Brain Injury, Chronic

SARASOTA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. James “Jim” Kelly, Neurologist, as its Chief Medical Officer, to oversee its upcoming Phase II clinical trial. Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. A 40-patient Phase I study was completed and showed the drug to be safe and well-tolerated. In the recent past, Dr. Kelly served as the Executive Director of the Marcus Institute for Brain Health (MIBH) and Professor of Neurology at the University of Colorado Anschutz Medical Campus in Aurora, Colorado. The MIBH specialized treatment program is funded by the Marcus Foundation to care for US military veterans with persistent symptoms of TBI. Dr. Kelly was also National Director of the Avalon Action Alliance TBI Programs for which the MIBH serves as the clinical coordinating center. “I am excited to join Oragenics as its Chief Medical Officer at such an important and pivotal time in the drug development process. I have been involved with the drug for many years now and look forward to testing the drug and showing it can improve patient outcomes in our upcoming Phase II clinical trials,” said Dr. Kelly. Prior to these recent positions, Dr. Kelly was the Director of the National Intrepid Center of Excellence (NICoE) at Walter Reed National Military Medical Center in Bethesda, MD. As its founding Director, he led the creation of an innovative interdisciplinary team of healthcare professionals who blended high-tech diagnosis and treatment with complementary and alternative medical interventions in a holistic, integrative approach to the care of US military personnel with the complex combination of TBI and psychological conditions, such as post-traumatic stress, depression, and anxiety. In this role, Dr. Kelly was frequently called upon by leaders of the Military Health System at the Pentagon, the US Congress, the Department of Veterans Affairs, and numerous military facilities in the continental US and abroad. Dr. Kelly has interacted with the FDA and clinical trials for brain injury throughout his esteemed career. He is a strong advocate for treatments in the acute phase of brain injury and understands the value of protecting the brain early on from inflammation, swelling and oxidative stress to gain better clinical outcomes. “We are fortunate to have such an esteemed neurologist as Dr. Kelly join our team in this important role at Oragenics. Dr. Kelly is recognized as a leading expert in concussion and other brain injuries and we are fortunate to have him lead our drug trials going forward. We are currently completing the drug manufacturing and formulation at GMP facilities to ensure the integrity of the drug before and during the trials, and we look forward to completing this work in the short-term and getting the Phase II trial underway,” stated Michael Redmond, President of Oragenics. In preclinical animal models, the drug has been shown to acutely improve molecular and behavioral outcomes following brain injury. In addition, intranasal delivery of the drug as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. “Our Phase I human study has shown ONP-002 to be well tolerated in humans. Our mission now is to show that the ONP-002 brain protective mechanisms in animals translates to humans. Our Phase II study is designed to establish time to first dose, relationships between drug application and blood biomarkers, and the evaluation of clinical endpoints to determine improved in patient outcomes, ” said Dr. Kelly. Concussion is an unmet medical need. There is an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders including Alzheimer’s Disease, Parkinson’s Disease and Chronic Traumatic Encephalopathy (CTE) have been linked to concussion. Post concussion syndrome is linked to long term disability and occurs in as high as 20% of concussed patients. Forward-Looking Statements This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake the Phase II clinical trial using its novel drug - device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to retain its key employees and independent contractors necessary to continue to develop its product candidates and in particular ONP-002 and the availability of those key employees and independent contractors; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the Company’s expectations as to the outcome of the Phase II clinical trial and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law. Released March 18, 2024 View source version on businesswire.com: Contacts Oragenics, Inc. Janet Huffman, Chief Financial Officer 813-286-7900 jhuffman@oragenics.com LHA Investor Relations Tirth T. Patel 212-201-6614 tpatel@lhai.com Source: Oragenics, Inc. View this news release online at:

SARASOTA, Fla.--( BUSINESS WIRE )--Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it is preparing to undertake the final steps of GMP manufacturing and formulation of its drug candidate for its expected Phase IIA clinical trial. The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion. Oragenics’ lead drug candidate, ONP-002, is a new chemical entity (NCE) designed to target the brain through self-propelled powdered delivery into the nasal cavity and onward to the brain. A 40-patient Phase I human study showed ONP-002 to be safe and well-tolerated. Oragenics is currently manufacturing the Active Pharmaceutical Ingredient (API) that will then be formulated and spray dried as a nanoparticle powder. Once formulated the powder is loaded into an intranasal device, believed to be novel, that is breath-propelled, which Oragenics believes will improve intranasal binding to the olfactory nerve beds for delivery directly to the brain. This application, believed to be novel, is designed as an acute field deliverable, intended to allow for concussed patients to get treatment in the early stages when the pathological cascade is most intense. Phase II patients will be recruited between the ages of 18-55 in the acute phase following concussion. Intranasal delivery of ONP-002 as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. “ Preclinical intranasal targeting of the brain has been shown to improve outcomes in animals and safety margin following concussion. We are excited to be finishing up ONP-002 manufacturing and formulation work needed for our Phase II study which is on the horizon,” commented Michael Redmond, President of Oragenics. Concussion is an unmet medical need. There is an estimated 69M concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders including Alzheimer’s Disease, Parkinson’s Disease and Chronic Traumatic Encephalopathy (CTE) have been linked to concussion. Post concussion syndrome is linked to long term disability and occurs in as high as 20% of concussed patients. “ Concussions can have serious long-term consequences. Manufacturing and formulating API in a GMP facility ensures the integrity of the drug before and during the trials, we look forward to completing this work in the short-term and getting the Phase II trial underway,” Greg Gironda, Oragenics Operational Consultant. Forward-Looking Statements This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake a Phase II clinical trial using its novel drug - device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company’s expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

Motorsports Now Part of Groundbreaking Study on Effects of Repetitive Head Impacts PATASKALA, Ohio, Feb. 29, 2024 /PRNewswire/ -- MDK Motorsports has launched a commitment to support research of the long-term effects of repetitive head impacts (RHI) in active and retired professional athletes through Cleveland Clinic Lou Ruvo Center for Brain Health's Professional Athletes Brain Health Study (PABHS). Continue Reading Human brain. The largest study of professional athletes exposed to RHI, the PABHS is aimed at understanding the long-term effects of these impacts, including means to detect accumulating brain injury early and factors that put certain individuals at higher (or lower) risk of developing Chronic Traumatic Encephalopathy (CTE). MDK Motorsports' support, both financially and with the referral of its athletes to participate in the study, marks an expansion of the program to include professional motorsports drivers and riders, signaling an important initiative for the burgeoning sport. Notably, the United States Auto Club (USAC) and Porsche Motorsport North America have also announced their support for the PABHS, underscoring the motorsports industry's commitment to brain health. The world of motorsports is experiencing rapid growth in the United States, and the effects of repetitive head impacts and gravitational forces on drivers, while not immediately apparent, can be significant. Exposure to RHI or trauma increases the risk of long-term brain damage, including CTE. Current peer-reviewed research suggests that motorsports participants, especially in disciplines like motocross, may face a higher risk of concussion and brain injury.Dr. Charles Bernick, a neurologist at the Lou Ruvo Center for Brain Health and primary investigator of the PABHS, expressed his enthusiasm about the addition of motorsports to the study, stating, "Our knowledge of concussion frequency in motorsports is limited, and there is a critical need to understand the long-term neurological effects of cumulative exposure to impacts and high velocity, high G forces that these athletes experience. The insights gained from motorsports have the potential to enhance long-term brain safety for professional drivers and athletes in other sports as well."While motorsports currently have concussion protocols in place, there are no existing studies on the prolonged effects of repetitive head contact on professional motorsports racers. Megan Kvamme, CEO, MDK Motorsports: "I am deeply honored to collaborate with Dr. Bernick on this significant research and education endeavor. Our mission at MDK Motorsports goes beyond the track; it's about caring for our driver and rider athletes. This initiative isn't just about addressing existing issues; it's about proactive protection. I call upon the entire racing community to actively participate in this study. Together, we can gain invaluable insights into this critical issue and ensure the safety and well-being of our athletes today and for generations to come." Kevin Miller, President & CEO, United States Auto Club (USAC): "We are excited to support this vital research and education initiative. Motorsports has always been about pushing the boundaries of performance, but it's equally important to prioritize the well-being of our racers. Brain health is paramount, and this underscores our commitment to protecting the men and women who thrill us on the track." Volker Holzmeyer, President & CEO, Porsche Motorsport North America: "Porsche is about learning from our experience on the racetrack and using that knowledge to improve our cars even further. For decades we have recognized the importance of physically and mentally fit drivers, and we are constantly looking for ways to educate. As a result, we are proud to support the work of the Professional Athletes Brain Health Study to further advance the cause." Jan Magnussen, former F1 driver and four-time winner at the 24 Hours of Le Mans: "After spending years in the fast-paced world of racing, I've seen firsthand the effects of repetitive head contact. That's why I fully support this important study. It's not just about understanding the past but protecting the future, including racers like my son, Kevin, who's making his mark in Formula One. Let's ensure they have long and healthy careers in motorsports." ABOUT MDK MOTORSPORTS For more information about MDK Motorsports, visit the team website and follow along via social media on Facebook and Instagram. SOURCE MDKMotorsports