Core Insights - Azitra, Inc. is a clinical stage biopharmaceutical company focused on innovative therapies for precision dermatology [4] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [3] - Recent updates include promising safety results from the Phase 1b clinical trial of the ATR-12 program for Netherton syndrome and the initiation of the Phase 1/2 trial for the ATR-04 program targeting EGFR inhibitor-associated dermal toxicity [2][4] Company Overview - Azitra's lead program, ATR-12, targets Netherton syndrome, a rare skin disease with no approved treatments, and is currently in a Phase 1b clinical trial [4] - The ATR-04 program addresses EGFR inhibitor-associated rash, which affects approximately 150,000 people in the U.S., and has received Fast Track designation from the FDA [4] - The company utilizes a proprietary platform of engineered proteins and a microbial library of around 1,500 bacterial strains, enhanced by AI and machine learning for drug discovery [4] Presentation Details - The virtual presentation by Travis Whitfill, Cofounder and COO, is scheduled for 7:00 AM ET on September 8, 2025 [3] - During the conference, one-on-one meetings will be held with registered investors and potential partners to discuss the company's business and clinical development strategy [3]

BRANFORD, Conn., Aug. 27, 2025 /PRNewswire/ -- Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the dosing of the first patient in its Phase 1/2 clinical trial of ATR04-484, a topically applied live biotherapeutic product candidate designed to treat EGFR inhibitor ("EGFRi")-associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impa ...

BRANFORD, Conn., Aug. 11, 2025 /PRNewswire/ -- Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the quarter ended June 30, 2025, and provided a business update.Q2 2025 and Recent Business Highlights Announced initial safety results and 50% enrollment of the Phase 1b clinical trial of the ATR-12 program in Netherton syndrome, demonstrating a promising safety prof ...

Company Overview - Azitra, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology [7] - The company's lead program, ATR-12, targets Netherton syndrome, a rare chronic skin disease with no approved treatment options [7] - Azitra's ATR-04 program addresses EGFR inhibitor-associated skin toxicity and has received Fast Track designation from the FDA [7] Reverse Stock Split Announcement - Azitra announced a reverse stock split at a ratio of 1 post-split share for every 6.66 pre-split shares, effective August 21, 2025 [1][2] - The reverse stock split will reduce the number of issued shares from approximately 23,476,354 to about 3,524,978 shares [5] - Stockholders will not need to exchange existing stock certificates, as shares held in brokerage accounts will be automatically adjusted [3][4] Stockholder Impact - The reverse stock split will affect all stockholders uniformly, maintaining their percentage interest in the company's equity, except for fractional shares [4] - Stockholders entitled to fractional shares will receive cash in lieu of those shares, calculated based on the average closing sales prices for the five trading days preceding the effective date [4] Additional Information - Further details regarding the reverse stock split can be found in the definitive proxy statement filed with the SEC on January 14, 2025 [6]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 001-41705 Azitra, Inc. (Exact name of registrant as specified in its charter) Delaware 46-4478536 (State or other jurisdict ...

Drug candidate ATR12-351 has been generally safe and well-tolerated with occasional, transient, mild to moderate symptoms at application site Trial is 50% enrolled; six patients have received ATR12-351, a live precision dermatology therapeutic candidate Azitra presenting at the 2025 BIO International ConventionBRANFORD, Conn., June 17, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, to ...

BRANFORD, Conn., June 10, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that the company will present at the BIO International Convention being held June 16-19, 2025, in Boston, Massachusetts. 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 ...

Core Insights - Azitra, Inc. is presenting a poster on its Phase 1/2 clinical trial of ATR04-484 for treating EGFR inhibitor-associated rash at ASCO 2025 [1][2] - ATR04-484 is a live biotherapeutic product derived from Staphylococcus epidermidis, engineered for safety and efficacy [2][4] - The FDA has granted Fast Track designation for ATR04-484, which addresses a significant dermatologic toxicity affecting approximately 150,000 patients in the U.S. [5] Company Overview - Azitra, Inc. focuses on innovative therapies for precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease [5] - The company utilizes a proprietary platform of engineered proteins and a microbial library of around 1,500 bacterial strains, enhanced by AI and machine learning [5] Clinical Trial Details - The Phase 1/2 trial is multicenter, randomized, double-blind, and vehicle-controlled, assessing the safety and tolerability of ATR04-484 [2][3] - The presentation at ASCO 2025 will be led by Mary Spellman, MD, Chief Medical Officer, and will focus on the treatment of EGFRi-induced dermal toxicity [4]

Core Viewpoint - Azitra, Inc. is advancing its clinical development of ATR04-484, a precision dermatology candidate aimed at treating EGFR inhibitor-associated rash, with plans to dose the first patient in a Phase 1/2 trial in the first half of 2025 [1][3]. Group 1: Clinical Trial Details - Azitra will present a poster on the Phase 1/2 clinical trial of ATR04-484 at the 28th Annual Meeting of the American Society of Gene and Cell Therapy, scheduled for May 15, 2025, in New Orleans, Louisiana [2]. - The presentation will be led by Mary Spellman, MD, Chief Medical Officer, highlighting the clinical development of ATR04-484 and the study design [2]. Group 2: Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on innovative therapies for precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease [3]. - The ATR-12 program includes a Phase 1b clinical trial in adult patients, while ATR-04 is designed for EGFR inhibitor-associated rash, which affects approximately 150,000 people in the U.S. [3]. - Azitra has received Fast Track designation from the FDA for the ATR-04 program and has an open IND for this indication [3]. Group 3: Technological Platform - Azitra's programs are developed from a proprietary platform of engineered proteins and topical live biotherapeutic products, which includes a microbial library of around 1,500 bacterial strains [3]. - The platform is enhanced by artificial intelligence and machine learning technologies that assist in analyzing and predicting drug-like molecules from the microbial library [3].

Core Insights - Azitra, Inc. is focused on developing innovative therapies for precision dermatology, with key programs targeting major dermatological diseases [3][5] - The company reported a net loss of $3.1 million for Q1 2025, compared to a loss of $2.9 million in Q1 2024, indicating ongoing financial challenges [7][12] - Azitra has received Fast Track designation from the FDA for its ATR-04 program, which addresses EGFRi-associated rash affecting approximately 150,000 patients annually in the U.S. [3][5] Business Highlights - The CEO highlighted the importance of 2025 for Azitra, with initial safety data for ATR-12 expected in the first half of the year and topline results by year-end [3] - The company plans to dose the first patient in the Phase 1/2 trial for ATR-04 by mid-2025, with a presentation scheduled at the prestigious ASCO 2025 conference [3][6] - Azitra's proprietary platform includes a microbial library of approximately 1,500 bacterial strains, enhanced by AI and machine learning for drug development [8] Financial Results - R&D expenses for Q1 2025 were $1.3 million, down from $1.5 million in Q1 2024, while G&A expenses increased to $1.9 million from $1.5 million [7][12] - As of March 31, 2025, the company had cash and cash equivalents of $3.2 million, a decrease from $4.6 million at the end of 2024 [7][12] - Total operating expenses for Q1 2025 were $3.1 million, compared to $3.0 million in the same period of 2024 [12]