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Azitra, Inc. to Present Research at BIO-Europe® Showing ATR-COSF Reduced Fine Lines and Improved Elasticity in Ex Vivo Human Skin Models

Initial human study results for ATR-COSF are anticipated by year-end, following findings in skin models studied outside the body.

(Very High)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

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Azitra (AZTR) announced ATR-COSF research showing reduced wrinkles and improved elasticity in human skin models studied outside the body.

ATR-COSF produced a 56% reduction in wrinkles from baseline in a human torso skin model. Other model results showed improved elasticity and wrinkle depth versus vehicle at 48 hours; elasticity improvements were observed with the 4% formulation. Azitra anticipates initial first-in-human study results by year-end.

The ongoing Phase 1/2 ATR-04 trial expanded in October 2026 to include rashes associated with KRAS and MEK inhibitors, alongside EGFR inhibitors, and patients with neurofibromatosis type 1 whose rash is associated with MEK inhibitors. Cofounder and Chief Operating Officer Travis Whitfill will present pipeline updates at BIO-Europe in Cologne.

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4 points · 0 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 0 points

Hollow bars mark forward-looking points. How the balance works

Positive

  • Moderate pointATR-04’s ongoing Phase 1/2 trial expanded in October 2026 to additional KRAS- and MEK-inhibitor-associated rash populations, including NF1.
  • Minor pointATR-COSF reduced wrinkles 56% from baseline in a human torso skin model outside the body.
  • Minor pointATR-COSF improved elasticity and wrinkle depth versus vehicle at 48 hours in skin models outside the body.
  • Minor point. Forward-looking: it has not happened yet and may not happen.Azitra anticipates initial first-in-human ATR-COSF study results by year-end.

Negative

  • None.

News Explained

Azitra says about 85,000 U.S. patients receive KRAS or MEK inhibitors annually, alongside about 220,000 receiving EGFR inhibitors; these figures put the populations relevant to ATR-04’s expanded eligibility in context.

Key Figures

Wrinkle reduction: 56% Formulation concentration: 4% Assessment timing: 48 hours +2 more
Wrinkle reduction
56%
From baseline in an ex vivo human torso skin model
Formulation concentration
4%
Formulation associated with improved elasticity in a second ex vivo model
Assessment timing
48 hours
Ex vivo models showed improved elasticity and wrinkle depth versus vehicle
KRAS or MEK inhibitor patients
Approximately 85,000 patients annually
United States
EGFR inhibitor patients
Approximately 220,000 patients annually
United States

Historical Context

1 past event · Latest: Oct 26
1 event
  1. Oct 26

    ATR-COSF results

    24h Move
    +114.0%

    Earlier ex vivo study reported wrinkle reductions and elasticity findings for the same ATR-COSF program.

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

Key Terms

ex vivo, recombinant filaggrin protein, phase 1/2 trial, egfr inhibitors, +1 more
5 terms
ex vivo technical
"an ex vivo human torso skin model"
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.
recombinant filaggrin protein medical
"a recombinant filaggrin protein designed for topical use"
A recombinant filaggrin protein is filaggrin—the human skin protein that helps aggregate keratin filaments and contributes to the skin barrier and natural moisturizing factors—produced by inserting the filaggrin gene (or a fragment of it) into a laboratory host (for example bacteria, yeast, insect, or mammalian cells) so the host synthesizes the protein. Recombinant forms can be full-length or truncated/modified versions engineered for research, diagnostic, or therapeutic use, and their properties can differ from native human filaggrin because of differences in processing and post‑translational modifications in the production host. The term denotes the method of production rather than a specific clinical effect or formulation.
phase 1/2 trial medical
"The Phase 1/2 trial of ATR-04 is ongoing"
A phase 1/2 trial combines the earliest human safety testing with an initial look at whether a treatment works, typically starting by checking tolerability and side effects and then expanding to measure early signs of benefit and the best dose. For investors, results from these trials are an early indicator of a drug’s clinical promise and regulatory path: positive data can materially increase a company’s value and reduce development risk, while negative data can sharply lower expectations.
egfr inhibitors medical
"in addition to EGFR inhibitors"
Drugs that block the epidermal growth factor receptor (EGFR), a protein on some cells that can act like a stuck “go” switch telling cells to grow and divide; by turning that switch off, these medicines can slow or stop tumor growth in certain cancers. Investors watch EGFR inhibitors because clinical trial results, regulatory approvals, safety issues and competition directly affect a drugmaker’s future sales, valuation and risk, much like a new product’s success or failure shapes a company’s prospects.
neurofibromatosis type 1 medical
"patients with neurofibromatosis type 1 (NF1)"
A genetic condition that causes noncancerous tumors to grow on nerves and can lead to skin changes, pain, learning challenges and other complications; severity varies widely from mild to serious. Investors track it because treatments, diagnostics and care pathways for this distinct patient group can drive clinical trial outcomes, regulatory approvals and long‑term revenue, much like a niche market where the size, unmet need and treatment complexity determine potential returns.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Initial results from first-in-human study with ATR-COSF anticipated by year-end

BRANFORD, Conn., Nov. 10, 2026 /PRNewswire/ -- Azitra, Inc. ("Azitra" or the "Company") (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that Cofounder and Chief Operating Officer, Travis Whitfill, Ph.D., MPH, will present pipeline updates including results for its ATR-COSF program, which is designed to deliver filaggrin domains into human skin to reduce the appearance of fine lines and wrinkles, at the BIO-Europe® conference in Cologne, Germany on November 10, 2026, at 4:45 pm CET.

Azitra Logo

"We look forward to presenting our ATR-COSF findings in greater detail at BIO-Europe and discussing how these results are guiding the development of a filaggrin-based topical cosmetic designed to reduce the appearance of fine lines and wrinkles," said Travis Whitfill, Ph.D., MPH, Cofounder and Chief Operating Officer of Azitra. "After a single application of ATR-COSF, we observed less visible wrinkling in one ex vivo human skin model and improvements in measures of elasticity with the 4% formulation in a second model. We believe these findings support taking ATR-COSF into a first-in-human study, with initial results anticipated by year-end. The program also illustrates how we are applying the microbial engineering platform behind our work in severe dermatologic conditions to develop new products for skincare."

In the presentation, Dr. Whitfill will highlight data from an ex vivo human torso skin model, in which ATR-COSF, a recombinant filaggrin protein designed for topical use, elicited a 56% reduction in wrinkles from baseline. In addition, ATR-COSF was shown to improve elasticity and improve the depth of wrinkles compared to vehicle in ex vivo models at 48 hours.

Dr. Whitfill's presentation will also provide updates on ATR-04 being studied for rashes associated with commonly prescribed cancer medications. The Phase 1/2 trial of ATR-04 is ongoing and was expanded in October 2026 to include patients with rashes due to KRAS and MEK inhibitors, in addition to EGFR inhibitors, as well as patients with neurofibromatosis type 1 (NF1) with rash associated with MEK inhibitors. Combined, approximately 85,000 patients undergo KRAS or MEK inhibitor treatment in the United States annually. The addition of these patients further broadens the potential clinical applications being explored for ATR-04 on top of the approximately 220,000 patients undergoing EGFR inhibitor treatment in the United States annually.

In addition to presenting the progress of Azitra's pipeline, Dr. Whitfill will also conduct one-on-one meetings with potential partners and investors during the conference. The presentation slides will be available online at ir.azitrainc.com.

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 skin rashes associated with cancer and neurofibromatosis treatments. Azitra has received Fast Track designation from the FDA for cancer treatment-associated rash, which impacts up to 300,000 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 expected effects of the protocol amendments, including on patient recruitment and enrollment, (iii) the safety and preliminary efficacy data from the trial, (iv) the potential of ATR-04 to treat EGFRi-, KRASi-, MEKi- associated skin rash and other similar rashes, including its potential to be the first live biotherapeutic developed for this indication, (v) the size of the potential patient population and the potential benefits of Fast Track designation, (vi) statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies, including our cosmeceutical strategy, and (vii) the design, timing and results of the first-in-human study of ATR-COSF, including the expected timing of initial results, and (viii) the potential of ATR-COSF as a cosmetic product.

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; the protocol amendments may not facilitate recruitment or accelerate enrollment as anticipated; 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 expanded patient populations may present different safety or efficacy profiles; the results from Cohort 1 may not be predictive of results in Cohort 2 or later-stage trials; results from ex vivo and other preclinical models may not be predictive of results in humans; the first-in-human study of ATR-COSF may be delayed or may not produce favorable results; 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 subsequent filings with the SEC, including our quarterly report on Form 10-Q filed on August 12, 2026. 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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SOURCE Azitra, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Azitra’s ATR-COSF skin-model research show?

ATR-COSF produced a 56% reduction in wrinkles from baseline in a human torso skin model studied outside the body. Additional model findings showed improved elasticity and wrinkle depth versus vehicle at 48 hours. These findings were from skin models, not human trial results.

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

Azitra anticipates initial first-in-human study results by year-end. ATR-COSF is being developed as a filaggrin-based topical cosmetic intended to reduce the appearance of fine lines and wrinkles.

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