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 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 & CEO of GeoVax, stated that with GEO-MVA representing an expedited path to potential commercialization, alongside multiple clinical data readouts for GEO-CM04S1 and the anticipated initiation of a Phase 2 trial for Gedeptin®, the year will provide a meaningful convergence of catalysts. The company was encouraged by the level of interest from investors, potential strategic partners, and global health stakeholders during recent meetings, reinforcing confidence in 2026 as a potential breakout year.
The GEO-MVA program, targeting Mpox and smallpox, represents GeoVax's most advanced program and near-term commercialization opportunity. The global vaccine market remains constrained by reliance on a single foreign manufacturer with insufficient production capacity, creating a structural supply imbalance. Following 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, supporting 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. With clinical material manufactured and fill-finish completed, the program is positioned to transition into Phase 3 execution, reinforcing its role as GeoVax's lead value driver. For more information about the company's programs, visit https://www.geovax.com.
In oncology, GeoVax continues to advance Gedeptin®, its gene-directed enzyme prodrug therapy, following encouraging safety and tumor-response signals from prior studies. Key 2026 inflection points include publication of results from the recently completed 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 informing potential expansion into additional solid tumor indications. The company continues to pursue a partnership-oriented development strategy for this program.
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. By enabling continuous, cell-line-based production, AGE1 provides a more reliable and scalable alternative to traditional methods. This technology 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 priorities. Collectively, these milestones reflect GeoVax's transition into a catalyst-rich period where multiple programs are advancing toward late-stage development and potential commercialization pathways.
Dodd emphasized that 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. As the company moves through 2026, years of platform development, regulatory engagement, and manufacturing investment are beginning to translate into tangible outcomes, positioning GeoVax for a pivotal year of execution and value creation.
