Stoke Therapeutics, Inc. has reported significant financial developments in its latest 10-K filing for the fiscal year ending December 31, 2024. The company, which focuses on RNA-based medicines to treat severe diseases, generated revenue of $36.6 million, a substantial increase from $8.8 million in the previous year. This growth is attributed primarily to its collaboration with Acadia Pharmaceuticals, which has yielded milestone payments and revenue from research and development services. Despite this increase in revenue, Stoke Therapeutics reported a net loss of $89.0 million for the year, down from a loss of $104.7 million in 2023, reflecting ongoing investments in research and development.

The company has made notable strides in its clinical programs, particularly with its lead product candidate, zorevunersen (STK-001), which is in late-stage clinical testing for Dravet syndrome. Following positive results from Phase 1/2a trials, Stoke Therapeutics plans to initiate a Phase 3 study, EMPEROR, in the second quarter of 2025. The company has also received Breakthrough Therapy Designation from the FDA for zorevunersen, which may expedite its development process. Additionally, Stoke is advancing its second product candidate, STK-002, for the treatment of Autosomal Dominant Optic Atrophy (ADOA), with plans for a Phase 1 study underway.

Operationally, Stoke Therapeutics has expanded its workforce to 128 employees, with a significant portion holding advanced degrees in relevant fields. The company is focused on enhancing its commercial capabilities in anticipation of potential product launches. As part of its growth strategy, Stoke has entered into a collaboration with Biogen for the global development and commercialization of zorevunersen, which includes an upfront payment of $165 million and potential milestone payments totaling $385 million. This partnership is expected to bolster Stoke's market presence and operational capacity.

Looking ahead, Stoke Therapeutics anticipates continued financial losses as it invests heavily in clinical trials and product development. The company reported cash, cash equivalents, and marketable securities totaling $246.7 million as of December 31, 2024, which it expects will fund operations through mid-2028. However, the company acknowledges the need for additional funding to support its ongoing research and development efforts, and it may seek to raise capital through equity offerings or collaborations. The future success of its product candidates will depend on the outcomes of clinical trials, regulatory approvals, and market acceptance, all of which carry inherent risks and uncertainties.

About Stoke Therapeutics, Inc.

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