Patent offers broad protections for ATR-12, an engineered strain of S. epidermidis that expresses a fragment of human LEKTI protein

ATR-12 is currently the subject of a Phase 1b trial for the treatment of Netherton syndrome

BRANFORD, Conn., May 6, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE:AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the issuance of a new U.S. patent protecting ATR-12, the company's lead product candidate. Azitra is advancing ATR-12 in a Phase 1b clinical trial as a treatment for Netherton syndrome, a chronic and potentially fatal skin disease that is estimated to affect approximately 20,000 patients globally.

The U.S. Patent, number 12,606,610 B2, was issued on April 21, 2026, and is titled, "Compositions and Methods for Treatment of Netherton Syndrome with LEKTI Expressing Recombinant Microbes". The patent covers microbes that secrete one or more domains of the lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein and methods of using these microbes to treat skin diseases, including Netherton's Syndrome.

"We are very pleased that the U.S. Patent Office recognized the substantial ingenuity and innovative work behind the creation of ATR-12," said Francisco Salva, Chief Executive Officer of Azitra. "This new patent confers broad protection for the ATR-12 program as we progress this unique treatment for patients living with Netherton syndrome, a severe skin disorder with no approved therapies. Strengthening our intellectual property portfolio is a key strategic value driver for Azitra as we advance a pipeline of innovative precision dermatology therapies built around the transdermal delivery of genetically engineered bacteria and proteins."

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.

Azitra, Inc. Announces New U.S. Patent Protecting ATR-12 Program