Azitra, Inc. Reports Q2 2024 Financial Results and Business Updates

Azitra, Inc., a clinical-stage biopharmaceutical company specializing in precision dermatology, has announced its financial results for the second quarter ending June 30, 2024, along with a business update. The company highlighted several key achievements and upcoming milestones, indicating significant progress in its development pipeline.

During Q2 2024, Azitra successfully completed a $10 million follow-on offering, anticipated to extend its cash runway into 2025. This financial boost is expected to facilitate the announcement of multiple clinical milestones in the near future. Additionally, the company has bolstered its global intellectual property portfolio with newly granted and allowed patents.

In terms of clinical advancements, Azitra showcased promising preclinical data from its candidate ATR-04 at the Society of Investigative Dermatology Annual Meeting. Similarly, positive preclinical data for ATR-12 and its clinical design for treating Netherton Syndrome were presented at the ASGCT Annual Meeting. The company has also initiated a Phase 1b clinical trial for ATR-12, now open for patient recruitment.

Azitra’s CEO, Francisco Salva, expressed optimism about the company's future, predicting significant milestones in the latter half of 2024 and beyond. In Q3 2024, the company plans to administer the first dose of ATR-12 to a Netherton syndrome patient. Additionally, an Investigational New Drug (IND) application for ATR-04, aimed at treating epidermal growth factor receptor inhibitor (EGFRi) rash, is expected to be filed and cleared, expanding the company’s clinical pipeline to two programs.

By the end of 2024, Azitra aims to report initial safety data from the ATR-12 Phase 1b trial and provide an update on its collaboration with Bayer. The company also plans to commence a first-in-human clinical trial for ATR-04 targeting EGFRi rash. Looking forward to mid-2025, Azitra expects to release topline data from the ATR-12 Phase 1b trial, potentially demonstrating a biological proof of concept for its innovative approach to treating Netherton syndrome.

Financially, Azitra's service revenue for the quarter was $7,500, a decline from $172,000 in the same period of 2023. Research and development expenses rose to $1.1 million from $0.8 million, and general and administrative expenses increased to $1.5 million from $0.8 million year-over-year. The company reported a net loss of $2.6 million, a significant decrease from the $5.1 million loss reported for the same period in 2023. As of June 30, 2024, Azitra held $0.8 million in cash and equivalents.

ATR-12, also known as ATR12-351, is an engineered strain of S. epidermidis designed to express a fragment of the human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is deficient in Netherton syndrome patients. This strain aims to deliver the missing LEKTI protein when applied topically, addressing a chronic and potentially fatal skin disorder affecting about 20,000 people worldwide. Azitra's Phase 1b clinical trial for ATR-12, identified as NCT06137157, is actively recruiting patients to assess its safety, tolerability, and efficacy.

ATR-04 is a live biotherapeutic candidate comprising an isolated, naturally derived strain of S. epidermidis. It has been engineered to be safer by removing an antibiotic resistance gene and modifying its growth control. ATR-04 is being developed to treat EGFRi-associated rash, a condition affecting approximately 150,000 patients in the U.S. Azitra plans to initiate a Phase 1/2 clinical trial for this condition by the end of 2024.

Azitra, Inc. is dedicated to developing advanced therapies for precision dermatology through engineered proteins and live biotherapeutic products. The company has developed a proprietary platform, enhanced with artificial intelligence and machine learning, to screen its microbial library for unique therapeutic properties. Azitra's initial focus is on genetically engineered strains of S. epidermidis, which it identifies as an optimal candidate for dermatologic therapies.