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.
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