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GeoVax Reports Q1 2026 Results, Advances GEO-MVA Phase 3 Trial for Mpox Vaccine

By Advos
GeoVax Labs reported a net loss of $5.3 million for Q1 2026 and provided updates on its GEO-MVA mpox/smallpox vaccine candidate, which is advancing toward a pivotal Phase 3 trial under an EMA-aligned expedited pathway, addressing global supply constraints for orthopoxvirus vaccines.

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GeoVax Reports Q1 2026 Results, Advances GEO-MVA Phase 3 Trial for Mpox Vaccine

GeoVax Labs, Inc. (Nasdaq: GOVX) reported a net loss of $5.3 million for the first quarter of 2026, compared to a net loss of $5.4 million in the same period last year, as the company focuses its resources on advancing its lead vaccine candidate, GEO-MVA, for mpox and smallpox. The clinical-stage biotechnology company also highlighted progress in its immuno-oncology platform, Gedeptin.

The company ended the quarter with $1.3 million in cash, down from $3.1 million at the end of 2025, reflecting ongoing investment in research and development. R&D expenses were $3.9 million, down from $5.4 million in the prior-year quarter, primarily due to the termination of a BARDA contract for its COVID-19 vaccine program in April 2025. General and administrative expenses decreased to $1.4 million from $1.7 million.

GeoVax's primary focus remains GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine candidate for mpox and smallpox. The company is preparing to initiate a pivotal Phase 3 immunobridging clinical study under an expedited regulatory pathway aligned with guidance from the European Medicines Agency (EMA). The study is expected to enroll approximately 500 participants and will evaluate neutralizing antibody responses compared to an approved MVA comparator vaccine. The company has completed manufacturing of cGMP clinical trial material and selected a contract research organization (CRO) to support trial initiation.

“We believe GEO-MVA is uniquely positioned at the intersection of global public health preparedness, biodefense resiliency, and domestic manufacturing priorities,” said David A. Dodd, Chairman and CEO of GeoVax. “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.”

The company is also advancing continuous cell-line manufacturing initiatives using the AGE1 platform to support future scalable production capacity. GeoVax believes GEO-MVA could address global orthopoxvirus vaccine supply limitations and support stockpile and international procurement opportunities.

On the oncology front, GeoVax continues to develop Gedeptin, a gene-directed enzyme prodrug therapy (GDEPT) platform. The company recently strengthened its intellectual property position through an exclusive license agreement with Emory University covering the use of Gedeptin in combination with immune checkpoint inhibitors. GeoVax believes Gedeptin's mechanism may help convert immunologically “cold” tumors into more responsive microenvironments, potentially enhancing checkpoint inhibitor activity in solid tumors, including head and neck cancer.

The company’s strategic prioritization reflects a focus on programs with clear regulatory and commercial pathways, with GEO-MVA at the forefront due to validated MVA platform, expedited regulatory alignment, and growing demand for diversified vaccine supply chains. GeoVax also sees Gedeptin as providing long-term optionality in the evolving immunotherapy landscape.

For more information, visit GeoVax's website.

Advos

Advos

@advos