Oragenics Receives NYSE American Approval of Compliance Plan and Extension Through February 2028
Sarasota, FL, Nov. 12, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company"), a clinical-stage biopharmaceutical company pioneering neurological therapeutics, today announced that NYSE Regulation has accepted the Company’s compliance plan (the “Plan”) and granted an extension through February 25, 2028 to regain compliance with NYSE American continued listing standards.
The acceptance of the Company’s Plan enables Oragenics to maintain its NYSE American listing while executing initiatives designed to strengthen its financial position and support long-term shareholder value creation. The Company will continue trading on NYSE American throughout the compliance period, subject to meeting plan milestones and ongoing review requirements.
As previously disclosed, on August 26, 2026, the Company received notice from NYSE American that it was not in compliance with Sections 1003(a)(ii) and (iii) of the NYSE American Company Guide since it reported a stockholders’ equity of $3.7 million as of June 30, 2026, and losses from continuing operations and/or net losses in its five most recent fiscal years ended December 31, 2025. On September 25, 2026, the Company submitted a comprehensive plan outlining actions already implemented and additional measures intended to restore compliance.
On November 11, 2026, NYSE Regulation notified the Company that it had completed its review and formally accepted the plan. The Company has until February 25, 2028, to regain compliance and will remain listed on NYSE American during this period, subject to meeting plan milestones and ongoing review requirements.
“We are pleased that NYSE Regulation has approved our compliance plan and recognized the actions we hope to take to strengthen the Company’s financial position,” said Janet Huffman, Chief Executive Officer of Oragenics. “We believe this approval allows us to maintain our NYSE American listing while we continue to pursue our strategic priorities, capital raising initiatives and investment strategies designed to enhance long-term value for our shareholders.”
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. Subject to its ability to raise additional capital, of which there can be no assurances, Oragenics hopes to continue progressing ONP-002 through Phase IIa clinical trials in Australia and to pursue U.S. Phase IIb trials in the future. During September 2026, the Company encountered device stability concerns that it is currently evaluating, which caused a pause in participant enrollment. As of the date hereof, this pause remains in effect. Furthermore, capital constraints are limiting the Company’s ability to continue to pursue its ONP-002 clinical trials. 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.
INVESTOR & MEDIA CONTACT
Investor & Media Relations
ir@oragenics.com