8-K

Azitra, Inc. (AZTR)

8-K 2026-03-13 For: 2026-03-13
View Original
Added on April 08, 2026

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

DC 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 13, 2026

AZITRA,

INC.

(Exact name of registrant as specified in its charter)

Delaware 001-41705 46-4478536
(State<br> or other jurisdiction of<br><br> <br>incorporation) (Commission<br><br> <br>File<br> Number) (IRS<br> Employer<br><br> <br>Identification<br> No.)

21Business Park Drive

Branford,CT 06405

(Address of principal executive offices)(Zip Code)

(203)646-6446

(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 obligations of the registrant under any of the following provisions:

Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement<br> 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<br> of each class Trading<br> Symbol(s) Name<br> of each exchange on which registered
Common Stock: Par value $0.0001 AZTR NYSE American

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. ☐

Item3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

On March 13, 2026, Azitra, Inc. (the “Company”) received notification (the “Letter”) from the NYSE American LLC (the “NYSE American”) stating that the Company is not in compliance with the minimum stockholders’ equity requirement of Section 1003(a)(iii) of the NYSE American Company Guide (the “Company Guide”) requiring stockholders’ equity of $6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. As of December 31, 2025, the Company had stockholders’ equity of $3.8 million and has had losses in its five most recent fiscal years ended December 31, 2025.

As previously reported, on October 1, 2025, the Company received a letter from the NYSE American stating that the Company is not in compliance with the minimum stockholders’ equity requirement of Section 1003(a)(ii) of the Company Guide requiring stockholders’ equity of $4.0 million or more if the Company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years. The Company submitted the Plan to the NYSE American on October 31, 2025 addressing how the Company intends to regain compliance with these requirements by April 1, 2027.

On December 16, 2025, the Company received notice from the NYSE American that it had accepted the Company’s plan (the “Plan”) to regain compliance with the NYSE American’s continued listing standards regarding the minimum stockholders’ equity requirement of Section 1003(a)(ii) of the Company Guide and granted a plan period through April 1, 2027 (“Plan Period Deadline”). The Company now seeks to adhere to the Plan for the purpose of regaining compliance with Section 1003(a)(iii) of the Company Guide by the Plan Period Deadline.

During the plan period, the Company must provide quarterly updates to NYSE American staff concurrent with its periodic filings. If the Company does not regain compliance with the NYSE American continued listing standards by the Plan Period Deadline, or if the Company does not make progress consistent with its Plan during the plan period, then the NYSE American may initiate delisting proceedings. The Company may appeal a staff delisting determination in accordance with the NYSE American rules.

The Company can provide no assurances that it will be able to make progress with respect to its Plan that the NYSE American will determine to be satisfactory, that it will regain compliance with Section 1003(a)(ii) and Section 1003(a)(iii) of the Company Guide on or before the Plan Period Deadline, or that developments and events occurring subsequent to the Company’s formulation of the Plan or its acceptance by the NYSE American, will not adversely affect the Company’s ability to make sufficient progress and/or regain compliance with Section 1003(a)(ii) and Section 1003(iii) of the Company Guide on or before the Plan Period Deadline or result in the Company’s failure to be in compliance with other NYSE American continued listing standards.

Item8.01 Other Events.

On March 13, 2026, the Company issued a press release relating to the matters described in Item 3.01 of this Current Report on Form 8-K, a copy of which is attached hereto as Exhibit 99.1.

Item9.01 Financial Statements and Exhibits.

(d) Exhibits:

99.1 Press Release dated March 13, 2026
104 Cover<br> Page Interactive Data File (embedded within the Inline XBRL document)

Forward-LookingStatements

The Company cautions you that statements included in this Current Report on Form 8-K that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding the Company’s expectations regarding compliance with the Plan and applicable NYSE American requirements, the Company locating or acquiring funding in the future, and actions of the Company and/or the NYSE American to be taken with respect to matters discussed in the Letter or other the notices received by the NYSE American that are referenced herein. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this Current Report on Form 8-K due to the risks and uncertainties associated with continued listing on the NYSE American, risks and uncertainties inherent in the Company’s business, and other risks described in the Company’s filings with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this Current Report on Form 8-K to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

**** AZITRA, INC.
Dated:<br> March 13, 2026 By: /s/ Francisco Salva
Name: Francisco<br> Salva
Title: Chief<br> Executive Officer

Exhibit99.1


AzitraReceives Notice of Non-Compliance from NYSE American and Makes NYSE American Section 610(b) Public Announcement

BRANFORD, Conn. - March 13, 2026 /PRNewswire/ - Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced it received a notice from the staff of NYSE American LLC (the “Exchange”) that Azitra was not in compliance with the Exchange’s continued listing standards under Section 1003(a)(iii) of the NYSE American Company Guide (the “Company Guide”). 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. As previously reported, on October 1, 2025, Azitra received a letter from the NYSE American stating that it is not in compliance with the minimum stockholders’ equity requirement of Section 1003(a)(ii) of the Company Guide requiring stockholders’ equity of $4.0 million or more if the Company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years.

On October 31, 2025, the Company submitted a plan (the “Plan”) to the NYSE American addressing how the Company intends to regain compliance with the requirements under Section 1003(a)(ii) by April 1, 2027, which Plan was accepted on December 16, 2025. In accordance with the notice from the Exchange, Azitra has until April 1, 2027 to regain compliance with the NYSE American’s listing standards regarding the minimum stockholders’ equity requirements of Section 1003(a)(ii) and Section 1003(a)(iii) of the Company Guide. If Azitra is not in compliance with the continued listing standards by April 1, 2027, or if Azitra does not make progress consistent with the Plan during the plan period, NYSE Regulation staff will initiate delisting proceedings as appropriate.

Azitra will continue its listing on NYSE American during the plan period and will be subject to periodic reviews, including quarterly monitoring for compliance with the Plan until it has regained compliance. Azitra is assessing and exploring multiple funding avenues and is committed to achieving compliance with the Exchange’s requirements.

Receipt of the notice from the Exchange has no immediate effect on the listing or trading of Azitra’s common stock on the Exchange, and does not affect Azitra’s business, operations or reporting requirements with the U.S. Securities and Exchange Commission (the “SEC”).

Azitra also advises that as previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2025, filed February 27, 2026, with the SEC, the audited financial statements contained an audit opinion from its independent registered public accounting firm that included a Substantial Doubt Regarding the Company’s Ability to Continue as a Going Concern paragraph. This announcement is made pursuant to NYSE American Company Guide Sections 410(h) and 610(b), which requires separate public announcement of the receipt of an audit opinion containing a going concern paragraph. This announcement does not represent any change or amendment to the Company’s consolidated financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2025.

AboutAzitra

Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company’s lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra’s additional advanced program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor (“EGFRi”) associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Azitra has an open IND for its ATR-04 program in patients with EGFRi associated rash. The ATR-12 and ATR-04 programs were developed from Azitra’s proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. For more information, please visit https://azitrainc.com**.**

Forward-lookingStatements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding Azitra’s ability to continue operations, Azitra’s expectations for compliance with the Plan and applicable Exchange requirements, Azitra locating or acquiring funding in the future, and actions of Azitra and/or the Exchange to be taken with respect to matters discussed in the notices referenced herein.

Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may experience delays in the dosing the first patient in this Phase 1/2 trial; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; our actions and/or the Exchange’s actions to be taken with respect to matters discussed in the notices from the Exchange; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra’s programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the SEC on February 27, 2026. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact

Norman Staskey

Chief Financial Officer

staskey@azitrainc.com

Investor Relations

Tiberend Strategic Advisors, Inc.

David Irish

231-632-0002

dirish@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

646-577-8520

cmcdonald@tiberend.com