Business Description

Overview GeoVax Labs, Inc. (“GeoVax”, “us”, “we” or the “Company”) is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and solid tumor cancers using novel proprietary platforms. GeoVax’s primary near-term strategic development priority is the advancement of GEO-MVA, a Modified Vaccinia Ankara (MVA) vaccine candidate for mpox, smallpox, and other poxviruses. GEO-MVA is being advanced on an expedited regulatory pathway in Europe and is intended to address a significant global supply constraint for orthopoxvirus vaccines. The Company believes GEO-MVA is well-positioned to support both civilian public health needs and broader preparedness and biodefense objectives. The advancement of GEO-MVA represents the Company’s most near-term opportunity to achieve regulatory approval and potential commercialization. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026. The Company’s lead clinical program in oncology is Gedeptin®, a novel oncolytic solid tumor gene-directed therapy, which recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial evaluating Gedeptin® in combination with an immune checkpoint inhibitor (ICI) as first-line treatment of patients with squamous cell head and neck cancer eligible for curative surgery, is planned to initiate during the first half of 2027. The Company is also developing GEO-CM04S1, a next-generation multi-antigen COVID-19 vaccine which is currently being evaluated in two Phase 2 clinical trials, (i) as a primary vaccine for immunocompromised patients, including those with hematologic cancers and other patient populations for whom currently authorized COVID-19 vaccines are inadequate and (ii) as a booster vaccine in patients with chronic lymphocytic leukemia (CLL), where an interim Data Safety Monitoring Board (DSMB) review demonstrated superior immune responses versus an mRNA vaccine. An additional clinical trial evaluating GEO-CM04S1 as a more robust booster vaccine in healthy adults who previously received an mRNA vaccine has completed enrollment with data readouts anticipated in the first half of 2026. Our corporate strategy is to advance, protect, and strategically leverage our proprietary vaccine and immunotherapy platforms to develop differentiated preventive and therapeutic solutions for infectious diseases and solid tumors. We aim to efficiently progress our product candidates through clinical development and pursue regulatory approval and commercialization through internal development and selective external licensing and partnership arrangements. We also work collaboratively with academic, governmental, and industry partners to validate our technologies, support development efforts and enhance the strategic value of our pipeline. 1 Our Clinical Development Pipeline The table below summarizes the status of our clinical development programs, including our lead near-term priority, GEO-MVA, each of which are discussed in greater detail in the sections that follow, along with earlier stage programs. Product Indication Clinical Trial Status GEO-MVA mpox & smallpox Vaccine against mpox and smallpox Phase 3 Initiation planned for H2 2026 Gedeptin® Advanced Head & Neck Cancer Effect on Targeted Tumors Phase 1/2 Completed Squamous Cell Head & Neck Cancer* First Line Therapy in Combination With Immune Checkpoint Inhibitor Phase 2 Initiation planned for H1 2027 Primary Vaccine for Immunocompromised/ Stem Cell Transplant Patients Phase 2 Enrollment ended Data readouts expected during 2026 GEO-CM04S1 COVID-19 Booster Vaccine for Immunocompromised/ Chronic Lymphocytic Leukemia Patients Phase 2 Enrollment completion expected during 2026 Booster Vaccine for Healthy Adults Phase 2 Enrollment ended Data readouts expected during H1 2026 GEO-MVA - Mpox and Smallpox Vaccine Modified Vaccinia Ankara (MVA) was originally developed as a third-generation smallpox vaccine approximately 50 years ago and is characterized by its inability to replicate in human cells. As a result, MVA-based vaccines are generally considered suitable for use in high-risk populations such as pregnant women, children and immunocompromised individuals who may be at increased risk from replicating vaccinia-based smallpox vaccines.…