Oragenics, Inc. Announces U.S.-Based Drug Manufacturing Agreement to Support ONP-002 Clinical Development
This agreement is expected to ensure Good Manufacturing Practice (GMP)-compliant drug product supply ahead of the planned Phase IIb clinical trials which the Company expects to start next year. The collaboration marks an important milestone for Oragenics as it secures domestic production capabilities to support its upcoming clinical and regulatory efforts.
'We are excited to partner with Sterling's facility in Cary, North Carolina, to support the production of ONP-002,' said Janet Huffman, Chief Executive Officer of Oragenics. 'This partnership is a critical milestone in our path forward for Phase IIb clinical trials. This partnership reinforces our commitment to quality, efficiency, and U.S.-based innovation and we believe this step will help streamline our clinical development strategy.'
Sterling will produce ONP-002 under strict cGMP conditions for use in Oragenics' planned Phase IIb trials, a proof-of-concept study which will evaluate early efficacy of ONP-002 in patients with mild traumatic brain injury (mTBI).
Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions, said: 'We are pleased to be partnering with Oragenics for the GMP production of its lead molecule for clinical trials. Our scientific expertise in CNS therapies and our ability to meet critical timelines will support the continued path to market for this transformative drug candidate.'
This U.S.-based manufacturing agreement builds upon Oragenics' broader strategy to develop scalable, accessible, and fast-acting treatments for neurological trauma, beginning with concussion, a condition that currently has no FDA-approved pharmacological therapies.
About Oragenics, Inc. Oragenics is a biotechnology company focused on developing intranasal therapeutics for neurological disorders. Its lead candidate, ONP-002, is being developed for the treatment of mild traumatic brain injury (mTBI), commonly known as concussion. The Company's intranasal delivery technology is designed to deliver fast, targeted, and non-invasive therapy to the brain. For more information, please visit www.oragenics.com.
About Sterling Pharma SolutionsSterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specializing in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services.
Sterling has six facilities employing more than 1,350 people: its HQ in Dudley, Cramlington, UK and a site in Newcastle upon Tyne, UK; a European presence in Ringaskiddy, Co. Cork, Ireland; a dedicated bioconjugation and ADCs facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, Wisconsin. Find out more at www.sterlingpharmasolutions.com.
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. 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 those described in our Form 10-K and other filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release 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.
Oragenics, Inc.Janet HuffmanChief Executive Officer813-286-7900jhuffman@oragenics.com
Investor Contact:Rich CockrellCG Capital866.889.1972ogen@cg.capital
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Unlike traditional hearing aids or temporary tinnitus pills, Audifort claims to target the root causes of hearing loss and ringing: poor inner ear circulation, oxidative stress, and nerve inflammation. Its plant-based, antioxidant-rich drops aim to restore hearing health from the inside out, offering a gentler, non-invasive solution. >>Still Unsure? Try Audifort Risk-Free with a 90-Day Money-Back Guarantee If You Don't Notice Improved Clarity. What really sets it apart is its liquid delivery system, designed for faster absorption—especially beneficial for older users with slower digestion or compromised nutrient uptake. With no harsh chemicals or stimulants, Audifort appeals to those looking for a natural, long-term solution. Verified reviews highlight sharper sound awareness, reduced nighttime buzzing, and an improved sense of equilibrium. While results can vary, many report a gradual, noticeable improvement in overall auditory health. The excitement surrounding Audifort isn't hype—it's being fueled by a formula that works in sync with the body's natural defenses, making it a standout in the hearing support space. What Are Audifort Drops? Audifort Drops are a natural liquid supplement designed to support and enhance hearing health using a blend of powerful herbs, essential vitamins, and key minerals. Formulated to address the underlying causes of hearing decline, this solution aims to improve inner ear circulation, reduce oxidative stress, and promote overall auditory clarity. Unlike conventional hearing aids or synthetic pills, Audifort works from within by nourishing the auditory system and helping maintain the health of the inner ear. The formula is carefully crafted to be both gentle and effective, with plant-based ingredients known for their antioxidant and anti-inflammatory properties. Easy to use, Audifort Drops can be seamlessly added to any daily routine. Whether you're trying to protect your current hearing ability or seeking to improve issues like ringing or sound distortion, this liquid supplement provides a safe, non-invasive alternative for long-term ear health support. >>Get Safe, GMP-Certified Audifort Drops at 73% Off – Only Available Through the Official Website. The Science Behind Audifort Drops Audifort Drops are formulated based on the latest scientific insights into auditory health. Each component is carefully selected for its proven benefits in supporting hearing function. The core ingredients include: Herbal Extracts: Plants like Ginkgo Biloba are included for their ability to improve circulation within the ears, helping to enhance blood flow to the inner ear and support hearing clarity. Vitamins and Minerals: Nutrients such as Vitamin B12, Vitamin D, and Magnesium are vital for maintaining proper nerve function and preventing hearing issues linked to nutritional deficiencies. Natural Antioxidants: These compounds help shield the delicate structures of the ear from oxidative stress, a major contributor to age-related hearing loss. Anti-Inflammatory Compounds: The formula also features natural ingredients that may reduce inflammation, further promoting overall ear health. Together, these ingredients create a comprehensive approach to hearing support, positioning Audifort Drops as a leading natural option for maintaining and enhancing ear health. Ingredient Deep Dive — What Sets It Apart Audifort isn't just a basic mix of herbal ingredients. It's a thoughtfully designed formula aimed at tackling three primary contributors to hearing decline: oxidative stress, poor circulation, and disrupted nerve signals within the auditory a closer look at the standout ingredients and why they matter: Grape Seed Extract – Rich in antioxidants, grape seed extract is known for supporting microcirculation. 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Key Benefits of Audifort Drops Audifort Drops are gaining attention as a natural alternative for maintaining and improving hearing health. Backed by well-researched ingredients, this formula offers a range of benefits for those seeking non-invasive support for their ears. Natural Hearing Support: The ingredients in Audifort Drops are chosen to address the root causes of hearing decline, helping to maintain long-term auditory wellness. Improves Sound Clarity: Supports better sound perception, making it easier for individuals with mild hearing challenges to hear more clearly. Protects Ear Health: Delivers powerful antioxidant support to help shield the ears and auditory nerves from damage caused by oxidative stress, environmental toxins, and noise exposure. Promotes Nerve Function: Helps maintain the health of auditory nerves, which play a vital role in delivering sound signals from the ears to the brain. 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Medical professionals have reviewed Audifort's formula and generally agree it's safe for most older adults, including those with mild health conditions like high blood pressure or diabetes. Still, individual medical advice is recommended. The liquid, under-the-tongue delivery also supports faster absorption and avoids digestive issues common with pills, especially in aging users. Audifort has a strong safety record when purchased from the official source. Straying from it increases the risk of counterfeit products and health concerns. >>Thinking About Audifort? Avoid Risks—Order Only from the Official Site for Guaranteed Freshness, Refunds, and Authentic Results! Who Should (and Shouldn't) Use Audifort? Audifort was developed with specific auditory and neurological stressors in mind, making it most effective for certain individuals. Adults over 40 experiencing ringing in the ears, difficulty hearing in noisy settings, sound sensitivity, or post-noise fatigue are ideal candidates. 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Audifort 382 NE 191st St PMP 82029 Miami, FL, 33179, USA 33179 support@ Attachment Audifort CONTACT: Brand Website: Project Name: Audifort Address: 382 NE 191st St PMP 82029 Miami, FL, 33179, USA Postal Code: 33179 Media Contact Email: support@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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