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Mar 31, 2024
Stoke Therapeutics Q1 2024 Earnings Report
Stoke Therapeutics reported financial results for the first quarter of 2024 and provided business updates.
Key Takeaways
Stoke Therapeutics reported a net loss of $26.4 million, or $0.57 per share, for the first quarter of 2024. The company's cash and cash equivalents totaled $178.6 million as of March 31, 2024. Revenue for the quarter was $4.2 million, primarily from the Acadia Pharmaceuticals collaboration.
Shared positive new data from 81 patients treated in the Phase 1/2a and OLE studies of STK-001 in children and adolescents with Dravet syndrome.
Plans to meet with regulatory agencies to discuss a randomized, controlled registrational study design with initial doses of 70mg of STK-001 followed by continued dosing at 45mg.
Completed an underwritten public offering of common stock and pre-funded warrants that resulted in net proceeds of $120.3 million.
Expanded and strengthened its management team with the appointments of Jason Hoitt as Chief Commercial Officer and Thomas (Tommy) Leggett as Chief Financial Officer.
Stoke Therapeutics
Stoke Therapeutics
Stoke Therapeutics Revenue by Segment
Revenue by Segment
Biogen Revenue
CapyFin.com Forward Guidance
The company plans to meet with regulatory agencies to discuss registrational study design for STK-001 and anticipates an update in the second half of 2024.
Positive Outlook
- Advancing STK-001, a disease-modifying medicine for Dravet syndrome.
- Data showed substantial and durable reductions in seizure frequency.
- Clinically meaningful improvements across multiple measures of cognition and behavior.
- Working with a sense of urgency to meet with regulatory agencies.
- Plans to initiate the Phase 1 study (OSPREY) of STK-002 for the treatment of Autosomal Dominant Optic Atrophy (ADOA) in 2024.
Challenges Ahead
- Risks related to the ability to advance, obtain regulatory approval of, and ultimately commercialize product candidates.
- The timing of data readouts and interim and final results of preclinical and clinical trials is uncertain.
- Receipt and timing of potential regulatory decisions are uncertain.
- Positive results in a clinical trial may not be replicated in subsequent trials.
- Successes in early stage clinical trials may not be predictive of results in later stage trials.