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

Azitra, Inc. Reports 2024 Financial Results and Clinical Development Updates

BRANFORD, Conn., Feb. 20, 2025 - Azitra, Inc. (NYSE American: AZTR), a biopharmaceutical company at the forefront of developing innovative dermatological therapies, has released its financial results for the full year ending December 31, 2024. The company's achievements reflect a robust pipeline aimed at addressing significant unmet needs in the field of precision dermatology.

Key Highlights for FY 2024

Azitra has made remarkable progress, particularly with its lead product, ATR-12. This engineered strain of Staphylococcus epidermidis is designed to treat Netherton syndrome, a rare skin disorder affecting adults, for which there are currently no approved treatments. As part of its clinical development, the company initiated a Phase 1b trial for ATR-12 in August 2024, focusing on safety and efficacy endpoints. Preliminary safety data is anticipated in the first half of 2025, with topline results expected by the end of that year.

In another significant achievement, Azitra received FDA approval to commence a Phase 1/2 clinical study for ATR-04, a product targeting EGFR inhibitor-associated dermal toxicity. The FDA's Fast Track designation places ATR-04 among those therapies that address urgent clinical needs, validating Azitra's commitment to tackling challenges in dermatological care.

Financial Overview

For the fiscal year 2024, Azitra reported a net loss of $9 million, reflecting the costs associated with the advancement of its clinical trials and generally increasing operational expenditures, particularly in research and development, which increased to $4.7 million compared to $3.6 million the previous year. The company ended the year with cash and cash equivalents of $4.6 million, alongside additional funds secured through public offerings in early 2025.

Innovative Therapeutics Development

CEO Francisco Salva highlighted the importance of Azitra's proprietary platform, which leverages engineered proteins and live biotherapeutic products to address various dermatological conditions. “Our innovative approach puts us in a position to help patients suffering from chronic skin diseases with limited treatment options,” Salva stated.

The Phase 1b trial for ATR-12 is critical given the urgency surrounding Netherton syndrome, often seen as life-threatening in early infancy. Current care practices fall short, which is a market opening that Azitra aims to fill with this innovative solution.

Simultaneously, ATR-04’s development is targeting a significant market opportunity with approximately 150,000 patients experiencing EGFRi-associated rashes in the U.S. annually, a condition that represents a healthcare burden exceeding $1 billion.

Looking Ahead

Azitra's plans for 2025 involve reaching several crucial milestones pertaining to its ATR-12 and ATR-04 products. Development will continue for both therapies with expectations for clinical data releases that may potentially alter the treatment landscape for many dermatological conditions. Salva expressed optimism about upcoming opportunities that could enhance shareholder value, stating, “Our dedicated team is positioned to facilitate transformative advancements in dermatological care throughout the year.”

The continued success of Azitra’s initiatives emphasizes the company's commitment to redefining standards in precision dermatology, potentially changing lives with targeted treatments, and demonstrating a resilient and innovative approach amidst the ongoing challenges within the biopharmaceutical industry.