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- **Phase 3 Momentum**: Over 200 patients pre-screened for Emperor, with 20 randomized, targeting H2 2026 enrollment completion.
- **FDA Engagement**: Multidisciplinary meeting highlights potential expedited pathways, leveraging 4-year data showing 80% seizure reduction and VABS-III improvements.
- **Financial Strength**: $328.6M cash runway, 126% YoY revenue growth, and $48.7M ATM raise support long-term growth.
- **Pipeline Innovation**: ADOA shows functional vision recovery in preclinical models; SYNGAP1 advancing with CNS platform validation.

**【CEO Summary Section】**
- Stoke Therapeutics reported significant progress in its phase 3 Emperor study for zorevunersen, with over 200 patients pre-screened and 20 randomized as of Q3 2025. The study aims to evaluate the drug's efficacy in reducing seizures and improving cognitive-behavioral outcomes in Dravet syndrome.
- The company secured a multidisciplinary meeting with the FDA to discuss potential expedited regulatory pathways, leveraging four years of clinical data showing durable seizure reduction (up to 80%) and cognitive improvements (VABS-III scores improving by 8-14 points).
- Stoke emphasized its commitment to rare disease innovation, with pipeline programs targeting haploinsufficiency in CNS, eye, and heart conditions, including SYNGAP1 and ADOA.

**【CFO Financial Commentary】
- Cash reserves stood at $328.6 million as of Q3 2025, supporting operations through mid-2028. Revenue increased 126% YoY to $10.6 million, driven by collaborations with Biogen and others.
- R&D expenses rose 69% YoY to $37.7 million, reflecting investments in the Emperor study and early-stage pipeline development.
- The company executed a $48.7 million ATM offering, enhancing liquidity for future growth initiatives.

**【Q&A Highlights】
- **FDA Meeting Insights**: The FDA expressed interest in Stoke's comprehensive data package, including 4-year safety and efficacy results. Discussions focused on potential adaptive trial designs and endpoints aligned with disease-modifying outcomes.
- **Enrollment Momentum**: Over 35 additional patients entered the formal screening phase, with an 80% success rate expected. The study aims to complete enrollment by H2 2026.
- **Safety Profile**: Zorevunersen demonstrated a favorable safety profile, with CSF protein elevations observed in 86% of OLE patients but no clinical manifestations. No treatment-related discontinuations were reported.
- **Pricing Strategy**: Stoke plans to position zorevunersen as a premium rare disease therapy, benchmarking against Spinraza and CF treatments, while prioritizing patient access.
- **Pipeline Updates**: ADOA phase 1/2a studies showed functional vision improvements in non-human primates, supporting clinical translation. SYNGAP1 is advancing with preclinical validation of Stoke's platform in CNS targets.

Stoke Therapeutics Inc (STOK) Q3 2025 Earnings Call Transcript

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