Q2 2025 Stoke Therapeutics Inc Earnings Call Transcript
Key Points
- Stoke Therapeutics Inc (STOK) is in a strong growth position with a late-stage registrational medicine and a well-capitalized balance sheet.
- The Phase 3 EMPEROR study for Dravet syndrome is off to a strong start with sites initiated in the US, UK, and Japan, and Europe expected to initiate in early 2026.
- Zorevunersen has shown promising long-term potential to modify the course of Dravet syndrome, with durable seizure reductions and improvements in cognition and behavior.
- The collaboration with Biogen enhances Stoke's ability to deliver zorevunersen globally and strengthens their balance sheet.
- Stoke Therapeutics Inc (STOK) has initiated a Phase 1 study of STK-002 for autosomal dominant optic atrophy, expanding their pipeline into new genetic diseases.
- The company faces risks and uncertainties with forward-looking statements, and actual results may differ materially.
- There are challenges in correlating seizure reductions with cognitive and behavioral improvements due to variability in patient responses.
- The elevated CSF protein levels observed in the open-label extension studies could be a concern, although no clinical manifestations have been associated with it.
- The recruitment and activation of clinical trial sites are rate-limiting factors for the Phase 3 EMPEROR study.
- The timeline for potential accelerated approval of zorevunersen remains uncertain, depending on discussions with the FDA.
Good afternoon and welcome to Stoke Therapeutics' second quarter 2025 conference call. I'm Tommy Leggett, Chief Financial Officer at Stoke. Joining me for prepared remarks are Ian Smith, our Interim Chief Executive Officer, Dr. Barry Ticho, Chief Medical Officer, and Dr. Kimberly Parkerson, Head of Neurology Clinical Development.
In addition, Jason Hoitt, our Chief Patient Officer, will participate in Q&A. As a reminder, today's webcast slides are available in the Investors section of our website. This webcast is being recorded and will be available for replay later today.
Before we begin, please note that today's discussion includes forward-looking statements. These are subject to risks and uncertainties, and actual results may differ materially. Please refer to the filings with the SEC for additional information. With that, I'll turn the call over to Ian.
Welcome everyone, and thank you for joining us today. I've been working with Stoke Therapeutics for
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