Oragenics advances concussion treatment into Phase 2 trials

SARASOTA, Fla. - Oragenics (NYSE:OGEN), Inc. (NYSE American: OGEN), a biotechnology firm specializing in intranasal pharmaceuticals for neurological disorders, announced it is moving forward with Phase 2 clinical trials for its lead drug candidate, ONP-002, targeting concussion treatment. The company plans to initiate the trial in the fourth quarter of 2024, focusing on the drug's safety and efficacy.

The stability of ONP-002 at various temperatures has been established, which is crucial for its use in diverse environments, such as military operations and sports activities. This stability negates the need for cold storage, simplifying field delivery. Oragenics has made substantial progress in preparing for the Phase 2 trial, including improving the intranasal drug formulation to increase the dosage, and completing the prototype of an automated intranasal device to aid administration to patients during the acute phase of injury.

Oragenics has successfully completed FDA-required cardiotoxicity and genotoxicity testing, confirming the drug's safety for further clinical development. These tests were the last step before submitting an Investigational New Drug (IND) application to the FDA, which is currently being prepared with the assistance of Syneos Health (NASDAQ:SYNH)'s regulatory team.

In addition to clinical advancements, Oragenics closed a public offering, raising approximately $1.1 million for the development of ONP-002. The company has also bolstered its leadership team with the appointments of Dr. William 'Frank' Peacock as Chief Clinical Officer and Dr. James 'Jim' Kelly as Chief Medical Officer, both of whom will oversee the upcoming Phase 2 trial.

Despite these developments, Oragenics also disclosed its ongoing non-compliance with certain NYSE American continued listing standards concerning stockholders' equity. The company has received approval for its Plan of Compliance from the NYSE American and has until October 18, 2025, to regain compliance.

Concussion remains a significant unmet medical need, with an estimated 69 million cases reported annually worldwide. Oragenics aims to address this with ONP-002 and its advancements in drug delivery technology.

This news is based on a press release statement from Oragenics, Inc. and provides an update on the company's progress without any endorsements of claims or potential impacts.

In other recent news, Oragenics, Inc. has reported significant advancements in its neurological treatment platform. The company's developmental drug, ONP-002, intended for treating concussions, has shown no evidence of causing DNA damage or genotoxicity in a preclinical study. Oragenics has also completed a prototype for an automated intranasal device designed to administer medication to concussed patients.

The company has successfully enhanced the formulation of ONP-002, planning to initiate a Phase II clinical trial to evaluate its safety and effectiveness. The company's lead drug candidate, ONP-002, has also completed a study indicating no cardiotoxicity risks.

Oragenics has postponed its 2023 Annual Meeting of Shareholders, with a new meeting date to be set and communicated in the future. The company has also received approval from the NYSE American for its compliance plan, demonstrating its commitment to rectifying previous non-compliance issues.

The company recently appointed Dr. William Frank Peacock as Chief Clinical Officer, who will oversee the upcoming Phase II clinical trial of ONP-002. Oragenics has also 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.

InvestingPro Insights

As Oragenics, Inc. (NYSE American: OGEN) forges ahead with its Phase 2 clinical trials for ONP-002, the company's financial health and market performance provide a broader context for potential investors. Recent data from InvestingPro paints a mixed picture of the company's financial standing. According to the latest metrics, Oragenics has experienced a significant revenue decline, with a -93.58% change in the last twelve months as of Q2 2024. This is coupled with a deeply negative gross profit margin of -207,381.97% in the same period, highlighting challenges in profitability and cost management.

Despite these financial headwinds, Oragenics has shown a strong return over the last month, with a 27.43% price total return, suggesting a recent uptick in investor confidence which could be related to the progress in the clinical trials of ONP-002. However, it's important to note that the stock has experienced a substantial 60.22% drop over the last six months, reflecting longer-term market reservations about the company's performance and outlook.

InvestingPro Tips indicate that while analysts anticipate sales growth in the current year, Oragenics suffers from weak gross profit margins and a valuation that implies poor free cash flow yield. These factors may be crucial for investors to consider, especially in light of the company's niche position in the biotechnology industry and its lack of profitability over the last twelve months. For those seeking a deeper dive into the company's prospects, InvestingPro offers additional insights, with a total of 9 InvestingPro Tips available at https://www.investing.com/pro/OGEN.

As Oragenics continues to navigate its clinical and financial milestones, these InvestingPro Insights and Tips could be vital for stakeholders looking to understand the risks and opportunities associated with the company.

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