Market Overview - The global market for concussion treatment was valued at $6.9 billion in 2020 and is forecast to reach $8.9 billion by 2027[66]. ONP-002 Development - ONP-002 has completed a Phase 1 clinical trial in healthy human subjects, showing it is safe and well tolerated, with a dosing regimen established at 2X/day for fourteen days[81]. - The Phase 2a feasibility study for ONP-002 is expected to start in Q4 2024, followed by a Phase 2b proof of concept study in the US[82]. - ONP-002 has demonstrated a large safety margin in toxicology studies and has shown positive behavioral outcomes in preclinical studies[78]. - ONP-002 has been shown to be stable up to 104 degrees for 18 months, indicating its suitability for field conditions[70]. - The company plans to apply for an Investigational New Drug application with the FDA based on Phase 1 data[81]. - Patents on ONP-002 and its nasal delivery device have been filed and/or issued, with significant patent protection extending to 2040[73]. Financial Performance - Research and development expenses for the nine months ended September 30, 2024, were $2,449,234, a decrease of 45% compared to $4,448,623 for the same period in 2023[91]. - General and administrative expenses increased by approximately $1 million or 29%, totaling approximately $4.8 million for the nine months ended September 30, 2024, compared to $3.7 million for the same period in 2023[103]. - The company reported no grant revenue for the three and nine month periods ended September 30, 2024, compared to $7,466 and $37,653 in grant revenue for the same periods in 2023[100]. - Other income and expense, net, was $(15,412) for the nine months ended September 30, 2024, compared to $200,271 for the same period in 2023, resulting in a change of $215,683 or 108%[104]. - Operating activities used cash of $6,579,029 during the nine months ended September 30, 2024, compared to $6,188,335 for the same period in 2023[105]. - Research and development expenses for the three months ended September 30, 2024, were $879,041, an increase of 14% compared to $769,350 for the same period in 2023[101]. Strategic Focus - The company has paused all research and development activities related to its vaccine product candidate and closed its facility in Alachua, Florida[88]. - The company focused its research and development expenses on the ONP-002 neurology asset, pausing further development of the COVID vaccine and lantibiotics programs due to limited resources[91]. - The company plans to manage research and development expenditures in a cost-effective manner while advancing its research efforts[93]. - The company views business development activities, including strategic alliances and mergers, as essential for enhancing shareholder value[87]. Compliance and Funding - The company has a working capital surplus of $1,986,837 as of September 30, 2024[105]. - As of December 31, 2023, stockholders' equity was reported at $3.2 million, and it decreased to $3 million by September 30, 2024[122]. - The company has reported losses from continuing operations and/or net losses in its five most recent fiscal years[122]. - The NYSE American has notified the company of non-compliance with continued listing standards, requiring stockholders' equity of at least $4 million due to reported losses[121]. - A compliance plan was submitted by the company by the May 18, 2024 deadline, which was accepted, allowing until October 18, 2025 to regain compliance[124]. - The company expects to incur substantial expenditures for research, nonclinical testing, and clinical trials, necessitating additional capital[128]. - Current cash and cash equivalents are limited, expected to fund operations only through Q4 2024, leading to cost-saving initiatives[130]. - The company plans to seek both equity and debt financing, as well as partnerships to secure additional capital for ongoing operations[128]. - The company has no committed sources of financing at this time, creating uncertainty regarding future funding availability[131]. - If the common stock is delisted, it could negatively impact liquidity, market price, and the ability to raise equity financing[127]. - The company is committed to achieving compliance with NYSE American's requirements but cannot assure success within the required timeframe[126].

Group 1 - Oragenics Inc. will present at the Centurion One Capital 2nd Annual Bahamas Summit on October 22-23, 2024 [1] - Michael Redmond, President of Oragenics, is scheduled to participate in a corporate presentation and Q&A session on October 22, 2024, at 1:20 pm ET [1] - The event will take place at the Rosewood Baha Mar Hotel in Nassau, Bahamas [1] Group 2 - Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and infectious diseases [2] - The company is developing drug candidates for treating mild traumatic brain injury (mTBI) and Niemann Pick Disease Type C (NPC) [2] - Oragenics also has proprietary powder formulation and an intranasal delivery device [2]

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 ...

• 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 ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-32188 ORAGENICS, INC. (Exact name of registrant as specified in its charter) FLORIDA 59-3410522 (State or other jurisdic ...

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 ...