OGEN 8-K
Oragenics Inc (OGEN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934.
Date
of Report:
(Date of earliest event reported)
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
(Former Name or Former Address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
ITEM 3.01 NOTICE OF DELISTING OR FAILURE TO SATISFY A CONTINUED LISTING RULE OR STANDARD; TRANSFER OF LISTING.
On August 26, 2026, Oragenics, Inc. (the “Company”) received notification (the “Notice”) from the NYSE American LLC (the “NYSE American”) that the Company is no longer in compliance with NYSE American’s continued listing standards. Specifically, the letter states that the Company is not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide (the “Company Guide”). Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. The Company reported stockholders’ equity of $3.7 million at June 30, 2026, and had net losses in its last five fiscal years ended December 31, 2025. The Company is also not currently eligible for any exemption in Section 1003(a) of the Company Guide from the stockholders’ equity requirements.
The Notice further provides that the Company must submit a plan of compliance (the “Plan”) by September 25, 2026 addressing how it intends to regain compliance with the continued listing standards by February 25, 2028. The Plan is required to include specific milestones, quarterly financial projections and details related to any strategic initiatives the Company plans to complete.
The Company has begun to prepare its Plan for submission to the NYSE American by the September 25, 2026 deadline. If the NYSE American accepts the Company’s plan, the Company will be able to continue its listing during the Plan period and will be subject to continued periodic review by the NYSE American staff. If the Plan is not timely submitted, or not accepted, or is accepted but the Company is not in compliance with the continued listing standards by February 25, 2028 or if the Company does not make progress consistent with the Plan during the Plan period, the Company will be subject to delisting procedures as set forth in the NYSE American Company Guide.
The Company will endeavor to undertake a transaction or transactions in the future to achieve compliance with the NYSE American’s requirements. However, there can be no assurance that the Company will be able to achieve compliance with the NYSE American’s continued listing standards within the required timeframe.
The Notice has no immediate impact on the listing of the Company’s shares of common stock, par value $0.001 per share (the “Common Stock”), which will continue to be listed and traded on the NYSE American during this period, subject to the Company’s compliance with the other listing requirements of the NYSE American. The Common Stock will continue to trade under the symbol “OGEN”, but will have an added designation of “.BC” to indicate the status of the Common Stock as “below compliance”. The notice does not affect the Company’s ongoing business operations or its reporting requirements with the Securities and Exchange Commission.
If the Common Stock ultimately were to be delisted for any reason, it could negatively impact the Company by (i) reducing the liquidity and market price of the Company’s Common Stock; (ii) reducing the number of investors willing to hold or acquire the Common Stock, which could negatively impact the Company’s ability to raise equity financing; and (iii) limiting the Company’s ability to use a registration statement to offer and sell freely tradable securities, thereby preventing the Company from accessing the public capital markets; and (iv) impairing the Company’s ability to provide equity incentives to its employees.
FORWARD LOOKING STATEMENTS. This Form 8-K contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s ability to regain compliance with NYSE American continued listing standards, the timing and outcomes of clinical trials, the Company’s regulatory strategy and anticipated IND submission, and the sufficiency of capital to fund operations. These statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including those described in the Company’s most recent Forms 10-K, 10-Q, and other filings with the SEC, available through EDGAR at www.sec.gov. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
ITEM 8.01 OTHER EVENTS.
On August 28, 2026, in accordance with the NYSE American’s procedures, the Company issued a press release discussing the matters disclosed in Item 3.01 above. A copy of the press release is included herewith as Exhibit 99.1, which is incorporated by reference into this Item 8.01.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release Dated, August 28, 2026. | |
| 104 | Cover page Interactive Data File (embedded in the cover page formatted in Inline XBRL) |
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on this 28th day of August 2026.
ORAGENICS, INC. (Registrant) | ||
| BY: | /s/ Janet Huffman | |
Janet Huffman Chief Executive Officer | ||
Exhibit 99.1
Oragenics Reports Continued Clinical Progress, Provides Regulatory and NYSE American Listing Update
SARASOTA, Fla.—August 28, 2026— Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biopharmaceutical company developing brain-targeted therapeutics through its proprietary intranasal delivery platform, today provided an update on its Phase IIa clinical trial, U.S. regulatory pathway, and NYSE American continued listing status.
Clinical & Regulatory Momentum Continues
Oragenics continues to advance ONP-002, its lead intranasal candidate for mTBI (concussion), through its Phase IIa feasibility trial in Australia. To date, the Company has dosed nine participants across its active trial sites.
| ● | Three Australian clinical sites now active: Alfred Health, Mackay, and Royal Adelaide Hospital | |
| ● | Nine participants dosed to date | |
| ● | Continued site-level enrollment support and monitoring underway across all active sites |
U.S. Regulatory Update
The Company has received responses from the U.S. Food and Drug Administration (FDA) related to its Type B meeting request briefing package, submitted in July 2026. Oragenics is currently reviewing these items and remains focused on its goal of submitting an Investigational New Drug (IND) application by the end of 2026.
NYSE American Listing Status
On August 26, 2026, Oragenics received a deficiency letter from NYSE American LLC notifying the Company that it is not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years.. This is the same continued listing standard the Company previously addressed and regained compliance with in October 2025.
Under NYSE American rules, the Company has 45 days from receipt of the deficiency letter within which to submit a plan to regain compliance with the continued listing standards. If the plan is accepted, the Company will continue its listing during a cure period, subject to periodic review by NYSE American staff. While the Company intends to submit a compliance plan to NYSE American within the required timeframe and will endeavor to undertake a transaction or transactions in the future to achieve compliance with the NYSE American’s requirements and believes that with continued execution of its clinical and regulatory milestones, it will regain full compliance with continued listing requirements, there can be no assurances in this regard. If the Plan is not timely submitted, or not accepted, or is accepted but the Company is not in compliance with the continued listing standards by February 25, 2028 or if the Company does not make progress consistent with the Plan during the Plan period, the Company will be subject to delisting procedures as set forth in the NYSE American Company Guide.
Looking Ahead
Oragenics remains focused on execution across its clinical, regulatory, and corporate objectives: continued Phase IIa enrollment and dosing in Australia, advancing its U.S. IND submission, and building out its broader CNS pipeline. The Company believes its recent progress — including a third active Australian site, nine participants dosed, and constructive engagement with the FDA — reflects continued momentum toward its year-end goals.
“We’re encouraged by the pace of enrollment in Australia and by the FDA’s engagement on our Type B package,” said Janet Huffman, Chief Executive Officer of Oragenics.
About Oragenics
Oragenics is a clinical-stage biopharmaceutical company pioneering brain-targeted therapeutics through its 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. For more information, visit www.oragenics.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, including statements regarding the Company’s ability to regain compliance with NYSE American continued listing standards, the timing and outcomes of clinical trials, the Company’s regulatory strategy and anticipated IND submission, and the sufficiency of capital to fund operations. These statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including those described in the Company’s most recent Forms 10-K, 10-Q, and other filings with the SEC, available through EDGAR at www.sec.gov. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Contacts
Investor Relations: irth Communications - [email protected]
Media Relations: irth Communications — [email protected]