Azitra, Inc. Announces Addition of MD Anderson Cancer Center as Clinical Site for Phase 1/2 Trial of ATR-04 Targeting EGFRi-Associated Skin Rash

Azitra (NYSE:AZTR) added The University of Texas MD Anderson Cancer Center as a clinical site for its Phase 1/2 study of topical ATR-04 (ATR04-484) for EGFR inhibitor-associated skin rash.

Rhea-AI Summary

Azitra (NYSE:AZTR) added The University of Texas MD Anderson Cancer Center as a clinical site for its Phase 1/2 study of topical ATR-04 (ATR04-484) for EGFR inhibitor-associated skin rash.

The multicenter, randomized, double-blind study (NCT06830863) is enrolling Cohort 1 (anticipated eight patients). ATR-04 has FDA Fast Track designation and an open IND.

Positive

• FDA Fast Track designation granted for ATR-04 treatment of EGFRi-associated rash
• MD Anderson added as sixth clinical site, potentially accelerating enrollment
• Open IND for ATR-04 enabling clinical development
• Targeted topical LBP engineered to reduce IL-36γ and S. aureus in preclinical studies

Negative

• Early-stage trial with Cohort 1 anticipated to enroll only eight patients
• No human efficacy data reported yet from ongoing ATR-04 study

Argus Feb 24 session

+2.69% close to close Open Argus

Details

News Market Reaction – AZTR

On Feb 24, the day this news came out, AZTR closed 2.69% above the previous close.

Data tracked by StockTitan Argus for the Feb 24 session.

Market Context

This announcement adds a major cancer center as the sixth site in Azitra’s Phase 1/2 trial of ATR-04...

Analysis

This announcement adds a major cancer center as the sixth site in Azitra’s Phase 1/2 trial of ATR-04 for EGFRi-associated rash, potentially supporting enrollment of the planned 8-patient Cohort 1. It reinforces earlier Fast Track recognition and prior dosing milestones in the program. Investors may focus on upcoming safety and early efficacy readouts, the scale of the approximately 150,000-patient U.S. population, and how Azitra funds continued development across its ATR-04 and ATR-12 pipelines.

Key Figures

Cohort 1 enrollment: 8 patients EGFRi rash incidence: up to 80% of patients Patients affected annually: approximately 150,000 +5 more

Cohort 1 enrollment

8 patients

Planned enrollment for Cohort 1 in Phase 1/2 ATR-04 trial

EGFRi rash incidence

up to 80% of patients

Proportion of EGFR inhibitor-treated patients affected by rash

Patients affected annually

approximately 150,000

Annual U.S. EGFRi-associated rash patient population

Clinical sites

6 sites

MD Anderson named as sixth clinical site for ATR-04 trial

Microbial library size

approximately 1,500 strains

Number of bacterial strains in Azitra’s platform library

Trial phase

Phase 1/2

Ongoing ATR-04 study in EGFRi-associated rash

Netherton trial phase

Phase 1b

ATR-12 clinical trial in adult Netherton syndrome patients

EGFRi rash impact

up to 80% of EGFRi patients

Frequency leading to treatment interruptions or discontinuations

Previous Clinical trial Reports

5 past events · Latest: Oct 20

Same Type 5 events

1. Oct 20

   Preclinical data update

   24h Move

   +0.4%

   Reported positive preclinical efficacy data for ATR-01 in ichthyosis vulgaris.

2. Aug 27

   Trial dosing start

   24h Move

   +35.9%

   Announced first patient dosed in Phase 1/2 ATR-04 trial for EGFRi rash.

3. Jun 17

   Safety data update

   24h Move

   -2.1%

   Reported generally safe, well-tolerated Phase 1b ATR-12 data in Netherton syndrome.

4. May 28

   Conference presentation

   24h Move

   -3.5%

   Announced ASCO 2025 poster on ATR-04 Phase 1/2 trial design and rationale.

5. Sep 18

   Fast Track designation

   24h Move

   +5.8%

   Received FDA Fast Track designation for ATR-04 in EGFRi-associated rash.

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

Key Terms

live biotherapeutic product, randomized, double-blind, vehicle-controlled, il-36γ, staphylococcus epidermidis, +2 more

6 terms

live biotherapeutic product medical

"ATR-04 is a first-in-class, topically applied live biotherapeutic product candidate"

A live biotherapeutic product is a medical therapy made from live microorganisms—such as bacteria or yeasts—developed to prevent, treat or cure disease by altering the body’s microbiome or immune response. For investors it matters because these products face unique scientific, manufacturing and regulatory hurdles (think of them as precision probiotics that require sterile production, cold chains, and rigorous clinical proof), which can affect development timelines, costs and commercial risk.

randomized, double-blind, vehicle-controlled medical

"The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical study"

A clinical trial design in which participants are assigned by chance to different groups, neither the participants nor the researchers know who receives the active drug, and the control group receives a “vehicle” — the same inactive formulation without the active ingredient. This setup acts like sealed, shuffled envelopes so outcomes aren’t swayed by expectations, producing more reliable evidence about whether a treatment works and is safe, which investors use to assess regulatory risk and commercial potential.

il-36γ medical

"reducing IL-36γ and Staphylococcus aureus levels, both of which are elevated"

IL-36γ is a small immune signaling protein that helps start and amplify inflammation by telling nearby cells to mobilize defenses; think of it as a neighborhood alarm that calls immune cells to action. For investors, changes in IL-36γ levels or therapies that block or boost its activity can indicate new drug targets, potential biomarkers for disease severity, or regulatory risks and opportunities in companies developing treatments for inflammatory and immune-related conditions.

staphylococcus epidermidis medical

"including an isolated, naturally derived Staphylococcus epidermidis strain in development"

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.

auxotrophy medical

"engineering auxotrophy to control the growth of ATR04-484."

Auxotrophy is a biological condition where a microbe or cell cannot make a specific nutrient it needs to grow and must get that nutrient from its environment. For investors, auxotrophy matters because engineered or natural auxotrophs are used in drug development, biotech manufacturing and safety controls: they can lower production costs by requiring added inputs, create dependency that helps contain organisms, or serve as targets for therapies, much like a car that only runs on a special fuel.

fast track designation regulatory

"The FDA has granted Fast Track designation to ATR-04 for the treatment"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

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

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MD Anderson Cancer Center expands ATR-04 clinical trial site footprint, offering potential to accelerate enrollment and patient treatment milestones

BRANFORD, Conn., Feb. 24, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the addition of The University of Texas MD Anderson Cancer Center as a clinical site for its ongoing Phase 1/2 clinical trial evaluating ATR-04 (ATR04-484). ATR-04 is a first-in-class, topically applied live biotherapeutic product candidate designed to treat EGFR inhibitor ("EGFRi")-associated rash.

"Expanding our clinical footprint to include MD Anderson Cancer Center, a world-renowned institution, is a significant milestone for the ATR-04 program," said Francisco Salva, CEO of Azitra. "As a leading cancer site that treats thousands of patients a year, oncologists at MD Anderson understand the impact of EGFRi-associated rash, which impacts up to 80% of patients receiving EGFRi therapies. As this major side effect frequently leads to treatment interruptions or discontinuations, the field is in need of innovative solutions like ATR-04, a topically applied product with the potential to help patients stay on their primary cancer treatments. We're glad to be working with the committed staff at MD Anderson, our sixth clinical site, as we aim to accelerate the development of our ATR-04 program."

The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical study (NCT06830863) is designed to evaluate the safety and tolerability of topical ATR04-484 for the treatment of EGFRi-associated dermal toxicity affecting the face of adult patients. ATR04-484 or its vehicle (3:1 randomization) will be applied to the face as well as affected areas on the neck, chest, back, and areas around nailbeds. The key objectives of the study will be to assess the safety and tolerability of topical ATR04-484 and to evaluate early efficacy signals. The study is currently enrolling patients for Cohort 1, which is anticipated to enroll a total of eight patients.

About ATR04-484

ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain in development for EGFRi-associated skin rash. The candidate was selected based on its preclinical profile of reducing IL-36γ and Staphylococcus aureus levels, both of which are elevated in patients with EGFRi-associated skin rash. The strain was then engineered to be safe by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04-484. Preclinical data have shown that ATR-04 can reduce levels of IL-36γ, a key pro-inflammatory cytokine elevated in these rashes. In addition, ATR-04 has also been shown to inhibit the growth of S. aureus in preclinical studies, which often colonizes the skin of affected patients. The FDA has granted Fast Track designation to ATR-04 for the treatment of EGFRi-associated rash, recognizing the high unmet medical need for the approximately 150,000 patients affected annually in the United States.

About Azitra

Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. Azitra'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, 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. 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 results for the Phase 1b clinical trial for our ATR-12, (ii) the development for the Phase 1/2 clinical trial for our ATR-04 program and the initiation of dosing and anticipated enrollment in the Phase 1/2 clinical trial for our ATR-04 program, and (iii) statements about our clinical and preclinical programs, including ATR-01, 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: the timing of clinical trials and their results as we may experience delays in the provision of results for ATR-12 and/or ATR-04 or, if we do, that such data 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 on February 24, 2025. 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.
Jon Nugent
205-566-3026
jnugent@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) announce about MD Anderson on February 24, 2026?

Azitra announced MD Anderson Cancer Center will join the Phase 1/2 ATR-04 trial as a clinical site. According to Azitra, this is the program's sixth site and is expected to help accelerate patient enrollment and treatment milestones.

What is the design and current enrollment status of Azitra's ATR-04 (AZTR) trial?

The ATR-04 study is a multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 trial. According to Azitra, Cohort 1 is currently enrolling and is anticipated to include a total of eight patients.

Does ATR-04 (AZTR) have any regulatory designations or IND status?

Yes. According to Azitra, ATR-04 has received FDA Fast Track designation and the program has an open IND, enabling continued clinical development in EGFRi-associated rash patients.

What is ATR04-484 and how does it aim to treat EGFRi-associated rash (AZTR)?

ATR04-484 is a topically applied live biotherapeutic containing an engineered Staphylococcus epidermidis strain. According to Azitra, preclinical data show it reduces IL-36γ and inhibits S. aureus growth linked to these rashes.

How might the addition of MD Anderson affect AZTR's ATR-04 development timeline?

Adding MD Anderson could speed patient recruitment and study milestones by expanding site capacity. According to Azitra, MD Anderson treats thousands of oncology patients annually, which may improve access to eligible participants.