STOK

8-K

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 11, 2026

Stoke Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-38938

47-1144582

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

45 Wiggins Ave

Bedford, Massachusetts

01730

(Address of Principal Executive Offices)

(Zip Code) Registrant’s Telephone Number, Including Area Code: (781) 430-8200

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

STOK

Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On January 11, 2026, Stoke Therapeutics, Inc. (the “Company”) issued a press release (the “Press Release”) announcing updates to timelines for the completion of enrollment and Phase 3 data readout from its ongoing EMPEROR study and that the Company expects to report that it had approximately $391.7 million in cash, cash equivalents and marketable securities as of December 31, 2025, which, when combined with eligible proceeds from the Biogen collaboration, is anticipated to fund the Company’s operations into 2028. The Company’s audited financial statements for the fiscal year ended December 31, 2025, are not yet available. Accordingly, the preliminary financial information included in the Press Release is an estimate subject to the completion of the Company’s financial closing procedures and any adjustments that may result from the completion of the audit of the Company’s financial statements. The preliminary financial information may differ materially from the actual results that will be reflected in the Company’s audited financial statements when they are completed and publicly disclosed. The information in this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1924, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), except as expressly set forth by specific reference in such a filing.

Item 7.01 Regulation FD.

On January 11, 2026, the Company issued the Press Release, a copy of which is furnished hereto as Exhibit 99.1 The information furnished with this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or the Securities Act, except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

The Press Release provides an update related to the design of the Company’s Phase 3 clinical trial of zorevunersen, including the following: Phase 3 Study of Zorevunersen

•

The Company expects to complete enrollment of 150 patients in the second quarter of 2026, with a data readout in mid-2027 that is anticipated to support the submission of a New Drug Application (an “NDA”) to the U.S. Food and Drug Administration (the “FDA”). The Company plans to initiate a rolling NDA submission in the first half of 2027.

•

The Company held a multidisciplinary meeting with the FDA to discuss the ongoing clinical development of zorevunersen, including the exploration of potential expedited regulatory pathways. No immediate changes to the zorevunersen development program we

8-K

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 04, 2025

Stoke Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-38938

47-1144582

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

45 Wiggins Ave

Bedford, Massachusetts

01730

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (781) 430-8200

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

STOK

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On November 4, 2025, Stoke Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2025. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit Number

Description

99.1

Press release issued by Stoke Therapeutics, Inc. regarding its third quarter 2025 financial results, dated November 4, 2025

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:

November 4, 2025

By:

/s/ Thomas E. Leggett

Thomas E. Leggett Chief Financial Officer

8-K

0001623526false00016235262025-08-122025-08-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 12, 2025

Stoke Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-38938

47-1144582

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

45 Wiggins Ave

Bedford, Massachusetts

01730

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (781) 430-8200

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

STOK

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On August 12, 2025, Stoke Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2025, and providing business updates, including new data from its ongoing open label extension (“OLE”) studies of zorevunersen extending out to three years and the initiation of the Phase 1 clinical study of STK-002 in patients with Autosomal Dominant Optic Atrophy (ADOA). A copy of the press release is attached as Exhibit 99.1 to this report. Item 7.01 Regulation FD. On August 12, 2025, the Company will be hosting an investor presentation (the “Presentation”), which will include business updates and certain key findings from an analysis of the ongoing OLE studies of zorevunersen. A copy of the Presentation is attached as Exhibit 99.2 to this report.

The information with this report, including Exhibits 99.1 and 99.2 to this report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this report, including Exhibits 99.1 and 99.2 to this report, shall not be incorporated by reference into any other filing under the Exchange Act or the Securities Act, except as shall be expressly set forth by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit Number

Description

99.1

Press release issued by Stoke Therapeutics, Inc. regarding its second quarter 2025 financial results, dated August 12, 2025

99.2

Presentation, dated as of August 12, 2025

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:

August 12, 2025

By:

/s/ Thomas E. Leggett

Thomas E. Leggett Chief Financial Officer