Azitra, Inc. Announces Revitalizing Results from Ex Vivo Study of ATR-COSF Demonstrating Ability to Reduce Fine Lines and Improve Elasticity in Human Skin

Initial human data are expected by year end, following tests of the cosmetic candidate in surgically removed skin.

Rhea-AI Summary

Azitra (AZTR) reported ex vivo results for its ATR-COSF cosmetic candidate showing improvements in wrinkles and elasticity in surgically removed human skin. In dorsal skin, a single 2% dose reduced the appearance of fine lines and wrinkles by approximately 15% at 3 hours, 20% at 24 hours and 50% at 48 hours. The hydrogel-only control showed worsening wrinkle appearance. ATR-COSF preserved net elasticity over 48 hours, while the control declined.

In face lift skin, the 4% formulation improved all measured elasticity parameters at 6 hours; the 2% formulation and control showed declines or no improvement. Azitra anticipates a first-in-human study of 4% ATR-COSF in approximately 30 subjects, with initial data expected by year end. The company said it remains funded for that milestone and existing financial instruments offer investors an opportunity to invest another $5.25 million to $10.5 million after data release.

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Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.First-in-human study of 4% ATR-COSF anticipated in approximately 30 subjects; initial data expected by year end.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Existing instruments offer investors an opportunity to invest another $5.25 million to $10.5 million after data release.
• Minor pointDorsal-skin wrinkle appearance fell approximately 15% at 3 hours, 20% at 24 hours and 50% at 48 hours.
• Minor pointDorsal-skin net elasticity was preserved over 48 hours with ATR-COSF, while the hydrogel-only control declined.
• Minor pointFace lift skin treated with 4% ATR-COSF improved across all measured elasticity parameters at 6 hours.
• Minor pointAzitra says it remains funded to reach its year-end initial human-data milestone.

Negative

• Minor pointFace lift skin treated with 2% ATR-COSF showed declining elasticity or no improvement at 6 hours.

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Details

Market move: AZTR +27.27% vs previous close. ATR-COSF ex vivo results

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$0.80 – $1.44 Day Range

On Oct 26, the day this news came out, the latest delayed price for AZTR is 27.27% above the previous close. Argus tracked a peak move of +29.0% during the session. Our momentum scanner has recorded 28 alerts for this stock so far that day. The latest delayed price is $0.91. Relative volume is exceptionally heavy at 118.2x the average.

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Key Figures

Fine-line and wrinkle reduction: approximately 15% Fine-line and wrinkle reduction: approximately 20% Fine-line and wrinkle reduction: approximately 50% +3 more

Fine-line and wrinkle reduction

approximately 15%

3 hours after one ATR-COSF dose in Model 1

Fine-line and wrinkle reduction

approximately 20%

24 hours after one ATR-COSF dose in Model 1

Fine-line and wrinkle reduction

approximately 50%

48 hours after one ATR-COSF dose in Model 1

First-in-human study size

approximately 30 subjects

Planned study of 4% ATR-COSF

Initial study results

by year end

First-in-human ATR-COSF study

Potential additional investment

$5.25 million to $10.5 million

Near-term opportunity after the clinical data release, from instruments issued in the earlier transaction

Historical Context

2 past events · Latest: Jul 15

2 events

1. Jul 15

   ATR-COSF ex vivo results

   24h Move

   +5.0%

   Earlier ex vivo work reported dose-dependent elasticity gains and improved recombinant filaggrin penetration.

2. Aug 12

   Q2 results

   24h Move

   +3.7%

   Q2 update disclosed initial ATR-COSF ex vivo anti-wrinkle activity and a planned human cosmetic study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

ex vivo, supernatant, filaggrin, hydrogel, +1 more

5 terms

ex vivo technical

"Ex vivo data in two models"

Ex vivo describes tests or treatments performed on living cells, tissues, or organs that have been removed from the body and studied in an external environment. For investors, ex vivo work sits between basic lab dish tests and whole‑animal or human studies, offering a more realistic preview of how a therapy or diagnostic might behave in real tissue — like running an engine on a test stand before putting it back into a car — which can reduce scientific risk and inform development milestones.

supernatant technical

"supernatant based formulation containing an active recombinant human domain"

Liquid that lies above a solid residue (pellet) or settled particles after a sample has been allowed to sit or has been spun in a centrifuge; the supernatant contains dissolved molecules and any remaining small suspended components and is removed for testing or further processing while heavier material remains in the pellet. Its precise composition depends on the original sample and the separation method used, so what is in the supernatant versus the pellet can change with centrifuge speed, time, and how the sample was handled.

filaggrin medical

"active recombinant human domain of the protein, filaggrin"

Filaggrin is a structural protein in the outer layer of skin that helps hold skin cells together and keep moisture and irritants out, like the mortar between bricks. Loss or mutation of filaggrin weakens the skin’s barrier, increasing the risk of eczema, allergies and infections. Investors care because filaggrin-related problems drive demand for dermatology drugs, diagnostics and preventive products, and can influence regulatory review and reimbursement decisions in that market.

hydrogel technical

"formulated in a hydrogel"

A hydrogel is a soft, jelly-like material made mostly of water combined with a network of flexible, supportive molecules. Its unique ability to hold large amounts of water while remaining stable makes it useful in various medical, industrial, and consumer applications. For investors, innovations involving hydrogels can signal growth opportunities in sectors like healthcare, biotechnology, and advanced materials.

recombinant human domain medical

"active recombinant human domain of the protein"

A recombinant human domain is a specific functional region or segment of a human protein that has been produced using recombinant DNA technology. Scientists isolate the gene sequence that encodes that domain (rather than the whole protein), insert it into an expression system such as bacteria, yeast, insect, or mammalian cells, and use the host to make and purify the domain as a separate protein product. Because it is only a fragment, its properties depend on correct folding and any required chemical modifications; when expressed in non‑human systems it may lack some native post‑translational changes and therefore can differ in activity or stability from the full, naturally occurring human protein.

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• 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., Oct. 26, 2026 /PRNewswire/ -- 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 10^th, 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

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SOURCE Azitra, Inc.

FAQ

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What did Azitra's ATR-COSF study show for fine lines and wrinkles?

A single 2% ATR-COSF dose reduced wrinkle appearance in dorsal skin explants by approximately 15% at 3 hours, 20% at 24 hours and 50% at 48 hours. These were ex vivo tests in surgically removed human skin, not results from treatment of living participants.

When does Azitra expect initial human results for ATR-COSF?

Azitra expects initial human data by year end. A first-in-human clinical study using 4% ATR-COSF is anticipated in approximately 30 subjects.

When will Azitra present detailed ATR-COSF results at BIO-Europe?

Azitra will present detailed ATR-COSF data at BIO-Europe in Cologne, Germany, on November 10, 2026, at 4:45 pm CET. Cofounder and Chief Operating Officer Travis Whitfill will give the in-person presentation.