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]

Core Viewpoint - Oragenics, Inc. has announced a public offering of up to 800,000 shares of Series H Convertible Preferred Stock and Warrants, aiming to raise approximately $20 million to fund ongoing clinical trials and other corporate purposes [1][2]. Group 1: Offering Details - The offering includes 800,000 shares of Preferred Stock and Warrants to purchase an additional 800,000 shares at an exercise price of $25.00 per share [1]. - The combined public offering price for each share of Preferred Stock and accompanying Warrant is set at $25.00 [1]. - The Preferred Stock can be converted into common stock at a conversion price of $2.50 per share [1]. Group 2: Financial Proceeds and Use - Gross proceeds from the offering are expected to be approximately $20 million before deducting fees and expenses [2]. - The net proceeds will be used to fund ongoing ONP-2 concussion clinical trials, repay a $3 million bridge note, and for general corporate purposes [2]. Group 3: Placement Agent and Regulatory Compliance - Dawson James Securities, Inc. is acting as the sole placement agent for the offering [3]. - The offering is being conducted under a registration statement filed with the SEC, which became effective on June 30, 2025 [4].

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]

Core Insights - Oragenics, Inc. is hosting a management update webinar on May 20, 2025, to discuss the unmet medical need in concussion treatment and its lead program ONP-002, a neuroprotective therapy for mild traumatic brain injury [1][3][6] - The company emphasizes that ONP-002 offers a novel therapeutic approach in a market lacking FDA-approved drug therapies for concussions [3] Company Overview - Oragenics is focused on developing intranasal therapeutics for neurological disorders, particularly ONP-002 for mild traumatic brain injury or concussion [4] - The company is advancing proprietary powder formulations and intranasal delivery technology to enhance drug administration [4] Product Development - ONP-002 is delivered intranasally, allowing for non-invasive and direct brain delivery while minimizing systemic exposure [3] - Preclinical studies have shown that ONP-002 can reduce inflammation, oxidative stress, and brain swelling following head injury, with a Phase I trial indicating the compound is safe and well tolerated [3]

Financial Performance - The company reported a net loss of $2.22 million for the three months ended March 31, 2025, a decrease of 9.54% compared to a net loss of $2.45 million in the same period of 2024[88]. - As of March 31, 2025, the company had an accumulated deficit of $219 million and reported net losses of $2.2 million for Q1 2025 and $10.5 million for the year 2024[98]. - Net cash used in operating activities for Q1 2025 was $2,112,090, a decrease from $3,064,249 in Q1 2024[99]. - The company expects to incur significant and increasing operating losses as it advances its Neurology Assets through nonclinical testing and clinical trials[98]. Expenses - Research and development expenses decreased by 48.52% to $341,542 for the three months ended March 31, 2025, down from $663,414 in the same period of 2024[88]. - General and administrative expenses decreased by 6.23% to $1.68 million for the three months ended March 31, 2025, compared to $1.80 million in the same period of 2024[88]. - Interest expense increased significantly by 2,710.54% to $199,127 for the three months ended March 31, 2025, compared to $7,085 in the same period of 2024[88]. - The company anticipates increased general and administrative expenses due to expanded research and development activities and efforts to raise additional capital[92]. Financing Activities - The company raised $2.6 million from the sale of 7.8 million shares in February 2025 and $2.2 million from a $3 million promissory note issued in March 2025[74][75]. - The company generated $4,668,328 from financing activities in Q1 2025, compared to $1,652,737 in Q1 2024[99]. - Significant financing activities in Q1 2025 included $2.6 million in net proceeds from common stock issuance and $2.2 million in borrowings on short-term notes payable[103]. - The company’s short-term notes payable totaled $3,132,963 as of March 31, 2025, which includes a $3.0 million non-interest bearing promissory note due July 14, 2025[105]. Cash Position - The company has $3.4 million in cash and cash equivalents as of March 31, 2025, which is expected to fund operations through Q3 2025[81]. - Cash used in operating activities was affected by a non-cash charge of $0.2 million for amortization of debt discount in Q1 2025[101]. Operational Focus - The company operates in a single reportable segment focused on the development of ONP-002, with no segment revenue reported for the three-month periods ended March 31, 2025, and 2024[86]. - The company has a projected product development timeline for ONP-002, with Phase 2a expected to start in Q2 2025 and Phase 2b in Q2 2026[72]. - The company plans to seek both equity and debt financing to support the commercialization and development of its Neurology Assets[80]. Market Conditions - Inflation has not had a material impact on the company's results of operations for the periods presented, except for payroll-related costs and government-imposed regulations[107]. - The company does not have any off-balance sheet arrangements[108]. - As a smaller reporting company, the company is not required to provide information on market risk[109].

Core Insights - Oragenics, Inc. is participating in the 15th Annual Traumatic Brain Injury Conference to showcase advancements in intranasal therapies for concussion and brain-related conditions [1][2] Company Overview - Oragenics is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, particularly its lead candidate ONP-002 for mild traumatic brain injury (mTBI) [6] - The company is advancing proprietary powder formulations and intranasal delivery technology to enhance drug administration [6] Conference Participation - The Annual Traumatic Brain Injury Conference is hosted by Arrowhead Sci-Tech Conferences & Events, bringing together leaders from various sectors to discuss TBI research and clinical care [2] - Dr. W. Frank Peacock, Chief Clinical Officer of Oragenics, will present on "An Update on HeadSMART II: Advancing Precision Strategies for Traumatic Brain Injury Detection and Management" [3] Research and Collaboration - The HeadSMART II trial is one of the largest ongoing U.S. emergency department prospective biomarker discovery trials for mild traumatic brain injury, expected to enroll over 2,000 patients [4] - Findings from HeadSMART II may reshape the understanding of the mTBI population and influence future clinical trial enrollment strategies [4] - Oragenics is collaborating with BrainBox Solutions to create a comprehensive test-to-treat platform for mTBI, combining diagnostic technologies with its therapeutic candidate ONP-002 [5]

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]

Core Insights - Oragenics, Inc. is focused on developing novel intranasal therapies for brain-related disorders, particularly targeting mild traumatic brain injury (mTBI) or concussion [1][4] - The company’s lead candidate, ONP-002, utilizes intranasal administration for rapid absorption and targeted delivery to the brain [3][4] Industry Developments - The 3rd Nasal Formulation & Delivery Summit highlighted innovations in intranasal drug delivery, emphasizing CNS therapeutics, emergency-use treatments, and applications for infectious diseases [2] - Dr. James Kelly, Chief Medical Officer of Oragenics, participated in a panel discussion, sharing insights on optimizing intranasal drug delivery and its benefits for neurological treatments [2][3] Company Commitment - Oragenics' involvement in the summit reflects its dedication to advancing non-invasive CNS therapeutics and engaging with the intranasal research community [3]