Azitra, Inc. Announces Poster Presentation at ASGCT 2026 Highlighting ATR-01 Program for Ichthyosis Vulgaris

Rhea-AI Summary

Azitra (NYSE American: AZTR) will present preclinical data for ATR-01 at ASGCT 2026 showing ATR01-616 delivers recombinant human filaggrin to skin, reduces transepidermal water loss (TEWL) in ex vivo pig skin (p < 0.001), and restores filaggrin and keratin co-localization in reconstructed human epidermis.

The poster supports advancement toward IND-enabling studies and a planned first-in-human trial in ichthyosis vulgaris.

Argus Apr 28 session

+11.08% close to close Open Argus

Details

News Market Reaction – AZTR

In the Apr 28 session, AZTR gained 11.08%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +11.1% in the session following this news. A strong positive reaction aligns with A...

Analysis

The stock surged +11.1% in the session following this news. A strong positive reaction aligns with Azitra’s pattern of moving in step with news tone, as prior financing and clinical updates saw aligned one-day moves. The ASGCT 2026 poster adds to positive ATR-01 preclinical data and highlights robust TEWL reduction with p < 0.001 and functional skin barrier restoration. However, investors have also faced listing-compliance risks and historical losses, suggesting that funding needs and execution milestones could influence how long enthusiasm persists.

Key Figures

Peak filaggrin production time: 6–8 hours TEWL reduction significance: p < 0.001 TEWL recovery time: 20 hours +1 more

Peak filaggrin production time

6–8 hours

Peak recombinant human filaggrin domain secretion after ATR01-616 application

TEWL reduction significance

p < 0.001

Reduced transepidermal water loss in ex vivo pig skin across all dose levels

TEWL recovery time

20 hours

Transepidermal water loss returned near baseline within 20 hours

ASGCT abstract number

2691

Poster abstract number at ASGCT 2026 Annual Meeting

Historical Context

5 past events · Latest: Mar 19

5 events

1. Mar 19

   Private placement financing

   24h Move

   +28.8%

   Up to $31.4M private placement to fund protein and peptide R&D.

2. Mar 13

   Listing compliance notice

   24h Move

   -7.5%

   NYSE American non-compliance and going concern paragraph in 10-K.

3. Mar 05

   Corporate governance update

   24h Move

   +2.5%

   Cancellation of special meeting due to lack of quorum and proposal withdrawal.

4. Feb 27

   Earnings and pipeline

   24h Move

   -6.1%

   Full-year 2025 loss, low cash, plus clinical progress across ATR-01/04/12.

5. Feb 24

   Clinical trial expansion

   24h Move

   +2.7%

   MD Anderson added as clinical site for ATR-04 Phase 1/2 trial.

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

Key Terms

filaggrin, staphylococcus epidermidis, transepidermal water loss, tewl, +4 more

8 terms

filaggrin medical

"ATR-01 delivers functional filaggrin, restoring skin barrier integrity"

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.

staphylococcus epidermidis medical

"using a modified Staphylococcus epidermidis strain."

A common bacterium that normally lives on human skin and in the body without causing harm, but can invade and cause infections when it gets onto medical devices, wounds, or into people with weak immune systems. Investors pay attention because outbreaks or device-related infections can slow product adoption, trigger safety reviews, increase healthcare costs, and lead to regulatory actions or liability—like a usually polite tenant who can cause big problems if a building is damaged.

transepidermal water loss medical

"leading to impaired skin barrier function and increased trans-epidermal water loss"

Transepidermal water loss (TEWL) is the rate at which water naturally evaporates through the outer layer of the skin, measured to assess how well the skin barrier is retaining moisture. Investors care because TEWL is a quantitative test used to support claims about moisturizers, barrier-repair products and clinical skin treatments; lower TEWL after using a product suggests it strengthens the skin’s barrier, similar to patching leaks in a water tank.

tewl medical

"reduced transepidermal water loss across all dose levels (p < 0.001)"

Transepidermal water loss (TEWL) is a measured rate at which water escapes through the outer layer of the skin, used to assess skin barrier health. For investors, TEWL is a common clinical or lab endpoint for dermatology products and cosmetic claims—improvements signal a treatment or formulation is restoring the skin’s protective seal, which can support marketing claims, regulatory acceptance, and commercial value. Think of it like checking how well a sealed container keeps water from evaporating.

reconstructed human epidermis medical

"studies in reconstructed human epidermis showed restoration of key structural features"

Reconstructed human epidermis (RHE) is a lab-grown, layered model of human skin created from human skin cells to mimic the outer skin barrier. Think of it as a crash-test dummy for products that lets scientists and regulators check irritation, absorption, and safety without using animals. Investors care because RHE can speed product testing, reduce costs and regulatory risk, and open markets where non-animal safety data are required or preferred.

auxotroph medical

"S. epidermidis strain designed as an auxotroph for controlled growth"

An auxotroph is a lab-grown microbe or cell that has lost the ability to make a specific nutrient on its own and therefore must be supplied with that nutrient to grow. For investors, auxotrophy matters because companies use it to control production, improve safety and prevent engineered organisms from surviving outside controlled environments—like giving a rocket a unique fuel so it only runs where intended—affecting regulatory risk, manufacturing costs and commercial viability.

live biotherapeutic medical

"engineered live biotherapeutic candidate ATR01-616, which is designed to treat"

A live biotherapeutic is a medical product made from live microorganisms intended to prevent, treat, or cure disease—think of it as a medicine made from helpful microbes rather than chemical compounds. Its live, biological nature means tighter safety rules, specialized manufacturing and storage, and a formal drug-approval pathway rather than simple supplement rules, so development costs, approval timelines and market uptake can strongly affect an investor’s risk and return.

non-viral vectors technical

"Session: Gene Addition: Non-Viral Vectors"

Non-viral vectors are methods or materials used to deliver genetic material or therapeutic payloads into cells without using a virus as the carrier. Think of them as delivery trucks instead of a biological courier: they can be simpler, cheaper and often safer, but may be less efficient than viral options. For investors, non-viral approaches matter because they can reduce manufacturing complexity, lower regulatory risk and influence the cost, scalability and market potential of gene and cell therapies.

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

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Preclinical data demonstrate ATR-01 delivers functional filaggrin, restoring skin barrier integrity and supporting advancement toward first-in-human studies

BRANFORD, Conn., April 28, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the presentation of new preclinical data from its ATR-01 program at the 2026 Annual Meeting of the American Society of Gene & Cell Therapy ("ASGCT 2026").

The poster highlights Azitra's engineered live biotherapeutic candidate ATR01-616, which is designed to treat ichthyosis vulgaris (IV) by delivering recombinant human filaggrin directly into the skin using a modified Staphylococcus epidermidis strain. IV is a common genetic skin disorder caused by filaggrin deficiency, leading to impaired skin barrier function and increased trans-epidermal water loss (TEWL).

The data being presented at ASGCT 2026 highlight ATR01-616's mechanism of action and translational potential, including its ability to elicit robust secretion of a recombinant human filaggrin domain, with peak production observed 6–8 hours following application. In an ex vivo pig skin model, ATR01-616 significantly reduced transepidermal water loss across all dose levels (p < 0.001), with levels returning near baseline within 20 hours. In parallel, studies in reconstructed human epidermis showed restoration of key structural features such as increased filaggrin levels and co-localization with keratin proteins, supporting functional integration into the skin barrier.

"These data provide compelling validation of our ATR-01 program and its potential to address the underlying cause of ichthyosis vulgaris," said Francisco Salva, Chief Executive Officer of Azitra. "By using the skin's natural bacteria to deliver functional filaggrin domains deeper into the epidermis, we are advancing a differentiated approach designed to restore skin barrier function and target the protein to where it is needed to address this genetically driven disease. The findings presented at ASGCT build on our previously reported positive preclinical data for ATR-01 and further support the program's advancement toward IND-enabling studies and a first-in-human clinical trial in patients with ichthyosis vulgaris."

ATR01-616 is a topical formulation containing a genetically engineered S. epidermidis strain designed as an auxotroph for controlled growth and optimized to secrete therapeutic filaggrin fragments. This approach enables localized, sustained delivery of protein therapeutics directly to affected skin, potentially overcoming limitations of existing treatments that do not address underlying disease biology and positioning ATR-01 as a novel, microbiome-based modality within dermatology.

Poster Details

• Title: An Engineered Human Filaggrin Secreting Staphylococcus epidermidis Strain for the Topical Treatment of Ichthyosis Vulgaris
• Presenter: Roger Léger, Ph.D., Vice President of Chemistry, Formulation and Development, Azitra, Inc.
• Abstract Number: 2691
• Session: Gene Addition: Non-Viral Vectors
• Meeting: ASGCT 2026 Annual Meeting

About Azitra, Inc.

Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's additional advanced program, ATR-04, utilizes another engineered strain of S. epidermidis for the treatment of 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 has an open IND for its ATR-04 program in patients with EGFRi associated rash. The ATR-12 and ATR-04 programs were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. Azitra is also developing its proprietary filaggrin protein and peptide technologies for the consumer, cosmeceutical market. The new initiative is the first amongst others, which aim to leverage Azitra's microbial genetic engineering platform to manufacture innovative proteins and peptides for the cosmetic and research 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 closing of the private placement, development of the Company's proprietary filaggrin protein and peptide technologies, and statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies.

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: failure to successfully complete our Phase 1b trial for ATR-12 program; delays in the dosing of our first patient in our Phase 1/2 trial for our ATR-04 program; ineffective product candidates; delays in regulatory approval or changes in regulatory framework outside of our control; inaccurate estimation of addressable markets of our product candidates; failure to timely raise additional required funding; emergence of more efficient competitors or more effective competing treatments; involvement in disputes surrounding the use of our intellectual property crucial to our success; inability to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and dependence 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 SEC on February 27, 2026. 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

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

What did Azitra (AZTR) report about ATR01-616 at ASGCT 2026?

Azitra reported preclinical results showing ATR01-616 secretes recombinant filaggrin and reduces TEWL in an ex vivo pig skin model. According to Azitra, data include significant TEWL reduction (p < 0.001) and restored filaggrin co-localization in reconstructed human epidermis.

How does ATR01-616 work to treat ichthyosis vulgaris according to Azitra (AZTR)?

ATR01-616 uses a modified Staphylococcus epidermidis strain to secrete human filaggrin domains directly into the skin. According to Azitra, the engineered auxotrophic strain enables localized, sustained delivery of filaggrin fragments to restore skin barrier function.

What evidence did Azitra (AZTR) present that ATR01-616 improves skin barrier function?

Azitra presented ex vivo pig skin data showing significant reduction in transepidermal water loss across doses (p < 0.001). According to Azitra, reconstructed human epidermis studies also showed increased filaggrin and co-localization with keratin proteins.

What are the next development steps Azitra (AZTR) indicated for the ATR-01 program?

Azitra indicated the ATR-01 program will advance toward IND-enabling studies and a first-in-human clinical trial in patients with ichthyosis vulgaris. According to Azitra, the ASGCT data further support that planned progression toward human studies.