GeoVax Identifies 2026 as Critical Inflection Year with Multiple Clinical, Regulatory, and Manufacturing Milestones

GeoVax Labs, Inc. has outlined 2026 as a pivotal inflection year driven by multiple late-stage clinical, regulatory, and manufacturing milestones across its diversified portfolio. The company emphasized this outlook during investor, banker, and partner engagements at the J.P. Morgan Healthcare Conference Week in San Francisco. According to David Dodd, Chairman & CEO of GeoVax, the company enters 2026 with increasing clarity on execution, prioritization, and value creation, with GEO-MVA representing an expedited path to potential commercialization alongside multiple clinical data readouts and anticipated trial initiations.

The GEO-MVA program, targeting Mpox and smallpox, represents GeoVax's most advanced program and near-term opportunity for potential commercialization. The global Mpox and smallpox vaccine market remains constrained by reliance on a single foreign manufacturer with insufficient production capacity to meet sustained worldwide demand. Following receipt of supportive Scientific Advice from the European Medicines Agency (EMA), GeoVax has regulatory alignment on a single, pivotal Phase 3 immunobridging study versus the approved MVA vaccine. Key 2026 milestones for GEO-MVA include initiation of the pivotal Phase 3 trial expected in the second half of 2026, continued engagement with European and global health authorities, and advancement toward a U.S.-sourced vaccine supply model addressing both civilian public health needs and biodefense preparedness.

In oncology, GeoVax continues to advance Gedeptin®, its gene-directed enzyme prodrug therapy, following encouraging safety and tumor-response signals from prior clinical studies. Key 2026 inflection points include publication of results from the recently completed Gedeptin trial, initiation of a Phase 2 study evaluating Gedeptin in combination with an immune checkpoint inhibitor as a potential first-line therapy for head and neck cancer by year-end, and updates on preclinical evaluations of Gedeptin in combination with immune checkpoint inhibitors. The company continues to pursue a partnership-oriented development strategy for Gedeptin designed to advance the program efficiently while preserving long-term upside.

GeoVax's next-generation COVID-19 vaccine, GEO-CM04S1, continues to advance as a differentiated, multi-antigen candidate designed to address unmet needs in immunocompromised and high-risk populations. During 2026, the company expects clinical data readouts from ongoing Phase 2 trials, continued evaluation of GEO-CM04S1 as both a primary and booster vaccine in immunocompromised populations, and additional translational insights supporting future regulatory and partnering discussions. The AGE1 continuous avian cell-line manufacturing process has the potential to significantly improve how MVA-based vaccines are produced by addressing historical scalability and supply constraints. AGE1 is directly integrated into the GEO-MVA program, strengthening GeoVax's ability to support sustained commercial supply, rapid scale-up, and domestic manufacturing.

Manufacturing progress anticipated during 2026 includes continued optimization of the AGE1 process to support commercial-scale GEO-MVA production and advancement of AGE1 as a scalable, U.S.-based manufacturing solution aligned with pandemic preparedness and supply-chain resilience priorities. Collectively, these milestones reflect GeoVax's transition into a catalyst-rich period where multiple programs are advancing in parallel toward late-stage development, regulatory decision points, and potential commercialization pathways. As Dodd emphasized during JP Morgan/Biotech Showcase Week, GeoVax has moved beyond platform validation and is now executing against clearly defined milestones, with GEO-MVA leading the portfolio and multiple additional programs advancing toward value-inflection events in 2026 and beyond.