8-K 1 d35010d8k.htm 8-K

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, 2021

Stoke Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware |  | 001-38938 |  | 47-114582
(State or other jurisdiction of incorporation or organization) |  | (Commission File Number) |  | (I.R.S. 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

Not Applicable

(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, 2021, Stoke Therapeutics, Inc., a Delaware corporation (the “Company”), plans to present certain preliminary financial and operating information in connection with a presentation (the “Presentation”) at the J.P. Morgan Healthcare Conference, including that the Company expects to report that it had cash, cash equivalents and restricted cash of approximately $287.6 million, and 36.6 million shares of common stock outstanding, as of December 31, 2020.

The Company’s audited financial statements for the fiscal year ended December 31, 2020 are not yet available. Accordingly, the preliminary financial information included in the Presentation is an estimate subject to the completion of Company’s financial closing procedures and any adjustments that may result from the completion of the audit of Company’s financial statements. The preliminary financial information may differ materially from the actual results that will be reflected in Company’s audited financial statements when they are completed and publicly disclosed.

The information in this Item 2.02 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, 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 information contained in this Item 2.02 shall not be incorporated by reference into any registration statement or other document filed by the Company with the SEC, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in such filing (or any reference to this Current Report on Form 8-K generally), except as shall be expressly set forth by specific reference in such filing.

Item 7.01. | Regulation FD.

The Company is furnishing its corporate deck, including the information for the Presentation, a full copy of which is attached 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 Securities Exchange Act of 1934, 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, except as expressly set forth by specific reference in such a filing.

Item 8.01 | Other Events.

In addition, on January 11, 2021, the Company’s Presentation will provide a business update with respect to the timing of certain upcoming milestones, including the following:

| • |  | First Half of 2021: Initiate Swallowtail Open Label Extension (OLE) study for STK-001;

| • |  | Second Half of 2021: Initiate multiple ascending dose (MAD) study of STK-001;

| • |  | Second Half of 2021: Preliminary safety and PK data from Phase 1/2a MONARCH study of STK-001;

| • |  | Second Half of 2021: Initiate ADOA natural history data collection;

| • |  | Year-End of 2021: Complete lead optimization for OPA1 compounds; and

| • |  | Year-End of 2021: Demonstrate in vivo proof of mechanism and safety for a third program.

The Company also reported that its cash and cash equivalents are expected to fund operations into 2024.

Item 9.01 | Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number |  | Description
99.1 |  | Corporate deck, dated as of January 2021.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts, including, but not limited to, statements regarding the Company’s expected cash, cash equivalents and restricted cash as of December 31, 2020, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, the risks identified in the Company’s filings with the Securities and Exchange Commission (“SEC”), including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 12, 2020, and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect the Company’s results of operations, which would, in turn, have a significant and adverse impact on the Company’s stock price. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.

SIGNATURE

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: January 11, 2021 |  |  |  | By: |  | /s/ Stephen J. Tulipano
|  |  |  |  |  | Stephen J. Tulipano
|  |  |  |  |  | Chief Financial Officer