Form 8-K

8-K — Azitra, Inc.

Accession: 0001493152-26-041706

Filed: 2026-09-08

Period: 2026-09-08

CIK: 0001701478

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

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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.)

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 ☒

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.

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

EX-99.1

Filename: ex99-1.htm · Sequence: 2

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.

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

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