On August 7, 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 second quarter 2026 results and a corporate restructuring to prioritize its efzofitimod program in interstitial lung disease (ILD), including pulmonary sarcoidosis and systemic sclerosis (SSc)-related ILD (SSc-ILD).
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The program prioritization aims to focus the Company’s resources on advancing its lead asset, efzofitimod, and targeted pipeline development to conserve capital in anticipation of receiving comments from the U.S. Food and Drug Administration (FDA) on the protocol for its planned Phase 3 study of efzofitimod in pulmonary sarcoidosis, a major form of ILD. The Company submitted the protocol in June 2026 and is expecting feedback from the FDA by the end of August 2026.
"We are proactively taking decisive, necessary action to focus our resources on our lead therapeutic candidate, efzofitimod, as we await feedback from the FDA on the protocol we submitted for our planned Phase 3 study in pulmonary sarcoidosis patients with restrictive lung disease. This approach positions aTyr to advance this planned Phase 3 study efficiently and continue completing the Phase 2 EFZO-CONNECT study in SSc-ILD," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We remain confident in the potential of efzofitimod to become a meaningful therapy for patients with these forms of ILD, and these changes are essential to our ability to achieve that goal. We are deeply grateful to our dedicated team members for their outstanding contributions, commitment, and perseverance, including those who have helped advance tRNA synthetase biology over the years."
Program Prioritization and Corporate Restructuring
Workforce reduction of approximately 60% will align organizational resources to support the efzofitimod program in ILD in anticipation of comments from the FDA on a protocol submitted for a planned Phase 3 study in pulmonary sarcoidosis and to complete the Phase 2 EFZO-CONNECT study in SSc-ILD.
Jill Broadfoot, aTyr’s Chief Financial Officer (CFO), will step down as of September 30, 2026, and transition to serve as a consultant to the Company. Brandon Yaras, aTyr’s Vice President of Finance, will be appointed as CFO as of October 1, 2026.
Nancy Denyes, aTyr’s General Counsel, will step down as of September 30, 2026, and transition to serve as a consultant to the Company.
The Company expects that this restructuring and additional cost saving measures will reduce annualized operating expenses by approximately $13 million, beginning in the fourth quarter of 2026.
Second Quarter 2026 and Subsequent Period Highlights
Protocol submitted to FDA in June 2026 for planned Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease. The Company is expecting feedback from the FDA by the end of August 2026. The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses. The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of ≤ 5.0 mg daily oral corticosteroid and/or a background immunosuppressant. All background treatment will remain stable throughout the duration of the study. The primary endpoint of the study will be change from baseline in forced vital capacity (FVC) at week 48 and the key secondary endpoint will be change from baseline in the King’s Sarcoidosis Questionnaire-Lung score at week 48.
Enrollment completed in the Phase 2 EFZO-CONNECT study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse SSc-ILD. Topline results are expected in the first quarter of 2027. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. The study enrolled 23 patients at multiple centers in the United States. Promising interim data from the study were reported in the second quarter of 2025.
Post hoc analysis of Phase 3 EFZO-FIT study in subgroup of patients with restrictive lung disease presented in a poster at the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) 2026 Congress in Porto, Portugal. The poster, which is titled, "Evaluating Efzofitimod in a Subset of Sarcoidosis with the Restrictive Phenotype," demonstrated clinically meaningful benefit for FVC and improvement in multiple patient-reported outcomes for patients treated with 5.0 mg/kg efzofitimod compared to placebo. The poster is available on the Company’s website.
Second Quarter 2026 Financial Highlights and Cash Position
Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of June 30, 2026, were $58.9 million. Based on its current cash and new 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. Future development of efzofitimod in the planned Phase 3 study in pulmonary sarcoidosis will require the Company to obtain additional capital through equity or debt offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements.
R&D Expenses: Research and development expenses were $6.7 million for the second 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 $4.1 million for the second 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 submitted a protocol to the FDA 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, AUG 7, 2026, View Source [SID1234669879])