporate the Omicron KP.2 Spike gene for enhanced variant coverage in 2026 trial launches.

In oncology, GeoVax expanded its Gedeptin program into new solid tumor indications following publication of KEYNOTE-689 Phase 3 results confirming the role of perioperative checkpoint inhibition in head and neck cancer. The company announced plans for a Phase 2 trial evaluating Gedeptin plus pembrolizumab plus fludarabine in first-line, resectable head and neck squamous cell carcinoma, with initiation targeted for the second half of 2026. Simultaneously, preclinical studies are expanding into triple-negative breast and cutaneous cancers in collaboration with Emory University's Winship Cancer Institute, assessing checkpoint combination strategies.

The company's U.S.-based MVA platform directly supports the Administration's and Congress's bipartisan calls for onshoring, Made in America, and pandemic-preparedness investments, as echoed in recent ASPR, BARDA, and State Department initiatives. GeoVax's continuous avian cell line manufacturing process aligns with legislative goals to modernize domestic biomanufacturing and reduce dependency on foreign vaccine suppliers. The company maintains engagements with ASPR, BARDA, CEPI, Africa CDC, WHO, and UNICEF, reinforcing commitment to biodefense, preparedness, and equitable access.

Financially, GeoVax reported a net loss of $6,318,914 for the three-month period ended September 30, 2025, compared to $5,815,468 for the comparable period in 2024. The company reported no government contract revenue for the quarter, compared to $2,789,484 in the third quarter of 2024, following BARDA's termination of the Project NextGen contract in April 2025. Research and development expenses decreased to $5,043,504 from $7,402,884 in the comparable 2024 period, primarily due to discontinued costs associated with the BARDA contract termination and lower costs for GEO-CM04S1 clinical trials and manufacturing. The company reported cash balances of $5,008,997 at September 30, 2025, compared to $5,506,941 at December 31, 2024. Further information is included in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission available at https://www.sec.gov.