Oragenics partners with Sterling Pharma Solutions for ONP-002 manufacturing.

Oragenics has partnered with Sterling Pharma Solutions to manufacture its lead drug candidate, ONP-002, for treating concussion. The agreement ensures GMP-compliant drug product supply ahead of planned Phase IIb clinical trials starting next year. The partnership marks an important milestone for Oragenics, securing domestic production capabilities to support its clinical and regulatory efforts.

SARASOTA, Fla., July 16, 2025 (GLOBE NEWSWIRE) — Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing intranasal therapeutics for neurological disorders, has entered into a manufacturing agreement with Sterling Pharma Solutions. This agreement aims to ensure Good Manufacturing Practice (GMP)-compliant drug product supply ahead of the company's planned Phase IIb clinical trials, expected to commence next year.

The partnership will see Sterling Pharma Solutions produce Oragenics' lead drug candidate, ONP-002, for the treatment of concussion. This agreement marks a significant milestone for Oragenics, securing domestic production capabilities to support its clinical and regulatory efforts.

"We are excited to partner with Sterling’s facility in Cary, North Carolina, to support the production of ONP-002," said Janet Huffman, Chief Executive Officer of Oragenics. "This partnership is a critical milestone in our path forward for Phase IIb clinical trials. This partnership reinforces our commitment to quality, efficiency, and U.S.-based innovation and we believe this step will help streamline our clinical development strategy."

Sterling Pharma Solutions will produce ONP-002 under strict cGMP conditions for use in Oragenics’ planned Phase IIb trials, a proof-of-concept study which will evaluate the early efficacy of ONP-002 in patients with mild traumatic brain injury (mTBI).

Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions, said: "We are pleased to be partnering with Oragenics for the GMP production of its lead molecule for clinical trials. Our scientific expertise in CNS therapies and our ability to meet critical timelines will support the continued path to market for this transformative drug candidate."

This U.S.-based manufacturing agreement builds upon Oragenics’ broader strategy to develop scalable, accessible, and fast-acting treatments for neurological trauma, beginning with concussion, a condition that currently has no FDA-approved pharmacological therapies.

References:
1. [https://www.globenewswire.com/news-release/2025/07/16/3116417/0/en/Oragenics-Inc-Announces-U-S-Based-Drug-Manufacturing-Agreement-to-Support-ONP-002-Clinical-Development.html](https://www.globenewswire.com/news-release/2025/07/16/3116417/0/en/Oragenics-Inc-Announces-U-S-Based-Drug-Manufacturing-Agreement-to-Support-ONP-002-Clinical-Development.html)
2. [https://www.marketscreener.com/quote/stock/ORAGENICS-INC-40561583/news/Oragenics-Inc-Announces-U-S-Based-Drug-Manufacturing-Agreement-to-Support-ONP-002-Clinical-Develo-50524637/](https://www.marketscreener.com/quote/stock/ORAGENICS-INC-40561583/news/Oragenics-Inc-Announces-U-S-Based-Drug-Manufacturing-Agreement-to-Support-ONP-002-Clinical-Develo-50524637/)