Core Insights - Oragenics, Inc. is hosting a management update webinar on May 20, 2025, to discuss the unmet medical need in concussion treatment and its lead program ONP-002, a neuroprotective therapy for mild traumatic brain injury [1][3][6] - The company emphasizes that ONP-002 offers a novel therapeutic approach in a market lacking FDA-approved drug therapies for concussions [3] Company Overview - Oragenics is focused on developing intranasal therapeutics for neurological disorders, particularly ONP-002 for mild traumatic brain injury or concussion [4] - The company is advancing proprietary powder formulations and intranasal delivery technology to enhance drug administration [4] Product Development - ONP-002 is delivered intranasally, allowing for non-invasive and direct brain delivery while minimizing systemic exposure [3] - Preclinical studies have shown that ONP-002 can reduce inflammation, oxidative stress, and brain swelling following head injury, with a Phase I trial indicating the compound is safe and well tolerated [3]

Core Insights - Oragenics, Inc. is advancing its lead therapeutic candidate, ONP-002, for concussion treatment, highlighting significant progress in regulatory, clinical, financial, and partnership initiatives [1][2] Strategic and Operational Milestones - ONP-002 is a neuroprotective, anti-inflammatory compound designed for intranasal administration to treat concussion, classified as a mild traumatic brain injury (mTBI) [3] - The drug has undergone extensive preclinical studies, including evaluations for cardiotoxicity and genotoxicity, and successfully completed a Phase I human study with no serious adverse events [4] - The company has finalized drug production for the Phase IIa clinical trial and submitted the Investigator's Brochure to regulatory authorities in Australia, with first patient enrollment expected soon [5][6] Strategic Partnerships - A collaboration with BRAINBox Solutions was established to combine ONP-002's therapeutic capabilities with BRAINBox's diagnostic tools, aiming to enhance concussion care [7][9] Financial Position and Capital Structure - Oragenics raised approximately $5 million in Q1 2025 through a mix of equity and non-dilutive debt financing, including $2.6 million from At-the-Market (ATM) equity sales and $2.25 million in non-dilutive debt [8][10] - The company simplified its capital structure by converting all outstanding Series A and B preferred shares to common stock, enhancing transparency for shareholders [10][11] Upcoming Milestones - Key projected milestones include HREC approval in Australia and first patient enrollment in the Phase IIa trial expected in Q2 2025, with completion of Phase IIa enrollment anticipated by Q4 2025 [12] - Additional milestones include interim safety and biomarker readout in Q4 2025 – Q1 2026, initiation of Phase IIb in Q1 2026, and FDA Accelerated Approval Filing in Q3 2026 [12] Commitment to Value Creation - The company is focused on advancing ONP-002 with urgency and precision, aiming to deliver a clinical breakthrough in concussion care and generate long-term value for shareholders [13][14]