Oragenics (NYSE American: OGEN), a clinical-stage biopharmaceutical company developing brain-targeted therapeutics through its proprietary intranasal delivery platform, provided updates on its Phase IIa feasibility trial of ONP-002 for mild traumatic brain injury (“mTBI”), its U.S. regulatory pathway and NYSE American continued listing status. The company has dosed nine participants across three active Australian clinical sites — Alfred Health, Mackay and Royal Adelaide Hospital — and has received responses from the U.S. Food and Drug Administration (“FDA”) related to its Type B meeting request briefing package submitted in July 2026. Oragenics is reviewing the FDA responses and remains focused on submitting an Investigational New Drug (“IND”) application by the end of 2026.
Oragenics also reported receiving an NYSE American deficiency letter on Aug. 26, 2026, related to stockholders’ equity requirements under Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. The company has 45 days from receipt of the letter to submit a plan to regain compliance and intends to do so within the required timeframe. If accepted, the plan would allow Oragenics to maintain its listing during a cure period, subject to periodic review, with a compliance deadline of Feb. 25, 2028.
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About Oragenics, Inc.
Oragenics, Inc. is a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology. The Company is working on advancing its lead candidate, ONP-002, as a potential first-in-class treatment for concussion and mild traumatic brain injury. Oragenics is working on commencing clinical trials in Australia for ONP-002 , with U.S. Phase 2b trials planned to follow. The Company’s intranasal delivery platform has potential applications across multiple neurological conditions, including Parkinson’s disease, Alzheimer’s disease, PTSD, and anxiety disorders. Oragenics is committed to developing innovative therapies that address significant unmet medical needs in neurological care. For more information, visit oragenics.com.
NOTE TO INVESTORS: The latest news and updates relating to OGEN are available in the company’s newsroom at https://nnw.fm/OGEN
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