ONP-002 - (Australian trial)

July 7, 2026: Oragenics (NYSE: OGEN) reported progress for ONP-002, an intranasal neurosteroid being studied for mild traumatic brain injury (mTBI/concussion). In its Australian Phase IIa trial, all three planned sites are now active and enrolling after Royal Adelaide Hospital received Research Governance Office approval and activated on June 29, 2026; Alfred Health enrolled the first participant on June 21, 2026, joining Mackay Base Hospital. The company said zero serious adverse events have been reported in subjects dosed to date and continues to target a Phase IIa data readout in Q4 2026.

Separately, Oragenics advanced its U.S. regulatory pathway by submitting a Type B meeting request to the FDA on June 26, 2026, seeking guidance on the planned U.S. clinical development program to support an IND application, which remains targeted for submission in Q4 2026. The company noted there are currently no FDA-approved pharmacological treatments for mTBI and stated U.S. Phase IIb trials are planned to follow pending IND submission.