{"success":true,"data":{"pressRelease":{"id":"21008","rtpr_id":"nGNXt3plT","ticker":"OGEN","exchange":"NYSE American","all_tickers":["OGEN"],"title":"Oragenics Activates Second Site in Phase IIa Clinical Trial of ONP-002 for Concussion and Mild Traumatic Brain Injury.","author":"Globe Newswire","published_at":"2026-05-05T12:30:00.576Z","article_body":"SARASOTA, Fla., May 05, 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 Alfred Hospital is now actively enrolling\nparticipants in its ongoing Phase IIa clinical trial evaluating ONP-002, the\nCompany’s lead candidate for the treatment of concussion and mild traumatic\nbrain injury (mTBI). To date, four patients have been enrolled and dosed at\nMackay Base Hospital in Queensland, Australia, the first site activated in the\ntrial.\n\nConcussion and mild traumatic brain injury represent the most prominent\nneurological condition without an FDA-approved pharmacological treatment.\nAccording to the CDC, an estimated 1.7 to 3.8 million people in the U.S.\nexperience traumatic brain injuries annually, with sports and recreational\nactivities among the leading causes.¹ Globally, an estimated 69 million\nindividuals sustain traumatic brain injuries each year. Despite this scale, no\npharmacological treatments have been approved — leaving patients, military\npersonnel, athletes, and families without effective options beyond rest and\nsymptom management. If approved by the FDA, we believe ONP-002 would be the\nfirst and only pharmacological standard of care for a global concussion market\nprojected to reach over $9 billion 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. The\npace of enrollment at Mackay Base Hospital since site activation on March 31,\n2026, reflects both strong site readiness and the depth of unmet clinical need\nin this patient population. ONP-002 is delivered via Oragenics’ proprietary\nintranasal spray-dry powder device.\n\nWe believe ONP-002 is a first-in-class intranasal neurosteroid designed to\naddress the underlying biology of brain injury — reducing neuroinflammation,\noxidative stress, and cerebral edema — rather than simply managing symptoms.\nThe drug candidate targets the biological cascade triggered by trauma, with\nthe potential to represent a paradigm shift from symptom management to active\nneurological intervention. The Phase IIa clinical data readout is projected\nbefore year-end 2026, and is expected to support the Company’s planned\ninvestigational new drug (IND) application submission to the FDA, targeting\nDecember 31, 2026, for a Phase IIb clinical trial in the U.S.\n\nJanet Huffman, Oragenics’ CEO, stated, \"Four patients have been dosed at\nMackay Base Hospital in less than a month of activation. That is not an\naccident — it is a reflection of what we have been saying since we started\nthis program: concussion patients have nowhere to turn, and when a trial opens\nits doors, they walk through them. We are executing against our clinical plan.\nTwo sites are now actively enrolling, and we intend to maintain this pace\nthrough the full 40-patient enrollment. For the millions of people who have\nbeen told there is nothing that can be done for concussion, we are here to\nprove otherwise.\"\n\nABOUT ONP-002\n\nONP-002 is an investigational neuroprotective, anti-inflammatory intranasal\ndrug candidate targeting mild traumatic brain injury (mTBI) and concussion.\nDesigned to interrupt biological pathways involved in inflammation, oxidative\nstress, and swelling following head trauma, ONP-002 has demonstrated safety\nand tolerability in Phase I clinical trials with zero serious adverse events\nacross all dose levels. The drug candidate utilizes Oragenics’ proprietary\nintranasal delivery platform to enable rapid, targeted brain delivery —\npotentially representing a paradigm shift from symptom management to active\nneurological intervention. Oragenics is advancing ONP-002 through Phase IIa\nclinical trials in Australia, with U.S. Phase IIb trials planned to follow\npending FDA investigational new drug application (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":"nGNXt3plT","title":"Oragenics Activates Second Site in Phase IIa Clinical Trial of ONP-002 for Concussion and Mild Traumatic Brain Injury.","author":"Globe Newswire","ticker":"OGEN","created":"2026-05-05T12:30:00.576Z","tickers":["OGEN"],"exchange":"NYSE American","article_body":"SARASOTA, Fla., May 05, 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 Alfred Hospital is now actively enrolling\nparticipants in its ongoing Phase IIa clinical trial evaluating ONP-002, the\nCompany’s lead candidate for the treatment of concussion and mild traumatic\nbrain injury (mTBI). To date, four patients have been enrolled and dosed at\nMackay Base Hospital in Queensland, Australia, the first site activated in the\ntrial.\n\nConcussion and mild traumatic brain injury represent the most prominent\nneurological condition without an FDA-approved pharmacological treatment.\nAccording to the CDC, an estimated 1.7 to 3.8 million people in the U.S.\nexperience traumatic brain injuries annually, with sports and recreational\nactivities among the leading causes.¹ Globally, an estimated 69 million\nindividuals sustain traumatic brain injuries each year. Despite this scale, no\npharmacological treatments have been approved — leaving patients, military\npersonnel, athletes, and families without effective options beyond rest and\nsymptom management. If approved by the FDA, we believe ONP-002 would be the\nfirst and only pharmacological standard of care for a global concussion market\nprojected to reach over $9 billion 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. The\npace of enrollment at Mackay Base Hospital since site activation on March 31,\n2026, reflects both strong site readiness and the depth of unmet clinical need\nin this patient population. ONP-002 is delivered via Oragenics’ proprietary\nintranasal spray-dry powder device.\n\nWe believe ONP-002 is a first-in-class intranasal neurosteroid designed to\naddress the underlying biology of brain injury — reducing neuroinflammation,\noxidative stress, and cerebral edema — rather than simply managing symptoms.\nThe drug candidate targets the biological cascade triggered by trauma, with\nthe potential to represent a paradigm shift from symptom management to active\nneurological intervention. The Phase IIa clinical data readout is projected\nbefore year-end 2026, and is expected to support the Company’s planned\ninvestigational new drug (IND) application submission to the FDA, targeting\nDecember 31, 2026, for a Phase IIb clinical trial in the U.S.\n\nJanet Huffman, Oragenics’ CEO, stated, \"Four patients have been dosed at\nMackay Base Hospital in less than a month of activation. That is not an\naccident — it is a reflection of what we have been saying since we started\nthis program: concussion patients have nowhere to turn, and when a trial opens\nits doors, they walk through them. We are executing against our clinical plan.\nTwo sites are now actively enrolling, and we intend to maintain this pace\nthrough the full 40-patient enrollment. For the millions of people who have\nbeen told there is nothing that can be done for concussion, we are here to\nprove otherwise.\"\n\nABOUT ONP-002\n\nONP-002 is an investigational neuroprotective, anti-inflammatory intranasal\ndrug candidate targeting mild traumatic brain injury (mTBI) and concussion.\nDesigned to interrupt biological pathways involved in inflammation, oxidative\nstress, and swelling following head trauma, ONP-002 has demonstrated safety\nand tolerability in Phase I clinical trials with zero serious adverse events\nacross all dose levels. The drug candidate utilizes Oragenics’ proprietary\nintranasal delivery platform to enable rapid, targeted brain delivery —\npotentially representing a paradigm shift from symptom management to active\nneurological intervention. Oragenics is advancing ONP-002 through Phase IIa\nclinical trials in Australia, with U.S. Phase IIb trials planned to follow\npending FDA investigational new drug application (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":"2026-05-05T12:30:00.609978844Z","server_sent_at_ms":1777984200609},"received_at":"2026-05-05T12:30:00.662Z","source_url":"https://www.globenewswire.com/news-release/2026/04/13/3272489/0/en/oragenics-doses-first-patient-in-phase-iia-clinical-trial-of-onp-002-for-mild-traumatic-brain-injury.html"},"analysis":{"id":"15551","press_release_id":"21008","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Oragenics activated Alfred Hospital as the second site in its Phase IIa trial of ONP-002 for concussion and mild traumatic brain injury.\n\nFour patients have been dosed at the initial Mackay Base Hospital site, targeting 40 patients total for the study.\n\nThe company projects a clinical data readout before year-end 2026 and plans to submit an IND to the FDA on December 31, 2026, for a U.S. Phase IIb trial.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Second site activation for ONP-002 trial signals operational momentum."},"keyFigures":{"drugName":"ONP-002","phaseOfTrial":"Phase IIa","customDimensions":{"data_readout_timeline":"before year-end 2026","patients_dosed_to_date":4,"total_target_enrollment":40}},"quotedText":"Four patients have been dosed at Mackay Base Hospital in less than a month of activation.","namedEntities":{"people":[{"name":"Janet Huffman","role":"CEO"}],"products":["ONP-002"],"companies":[{"name":"Oragenics, Inc.","ticker":"OGEN"},{"name":"Alfred Hospital","relationship":"trial site"},{"name":"Mackay Base Hospital","relationship":"trial site"}],"dollarAmounts":[{"amount":"$9 billion","context":"projected global concussion market by 2030"}]},"materialImpact":{"score":3,"reasoning":"Activation of a second clinical trial site accelerates enrollment for the company's lead asset ONP-002, supporting the year-end data readout timeline and de-risking execution."},"tickerRelevance":{"others":[],"primary":"OGEN"},"globalImportance":20,"audienceRelevance":15,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"operational-milestone","sectorWeight":"biotech"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Oragenics activated Alfred Hospital as the second site in its Phase IIa trial of ONP-002 for concussion and mild traumatic brain injury.\n\nFour patients have been dosed at the initial Mackay Base Hospital site, targeting 40 patients total for the study.\n\nThe company projects a clinical data readout before year-end 2026 and plans to submit an IND to the FDA on December 31, 2026, for a U.S. Phase IIb trial.","key_figures":{"drugName":"ONP-002","phaseOfTrial":"Phase IIa","customDimensions":{"data_readout_timeline":"before year-end 2026","patients_dosed_to_date":4,"total_target_enrollment":40}},"named_entities":{"people":[{"name":"Janet Huffman","role":"CEO"}],"products":["ONP-002"],"companies":[{"name":"Oragenics, Inc.","ticker":"OGEN"},{"name":"Alfred Hospital","relationship":"trial site"},{"name":"Mackay Base Hospital","relationship":"trial site"}],"dollarAmounts":[{"amount":"$9 billion","context":"projected global concussion market by 2030"}]},"model_name":"glm-4.7","prompt_hash":"sha256:a2703c5a1b5285fe","schema_hash":"sha256:1f8af1196c7db48c","created_at":"2026-05-05T14:28:34.400Z","global_importance":20,"audience_relevance":15,"importance_components":{"tickerTier":"micro-cap","eventGravity":"operational-milestone","sectorWeight":"biotech"}},"durationMs":120812,"modelName":"glm-4.7"}}