Form 8-K

8-K — Azitra, Inc.

Accession: 0001493152-26-045260

Filed: 2026-10-01

Period: 2026-10-01

CIK: 0001701478

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

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): October 1, 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 1, 2026, the Company 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 1, 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 1, 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. Advances ATR-04 Phase 1/2 Clinical Trial to Cohort 2 Following Safety Review Committee Clearance

BRANFORD,

Conn. – October 1, 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 the completion of Cohort

1 in its Phase 1/2 clinical trial evaluating ATR04-484 as a potential treatment for EGFR inhibitor (EGFRi)-associated skin rash. Following

its review of available safety data from patients enrolled in Cohort 1, the study’s safety review committee recommended that the

trial may proceed to Cohort 2, enabling Azitra to begin enrollment and dosing in the second cohort.

The

multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical study (NCT06830863) is designed to evaluate the safety

and tolerability of topical ATR-04 for the treatment of EGFRi-associated dermal toxicity affecting adult patients. The safety, bioavailability,

pharmacodynamics, and preliminary efficacy of ATR04-484 are being compared to its vehicle (3:1 randomization) in two patient cohorts.

Seven patients in Cohort 1 received a single 4g application of ATR04-484 to the face, chest and back, followed by a 7-day observation

period then once-daily application for 28 days. Cohort 2 is expected to enroll approximately 24 patients who will receive a 4g application

once daily for 28 days. The study is currently being conducted at six clinical sites, including MD Anderson Cancer Center and Yale University.

The safety review was based on six patients.

“Proceeding

to Cohort 2 following the safety review committee’s review of Cohort 1 data represents an important milestone for our ATR-04 program,”

said Francisco Salva, Chief Executive Officer of Azitra. “We believe ATR-04 has the potential to become the first live biotherapeutic

specifically developed to address cancer treatment-associated rash, a debilitating side effect that impacts thousands of cancer patients

and can disrupt life-saving treatment. With positive safety data from the first cohort, we are focused on advancing into the next phase

of the trial.”

EGFR

inhibitors have become an important component of treatment for several cancers, including non-small cell lung cancer and colorectal cancer.

However, these targeted therapies frequently cause a painful papulopustular skin rash that affects approximately 50-80% of patients.

The severity of the rash can significantly impair quality of life and often leads to dose reductions, treatment interruptions or discontinuation

of otherwise effective cancer therapies, underscoring the need for new treatment options.

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 EGFRi-associated skin rash. The candidate was selected based on its preclinical profile of reducing IL-36γ and Staphylococcus

aureus levels, both of which are elevated in patients with EGFRi-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.

Preclinical data have shown that ATR04-484 can reduce levels of IL-36γ, a key pro-inflammatory cytokine elevated in these rashes.

ATR04-484 has also been shown to inhibit the growth of S. aureus in preclinical studies, which often colonizes the skin of affected

patients. The U.S. Food and Drug Administration (the “FDA”) has granted Fast Track designation to ATR04-484 for the treatment

of EGFRi-associated rash, recognizing the high unmet medical need for the approximately 150,000 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 EGFR inhibitor

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 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 safety and preliminary efficacy data from the trial, (iii) the

potential of ATR-04 to treat EGFRi-associated skin rash, including its potential to be the first live biotherapeutic developed for this

indication, (iv) the size of the potential patient population and the potential benefits of Fast Track designation, and (v) 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; 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 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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