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Azitra, Inc. Reports Full Year 2025 Financial Results and Business Updates

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company, has recently published its financial results for the year ended December 31, 2025, along with notable updates regarding its clinical programs that are revolutionizing dermatological treatments. With a focus on precision dermatology, Azitra has made significant strides in developing therapies aimed at addressing various skin conditions, particularly those linked to severe dermatological toxicities.

2025 Highlights

1. Clinical Trials and Progress: In 2025, Azitra initiated a Phase 1/2 clinical trial for its promising candidate, ATR-04, which targets oncology patients experiencing skin toxicities due to EGFR inhibition. Notably, the data was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, where the response from industry leaders was overwhelmingly positive. The company highlighted that ATR-04 has already received Fast Track designation from the FDA, indicating its potential significance for approximately 150,000 individuals in the U.S. struggling with skin-related side effects from cancer therapies.

2. Preclinical Success: The company also announced encouraging preclinical outcomes for ATR-01, a program focused on treating ichthyosis vulgaris, a genetic skin disorder affecting around 1.3 million people in the U.S. With no current treatment options beyond managing symptoms, the positive data results signal hope for breakthrough therapies that can improve quality of life for affected individuals.

3. Safety Data from Phase 1b Trials: Azitra reported favorable safety data from a Phase 1b trial concerning ATR-12, designated for treating Netherton syndrome—another rare skin condition. The ongoing trial has so far shown that the treatment is safe and well-tolerated by the participants.

4. Financial Position: The company completed various financing rounds totaling $8.5 million this past year, strengthening its financial foundation to propel ongoing research and development efforts. Although the net loss for the year was reported at $11 million, slight improvements in administrative and research expenses reflect a stable operational approach.

Financial Overview

For the fiscal year ending December 31, 2025, Azitra reported total expenditures of $10.97 million, with research and development constituting $4.8 million and general administrative expenses amounting to $6.2 million. The company had cash and cash equivalents of $2.1 million as of year-end, a decrease from the preceding year.

Francisco Salva, CEO of Azitra, expressed optimism about the forward momentum of the company. He noted, "2025 was indeed a landmark year, as we advanced clinical programs aimed at transforming dermatological care through innovative, engineered products. As we build on this momentum, we are excited about several key milestones to come in 2026, including topline data and continued studies across our innovative drug candidates."

The ATR-12 program, currently in Phase 1b trials, is one of Azitra's flagship efforts that aims to provide a viable treatment for individuals with Netherton syndrome—a rare genetic condition characterized by severe skin inflammation and other debilitating symptoms.

* Looking Ahead: 2026 is anticipated to be pivotal. Azitra aims to disclose topline data for its ATR-12 and ATR-04 programs within the first half of the year. This progress is crucial not only for advancing therapeutic developments but also for increasing shareholder value as the company solidifies its position in the biopharmaceutical landscape.

Through its commitment to innovation and adaptive approaches, Azitra, Inc. strives to make significant impacts on the lives of those suffering from debilitating skin conditions, reaffirming how important their advancements are within the biopharmaceutical community. As they continue to navigate these complexities, all eyes will remain on their promising pipeline and future developments that could bring forth much-needed solutions for patients across various severe dermatological conditions.