GeoVax Labs (GOVX) investor relations material

Strategic focus and development milestones

• Multiple clinical-stage programs targeting infectious diseases, oncology, and vaccines are advancing toward key catalysts and milestones, with potential revenue generation expected within three to four years.

• GEO-MVA, a Modified Vaccinia Ankara-based vaccine, has secured an expedited regulatory path, bypassing phase I and II trials and moving directly to a phase III immunobridging trial, with product manufacturing and release testing already underway.

• The GEO-MVA program aims to address global supply shortages for Mpox and smallpox vaccines, positioning as the first U.S. supplier and second globally, with significant demand in Africa and ongoing engagement with WHO and other international bodies.

• GEO-CM04S1, a multi-antigen COVID-19 vaccine, is in advanced phase II trials targeting immunocompromised populations, showing promising results compared to mRNA vaccines, especially in blood cancer patients.

• Gedeptin, a gene therapy for solid tumors, is advancing to a phase II trial for head and neck cancer, with plans for combination studies with Keytruda and potential expansion to other cancer types.

Manufacturing innovation and partnerships

• A new continuous cell line manufacturing process for MVA vaccines is being developed to overcome historical bottlenecks, aiming for faster, lower-cost production.

• Over 130 patents across 22 families support the pipeline, with worldwide rights held for all assets and ongoing discussions for collaborations and partnerships to support broad product registration.

• Significant interest from potential partners is driven by the opportunity to break the current global monopoly in MVA-based vaccines and meet unmet market demand.

Financial strategy and outlook

• Annual capital needs are estimated at $30–$35 million, with a focus on non-dilutive funding, strategic partnerships, and reducing reliance on equity financing, especially after GEO-MVA phase III success.

• Expedited regulatory pathways and orphan drug status are leveraged to accelerate development and de-risk programs, particularly for GEO-MVA and Gedeptin.

• The company is prioritizing GEO-MVA to enable subsequent advancement of other assets and achieve key inflection points for revenue generation.