Form 8-K

8-K — Azitra, Inc.

Accession: 0001493152-26-049191

Filed: 2026-10-29

Period: 2026-10-29

CIK: 0001701478

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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): October 29, 2026

AZITRA,

INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-41705

46-4478536

(State

or other jurisdiction

(Commission

(IRS

Employer

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

8.01 Other Events.

October 29, 2026, Azitra, Inc. issued a press release. A copy of the press release is furnished as Exhibit 99.1 to this Current Report

on Form 8-K.

Item

9.01 Financial Statements and Exhibits

(d)

Exhibits.

99.1

Press release dated October 29, 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:

October 29, 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. Expands Eligibility for ATR-04 Phase 1/2 Clinical Trial to Include Patients with Rashes due to KRAS and MEK Inhibitors

Expanded

eligibility significantly broadens potential treatment opportunities for ATR-04 beyond EGFR inhibitor-associated skin rash

Additional

protocol modifications expected to facilitate patient recruitment and accelerate clinical trial enrollment

BRANFORD,

Conn. – October 29, 2026 — Azitra, Inc. (“Azitra” or the “Company”) (NYSE American: AZTR), a clinical-stage

biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced amendments to its ongoing

Phase 1/2 clinical trial of ATR04-484 that significantly expand patient eligibility to include individuals with rash associated with

KRAS and MEK inhibitors. The expanded eligibility also includes patients with neurofibromatosis type 1 (NF1) with rash associated with

MEK inhibitors. The amendments also shorten the required washout periods for antibiotics and steroids. Together, these changes broaden

the potential treatment opportunities for ATR-04 beyond its initial focus on epidermal growth factor receptor inhibitor (EGFRi)-associated

skin rash, while expanding the pool of eligible patients to facilitate recruitment.

The

multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 study (NCT06830863) is evaluating the safety, tolerability,

bioavailability, pharmacodynamics, and preliminary efficacy of topical ATR04-484. The protocol amendments for the Phase 1/2 clinical

trial follow Azitra’s recent announcement that the study’s safety review committee recommended proceeding to Cohort 2 following

its review of available safety data from Cohort 1. Cohort 2 is expected to enroll approximately 24 patients who will receive once-daily

treatment for 28 days.

KRAS

inhibitors and MEK inhibitors are precision therapeutics used to treat various cancers, including non-small cell lung cancer (NSCLC),

melanoma, colorectal cancer, and ovarian cancer. Combined, approximately 85,000 patients undergo KRAS or MEK inhibitor treatment in the

United States annually. While these therapies have expanded treatment options for patients with cancer, dermatologic adverse effects,

including skin rash, can substantially impair quality of life and may require dose reductions, treatment interruptions or discontinuation.

The addition of these patients further broadens the potential clinical applications being explored for ATR-04 on top of the approximately

220,000 patients undergoing EGFRi treatment in the United States annually.

The

expanded eligibility criteria include patients with NF1 with MEK inhibitor-associated rash. NF1 is a rare genetic disorder characterized

by the development of tumors along nerves that affects approximately 100,000 patients in the United States.

“These

expansions to the Phase 1/2 trial protocol represent a significant step for our ATR-04 program, increasing the possibility for this innovative

treatment to benefit cancer and certain neurofibromatosis patients experiencing debilitating rash due to several targeted therapies,”

said Francisco Salva, Chief Executive Officer of Azitra. “While these therapies have transformed treatment for many patients, associated

skin toxicities can significantly impact quality of life and interfere with treatment. By expanding our study to include patients with

rash due to KRAS and MEK inhibitors, we are broadening the potential opportunity for ATR-04. Equally important, we believe the additional

protocol modifications will facilitate patient recruitment and help accelerate enrollment. Following our recent advancement to Cohort

2, we are encouraged by the continued progress of this program and its potential to provide a new treatment option for patients affected

by debilitating skin conditions.”

About

Azitra’s ATR-04 Program

ATR04-484

is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain in development

for skin rashes associated with various therapies for cancer treatment and neurofibromatosis. ATR04-484 was selected based on its preclinical

profile of reducing the pro-inflammatory cytokine IL-36γ and Staphylococcus aureus levels, both of which are elevated in

patients with cancer treatment-associated skin rash. The strain was then engineered with the aim of improving its safety profile by deleting

an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04. The U.S. Food and Drug Administration (the “FDA”)

has granted Fast Track designation to ATR04-484 for cancer treatment-associated rash, recognizing the high unmet medical need for up

to 300,000 patients affected annually in the United States.

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 skin rashes

associated with cancer and neurofibromatosis treatments. Azitra has received Fast Track designation from the FDA for cancer treatment-associated

rash, which impacts up to 300,000 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,” “would,” “target,”

“continue,” “ongoing” 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 (i) the expected enrollment, dosing and

conduct of Cohort 2 of the Phase 1/2 clinical trial of ATR-04, (ii) the expected effects of the protocol amendments, including on patient

recruitment and enrollment, (iii) the safety and preliminary efficacy data from the trial, (iv) the potential of ATR-04 to treat EGFRi-,

KRASi-, MEKi- associated skin rash and other similar rashes, including its potential to be the first live biotherapeutic developed for

this indication, (v) the size of the potential patient population and the potential benefits of Fast Track designation, and (vi) statements

about our clinical and preclinical programs, and corporate and clinical/preclinical strategies, including our cosmeceutical strategy.

You

should not place undue reliance on any forward-looking statements. 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 enrollment

delays; the protocol amendments may not facilitate recruitment or accelerate enrollment as anticipated; we may experience delays in the

provision of initial or additional safety data, as applicable, and topline results for ATR-04 and, if we do, such data and results may

not be favorably received; the expanded patient populations may present different safety or efficacy profiles; the results from Cohort

1 may not be predictive of results in Cohort 2 or later-stage trials; 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 August 12, 2026 with the SEC. Azitra explicitly disclaims any obligation to update any forward-looking

statements to reflect events or circumstances that occur after the date hereof, 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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