Form 8-K

8-K — Azitra, Inc.

Accession: 0001493152-26-033358

Filed: 2026-07-15

Period: 2026-07-15

CIK: 0001701478

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-99.1 (ex99-1.htm)

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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): July 15, 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

8.01 Other Events.

July 15, 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 July 15, 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: July 15, 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 Breakthrough Repeat Dose and Anti-Wrinkle Ex Vivo Results for

ATR-COSF Program, Demonstrating Increased Distribution and Elasticity

● ATR-COSF

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

protein, filaggrin (“rHDfilaggrin”). This S. epidermis derived supernatant

is in development as a high value cosmetic ingredient

● Ex

vivo data successfully showed controlled distribution of the rHDfilaggrin into the stratum

granulosum in increased amounts over prior single dose experiments in human skin

● Single

dose ex vivo experiments established improvements in elasticity and reduced the appearance

of new fine lines and wrinkles in human skin

BRANFORD,

Conn. – July 15, 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 promising results from two separate

ex vivo human skin tissue studies. The studies evaluated the distribution and anti-wrinkle activity of Azitra’s filaggrin

domain containing supernatant in two separate experimental studies.

The

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

filaggrin protein. In the first study, ATR-COSF supernatant was found to provide a positive penetration and distribution profile for

rHDfilaggrin in a multiple dose, ex vivo model. The study, which utilized fresh, healthy human skin explants, demonstrated a remarkable

increase in rHDfilaggrin delivered through the stratum corneum and into the stratum granulosum layers, compared to single dose previous

work. Additionally, improved concentration in the stratum corneum and stratum granulosum layers was seen with the formulated product

in comparison to concentrated supernatant alone.

The

first ex vivo model offers a biologically relevant system for evaluating skin penetration while preserving the architecture of

human skin. The healthy human skin explants were first stimulated with TH2 cytokines to reduce the levels of endogenous filaggrin in

the samples. The study used a 2% lyophilized supernatant in a hydrogel formulation. rHDfilaggrin penetration in the middle to lower stratum

corneum was detected following a single application of the 2% formulation. Increased amounts of rHDfilaggrin were observed with additional

applications. Safety testing conducted in accordance with standardized guidelines demonstrated that the 2% supernatant formulation is

non-irritating and non-corrosive to the skin and eyes.

the figure above, (A) depicts the explanted healthy human skin explant prior to any treatment. Native filaggrin as well as profilaggrin

in keratohyalin granules (stained in green) are apparent in the stratum granulosum (SG) layer. (B) shows the skin sample after TH2 cytokine

stimulation to reduce or eliminate native filaggrin in the stratum granulosum layer. Furthermore, TH2 cytokine stimulation markedly reduced

the presence of keratohyalin granules, resulting in decreased endogenous filaggrin. This reduction facilitates the differentiation and

detection of rHDfilaggrin following application. (C) shows penetration and distribution of rHDfilaggrin into the stratum granulosum layer

after one application of the cell free supernatant. (D) shows penetration and distribution of rHDfilaggrin into the stratum granulosum

layer after three applications of the lyophilized cell free supernatant in a hydrogel formulation.

The

second ex vivo model utilized defatted human skin explants to assess the effect of the lyophilized rHDfilaggrin supernatant in

a hydrogel formulation on human skin elasticity. Concentrations of the supernatant in the hydrogel were varied from 0.0% to 7.5% (weight/weight

or “w/w”). Elasticity was measured at 20 hours post application. Skin samples were incubated at 30ºC. The hydrogel alone

results are shown in open circles and the active are in black squares.

Human

Skin Elasticity Measurement vs Supernatant Concentration

The

hydrogel containing the lyophilized supernatant was active in increasing the elasticity of ex vivo human skin sections in a dose-dependent

manner. Minimal and maximum effects in elasticity enhancement were observed in hydrogels containing 0.09% w/w (1.6-fold) and 7.5% w/w

(4.4-fold) of active ingredient, respectively. Hydrogels containing 0.28% w/w of active ingredient restored ex vivo abdominoplasty skin

elasticity to values historically observed in healthy skin. Pictures taken of skin samples after the incubation period treated with placebo

or the 0.3% w/w supernatant hydrogel are shown below. The active treated sample showed approximately two times the elasticity compared

to the placebo treated skin sample, highlighting the formulation’s potential as a novel cosmetic ingredient for improving skin

firmness and resilience.

Placebo

Treated

Active

Treated – 0.3% Supernatant

“Our

team at Azitra continues to be highly motivated by the prospects of our ATR-COSF program and its potential to have a substantial effect

on improving the appearance of fine lines and wrinkles. Our plan is to continue to optimize our formulations and test on additional ex

vivo human wrinkle models as we head towards starting our human study, which is being designed to translate our cutting edge science

into observable, visible wrinkle reduction benefits for consumers,” said Francisco Salva, CEO of Azitra. “Filaggrin is a

protein that is critical to the maintenance of our skin’s elasticity and pliability and overall healthy appearance.”

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 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, and (iv) statements about our 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 the provision of initial safety data and topline results

for ATR-COSF, 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 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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