ORAGENICS, INC.


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Locations: NEW YORK, II, UNITED STATES, NORTH AMERICA, CANADA, FLORIDA

Oragenics, Inc. Announces Notification of Noncompliance with Additional NYSE American Continued Listing Standards

Retrieved on: 
Friday, April 19, 2024
Biotechnology, Pharmaceutical, Finance, General Health, Health, Accounting, Professional Services, Other Health, Security (finance), Plan, Notice, Common stock, DSM-IV codes, Letter

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.

Key Points: 
  • 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").
  • If the NYSE American accepts the Company’s plan, the Company will be able to continue its listing during the Plan period and will be subject to continued periodic review by the NYSE American staff.
  • However, there can be no assurance that the Company will be able to achieve compliance with the NYSE American’s continued listing standards within the required timeframe.

Oragenics, Inc. Files 10K and Provides Company Update

Retrieved on: 
Monday, April 1, 2024
General Health, Finance, Accounting, Health, Professional Services, Annual report, Brain, Concussion, Security (finance), Contract research organization, Bank statement, DSM-IV codes, Government, Pharmaceutical industry

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.

Key Points: 
  • 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:
    The Company acquired a platform technology intended to treat multiple neurological disorders.
  • We are excited about the progress the Company has made in the past several months.
  • See further discussion in footnote 1 of the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K.

Oragenics Appoints James Kelly MD, Chief Medical Officer, to Lead Phase II Clinical Trials for Treating Concussion

Retrieved on: 
Monday, March 18, 2024
Pharmaceutical, Health, Neurology, Clinical Trials, Depression, Metabolism, Brain, NCE, Acute stress disorder, Concussion, Veterans' affairs, Executive, Common, Inflammation, Patient, United States Congress, TBI, Foundation (nonprofit), Anxiety, CTE, University, Military personnel, Oxidative stress, Human, GMP, Nasal cavity, Traumatic brain injury, DSM-IV codes, Phase, Traffic, Swelling, FDA, Animal, Pentagon, Chronic traumatic encephalopathy, Phase II, Marcus Foundation, Medical device

Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion.

Key Points: 
  • Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion.
  • Dr. Kelly was also National Director of the Avalon Action Alliance TBI Programs for which the MIBH serves as the clinical coordinating center.
  • “I am excited to join Oragenics as its Chief Medical Officer at such an important and pivotal time in the drug development process.
  • Dr. Kelly has interacted with the FDA and clinical trials for brain injury throughout his esteemed career.

Oragenics, Inc. Prepares Drug for Phase II Clinical Trials to Treat Concussion

Retrieved on: 
Tuesday, March 5, 2024
Pharmaceutical, Health, Clinical Trials, Mental Health, CTE, Nasal administration, Active ingredient, Metabolism, IIA, Traumatic brain injury, Concussion, API, Nasal cavity, Animal, GMP, Common, Traffic, Safety, Patient, DSM-IV codes, Phase, Chronic traumatic encephalopathy, NCE, Brain, Pharmaceutical industry

The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion.

Key Points: 
  • The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion.
  • A 40-patient Phase I human study showed ONP-002 to be safe and well-tolerated.
  • Phase II patients will be recruited between the ages of 18-55 in the acute phase following concussion.
  • “Preclinical intranasal targeting of the brain has been shown to improve outcomes in animals and safety margin following concussion.

Oragenics Announces Closing of Public Offering

Retrieved on: 
Friday, March 1, 2024
Biotechnology, Neurology, Health, Genetics, Pharmaceutical, ThinkEquity, State Street, DSM-IV codes, Prospectus, Sale, Concussion, Life insurance

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.

Key Points: 
  • 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.
  • ThinkEquity and Laidlaw & Company (UK) Ltd. acted as joint book-running managers for the offering.
  • The final prospectus supplement relating to the offering was filed with the SEC and is available on the SEC's website at http://www.sec.gov .

Oragenics Announces Proposed Public Offering

Retrieved on: 
Tuesday, February 27, 2024
Biotechnology, Neurology, Infectious Diseases, Health, Pharmaceutical, ThinkEquity, Prospectus, Concussion, Sale, Form, State Street, S-3, DSM-IV codes, Security (finance)

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.

Key Points: 
  • 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 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.
  • ThinkEquity and Laidlaw & Company (UK) Ltd. are acting as joint book-running managers for the offering.
  • The offering will be made only by means of a written prospectus.

Oragenics Announces Pricing of Public Offering

Retrieved on: 
Wednesday, February 28, 2024
Health, Infectious Diseases, Neurology, General Health, Pharmaceutical, Biotechnology, ThinkEquity, S-3, Security (finance), State Street, DSM-IV codes, Sale, Form, Concussion, Life insurance

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.

Key Points: 
  • 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.
  • ThinkEquity and Laidlaw & Company (UK) Ltd. are acting as joint book-running managers for the offering.

Oragenics, Inc. Announces Leadership Transition

Retrieved on: 
Monday, February 12, 2024
Health, Hospitals, Neurology, Managed Care, Pharmaceutical, Biotechnology, Separation, DSM-IV codes, Separable space, Employment, Management

Ms. Murphy will, however, continue to serve the Company as a member of the Company’s board of directors (the “Board”).

Key Points: 
  • 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.
  • The Board will provide direction to the Company during this transition in management, with Charlie Pope, the Company’s Chairman of the Board, serving, on an interim basis, as Executive Chairman, effective immediately.
  • In addition, effective February 12, 2024, the Board appointed Michael Redmond, the Company’s President, as the Company’s Interim Principal Executive Officer.

Oragenics, Inc. Announces Expiration of Its Investment Banking Engagement Agreement

Retrieved on: 
Wednesday, February 7, 2024
Biotechnology, Health, Finance, Other Health, Pharmaceutical, Professional Services, Other Science, Mental Health, Research, Medical Devices, Managed Care, General Health, Science, Medical Supplies, DSM-IV codes

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.

Key Points: 
  • 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. Preparing for Phase II Clinical Trials to Treat Concussion

Retrieved on: 
Monday, February 5, 2024
Mental Health, Health, Neurology, Clinical Trials, General Health, Pharmaceutical, NCE, Memory, Concussion, CTE, Chronic traumatic encephalopathy, Traumatic brain injury, Nasal administration, Patient, Safety, Diagnosis, Brain, Animal, DSM-IV codes, Nasal cavity, Phase, Traffic, Common, Pharmaceutical industry

Oragenics has begun the final process of synthesizing and formulating the drug needed for its Phase II clinical trial.

Key Points: 
  • Oragenics has begun the final process of synthesizing and formulating the drug needed for its Phase II clinical trial.
  • We are excited to get the Phase II clinical trials underway,” commented Dr. James “Jim” Kelly, Neurologist and Executive Director of the Marcus Institute of Brain Health and an advisor on the planned phase II trial.
  • The drug has a large safety margin between dosages used in the animal toxicology program and those used in the Phase I study and planned for the upcoming Phase II clinical trial.
  • Post concussion syndrome is linked to long term disability and occurs in as high as 20% of concussed patients.