Oragenics announces ONP-002 safe in preclinical study

SARASOTA, Fla. - Oragenics (NYSE:OGEN), Inc. (NYSE American: OGEN) has reported that its developmental drug, ONP-002, intended for treating concussions, has shown no evidence of causing DNA damage or genotoxicity in an animal study. ONP-002, a novel chemical entity (NCE), is designed to be administered intranasally, targeting the brain directly through the nasal cavity.

The company conducted the study to meet the requirements of the U.S. Food and Drug Administration (FDA) for preclinical safety, which mandates testing on cells and animals to ensure the absence of genotoxic effects that could lead to cancer.

The study involved administering three different concentrations of ONP-002 to animals and analyzing their bone marrow for DNA damage. Results indicated no genetic mutations, suggesting the drug does not disrupt the cell cycle or division.

Oragenics partnered with VivoPharm, Inc. to conduct this study under Good Laboratory Practices (GLP) conditions. Michael Redmond, President of Oragenics, expressed confidence in the safety profile of ONP-002, citing previous successful toxicology and cardiac safety tests.

The company aims to address the unmet medical need for concussion treatment, with an estimated 69 million cases reported annually worldwide. Concussions are commonly caused by falls, motor vehicle accidents, and contact sports and can lead to long-term disabilities in up to 20% of affected individuals. Oragenics plans to initiate a Phase II clinical trial for ONP-002, monitoring safety parameters throughout the drug development process.

Oragenics is a development-stage biotechnology company focusing on nasal delivery of pharmaceuticals for neurological disorders and infectious diseases. The company's pipeline includes drug candidates for mild traumatic brain injury (mTBI), also known as concussion, and Niemann Pick Disease Type C (NPC), along with proprietary powder formulations and intranasal delivery devices.

The information is based on a press release statement from Oragenics, Inc., which also contains forward-looking statements regarding the potential for timely and successful Phase II clinical trials. These statements are subject to various risks and uncertainties, and investors are cautioned not to place undue reliance on them.

In other recent news, Oragenics, Inc. has achieved several key milestones in its pursuit of novel treatments for neurological disorders. The company completed a prototype for an automated intranasal device designed to administer medication to concussed patients. This development complements their ongoing work on ONP-002, their lead drug candidate for treating concussions, which is set to enter a Phase II study.

Oragenics has also gained approval for its compliance plan from the NYSE American, a crucial step in rectifying issues that previously led to non-compliance with the exchange's listing standards. This acceptance underscores the company's commitment to adhering to regulatory requirements.

The company's leadership team has been strengthened with the appointment of Dr. William Frank Peacock as Chief Clinical Officer. Dr. Peacock's extensive experience in emergency medicine research will be invaluable in overseeing the upcoming Phase II clinical trial of ONP-002.

In a strategic move to create long-term value, Oragenics has established a subsidiary in Australia and secured approximately $2.1 million through a public offering, along with an additional $890,000 from a private transaction. These funds are anticipated to support the ongoing development of their neurological drug candidates. These recent developments underscore Oragenics' dedication to advancing its product portfolio and addressing the global health challenge posed by concussions.

InvestingPro Insights

In light of Oragenics, Inc.'s recent announcements regarding their developmental drug ONP-002, it's important for investors to consider the financial health and market performance of the company. According to InvestingPro data, Oragenics has faced significant challenges, with revenue for the last twelve months as of Q2 2024 showing a substantial decline of 93.58%. This decrease is reflected in their gross profit margin, which stands at a concerning -207381.97%, indicating that the company spends far more on production than it earns from sales.

Despite these financial headwinds, Oragenics has seen some positive momentum in its stock performance. An InvestingPro Tip highlights a significant return over the last week, with a 56.18% increase in price total return. Moreover, there was a strong return over the last month, at 25.56%, suggesting that recent developments may have sparked investor interest. However, it is important to note that the stock has taken a substantial hit over the last six months, with a price total return decrease of -62.67%.

Investors considering Oragenics should be aware of the company's status as a niche player in the biotechnology industry, as mentioned in an InvestingPro Tip. Furthermore, with the company not profitable over the last twelve months and suffering from weak gross profit margins, financial caution may be warranted. For those looking to delve deeper into Oragenics' financials and stock performance, additional InvestingPro Tips are available, providing a more comprehensive analysis of the company's outlook.

For further insights and tips on Oragenics, Inc., investors can refer to the 9 additional InvestingPro Tips available at https://www.investing.com/pro/OGEN.

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