#USA #MD Anderson #Azitra #ATR-12 #Branford

Azitra, Inc. Reports Q1 2026 Results

On May 13, 2026, Azitra, Inc. (NYSE American: AZTR), a biopharmaceutical company dedicated to pioneering therapies in precision dermatology, released its financial results for the first quarter of 2026. The company also shared an update about its strategic initiatives aimed at enhancing patient care and expanding its product offerings.

Key Business Highlights

During the first quarter, Azitra achieved several significant milestones:
1. New Partnerships: The company announced the inclusion of MD Anderson Cancer Center as a clinical site for its Phase 1/2 trial of ATR-04. This trial focuses on managing skin rashes associated with EGFR inhibitors, a common side effect experienced by cancer patients undergoing such treatments. MD Anderson's reputation as a leading oncology institution is expected to facilitate patient access and ensure effective trial management.
2. Cosmetic Innovations: Azitra launched new protein and peptide initiatives tailored for the cosmetic and cosmeceutical sectors. Utilizing its proprietary filaggrin technology, these programs are designed to tackle common skin concerns such as fine lines, wrinkles, and conditions akin to eczema.
3. Patent Advancements: The company secured a new U.S. patent that safeguards its leading candidate ATR-12, which is being developed to treat Netherton syndrome, a rare genetic skin disorder. This patent strengthens Azitra's competitive position in the biopharmaceutical landscape.
4. Scientific Engagement: Azitra presented a poster at the 2026 American Society of Gene and Cell Therapy Annual Meeting (ASGCT), showcasing promising preclinical data related to ATR-01. This platform illustrates Azitra’s commitment to advancing engineered live biotherapeutic therapies.
5. Financing Strategies: The company priced a private placement financing round aimed at raising approximately $10.5 million, with an opportunity to generate an additional $20.9 million through warrants. This capital will support ongoing clinical trials and research initiatives.

CEO Statement

Francisco Salva, CEO of Azitra, commented on the company's progress: "The first quarter of 2026 marked a period of meaningful execution across our clinical and strategic priorities as we continue to advance Azitra’s leadership in precision dermatology. Notably, we significantly broadened our clinical footprint for our Phase 1/2 Trial of ATR-04, thanks to the addition of MD Anderson, which we believe will enhance patient access and support efficient trial execution."

Pipeline Achievements and Future Prospects

Azitra is also making headway on various pipeline programs:

• - ATR-COSF Initiative: Aiming to improve skin conditions, results from ongoing studies are expected in mid-2026, with plans for human application studies in Q3 2026.
• - ATR-12 Clinical Trials: Following the positive safety data reported in June 2025, Azitra plans to share topline results from the Phase 1b trial for Netherton syndrome in H2 2026.
• - ATR-04 for Cancer Patients: The Phase 1/2 trial commenced dosing its first patient in Q3 2025, and results are anticipated later in 2026.
• - ATR-01 for Ichthyosis Vulgaris: Positive preclinical results were reported in Q3 2025, as studies continue into this promising treatment avenue.

Financial Overview

Azitra's financial performance reflects its ongoing investments in research and development. In Q1 2026:

• - R&D expenses reached $1.6 million, up from $1.3 million in Q1 2025.
• - General and administrative (GA) expenses rose to $2.4 million, compared to $1.9 million the previous year.
• - The net loss for Q1 2026 was $3.9 million, compared to $3.1 million for the same quarter in 2025. However, cash reserves increased to $10.1 million by the end of the quarter, positioning Azitra well for upcoming challenges.

In summary, Azitra, Inc. continues to demonstrate robust growth in both clinical and business spheres, paving the way for innovative treatments in dermatology. With a strong pipeline and strategic partnerships, the company aims for impactful advancements in skin care therapies.