EQS-News: GeoVax Highlights 2026 as a Pivotal Year for Progress

Management Highlights 2026 as a Portfolio-Wide Inflection Year Driven by Regulatory De-Risking, Clinical Readouts, and Scalable Manufacturing

ATLANTA, GA - January 20, 2026 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today provided a post-conference update following the J.P. Morgan Healthcare Conference Week in San Francisco, where, during investor, banker and partner engagements, the Company outlined 2026 as a pivotal inflection year driven by multiple late-stage clinical, regulatory, and manufacturing milestones across its diversified portfolio.

“GeoVax enters 2026 with increasing clarity on execution, prioritization, and value creation,” said David Dodd, Chairman & CEO of GeoVax. “With GEO-MVA representing an expedited path to potential commercialization, alongside multiple clinical data readouts relative to GEO-CM04S1, our multi-antigen COVID-19 vaccine and, the anticipated initiation of the Phase 2 Gedeptin® trial, we believe that this year will provide a meaningful convergence of regulatory, clinical, and manufacturing catalysts for the Company.”

Dodd added, “We were particularly encouraged by the level of interest and the quality of discussions we had during JP Morgan/Biotech Showcase with investors, potential strategic partners, and global health stakeholders. The feedback we received around GeoVax’s progress, our differentiated platforms, and our regulatory momentum, especially for GEO-MVA, reinforces our confidence that 2026 has the potential to be a pivotal breakout year for the Company.”

GEO-MVA (Mpox & Smallpox): Expedited Path to Commercialization in a Currently Constrained Market

GEO-MVA is GeoVax’s most advanced program and represents the Company’s near-term opportunity for potential commercialization. The global Mpox and smallpox vaccine market remains constrained by reliance on a single foreign manufacturer whose production capacity has proven insufficient to meet sustained worldwide demand, particularly during periods of expanding or recurring outbreaks. This structural supply imbalance underscores both the commercial opportunity and the public health imperative for an additional, scalable MVA vaccine source.

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. This guidance supports an expedited development pathway and meaningfully de-risks the regulatory route toward potential approval and revenue generation.

Key 2026 milestones for GEO-MVA include:

• Initiation of the pivotal Phase 3 immunobridging trial, expected in the second half of 2026
• Continued engagement with European and global health authorities seeking to diversify Mpox and smallpox vaccine supply in light of ongoing global demand pressures
• Advancement toward a U.S.-sourced vaccine supply model addressing both civilian public health needs and biodefense preparedness

With GEO-MVA clinical material manufactured and fill-finish completed, the program is positioned to transition from development into Phase 3 execution in 2026, reinforcing its role as GeoVax’s lead value driver and shortest path to potential commercialization.

Gedeptin® (Oncology): Advancing Toward Combination-Driven Value Inflection

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
• Updates on preclinical evaluations of Gedeptin in combination with immune checkpoint inhibitors, informing potential expansion into additional solid tumor indications.

GeoVax continues to pursue a partnership-oriented development strategy for Gedeptin, designed to advance the program efficiently while preserving long-term upside.

GEO-CM04S1 (COVID-19): Multiple Clinical Data Readouts

GeoVax’s next-generation COVID-19 vaccine, GEO-CM04S1, continues to advance as a differentiated, multi-antigen (Spike + Nucleocapsid) candidate designed to address unmet needs in immunocompromised and high-risk populations inadequately served by current single-antigen vaccines.

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
• Additional translational insights supporting future regulatory and partnering discussions

AGE1 Continuous Cell-Line Manufacturing: Advancing MVA Scalability and Supply

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 chicken embryo fibroblast–dependent methods.

AGE1 is directly integrated into the GEO-MVA program, strengthening GeoVax’s ability to support sustained commercial supply, rapid scale-up, and domestic manufacturing - capabilities increasingly critical as global demand for Mpox and smallpox vaccines exceeds available supply.

Manufacturing progress anticipated during 2026 includes:

• Continued optimization of the AGE1 process to support commercial-scale GEO-MVA production
• Advancement of AGE1 as a scalable, U.S.-based manufacturing solution aligned with pandemic preparedness and supply-chain resilience priorities

Positioned for Execution

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 we emphasized during JP Morgan/Biotech Showcase Week, GeoVax has moved beyond platform validation,” Dodd added. “We are 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.”

Dodd concluded, “As we move through 2026, GeoVax is entering a phase where years of platform development, regulatory engagement, and manufacturing investment begin to translate into tangible outcomes. With GEO-MVA advancing along a clearly defined path toward commercialization, multiple clinical data readouts expected across our COVID-19 and oncology programs, and a scalable manufacturing foundation in place, we believe GeoVax is well positioned for a pivotal year of execution and value creation.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:
info@geovax.com
678-384-7220

Media Contact:
Jessica Starman
media@geovax.com 

View the original release on www.newmediawire.com

News Source: GeoVax, Inc.