SARASOTA, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related disorders, today announced that it has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate its Phase II clinical trial evaluating ONP-002, the Company's proprietary neuroprotective therapy, for the treatment of mild traumatic brain injury (mTBI), aka concussion. This approval marks a significa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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 No. 001-32188 Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ORAGENICS, INC. (Exact name of registrant as specified in its charter) Florida 59-3410522 (State or other jurisdiction of in ...

Core Viewpoint - Oragenics, Inc. has submitted a clinical trial protocol for its neurosteroid therapy ONP-002 to the Health and Disability Ethics Committee in New Zealand, marking a significant step in the development of treatments for mild traumatic brain injury (mTBI) or concussion [1][2][3] Company Overview - Oragenics, Inc. is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, with ONP-002 as its lead candidate for treating mTBI or concussion [4] - The company is also advancing proprietary powder formulations and intranasal delivery technology to enhance drug administration [4] Clinical Trial Details - The Phase II clinical trial for ONP-002 aims to evaluate its efficacy in treating mTBI or concussion, with patient enrollment planned in both Australia and New Zealand [2][3] - The trial will be conducted at Christchurch Hospital, the largest tertiary, teaching, and research hospital on New Zealand's South Island, which treats over 83,000 patients annually [2][3] Treatment Significance - There are currently no pharmaceutical therapies available for treating concussion, highlighting an unmet medical need [3] - ONP-002 is designed for intranasal administration, providing a non-invasive and efficient route for drug delivery to the brain, and has shown promising results in preclinical models [3]

SARASOTA, Fla., April 07, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related disorders, today announced that Chief Medical Officer Dr. James Kelly participated in a panel discussion at the 3rd Nasal Formulation & Delivery Summit, which took place April 1-3, 2025, in Boston, MA. The conference brought together industry leaders to discuss the latest innovations in intranasal drug delivery, with a focus on C ...

SARASOTA, Fla., April 07, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related disorders, today announced that Chief Medical Officer Dr. James Kelly participated in a panel discussion at the 3rd Nasal Formulation & Delivery Summit, which took place April 1-3, 2025, in Boston, MA. The conference brought together industry leaders to discuss the latest innovations in intranasal drug delivery, with a focus on CNS therape ...

SARASOTA, Fla., March 27, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a biotechnology company focused on developing novel intranasal therapies for brain-related conditions, today provided shareholders with an update on its strategic and financial progress for the first quarter of 2025. The Company has made meaningful advancements across regulatory, clinical, financial, and partnership initiatives, further positioning its lead therapeutic candidate, ONP-002, as a first-in-class solution for treatin ...

Company Overview - Oragenics, Inc. is a biotechnology company focused on innovative treatments for concussion and brain-related health conditions, including drug candidates for mild traumatic brain injury (mTBI) and Niemann Pick Disease Type C (NPC) [3] Financial Performance - The company filed its Annual Report on Form 10-K for the year ended December 31, 2024, with the U.S. Securities and Exchange Commission on March 14, 2025 [1] - The audited consolidated financial statements received an unqualified audit opinion from an independent registered public accounting firm, indicating a positive assessment of the company's financial health [2] Strategic Focus - Oragenics is committed to advancing its innovative pipeline, exploring strategic opportunities, and securing necessary resources to support long-term growth [2]

Financial Performance - The company reported net losses of $20.7 million and $10.6 million for the years ended December 31, 2023 and 2024, respectively, with an accumulated deficit of $216.8 million as of December 31, 2024[346]. - For the year ended December 31, 2024, the company reported a net loss of $10.6 million, a decrease of 49% compared to a net loss of $20.7 million in 2023[381]. - Total operating expenses decreased by 50% to $10.6 million in 2024 from $20.9 million in 2023, primarily due to a significant reduction in research and development expenses[381]. - Cash used in operating activities was $8.6 million in 2024, compared to $7.3 million in 2023, reflecting the net loss adjusted for non-cash items[388]. - The company recorded a working capital deficit of $211,885 at December 31, 2024, compared to a surplus of $2.1 million at December 31, 2023[390]. - The company has a full valuation allowance against deferred tax assets of approximately $46.96 million as of December 31, 2024, indicating uncertainty in realizing these assets[373]. - The company expects to incur substantial net losses and negative cash flows for the foreseeable future, impacting shareholder equity and working capital[349]. Research and Development - The company has completed pre-clinical animal studies and Phase 1 trials for its lead product ONP-002, with Phase 2a expected to start in Q1/Q2 2025 and Phase 3 anticipated to begin in Q1 2027[341]. - Research and development expenses are anticipated to increase as the company advances its ONP-002 product development program, while costs related to other product candidates have been paused pending additional financing[364]. - Research and development expenses were $4.1 million in 2024, down 73% from $15.5 million in 2023, largely due to the expensing of $10.3 million related to the acquisition of a concussion asset in 2023[383]. Funding and Capital - In February 2025, the company raised $2.75 million from the sale of 7.8 million shares of common stock under its ATM agreement[344]. - A private placement on March 13, 2025, generated gross proceeds of $2.5 million from the sale of a $3 million promissory note and 1 million shares of Series G Preferred Stock[345]. - The company plans to seek additional capital through equity and debt financing, strategic alliances, and partnerships to support its operations and research initiatives[353]. Revenue and Grants - Grant revenue was $0 in 2024, a 100% decrease from $37,653 in 2023, attributed to the expiration of a small business innovation research grant[382]. - The company has incurred significant expenses related to its licensing agreements, which may negatively impact its financial capabilities[347]. Product Development - The proprietary formulation of ONP-002 allows for rapid brain accessibility, with a novel intranasal device designed to minimize systemic exposure and side effects[340]. - The company expects to incur significant and increasing operating losses as it advances its Neurology Assets through nonclinical testing and clinical trials[386].

Core Insights - Oragenics, Inc. has submitted its Investigator's Brochure (IB) application for the Phase II clinical trial of ONP-002, a novel intranasal neurosteroid aimed at treating mild traumatic brain injury (mTBI) [1][5] - The Phase II study will assess the feasibility, safety, tolerability, and pharmacokinetics of ONP-002 in mTBI patients, with a focus on cognitive and visual motor testing [2][6] Company Overview - Oragenics is a biotechnology company focused on developing nasal delivery systems for pharmaceutical treatments in neurology and infectious diseases, including therapies for mTBI and Niemann Pick Disease Type C [7] Clinical Trial Details - The Phase II trial is randomized, double-blind, and placebo-controlled, enrolling 40 participants, with 20 receiving ONP-002 and 20 receiving a placebo [6] - Participants will receive nine doses over five days, with the first dose administered within 12 hours of injury [6] Medical Context - Mild TBI, or concussion, is a common form of head trauma with no FDA-approved drug therapies currently available, indicating a significant unmet medical need [4]

Core Viewpoint - Oragenics, Inc. has submitted its Investigator's Brochure for ONP-002, a novel intranasal neurosteroid, in preparation for a Phase II clinical trial aimed at treating mild traumatic brain injury (mTBI) [1][5] Group 1: Clinical Development - The submission of the Investigator's Brochure is a significant milestone in advancing the clinical program for ONP-002, bringing the company closer to initiating the clinical trial [5] - The Phase II trial will assess the feasibility, safety, tolerability, and pharmacokinetics of ONP-002 in adults with mTBI, enrolling 40 participants in a randomized, double-blind, placebo-controlled design [6] - Participants will receive a total of nine doses over five days, with the first dose administered within 12 hours of injury, and various cognitive and biomarker tests will be conducted to evaluate the drug's impact [6] Group 2: Product Background - ONP-002 has shown promising preclinical results, indicating its potential to reduce inflammation, oxidative stress, and brain swelling [2] - A prior Phase I study confirmed the safety and tolerability of ONP-002 at multiple intranasal doses in healthy adults [2] - The Investigator's Brochure includes comprehensive clinical and non-clinical data on ONP-002, serving as a critical foundation for the study [3] Group 3: Market Context - Mild TBI, or concussion, is a common form of head trauma with no FDA-approved drug therapies currently available, highlighting a significant unmet medical need [4] - The company is focused on delivering a therapeutic option for patients suffering from mTBI, with expectations of receiving regulatory approvals to initiate the trial soon [5]