Oragenics gets HREC approval, starts Phase IIa site activation for ONP-002 in Australia; explores CNS asset acquisition

ORAGENICS INC

Received final HREC approval in Australia for Phase IIa trial of ONP-002 for concussion/mTBI.
Completed first site initiation visit (SIV) for Phase IIa trial; two more sites in final RGO review.
Phase IIa trial of 40 patients; first dose within 12 hours of injury; data readout expected before year-end 2026.
Exploring discussions with third parties for potential acquisition of CNS assets focusing on brain health/recovery.
No definitive agreements reached; platform expansion independent of Receptor.AI partnership.

item 8.01 item 9.01

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