Oragenics provided update to shareholders

Oragenics provided a corporate update reflecting on the company’s progress throughout 2024, including key milestones in the development of ONP-002, its lead candidate for the treatment of concussions. The company’s lead program, ONP-002, is a first-in-class neurosteroid being developed to treat moderate to severe concussions. Intranasal delivery provides numerous advantages over traditional systemic methods. Oragenics has made significant advancements in the development of ONP-002 during 2024, including: Strengthened Clinical Leadership; Phase II Clinical Trial Preparation; Successful Cardiotoxicity Test; FDA-Required Genotoxicity Studies; Partnership with Avance Clinical; Temperature Stability Achieved; Spray-Dry Manufacturing and Device Completion; Improved Drug Percentage in Final Formulationl Completion of FDA-Recognized Study for Concussion Drug, ONP-002: Intranasal casting studies are critical for FDA approval of pharmaceuticals delivered via the nasal passage. Looking Ahead: Key Milestones: Oragenics anticipates several key milestones in the coming months, including: Initiation of Phase II Clinical Trials: The company plans to begin Phase II trials later this year, initially in Australia, followed by U.S. trials. These trials will evaluate safety and efficacy – evaluating the effects of ONP-002 on concussion patient symptom reduction and functional recovery. In preparation for its upcoming Phase II clinical trials, Oragenics plans to submit the Australian Regulatory Submission Brochure during the fourth quarter of 2024. This submission is a critical component for the regulatory approval of the trial in Australia and outlines the clinical trial safety and efficacy protocols, informed consent protocols, and data collection methods.