A CNS Platform Built to Define a Category.

Oragenics is building a proprietary central nervous system drug delivery platform — one that solves the most fundamental problem in neurological medicine: getting therapeutics directly to the brain, faster and more effectively than any existing approach.

Our lead asset, ONP-002, is the first pharmacological treatment in clinical development with an FDA pathway for acute concussion. But ONP-002 is the proof of concept, not the ceiling. The same proprietary intranasal delivery platform has potential applications across PTSD, stroke, seizures, Alzheimer’s, Parkinson’s, and other CNS disorders — in a nasal drug delivery market projected to exceed $125 billion by 2030.

Platform. Pipeline. No competition. This is what getting there first looks like.

The opportunity

The problem is enormous. The solution doesn’t exist yet.

Concussion is one of the most common neurological injuries in the world — 69 million cases annually. There is no approved pharmacological treatment anywhere in the world. Untreated concussions carry real long-term consequences, including increased dementia risk.

The concussion therapeutics market is projected to reach $8.9 billion by 2027. The broader nasal drug delivery market is projected to exceed $125 billion by 2030. Oragenics is positioned to own the concussion treatment category.

ONP-002: First-In-Class, Proven Safe, Phase 2 Active.

The asset

ONP-002 is a first-in-class intranasal neurosteroid designed to treat the underlying biology of brain injury — not just its symptoms. Delivered via a proprietary intranasal device, it travels through the olfactory pathway directly to the brain, reducing swelling and inflammation, preserving blood-brain barrier integrity, and promoting cell survival.

Phase 1 trials demonstrated safety and tolerability across 40 patients with zero serious adverse events. ONP-002 is now in an active Phase 2a randomized, placebo-controlled trial enrolling patients in Australia.

The investment case

Multiple levers for value creation

• First and only in a category without a treatment. ONP-002 is the only pharmacological treatment in clinical development with an FDA pathway for concussion — addressing a $49B market with zero direct competition.
• Zero competition in the space that matters most. No competitor has an approved pharmacological treatment for concussion. Oragenics has the clearest path to becoming the standard of care.
• A proprietary delivery platform with licensing potential. Our intranasal direct-to-brain delivery system is not just a mechanism — it’s a protected asset with IP through 2040+. The same platform that delivers ONP-002 has potential applications across PTSD, stroke, seizures, Alzheimer’s, and Parkinson’s — and represents a standalone licensing opportunity in a $125B+ nasal drug delivery market.
• A Phase 2 ready asset with a validated safety profile. Phase 1 is complete. The data is clean. The de-risking work has been done.
• A clear U.S. regulatory pathway. The Australian Phase 2a trial is structured to generate the clinical data needed for a U.S. IND submission, targeted for 2026.
• Demonstrated financial discipline. Strong balance sheet with controlled and capital efficiency throughout clinical development.
  

The team

Expert leaders. Renowned scientists.

Janet Huffman

CEO & CFO

Former CFO of TRxADE HEALTH (Nasdaq). Founding CFO of Banyan Pediatric Care Centers. USF accounting graduate.

James P. Kelly, MD

Chief Medical Officer

Executive Director, Marcus Institute for Brain Health. Professor of Neurology, U of Colorado. Former Director, NICoE at Walter Reed.

William “Frank” Peacock, MD

Chief Clinical Officer

Vice Chair for Emergency Medicine Research, Baylor College of Medicine. World-renowned TBI biomarker researcher.

Near-term catalysts

Milestones that matter

• Phase 2a trial underway in Australia
• Phase 2a data readout expected in 2026
• U.S. IND submission in progress
• AI-driven pipeline expansion in collaboration with Receptor.AI
• Strategic partnership development in the concussion care ecosystem