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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
or other jurisdiction of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
21
Business 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
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 |
| 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.
Item
3.01 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.
Item
8.01 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.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits:
| 99.1 |
|
Press Release dated March 13, 2026 |
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
Forward-Looking
Statements
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:
March 13, 2026 |
By: |
/s/
Francisco Salva |
| |
Name: |
Francisco
Salva |
| |
Title: |
Chief
Executive Officer |
Exhibit
99.1
Azitra
Receives 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.
About
Azitra
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-looking
Statements
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
