Azitra, Inc. (NYSE: AZTR), a clinical-stage biopharmaceutical company focused on precision dermatology, has reported significant advancements in its pipeline, particularly for ATR-12 in Netherton syndrome and ATR-04 in EGFR inhibitor (EGFRi)-associated rash. The company's Q3 2024 financial results and business update highlight key milestones achieved in these programs.
ATR-12 for Netherton Syndrome
ATR-12, an engineered strain of S. epidermidis, is designed to deliver a fragment of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is deficient in Netherton syndrome patients. Netherton syndrome is a chronic and potentially fatal skin disease affecting approximately 20,000 individuals globally. The Phase 1b clinical trial (NCT06137157) is currently recruiting adult patients to assess the safety, tolerability, and efficacy of ATR-12.
The first patient has been dosed with ATR-12 in this ongoing trial. Initial safety data from the first set of Netherton syndrome patients is expected in Q1 2025, with topline data anticipated by the end of 2025.
ATR-04 for EGFRi-Associated Rash
ATR-04 is a live biotherapeutic product candidate derived from a naturally isolated S. epidermidis strain, engineered for enhanced safety and controlled growth. It is being developed to treat EGFRi-associated rash, a common side effect of EGFR inhibitor therapies, affecting approximately 150,000 patients in the United States. This rash is caused by the suppression of skin immunity by EGFRis, leading to inflammation and elevated levels of IL-36γ and S. aureus.
The FDA has granted Fast Track designation to ATR-04, which is intended to accelerate the development and review of drugs for serious conditions and unmet medical needs. Azitra plans to initiate a Phase 1/2 clinical study in early 2025 to evaluate ATR-04 in patients undergoing EGFRi treatment.
Management Commentary
Francisco Salva, CEO of Azitra, stated, "Azitra achieved a number of significant milestones in the third quarter of 2024 to propel our pipeline forward, highlighted by the dosing of the first patient with ATR-12 in our ongoing Netherton syndrome trial. Additionally during the quarter, we completed a follow-on offering of $10 million in gross proceeds, submitted an IND for ATR-04 for skin rash from epidermal growth factor receptor inhibitors (EGFRis), obtained IND clearance and Fast Track designation for ATR-04, and strengthened our IP portfolio."
Financial Highlights
Azitra reported $0 service revenue for Q3 2024, compared to $310,700 for the same period in 2023. Research and Development (R&D) expenses increased to $1.0 million from $0.5 million year-over-year, reflecting increased investment in its pipeline programs. General and Administrative (G&A) expenses were $1.9 million, compared to $1.8 million in 2023. The net loss for the quarter was $1.0 million, an improvement from the $1.9 million loss in the comparable period of 2023. As of September 30, 2024, the company held $7.3 million in cash and cash equivalents.
About Azitra, Inc.
Azitra, Inc. is focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The company's proprietary platform includes a microbial library of approximately 1,500 unique bacterial strains, augmented by artificial intelligence and machine learning technology.
