Item 7.01.
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Regulation FD Disclosure.
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On September 30, 2021, Cyclerion Therapeutics, Inc. (the “Company”) released an updated corporate presentation (the “Corporate Presentation”). The
Corporate Presentation includes clinical study progress updates related to the development of CY6463, the Company’s first-in-class, CNS-penetrant soluble guanylate cyclase (sGC) stimulator for the treatment of neurological diseases associated with
cognitive impairment. The Company announces and the Corporate Presentation states that (1) first patients have been enrolled in a Phase 1b study in Cognitive Impairment Associated with Schizophrenia (CIAS); (2) enrollment remains ongoing in a Phase
2a study in Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes (MELAS), and that topline clinical results are now expected in H1 2022; and (3) patient screening is underway in a Phase 2a study in Alzheimer’s disease with
vascular pathology (ADv).
Beginning on September 30, 2021, the Company intends to use the Corporate
Presentation, or portions thereof, in one or more meetings with investors. The Corporate Presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K, is incorporated by reference herein and is posted on the Company’s website, www.cyclerion.com.
The information set forth in and incorporated by reference into this Item 7.01 is being furnished pursuant to Item 7.01 of Form 8-K and shall not be
deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the
Securities Act of 1933 or the Exchange Act, whether made before or after the date hereof, except as expressly provided by specific reference in such a filing. By filing this Current Report on Form 8-K and furnishing the information in and
incorporated by reference into this Item 7.01, the Company makes no admission as to the materiality of such information. The information contained in the presentations is summary information that is intended to be considered in the context of the
Company’s filings with the Securities and Exchange Commission (the ‘SEC’) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or
revise the information contained in this report, or incorporated by reference herein, although it may do so from time to time as its management believes is appropriate or as required by applicable law. Any such updating may be made through the
filing of other reports or documents with the SEC, through press releases, by updating its website or through other public disclosure.
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This report and the Corporate Presentation may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Exchange Act. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including
statements about the anticipated timing of release of topline results of our clinical trials; the progression of our discovery programs into clinical development; and the business and operations of the Company. We may, in some cases use terms such as
“predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these
forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the
risks listed under the heading “Risk Factors” and elsewhere in our 2020 Form 10-K filed on February 25, 2021, and our subsequent SEC filings including the Form 10-Qs filed on April 30, 2021 and July 29, 2021. Investors are cautioned not to place
undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) would speak only as of the respective dates of this report and the webcast, and the Company undertakes no obligation to update these
forward-looking statements, except as required by law.