{"success":true,"data":{"pressRelease":{"id":"1631","rtpr_id":"nGNX3CKWVq","ticker":"OGEN","exchange":"NYSE American","all_tickers":["OGEN"],"title":"Oragenics Reports 8 study drug doses in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury","author":"Globe Newswire","published_at":"2026-04-20T13:00:03.490Z","article_body":"• Enrollment underway at Mackay Base Hospital in Queensland, Australia;\nadditional sites in final activation stages\n\nSARASOTA, Fla., April 20, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE\nAmerican: OGEN), a clinical-stage biotechnology company developing\nbrain-targeted therapeutics through proprietary intranasal delivery\ntechnology, today announced that 2 patients and 8 study drug doses have been\nadministered in its ongoing Phase IIa clinical trial evaluating ONP-002, the\nCompany’s lead candidate for the treatment of mild traumatic brain injury\n(mTBI) a.k.a., concussion. Enrollment is progressing at Mackay Base Hospital\nin Queensland, Australia, the first activated site in the trial, with\nadditional sites completing final activation steps.\n\nTraumatic brain injury represents a significant neurological condition without\nan FDA-approved pharmacological treatment. According to the CDC, an estimated\n1.7 to 3.8 million people in the U.S. experience traumatic brain injuries\nannually, with sports and recreational activities among the leading causes.¹\nGlobally, an estimated 69 million individuals sustain traumatic brain injuries\neach year. Despite this scale, no pharmacological treatments have been\napproved — leaving patients, military personnel, athletes, and families\nwithout FDA-approved effective options beyond rest and symptom management. If\napproved by the FDA, ONP-002 would be the first and only pharmacological\nstandard of care for a global concussion market projected to reach over $9\nbillion by 2030.²\n\nThe Company’s Phase IIa trial is designed to enroll 40 patients who meet\nenrollment criteria based on CT scan findings, presenting symptoms, and\nemergency room or hospital admission. Patients receive first dosing within 12\nhours of concussion, followed by continued treatment for up to 30 days. We\nbelieve early enrollment activity reflects both strong site readiness and the\nsignificant unmet clinical need in this patient population. ONP-002 is\ndelivered via Oragenics’ proprietary intranasal spray-dry powder device.\n\nONP-002 is a first-in-class intranasal neurosteroid designed to address the\nunderlying biology of brain injury — with the promise of reducing\nneuroinflammation, oxidative stress, and cerebral edema — rather than simply\nmanaging symptoms. The drug candidate is designed to target the biological\ncascade triggered by trauma, with the potential to represent a paradigm shift\nfrom symptom management to active neurological intervention.\n\nOragenics CEO, Janet Huffman, stated; “Two participants dosed and eight\nstudy drug doses administered is exactly the kind of early momentum we\nexpected when we activated Mackay Base Hospital. The speed of enrollment\ncombined with participants successfully moving through the trial is an\nexciting milestone that will be strengthened with the additional onboarding of\nAlfred Hospital in April. These early enrollments support our belief that\nthere is a population of patients and clinicians who have been waiting for\nthis. We believe every participant dose is a step toward an answer for the\nmillions of people who have been told there is nothing that can be done for\nconcussion”.\n\nOragenics CMO, Dr. James Kelly, added; “Each participant dose in this trial\nrepresents a person who presented with a concussion and had no pharmacological\ntreatment available to them. That is the reality we are working to change. Our\nPhase I safety profile was strong, and early Phase IIa enrollment is\nproceeding in alignment with our clinical plan. ONP-002 targets the injury\nitself – not just the symptoms – and we are gathering the data we need to\nbring that approach forward.”\n\nABOUT ONP-002\n\nONP-002 is an investigational neuroprotective, anti-inflammatory intranasal\ndrug candidate targeting mild traumatic brain injury (mTBI) a.k.a.,\nconcussion. Designed to interrupt biological pathways involved in\ninflammation, oxidative stress, and swelling following head trauma, ONP-002\nhas demonstrated safety and tolerability in Phase 1 clinical trials with zero\nserious adverse events across all dose levels. The drug candidate utilizes\nOragenics’ proprietary intranasal delivery platform to enable rapid,\ntargeted brain delivery — potentially representing a paradigm shift from\nsymptom management to active neurological intervention. Oragenics is advancing\nONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb\ntrials planned to follow pending FDA investigational new drug application\n(IND) approval.\n\nABOUT ORAGENICS, INC.\n\nOragenics, Inc. is a clinical-stage biotechnology company developing\nbrain-targeted therapeutics through proprietary intranasal delivery\ntechnology. The Company’s lead candidate, ONP-002, is being advanced as a\npotential first-in-class treatment for concussion and mild traumatic brain\ninjury. Oragenics is progressing ONP-002 through Phase IIa clinical trials in\nAustralia, with U.S. Phase IIb trials planned to follow. The Company believes\nits intranasal delivery platform has potential applications across multiple\nneurological conditions. Oragenics is committed to developing innovative\ntherapies that address significant unmet medical needs in neurological care.\nFor more information, visit www.oragenics.com.\n\nFORWARD-LOOKING STATEMENTS\n\nThis communication contains \"forward-looking statements\" within the meaning of\nthe safe harbor provisions of the U.S. Private Securities Litigation Reform\nAct of 1995. Statements in this news release concerning the Company’s\nexpectations, plans, business outlook or future performance, and any other\nstatements concerning assumptions made or expectations as to any future\nevents, conditions, performance or other matters, are \"forward-looking\nstatements.\" Forward-looking statements include statements regarding the\nCompany’s intentions, beliefs, projections, outlook, analyses or current\nexpectations concerning, among other things: our research, development and\nregulatory activities and expectations relating to product candidates,\nincluding without limitation ONP-002 and our proprietary nasal device; the\neffectiveness of these programs or the possible range of application and\npotential curative effects and safety in the treatment of diseases; and the\ntiming, conduct, interim results announcements and outcomes of our clinical\ntrials of our product candidates, including ONP-002 for the treatment of\nconcussion and mTBI. These forward-looking statements are based on\nmanagement’s beliefs and assumptions and information currently available.\nThe words \"believe,\" \"expect,\" \"anticipate,\" \"intend,\" \"estimate,\" \"project,\"\n\"potential,\" \"may,\" \"will,\" \"could,\" \"should,\" and similar expressions that do\nnot relate solely to historical matters identify forward-looking statements.\nInvestors should be cautious in relying on forward-looking statements because\nthey are subject to a variety of risks, uncertainties, and other factors that\ncould cause actual results to differ materially from those expressed in any\nsuch forward-looking statements. These factors include, but are not limited\nto, those described in our most recent Form 10-K, Form 10-Q and other filings\nwe make with the U.S. Securities and Exchange Commission. You should consider\nthese factors in evaluating the forward-looking statements included in this\npress release and not place undue reliance on such statements. All information\nwe set forth in this press release is as of the date hereof. We do not assume\nany obligation to publicly provide revisions or updates to any forward-looking\nstatements, whether as a result of new information, future developments or\notherwise, should circumstances change, except as otherwise required by law.\n\nINVESTOR & MEDIA CONTACT\nInvestor & Media Relations\nirth Communications\n800-383-4880\nir@oragenics.com\n\nFOOTNOTES\n¹ American Association of Neurological Surgeons; Sports Related Head Injury /\nCDC TBI Data\n² Grand Market Research; Concussion Market (2025–2030)\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/8b2c9d06-f009-4a6e-a465-8a1fe9640993)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX3CKWVq","title":"Oragenics Reports 8 study drug doses in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury","author":"Globe Newswire","ticker":"OGEN","created":"2026-04-20T13:00:03.490Z","tickers":["OGEN"],"exchange":"NYSE American","article_body":"• Enrollment underway at Mackay Base Hospital in Queensland, Australia;\nadditional sites in final activation stages\n\nSARASOTA, Fla., April 20, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE\nAmerican: OGEN), a clinical-stage biotechnology company developing\nbrain-targeted therapeutics through proprietary intranasal delivery\ntechnology, today announced that 2 patients and 8 study drug doses have been\nadministered in its ongoing Phase IIa clinical trial evaluating ONP-002, the\nCompany’s lead candidate for the treatment of mild traumatic brain injury\n(mTBI) a.k.a., concussion. Enrollment is progressing at Mackay Base Hospital\nin Queensland, Australia, the first activated site in the trial, with\nadditional sites completing final activation steps.\n\nTraumatic brain injury represents a significant neurological condition without\nan FDA-approved pharmacological treatment. According to the CDC, an estimated\n1.7 to 3.8 million people in the U.S. experience traumatic brain injuries\nannually, with sports and recreational activities among the leading causes.¹\nGlobally, an estimated 69 million individuals sustain traumatic brain injuries\neach year. Despite this scale, no pharmacological treatments have been\napproved — leaving patients, military personnel, athletes, and families\nwithout FDA-approved effective options beyond rest and symptom management. If\napproved by the FDA, ONP-002 would be the first and only pharmacological\nstandard of care for a global concussion market projected to reach over $9\nbillion by 2030.²\n\nThe Company’s Phase IIa trial is designed to enroll 40 patients who meet\nenrollment criteria based on CT scan findings, presenting symptoms, and\nemergency room or hospital admission. Patients receive first dosing within 12\nhours of concussion, followed by continued treatment for up to 30 days. We\nbelieve early enrollment activity reflects both strong site readiness and the\nsignificant unmet clinical need in this patient population. ONP-002 is\ndelivered via Oragenics’ proprietary intranasal spray-dry powder device.\n\nONP-002 is a first-in-class intranasal neurosteroid designed to address the\nunderlying biology of brain injury — with the promise of reducing\nneuroinflammation, oxidative stress, and cerebral edema — rather than simply\nmanaging symptoms. The drug candidate is designed to target the biological\ncascade triggered by trauma, with the potential to represent a paradigm shift\nfrom symptom management to active neurological intervention.\n\nOragenics CEO, Janet Huffman, stated; “Two participants dosed and eight\nstudy drug doses administered is exactly the kind of early momentum we\nexpected when we activated Mackay Base Hospital. The speed of enrollment\ncombined with participants successfully moving through the trial is an\nexciting milestone that will be strengthened with the additional onboarding of\nAlfred Hospital in April. These early enrollments support our belief that\nthere is a population of patients and clinicians who have been waiting for\nthis. We believe every participant dose is a step toward an answer for the\nmillions of people who have been told there is nothing that can be done for\nconcussion”.\n\nOragenics CMO, Dr. James Kelly, added; “Each participant dose in this trial\nrepresents a person who presented with a concussion and had no pharmacological\ntreatment available to them. That is the reality we are working to change. Our\nPhase I safety profile was strong, and early Phase IIa enrollment is\nproceeding in alignment with our clinical plan. ONP-002 targets the injury\nitself – not just the symptoms – and we are gathering the data we need to\nbring that approach forward.”\n\nABOUT ONP-002\n\nONP-002 is an investigational neuroprotective, anti-inflammatory intranasal\ndrug candidate targeting mild traumatic brain injury (mTBI) a.k.a.,\nconcussion. Designed to interrupt biological pathways involved in\ninflammation, oxidative stress, and swelling following head trauma, ONP-002\nhas demonstrated safety and tolerability in Phase 1 clinical trials with zero\nserious adverse events across all dose levels. The drug candidate utilizes\nOragenics’ proprietary intranasal delivery platform to enable rapid,\ntargeted brain delivery — potentially representing a paradigm shift from\nsymptom management to active neurological intervention. Oragenics is advancing\nONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb\ntrials planned to follow pending FDA investigational new drug application\n(IND) approval.\n\nABOUT ORAGENICS, INC.\n\nOragenics, Inc. is a clinical-stage biotechnology company developing\nbrain-targeted therapeutics through proprietary intranasal delivery\ntechnology. The Company’s lead candidate, ONP-002, is being advanced as a\npotential first-in-class treatment for concussion and mild traumatic brain\ninjury. Oragenics is progressing ONP-002 through Phase IIa clinical trials in\nAustralia, with U.S. Phase IIb trials planned to follow. The Company believes\nits intranasal delivery platform has potential applications across multiple\nneurological conditions. Oragenics is committed to developing innovative\ntherapies that address significant unmet medical needs in neurological care.\nFor more information, visit www.oragenics.com.\n\nFORWARD-LOOKING STATEMENTS\n\nThis communication contains \"forward-looking statements\" within the meaning of\nthe safe harbor provisions of the U.S. Private Securities Litigation Reform\nAct of 1995. Statements in this news release concerning the Company’s\nexpectations, plans, business outlook or future performance, and any other\nstatements concerning assumptions made or expectations as to any future\nevents, conditions, performance or other matters, are \"forward-looking\nstatements.\" Forward-looking statements include statements regarding the\nCompany’s intentions, beliefs, projections, outlook, analyses or current\nexpectations concerning, among other things: our research, development and\nregulatory activities and expectations relating to product candidates,\nincluding without limitation ONP-002 and our proprietary nasal device; the\neffectiveness of these programs or the possible range of application and\npotential curative effects and safety in the treatment of diseases; and the\ntiming, conduct, interim results announcements and outcomes of our clinical\ntrials of our product candidates, including ONP-002 for the treatment of\nconcussion and mTBI. These forward-looking statements are based on\nmanagement’s beliefs and assumptions and information currently available.\nThe words \"believe,\" \"expect,\" \"anticipate,\" \"intend,\" \"estimate,\" \"project,\"\n\"potential,\" \"may,\" \"will,\" \"could,\" \"should,\" and similar expressions that do\nnot relate solely to historical matters identify forward-looking statements.\nInvestors should be cautious in relying on forward-looking statements because\nthey are subject to a variety of risks, uncertainties, and other factors that\ncould cause actual results to differ materially from those expressed in any\nsuch forward-looking statements. These factors include, but are not limited\nto, those described in our most recent Form 10-K, Form 10-Q and other filings\nwe make with the U.S. Securities and Exchange Commission. You should consider\nthese factors in evaluating the forward-looking statements included in this\npress release and not place undue reliance on such statements. All information\nwe set forth in this press release is as of the date hereof. We do not assume\nany obligation to publicly provide revisions or updates to any forward-looking\nstatements, whether as a result of new information, future developments or\notherwise, should circumstances change, except as otherwise required by law.\n\nINVESTOR & MEDIA CONTACT\nInvestor & Media Relations\nirth Communications\n800-383-4880\nir@oragenics.com\n\nFOOTNOTES\n¹ American Association of Neurological Surgeons; Sports Related Head Injury /\nCDC TBI Data\n² Grand Market Research; Concussion Market (2025–2030)\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/8b2c9d06-f009-4a6e-a465-8a1fe9640993)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-04-20T13:00:03.528552652Z","server_sent_at_ms":1776690003528},"received_at":"2026-04-20T13:00:03.581Z","source_url":"https://www.globenewswire.com/news-release/2026/04/20/3277097/0/en/oragenics-reports-8-study-drug-doses-in-phase-iia-clinical-trial-of-onp-002-for-mild-traumatic-brain-injury.html"},"analysis":{"id":"914","press_release_id":"1631","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Oragenics reported that 2 patients have been dosed and 8 study drug doses administered in its Phase IIa clinical trial of ONP-002 for mild traumatic brain injury (concussion), with enrollment progressing at Mackay Base Hospital in Queensland, Australia.\n\nThe trial is designed to enroll 40 patients who receive first dosing within 12 hours of concussion, followed by continued treatment for up to 30 days. Additional sites, including Alfred Hospital, are in final activation stages.\n\nONP-002 is a first-in-class intranasal neurosteroid targeting the underlying biology of brain injury rather than symptom management. If approved, it would be the only FDA-approved pharmacological treatment for concussion, addressing a global market projected to exceed $9 billion by 2030.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"First-in-class concussion drug ONP-002 shows early Phase IIa enrollment momentum in Australia's no-FDA-approved-treatment concussion space."},"keyFigures":{"drugName":"ONP-002","phaseOfTrial":"Phase IIa","customDimensions":{"patients_dosed":2,"doses_administered":8,"planned_enrollment":40,"projected_market_2030":"$9 billion"}},"quotedText":"Two participants dosed and eight study drug doses administered is exactly the kind of early momentum we expected when we activated Mackay Base Hospital.","namedEntities":{"people":[{"name":"Janet Huffman","role":"CEO"},{"name":"Dr. James Kelly","role":"CMO"}],"products":["ONP-002"],"companies":[{"name":"Oragenics, Inc.","ticker":"OGEN"},{"name":"Mackay Base Hospital","relationship":"clinical trial site"},{"name":"Alfred Hospital","relationship":"planned clinical trial site"}],"dollarAmounts":[{"amount":"$9 billion","context":"projected global concussion market by 2030"}]},"materialImpact":{"score":2,"reasoning":"Early enrollment update with only 2 of 40 planned patients dosed. Positive momentum signal but no efficacy data; Phase IIa is still in very early stages with binary outcomes far ahead."},"tickerRelevance":{"others":[],"primary":"OGEN"},"eventTypeSecondary":[]},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Oragenics reported that 2 patients have been dosed and 8 study drug doses administered in its Phase IIa clinical trial of ONP-002 for mild traumatic brain injury (concussion), with enrollment progressing at Mackay Base Hospital in Queensland, Australia.\n\nThe trial is designed to enroll 40 patients who receive first dosing within 12 hours of concussion, followed by continued treatment for up to 30 days. Additional sites, including Alfred Hospital, are in final activation stages.\n\nONP-002 is a first-in-class intranasal neurosteroid targeting the underlying biology of brain injury rather than symptom management. If approved, it would be the only FDA-approved pharmacological treatment for concussion, addressing a global market projected to exceed $9 billion by 2030.","key_figures":{"drugName":"ONP-002","phaseOfTrial":"Phase IIa","customDimensions":{"patients_dosed":2,"doses_administered":8,"planned_enrollment":40,"projected_market_2030":"$9 billion"}},"named_entities":{"people":[{"name":"Janet Huffman","role":"CEO"},{"name":"Dr. James Kelly","role":"CMO"}],"products":["ONP-002"],"companies":[{"name":"Oragenics, Inc.","ticker":"OGEN"},{"name":"Mackay Base Hospital","relationship":"clinical trial site"},{"name":"Alfred Hospital","relationship":"planned clinical trial site"}],"dollarAmounts":[{"amount":"$9 billion","context":"projected global concussion market by 2030"}]},"model_name":"glm-5.1","prompt_hash":"sha256:2f2748f0fcc8c4f2","schema_hash":"sha256:ad96b863d7123008","created_at":"2026-04-20T13:17:58.743Z","global_importance":3,"audience_relevance":3,"importance_components":{"method":"backfill-heuristic","signals":{"bodyLong":false,"headlineTier1":false,"tickerCovered":false,"hadSignificance":false},"version":1,"computedAt":"2026-04-27T11:52:53.031Z"}},"durationMs":28920,"modelName":"glm-5.1"}}