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Company Overview
Oragenics Inc (OGEN) is a publicly-traded biopharmaceutical company renowned for advancing a unique pipeline of proprietary technologies. The company focuses on the development and research of innovative pharmaceutical therapies in both neurology and infectious diseases, as well as breakthrough products in the field of oral health. With an emphasis on non-traditional drug delivery systems, Oragenics has established itself as a significant player in the clinical-stage biotechnology sector.
Innovative Technology and Product Pipeline
At the heart of Oragenics is its proprietary Probiora3 technology, which underpins a range of novel offerings. Among these is a new probiotic mint product designed to naturally support gum and tooth health while providing benefits such as breath freshening and tooth whitening. This product exemplifies the company’s commitment to revolutionizing oral health through innovative research and formulation techniques.
In addition, Oragenics is developing a groundbreaking intranasal delivery system that is engineered to facilitate rapid drug uptake into the brain. This technology is critical for their lead therapeutic candidate, a fully synthetic neurosteroid designed for the treatment of concussions. The formulation is lipophilic and able to cross the blood-brain barrier swiftly, targeting inflammation, oxidative stress, and swelling—an approach that is firmly rooted in advanced neuropharmacological principles.
Research and Development in Neurology and Infectious Diseases
The company’s robust R&D pipeline extends beyond oral health and encompasses therapeutic interventions for infectious diseases and neurological disorders. Through rigorous preclinical and clinical studies, Oragenics is addressing significant treatment gaps in conditions such as mild traumatic brain injury and other neurodegenerative challenges. Its research methodology integrates intranasal casting studies that simulate drug delivery within the nasal passage, a model that is accepted by regulatory agencies as a surrogate for human administration.
Market Position and Competitive Landscape
Oragenics operates in a competitive environment where innovation in drug delivery systems is paramount. The strategic integration of advanced diagnostic platforms with therapeutic interventions positions the company uniquely against traditional systemic drug delivery approaches. By focusing on rapid and targeted delivery, Oragenics aims to reduce systemic exposure while enhancing therapeutic outcomes, a differentiation that is increasingly valued in the biotech industry.
Operational Excellence and Industry Expertise
- Technical Prowess: Leveraging deep expertise in pharmaceutical research, Oragenics uses innovative methods such as nanoparticle spray drying to enhance drug formulation and absorption.
- Extensive Pipeline: With a comprehensive portfolio of candidates in various stages of development—from discovery to clinical trials—the company is well-positioned to address unmet medical needs across several therapeutic areas.
- Regulatory Engagement: The utilization of FDA-accepted studies, such as intranasal casting, underscores the company’s commitment to rigorous scientific evaluation and regulatory compliance.
Scientific Rigor and Transparent Communication
Oragenics is committed to maintaining transparency in its research and development processes. By delivering detailed clinical and preclinical data, the company fosters trust among investors, healthcare professionals, and regulatory bodies. Its strategic communications emphasize evidence-based research, underscoring both the strengths and challenges inherent in bringing innovative therapies to market.
Conclusion
In summary, Oragenics stands as a paradigm of innovation in the biopharmaceutical sector. Through its pioneering work in intranasal drug delivery, advanced formulations, and a focused pipeline in neurology and infectious diseases, the company demonstrates both depth of research and a commitment to addressing critical health challenges. Its methodical, science-driven approach makes Oragenics a pivotal name to watch in the evolving landscape of biotechnology.
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.
Oragenics, Inc. (NYSE American: OGEN) announced the adjournment of its Annual Meeting of Shareholders originally scheduled for November 22, 2021, due to insufficient quorum. The meeting will reconvene on January 25, 2022, at 4:00 p.m. ET, to allow more time for shareholders to vote on proposals detailed in the proxy statement filed with the SEC on October 13, 2021. Currently, only 40% of shares are represented by proxy. Shareholders are encouraged to vote by January 24, 2022, at 11:59 p.m. ET. The company is enlisting Alliance Advisors to help secure the necessary votes.
Oragenics (NYSE American: OGEN) has been awarded a $250,000 small business innovation research grant for its lantibiotics research. The funding will support the development of novel antibiotics addressing ESKAPE pathogens, which are increasingly resistant to existing treatments. The grant, part of the National Institutes of Health's initiative, emerges amidst rising antibiotic resistance and aims to enhance the company’s R&D capabilities in collaboration with Florida International University. Executive Chairman Frederick W. Telling expressed optimism about the potential of lantibiotics in combating life-threatening infections.
Oragenics, Inc. (NYSE American: OGEN) has launched a study to evaluate the immunogenicity and viral load reduction of its SARS-CoV-2 vaccine candidate, Terra CoV-2, using novel adjuvants for both intranasal and intramuscular formulations. The hamster challenge study aims to assess cross-neutralization against COVID-19 variants, with results expected in November. These findings will contribute to the Investigational New Drug filing with the FDA, anticipated in Q1 2022, to advance into human clinical trials.
Oragenics, Inc. (NYSE American: OGEN) announces promising results in its COVID-19 vaccine development, utilizing a stabilized pre-fusion spike protein trimer that generates neutralizing antibodies in mice. Collaborating with NIH, the company is advancing candidates for a hamster viral challenge study, set to begin this month. OGEN plans to submit an IND application for its Terra CoV-2 vaccine in Q1 2022, confident in the immunogenicity of its novel adjuvants. The firm aims to improve vaccine development speed, addressing potential COVID-19 variants amidst ongoing public health challenges.
Oragenics, Inc. (AMEX: OGEN) announced the adjournment of its reconvened annual meeting of shareholders on August 23, 2021, due to a lack of quorum. A new date for the annual meeting will be established, along with a new record date, as the previous one from May 5, 2021 is no longer valid. Oragenics focuses on combating infectious diseases, with its lead product, Terra CoV-2, aimed at preventing COVID-19 and its variants.
Oragenics, Inc. (NYSE American: OGEN) has entered a licensing agreement with the National Research Council of Canada to develop next-generation vaccines against SARS-CoV-2 and its variants. The collaboration leverages NRC technologies, enhancing the speed of cell line production for spike protein antigens from six months to six to eight weeks. The company has initiated preclinical studies and aims to advance vaccine candidates rapidly. This strategy may position Oragenics competitively against existing vaccines, particularly with additional options like intranasal administration.
Oragenics, Inc. (NYSE American: OGEN) has announced that its annual shareholder meeting, convened on June 30, 2021, was adjourned due to a lack of quorum. The meeting is rescheduled for August 23, 2021, at 4:00 p.m. The Company continues to solicit votes to meet the quorum requirement of a majority of shares. Currently, only 40% of the shares are represented by proxy. Shareholders of record as of May 5, 2021, are urged to vote by August 22, 2021. If quorum is not reached, further adjournment may incur additional costs.