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 9, 2023
Stoke Therapeutics, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 001-38938 | 47-1144582 | ||
(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 | Name of each exchange | ||
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 7.01. | Regulation FD. |
On January 9, 2023, Stoke Therapeutics, Inc., a Delaware corporation (the “Company”), posted an updated corporate presentation with additional information to its website, in advance of making a formal presentation of such information (the “Presentation”) at the J.P. Morgan Healthcare Conference on January 10, 2023. The Company is furnishing a copy of 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. |
The Presentation provides a business update with respect to the anticipated timing of certain milestones, including the following:
STK-001: Dravet Syndrome
• | Data from patients treated with multiple doses of 45mg is expected in mid-2023; |
• | Data from patients treated with multiple doses of 70mg is expected in the second half of 2023; and |
• | The Company expects to complete Phase 1/2a in 2023 to enable a Phase 3 program in 2024. |
STK-002: Autosomal Dominant Optic Atrophy (“ADOA”)
• | Clinical Trial Application submission in the United Kingdom for planned Phase 1/2 study in patients with ADOA is expected in the first half of 2023 to enable the Company to start a Phase 1/2 study in 2024. |
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit Number | Description | |
99.1 | Presentation, dated as of January 2023. | |
104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document). |
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 ability of STK-001 to treat the underlying causes of Dravet syndrome and reduce seizures or show improvements in non-seizure comorbidities at the indicated dosing levels or at all, the ability of STK-002 to treat the underlying causes of Autosomal Dominant Optic Atrophy, and the timing and expected progress of clinical trials, data readouts and presentations for STK-001 and STK-002. Statements including words such as “anticipate,” “plan,” “will,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they prove incorrect or do not fully materialize, could cause the Company’s results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, risks and uncertainties related to: the Company’s ability to advance, obtain regulatory approval of, and ultimately commercialize its produce candidates; the timing of data readouts and interim and final results of preclinical and clinical trials; positive results in a clinical trial may not be replicated in subsequent trials or successes in early stage clinical trials may not be predictive of results in later stage trials; preliminary interim data readouts of ongoing trials may show results that change when such trials are completed; the Company’s ability to fund development activities and achieve development goals into 2025; the Company’s ability to protect its intellectual property; the direct and indirect impacts of the ongoing COVID-19 pandemic and its variants on the Company’s business; and other risks and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, its quarterly reports on Form 10-Q and the other documentation the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
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 9, 2023 | By: | /s/ Stephen J. Tulipano | ||||
Stephen J. Tulipano | ||||||
Chief Financial Officer |