Oragenics Updates on Concussion Drug and NYSE Compliance

Oragenics, Inc., headquartered in Sarasota, Florida, has announced notable advancements in its business strategy for 2024. The company, listed on the NYSE American under the ticker OGEN, is devoted to developing innovative intranasal pharmaceuticals for treating neurological conditions. The primary focus is on their leading candidate, ONP-002, aimed at treating concussions. Plans are underway to commence Phase 2 human trials in the fourth quarter of this year.

The company has achieved several key milestones:

Stability of ONP-002 Across Various Temperatures: Oragenics has demonstrated that ONP-002 remains stable under both high and low temperatures. This eliminates the need for cold storage, making it practical for use in varying field conditions such as military training and contact sports, which often occur in extreme temperatures.

Phase 2 Clinical Trial Preparation: Significant progress has been made in preparing for Phase 2 clinical trials for ONP-002. The company has partnered with Avance Clinical to conduct these trials in Australia. Phase 1 data, which established the safety of ONP-002, have been reviewed and accepted. Efforts are ongoing to identify and educate clinical sites on patient enrollment. The formulation of the spray dry drug and the filling of devices for the trials are nearing completion.

Improvements in Drug Formulation: The intranasal drug formulation has been enhanced to increase the dosage of ONP-002 by four times. This improvement aims to expose the brain to a higher amount of the drug in a single treatment.

Development of Automated Intranasal Device: Oragenics has completed a prototype for an automated intranasal device. This device is intended for use in concussed patients who may be dazed, confused, or unconscious, facilitating drug administration during the initial phase of injury.

Successful Completion of FDA-Required Testing: ONP-002 has cleared the FDA-required cardiotoxicity and genotoxicity tests, confirming the drug's safety for further development. These tests were the final steps needed to submit an Investigational New Drug (IND) application to the FDA. The IND package is currently being prepared with the assistance of Syneos Health’s regulatory team. This will support the initiation of a Phase 2b study in the U.S. to evaluate the drug's effects on clinical outcomes following concussion.

Completed Public Offering: The company successfully closed a public offering, raising approximately $1.1 million. The funds will support the continued development of ONP-002 and other corporate needs.

Appointment of Medical Advisors: Dr. William ‘Frank’ Peacock, an expert in emergency medicine and diagnostic biomarkers, has been appointed as Chief Clinical Officer. Dr. James ‘Jim’ Kelly, a renowned neurologist and key opinion leader in concussion, has joined as Chief Medical Officer. They will oversee the upcoming Phase 2 clinical trial for treating concussions in emergency settings.

Michael Redmond, President of Oragenics, expressed satisfaction with the progress made in advancing ONP-002 towards Phase 2 clinical trials. He highlighted the company’s commitment to improving drug safety, completing essential FDA tests, and enhancing delivery technology and formulation. These efforts, combined with strategic leadership appointments, position Oragenics as a leader in developing medical solutions for acute neurological trauma, addressing a critical unmet need.

Continued Non-Compliance and NYSE Approved Plan to Gain Compliance: Despite the advances, Oragenics has faced challenges with compliance regarding NYSE American’s continued listing standards. The company received a notice indicating non-compliance with certain subsections that require specific stockholders’ equity thresholds. However, Oragenics submitted a compliance plan, which has been approved by the NYSE American. The company has until October 18, 2025, to regain compliance. Despite these issues, the listing and trading of Oragenics’ stock will continue under the symbol “OGEN” with a “.BC” designation indicating its below-compliance status. The company remains dedicated to resolving these compliance issues while advancing its business and clinical operations.

About Concussion: Concussion is a significant medical need with an estimated 69 million cases reported annually worldwide. Common causes include falls, motor vehicle accidents, and contact sports. Concussions have 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 patients.

About Oragenics: Oragenics is a biotechnology company focused on the nasal delivery of pharmaceuticals for neurology and infectious diseases. Their product pipeline includes treatments for mild traumatic brain injury (concussion), Niemann Pick Disease Type C, and proprietary powder formulations and intranasal delivery devices.

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