Stoke Therapeutics reports Q3 2026 results

Item 2.02 Results of Operations and Financial Condition.

On October 29, 2026, Stoke Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the quarter end September 30, 2026.¹

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description

99.1

Press release issued by Stoke Therapeutics, Inc. regarding its quarter end September 30, 2026 financial results, dated October 29, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

STOKE THERAPEUTICS, INC.

Date:

October 29, 2026

By:

/s/ Thomas E. Leggett²

Thomas E. Leggett

Chief Financial Officer²

EX 99.1

Stoke Therapeutics Announces Third Quarter 2026 Financial Results and Provides Business Updates

–Phase 3 EMPEROR study of zorevunersen, an investigational medicine for Dravet syndrome: ~110 patients through Week 28 primary endpoint, ~20 patients through Week 52 and all continuing into open-label treatment period; data readout anticipated in Q3 2027 followed by the planned U.S. NDA submission in H2 2027³–

–Successful FDA meeting to align on U.S. NDA submission: Changes in cognition and behavior, a key secondary endpoint in EMPEROR, will be analyzed using a multicomponent assessment of four Vineland-3 subdomains⁵–

–Webcast and conference call for analysts and investors at 4:30PM Eastern Time today–

BEDFORD, Mass., October 29, 2026 – Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome. The Company today reported financial results for the third quarter ended September 30, 2026, and provided business updates including progress of the global Phase 3 EMPEROR study, ongoing preparations to support regulatory submissions for zorevunersen in the U.S., and the advancement of STK-002 as a potential treatment for people with Autosomal Dominant Optic Atrophy (ADOA).

"The Phase 3 EMPEROR study of zorevunersen continues to progress well. Approximately 110 of 162 enrolled patients have completed their Week 28 visit when the primary endpoint of change in major motor seizure frequency is measured and approximately 20 are through Week 52, the end of the treatment period. All 20 of these patients are continuing into the open-label extension period of the study and to date, no patients have discontinued treatment," said Ian F. Smith, Chief Executive Officer and Director of Stoke Therapeutics. "Our NDA planning is on track following our recent discussion with the FDA. Importantly, the key secondary endpoint of changes in patients' cognition and behavior will be measured using a multicomponent assessment of four Vineland-3 subdomains. This multicomponent measure reflects the diversity of effects that people with Dravet syndrome experience and how to best evaluate them in a clinical trial. We look forward to the Phase 3 data readout in the third quarter of 2027 and completing our NDA submission in the second half of 2027."

Mr. Smith continued, "Our second clinical program, STK-002, targets the protein haploinsufficiency that causes ADOA and therefore may have the potential to improve vision in people living with this severe genetic disease that often leads to blindness. Dosing in the first two cohorts is complete and dosing in the third cohort is underway with the fourth cohort expected to follow in early 2027. Safety

EX 99.1

and efficacy data are anticipated in the first half of 2027. With this progress across the business, we are building Stoke for the future with the team and capabilities to realize the full potential of zorevunersen, our pipeline and our unique scientific approach."

Program Highlights

Dravet syndrome (zorevunersen)

• Pivotal Phase 3 EMPEROR Study Progress: Global enrollment is now complete. Enrollment of 162 patients in the primary analysis population (the United States, United Kingdom and Japan) was completed in June 2026, and a data readout from these patients is anticipated in the third quarter of 2027. Patients are progressing through the study and as of October 29, 2026:

o All 162 patients are through Week 8 and have received either two 70 mg loading doses of zorevunersen or sham.

o Approximately 130 are through Week 24 and therefore have completed three of the four doses of zorevunersen or sham in the 52-week treatment period.

o Approximately 110 are through Week 28, the time point at which the primary endpoint of change from baseline in log-transformed major motor seizure frequency is measured.

o Approximately 65 are through Week 40 and have therefore completed all doses of zorevunersen or sham in the 52-week treatment period.

o Approximately 20 are through Week 52, the end of the treatment period. All of these patients are continuing into the open-label treatment period.

o No patients have discontinued treatment in the study.

• Successful Meeting with the FDA: Stoke recently met with the U.S. Food and Drug Administration (FDA) to align on key aspects of the planned U.S. New Drug Application (NDA) for zorevunersen.⁴ Stoke plans to continue actively engaging with the FDA and to submit data throughout the first half of 2027 to support rapid completion of the NDA submission in the second half of 2027. An important outcome from the discussion included:

o New Multicomponent Assessment: For the NDA, Stoke plans to use a multicomponent assessment of four prespecified Vineland-3 subdomains to evaluate changes in cognition and behavior in the Phase 3 EMPEROR study. These fo