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SARASOTA, Fla. - Oragenics, Inc. (NYSE American:OGEN), currently trading at $1.16 per share, announced Monday it plans to launch Phase IIa clinical trials for its lead drug candidate ONP-002 in the third quarter of 2025, as the company aims to develop what could become the first FDA-approved pharmaceutical treatment for concussion. According to InvestingPro data, the company’s stock has seen significant volatility, with shares down over 97% in the past year.
The biotechnology company reported it has secured Human Research Ethics Committee approval in Australia and appointed Southern Star Research as its Clinical Research Organization. Oragenics also finalized a manufacturing agreement with Sterling Pharma Solutions for production at their North Carolina facility.
ONP-002 is delivered through the company’s proprietary intranasal delivery system, which is designed to provide targeted delivery of therapeutics to the brain while bypassing systemic circulation.
"We’re not just developing another drug, we’re striving to pioneer a new era of brain-first recovery that could transform how we treat neurological trauma," said Janet Huffman, Chief Executive Officer of Oragenics, in the press release statement.
The company completed a $16.5 million capital raise through Series H Convertible Preferred Stock and Warrants, with approximately $15.2 million in net proceeds after expenses. Oragenics reported a 50% reduction in research and development expenses and an 8% decrease in general and administrative costs for the six months ended June 30, 2025, compared to the same period last year. InvestingPro analysis reveals the company’s financial health score is currently rated as "WEAK," with a current ratio of 0.5 indicating potential liquidity challenges. Get access to 12 additional ProTips and comprehensive financial metrics with InvestingPro.
Following the anticipated Phase IIa trial initiation in Q3 2025, the company plans to submit an Investigational New Drug (IND) application to the FDA for Phase IIb clinical trials by the fourth quarter of 2025.
Oragenics acquired ONP-002 in 2024 as part of a strategic shift toward neurological therapeutics. With a current market capitalization of just $0.95 million and analysts setting a consensus target price of $2.00, the company cites a global concussion market opportunity of $8.9 billion by 2027, with no FDA-approved pharmacological treatments currently available for concussion or mild traumatic brain injury. Based on InvestingPro’s Fair Value analysis, the stock appears to be trading near its fair value despite recent market volatility.
In other recent news, Oragenics, Inc. announced a partnership with Sterling Pharma Solutions to produce its lead drug candidate, ONP-002, for concussion treatment. This agreement ensures a Good Manufacturing Practice-compliant drug supply for upcoming Phase IIb clinical trials. Additionally, Oragenics revealed plans to raise approximately $20 million through a preferred stock offering, selling up to 800,000 shares of Series H Convertible Preferred Stock and warrants. Each preferred share will be convertible into common stock at a price of $2.50 per share. The company also announced a one-for-thirty reverse stock split, effective June 3, 2025, consolidating every 30 existing shares into one new share. In further developments, Oragenics received approval from the Human Research Ethics Committee in Australia to begin Phase II clinical trials for ONP-002, targeting mild traumatic brain injuries. This trial is set to start in the second quarter of 2025, focusing on patients in level 1 trauma emergency departments.
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