Atyr Pharma reports $10.8M Q1 loss, eyes June Phase 3 IND
ATYR•Atyr Pharma reported a $10.8 million Q1 loss (11 cents per share) and held $68.3 million in cash and investments as of March 31. The company plans to file a June IND for a global Phase 3 pulmonary sarcoidosis trial using forced vital capacity as its primary endpoint.
1. Q1 Financial Results
Atyr Pharma posted a net loss of $10.8 million, or $0.11 per share, in the first quarter. The company ended March 31 with $68.3 million in cash, cash equivalents, restricted cash and investments, while its shares closed at $0.56 versus $3.03 a year ago.
2. FDA Meeting and IND Filing Plans
Following a Type C meeting with the FDA on the Phase 3 EFZO-FIT study, the company plans to submit an IND in June 2026 for a new global Phase 3 trial of efzofitimod in chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease.
3. Phase 3 Study Design
The planned 54-week, randomized, double-blind, placebo-controlled trial will enroll up to 372 patients receiving stable oral corticosteroids or background immunosuppressants. Patients will receive either 5.0 mg/kg efzofitimod or placebo intravenously every three weeks for 17 doses, with change in forced vital capacity at week 48 as the primary endpoint and change in KSQ-Lung score as key secondary.
4. Phase 2 EFZO-CONNECT Trial Progress
Enrollment in the Phase 2 EFZO-CONNECT proof-of-concept study for systemic sclerosis-associated ILD is on track to complete in the first half of 2026. The 28-week trial randomizes up to 25 patients 2:2:1 to 270 mg or 450 mg efzofitimod or placebo administered monthly for six doses to assess safety, tolerability and efficacy.
