Oragenics is a clinical-stage biopharmaceutical company with a single program: ONP-002, a synthetic neurosteroid for the treatment of mild traumatic brain injury (mTBI), commonly known as concussion. ONP-002 is formulated as a powder and delivered intranasally via a proprietary breath-powered device, which closes the soft palate to direct the drug toward the olfactory region, enabling it to diffuse into the brain and bypass the blood-brain barrier. The drug is designed to reduce brain swelling, oxidative stress, and inflammation following a concussion. ONP-002 completed Phase 1 trials in Australia, demonstrating safety and tolerability in healthy subjects. Phase 2a trials are expected to begin in Australia in Q1 2026, with a U.S.-based Phase 2b trial expected in Q1 2027 and Phase 3 estimated to start in Q1 2028. Oragenics has no commercial products and no revenue; it funds operations through equity markets and relies on consultants, CROs, and third-party manufacturers given its minimal employee base. If ONP-002 receives regulatory approval, Oragenics plans to commercialize through licensing and distribution partnerships — collecting upfront fees and royalties — rather than building its own sales force. The company is also pursuing grants and pharmaceutical partnerships to help fund development.