Azitra is developing ATR04-484 for the treatment of EGFR inhibitor-associated rash with plans to dose first patient in Phase 1/2 trial in the first half of 2025 BRANFORD, Conn., April 25, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that an abstract detailing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash has been accepted for pre ...

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]

Financial Performance - Azitra reported a net loss of $8.97 million for the year ended December 31, 2024, compared to a net loss of $11.28 million for 2023, representing a 20.6% improvement[8]. - General and Administrative (G&A) expenses rose to $6.3 million in 2024, up from $4.5 million in 2023, marking a 40% increase[8]. - Cash and cash equivalents as of December 31, 2024, were $4.6 million, which does not include approximately $2.2 million from follow-on offerings in January and February 2025[8]. - The company closed public offerings totaling $15 million in 2024, enhancing its financial position[4]. - Azitra's total assets increased to $7.36 million as of December 31, 2024, compared to $5.12 million in 2023, indicating a 43.9% growth[17]. Research and Development - Research and Development (R&D) expenses increased to $4.7 million in 2024 from $3.6 million in 2023, reflecting a 30.6% rise[7]. - Azitra initiated a Phase 1b clinical trial for ATR-12 in adult Netherton syndrome patients in August 2024, with initial safety data expected in the first half of 2025[4]. - ATR-04, targeting EGFR inhibitor-associated rash, has a market opportunity exceeding $1 billion, with plans to initiate a Phase 1/2 clinical trial in the first half of 2025[3][6]. - The FDA granted Fast Track designation to ATR-04, highlighting the unmet need for treatment of EGFRi-associated skin rash[4]. - Azitra's intellectual property portfolio was strengthened with newly granted and allowed patents during the year[4].

Drug Development and Pipeline - The company has a proprietary microbial library consisting of approximately 1,500 unique bacterial strains, which can be screened for therapeutic characteristics [22]. - ATR-12, a genetically modified strain for treating Netherton syndrome, received Pediatric Rare Disease Designation from the FDA in 2019, with initial safety results expected in the first half of 2025 [23][29]. - ATR-04, targeting papulopustular rash in cancer patients, obtained IND clearance from the FDA in August 2024, with the first patient expected to be dosed in the first half of 2025 [24][29]. - The company plans to perform lead optimization and IND-enabling studies for ATR-01, targeting ichthyosis vulgaris, in 2025, with a potential patient population of approximately 1.3 million in the U.S. [28]. - ATR-12, a drug candidate for Netherton syndrome, is projected to represent a potential global sales opportunity of $250 million by mid-2030 [47]. - ATR-04 is projected to represent a $1 billion global sales opportunity by 2030 for the treatment of EGFRi-associated rash [67]. - The primary endpoint of the Phase 1b clinical trial for ATR-12 is safety, with secondary endpoints including efficacy signals and pharmacokinetics [66]. - ATR-04 aims to reduce the need for systemic antibiotics, addressing concerns related to antibiotic-related adverse events in EGFRi patients [74]. - ATR-01 is being developed as a topical treatment for ichthyosis vulgaris, targeting a patient population of approximately 1.3 million in the United States [88]. Partnerships and Collaborations - The company has established partnerships with Carnegie Mellon University and Fred Hutchinson Cancer Center to enhance its drug discovery capabilities using AI and whole genome sequencing [25][26]. - The company entered a Joint Development Agreement with Bayer in December 2019, focusing on two bacterial strains for further development, with Bayer holding exclusive licensing options [28][29]. - The company has established partnerships with leading academic institutions, including Fred Hutchinson Cancer Center and Carnegie Mellon University, to enhance its research and development capabilities [33]. - Bayer has entered into a Joint Development Agreement with the company, providing a one-time payment of $150,000 and an additional $375,000 for further characterization work [101]. Technology and Innovation - The SyMPL technology platform acquired from Fred Hutch allows for the genetic modification of previously intractable bacterial species, significantly expanding the potential for protein production [41]. - The company has leveraged artificial intelligence and machine learning to predict and confirm the therapeutic potential of compounds produced by its microbial library [37]. - The company’s proprietary process for protein delivery bypasses the skin's natural barrier, enabling targeted therapeutic applications [39]. - The genetic engineering of S. epidermidis has previously been limited, but the company has successfully overcome these challenges, improving transformation efficiency by over 10,000 times [45]. - The company is utilizing synthetic biology tools to enhance the delivery of human filaggrin protein in ATR-01, aiming to improve skin barrier function [93]. Regulatory and Compliance - The company emphasizes the importance of obtaining marketing approval from the FDA for its product candidates, which is critical for commercialization [20]. - Regulatory compliance is critical, with potential fines and marketing application refusals for non-compliance with FDA regulations [128]. - The FDA requires a comprehensive process for marketing new biologics, including preclinical tests, IND submission, and clinical trials [133]. - The IND application becomes effective 30 days after submission unless the FDA raises concerns, which could delay clinical trials [134]. - The FDA aims to complete its initial review of a BLA within ten months, or six months for serious conditions, but this timeline can extend [147]. - If a BLA is approved, the company must comply with post-approval regulatory requirements, including reporting adverse reactions and production issues [149]. - The FDA may require post-marketing Phase 4 testing to monitor the safety and efficacy of approved products [152]. - The FDA can designate products for expedited review if they address unmet medical needs in serious conditions [153]. - The FDA may designate a product for Fast Track review if it addresses unmet medical needs for serious diseases, allowing for greater interactions and a rolling review process [154]. - The FDA established a regulatory scheme for expedited review of "breakthrough therapies," which may show substantial improvement over existing therapies based on preliminary clinical evidence [155]. Intellectual Property - The ATR-12 product candidate is protected by three issued US patents and 40 pending foreign applications, with one patent expiring in 2035 [118]. - The ATR-04 product candidate has one issued US patent and 20 pending foreign applications, with the issued patent expiring in 2039 [119]. - The company holds an exclusive license agreement with Fred Hutchinson Cancer Center, which includes patents expiring in 2037 and 2040 [125]. - The company actively seeks to protect its intellectual property through patents, trade secrets, and know-how [112]. - The patent portfolio includes broad coverage for therapeutic bacteria compositions for treating abnormal skin conditions, with a key patent expiring in May 2035 [115]. Market and Financial Considerations - Sales of product candidates in the U.S. may depend on third-party payers' coverage, which are increasingly challenging medical product prices, potentially limiting net revenue [205]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the medical necessity and cost-effectiveness of its products for reimbursement [206]. - Pricing and reimbursement schemes vary widely by country, with some requiring agreed-upon prices before marketing, which could delay commercialization efforts [207]. - The marketability of products may suffer if government and third-party payors do not provide adequate coverage and reimbursement [208]. - Legislative initiatives, including the Affordable Care Act, may reduce the profitability of drug products through increased rebates and mandatory discounts [210]. - The Inflation Reduction Act of 2022 allows HHS to negotiate prices for certain high-expenditure drugs under Medicare, with negotiated prices effective in 2026 [213]. - The company may face increased scrutiny over drug pricing and reimbursement methodologies, impacting its financial operations [212]. - Future changes in coverage policies and reimbursement rates may adversely affect the company's product pricing and profitability [209].

Core Viewpoint - Azitra, Inc. has entered into a securities purchase agreement to sell 3,339,300 shares of common stock at $0.2785 per share, aiming to raise approximately $930.0 thousand for working capital and general corporate purposes [1] Group 1: Offering Details - The offering is expected to close on February 5, 2025, subject to customary closing conditions [1] - Maxim Group LLC is acting as the sole placement agent for the offering [2] - The offering is made under an effective shelf registration statement previously filed with the SEC [3] Group 2: Company Overview - Azitra, Inc. is focused on developing innovative therapies for precision dermatology, with its lead product ATR-12 targeting Netherton syndrome, a rare skin disease [5] - ATR-12 is currently in a Phase 1b clinical trial for adult patients, while ATR-04 is being developed for EGFR inhibitor associated rash and has received Fast Track designation from the FDA [5] - 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 [5]

Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology [2] - The company's lead product, ATR-12, is designed to treat Netherton syndrome, a rare chronic skin disease with no approved treatment options [2] - ATR-12 is currently being evaluated in a Phase 1b clinical trial in adult patients with Netherton syndrome [2] - Azitra's second product, ATR-04, targets EGFR inhibitor associated rash, which affects approximately 150,000 people in the U.S. [2] - Azitra has received Fast Track designation from the FDA for ATR-04 [2] - The company utilizes a proprietary platform of engineered proteins and topical live biotherapeutic products, supported by a microbial library of around 1,500 bacterial strains [2] Upcoming Events - Azitra will present at the BIO CEO & Investor Conference on February 10, 2025, at 3:45 p.m. ET in New York City [1] - The presentation will be led by Travis Whitfill, Chief Operating Officer, and will include one-on-one meetings with registered investors and potential partners [1]

Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology [2] - The company's lead product, ATR-12, is designed to treat Netherton syndrome, a rare chronic skin disease with no approved treatment options [2] - ATR-12 is currently being evaluated in a Phase 1b clinical trial in adult patients with Netherton syndrome [2] - Azitra's second product, ATR-04, targets EGFR inhibitor associated rash and has received Fast Track designation from the FDA [2] - Approximately 150,000 people in the U.S. are affected by EGFRi associated rash [2] - Azitra utilizes a proprietary platform of engineered proteins and a microbial library of around 1,500 bacterial strains, enhanced by AI and machine learning technology [2] Upcoming Events - Azitra will present at The Microcap Conference 2025 on January 29, 2025, at 11:00 a.m. ET [1] - The event will take place at Borgata Hotel Casino & Spa, Atlantic City, NJ [1] - CEO Francisco Salva will lead the presentation, and the management team will hold one-on-one meetings with registered investors and potential partners [1]

Core Viewpoint - Azitra, Inc. has announced a public offering of 4,857,780 shares of common stock at a price of $0.30 per share, aiming to raise approximately $1.5 million for working capital and corporate purposes [1]. Company Overview - Azitra, Inc. is a clinical-stage biopharmaceutical company focused on precision dermatology, with its lead product ATR-12 targeting Netherton syndrome, a rare skin disease with no approved treatments [5]. - ATR-12 is currently in a Phase 1b clinical trial for adult patients with Netherton syndrome, while ATR-04 is being developed for EGFR inhibitor-associated rash, which affects around 150,000 people in the U.S. [5]. - 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 technologies [5]. Offering Details - The public offering is conducted under an effective shelf registration statement filed with the SEC, and the offering is expected to close on January 16, 2025 [3][1]. - Maxim Group LLC is acting as the sole placement agent for this offering [2].

Core Viewpoint - Azitra, Inc. has initiated a public offering of its common stock to raise funds for working capital and general corporate purposes [1][2]. Group 1: Company Overview - Azitra, Inc. is a clinical-stage biopharmaceutical company focused on precision dermatology [5]. - The company's lead product, ATR-12, targets Netherton syndrome, a rare skin disease with no approved treatments [5]. - ATR-12 is currently in a Phase 1b clinical trial for adult patients with Netherton syndrome [5]. - Azitra's second product, ATR-04, is being developed for EGFR inhibitor-associated rash and has received Fast Track designation from the FDA [5]. - Approximately 150,000 people in the U.S. are affected by EGFRi associated rash [5]. - Azitra utilizes a proprietary platform of engineered proteins and a microbial library of around 1,500 bacterial strains, enhanced by AI and machine learning technologies [5]. Group 2: Offering Details - The public offering is conducted under an effective shelf registration statement filed with the SEC [3]. - Maxim Group LLC is the sole placement agent for the offering [2]. - The offering is subject to market conditions, and there is no guarantee regarding its completion or terms [1].