SEC Form 8-K filed by Cyclerion Therapeutics Inc.
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| Item 8.01 | Other Events |
On December 1, 2025, Akebia Therapeutics, Inc. (“Akebia”) publicly announced that it has recently initiated Phase 2 clinical trials for the treatment of focal segmental glomerulosclerosis (“FSGS”) using Praliciguat, an oral soluble guanylate cyclase licensed to Akebia by Cyclerion Therapeutics, Inc. (Cyclerion”).
Pursuant to the terms of Amendment #1 to the License Agreement by and between Akebia and Cyclerion, upon initiation (defined as first patient dosed) of a Phase 2 clinical trial in the U.S. for a product, a $1.0 million regulatory milestone payment would be due to Cyclerion. At this time, Akebia has stated that it currently expects to dose its first patient with Praliciguat in the Phase II study in 2026.
Disclaimer on 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, including, but not limited to, statements regarding planned Phase 2 clinical studies which Akebia has announced it has recently initiated for use of Praliciguat in treating FSGS and if and when Akebia will begin dosing patients in the Phase II clinical trial. Statements regarding the Company’s business and announcements by Akebia regarding the use of Praliciguat in FSGS that are not historical facts may be “forward-looking statements” that involve risks and uncertainties. Forward-looking statements are based on management’s current, preliminary expectations (based on information publicly disclosed by Akebia) and are subject to risks and uncertainties that could cause actual results to differ from the results predicted. These risks and uncertainties include risks and uncertainties included under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as updated by its subsequent filings with the SEC, all of which are available on the Company’s investor relations website at http://www.cyclerion.com and on the SEC’s website at http://www.sec.gov. Undue reliance should not be placed on 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.
| Cyclerion Therapeutics, Inc. | ||||||
| Dated: December 1, 2025 | By: | /s/ Regina Graul | ||||
| Name: | Regina Graul | |||||
| Title: | President and Chief Executive Officer | |||||