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SARASOTA, Fla. - Oragenics, Inc. (NYSE American: OGEN), a micro-cap biotechnology company with a market capitalization of $3.87 million, has announced today the receipt of approval from the Human Research Ethics Committee (HREC) in Australia to commence Phase II clinical trials for its intranasal neuroprotective therapy, ONP-002, intended for the treatment of mild traumatic brain injury (mTBI), also known as concussion. According to InvestingPro data, the company maintains a positive cash position relative to debt, providing some financial flexibility for its clinical development programs. This authorization is a key step in the company’s expansion of its clinical development efforts on a global scale.
The clinical trials are set to begin in Australia, with patient enrollment expected to start in the second quarter of 2025. The study will target patients presenting with concussions in level 1 trauma emergency departments, which are often the first point of care for individuals who have experienced motor vehicle accidents, falls, or sports-related injuries.
Janet Huffman, CEO of Oragenics, expressed optimism about the development, stating, "Receiving HREC approval in Australia brings us one step closer to offering a much-needed therapeutic option for patients suffering from concussions." The company is also considering enrollment sites in New Zealand, indicating a broader reach for the ONP-002 program. While the company’s stock has faced significant headwinds, declining 88% over the past year, InvestingPro analysis reveals additional insights about the company’s potential, with over 8 key investment tips available to subscribers.
ONP-002 is designed for non-invasive intranasal administration, which is considered an efficient method for delivering medication directly to the brain. In preclinical studies, ONP-002 has shown potential in reducing inflammation, oxidative stress, and brain swelling associated with concussions. A completed Phase I clinical trial revealed that ONP-002 was safe and well-tolerated by participants.
The drug represents a potential acute therapy for concussions, a common condition that lacks a wide range of treatment options. Oragenics is also working on advancing proprietary powder formulations and intranasal delivery technology to improve drug administration.
This announcement is based on a press release statement by Oragenics and includes forward-looking statements subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those projected. With an EBITDA of -$9.91 million in the last twelve months and a Financial Health Score of 1.07 (rated as WEAK by InvestingPro), investors are cautioned not to place undue reliance on these forward-looking statements. The company has not committed to providing updates on any changes except as required by law.
In other recent news, Oragenics, Inc. announced the appointment of Janet Huffman as the new Chief Executive Officer, effective May 2, 2025. Huffman, who has been serving as the company’s Chief Financial Officer and Interim CEO, will continue in her role as CFO. The company also held its annual shareholder meeting, where shareholders approved a reverse stock split and increased the number of shares available under the 2021 Equity Incentive Plan. Additionally, Cherry Bekaert LLP was ratified as the independent auditor for the fiscal year ending December 31, 2025. In a separate development, Oragenics reported significant progress in the development of its lead therapeutic candidate, ONP-002, aimed at treating concussions. The company has reached several milestones, including a partnership with BRAINBox Solutions and the submission of the Investigator’s Brochure for a Phase IIa clinical trial in Australia. Oragenics also raised approximately $5 million through equity and debt financing to strengthen its financial position. These recent developments highlight the company’s ongoing efforts in drug development and corporate governance.
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