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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 has extended its licensing agreement with the National Research Council of Canada to develop an intranasal vaccine targeting future variants of coronaviruses. This collaboration leverages NRC's rapid cell expression technologies, reducing production time for vaccine candidates from months to weeks. The company has also shown promising results with its intranasal NT-CoV2-1 vaccine in preclinical studies, paving the way for further clinical trials.
Oragenics, Inc. (AMEX: OGEN) announced that its 2021 financial statements contained an unqualified audit opinion with a going concern paragraph. This follows compliance with NYSE American regulations regarding audit opinions. The statements reflect no changes or amendments. Oragenics develops infectious disease treatments, including the NT-CoV2-1 intranasal COVID-19 vaccine and a lantibiotics program targeting antibiotic-resistant bacteria. Investors are cautioned about reliance on forward-looking statements due to inherent risks.
Oragenics, Inc. (AMEX: OGEN) has initiated a GLP toxicology study for its NT-CoV2-1 vaccine candidate, targeting safety and immunogenicity in rabbits. This study aims to gather IND-enabling data for human trials. Conducted by Frontage Laboratories, results are expected by August. The vaccine's intranasal delivery may reduce transmission of COVID-19. Previously, NT-CoV2-1 showed protective results in hamsters. The company focuses on combating infectious diseases, leveraging NIH and NRC research for its vaccine development.
Oragenics, Inc. (NYSE American: OGEN) has partnered with KBI Biopharma to manufacture materials for its intranasal vaccine candidate NT-CoV2-1, which targets SARS-CoV-2. The collaboration includes a 200L demonstration and a 500L cGMP run, positioning Oragenics for a future Phase 2 clinical trial. This vaccine aims to enhance protection at the viral entry points in the respiratory tract, potentially reducing transmission compared to traditional intramuscular vaccines. Previous preclinical trials showed significant immune responses and viral load reductions.
Oragenics, Inc. (NYSE American: OGEN) has released a preprint manuscript detailing its intranasal vaccine, NT-CoV2-1, co-developed with Inspirevax and Canada's NRC. The study found that this vaccine formulation is immunogenic and effective in lowering viral loads in hamsters while generating strong antibody responses in both mice and hamsters. The results support continued development, aiming for FDA submission to advance towards human trials. The intranasal delivery method could enhance protection against COVID-19 compared to traditional vaccines.
Oragenics, Inc. (NYSE American: OGEN) announced that its reconvened Annual Meeting on
Oragenics, Inc. (NYSE American: OGEN) has extended its licensing and collaboration agreement with the National Research Council of Canada to develop an intranasal vaccine targeting the SARS-CoV-2 Omicron variant. This partnership enables rapid production of spike protein antigens, reducing production time from months to weeks. Oragenics has shown promising results in preclinical studies, demonstrating protection in hamsters against SARS-CoV-2, paving the way for future human clinical trials.
Oragenics, Inc. (NYSE American: OGEN) will participate in Alliance Global Partners' Virtual Series on December 14, 2021, at 1:00 p.m. Eastern time. Executive Chairman Frederick W. Telling, Ph.D., will be interviewed about the Company’s Terra CoV-2 program and its SARS-CoV-2 vaccine candidate. Interested parties can register for the live webcast and replay requests can be made via email. Oragenics focuses on combating infectious diseases with its lead product, Terra CoV-2, aimed at preventing COVID-19 and its variants.
Oragenics, Inc. (AMEX: OGEN), in collaboration with Florida International University, published a study on antimicrobial lanthipeptides in the Journal of Chemical Theory and Computation. The research highlights the urgent need for new antibiotics amidst rising resistance to current treatments. Oragenics is developing lantibiotics that affect bacterial cell walls and membranes, showcasing their potential against antibiotic-resistant infections. The company aims to broaden its lantibiotic pipeline to combat Gram-negative infections while advancing its COVID-19 vaccine candidate, Terra CoV-2.
Oragenics, Inc. (NYSE American: OGEN) announced positive results from a hamster challenge study assessing its SARS-CoV-2 vaccine candidate. Both intranasal and intramuscular formulations demonstrated robust immune responses, successfully reducing viral loads to undetectable levels. The company plans to focus on the intranasal delivery route, citing advantages such as ease of distribution and potential for mucosal immunity. This study will support their Investigational New Drug filing to the FDA, expected in Q2 2022, advancing the program into human clinical trials.