Azitra, Inc. to Present Abstract at American Society of Gene and Cell Therapy Highlighting Phase 1/2 Study Targeting Cancer Therapy-Associated Rash

Rhea-AI Summary

Azitra (NYSE: AZTR) announced its upcoming presentation at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) regarding their Phase 1/2 clinical trial of ATR04-484. The presentation, scheduled for May 15, 2025, will focus on this novel compound designed to treat EGFR inhibitor-associated rash. The company plans to begin dosing its first patient in the Phase 1/2 trial in the first half of 2025. Chief Medical Officer Mary Spellman, MD, will present details about the topical treatment's development and clinical study design at the conference in New Orleans.

Azitra plans to dose first patient in a Phase 1/2 trial in the first half of 2025 for its precision dermatology candidate ATR04-484, designed for the treatment of EGFR inhibitor-associated rash

BRANFORD, Conn., May 14, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that it will present a poster describing the Phase 1/2 clinical trial of ATR04-484 for EGFR inhibitor ("EGFRi")-associated rash at the 28^th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT). ASGCT is being held May 13-17, 2025, in New Orleans, Louisiana.

Details of the presentation are as follows:

Event:	American Society of Gene and Cell Therapy
Location:	New Orleans Ernest N. Morial Convention Center, New Orleans, Louisiana
When:	May 15, 2025; 5:30-7:00PM CT
Title:	A Novel Staphylococcus epidermidis Compound for the Topical Treatment Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Dermal Toxicity
Presenter:	Mary Spellman, MD, Chief Medical Officer
Registration:	https://annualmeeting.asgct.org/register

"The Annual Meeting of ASGCT is an important conference for researchers and industry leaders who are seeking to develop next-generation cell and gene therapies for patients in need," said Mary Spellman, MD, Chief Medical Officer of Azitra. "We are excited to present supporting evidence for the clinical development of topical ATR04-484 and our Phase 1/2 clinical study design, in anticipation of initiating dosing for the first patient in the coming month."

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, 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 the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, 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 that we may fail to present this abstract detailing the Phase 1/2 clinical trial or, if we are able to do so, that the abstract will be favorably received; we may experience delays in the dosing the first patient in this Phase 1/2 trial; our product candidates may not be effective; there may be 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 SEC 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

View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-inc-to-present-abstract-at-american-society-of-gene-and-cell-therapy-highlighting-phase-12-study-targeting-cancer-therapy-associated-rash-302455641.html

SOURCE Azitra, Inc.

FAQ

What will Azitra (AZTR) present at the 2025 ASGCT Annual Meeting?

Azitra will present a poster describing the Phase 1/2 clinical trial of ATR04-484, their treatment for EGFR inhibitor-associated rash, at the ASGCT Annual Meeting on May 15, 2025.

When does Azitra plan to begin patient dosing for ATR04-484's Phase 1/2 trial?

Azitra plans to dose the first patient in the Phase 1/2 trial of ATR04-484 in the first half of 2025.

Who will present Azitra's research at the 2025 ASGCT conference?

Dr. Mary Spellman, Chief Medical Officer of Azitra, will present the research at the ASGCT conference.

What is ATR04-484 designed to treat?

ATR04-484 is designed to treat EGFR inhibitor (EGFRi)-associated rash as a topical treatment.