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Oragenics Receives NYSE American Approval of Compliance Plan and Extension Through February 2028

Key Takeaway: Oragenics, Inc. received NYSE American approval for its compliance plan, allowing it to remain listed until February 2028. The plan aims to strengthen the company's financial position amid reported losses and equity concerns. CEO Janet Huffman expressed optimism about the company's strategic priorities and capital-raising initiatives.

Market Sentiment Analysis

POSITIVE FACTORS

  • NYSE accepted Oragenics' compliance plan.
  • Extension granted until February 2028.
  • Company aims to strengthen financial position.
  • CEO expresses optimism about future strategies.

CONCERNS & RISKS

  • Company reported stockholders' equity of only $3.7 million.
  • Losses from continuing operations in the last five years.
  • Device stability concerns paused participant enrollment.
  • Capital constraints limit clinical trial progress.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+28%
120-day peak, hindsight
Typical move
9.7%
average across 2 past catalysts
Cash runway
~3 mo
High dilution risk
Lead asset
ONP-002
Phase 2 · Mild Traumatic Brain Injury, Concussion

Full Press Release Details

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

Frequently Asked Questions

What compliance plan did Oragenics receive approval for?

Oragenics received approval for a compliance plan to maintain its NYSE listing.

How long is the extension granted to Oragenics?

The extension is granted until February 25, 2028.

What financial issues did Oragenics face?

The company reported stockholders' equity of $3.7 million and ongoing losses.

What is ONP-002?

ONP-002 is Oragenics' lead candidate for treating concussion and mild traumatic brain injury.

Last updated: Nov 12, 2026