Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology [3] - The company's lead program, ATR-12, targets Netherton syndrome, a rare chronic skin disease with no approved treatment options [3] - Azitra's additional clinical program, ATR-04, addresses EGFR inhibitor associated skin toxicity, with a Phase 1/2 clinical trial initiated [3] Clinical Development - ATR-12 is currently in a Phase 1b clinical trial for adults with Netherton syndrome [3] - ATR-04 has received Fast Track designation from the FDA for treating EGFRi associated rash, which affects approximately 150,000 people in the U.S. [3] - Azitra's programs are developed from a proprietary platform of engineered proteins and topical live biotherapeutic products, utilizing a microbial library of around 1,500 bacterial strains [3] Upcoming Events - Azitra will present at the Biotech Showcase 2026 in San Francisco from January 12-14, 2026 [1] - The presentation will include one-on-one meetings with registered investors and potential partners to discuss the company's clinical development strategy and recent achievements [2] - The event is scheduled for January 13, 2026, at 2:30 PM PT, with Travis Whitfill, the Chief Operating Officer, as the presenter [2]

As filed with the Securities and Exchange Commission on December 10, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AZITRA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 46-4478536 (I.R.S. Employer Identification Number) 21 Business Park Drive Br ...

Core Insights - Azitra, Inc. announced positive preclinical progress for its ATR-01 program targeting ichthyosis vulgaris, a genetic disorder affecting approximately 1.3 million people in the U.S. [1][2] - The ATR-01 program utilizes an engineered strain of S. epidermidis, ATR01-616, which secretes functional filaggrin, showing promising results in preclinical models [2][3] - The company plans to present detailed data at the BIO-Europe conference in November 2025 and aims to submit an IND for ATR-01 in 2026 [1][3] Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease [3] - The company also has an advanced program, ATR-04, for treating EGFR inhibitor-associated rash, which has received Fast Track designation from the FDA [3] - Azitra's programs are developed from a proprietary platform of engineered proteins and topical live biotherapeutic products, supported by artificial intelligence and machine learning [3]

As filed with the U.S. Securities and Exchange Commission on August 29, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AZITRA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 46-4478536 (I.R.S. Employer Identification Number) 21 Business Park Drive ...

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]

Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology [4] - The company's lead program, ATR-12, targets Netherton syndrome, a rare chronic skin disease, while ATR-04 is aimed at treating EGFR inhibitor-associated rash [4] - Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which affects approximately 150,000 people in the U.S. [4] Product Development - Azitra is developing ATR04-484 for the treatment of EGFR inhibitor-associated rash, with plans to dose the first patient in a Phase 1/2 trial in the first half of 2025 [1][2] - ATR04-484 is a live biotherapeutic product candidate that includes an isolated, naturally derived Staphylococcus epidermidis strain, engineered for safety [2] - The product is designed to address the dermatologic toxicities associated with EGFR inhibitors, which can lead to significant discomfort for patients [2] Clinical Trials and Presentations - An abstract detailing the Phase 1/2 clinical trial of ATR04-484 has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting [1][2] - The full ASCO abstracts will be available on May 22, 2025 [3] Market Context - EGFR inhibitors are a class of cancer drugs used primarily to treat non-small cell lung cancer (NSCLC) and colorectal cancer [3] - The development of ATR04-484 is significant as it addresses a common side effect of EGFR inhibitors, which can hinder treatment efforts [2]

As filed with the U.S. Securities and Exchange Commission on July 19, 2024. Registration No. 333-280806 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AZITRA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 46-4478536 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) ...

As filed with the U.S. Securities and Exchange Commission on July 15, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER (I.R.S. Employer Identification Number) 21 Business Park Drive Branford, CT 06405 (203) 646-6446 THE SECURITIES ACT OF 1933 AZITRA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 46-4478536 (Primary Standard Indust ...

As filed with the U.S. Securities and Exchange Commission on January 19, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER (Name, address, including zip code, and telephone number, including area code, of agent for service) Delaware 2834 46-4478536 (I.R.S. Employer Identification Number) 21 Business Park Drive Branford, CT 06405 (203) 646-6446 THE SECURITIES ACT OF 1933 (State or other jurisdiction of incorporation or org ...

As filed with the U.S. Securities and Exchange Commission on June 5, 2023 Registration No. 333-269876 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 5 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 (Exact name of registrant as specified in its charter) AZITRA, INC. (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 46-4478536 (I.R.S. Employer Identification Number) 2 ...