OGEN · Oragenics, Inc.

Oragenics achieved a key clinical milestone with the first patient dosing in its Phase IIa trial of ONP-002, signaling operational execution and high unmet need in concussion treatment where no FDA-approved pharmacological options exist. The rapid dosing at Mackay Base Hospital post-activation on March 31, 2026, reflects strong site readiness and patient availability, bolstered by prior Phase 1 safety data showing no serious adverse events across 40 patients. The randomized, placebo-controlled study in 40 patients assesses safety, tolerability, and neurocognitive outcomes over 30 days, with findings aimed at supporting a Q4 2026 FDA IND for U.S. trials. Additional sites at Alfred Hospital and Royal Adelaide Hospital are on track for Q2 2026 activation, managed by Southern Star Research CRO and with drug supply from Sterling Pharma. CEO Janet Huffman emphasized the urgency of addressing the lack of treatments for millions affected annually, while CMO Dr. James Kelly highlighted ONP-002's potential to target underlying neuroinflammation and edema via proprietary intranasal delivery, positioning it as a potential first-in-class therapy.