Azitra, Inc. Announces Breakthough Repeat Dose and Anti-Wrinkle Ex Vivo Results for ATR-COSF Program, Demonstrating Increased Distribution and Elasticity

Rhea-AI Summary

Azitra (NYSE American: AZTR) reported new ex vivo human skin data for its ATR-COSF cosmetic program, a supernatant from engineered S. epidermidis that secretes a recombinant human filaggrin domain (rHDfilaggrin). Multiple-dose experiments in TH2-stimulated healthy skin explants showed increased rHDfilaggrin penetration through the stratum corneum into the stratum granulosum versus prior single-dose work, with higher concentrations when formulated as a 2% lyophilized hydrogel compared with concentrated supernatant alone.

In a second ex vivo model using defatted human skin, ATR-COSF hydrogels containing 0.09–7.5% (w/w) supernatant increased elasticity in a dose-dependent manner, from 1.6-fold to 4.4-fold. A 0.28% (w/w) formulation restored elasticity to levels historically observed in healthy skin, and a 0.3% (w/w) sample showed about twice the elasticity of placebo. Safety testing found the 2% supernatant hydrogel non-irritating and non-corrosive to skin and eyes, supporting its potential as a high-value anti-wrinkle cosmetic ingredient, according to Azitra.

Positive

• Dose-dependent elasticity gains up to 4.4-fold at 7.5% w/w active
• Elasticity restored to healthy levels at 0.28% w/w supernatant
• Active-treated skin showed ~2x elasticity versus placebo at 0.3% w/w
• Multiple-dose model showed increased rHDfilaggrin penetration versus single-dose work
• 2% supernatant hydrogel classified as non-irritating and non-corrosive in testing

Negative

• None.

News Explained

The July 15 release places ATR-COSF work in ex vivo testing: Azitra will continue optimizing formulations and testing additional ex vivo wrinkle models while designing a human study.

Market reaction after ATR-COSF ex vivo data: AZTR +4.97% in the Jul 15 session

+4.97%

22 alerts

+4.97% Session close to close

+16.4% Peak Tracked

-5.0% Trough Tracked

$2.19M Market Cap

0.2x Rel. Volume

In the Jul 15 session, AZTR gained 4.97%, reflecting a moderate positive market reaction. Argus tracked a peak move of +16.4% during that session. Argus tracked a trough of -5.0% from its starting point during tracking. Our momentum scanner triggered 22 alerts that day, indicating elevated trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

With short interest described as low and an S-1 registering up to 255,699,381 resale shares, this AT...

Analysis

With short interest described as low and an S-1 registering up to 255,699,381 resale shares, this ATR-COSF data sits against a backdrop of ample potential supply. Investors may watch how future human studies intersect with that dilution overhang.

Key Figures

Supernatant concentration: 2% lyophilized supernatant Dose range: 0.0% to 7.5% w/w Elasticity measurement time: 20 hours +5 more

8 metrics

Supernatant concentration 2% lyophilized supernatant Hydrogel formulation used in first ex vivo penetration study

Dose range 0.0% to 7.5% w/w Supernatant concentrations in elasticity ex vivo model

Elasticity measurement time 20 hours Time post application for elasticity assessment

Incubation temperature 30ºC Incubation conditions for skin samples

Minimal effective dose 0.09% w/w (1.6-fold) Lowest hydogel supernatant level with elasticity enhancement

Maximal effect dose 7.5% w/w (4.4-fold) Highest elasticity enhancement in ex vivo model

Restorative dose 0.28% w/w Dose restoring abdominoplasty skin elasticity to healthy levels ex vivo

Active vs placebo elasticity ≈2x 0.3% w/w supernatant hydrogel vs placebo in ex vivo samples

Historical Context

5 past events · Latest: Jun 17 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 17	Strategic update	Positive	+10.3%	CEO letter detailing strategic reorientation and financing-supported growth initiatives.
Jun 16	Conference appearance	Positive	+10.3%	BIO International presentation on pipeline progress and new filaggrin-based initiative.
Jun 04	Annual meeting quorum issue	Negative	-3.2%	Adjournment of 2026 annual meeting due to failure to reach quorum.
May 27	Annual meeting scheduling	Negative	-0.6%	Plan to open and immediately adjourn annual meeting to allow more proxy time.
May 13	Q1 2026 earnings	Neutral	-1.5%	Q1 2026 results with clinical progress, cosmeceutical initiative, and private placement pricing.

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

Pattern Detected

Recent Azitra headlines, whether strategic, clinical, or governance-related, have generally seen share moves that align with the apparent tone of the news.

Key Terms

ex vivo, stratum corneum, stratum granulosum, hydrogel, +2 more

6 terms

ex vivo medical

"promising results from two separate ex vivo human skin tissue studies."

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.

stratum corneum medical

"delivered through the stratum corneum and into the stratum granulosum layers"

The stratum corneum is the outermost layer of the skin, made of dead flattened cells and lipids that form a protective barrier like the mortar between bricks. It controls how well water, chemicals, and medicines applied to the skin can enter the body, so its condition and composition matter to investors in dermatology, cosmetics, and drug-delivery companies because it influences product effectiveness, formulation choices, regulatory testing, and clinical results.

stratum granulosum medical

"delivered through the stratum corneum and into the stratum granulosum layers"

A thin middle layer of the outer skin (epidermis) where cells pack together, make keratohyalin proteins and release lipids that help form the skin’s protective barrier. Think of it as the mortar between bricks: it helps glue and seal the skin surface as cells mature and move outward into the waterproof top layer. Its role in barrier function and drug absorption matters to investors because it affects the science, safety, regulatory review, and marketability of topical drugs, cosmetics, and dermatology treatments.

hydrogel medical

"The study used a 2% lyophilized supernatant in a hydrogel formulation."

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.

cytokines medical

"The healthy human skin explants were first stimulated with TH2 cytokines"

Small proteins produced by immune and other cells that act as on/off signals or “text messages,” telling cells to ramp up, calm down, grow, or move during infection, injury, or disease. Investors watch cytokines because they are common drug targets and biomarkers—changes in cytokine activity can make a therapy work, cause serious side effects, or determine clinical trial and regulatory outcomes, all of which affect a company’s value.

w/w technical

"Concentrations of the supernatant in the hydrogel were varied from 0.0% to 7.5% (weight/weight or "w/w")"

Abbreviation for “week‑over‑week,” a way to compare a number from one week to the same number in the previous week. It expresses the percentage or absolute change in things like sales, production, trading volume, or prices over a one‑week period, helping readers see short‑term momentum or shifts. Think of it as comparing this week’s grocery bill to last week’s to see how spending changed.

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

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• 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 /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 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.  

In 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. 

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.

"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  

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SOURCE Azitra, Inc.

FAQ

What did Azitra (AZTR) announce about its ATR-COSF ex vivo skin studies on July 15, 2026?

Azitra reported two ex vivo human skin studies showing improved rHDfilaggrin penetration and dose-dependent elasticity increases with its ATR-COSF hydrogel. According to Azitra, formulations restored elasticity to levels historically observed in healthy skin and approximately doubled elasticity versus placebo at certain concentrations.

How does the ATR-COSF formulation from Azitra (AZTR) affect skin elasticity ex vivo?

Azitra’s ATR-COSF hydrogel increased ex vivo human skin elasticity in a dose-dependent manner, from 1.6-fold to 4.4-fold. According to Azitra, a 0.28% w/w concentration restored elasticity to historically healthy levels, while 0.3% w/w produced about twice the elasticity of placebo-treated samples.

What were the penetration results for rHDfilaggrin in Azitra (AZTR) ATR-COSF multiple-dose experiments?

Multiple-dose ATR-COSF applications increased rHDfilaggrin penetration into the stratum corneum and stratum granulosum versus prior single-dose experiments. According to Azitra, a 2% lyophilized supernatant hydrogel achieved higher rHDfilaggrin concentrations than concentrated supernatant alone in ex vivo human skin explants.

Is Azitra’s ATR-COSF cosmetic hydrogel formulation reported to be safe for skin and eyes?

Azitra reports that a 2% ATR-COSF supernatant hydrogel was non-irritating and non-corrosive to skin and eyes in standardized safety testing. According to Azitra, these findings support its development as a high-value cosmetic ingredient targeting firmness, resilience and wrinkle appearance.

What are the next development steps for Azitra (AZTR) ATR-COSF after the ex vivo results?

Azitra plans to further optimize ATR-COSF formulations and test in additional ex vivo wrinkle models before starting a human study. According to Azitra, the goal is to translate these ex vivo findings into observable wrinkle-reduction benefits for cosmetic consumers.

What is ATR-COSF in Azitra’s (AZTR) dermatology pipeline and how is it produced?

ATR-COSF is a cosmetic program using supernatant from engineered S. epidermidis secreting a recombinant human filaggrin domain. According to Azitra, this lyophilized supernatant is formulated into hydrogels as a high-value ingredient to support skin elasticity, firmness and wrinkle appearance.