Oragenics dosed first patient in Phase IIa trial of ONP-002 for mild traumatic brain injury

ORAGENICS INC

First patient dosed at Mackay Hospital (Australia) days after site activation on March 31, 2026.
Phase IIa is randomized, placebo-controlled, targeting 40 patients; dosing within 12 hours of concussion.
Additional sites (Alfred Hospital, Royal Adelaide Hospital) expected to activate in Q2 2026.
Company plans to submit IND to FDA in Q4 2026 for U.S. Phase IIb trials.
Phase 1 safety data showed zero serious adverse events across all dose levels.

item 8.01 item 9.01

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