Oragenics Targets Projected $9 Billion Market by Advancing First and Only Clinical-Stage Concussion and Mild Traumatic Brain Injury Therapy

Core Insights - Oragenics, Inc. is advancing ONP-002, a novel intranasal neurosteroid, as a potential first pharmacological treatment for concussion and mild traumatic brain injury (mTBI) [1][3][11] - The company is well-prepared to initiate clinical site onboarding and first patient dosing in Australia for a Phase 2 clinical trial [1][2][8] Clinical Development - The Phase 2a clinical trial will evaluate 40 patients who meet specific enrollment criteria, with dosing occurring within 12 hours of concussion [10] - The trial aims to assess safety and tolerability through follow-up visits, including nasal examinations and neurocognitive testing [10] - Interim data from the Phase 2a trial is expected throughout 2026, with a final readout anticipated in Q4 2026 [8] Market Opportunity - The global concussion market is projected to exceed $9 billion by 2030, with ONP-002 positioned to be the first commercial treatment in this space [3][5] - The nasal drug delivery market is expected to reach nearly $93 billion by 2030, indicating significant potential for ONP-002 if approved [5] Financial Position - Oragenics raised $16.5 million through a public offering of Series H convertible preferred stock and warrants, supporting ongoing clinical development [8] - The company maintains a clean balance sheet with zero debt, fully funding the Phase 2a trial [8] Strategic Collaborations - A strategic collaboration has been formed with Receptor.AI to enhance drug discovery capabilities, potentially expanding the company's molecule portfolio beyond ONP-002 [8]