UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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 June 30, 2025 or (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 (Address of principal executive offices, including zip ...

Core Viewpoint - Oragenics, Inc. has selected Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, aimed at treating concussion, highlighting the strategic partnership's importance for operational readiness and study initiation [1][2][3]. Group 1: Company Overview - Oragenics, Inc. is a clinical-stage biotechnology company focused on intranasal drug delivery for neurological conditions, with its lead candidate ONP-002 in clinical development for concussion treatment [7]. - Southern Star Research is a full-service CRO with expertise in early-phase trials across Australia and Asia-Pacific, known for its operational rigor and regulatory knowledge [2][8]. Group 2: Clinical Trial Details - The Phase IIa trial will be a randomized, double-blind, placebo-controlled study evaluating ONP-002 in adults with mild traumatic brain injury (mTBI), assessing safety, tolerability, pharmacokinetics (PK), and early pharmacodynamic (PD) effects [5][6]. - The study has received Human Research Ethics Committee (HREC) approval, and patient enrollment and dosing are expected to begin shortly [3][4]. Group 3: Strategic Advantages - Conducting the study in Australia offers several advantages, including streamlined regulatory processes, access to experienced trial sites, and eligibility for Australia's R&D tax incentive program, enhancing cost-efficiency [9]. - ONP-002 is a proprietary intranasal neurosteroid designed to improve drug delivery to the brain while minimizing systemic exposure, showing promise in preclinical models for reducing brain inflammation and improving cognitive functions [4].

Core Insights - Oragenics, Inc. has entered into a manufacturing agreement with Sterling Pharma Solutions for the GMP production of its lead drug candidate, ONP-002, aimed at treating concussion [1][2][3] - This partnership is a significant milestone for Oragenics, ensuring domestic production capabilities ahead of planned Phase IIb clinical trials expected to start next year [2][4] - The collaboration emphasizes Oragenics' commitment to quality and efficiency in developing treatments for neurological trauma, starting with concussion, which currently lacks FDA-approved pharmacological therapies [4][5] Company Overview - Oragenics, Inc. is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, with ONP-002 targeting mild traumatic brain injury (mTBI) [5] - The company's intranasal delivery technology aims to provide fast, targeted, and non-invasive therapy to the brain [5] Partner Overview - Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with over 50 years of experience in small molecule API development and manufacturing [6][7] - The company specializes in handling complex API challenges and has multiple facilities in the US and UK, employing over 1,350 people [7]

Core Viewpoint - Oragenics, Inc. successfully closed a public offering of Series H Convertible Preferred Stock and Warrants, raising approximately $16.5 million to advance its lead intranasal drug candidate, ONP-002, for mild traumatic brain injury [1][4][5] Group 1: Offering Details - The company issued 660,000 shares of Series H Convertible Preferred Stock along with Warrants to purchase an additional 660,000 shares, at a combined public offering price of $25.00 per unit [2][3] - If all Warrants are exercised, the company could raise an additional $16.5 million, totaling $33 million from the offering [2] Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance the clinical development of ONP-002, support other R&D activities, repay a $3 million bridge note, and fund working capital and general corporate purposes [4] Group 3: Company Background - Oragenics is a clinical-stage biotechnology company focused on intranasal therapeutics for neurological disorders, with ONP-002 being developed for the treatment of mild traumatic brain injury [9]

SARASOTA, Fla., July 01, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced that it has entered into a placement agency agreement for the purchase and sale of up to 800,000 shares of the Company’s Series H Convertible Preferred Stock (“Preferred Stock”), no par value, and Warrants to purchase up to an additional 800,000 shares of Preferred Stock of the Company at an ex ...

Company Overview - Oragenics, Inc. is a biotechnology company focused on developing intranasal therapeutics for neurological disorders [3] - The company's lead candidate, ONP-002, is being developed for the treatment of mild traumatic brain injury (mTBI), commonly known as concussion [3] Upcoming Events - Oragenics will present at the 2025 BIO International Convention from June 16–19, 2025, in Boston, Massachusetts [1] - The company will also attend the 42nd Annual National Neurotrauma Society (NNS) Symposium from June 15–18, 2025, in Philadelphia, Pennsylvania [1][2] Product Focus - ONP-002 is an intranasal neurosteroid aimed at treating concussion, utilizing a delivery technology designed for fast, targeted, and non-invasive therapy to the brain [2][3]

Core Viewpoint - Oragenics, Inc. has announced a One-for-Thirty reverse stock split to enhance its capital market presence and align with long-term investors' expectations [1][4]. Group 1: Reverse Stock Split Details - The reverse stock split will combine every 30 pre-split shares into one new share, effective at 12:01 a.m. Eastern Time on June 3, 2025 [2][3]. - Fractional shares resulting from the split will be rounded up to the nearest whole share for each shareholder [2]. - The split will not affect the par value of the common stock or the number of authorized but unissued shares [2][3]. Group 2: Company Strategy and Leadership Comments - The CEO, Ms. Janet Huffman, emphasized that the reverse split is aimed at strengthening the company's capital markets presence and attracting quality-focused investors [4]. - The company believes that increasing the share price and reducing share count will better align with investor expectations [4]. Group 3: Company Overview - Oragenics is a clinical-stage biotechnology company focused on developing innovative treatments for neurological disorders, with its lead asset being ONP-002, an intranasal therapy for concussion treatment [5].

Core Insights - Oragenics, Inc. has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate a Phase II clinical trial for its proprietary neuroprotective therapy ONP-002, aimed at treating mild traumatic brain injury (mTBI) or concussion [1][2] Company Developments - The approval allows Oragenics to expand its clinical development efforts internationally, with patient enrollment expected to begin in the second quarter of 2025 [2] - ONP-002 is designed for intranasal administration, providing a non-invasive method for drug delivery to the brain, and has shown promise in preclinical models by reducing inflammation, oxidative stress, and brain swelling associated with concussions [2] - A Phase I clinical trial indicated that ONP-002 is safe and well-tolerated, positioning it as a potential acute therapy for concussions [2] Market Position - The company is enhancing its geographic footprint by considering enrollment sites in both Australia and New Zealand, which could significantly broaden the reach of the ONP-002 program [2] - Oragenics is also advancing proprietary powder formulations and intranasal delivery technology to improve drug administration for neurological disorders [3]

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]