Quarterly ResultMay 7, 2026, 04:20 PM
Zymeworks Q1 Net Loss $44.2M; Zanidatamab FDA PDUFA Aug 25
AI Summary
Zymeworks Inc. reported a net loss of $44.2 million for Q1 2026, compared to a $22.6 million net loss in Q1 2025, with total revenue decreasing to $2.4 million from $27.1 million due to non-recurring milestones in the prior year. The company announced significant clinical progress, including U.S. FDA Priority Review for zanidatamab with a PDUFA date of August 25, 2026, and positive Phase 1 data for ZW191. Zymeworks expects $250.0 million from Jazz for U.S. approval and $15.0 million from BeOne for China approval of Ziihera, contributing to an anticipated cash runway beyond 2028. The company also announced several leadership appointments.
Key Highlights
- U.S. FDA accepted sBLA for zanidatamab with Priority Review; PDUFA target date August 25, 2026.
- Q1 2026 net loss increased to $44.2 million from $22.6 million in Q1 2025.
- Total revenue for Q1 2026 was $2.4 million, down from $27.1 million in Q1 2025.
- Reported $403.8 million in cash, cash equivalents, and marketable securities as of March 31, 2026.
- Utilized $95.8 million for share repurchases as of May 6, 2026, under a $125.0 million program.
- Expected $250.0 million milestone from Jazz for U.S. approval of Ziihera in GEA.
- ZW191 Phase 1 trial showed 56% confirmed objective response rate in platinum resistant ovarian cancer.
- Appointed Kristin Stafford as EVP, CFO, and Dr. Adam Schayowitz as EVP, Head of R&D.