Form 8-K

8-K — Azitra, Inc.

Accession: 0001493152-26-048431

Filed: 2026-10-26

Period: 2026-10-26

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 26, 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.

Press

Release

October 26, 2026, Azitra, Inc. (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.

ATM

Program

Effective

October 26, 2026, the Company has decided not to utilize its at-the-market offering program (the “ATM Program”) under the sales

agreement, dated September 28, 2026, between the Company and A.G.P./Alliance Global Partners for the foreseeable future and will not sell shares under the ATM Program. From September 28, 2026 through

October 26, 2026, the Company sold an aggregate of 1,000 shares of common stock under the ATM Program for aggregate gross proceeds of

approximately $126. The Company may resume sales under the ATM Program or pursue other financing transactions at any time in its discretion,

and makes no assurance as to whether or when it will do so.

The

Company determined not to utilize the ATM Program for the foreseeable future after considering, among other factors, the Company’s

current capital resources, anticipated upcoming operational milestones, the recent trading price of the common stock, and the dilutive

effect of equity issuances on existing stockholders.

This

Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there

be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration

or qualification under the securities laws of any such state or jurisdiction.

Cautionary

Note Regarding Forward-Looking Statements.

This

Current Report on Form 8-K 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 “anticipates,” “believes,” “could,”

“expects,” “intends,” “may,” “plans,” “potential,” “will,” “foreseeable

future,” and variations of these words or similar expressions. Any statements in this Current Report on Form 8-K that are not statements

of historical fact may be deemed forward-looking statements. These include, without limitation, statements about the Company’s

intentions regarding the ATM Program; the Company’s future financing activities and capital resources; the expected timing of the

Company’s initiation, enrollment and provision of data and results for its ATR-COSF program; and the Company’s anticipated

trials, clinical and preclinical programs, including ATR-COSF, and its corporate and clinical/preclinical strategies, including its cosmeceutical

strategy. These statements are based on management’s current expectations and are subject to risks and uncertainties that could

cause actual results to differ materially, including the resumption of sales under the ATM Program or pursuit of other financing activities;

holders of warrants may not exercise them; possible delays in the initiation and enrollment of, and the provision of data and results

from the Company’s ATR-COSF human trial and data; the Company’s need for additional capital to fund its operations and clinical

programs, market conditions, and the other risks described under “Risk Factors” in the Company’s Annual Report on Form

10-K for the year ended December 31, 2025 and subsequent filings with the Securities and Exchange Commission. Forward-looking statements

speak only as of the date of this report, and the Company undertakes no obligation to update them except as required by law.

Item

9.01 Financial Statements and Exhibits

(d)

Exhibits.

99.1

Press release dated October 26, 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 26, 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. Announces Revitalizing Results from Ex Vivo Study of ATR-COSF Demonstrating Ability

Reduce Fine Lines and Improve Elasticity in Human Skin

● ATR-COSF

uses a supernatant based formulation containing an active recombinant human domain of the

protein, filaggrin.

● Ex

vivo data in two models of recent cosmetic surgery explants showed visible improvements

in fine lines, wrinkles and elasticity after a single dose with the ATR-COSF cosmetic product

candidate

● Continued

improvement seen up to 48 hours

● First-in-human

study with ATR-COSF initial results anticipated by year end

● Further

details to be presented in a live presentation at BIO-Europe ®

BRANFORD,

Conn. - October 26, 2026 - Azitra, Inc. (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 Cofounder and Chief Operating

Officer, Travis Whitfill, PhD, MPH, will present progress for its cosmetic ATR-COSF program targeting the appearance of fine lines and

wrinkles. The detailed data will be presented in person at the BIO-Europe® conference in Cologne, Germany on November

10th, 2026, at 4:45 pm CET.

The

ATR-COSF program uses the supernatant from a strain of S. epidermidis engineered to secrete a functional unit of the human filaggrin

protein and is formulated in a hydrogel. The cosmetic product candidate was evaluated in two different models of ex vivo cosmetic

surgery skin, which was maintained in serum free, nutrient-rich media.

Model

1: Dorsal Skin

The

first model utilized dorsal torsoplasty skin explants received ~18 hours after surgery. ATR-COSF at 2% concentration in a hydrogel was

topically applied to the skin samples. In addition, a hydrogel vehicle without the cosmetic supernatant ingredient was used as a control.

Surface evaluation of wrinkles (“SEw”) and elasticity were measured at the following time points: pre-application and post-application

at T=3 hours, T=4.5 hours, T=24 hours, and T=48 hours.

SEw

analysis revealed that human skin topically treated with one dose of ATR-COSF showed consequential reductions in the appearance of fine

lines and wrinkles of approximately 15% at 3 hours, which further improved to approximately 20% at 24 hours and showed an overall reduction

of approximately 50% at 48 hours.

contrast, a single dose of the hydrogel vehicle alone did not improve the appearance of fine lines and wrinkles. Instead, the appearance

of fine lines and wrinkles increased by approximately 15% at the 3-hour time point and further increased to approximately 20% by 48 hours.

ATR-COSF

also preserved net skin elasticity over the 48-hour period, whereas the hydrogel vehicle alone was associated with a meaningful decline

in elasticity.

Model

2: Face Lift

The

second model utilized face lift skin explants received ~48 hours after surgery. ATR-COSF at concentrations of 2% and 4%, along with the

hydrogel vehicle-only control, were topically applied as a single dose. Skin elasticity was measured 6 hours post-application.

The

following parameters of elasticity were measured after application of a single dose:

- R0:

Maximum deformation under suction; indicates tissue distensibility

- R2:

Overall elasticity, including the skin’s ability to recover after suction

- R5:

Net elasticity; useful for comparing elastic behavior between samples

- R7:

Proportion of immediate elastic recovery

- R8:

Total recovery

the 6-hour time point, the 4% ATR-COSF formulation outperformed the 2% formulation and the hydrogel alone in each of the above elasticity

measures. Both the 2% ATR-COSF formulation and hydrogel alone showed either a decline in elasticity or no improvement, whereas the ATR-COSF

4% formulation demonstrated clear improvements across the measured elasticity parameters.

first-in-human clinical study of 4% ATR-COSF is anticipated in approximately 30 subjects with initial data expected by year end.

“Our

latest ex vivo results bridge the gap between our scientific labs and real life. By successfully delivering filaggrin domains

into human skin and for the first time demonstrating improvements on the appearance of fine lines and wrinkles, we are opening a new

frontier in anti-aging cosmetic science. We look forward to presenting our ATR-COSF results in more detail during BIO-EUROPE,”

said Francisco Salva, CEO of Azitra.

continued, “We remain appropriately funded to remain on track to reach our next goal of releasing initial data from our clinical,

human anti-wrinkle study by year end, a key milestone for our fundamental, institutional investors who supported us earlier this year.

Once the data is released, they have a near term opportunity to invest another $5.25 million to $10.5 million from financial instruments

issued in that transaction.”

addition to presenting the progress of the ATR-COSF program, Dr. Whitfill will also conduct one-on-one meetings with potential partners

and investors during the conference.

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 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,” 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 provision of data and results for our ATR-COSF program and (ii) statements

about our anticipated trials, clinical and preclinical programs, including ATR-COSF, and corporate and clinical/preclinical strategies,

including our cosmeceutical strategy.

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 in initiation, enrollment, and the provision of initial

safety data and topline results for ATR-COSF 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; holders of our outstanding warrants may not exercise them;

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 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

SOURCE

Azitra, Inc.

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