SARASOTA, Fla. - Oragenics (NYSE:OGEN), Inc. (NYSE American: OGEN), a pharmaceutical company specializing in the development of treatments for neurological disorders, announced today the completion of a prototype for an automated intranasal device. This device is intended to administer medication to concussed patients who may be confused, dazed, or unconscious during the acute phase following an injury.
The company's lead drug candidate, ONP-002, is a new chemical entity (NCE) that targets the brain by delivery through the nasal cavity. Oragenics is currently planning a Phase II study to assess the effectiveness of ONP-002 on blood biomarkers and patient-reported outcomes in individuals who have suffered a concussion.
Concussions, which can result in loss of consciousness and acute memory impairment, are often associated with extended post-concussion symptoms and poor clinical outcomes. Oragenics' new automated device is designed to be used by medical staff when patients are unable to follow instructions due to altered mental states. The device aims to provide an optimal drug delivery route to improve clinical outcomes for these patients.
President of Oragenics, Michael Redmond, expressed optimism about the new technology, emphasizing its potential to treat a range of concussive injuries. He noted that the automated device complements their breath-propelled device, which requires patient participation, and is also planned for use in the upcoming Phase II trial.
Concussion is a significant medical concern with an estimated 69 million cases reported annually worldwide. Common causes include falls, motor vehicle accidents, and contact sports. The condition has been linked to other neurological disorders such as Alzheimer's Disease, Parkinson's Disease, and Chronic Traumatic Encephalopathy (CTE). Post-concussion symptoms can lead to long-term disability in up to 20% of those affected.
Oragenics has yet to begin the Phase II clinical trial and the success of the prototype device and ONP-002 in treating concussions will be subject to the outcomes of future clinical trials and regulatory review processes. This announcement is based on a press release statement from Oragenics.
In other recent news, biotechnology firm Oragenics, Inc. has been granted approval for its compliance plan by the NYSE American, aimed at rectifying the issues that led to non-compliance with the exchange's listing standards. Meanwhile, Oragenics has been making strides in its neurological treatment platform, successfully completing a Phase I trial for a novel technology designed to treat concussions and other neurological disorders. The company has also secured approximately $2.1 million through a public offering and an additional $890,000 from a private transaction.
Oragenics recently appointed Dr. William Frank Peacock as Chief Clinical Officer, who will oversee the upcoming Phase II clinical trial of ONP-002, the company's lead drug candidate for treating mild Traumatic Brain Injury (mTBI), or concussion. This follows a 40-patient Phase I study that found ONP-002 to be safe and well-tolerated.
In other developments, Oragenics has established a subsidiary in Australia to capitalize on research and development rebates provided by the Australian government. The company has also contracted with Avance Clinical, a Contract Research Organization, for the Phase II study of ONP-002. These recent developments reflect Oragenics' continued commitment to advancing its product portfolio and its strategic endeavors to create long-term value.
InvestingPro Insights
As Oragenics, Inc. (NYSE American: OGEN) pushes forward with its innovative solutions for neurological disorders, particularly its automated intranasal device for concussed patients, the company's financial health and market performance provide additional context for investors. According to recent metrics from InvestingPro, Oragenics has experienced a significant downturn in its stock price, with a one-month total return plummeting by -54.5% and a six-month total return of -81.64%. This reflects the market's reaction to the company's recent performance and outlook.
Financially, Oragenics' revenue for the last twelve months as of Q1 2024 stood at a mere 0.02M USD, coupled with a drastic revenue decline of -84.54% over the same period. The company's gross profit margin has been deeply negative, reported at -70099.44%, indicating substantial challenges in generating profitable sales. These figures underscore the financial hurdles Oragenics faces as it seeks to bring its new medical device and drug candidate to market.
Despite these challenges, an InvestingPro Tip highlights that analysts anticipate sales growth in the current year, which may offer a glimmer of hope for the company's financial turnaround. Additionally, the company's liquid assets exceed short-term obligations, suggesting some degree of financial flexibility in the near term.
Investors interested in a deeper dive into Oragenics' financials and performance can find a comprehensive list of 12 additional InvestingPro Tips at https://www.investing.com/pro/OGEN. To enhance your investment research on Oragenics and other companies, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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