GeoVax Advances GEO-MVA Phase 3 Trial as First Quarter 2026 Loss Narrows

GeoVax Labs, Inc. (Nasdaq: GOVX) reported a net loss of $5.3 million for the first quarter of 2026, compared to $5.4 million in the same period last year, as the company pivots its focus toward advancing its GEO-MVA vaccine candidate for mpox and smallpox under an expedited regulatory pathway aligned with guidance from the European Medicines Agency (EMA). The clinical-stage biotechnology company provided a business update alongside its financial results, highlighting operational execution activities supporting the planned Phase 3 immunobridging clinical study for GEO-MVA.

“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. The company believes GEO-MVA is uniquely positioned at the intersection of global public health preparedness, biodefense resiliency, and domestic manufacturing priorities. With ongoing evolution of mpox, continued global supply constraints, and dependence on a single foreign supplier for MVA-based orthopoxvirus vaccines, establishing additional scalable supply sources has become critical.

The planned Phase 3 immunobridging study is expected to enroll approximately 500 participants and will evaluate neutralizing antibody responses relative to an approved MVA comparator vaccine. The study design aims to provide rapid clinical validation through established immunobridging endpoints. GeoVax has completed and released cGMP clinical trial material and fill/finish product for clinical use, and has initiated Phase 3 execution activities including CRO selection and trial infrastructure activation.

In the immuno-oncology space, GeoVax continues advancing Gedeptin®, its gene-directed enzyme prodrug therapy (GDEPT) platform. The company recently strengthened its positioning through an exclusive license agreement with Emory University covering intellectual property related to Gedeptin in combination with immune checkpoint inhibitors. GeoVax believes Gedeptin’s localized tumor-targeting and immune-activating mechanism may help convert immunologically “cold” tumors into more responsive tumor microenvironments, potentially enhancing checkpoint inhibitor activity.

Financially, the company reported research and development expenses of $3.9 million for the quarter, down from $5.4 million in the prior year, primarily due to lower costs associated with discontinued BARDA/RRPV activities and reduced spending on the GEO-CM04S1 COVID-19 vaccine program. General and administrative expenses decreased to $1.4 million from $1.7 million, driven by lower investor relations consulting costs and reduced stock-based compensation. GeoVax reported cash balances of approximately $1.3 million as of March 31, 2026, compared to $3.1 million at December 31, 2025.

The company’s primary emphasis remains on GEO-MVA, reflecting established MVA platform validation, expedited regulatory alignment, and large existing and anticipated orthopoxvirus vaccine demand. GeoVax believes its immuno-oncology strategy centered on Gedeptin may provide meaningful long-term optionality within the rapidly evolving checkpoint inhibitor landscape. Additional information is included in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

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