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Oragenics Inc. (NYSE American: OGEN) is a publicly-traded biopharmaceutical company specializing in innovative, proprietary technologies aimed at improving human health. Based in Sarasota, Florida, Oragenics is renowned for its cutting-edge research and development in the fields of neurology and infectious diseases. The company’s core business revolves around the development of novel pharmaceutical treatments, including nasal delivery medications, which promise significant advancements in therapeutic efficacy and patient outcomes.
Oragenics’ flagship product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid. Designed to cross the blood-brain barrier effectively, ONP-002 targets mild Traumatic Brain Injury (mTBI), commonly known as concussion. The drug reduces swelling, oxidative stress, and inflammation while restoring proper blood flow through gene amplification. This revolutionary approach positions ONP-002 as a potential game-changer in treating brain injuries.
In addition to ONP-002, Oragenics boasts a diverse product pipeline, including therapies targeting Niemann-Pick Disease Type C (NPC) and other infectious diseases. The company is also recognized for its ProBiora3 technology, which is the foundation of products like evoraplus™—a unique probiotic mint that promotes oral health by supporting gums, freshening breath, and whitening teeth.
Recent achievements highlight Oragenics' relentless pursuit of excellence. The company is preparing to initiate a Phase II clinical trial for ONP-002, with advancements in drug formulation aimed at optimizing intranasal delivery. Collaborating with Avance Clinical Pty Ltd, Oragenics is focused on conducting this trial in emergency departments at level one trauma centers, ensuring robust and well-structured studies.
The leadership team at Oragenics, led by President Michael Redmond and Chief Medical Officer Dr. James Kelly, emphasizes the importance of partnerships and advanced research. Their dedication is reflected in Oragenics' preclinical studies, which have shown significant improvements in molecular and behavioral outcomes following brain injury. The company's innovative approach to intranasal delivery as nanoparticles has further enhanced brain exposure and metabolism.
Oragenics' commitment to addressing unmet medical needs, such as concussions—which affect millions globally each year—has positioned the company as a pivotal player in the biopharmaceutical industry. Through continuous innovation and strategic collaborations, Oragenics aims to provide effective treatments for neurological disorders and improve patient outcomes worldwide.
For more information, visit www.oragenics.com.
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.
Oragenics, Inc. partners with Avance Clinical for a Phase II clinical trial in Australia to evaluate ONP-002 for mild Traumatic Brain Injury (TBI). The partnership aims to address the significant unmet medical need for concussion treatment through innovative intranasal pharmaceuticals. Oragenics' lead drug candidate, ONP-002, has shown promise in a Phase I trial and is delivered through a unique intranasal device designed for direct brain delivery. Avance Clinical's expertise in managing clinical trials in Australia, New Zealand, and North America brings valuable experience to the collaboration, highlighting the potential for future concussion treatment protocols.
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