Company Overview - Oragenics, Inc. is a biopharmaceutical company focused on developing novel therapies for neurological disorders, particularly through innovative intranasal technology [2] - The lead program, ONP-002, is a first-in-class neurosteroid aimed at treating moderate to severe concussions, offering advantages such as faster brain delivery and reduced systemic exposure [2] Market Need - There are over 3 million concussion occurrences annually in the U.S. and an estimated 69 million globally, with up to 50% of cases believed to go unreported [3] - The urgency for effective treatments is heightened due to the lack of FDA-approved options for patients [3] Key Milestones in Development - In 2024, Oragenics appointed Dr. James Kelly and Dr. William Peacock to strengthen clinical leadership for ONP-002 [4] - The company is preparing to initiate Phase II clinical trials following successful Phase I trials that confirmed the safety and tolerability of ONP-002 [5] - ONP-002 passed FDA-required cardiotoxicity tests, indicating a strong cardiac safety margin [6] - Successful completion of FDA-required genotoxicity studies confirmed that ONP-002 does not cause DNA damage [7] - A partnership with Avance Clinical was established to enhance the execution of Phase II trials [8] - ONP-002 demonstrated temperature stability, eliminating the need for cold-chain storage, which is crucial for field delivery [9] - The company completed the spray-dry formulation and filled intranasal delivery devices for the upcoming Phase II trial [10] - A novel nanoparticle formulation was developed to enhance intranasal absorption, increasing the drug amount per dose by fourfold [11] - Completion of FDA-recognized intranasal casting studies supports the drug's delivery mechanism [12] Recent Financing - In September 2024, Oragenics raised approximately $4.45 million through a public offering, contributing to over $6 million raised throughout the year [13] Future Plans - The company plans to initiate Phase II clinical trials later in 2024, starting in Australia and then moving to the U.S. [14] - Clinical site selection is underway with Avance Clinical and major neurotrauma centers in Australia [15] - An Australian Regulatory Submission Brochure will be submitted in Q4 2024, outlining safety and efficacy protocols [16] - Continued development of the intranasal delivery system remains a key focus for the company [17] Commitment to Shareholders - Oragenics emphasizes transparency and open communication with shareholders, promising to provide updates on progress and commercialization efforts for ONP-002 [18]

SARASOTA, Fla., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Oragenics Inc. (NYSE American: OGEN), a company focused on developing new treatments for brain-related health conditions, has completed a key study for their new concussion drug, ONP-002. This drug is designed to be delivered through the nose, which could help it reach the brain quickly after a head injury. The recent study shows that the drug successfully targets areas inside the nose that are connected to the brain. This makes it more likely to reach and t ...

As filed with the Securities and Exchange Commission on September 3, 2024 Registration No. 333-281618 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1/A Amendment No. 1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ORAGENICS, INC. (Exact name of registrant as specified in its charter) Florida 59-3410522 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1990 Main Street, Suite 750 Sarasota, Florida 34236 (813) 286-790 ...

• Falls and car accidents lead incidence of concussions in emergency departments • Spray-dried drug formulation allows for easy delivery to patients • No pharmaceutical treatment is available for concussion; drug, ONP-002, could be first of its kind to treat concussion SARASOTA, Fla., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("the Company"), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced the compl ...

As filed with the Securities and Exchange Commission on August 16, 2024 Registration No. 333-[ ] UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ORAGENICS, INC. (Exact name of registrant as specified in its charter) Florida 59-3410522 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1990 Main Street, Suite 750 Sarasota, Florida 34236 (813) 286-7900 (Address, including z ...

SARASOTA, Fla., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("the Company"), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced recent and key 2024 business progress. The Company continues to execute its business strategy to develop and advance its lead candidate, ONP-002, for the treatment of concussion. Phase 2 human trials are being planned with anticipation of starting in the fourth quarter of this y ...

• ONP-002 stability eliminates need for cumbersome cold storage • No FDA-approved pharmaceutical treatment available for concussion SARASOTA, Fla., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced its lead candidate for treating concussion, ONP-002, is stable across a wide temperature range, eliminating the need for cumbersome cold storage for the drug devic ...

– ONP-002 showed no cancer-causing DNA damage – Phase II clinical trial being planned SARASOTA, Fla., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced its lead candidate for treating concussion, ONP-002, successfully completed a study that indicates it does not cause DNA damage and genotoxicity in an animal model. ONP-002 is a new chemical entity (NCE) desig ...

SARASOTA, Fla., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced its lead candidate for treating concussion successfully completed a study that indicates ONP002 does not cause cardiotoxicity. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. Prior to conducting a clinical trial ...

SARASOTA, Fla., June 27, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has completed a prototype of its automated intranasal device for use in concussed patients who are initially confused, dazed or unconscious in the acute phase of injury. Oragenics' lead drug candidate, ONP-002, is a new chemical entity (NCE) designed to target the brain through delivery into ...