#United States #Azitra #ATR-12 #Branford #ATR-04

Azitra, Inc. Reports Progress on Clinical Trials and Financial Results for Q1 2025

Azitra, Inc., a clinical stage biopharmaceutical company specializing in precision dermatology therapies, recently announced their financial results for the first quarter of 2025, along with crucial updates regarding their clinical trials. With a focus on developing innovative treatments, Azitra is actively working on therapies for dermatological conditions that currently lack effective treatment options.

Key Highlights from Q1 2025

During the first quarter of 2025, Azitra achieved several significant milestones:

• - Poster Acceptance at ASCO 2025: The company announced the acceptance of a poster that details the Phase 1/2 clinical trial of its ATR-04 program, aimed at treating EGFR inhibitor (EGFRi) associated rash, which will be presented at the prestigious 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
• - Financial Partnership for Clinical Pipeline: Azitra entered into a Purchase Agreement with Alumni Capital LP, allowing for investments of up to $20 million to support its clinical research and development initiatives.
• - Public Offerings: The company successfully completed two public offerings, raising a total of $2.2 million.

CEO Statement

Francisco Salva, CEO of Azitra, emphasized the significance of the early part of 2025 for the company, stating: “This has been a vital period for Azitra as we build towards key milestones expected by mid-year for our first-in-class, precision, live biotherapeutic candidates designed for major undertreated dermatological diseases.” He provided insights into the lead program ATR-12, which targets Netherton syndrome, a rare and debilitating skin disease. Initial safety data from this clinical trial is anticipated to be available in the first half of 2025, with topline results expected by year-end.

Clinical Trial Updates

Azitra is also preparing for the initiation of the Phase 1/2 trial for ATR-04. This program features a live biotherapeutic candidate derived from an isolated strain of S. epidermidis, intended for treating EGFRi-associated rash— a troublesome dermatologic issue that affects approximately 150,000 patients annually in the United States. Given the crucial role of EGFRi in cancer treatments, the company recognizes the necessity for effective solutions in this area and has been invited to present at the ASCO conference.

2025 Milestones Ahead

The remainder of 2025 is projected to be filled with significant milestones for Azitra, presenting ample opportunities to demonstrate the efficacy of both ATR-12 and ATR-04. Noteworthy upcoming milestones include:

• - Initial Safety Data: Expected from the first group of patients with Netherton syndrome participating in the ATR-12 Phase 1b trial in the first half of 2025.
• - First Patient Dosing: Planned for ATR-04 in its Phase 1/2 trial also during the first half of 2025.
• - Topline Results: From the Phase 1b trial with ATR-12 by the end of 2025.

Financial Performance

For the quarter ending March 31, 2025, Azitra reported:

• - R&D Expenses: $1.3 million, a reduction from $1.5 million in the previous year.
• - Administrative Costs: $1.9 million, up from $1.5 million year-over-year.
• - Net Loss: A loss of $3.1 million compared to $2.9 million during the same quarter last year.
• - Cash Reserves: As of March 31, 2025, the company had cash and equivalents totaling $3.2 million.

About Azitra, Inc.

Azitra, Inc. is committed to developing groundbreaking therapies for precision dermatology, focusing on its lead projects: ATR-12 for Netherton syndrome and ATR-04 for EGFRi-associated rash. With a proprietary platform known for its engineered strains of S. epidermidis and advanced AI technologies, Azitra stands poised to potentially revolutionize the field of dermatological treatments. The challenges posed by conditions like Netherton syndrome illustrate an urgent need for innovation in this sector, and Azitra is determined to meet that need.

As the year progresses, Azitra’s continued focus on FDA Fast Track designated conditions reflects its commitment to improving patient outcomes in dermatology. For additional information about their programs and milestones, visit Azitra's official website.