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Mar 31, 2025
Stoke Therapeutics Q1 2025 Earnings Report
Stoke Therapeutics reported its first quarter 2025 financial results, highlighting strong execution in advancing zorevunersen into Phase 3 development for Dravet syndrome and a strategic collaboration with Biogen.
Key Takeaways
Stoke Therapeutics reported a net income of $112.9 million for the first quarter of 2025, a significant increase from a net loss in the prior year, driven by substantial revenue from a collaboration agreement with Biogen. The company also reported strong cash reserves, anticipated to fund operations beyond 2H 2027.
Regulatory alignment was achieved for the Phase 3 EMPEROR study of zorevunersen, with study start anticipated in 2Q 2025.
A collaboration with Biogen was established for zorevunersen, bringing in $165 million upfront and potential milestones up to $385 million.
The company reported $380.3 million in cash, cash equivalents, and marketable securities, expected to fund operations beyond 2H 2027.
Net income for the quarter was $112.9 million, or $1.90 per diluted share, a substantial improvement from a net loss of $26.4 million in the same period last year.
Revenue by Segment
Forward Guidance
Stoke Therapeutics anticipates initiating the Phase 3 EMPEROR study for zorevunersen in Q2 2025, with data readout expected in 2H 2027, which is projected to support global regulatory filings. The company's cash position is expected to fund operations beyond 2H 2027 and into launch readiness by mid-2028.
Positive Outlook
- Initiation of Phase 3 EMPEROR study for zorevunersen in 2Q 2025.
- Expected data readout for Phase 3 study in 2H 2027 to support global regulatory filings.
- Strategic collaboration with Biogen provides significant upfront capital and potential milestones.
- Cash and cash equivalents anticipated to fund operations beyond 2H 2027 and into launch readiness projected to mid-2028.
- Zorevunersen has demonstrated potential for disease modification and received orphan drug and breakthrough therapy designations.
Challenges Ahead
- The Company's ability to advance, obtain regulatory approval and ultimately commercialize its product candidates is subject to risks and uncertainties.
- If Biogen were to breach or terminate the collaboration, the Company would not obtain the anticipated financial or other benefits.
Historical Earnings Impact
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