SARASOTA, Fla. - Oragenics (NYSE:OGEN), Inc. (NYSE American: OGEN), a biotechnology firm specializing in intranasal pharmaceuticals for neurological conditions, today announced that its concussion treatment candidate, ONP-002, has successfully completed a study indicating no cardiotoxicity risks. The study is a critical step in ensuring the safety of ONP-002, a new chemical entity (NCE) designed to be delivered through the nasal cavity to the brain.
The company conducted the hERG (human Ether-à-go-go-Related Gene) ion channel studies under Good Laboratory Practices (GLP) with Charles River Laboratories. These studies are essential for meeting U.S. Food and Drug Administration (FDA) requirements, which mandate testing on cardiac receptors to rule out electrical malformations before clinical trials.
Oragenics reported that inhibitory concentrations of ONP-002 were greater than 10 micromolar, suggesting a significant cardiac safety margin. This finding is based on Phase I clinical trial dosing and subsequent blood plasma concentrations, indicating that ONP-002 is unlikely to cause cardiac arrhythmia.
President of Oragenics, Michael Redmond, stated that the company is pleased with the strong safety margin for the heart demonstrated by ONP-002, which allows them to proceed with planning Phase II trials. He emphasized that safety is their top priority and that all safety parameters will be continuously monitored throughout the trials.
Concussions, which result from falls, motor vehicle accidents, and contact sports, pose a substantial unmet medical need with an estimated 69 million cases reported annually worldwide. The Centers for Disease Control and Prevention (CDC) estimates that the total annual healthcare cost for nonfatal traumatic brain injuries (TBIs), including concussions, exceeds $40.6 billion.
Oragenics' focus extends beyond concussions to fighting infectious diseases and developing treatments for other neurological disorders, such as Niemann Pick Disease Type C (NPC). The company's pipeline includes a proprietary powder formulation and an intranasal delivery device.
The information in this article is based on a press release statement from Oragenics. The company's forward-looking statements reflect management's current beliefs and assumptions, but they are subject to a variety of risks and uncertainties that could cause actual results to differ materially from those projected.
In other recent news, Oragenics, Inc. has reported a series of significant developments. The biotechnology firm has completed a prototype for an automated intranasal device designed to administer medication to concussed patients. The device is intended for use in a planned Phase II study of ONP-002, Oragenics' lead drug candidate that targets the brain via nasal delivery.
Oragenics has also received approval from the NYSE American for its compliance plan, demonstrating its commitment to rectifying previous non-compliance issues. The company has raised approximately $2.1 million through a public offering and an additional $890,000 from a private transaction, which are anticipated to support ongoing development activities.
The firm has appointed Dr. William Frank Peacock as Chief Clinical Officer, who will oversee the upcoming Phase II clinical trial of ONP-002. Furthermore, Oragenics has established a subsidiary in Australia to capitalize on research and development rebates provided by the Australian government. These recent developments highlight Oragenics' continued efforts to advance its product portfolio and create long-term value.
InvestingPro Insights
Oragenics, Inc. (NYSE American: OGEN) has shown a commitment to addressing critical health concerns through its pharmaceutical developments, as seen with the recent safety milestone for its concussion treatment candidate, ONP-002. While the company's clinical advancements are promising, a look at the financial health and market performance through InvestingPro provides a broader context for investors evaluating the company's prospects.
An InvestingPro Tip highlights that analysts are anticipating sales growth for Oragenics in the current year, which could reflect optimism surrounding the company's pipeline and its potential to meet unmet medical needs. On the other hand, Oragenics operates with a moderate level of debt, which is an important consideration for investors as it can impact the company's financial flexibility and future growth.
InvestingPro Data reveals some challenges the company is facing. Revenue for the last twelve months as of Q1 2024 was reported at $0.02 million, with a significant decrease in revenue growth of -84.54% during the same period. Additionally, the gross profit margin stood at an alarming -70099.44%, indicating that the company is currently not generating profit from its sales. The stock price has also taken a notable hit, with a six-month total return of -75.09%, reflecting investor concerns and market reactions to the company's performance.
These financial metrics, alongside the InvestingPro Tips, can provide investors with a more nuanced understanding of Oragenics' position in the biotechnology sector. For those interested in a deeper dive into the company's financials and market performance, additional InvestingPro Tips are available, offering further insights into Oragenics' operational and financial strategies.
As Oragenics progresses with its clinical trials and seeks to bring new treatments to market, understanding both the scientific and financial aspects of the company will be crucial for investors. With 11 additional InvestingPro Tips available, interested parties can access a wealth of information to better inform their investment decisions.
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