On November 5, 2026 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported third quarter 2026 results and provided a corporate update.
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"During the last quarter we reached alignment with the U.S. Food and Drug Administration (FDA) on the protocol for a Phase 3 study of our lead therapeutic candidate, efzofitimod, in pulmonary sarcoidosis patients with restrictive lung disease, a major form of interstitial lung disease (ILD) with a high unmet medical need," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We believe the efzofitimod program is well-positioned, considering the late-stage development status in an indication with a multi-billion-dollar global market opportunity, and have determined that at this time the best way for us to advance efzofitimod is to prioritize strategic partnerships."
Third Quarter 2026 and Subsequent Period Highlights
Reached alignment with the FDA on the protocol for a global Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease. The Company recently initiated study-related activities for the trial and is prioritizing strategic partnerships and/or licensing arrangements in order to advance the Phase 3 study beyond the completion of the initial study-related activities.
Completed enrollment in the Phase 2 EFZO-CONNECT study of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc)-related ILD (SSc-ILD). Full study results are expected in the second quarter of 2027. These will include data for multiple study endpoints, including the modified Rodnan Skin Score, skin histopathology, gene expression profiling, immune biomarkers, forced vital capacity, and an exposure response analysis.
Published the results of the Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis in The Lancet Respiratory Medicine. The peer-reviewed publication reinforces efzofitimod’s differentiated profile and potential to advance pulmonary sarcoidosis care. The publication is available on the Company’s website.
Published a manuscript demonstrating the mechanism of action and anti-fibrotic effects of ATYR0101 in the Journal of Biological Chemistry. ATYR0101 is a fusion protein that interacts with latent transforming growth factor beta binding protein 1 (LTBP-1) through a unique way that presents a differentiated approach to targeting fibrosis. The publication is available on the Company’s website.
Announced a research collaboration for pediatric osteosarcoma with Montefiore Einstein involving preclinical studies of ATYR2810, the Company’s monoclonal antibody that targets the neuropilin-2 (NRP2) receptor. The collaboration is to further the development and testing of ATYR2810 in an aggressive cancer where NRP2 is implicated.
Third Quarter 2026 Financial Highlights and Cash Position
Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of September 30, 2026, were $50.3 million. Based on its current cash and operating expense forecast and plans, the Company anticipates that this cash position will be sufficient to fund the Company’s current operations into late 2028.
R&D Expenses: Research and development expenses were $10.4 million for the third quarter 2026, which consisted primarily of costs for the Phase 2 EFZO-CONNECT study and research and development costs for the Company’s preclinical product candidates.
G&A Expenses: General and administrative expenses were $8.3 million for the third quarter 2026.
About Efzofitimod
Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr recently initiated study-related activities for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.
(Press release, aTyr Pharma, NOV 5, 2026, View Source [SID1234674347])