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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): September 8, 2026
AZITRA,
INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-41705 |
|
46-4478536 |
| (State or other jurisdiction |
|
(Commission |
|
(IRS Employer |
| of incorporation) |
|
File Number) |
|
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
7.01 Regulation FD Disclosure.
On
September 8, 2026, Azitra, Inc. (the “Company”) issued a press release announcing that it will provide a virtual presentation
at the H.C. Wainwright 28th Annual Global Investment Conference. The press release includes a link to the pre-recorded presentation
by Dr. Travis Whitfill, the Company’s Chief Operating Officer. A copy of the press release is furnished as Exhibit 99.1 to this
Current Report on Form 8-K.
The
information in this Item 7.01 of this Current Report on Form 8-K, including the information contained in Exhibit 99.1 is being furnished
to the U.S. Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section,
and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange
Act, except as shall be expressly set forth by a specific reference in such filing.
Item
9.01 Financial Statements and Exhibits
(d)
Exhibits.
| 99.1 |
Press release dated September 8, 2026. |
| 104 |
Cover Page Interactive Data File (embedded within the
Inline XBRL document) |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
AZITRA, INC. |
| |
|
|
| Dated: September 8, 2026 |
By: |
/s/ Francisco
D. Salva |
| |
|
Francisco D. Salva |
| |
|
Chief Executive Officer |
Exhibit
99.1
Azitra,
Inc. to Present at the H.C. Wainwright 28th Annual Global Investment Conference
BRANFORD,
Conn. – September 8, 2026 — Azitra, Inc. (“Azitra” or the “Company”) (NYSE American: AZTR), a clinical-stage
biopharmaceutical company focused on developing innovative therapies for precision dermatology and high value cosmetic proteins and peptides,
today announced that Travis Whitfill Ph.D., MPH, Azitra’s Co-founder and Chief Operating Officer, will deliver a virtual presentation
at the H.C. Wainwright 28th Annual Global Investment Conference, to be held from September 14-16, 2026, in New York City.
In
the prerecorded presentation, Dr. Whitfill will provide an update on Azitra’s recent progress and key pipeline activities, including
initial data from the ATR-COSF program supporting the Company’s strategy to leverage its microbial genetic engineering platform
beyond traditional therapeutics, including cosmetic applications targeting fine lines and wrinkles. He will also discuss continued enrollment
in the first cohort of the Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash.
Details
of the presentation are as follows:
| Event: |
H.C.
Wainwright 28th Annual Global Investment Conference |
| Date: |
September
14-16, 2026 |
| Presenter:
|
Travis
Whitfill Ph.D., MPH, Co-founder and Chief Operating Officer |
| Link: |
https://journey.ct.events/view/e79c38bd-e846-43ef-9594-230c8c543204 |
During
the conference, Dr. Whitfill will conduct one-on-one meetings with registered investors and potential partners, highlighting the Company’s
business and clinical development strategy, recent corporate achievements, and anticipated milestones.
About
Azitra, Inc.
Azitra,
Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and novel products
across therapeutics, cosmeceuticals and biotechnology applications. The Company’s portfolio is highlighted by ATR-COSF, a recombinant
protein technology designed for cosmetic and skincare applications, and ATR-04, an investigational live biotherapeutic for EGFR inhibitor
(“EGFRi”) associated rash. Azitra has received Fast Track designation from the FDA for EGFR inhibitor-associated rash, which
impacts approximately 150,000 people in the U.S. Azitra is also advancing additional recombinant protein initiatives designed to support
biotechnology research and manufacturing applications. Azitra’s technology platforms combine engineered proteins, topical live
biotherapeutics, artificial intelligence, and a proprietary microbial library to develop differentiated products for consumer, research
and healthcare markets. 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 the expected timing of (i) our potential resumption and expected timing of initial safety data and topline
results for the Phase 1b trial for our ATR-12, (ii) the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, (iii)
our provision of initial safety data and topline results for the Phase 1/2 clinical trial for our ATR-04 program, (iv) statements about
our clinical and preclinical programs, and corporate and clinical/preclinical strategies, including our cosmeceutical strategy and our
recombinant protein platform, (v) the expected timing of our planned human cosmetic application study for ATR-COSF, and (vi) statements
regarding our strategy plans and priorities, including those outlined in our recent shareholder letter.
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:
the timing of clinical trials and their results; we may experience delays in the provision of initial safety data and topline results
for ATR-COSF, our recombinant protein platform, ATR-12 and ATR-04 and, if we do, such data and results may not be favorably received;
the safety and efficacy of our product candidates; possible 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; 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 United States Securities and Exchange
Commission (the “SEC”) on February 27, 2026 and our quarterly report on Form 10-Q filed on May 13, 2026 and August 12, 2026
with the SEC. 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