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SARASOTA, Fla. - Oragenics, Inc. (NYSE American:OGEN), a micro-cap biotech company with a market capitalization of $1.1 million, announced Wednesday it has entered into a manufacturing agreement with Sterling Pharma Solutions for the production of its lead drug candidate ONP-002, which is being developed to treat concussion. According to InvestingPro data, the company maintains a strong cash position relative to debt, a crucial factor for clinical-stage biotechs.
The agreement secures Good Manufacturing Practice (GMP)-compliant drug product supply ahead of Oragenics’ planned Phase IIb clinical trials expected to begin next year. Sterling will produce ONP-002 at its Cary, North Carolina facility under strict cGMP conditions. The company’s overall financial health score is rated as ’Weak’ by InvestingPro, with the stock trading near its 52-week low.
"This partnership is a critical milestone in our path forward for Phase IIb clinical trials," said Janet Huffman, Chief Executive Officer of Oragenics.
The upcoming proof-of-concept study will evaluate early efficacy of ONP-002 in patients with mild traumatic brain injury (mTBI), commonly known as concussion, a condition that currently has no FDA-approved pharmacological therapies.
Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions, said the company’s scientific expertise in CNS therapies and ability to meet critical timelines will support the continued development of the drug candidate.
Oragenics is developing ONP-002 as part of its strategy to create scalable, accessible treatments for neurological trauma using intranasal delivery technology designed to provide fast, targeted therapy to the brain.
The information in this article is based on a press release statement from Oragenics. For comprehensive financial analysis and additional insights on Oragenics, including 12 more key ProTips and detailed metrics, visit InvestingPro.
In other recent news, Oragenics, Inc. announced a preferred stock offering expected to raise approximately $20 million, with proceeds intended to fund clinical trials for its ONP-2 concussion treatment, among other purposes. The offering involves 800,000 shares of Series H Convertible Preferred Stock and warrants, priced at $25.00 per share, with Dawson James Securities acting as the sole placement agent. Additionally, Oragenics has received approval from the Human Research Ethics Committee in Australia to commence Phase II clinical trials for its ONP-002 therapy for mild traumatic brain injury. The trials are set to begin in Australia, with potential expansion to New Zealand. The company also announced a one-for-thirty reverse stock split, aiming to consolidate its shares and align with long-term investor expectations. Janet Huffman has been appointed as the new CEO, continuing her role as CFO, with her employment agreement outlining various terms and severance packages. Shareholders have approved key proposals, including the reverse stock split and an increase in shares available under the company’s 2021 Equity Incentive Plan. These developments reflect Oragenics’ strategic efforts to strengthen its capital market presence and advance its clinical programs.
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