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Oragenics Inc. reports developments as a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology. The company’s lead candidate, ONP-002, is an investigational intranasal neurosteroid being evaluated for concussion and mild traumatic brain injury, with updates centered on clinical trial operations, regulatory clearances, site activity and dosing milestones.
Company news also covers annual-report disclosures, operating and financial results, capital-structure actions, material agreements, shareholder voting matters and governance updates. Oragenics’ communications frequently connect its CNS strategy, intranasal delivery platform and public-company reporting obligations as an NYSE American-listed biotechnology issuer.
Oragenics (AMEX:OGEN), a biotech firm, announced the publication of a study on its intranasal COVID-19 vaccine candidate, NT-CoV2-1, in Scientific Reports. Co-authored with Inspirevax and the National Research Council of Canada, the study demonstrated efficacy in mice and hamsters, highlighting robust immune responses. The company aims to use this data, alongside ongoing toxicology studies, to support its application for human clinical trials. Oragenics focuses on developing treatments for infectious diseases, emphasizing innovative vaccine delivery methods.
Oragenics, Inc. (AMEX: OGEN) shared a letter from Executive Chairman Frederick W. Telling, Ph.D., outlining the company’s vaccine development strategy, particularly its intranasal COVID-19 vaccine candidate, NT-CoV2-1. The vaccine aims to address both pandemic and endemic phases of COVID-19. Oragenics has made progress in preclinical studies and plans to initiate a Phase 1 clinical study in North America. The company is positioning NT-CoV2-1 as a single-dose booster to meet evolving market demands, highlighting its advantages in mucosal immunity, needle-free administration, and logistical ease.
Oragenics, Inc. (NYSE American: OGEN) announced its participation in the World Vaccine Congress Washington from April 18-22, showcasing its lead product, NT-CoV2-1, an intranasal COVID-19 vaccine candidate. The vaccine aims for patient-friendly administration and robust immune response. NT-CoV2-1 has shown promising results in animal studies, with a Phase 1 trial expected to begin this year. Kimberly Murphy, a board member and former GSK executive, will represent the company. Oragenics focuses on combating infectious diseases, leveraging research from NIH and NRC.
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 January 25, 2022 was again adjourned due to insufficient quorum. The meeting has been rescheduled to February 25, 2022, at 4:00 p.m. Eastern Time. Currently, approximately 40% of outstanding shares have submitted proxies. The company has engaged Alliance Advisors to assist in soliciting votes. Shareholders are encouraged to vote by February 24, 2022, to achieve the required majority for proposals in the proxy statement filed on October 13, 2021.
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.