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]

Core Insights - Oragenics, Inc. is focused on developing novel intranasal therapies for brain-related disorders, particularly its lead candidate ONP-002 for mild traumatic brain injury (mTBI) [1][4] - The company participated in the 3rd Nasal Formulation & Delivery Summit, highlighting its commitment to innovation in non-invasive CNS therapeutics [1][3] Company Developments - Dr. James Kelly, Chief Medical Officer of Oragenics, shared insights on optimizing intranasal drug delivery and its advantages in neurological treatment during the summit [2] - ONP-002 is designed for rapid absorption and targeted brain delivery through intranasal administration, aiming to improve outcomes for concussion patients [3][4] Industry Context - The summit gathered industry leaders to discuss innovations in intranasal drug delivery, focusing on CNS therapeutics, emergency-use treatments, and infectious disease applications [2]

Core Insights - Oragenics, Inc. is advancing its lead therapeutic candidate, ONP-002, for concussion treatment, highlighting significant progress in regulatory, clinical, financial, and partnership initiatives [1][2] Strategic and Operational Milestones - ONP-002 is a neuroprotective, anti-inflammatory compound designed for intranasal administration to treat concussion, classified as a mild traumatic brain injury (mTBI) [3] - The drug has undergone extensive preclinical studies, including evaluations for cardiotoxicity and genotoxicity, and successfully completed a Phase I human study with no serious adverse events [4] - The company has finalized drug production for the Phase IIa clinical trial and submitted the Investigator's Brochure to regulatory authorities in Australia, with first patient enrollment expected soon [5][6] Strategic Partnerships - A collaboration with BRAINBox Solutions was established to combine ONP-002's therapeutic capabilities with BRAINBox's diagnostic tools, aiming to enhance concussion care [7][9] Financial Position and Capital Structure - Oragenics raised approximately $5 million in Q1 2025 through a mix of equity and non-dilutive debt financing, including $2.6 million from At-the-Market (ATM) equity sales and $2.25 million in non-dilutive debt [8][10] - The company simplified its capital structure by converting all outstanding Series A and B preferred shares to common stock, enhancing transparency for shareholders [10][11] Upcoming Milestones - Key projected milestones include HREC approval in Australia and first patient enrollment in the Phase IIa trial expected in Q2 2025, with completion of Phase IIa enrollment anticipated by Q4 2025 [12] - Additional milestones include interim safety and biomarker readout in Q4 2025 – Q1 2026, initiation of Phase IIb in Q1 2026, and FDA Accelerated Approval Filing in Q3 2026 [12] Commitment to Value Creation - The company is focused on advancing ONP-002 with urgency and precision, aiming to deliver a clinical breakthrough in concussion care and generate long-term value for shareholders [13][14]

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]

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]