Oragenics Inc. - OGEN STOCK NEWS

Oragenics has developed a new formulation for its neurosteroid, ONP-002, designed for treating concussions via intranasal delivery. The formulation aims to enhance brain uptake and bioavailability, leading to longer absorption times. A Phase II study is planned to evaluate the drug's safety and effectiveness in concussed patients by examining blood biomarker profiles and functional outcomes. The improved formulation is part of Oragenics' platform for acute-field drug delivery, with the goal of reducing immediate and long-term concussion symptoms. Concussion, affecting 69 million people annually worldwide, is linked to various severe neurological disorders.

Oragenics (NYSE American: OGEN) has announced the development of an automated intranasal device for treating concussed patients. The new prototype is designed for initial use in acute settings where patients are confused, dazed, or unconscious. Oragenics' lead drug candidate, ONP-002, aims to target the brain through nasal delivery. A Phase II study will evaluate ONP-002's effectiveness on blood biomarkers and patient-reported outcomes. The automated device is particularly intended for patients unable to self-administer the drug due to mental impairment. Concussions, affecting around 69 million people annually, often result from falls, motor vehicle accidents, and contact sports.

Oragenics announced the closing of its public offering of 1,100,000 shares at $1.00 per share, raising approximately $1.1 million. The funds will support the development of their ONP-002 product candidate and cover general corporate expenses. Dawson James Securities acted as the sole placement agent, and the offering was made under a shelf registration statement filed with the SEC. Legal representation was provided by Shumaker, Loop & Kendrick, LLP for Oragenics and ArentFox Schiff LLP for the placement agent.

Oragenics, a company focused on developing intranasal pharmaceuticals for neurological disorders, announced the pricing of a public offering. The company plans to offer 1,100,000 shares of its common stock at $1.00 per share, aiming to raise around $1.1 million before costs. The closing date is expected on or about June 26, 2024, pending customary conditions. The net proceeds will fund the development of Oragenics' product candidate ONP-002, along with other corporate purposes and working capital. Dawson James Securities is the sole placement agent for this offering. This offering is made under a shelf registration statement filed and declared effective by the SEC. Interested investors should read the full prospectus available on the SEC website.

Oragenics, Inc. (NYSE: OGEN), a company focused on intranasal pharmaceuticals for neurological disorders, announced a proposed public offering of its common stock or pre-funded warrants.

All securities in the offering will be sold by Oragenics. The proceeds will fund the development of its ONP-002 product candidate and cover general corporate expenses. Dawson James Securities, Inc. will serve as the sole placement agent.

The offering is being made under a shelf registration statement filed with the SEC. The terms will be detailed in a prospectus supplement available on the SEC's website.

The completion of the offering is subject to market conditions, and there's no assurance on its size or terms.

Oragenics (NYSE American: OGEN) announced that the NYSE American has accepted its compliance plan, allowing it to remain listed. The company has until October 18, 2025, to regain compliance with the exchange's standards. Quarterly monitoring will be conducted to ensure progress. Failure to meet these requirements may result in delisting proceedings.

Oragenics has appointed Dr. William “Frank” Peacock as Chief Clinical Officer, with a focus on conducting a Phase II clinical trial for ONP-002, a drug aimed at treating concussions in the Emergency Department. Dr. Peacock, a renowned emergency medicine expert, will oversee this trial in collaboration with Avance Clinical. Previous Phase I trials indicated ONP-002 is safe and well-tolerated. The trial aims to assess biomarkers and symptom severity post-concussion. Concussions, affecting 69 million people globally each year, remain a critical unmet medical need. Dr. Peacock's extensive background in emergency medicine and concussion research is expected to be pivotal for the success of this trial.

Oragenics announced a webinar on neurotrauma medicine to be held on May 20, 2024, at 12:00 PM ET. The webinar will focus on Traumatic Brain Injury (TBI), its causes, and its links to long-term neurological disorders. The company will discuss their lead drug candidate, ONP-002, a neurosteroid for mild TBI, and present outcomes from preclinical and Phase I trials. Details of the forthcoming Phase II trial in acute and emergency departments will also be covered. Expert speakers include Dr. James P. Kelly and Dr. Frank Peacock IV.

Oragenics (NYSE American: OGEN) announced preparations for a Phase II clinical trial of its lead drug candidate, ONP-002, designed to treat mild Traumatic Brain Injury (mTBI). The trial will focus on intranasal delivery for rapid brain targeting, bypassing the blood-brain barrier. Oragenics has optimized the drug formulation and secured intranasal devices, partnering with Avance Clinical to implement the trial in emergency departments of level one trauma centers. Preclinical studies showed promising results in brain injury outcomes, and Phase I trials confirmed ONP-002's tolerability in humans. Concussions, a significant global health issue, often lead to long-term neurological disorders, highlighting the need for effective treatments like ONP-002.