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]

Core Insights - Oragenics, Inc. is participating in the Emergencies in Medicine Conference to present advancements in concussion treatments, specifically focusing on their novel intranasal neurosteroid, ONP-002 [1][2][3] Company Overview - Oragenics is a development-stage biotechnology company that specializes in nasal delivery of pharmaceutical medications targeting neurological conditions and infectious diseases, including treatments for mild traumatic brain injury (concussion) and Niemann Pick Disease Type C [4] Product Development - The presentation by Dr. James Kelly will highlight the "Trigger-to-Treat" program for concussion, emphasizing ONP-002's role in acute treatment and its integration with BRAINBox Solutions' diagnostic platform for improved concussion detection and patient stratification [2][3] Clinical Advancements - The "Trigger-to-Treat" paradigm aims to enhance acute concussion care by enabling early identification of high-risk patients and timely interventions, potentially accelerating recovery and reducing long-term neurological complications [3] Conference Details - The Emergencies in Medicine Conference serves as a platform for healthcare professionals and researchers to discuss innovations in emergency and trauma care, with a significant focus on concussion treatment [3]

Core Insights - Oragenics, Inc. has announced the appointment of Dr. James Kelly as a member of the Medical Board of The Leigh Steinberg Foundation, which focuses on concussion and brain health [1][2][4] - Dr. Kelly's leadership in brain injury research and treatment is recognized, enhancing his influence in the field of concussion care [2][3] - The foundation aims to advance brain health through research, awareness, and actionable solutions for those affected by concussions and traumatic brain injuries [2][6] Company Overview - Oragenics, Inc. is a clinical-stage biotechnology company dedicated to developing innovative treatments for neurological disorders, with its lead asset being ONP-002, an intranasal therapy for concussion [5] - The company emphasizes its commitment to pioneering new approaches in neuroscience to improve patient outcomes [5] Leadership and Contributions - Dr. Kelly has a distinguished background, having previously served as the founding director of the National Intrepid Center of Excellence, where he advanced the diagnosis and treatment of brain injuries, particularly for military personnel [3] - His experience includes working with athletes and individuals affected by concussions, positioning him as a key advocate for improved care and research [3] Foundation's Mission - The Leigh Steinberg Foundation is dedicated to raising awareness and supporting research for better care strategies for individuals suffering from brain injuries, especially in sports and military communities [6] - Dr. Kelly's involvement with the foundation aligns with Oragenics' mission to advance brain injury treatment and improve patient outcomes [4]

Core Perspective - The collaboration between Oragenics and BRAINBox Solutions aims to develop the first intranasal therapy for mild traumatic brain injury (mTBI), also known as concussion, establishing a comprehensive test-to-treat platform [1][2][4] Group 1: Partnership Details - Oragenics and BRAINBox Solutions are combining their technologies to create a comprehensive solution for concussion care, integrating advanced diagnostics with therapeutic development [1][2] - BRAINBox's diagnostic platform utilizes neurological biomarkers, neuropsychological assessments, and AI-driven analytics for early and accurate TBI assessments, while Oragenics' ONP-002 is designed to mitigate brain injury effects [2][3] Group 2: Clinical Development - The partnership is expected to enhance patient outcomes by providing rapid diagnosis, predictive prognosis, and timely treatment for concussion patients [2][3] - ONP-002 has shown significant potential in preclinical studies to reduce brain injury effects and support recovery, with a Phase I clinical trial indicating it is well-tolerated [3] Group 3: Market Opportunity - With over 5 million concussions occurring annually in the U.S., there is a significant unmet need for effective diagnostic and therapeutic solutions in the TBI market [4] - This partnership positions both companies at the forefront of innovation in TBI care, offering a compelling opportunity for advancing healthcare solutions in neurology [4]

Core Insights - Oragenics, Inc. is participating in the 12th Annual Brain Health Summit to discuss advancements in concussion treatment and brain health [1][2] - The summit aims to raise awareness and explore innovative approaches to treating traumatic brain injuries (TBI) [1][2] Company Overview - Oragenics is a biotechnology company focused on developing nasal delivery systems for neurological treatments and infectious diseases, including mild traumatic brain injury (mTBI) and Niemann Pick Disease Type C (NPC) [4] - The company is advancing its intranasal neurosteroid, ONP-002, to address unmet needs in concussion treatment [3] Event Details - The Brain Health Summit, hosted by Leigh Steinberg, will feature discussions on the long-term impacts of TBIs and strategies for prevention [2][3] - Dr. Nicole Roberts will moderate the event, emphasizing health innovation and its impact on vulnerable populations [3]

Core Viewpoint - Oragenics, Inc. has made significant strategic advancements since its $4 million capital raise in September 2024, including leadership changes and preparations for clinical trials, while focusing on innovative treatments for brain-related health conditions [1][2][5]. Leadership Transition - Janet Huffman has been appointed as the interim Chief Executive Officer, bringing extensive experience in capital raising, mergers and acquisitions, and financial planning [2][4]. - The Board of Directors expressed confidence in Ms. Huffman's leadership, highlighting her strategic capabilities and understanding of the company's operations [4]. Financial Overview - The company has strategically allocated resources since the capital raise to enhance operational efficiency [5]. Strategic Progress and Upcoming Milestones - Improvements have been made to the formulation and intranasal delivery device for ONP-002, with steps taken to secure intellectual property [6]. - The company is finalizing site agreements for Phase II clinical trials in Australia, aiming to dose the first patient by the end of Q1 2025 or early Q2 2025 [6][11]. - Completion of the spray-dry campaign is expected to ensure sufficient drug-device units for upcoming trials [6]. - Prototyping for an automated intranasal device for patients with altered states of consciousness has been completed [6]. - The company is on track for the closure of the Phase I clinical trial and submission of data for investigational new drug (IND) and investigator's brochure (IB) approval [6]. Future Outlook - The company is optimistic about 2025, focusing on advancing ONP-002 and laying the groundwork for future growth [8]. - Goals include the submission of the IB package by Q1 2025 for Australia Phase II clinical trials and formalizing strategic partnerships in Australia [11].

Group 1 - Oragenics, Inc. has converted its remaining outstanding convertible Series A and Series B Preferred Shares into common stock, simplifying its capital structure and eliminating approximately $2.35 million in liquidation preference [1][2][3] - The conversion involved 5,417,000 Series A Preferred Shares and 4,050,000 Series B Preferred Shares, resulting in the issuance of approximately 22,000 common shares [2] - The Chief Financial Officer of Oragenics stated that this conversion is a pivotal step in strengthening the company's foundation for future growth and aligns with its commitment to creating long-term value for shareholders [3] Group 2 - Oragenics is focused on developing innovative treatments for brain-related health conditions, including drug candidates for mild traumatic brain injury and Niemann Pick Disease Type C [4]

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]

SARASOTA, Fla., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biopharmaceutical company committed to developing novel therapies for neurological disorders, today provided a corporate update reflecting on the company's progress throughout 2024, including key milestones in the development of ONP-002, its lead candidate for the treatment of concussions. Company Overview: A Vision for Innovation in Neurology Oragenics is focused on revolutionizing drug delivery for neurological diso ...