Stoke Therapeutics Reports Q1 Loss $50M; Zorevunersen 4-Year OLE Data Positive
Stoke Therapeutics reported a net loss of $50.0 million, or $0.79 per share, for Q1 2026, with revenue decreasing to $6.2 million from $158.6 million in Q1 2025 due to a prior year IP license recognition. The company announced positive new 4-year longitudinal data from its zorevunersen Phase 1/2a open-label extension studies for Dravet syndrome, showing statistically significant improvements in cognition and behavior, and durable seizure reductions. Enrollment for the Phase 3 EMPEROR study is expected to complete in June 2026, with a data readout in mid-2027 to support a rolling U.S. NDA submission in Q1 2027. Stoke also initiated a Phase 1 study for STK-002 for Autosomal Dominant Optic Atrophy and maintains a strong financial position with $411.0 million in cash, expected to fund operations into 2028.
Key Highlights
- Zorevunersen 4-year OLE data showed statistically significant improvements in cognition and behavior.
- Zorevunersen Phase 3 EMPEROR study enrollment of ~150 patients expected to complete June 2026.
- Q1 2026 net loss was $50.0 million, or $0.79 per share.
- Q1 2026 revenue was $6.2 million, down from $158.6 million in Q1 2025.
- R&D expenses increased to $39.7 million in Q1 2026 from $32.7 million in Q1 2025.
- SG&A expenses increased to $20.0 million in Q1 2026 from $14.7 million in Q1 2025.
- Cash, cash equivalents, and marketable securities totaled $411.0 million as of March 31, 2026.
- Raised $80.7 million through ATM sales in Q1 2026.