Azitra, Inc. Reports Third Quarter 2025 Financial Results and Key Developments

Azitra, Inc. (NYSE American: AZTR), a prominent clinical-stage biopharmaceutical firm, reported on November 12, 2025, its financial performance for the quarter ending September 30, 2025, along with crucial updates regarding its developmental programs. As a company specializing in innovative therapies for precision dermatology, Azitra continues to make notable strides in its clinical trials and product developments.

Q3 2025 Highlights

Progress in Clinical Trials

One of the standout accomplishments reported during this quarter was the dosing of the first patient in the Phase 1/2 clinical trial for the ATR-04 program, aimed at treating oncology patients experiencing EGFR inhibitor (EGFRi)-associated rash. This treatment is of particular importance as it addresses a significant side effect that affects approximately 150,000 individuals in the United States annually. The company’s CEO, Francisco Salva, noted, “This candidate previously received Fast Track designation from the FDA as there is an incredible opportunity to help alleviate a major dermatologic toxicity associated with EGFR inhibitor treatments.” He emphasized the urgency of this initiative, as skin toxicity can lead to interruptions in vital cancer treatments, severely impacting patient outcomes.

In addition to the ATR-04 program, Azitra presented promising preclinical data at the BIO-Europe® conference for its ATR-01 program, focused on ichthyosis vulgaris, a genetic skin disorder that impacts around 1.3 million people in the U.S. Operating within a realm where treatments are limited to mere symptom management, Azitra’s innovative approach aims to deliver functional filaggrin, crucial for skin health.

Financial Overview

From a financial perspective, the quarter ended with a reported net loss of $2.8 million, which, while an increase from $1.0 million in the same period last year, reflects Azitra’s ongoing investments in research and development. The R&D expenses totaled $1.2 million, slightly rising from $1.0 million year-over-year. Conversely, the General and Administrative expenses saw a decrease, coming in at $1.6 million compared to $1.9 million in 2024.

As of September 30, 2025, Azitra’s cash and cash equivalents stood at $1.4 million, indicative of the firm’s current liquidity position amidst extensive R&D endeavors.

Outlook for Future Programs

Mr. Salva conveyed optimism about progressing further with the company’s leading program, ATR-12, which targets Netherton syndrome, a rare and severe skin condition that currently has no approved treatment. “We are optimistic that this novel approach has potential to be life-changing for these patients,” he stated, underscoring the urgency for viable treatment options in areas of critical need.

The latter part of 2025 is shaping up to be a proactive period for Azitra, which continues to develop its unique proprietary platform for engineered proteins and topical live biotherapeutic products. This platform is bolstered by a library of approximately 1,500 bacterial strains selected with the aid of advanced artificial intelligence and machine learning technologies.

In conclusion, Azitra, Inc. presents a strong case for investment and interest as it advances its groundbreaking programs in dermatology. The combination of significant clinical progress and an adaptive business strategy positions Azitra to effectively address the pressing challenges of skin diseases with innovative solutions. With its pipeline of therapies moving forward, the company looks poised to impact the pharmaceutical landscape positively, advocating for patients in need by leveraging cutting-edge science.