Articles from Oragenics, Inc.

Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced that it received a notice (the “Notice”) from the NYSE American LLC (the “NYSE American”) dated April 18, 2024, notifying the Company that it is no longer in compliance with NYSE American continued listing standards. Specifically, the letter states that the Company is not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide (the "Company Guide"). Section 1003(a)(ii) requires a listed company to have stockholders' equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders' equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. The Company reported a stockholders’ equity of $3.2 million as of December 31, 2023, and losses from continuing operations and/or net losses in its five most recent fiscal years ended December 31, 2023.

Oragenics, Inc. (the “Company”) (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced that it has filed its annual report on March 29, 2024. The Company is pleased to report it has executed on its strategy to diversify its product development portfolio and makes progress in transforming the Company to create long term value. Some key items that have helped to improve the Company moving forward are:

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.

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, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders, today announced the closing of its previously announced underwritten public offering of 1,400,000 shares of its common stock at a public offering price of $1.50 per share, for gross proceeds of $2.1 million, before deducting underwriting discounts, and offering expenses payable by the Company. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 210,000 shares of its common stock at the public offering price, less discounts, to cover over-allotments, if any.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders, today announced the pricing of an underwritten public offering of 1,400,000 shares of its common stock at a public offering price of $1.50 per share, for gross proceeds of $2.1 million, before deducting underwriting discounts and offering expenses payable by the Company. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 210,000 shares of its common stock at the public offering price, less discounts, to cover over-allotments, if any. The offering is expected to close on March 1, 2024, subject to satisfaction of customary closing conditions.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants to purchase shares of common stock (“Pre-Funded Warrants”) in lieu thereof) in an underwritten public offering. The Company expects to grant the underwriters a 45-day option to purchase up to an additional 15% of the number of shares of common stock and/or Pre-Funded Warrants sold in this offering to cover over-allotments, if any. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Oragenics, Inc. (NYSE American: OGEN) (the “Company”), a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders, today announced that, on February 12, 2024, the Company and Kimberly Murphy, the Company’s Chief Executive Officer, entered into a mutually agreeable Separation Agreement (the “Separation Agreement”), pursuant to which Ms. Murphy’s employment with the Company terminated effective February 12, 2024. Ms. Murphy will, however, continue to serve the Company as a member of the Company’s board of directors (the “Board”). The Separation Agreement provides Ms. Murphy with the benefits under her employment agreement with the Company for a separation without cause. Ms. Murphy’s resignation as an officer was not due to any disagreement with the Company on any matter related to its operations, policies or practices.

Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders, today announced that its engagement agreement with its investment bank has expired and that it does not intend to extend the engagement at this time due to market conditions.

Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders, today announced it is preparing for a Phase II clinical trial using its novel drug - device combination 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. A 40-patient Phase I study showed ONP-002 to be safe and well-tolerated.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced it has terminated its previously announced “at-the-market” (“ATM”) equity offering program.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announces it has completed its previously announced acquisition of assets related to Odyssey Health, Inc.’s (OTCQB: ODYY) (“Odyssey”) proprietary neurological drug therapies and technologies.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced the appointments of Bruce Cassidy and John Gandolfo to the Board of Directors effective October 4, 2023.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) and Odyssey Health, Inc. (OTCQB: ODYY) (“Odyssey”) announce the signing of a definitive agreement under which Oragenics will acquire Odyssey’s assets related to its proprietary neurological drug therapies and technologies. The assets include drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as Odyssey’s proprietary powder formulation and its nasal delivery device. Odyssey will retain its other assets and operations.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) and Lantern Bioworks announce a groundbreaking partnership, marked by the formalization of a materials transfer agreement. This milestone follows rigorous testing and validation of Oragenics’ biological samples, which are poised to potentially revolutionize dental caries prevention by replacing harmful bacterial strains with non-pathogenic counterparts.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), biotech company dedicated to fighting infectious diseases including coronaviruses, today announced it has entered into definitive agreements with two healthcare-focused investors, in which the Company issued in a private placement (the “Private Placement Offering”), an aggregate of (i) 404,728 shares of the Company’s common stock, $0.001 par value (the “Common Stock”), and (ii) 404,728 shares of Series E Mirroring Preferred Stock (the “Series E Preferred Stock”).

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotechnology company dedicated to fighting infectious diseases, announces the award of a grant from CQDM, a Canadian bioresearch consortium, for the collaborative development of a variant-agnostic COVID-19 protein subunit vaccine candidate. The project, which aims to build upon Oragenics’ current lead intranasal vaccine candidate NT-CoV2-1, is a collaboration with the National Research Council of Canada (NRC) and Inspirevax.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotechnology company dedicated to fighting infectious diseases including COVID-19, announces that Kim Murphy, Chief Executive Officer, will be participating in the World Vaccine Congress Washington, being held April 3-6, 2023, in Washington, D.C.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotechnology company dedicated to fighting infectious diseases, today reports favorable findings from third party laboratory testing of several compounds in Oragenics’ lantibiotics platform to combat multiple pathogens despite the resistance of those pathogens to standard-of-care antibiotics. Lantibiotics are a novel class of antibiotics with the potential to treat serious, life-threatening infections.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotechnology company dedicated to fighting infectious diseases including COVID-19, announces the appointment of Janet Huffman as Chief Financial Officer, effective March 7, 2023. Ms. Huffman is a seasoned financial executive with more than a dozen years of leadership experience at publicly traded and private healthcare companies.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced that the Company has entered into an exclusive global license agreement with Inspirevax Inc. for its novel intranasal mucosal adjuvant, BDX301, for the development of NT-CoV2-1, Oragenics’ lead intranasal COVID-19 vaccine candidate.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced that the Company has received formal notice from the NYSE American, LLC (“NYSE American”) stating that the Company has regained compliance with the NYSE American’s continued listing standards.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced that its Board of Directors (the “Board”) on December 22, 2022 approved a 1-for-60 reverse stock split of the Company’s issued and outstanding shares of common stock, par value $0.001 per share, accompanied by a corresponding decrease in the Company’s authorized shares of common stock (the “Reverse Stock Split”), such that, following the consummation of the Reverse Stock Split, the number of authorized shares of common stock will be reduced from 250,000,000 shares to 4,166,666 shares. As a result of the Reverse Stock Split, the Company’s common stock is expected to begin trading on a split-adjusted basis when the markets open on January 23, 2023.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotechnology company dedicated to fighting infectious diseases including COVID-19, today announced results indicating no toxicity signals or adverse events from its Good Laboratory Practices (GLP) toxicology study in rabbits evaluating the safety and immunogenicity of its NT-CoV2-1 intranasal vaccine candidate. Oragenics believes the findings of the final toxicology report, including a full histopathology evaluation, confirm a safety and immunogenicity profile that further support its plan to submit regulatory filings required to progress to a Phase 1 clinical study.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced that it received a Notice (the “Notice”) on December 19, 2022 from the NYSE American LLC (the “NYSE American”) stating that the Company is not in compliance with the continued listing standards as set forth in Section 1003(f)(v) of the NYSE American Company Guide ("Company Guide").

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced that on December 16, 2022 the Board of Directors appointed Charles Pope as its Chairman of the Board of Directors succeeding Dr. Frederick W. Telling, who has served as a director since June 2010 and as Chairman since February 2011. Dr. Telling will remain on the Board as an independent director and as a member of both the audit and nominating and corporate governance committees.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including COVID-19, announces its participation in the 2022 BioFlorida Annual Conference, being held November 2-4 in Miami.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including coronaviruses, today issued the following letter to shareholders from its President and Chief Executive Officer, Kim Murphy.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced favorable preliminary results from its ongoing Good Laboratory Practice (GLP) toxicology study to evaluate the safety profile and immunogenicity of its NT-CoV2-1 vaccine candidate in rabbits. These initial results continue to demonstrate a safety profile and immune responses that the Company believes will support regulatory filings required to progress to a Phase 1 clinical study. The final toxicology report, including ongoing histopathology evaluation, is expected by year-end.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including coronaviruses, announces the appointment of Ms. Kimberly M. Murphy, member of the Board of Directors, as President and Chief Executive Officer effective June 23, 2022. Ms. Murphy brings more than 25 years of vaccine industry experience at leading pharmaceutical companies including serving as a key leader in the successful US and Global launch of Merck’s HPV/Gardasil Franchise. Ms. Murphy joined Oragenics’ Board of Directors in 2020.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today issued the following letter to shareholders from its Executive Chairman, Frederick W. Telling, Ph.D.:

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including coronavirus, today announced that Kimberly Murphy, a member of the Company’s Board of Directors, will attend the upcoming World Vaccine Congress Washington that will be held on April 18-22 to showcase the Company’s lead product, NT-CoV2-1, an intranasal vaccine candidate, and to pursue business development opportunities.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced it has extended a licensing and collaboration agreement with the National Research Council of Canada (NRC) that enables Oragenics to pursue an intranasal vaccine designed to protect against future variants of coronaviruses. The NRC cell expression technologies provide Oragenics with a platform that can generate cell lines for high-yield production of spike protein antigens for existing and emerging variants of concern. This platform could allow production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines. The NRC technologies, developed with support from the NRC’s Pandemic Response Challenge program, will expedite the evaluation of future intranasal vaccine candidates in preclinical and clinical studies.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced that, as previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2021, which was filed on March 24, 2022 with the Securities and Exchange Commission, the audited financial statements contained an unqualified audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern. See further discussion in footnote 1 to the Company’s financial statements included in the Company’s Annual Report on Form 10-K. This announcement is made pursuant to NYSE American LLC Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph. This announcement does not represent any change or amendment to the Company’s financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2021.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced the initiation of a Good Laboratory Practice (GLP) toxicology study to evaluate the safety profile and immunogenicity of its NT-CoV2-1 vaccine candidate in rabbits. The study is designed to provide Investigational New Drug (IND)-enabling data to help advance this candidate to human clinical studies. Oragenics has contracted with Frontage Laboratories (through its wholly owned subsidiary Experimur) to conduct the study, with top-line interim data expected in August.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced that the Company’s reconvened Annual Meeting of Shareholders (the “Annual Meeting”), on January 25, 2022, at 4:00 p.m. was convened and again adjourned, without any business being conducted, due to lack of the required quorum.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced it has extended a licensing and collaboration agreement with the National Research Council of Canada (NRC) that will enable Oragenics to pursue an intranasal vaccine designed to protect against the SARS-CoV-2 Omicron variant. The NRC cell expression technologies provide Oragenics with a platform that can generate cell lines for high-yield production of spike protein antigens for existing and emerging variants of concern. This platform should allow production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines. The NRC technologies, developed with support from the NRC’s Pandemic Response Challenge program, will expedite the evaluation of an Omicron-specific Terra-CoV-2 candidate in preclinical and clinical studies.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced that the Company will participate in Alliance Global Partners’ (AGP) Virtual Series on Tuesday December 14, 2021 at 1:00 p.m. Eastern time. Frederick W. Telling, Ph.D., Executive Chairman will be interviewed in a virtual “Fireside Chat” by Matthew Cross, Managing Director of Biotechnology Equity Research at AGP. The discussion will be focused on the Company’s Terra CoV-2 program and the ongoing preclinical development plan for its SARS-CoV-2 vaccine candidate.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) in collaboration with researchers from Florida International University’s Department of Physics and Biomolecular Sciences Institute, today announced the publication of a study entitled “Lipid II Binding and Transmembrane Properties of Various Antimicrobial Lanthipeptides.” The study was published in the Journal of Chemical Theory and Computation (https://doi.org/10.1021/acs.jctc.1c00666). The alarming rise in antibiotic resistant infections in recent years and the dire need for the development of new antimicrobials is globally recognized. Oragenics’ lantibiotics are promising candidates to fight antibiotic-resistant bacteria due to their unique and dual mode of action, including interference with cell wall synthesis by binding to Lipid II and creation of unique pores in bacterial membranes. In this publication, atomic-scale molecular dynamics computational studies were used to compare both the Lipid II binding ability and the membrane interactions of several lanthipeptides, demonstrating the unique properties of Oragenics’ lantibiotics and unveiling a rational path to improve the therapeutic profile of our compounds.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced the results from its study to evaluate the immunogenicity and viral load reduction impact of its SARS-CoV-2 vaccine candidate in a hamster challenge study. The study provided preclinical data for formulations designed for both intranasal and intramuscular administration.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced that the Company’s Annual Meeting of Shareholders (the “Annual Meeting”), on November 22, 2021, at 9:00 a.m. was convened and adjourned, without any business being conducted, due to lack of the required quorum.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced that it was awarded a small business innovation research grant in the amount of $250,000 (“Computer-aided Design for Improved Lantibiotics” R41GM136034) for the Company’s continued research and development of lantibiotics, including its collaborative program with the Biomolecular Sciences Institute at Florida International University (FIU). The grant provides Oragenics with funding to develop novel lantibiotics for the treatment of ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.).

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced the initiation of a study to evaluate the immunogenicity and viral load reduction impact of its SARS-CoV-2 vaccine candidate in a hamster challenge study. The study will provide data for several vaccine formulations, using adjuvants specific for both intranasal and intramuscular routes of administration. An assessment of cross-neutralization titers against the Wuhan, Beta and Delta variants of COVID-19 and reduction in the viral load of the Wuhan challenge virus will be used to establish the most promising formulations to advance to human clinical studies. The study is being conducted by the Company’s Canadian collaborator with results expected in November.

Oragenics, Inc. (NYSE American: OGEN) (the Company) announces that the stabilized pre-fusion spike protein trimer produced by its Canadian collaborator and licensed by the Company from the National Institutes of Health (NIH) generates neutralizing antibodies in mice after immunization against SARS-CoV-2, when administered with several novel intramuscular (IM) and intranasal (IN) adjuvants. The expression platform, developed with support from Oragenics’ Canadian collaborator, will expedite the evaluation of hybrid SARS-CoV-2 antigen candidates that are scheduled to be evaluated in a hamster viral challenge study beginning with dosing at the end of this month. The mouse immunogenicity study enabled the down-selection of the four adjuvant candidates tested thus far, with two being advanced to assess inhibition of viral replication in hamsters, and IND-enabling toxicology studies. A manuscript suitable for publication, inclusive of the mouse data, will be prepared upon completion of the hamster study.

Oragenics, Inc. (NYSE American: OGEN) Oragenics, Inc. (“Oragenics” or the “Company”) today announced the Company’s reconvened annual meeting of shareholders, on August 23, 2021 at 4:00 p.m. was adjourned due to a lack of quorum. The Company intends to seek approval for the proposals submitted to its shareholders at a new postponed annual meeting date when practicable. The new annual meeting date will be established by the Company and a new record date, will be set in conjunction therewith; the former record date of May 5, 2021, is no longer valid.

Oragenics, Inc. (NYSE American: OGEN) today announced it has entered into a licensing agreement with the National Research Council of Canada (NRC) that will enable Oragenics to pursue the rapid development of next-generation vaccines against the SARS-CoV-2 virus and its variants. The NRC technologies, in combination with the U.S. National Institutes of Health (NIH) elements found in the Company’s Terra CoV-2 vaccine, provide Oragenics with a platform that can generate cell lines for high-yield production of spike protein antigens for existing and emerging variants of concern. This platform should allow production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines. The NRC technologies, developed with support from the NRC’s Pandemic Response Challenge Program, will expedite the evaluation of SARS-CoV-2 antigen candidates in preclinical and clinical studies.

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced that the Company’s annual meeting of shareholders, on June 30, 2021, at 9:00 a.m. was convened and adjourned, without any business being conducted, due to lack of the required quorum.

Oragenics, Inc. (NYSE American: OGEN) today issued the following letter to shareholders from its Executive Chairman, Frederick W. Telling, PhD:

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced that on May 2, 2021, Dr. Alan Joslyn resigned as Chief Executive Officer, President and director of Oragenics, Inc. to pursue other opportunities.