Oragenics, Inc. Updates Shareholders on Concussion Drug Progress and Phase II Trial Preparation

Company Overview - Oragenics, Inc. is a biopharmaceutical company focused on developing novel therapies for neurological disorders, particularly through innovative intranasal technology [2] - The lead program, ONP-002, is a first-in-class neurosteroid aimed at treating moderate to severe concussions, offering advantages such as faster brain delivery and reduced systemic exposure [2] Market Need - There are over 3 million concussion occurrences annually in the U.S. and an estimated 69 million globally, with up to 50% of cases believed to go unreported [3] - The urgency for effective treatments is heightened due to the lack of FDA-approved options for patients [3] Key Milestones in Development - In 2024, Oragenics appointed Dr. James Kelly and Dr. William Peacock to strengthen clinical leadership for ONP-002 [4] - The company is preparing to initiate Phase II clinical trials following successful Phase I trials that confirmed the safety and tolerability of ONP-002 [5] - ONP-002 passed FDA-required cardiotoxicity tests, indicating a strong cardiac safety margin [6] - Successful completion of FDA-required genotoxicity studies confirmed that ONP-002 does not cause DNA damage [7] - A partnership with Avance Clinical was established to enhance the execution of Phase II trials [8] - ONP-002 demonstrated temperature stability, eliminating the need for cold-chain storage, which is crucial for field delivery [9] - The company completed the spray-dry formulation and filled intranasal delivery devices for the upcoming Phase II trial [10] - A novel nanoparticle formulation was developed to enhance intranasal absorption, increasing the drug amount per dose by fourfold [11] - Completion of FDA-recognized intranasal casting studies supports the drug's delivery mechanism [12] Recent Financing - In September 2024, Oragenics raised approximately $4.45 million through a public offering, contributing to over$6 million raised throughout the year [13] Future Plans - The company plans to initiate Phase II clinical trials later in 2024, starting in Australia and then moving to the U.S. [14] - Clinical site selection is underway with Avance Clinical and major neurotrauma centers in Australia [15] - An Australian Regulatory Submission Brochure will be submitted in Q4 2024, outlining safety and efficacy protocols [16] - Continued development of the intranasal delivery system remains a key focus for the company [17] Commitment to Shareholders - Oragenics emphasizes transparency and open communication with shareholders, promising to provide updates on progress and commercialization efforts for ONP-002 [18]