Company also advances U.S. regulatory pathway for ONP-002 with FDA Type B meeting request

All three Australian Phase IIa trial sites — Mackay Base Hospital, Alfred Health, and Royal Adelaide Hospital — are now active and enrolling, following Royal Adelaide Hospital's Research Governance Office (RGO) approval
Alfred Health enrolls first participant in the Phase IIa clinical trial
Company submits Type B meeting request to the U.S. Food and Drug Administration (FDA), advancing the U.S. regulatory pathway for ONP-002

SARASOTA, Fla., July 07, 2026 (GLOBE NEWSWIRE) -- Oragenics (NYSE:OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that all three sites in its Australian Phase IIa clinical trial are now active and enrolling — alongside continued progress on its U.S. regulatory program for ONP-002, being evaluated for the treatment of mTBI (concussion).

Full Site Activation Achieved Across Australian Trial Network

With Royal Adelaide Hospital's activation on June 29, 2026, all three planned Australian trial sites — Mackay Base Hospital, Alfred Health, and Royal Adelaide Hospital — are now active and enrolling participants in the Company's Phase IIa clinical trial, completing the planned site network for the study.

On June 21, 2026, Alfred Health enrolled its first participant, joining Mackay Base Hospital as an active enrolling site. Royal Adelaide Hospital received Research Governance Office (RGO) approval on June 29, 2026, becoming the third and final site to activate.

Zero serious adverse events have been reported across all subjects dosed to date. The Company continues to target a Phase IIa data readout in the fourth quarter of 2026.

FDA Type B Meeting Request Submitted

On June 26, 2026, the Company submitted a Type B meeting request to the FDA. The meeting request is intended to facilitate FDA guidance on the Company's planned U.S. clinical development program for ONP-002, in support of the Company's Investigational New Drug (IND) application, which remains targeted for submission in Q4 2026.

"Reaching full site activation across our Australian trial network, alongside our formal engagement with the FDA on the U.S. regulatory path for ONP-002, reflects the disciplined execution of our clinical strategy," said Janet Huffman, CEO of Oragenics. "We look forward to continued progress toward our Phase IIa data readout and U.S. IND submission."

About ONP-002

ONP-002 is a first-in-class intranasal neurosteroid being investigated for the treatment of mTBI (concussion). There are currently no FDA-approved pharmacological treatments for mTBI.

About Oragenics

Oragenics is a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal delivery technology. The Company's lead candidate, ONP-002, is being developed as a potential first-in-class treatment for mTBI (concussion). Oragenics is advancing ONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb trials planned to follow pending IND submission. The Company's intranasal delivery platform has potential applications across a range of acute and chronic neurological conditions. For more information, visit www.ClientP.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements 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. These statements include, but are not limited to, statements regarding the expected timing and outcomes of the Company's Phase IIa and planned Phase IIb clinical trials, the Company's regulatory strategy and engagement with the FDA, the anticipated timing of the Company's IND submission, the potential applications of Oragenics's intranasal delivery platform, and the Company's ability to advance its clinical programs with available capital. These forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to the clinical development process, patient enrollment and trial execution, regulatory approval processes, the Company's ability to secure adequate funding for operations, and those risks set forth in Oragenics's most recent Forms 10-K, 10-Q, and other SEC filings available through EDGAR at www.sec.gov. Oragenics undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release, except as may be required by law.

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Source: Oragenics