[8-K] Stoke Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

Stoke Therapeutics reported financial results for the quarter ended June 30, 2025 and provided business updates, including new data from ongoing open label extension (OLE) studies of zorevunersen extending out to three years and the initiation of a Phase 1 clinical study of STK-002 in patients with Autosomal Dominant Optic Atrophy (ADOA).

The company furnished a press release and an investor presentation as Exhibits 99.1 and 99.2, with the presentation including certain key findings from an analysis of the OLE studies; the company states these materials are furnished, not filed, and are not incorporated by reference into other filings.

Positive

• New OLE data for zorevunersen extending out to three years, indicating continued long-term follow-up
• Initiation of a Phase 1 clinical study of STK-002 in patients with Autosomal Dominant Optic Atrophy (ADOA)
• Quarterly financial results and business updates were publicly announced and accompanied by a furnished press release and investor presentation

Negative

• None.

Insights

Biotech R&D Analyst

TL;DR: Announcement contains potentially material clinical updates—three-year OLE data disclosure and a new Phase 1 start—though no trial results are included here.

The filing signals continued clinical progress: ongoing OLE data for zorevunersen reaching three years suggests longer-term follow-up is underway, and initiation of a Phase 1 study for STK-002 broadens the pipeline into ADOA. From an R&D perspective, these are material program milestones because they support development continuity and future data flow. However, the 8-K itself provides no efficacy, safety, enrollment, or endpoint outcomes, so definitive assessment of clinical or commercial impact is not possible from this filing alone.

Clinical Development Specialist

TL;DR: Furnishing of presentation and press release is actionable for investors but lacks detailed clinical data; the Phase 1 initiation is a clear operational milestone.

Initiating a first-in-patient or Phase 1 study for STK-002 is an operationally important event that typically increases program visibility and starts the clock on early human safety and pharmacology data generation. The mention of three-year OLE follow-up for zorevunersen indicates longer-term surveillance of treated patients, which can inform durability and safety profiles. The filing does not disclose numerical results, safety signals, or timelines for upcoming data releases, limiting the ability to judge near-term valuation impact.

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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): 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

FAQ

What did Stoke Therapeutics (STOK) announce in this 8-K?

The company announced its quarter ended June 30, 2025 financial results and business updates, disclosed new OLE data for zorevunersen extending to three years, and announced initiation of a Phase 1 study for STK-002 in ADOA.

Are the press release and investor presentation included with the filing?

Yes. A press release is attached as Exhibit 99.1 and the investor presentation as Exhibit 99.2.

Does the filing provide clinical results for the zorevunersen OLE data?

No. The filing states there are new OLE data extending to three years and that key findings are in the presentation, but it does not include numerical efficacy or safety results within the 8-K text.

Is the information in the 8-K considered filed with the SEC?

The company states the press release and presentation are furnished, not filed, and therefore are not subject to certain liabilities under the federal securities laws or incorporated by reference into other filings.

Who signed the report on behalf of Stoke Therapeutics?

The report is signed on behalf of the registrant by Thomas E. Leggett, Chief Financial Officer.