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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 |
| of
incorporation) |
|
File
Number) |
|
Identification
No.) |
21
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 ☒
If
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
On
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 |
Exhibit 99.1
Azitra,
Inc. Announces Revitalizing Results from Ex Vivo Study of ATR-COSF Demonstrating Ability
to
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.
In
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 |
At
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.
A
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.
He
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.”
In
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.
