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aTyr Pharma Announces Fourth Quarter and Full Year 2025 Results and Provides Corporate Update
Globenewswire· 2026-03-05 21:01
Core Insights - aTyr Pharma is preparing for a meeting with the FDA in mid-April 2026 to discuss the Phase 3 EFZO-FIT™ study results for efzofitimod in pulmonary sarcoidosis [1][4] - The Phase 2 EFZO-CONNECT™ study for efzofitimod in systemic sclerosis-related interstitial lung disease is on track to complete enrollment in the first half of 2026 [1][4] - The company ended 2025 with a cash position of $80.9 million [1][10] Phase 3 EFZO-FIT™ Study - The Phase 3 EFZO-FIT™ study evaluated the efficacy and safety of efzofitimod in 268 patients with symptomatic pulmonary sarcoidosis [4] - The study did not meet its primary endpoint regarding the reduction in mean daily oral corticosteroid dose at week 48 [4] - Clinical benefits were observed for the 5.0 mg/kg dose across multiple efficacy parameters, including improvements in the King's Sarcoidosis Questionnaire scores and fatigue assessments [4] Phase 2 EFZO-CONNECT™ Study - The Phase 2 EFZO-CONNECT™ study aims to evaluate efzofitimod's efficacy, safety, and tolerability in patients with systemic sclerosis-related ILD [4] - This study is a randomized, double-blind, placebo-controlled trial with a total of 25 patients expected to be enrolled [4] - Interim data from this study were reported as promising in the second quarter of 2025 [4] Financial Highlights - Research and development expenses for 2025 were $60.2 million, primarily for the EFZO-FIT™ and EFZO-CONNECT™ studies [10] - General and administrative expenses for the same period were $17.6 million [10] - The total net loss for 2025 was $74.1 million, with a net loss per share of $0.80 [12] Company Overview - aTyr Pharma is a clinical-stage biotechnology company focused on developing therapies for fibrosis and inflammation using its proprietary tRNA synthetase platform [8] - Efzofitimod is a novel biologic immunomodulator in clinical development for interstitial lung disease, targeting inflammation and fibrosis without immune suppression [7][8]