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.
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