Geovax Labs Stock Earnings Reports

Key investor takeaways: GeoVax received EMA guidance enabling an expedited regulatory path for GEO-MVA (Mpox/smallpox) that could allow bypassing Phase I/II and proceeding to a Phase III immunobridging trial — the company completed cGMP production and quality release of a clinical batch and expects vaccine availability for clinical evaluation later in 2025, with ongoing discussions about potential emergency use distribution and strong stakeholder interest in U.S.-based MVA supply onshoring. GEO-CMO4S1 (multi-antigen COVID-19 vaccine) remains focused on immunocompromised populations (including stem cell transplant and CLL patients); enrollment continues and multiple clinical presentations are planned this year to support differentiation and partnership discussions. Gedeptin (oncology) protocol was modified after KEYNOTE-689 to a neoadjuvant, first-line setting with pembrolizumab (pembro) and major pathologic response as the primary endpoint; the Phase II trial is targeted to start in H2 2026 with a Simon two-stage design (expected ~36–40 patients). The advanced MVA manufacturing process and AGE1 cell-line manufacturing proposal were selected by BARDA but remain contingent on BARDA funding (in a two-year “basket” hold). Financials and funding: revenues of $2.5M for the six months ended June 30, 2025 (BARDA-related), R&D of ~$10M for the same period, net loss of ~$10.7M (6 months), cash $3.1M at June 30, 2025 (bolstered by a subsequent July follow-on offering of ~ $6M net proceeds); clinical programs are the primary near-term cash usage and management is pursuing partnerships and non-dilutive funding to extend runway. Near-term milestones to watch: availability of GEO-MVA for clinical evaluation (late 2025), preparations and regulatory filings for the immunobridging trial (targeted start H2 2026), continued CMO4S1 enrollment and data presentations, initiation of Gedeptin Phase II (H2 2026), and progress on advanced MVA manufacturing/BARDA funding. Main risks: funding needs and dilution risk, timing/pace of trial enrollment and regulatory interactions, dependence on external stakeholders for potential emergency or government procurements.