GeoVax Labs, Inc., a clinical-stage biotechnology company, has outlined 2026 as a pivotal inflection year driven by multiple late-stage clinical, regulatory, and manufacturing milestones across its diversified portfolio of vaccines and immunotherapies. The company's leadership emphasized this outlook following engagements at the J.P. Morgan Healthcare Conference Week in San Francisco, highlighting increasing clarity on execution and value creation.
David Dodd, Chairman and CEO of GeoVax, stated that the company enters 2026 with GEO-MVA representing an expedited path to potential commercialization, alongside multiple clinical data readouts for its COVID-19 vaccine and the anticipated initiation of a Phase 2 oncology trial. Dodd noted that feedback from investors and potential strategic partners during the conference reinforced confidence that 2026 could be a pivotal breakout year for the company.
The GEO-MVA program, targeting Mpox and smallpox, represents GeoVax's most advanced program and near-term commercialization opportunity. The global market for these vaccines 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, GeoVax has regulatory alignment on a single, pivotal Phase 3 immunobridging study versus the approved MVA vaccine, which supports an expedited development pathway.
Key 2026 milestones for GEO-MVA include initiation of the pivotal Phase 3 trial expected in the second half of the year, continued engagement with European and global health authorities seeking to diversify vaccine supply, and advancement toward a U.S.-sourced vaccine supply model addressing both civilian public health needs and biodefense preparedness. With clinical material manufactured and fill-finish completed, the program is positioned to transition from development into Phase 3 execution.
In oncology, GeoVax continues to advance Gedeptin®, its gene-directed enzyme prodrug therapy, with key 2026 inflection points including publication of results from a recently completed trial and 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. The company continues to pursue a partnership-oriented development strategy for this program.
For its next-generation COVID-19 vaccine, GEO-CM04S1, GeoVax expects clinical data readouts from ongoing Phase 2 trials during 2026. The multi-antigen candidate is designed to address unmet needs in immunocompromised and high-risk populations inadequately served by current single-antigen vaccines. The company will continue evaluation of GEO-CM04S1 as both a primary and booster vaccine in these populations.
Manufacturing scalability represents another critical component of GeoVax's 2026 outlook. 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. Integrated into the GEO-MVA program, AGE1 provides a more reliable and scalable alternative to traditional chicken embryo fibroblast-dependent methods. 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.
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. Dodd emphasized that the company 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. For more information about the company's clinical trials and updates, visit www.geovax.com.
