Oragenics, Inc.

Oragenics, Inc. (NYSE: OGEN) is a clinical-stage biotechnology company focused on intranasal delivery of pharmaceutical medications for neurological disorders. Its lead candidate, ONP-002, is a first-in-class, novel neurosteroid administered through an intranasal device for the treatment of mild traumatic brain injury, commonly known as concussion. With concussions representing a sizable market opportunity of approximately $400 billion a year globally and currently lacking FDA-approved treatments, ONP-002 is positioned to provide the first FDA-approved pharmaceutical treatment for a significant unmet medical need. The drug has shown promise in preclinical behavioral trials, improving memory and motor function, while reducing depression and anxiety. Mechanistically, ONP-002 reduces brain inflammation, oxidative stress, swelling, and blood-brain barrier integrity. Oragenics has successfully completed a Phase I clinical trial in healthy human volunteers that assessed the safety and pharmacokinetics of ONP-002. The company is now moving into a Phase II clinical trial for concussed patients. The Phase IIa feasibility study will be conducted in Australia and a Phase IIb clinical study will be conducted in the US.