Oragenics Secures $16.5M in Funding, Plans Q3 2025 Trials for Concussion Treatment

Oragenics raised $16.5 million in funding and plans to begin Phase IIa trials for its concussion treatment candidate, ONP-002, in Q3 2025. The company aims to enter the $8.9 billion global concussion market by 2027 and become the first FDA-approved pharmacological treatment for concussion. Oragenics has secured HREC approval in Australia, appointed a CRO, and finalized a cGMP manufacturing agreement to support clinical trials.

SARASOTA, Fla. - Oragenics, Inc. (NYSE American: OGEN) has raised $16.5 million in funding through a Series H Convertible Preferred Stock and Warrants offering. This capital infusion will support the company's lead candidate, ONP-002, a revolutionary intranasal treatment for concussion, as it prepares to enter Phase IIa trials in the third quarter of 2025 [1].

The funding will enable Oragenics to accelerate the clinical development of ONP-002, with the aim of becoming the first FDA-approved pharmacological treatment for concussion. The company has secured significant milestones in the second quarter of 2025, including Human Research Ethics Committee (HREC) approval in Australia, appointment of a Clinical Research Organization (CRO), and finalization of a cGMP manufacturing agreement with Sterling Pharma Solutions. These achievements position Oragenics to maintain a competitive edge in the rapidly growing intranasal neurotrauma space [1].

Oragenics aims to capitalize on the $8.9 billion global concussion market, which is projected to reach by 2027. The company's proprietary intranasal delivery system offers targeted, non-invasive drug administration directly to the brain, bypassing systemic circulation and reducing side effects. This technology has the potential to extend beyond concussion treatment to acute neurological emergencies and chronic neurodegenerative diseases [1].

The recent capital raise reflects growing investor confidence in Oragenics' transformational approach to neurotrauma treatment. The company plans to use the funds to accelerate clinical development, advance platform technology, strengthen manufacturing and regulatory capabilities, and support operational excellence and working capital needs [1].

References:
[1] https://www.quiverquant.com/news/Oragenics%2C+Inc.+Reports+Progress+on+Intranasal+Concussion+Treatment+ONP-002+and+Q2+2025+Milestones