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].

SARASOTA, Fla., Oct. 18, 2024 (GLOBE NEWSWIRE) -- Oragenics Inc. (NYSE American: OGEN), a company focused on developing new treatments for brain-related health conditions, announced it will be presenting at the Centurion One Capital 2nd Annual Bahamas Summit to be held at the Rosewood Baha Mar Hotel on October 22-23, 2024, in Nassau, Bahamas. Michael Redmond, President of Oragenics, will participate in a corporate presentation and Q&A session on October 22, 2024 at 1:20 pm ET. Details for the presentation a ...

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 ...

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 ...