STOK

Stoke Therapeutics, Inc. (STOK) - Q2 2026 Filing Summary

Business Context and Reporting Period

This Form 10-Q covers the quarterly period ended June 30, 2026. Stoke Therapeutics is a late-stage clinical biotechnology company focused on developing RNA-based medicines to upregulate protein expression for severe genetic diseases. The company's lead candidate, zorevunersen (STK-001), is in a global Phase 3 study (EMPEROR) for Dravet syndrome. A second candidate, STK-002, is in a Phase 1 study (OSPREY) for Autosomal Dominant Optic Atrophy (ADOA).

Key Financial Metrics

Note: Revenue is derived primarily from collaboration agreements with Biogen and Acadia Pharmaceuticals. There is no product sales revenue.

Material Changes vs. Prior Period

• Revenue Decline: Revenue decreased significantly year-over-year. The six-month 2025 period included a one-time recognition of $150.8 million related to the Biogen IP license performance obligation, which did not recur in 2026.
• Increased Operating Loss: Net loss widened to $61.6 million in Q2 2026 compared to $23.5 million in Q2 2025. This was driven by a $23.6 million increase in Research and Development (R&D) expenses and a $10.0 million increase in Sales, General, and Administrative (SG&A) expenses.
• R&D Spend: R&D expenses rose to $49.5 million in Q2 2026, primarily due to increased costs for the zorevunersen Phase 3 EMPEROR trial and the initiation of the STK-002 Phase 1 OSPREY trial.
• Collaboration Updates: In September 2025, Acadia terminated the MECP2 and undisclosed neurodevelopmental programs under their agreement; rights to these targets returned to Stoke. The SYNGAP1 collaboration remains active.

Guidance, Outlook, and Risks

• Clinical Milestones:
  • EMPEROR (Dravet): Enrollment of 162 patients in the U.S., UK, and Japan is complete. A Phase 3 data readout is anticipated in Q3 2027, supporting a rolling U.S. NDA submission in H2 2027 and a potential commercial launch in early 2028.
  • OSPREY (ADOA): First patient dosed in February 2026. Dosing of the first cohort is complete with no serious safety events. Readout of safety and efficacy is expected in H1 2027.
• Liquidity: Management believes current cash, cash equivalents, and marketable securities ($354.3 million), plus subsequent ATM proceeds ($65.7 million), will fund operations through the potential U.S. commercialization of zorevunersen in early 2028.
• Capital Raises: The company has an active At-The-Market (ATM) sales agreement. Since June 30, 2026, it sold approximately 2.1 million shares for net proceeds of $65.7 million.
• Risks: Key risks include the uncertainty of clinical trial outcomes, the high cost of development, reliance on third-party manufacturers, and the need for additional capital if development timelines extend or commercialization costs exceed expectations.

Investor Verification Checklist

• Revenue Recognition: Verify the timing and accounting treatment of the Biogen collaboration revenue, noting the significant drop from the 2025 upfront license recognition.
• Cash Burn Rate: Monitor the quarterly cash burn rate against the stated runway to early 2028, considering the increased R&D spend for Phase 3 trials.
• ATM Utilization: Track the volume of shares sold under the ATM program and the resulting dilution to existing shareholders.
• Clinical Enrollment: Confirm the status of patient enrollment in the EMPEROR trial, particularly the additional cohorts in Europe and China, and any potential delays.
• Collaboration Terms: Review the specific milestone triggers and royalty structures remaining in the Biogen and Acadia agreements to assess future revenue potential.