GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, reported financial results for the quarter ended March 31, 2026, and provided a business update highlighting continued advancement of GEO-MVA, its Modified Vaccinia Ankara (MVA) vaccine candidate for mpox and smallpox, together with strategic progress in its immuno-oncology initiatives centered on Gedeptin.
During the quarter and subsequent period, GeoVax continued operational execution activities supporting initiation of the planned Phase 3 immunobridging clinical study for GEO-MVA under an expedited regulatory pathway aligned with guidance received from the European Medicines Agency (EMA). The Company believes this pathway positions GEO-MVA for a potentially accelerated route toward regulatory authorization and commercialization as an additional source of MVA-based orthopoxvirus vaccine supply.
“GeoVax has strategically aligned the organization around GEO-MVA and the significant global opportunity for a diversified MVA vaccine supply,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Our efforts are now centered on operational execution of the Phase 3 immunobridging program, supported by completed manufacturing activities, CRO selection, regulatory alignment, and advancing clinical trial initiation.”
Dodd continued, “We believe GEO-MVA is uniquely positioned at the intersection of global public health preparedness, biodefense resiliency, and domestic manufacturing priorities. The ongoing evolution of mpox, continued global supply constraints, and dependence on a single foreign supplier for MVA-based orthopoxvirus vaccines reinforce the importance of establishing additional scalable supply sources.”
Recent GEO-MVA milestones include advancement under an EMA-aligned expedited regulatory pathway utilizing a single pivotal Phase 3 immunobridging clinical study, initiation of Phase 3 execution activities including CRO selection and trial infrastructure activation, and completion and release of cGMP clinical trial material and fill/finish product for clinical use. The planned Phase 3 immunobridging study is expected to enroll approximately 500 participants evaluating neutralizing antibody responses relative to an approved MVA comparator vaccine. The study design is intended to provide rapid clinical validation through established immunobridging endpoints.
GeoVax also continues advancing Gedeptin, its gene-directed enzyme prodrug therapy (GDEPT) immuno-oncology platform, including planned combination strategies involving immune checkpoint inhibitors in head and neck cancer. The Company recently strengthened its immuno-oncology positioning through an exclusive license agreement with Emory University covering intellectual property related to Gedeptin in combination with immune checkpoint inhibitors.
For the three months ended March 31, 2026, GeoVax reported a net loss of $5.3 million, compared to $5.4 million for the same period in 2025. Research and development expenses were $3.9 million in 2026, down from $5.4 million in 2025, primarily reflecting lower costs associated with discontinued BARDA/RRPV activities and reduced spending related to GEO-CM04S1 clinical activities. General and administrative expenses were $1.4 million, compared to $1.7 million in the prior year. The Company reported cash balances of approximately $1.3 million as of March 31, 2026, compared to $3.1 million at December 31, 2025.
More information is available in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. For additional details, visit www.geovax.com.