ONP-002 - (Australian trial)

September 16, 2026: Oragenics (NYSE: OGEN) announced that Chief Medical Officer James P. Kelly, MD, will present ONP-002 at the IPAC-RS 2026 Nasal Innovation Forum on September 17, 2026, in Jersey City, New Jersey. The presentation will cover the clinical translation of ONP-002, an intranasal neurosteroid candidate for mild traumatic brain injury/concussion, including its proposed mechanism, proprietary breath-powered nasal delivery device, ongoing Phase IIa feasibility trial in Australia, and planned U.S. development strategy.

ONP-002 is delivered as a spray-dried nanoparticle powder via a device designed to target the superior nasal roof for direct olfactory nerve/brain delivery while minimizing systemic exposure. The company said the program is intended to address concussion, where there are no FDA-approved pharmacological treatments.

Current status: Phase I single- and multiple-ascending-dose safety trials have been completed with a favorable safety and tolerability profile. The Phase IIa feasibility trial is enrolling at three sites in Australia. Oragenics said it is advancing an IND application, with submission anticipated in Q4 2026, and noted U.S. Phase IIb trials are planned after the IND.