SARASOTA, Fla. - Oragenics (NYSE:OGEN), Inc. (NYSE American: OGEN) has announced progress in the development of its lead drug candidate, ONP-002, intended for the treatment of concussions. The company, dedicated to creating therapies for neurological disorders, has reached several key milestones in 2024, including the preparation for Phase II clinical trials.
The biopharmaceutical firm has focused on an intranasal delivery system for ONP-002, a neurosteroid, which offers advantages such as faster brain delivery and reduced systemic exposure. With over 3 million annual concussion cases in the U.S. and an estimated 69 million worldwide, the need for effective treatment is pressing, especially as up to 50% of cases may go unreported.
In 2024, Oragenics has made significant strides, including the appointment of Dr. James Kelly and Dr. William Peacock as Chief Medical Officer and Chief Clinical Officer, respectively. These appointments bring extensive expertise in brain health and emergency medicine to the company.
The safety and tolerability of ONP-002 were established in Phase I trials, and the drug has passed FDA-required cardiotoxicity tests, indicating a low risk of causing cardiac arrhythmias. Genotoxicity testing also confirmed that the drug does not cause DNA damage, an important safety milestone before proceeding to Phase II trials.
A partnership with Avance Clinical, a leading contract research organization (CRO), was established in May 2024 to strengthen the execution of the upcoming Phase II trial. ONP-002 has also demonstrated temperature stability, which is critical for use in environments where concussions are common, such as sports or military settings.
In terms of manufacturing, the company has completed spray-dry formulation and device filling for the intranasal delivery of ONP-002, which is expected to enhance the drug's absorption and increase the dosage delivered to the brain.
Oragenics has raised over $6 million throughout 2024, including a public offering in September that generated approximately $4.45 million. These funds are earmarked for advancing ONP-002 into Phase II clinical trials.
Looking ahead, Oragenics plans to initiate Phase II trials later in the year, initially in Australia, followed by trials in the U.S. The company is working on clinical site selection and developing protocols for patient inclusion in emergency departments. An Australian Regulatory Submission Brochure is also slated for submission in the fourth quarter of 2024.
Oragenics remains dedicated to transparency with its shareholders, promising ongoing updates on the progress of ONP-002. This press release statement is based on information available as of the date hereof and includes forward-looking statements subject to risks and uncertainties.
In other recent news, Oragenics, Inc. has made significant strides in its operations. The biopharmaceutical company has initiated a public offering of over 8 million shares, projected to generate approximately $4.45 million. This funding will be directed towards the development of its ONP-002 product candidate and for general corporate purposes.
Oragenics also granted stock options to top executives under its 2021 Equity Incentive Plan. President J. Michael Redmond and Chief Financial Officer Janet Huffman were granted 100,000 and 80,000 shares respectively.
In terms of corporate governance, the company has rescheduled its 2023 Annual Meeting of Shareholders from August to December 2024.
On the clinical front, Oragenics has advanced its concussion treatment, ONP-002, into Phase 2 clinical trials. The company recently announced that ONP-002 showed no evidence of causing DNA damage or genotoxicity in a preclinical study, and no cardiotoxicity risks in another study. Analysts from Dawson James Securities, Inc. have served as the exclusive placement agent for the transaction.
Finally, Oragenics has strengthened its leadership team with the appointments of Dr. William 'Frank' Peacock as Chief Clinical Officer and Dr. James 'Jim' Kelly as Chief Medical Officer, who will oversee the upcoming Phase 2 trial.
InvestingPro Insights
As Oragenics (NYSE American: OGEN) advances its lead drug candidate ONP-002 for concussion treatment, investors should consider some key financial metrics and insights from InvestingPro.
According to InvestingPro data, Oragenics has a market capitalization of $3.12 million, reflecting its status as a small-cap biopharmaceutical company. This aligns with the company's focus on developing innovative therapies for neurological disorders, particularly its progress with ONP-002.
An InvestingPro Tip highlights that Oragenics holds more cash than debt on its balance sheet. This financial position is crucial for a company in the developmental stage of its key drug candidate, as it provides flexibility to fund ongoing research and clinical trials, such as the upcoming Phase II trials for ONP-002.
Another relevant InvestingPro Tip indicates that analysts anticipate sales growth in the current year. This expectation could be tied to the potential commercialization of ONP-002, should it successfully progress through clinical trials. The company's recent fundraising efforts, including the $4.45 million public offering in September, further support its ability to advance its drug development programs.
It's worth noting that InvestingPro offers 12 additional tips for Oragenics, providing a more comprehensive analysis for investors interested in the company's prospects.
While the company's progress in drug development is promising, investors should be aware that Oragenics is not currently profitable, as indicated by its negative P/E ratio of -0.16 for the last twelve months as of Q2 2024. This is not unusual for biopharmaceutical companies in the research and development phase, but it underscores the importance of successful clinical trials and potential future revenue streams from products like ONP-002.
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