Oragenics Reports 8 study drug doses in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury

• Enrollment underway at Mackay Base Hospital in Queensland, Australia; additional sites in final activation stages

SARASOTA, Fla., April 20, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that 2 patients and 8 study drug doses have been administered in its ongoing Phase IIa clinical trial evaluating ONP-002, the Company's lead candidate for the treatment of mild traumatic brain injury (mTBI) a.k.a., concussion. Enrollment is progressing at Mackay Base Hospital in Queensland, Australia, the first activated site in the trial, with additional sites completing final activation steps.

Traumatic brain injury represents a significant neurological condition without an FDA-approved pharmacological treatment. According to the CDC, an estimated 1.7 to 3.8 million people in the U.S. experience traumatic brain injuries annually, with sports and recreational activities among the leading causes.¹ Globally, an estimated 69 million individuals sustain traumatic brain injuries each year. Despite this scale, no pharmacological treatments have been approved — leaving patients, military personnel, athletes, and families without FDA-approved effective options beyond rest and symptom management. If approved by the FDA, ONP-002 would be the first and only pharmacological standard of care for a global concussion market projected to reach over $9 billion by 2030.²

The Company's Phase IIa trial is designed to enroll 40 patients who meet enrollment criteria based on CT scan findings, presenting symptoms, and emergency room or hospital admission. Patients receive first dosing within 12 hours of concussion, followed by continued treatment for up to 30 days. We believe early enrollment activity reflects both strong site readiness and the significant unmet clinical need in this patient population. ONP-002 is delivered via Oragenics' proprietary intranasal spray-dry powder device.

ONP-002 is a first-in-class intranasal neurosteroid designed to address the underlying biology of brain injury — with the promise of reducing neuroinflammation, oxidative stress, and cerebral edema — rather than simply managing symptoms. The drug candidate is designed to target the biological cascade triggered by trauma, with the potential to represent a paradigm shift from symptom management to active neurological intervention.

Oragenics CEO, Janet Huffman, stated; "Two participants dosed and eight study drug doses administered is exactly the kind of early momentum we expected when we activated Mackay Base Hospital. The speed of enrollment combined with participants successfully moving through the trial is an exciting milestone that will be strengthened with the additional onboarding of Alfred Hospital in April. These early enrollments support our belief that there is a population of patients and clinicians who have been waiting for this. We believe every participant dose is a step toward an answer for the millions of people who have been told there is nothing that can be done for concussion".

Oragenics CMO, Dr. James Kelly, added; "Each participant dose in this trial represents a person who presented with a concussion and had no pharmacological treatment available to them. That is the reality we are working to change. Our Phase I safety profile was strong, and early Phase IIa enrollment is proceeding in alignment with our clinical plan. ONP-002 targets the injury itself – not just the symptoms – and we are gathering the data we need to bring that approach forward."

ABOUT ONP-002

ONP-002 is an investigational neuroprotective, anti-inflammatory intranasal drug candidate targeting mild traumatic brain injury (mTBI) a.k.a., concussion. Designed to interrupt biological pathways involved in inflammation, oxidative stress, and swelling following head trauma, ONP-002 has demonstrated safety and tolerability in Phase 1 clinical trials with zero serious adverse events across all dose levels. The drug candidate utilizes Oragenics' proprietary intranasal delivery platform to enable rapid, targeted brain delivery — potentially representing a paradigm shift from symptom management to active neurological intervention. Oragenics is advancing ONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb trials planned to follow pending FDA investigational new drug application (IND) approval.

ABOUT ORAGENICS, INC.

Oragenics, Inc. is a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology. The Company's lead candidate, ONP-002, is being advanced as a potential first-in-class treatment for concussion and mild traumatic brain injury. Oragenics is progressing ONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb trials planned to follow. The Company believes its intranasal delivery platform has potential applications across multiple neurological conditions. Oragenics is committed to developing innovative therapies that address significant unmet medical needs in neurological care. For more information, visit www.oragenics.com.

FORWARD-LOOKING STATEMENTS

This communication contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements include statements regarding the Company's intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to product candidates, including without limitation ONP-002 and our proprietary nasal device; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates, including ONP-002 for the treatment of concussion and mTBI. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project," "potential," "may," "will," "could," "should," and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, those described in our most recent Form 10-K, Form 10-Q and other filings we make with the U.S. Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. All information we set forth in this press release is as of the date hereof. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

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FOOTNOTES

¹ American Association of Neurological Surgeons; Sports Related Head Injury / CDC TBI Data

² Grand Market Research; Concussion Market (2025–2030)