GeoVax Labs (NASDAQ:GOVX) Chairman and CEO David Dodd said the clinical-stage biotechnology company is preparing to advance its lead vaccine program, GEO-MVA, into a pivotal Phase 3 trial under an expedited European regulatory pathway.
Speaking during a Tribe Public webinar hosted by John Heerdink, managing member of Tribe Public, Dodd described GeoVax’s priority program as an MVA-based vaccine targeting Mpox and smallpox. He said the company is focused on infectious disease preparedness at a time when emerging viral threats are spreading more quickly because of global travel and insufficient vaccine supply chains.
GEO-MVA Trial Expected to Begin in Fourth Quarter 2026
Dodd said the European Medicines Agency has provided GeoVax with an expedited pathway for GEO-MVA, waiving traditional Phase 1 and Phase 2 trials. The company plans to conduct a 500-person immunobridging Phase 3 trial comparing GEO-MVA with MVA-BN, the Mpox and smallpox vaccine supplied by Bavarian Nordic.
The trial is expected to enroll healthy adults, with 250 participants receiving GEO-MVA and 250 receiving MVA-BN. Dodd said the study will evaluate two endpoints: neutralizing antibody response and seroconversion rate. He said GeoVax expects the trial to be completed within 12 weeks after initiation, with a data readout targeted for mid-2027.
Dodd said GeoVax believes GEO-MVA has a strong chance of demonstrating non-inferiority because its MVA vaccine and Bavarian Nordic’s product were derived from the same parental cell line. He said GeoVax has genetically sequenced its version and found a 100% match across regions of interest reviewed by regulators.
If the trial meets its endpoints, Dodd said GeoVax plans to pursue Emergency Use Listing with the World Health Organization and expedited approval with the EMA. The company would then conduct a 3,000-person safety study, with two-thirds of participants in Africa and one-third in the European Union.
Company Highlights Mpox Vaccine Supply Gap
Dodd said the market for Mpox-related vaccines was approximately $700 million last year, based on estimated sales from Bavarian Nordic, Emergent BioSolutions and Japan’s KM Biologics. He said roughly eight million doses were delivered and administered in 2025.
However, Dodd said there was additional unmet demand for more than 15 million doses, including about 10 million requested from Africa. He estimated that unmet demand represented approximately $1.3 billion in additional opportunity, bringing the potential market to about $2 billion.
“Our focus will be to go after what is being unmet, not to directly compete with someone who’s already supplying,” Dodd said.
He said potential customers include groups involved in vaccine stockpiles and outbreak response, including Africa CDC, UNICEF, Gavi, the WHO, Europe’s HERA and national strategic stockpiles.
Funding and Balance Sheet Remain Key Issues
Asked about financing, Dodd said GeoVax is pre-revenue and depends on equity sales or non-dilutive funding to support development. He said the company raised more than $4 million last week through a combination of a private investment in public equity and organic warrant exercises after heavy trading in its stock.
Dodd said GeoVax continues to pursue additional capital and non-dilutive funding sources globally. He said the company is focused on raising less than $20 million to support the current pathway through authorization-related activities.
“The biggest milestone right now is our balance sheet,” Dodd said.
Manufacturing Strategy Includes U.S. Expansion
Dodd said current MVA manufacturing is slow and cumbersome, and GeoVax is working toward a cell-line-based manufacturing process that could increase scale, lower costs and reduce production time. He said the company expects that transition to take three to five years.
GeoVax currently works with Oxford Biomedica, which Dodd said operates manufacturing facilities in the United Kingdom and France and also has facilities in Boston and North Carolina. He said GeoVax anticipates eventually transitioning to a U.S.-domiciled manufacturing facility capable of supporting Phase 3 or commercial-grade production.
Dodd said the company will initially go to market using the existing manufacturing process for regulatory reasons before transitioning to the newer approach. He said the future cell-line process could provide a five-fold cost reduction opportunity, though he declined to disclose expected pricing per dose.
Broader Infectious Disease Platform
Dodd also discussed GeoVax’s prior work on vaccines targeting Ebola Zaire, Ebola Sudan and Marburg. He said the company previously showed 100% protection in a single-dose non-human primate study for Ebola Zaire and has carried those programs through non-human primate testing.
However, Dodd said GeoVax is not currently working on the newest Ebola strain because it is focused on advancing GEO-MVA into the planned Phase 3 trial.
Heerdink disclosed at the start of the event that he is currently a shareholder of GeoVax and has at times been an adviser to the company.
About GeoVax Labs (NASDAQ:GOVX)
GeoVax Labs, Inc is a clinical-stage biotechnology company focused on the development of novel vaccines and immunotherapies against infectious diseases. Leveraging a proprietary Modified Vaccinia Ankara (MVA) viral vector platform, GeoVax aims to induce robust and durable immune responses by expressing virus-like particles (VLPs) in vaccinated individuals. The company’s pipeline encompasses vaccine candidates for HIV, Ebola, Lassa, Zika, MERS and emerging coronaviruses, reflecting a commitment to addressing high-priority global public health threats.
The cornerstone of GeoVax’s technology is its MVA-VLP platform, which combines the safety profile of a non-replicating poxvirus vector with the potent antigen presentation of VLPs.
