ONP-002 / Oragenics - LARVOL DELTA

Oragenics Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in Australia (The Manila Times) - "Oragenics has now secured all necessary regulatory approvals and submitted all required filings to proceed with clinical site onboarding at three sites in Australia, with Bayside Health (Alfred Health) serving as the Lead Site...Oragenics’ approved Phase IIa clinical trial is a randomized, placebo-controlled study designed to evaluate 40 patients who meet enrollment criteria based on CT scan findings, presenting symptoms, and emergency room or hospital admission...The Phase IIa clinical data readout is projected before year-end 2026. Oragenics expects that findings will support its planned investigational new drug (IND) application submission to the FDA for further clinical trials in the U.S."

New P2a trial • P2a data • CNS Disorders

Oragenics Partners with DUCK FLATS Pharma to Support FDA IND Readiness and Clinical Trial Design for Concussion Program (The Manila Times) - "The engagement is intended to align the Company’s upcoming Phase 2a clinical trial in Australia with its U.S regulatory strategy."

Commercial • New P2a trial • CNS Disorders