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 ...

BRANFORD, Conn., May 28, 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 in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) being held May 30-June 3, 2025 in Chicago.The presentation titled, "Epidermal growth factor recep ...

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]

Financial Performance - For Q1 2025, Azitra reported a net loss of $3.1 million, compared to a net loss of $2.9 million in Q1 2024, reflecting a year-over-year increase of approximately 6.9%[9] - General and Administrative (G&A) expenses increased to $1.9 million in Q1 2025, up 26.8% from $1.5 million in Q1 2024[9] - Total operating expenses for Q1 2025 were $3.1 million, compared to $3.0 million in Q1 2024, indicating a slight increase of 4.7%[9] Research and Development - Research and Development (R&D) expenses for Q1 2025 were $1.3 million, a decrease of 13.3% from $1.5 million in the same period of 2024[9] - Azitra plans to provide initial safety data from the Phase 1b trial for ATR-12 by mid-2025, with topline results expected by year-end 2025[4] - The company anticipates dosing the first patient in the Phase 1/2 trial for ATR-04 by mid-2025, targeting EGFRi-associated rash affecting approximately 150,000 patients annually in the U.S.[4] Funding and Capital - Azitra entered into a Purchase Agreement for up to $20 million with Alumni Capital LP to fund its clinical pipeline[5] - The company closed two public offerings, raising a total of $2.2 million[5] Cash Position - As of March 31, 2025, cash and cash equivalents stood at $3.2 million, down from $4.6 million at the end of 2024[9] Technology and Innovation - Azitra's proprietary platform includes a microbial library of approximately 1,500 bacterial strains, enhanced by AI and machine learning technologies[7]

IPO and Stock Information - The company completed its IPO on June 21, 2023, issuing 50,000 shares at $150 per share, converting all convertible preferred stock and notes into 298,384 common shares[136]. - As of May 13, 2025, the company had 16,476,354 shares of common stock outstanding, reflecting a 30-for-1 reverse stock split on July 1, 2024[137]. Product Development and Pipeline - The company has a proprietary microbial library of approximately 1,500 unique bacterial strains, with over 60 distinct species identified for potential therapeutic engineering[139]. - ATR-12, a genetically modified strain for treating Netherton syndrome, received FDA clearance for a Phase 1b trial, with initial safety results expected in the first half of 2025[140]. - ATR-04, targeting EGFRi-associated rash in cancer patients, obtained IND clearance in August 2024, with the first patient expected to be dosed in the first half of 2025[140]. - The company plans to perform IND-enabling studies for ATR-01, targeting ichthyosis vulgaris, with an IND filing anticipated in early 2026[140]. - The company has established a Joint Development Agreement with Bayer for two bacterial strains, focusing on preclinical properties and potential licensing[140]. - The company holds an exclusive license for SyngenicDNA Minicircle Plasmid technologies, which is expected to enhance genetic transformations of microbial species[144]. - The company aims to build a sustainable precision dermatology company with a diverse pipeline of product candidates, leveraging its proprietary microbial library[145]. - The company is exploring strategic partnerships to accelerate development and expand its research and development pipeline, while maintaining significant rights to core technologies[149]. Financial Performance - General and administrative costs increased by $361,611, or 24%, to $1,850,138 compared to the prior year period[152]. - Research and development expenses decreased by $222,870, or 15%, to $1,250,100, primarily due to a decrease in CMC costs and consultant costs[154]. - Total operating expenses rose by $138,741, or 5%, to $3,100,238, resulting in a loss from operations of $3,100,238[151]. - Interest income surged by $29,555, or 388%, to $37,164, contributing to a total other income increase of $3,271, or 11%[156]. - As of March 31, 2025, total assets were approximately $5.9 million, with working capital of approximately $2.6 million[157]. - Net cash used in operating activities was $3,071,762, compared to $3,020,008 in the prior year[161]. - Financing activities provided $1,745,439 in cash, primarily from follow-on public offerings[164]. - The company anticipates a significant increase in research and development expenses due to planned clinical trial activities[155]. Management and Operational Concerns - Management expressed substantial doubt about the company's ability to continue as a going concern due to significant losses and the need for additional capital[160]. - The company identified a material weakness in its disclosure controls and procedures related to accounting functions[168].

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]

Company Overview - Azitra, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology [2] - The lead product, ATR-12, is designed to treat Netherton syndrome, a rare chronic skin disease with no approved treatment options [2] - ATR-04, another product, is being developed for EGFR inhibitor associated rash, which affects approximately 150,000 people in the U.S. [2] Clinical Development - ATR-12 is currently being evaluated in a Phase 1b clinical trial in adult patients with Netherton syndrome [2] - Azitra has received Fast Track designation from the FDA for ATR-04 targeting EGFRi associated rash [2] - The company utilizes a proprietary platform of engineered proteins and a microbial library of approximately 1,500 bacterial strains, enhanced by AI and machine learning technology [2] Upcoming Events - Chief Operating Officer Travis Whitfill will present at the Microbiome Times Partnering Forum in Brussels on March 19, 2025 [1] - The presentation will focus on early clinical experience with ATR-12 for treating skin diseases [1] - Azitra's management team will conduct one-on-one meetings with registered investors and potential partners during the conference [1]

Core Insights - Azitra, Inc. is focused on developing innovative therapies for precision dermatology, with a therapeutic pipeline that includes engineered proteins delivered through topical live biotherapeutic products [3][10] - The company reported a net loss of $9.0 million for the year ended December 31, 2024, an improvement from a net loss of $11.3 million in 2023 [9][15] - Azitra's lead product, ATR-12, is in a Phase 1b clinical trial for Netherton syndrome, with initial safety data expected in the first half of 2025 and topline results by year-end 2025 [5][6] Financial Performance - Service revenue for the year ended December 31, 2024, was $0.8 thousand, compared to $0.7 million in 2023 [8] - Research and Development (R&D) expenses increased to $4.7 million in 2024 from $3.6 million in 2023 [8] - General and Administrative (G&A) expenses rose to $6.3 million in 2024 from $4.5 million in 2023 [9] Clinical Development - ATR-12 is designed to treat Netherton syndrome, a rare skin disease with no approved treatments, and has shown promising preclinical data [4][10] - ATR-04, another product candidate, targets EGFR inhibitor-associated rash, affecting approximately 150,000 patients annually in the U.S., representing a market opportunity exceeding $1 billion [3][7] - The FDA granted Fast Track designation to ATR-04, recognizing the unmet need for treatment of EGFRi-associated skin rash [5][13] Upcoming Milestones - Initial safety data for ATR-12 is anticipated in the first half of 2025, with topline data expected by year-end 2025 [6][8] - A Phase 1/2 clinical trial for ATR-04 is set to begin in the first half of 2025 [5][13] - Azitra aims to achieve multiple value-building milestones throughout 2025, positioning itself as a leader in developing transformative drugs for underserved dermatological conditions [3][4]