Praliciguat

- Dina Katabi, Ph.D.: World leader in healthcare AI applications at MIT; inventor of groundbreaking wireless devices for passive assessment of symptoms, behavior, and treatment responses in neurological and psychiatric disorders - Michael Higgins: Seasoned biopharma executive possessing business and financial acumen with CEO and extensive board experience; former entrepreneur-in-residence at Polaris Partners with a track record of launching successful companies CAMBRIDGE, Mass., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a biopharmaceutical company on a mission to develop treatments for serious diseases, today announced the appointments of Dina Katabi, Ph.D., and Michael Higgins to its Board of Directors. “Dina and Michael bring a unique combination of leadership capabilities, operating experience, and vast cutting-edge scientific knowledge. Having a world-renowned innovator and a biopharma veteran join the board facilitates the transformation of Cyclerion as we look ahead to possible licenses, mergers, acquisitions and/or other targeted investments,” said Errol DeSouza, Ph.D., chairperson of Cyclerion Therapeutics. Dina Katabi, Ph.D., is the Thuan and Nicole Pham Professor of Electrical Engineering and Computer Science at the Massachusetts Institute of Technology (MIT), the director of MIT’s Center for Wireless Networks and Mobile Computing, and a member of the National Academy of Engineering, the National Academy of Sciences, and the American Academy of Arts and Sciences. She is also a recipient of the MacArthur Genius Award. Her research focuses on digital health, machine learning, and wireless and mobile technologies. Several start-ups have been spun out of Dr. Katabi's lab. She is the co-founder and president of Emerald Innovations, a health analytics company that specializes in digital health solutions for passive, contactless, in-home monitoring. She received her Ph.D. and M.S. in Computer Science from MIT and her B.S. from Damascus University. Michael Higgins is a serial entrepreneur who has helped launch and build numerous companies during his 30+ year career. Michael served as Voyager Therapeutics’ Interim Chief Executive Officer from June 2021 to March 2022. In this role he was able to stabilize and relaunch the company through the completion of three major business development deals, and the restructuring of the management team and research portfolio. Mr. Higgins was an entrepreneur-in-residence at Polaris Partners from 2015 to 2020 where he helped the founding team launch Camp4 Therapeutics. From 2003 through 2014 he served as Senior Vice President, Chief Operating Officer at Ironwood Pharmaceuticals Inc., evolving the company from its early days as a venture backed start-up to a fully integrated commercial organization. Mr. Higgins has been a long-time board member and board chair at other public and private companies. He is currently Chairman of the Board of Voyager Therapeutics as well as Pulmatrix Therapeutics. He also served as Audit Committee Chair at Voyager and has extensive compensation committee and governance committee experience. His financial expertise ranges from seed stage financing to IPOs, and beyond. He earned a B.S. from Cornell University and an M.B.A. from the Amos Tuck School of Business at Dartmouth College. About Cyclerion TherapeuticsCyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments for serious diseases. Cyclerion acquired 10 percent equity ownership in Tisento Therapeutics as part of an asset sale agreement in which Tisento acquired the brain-penetrant soluble guanylate cyclase (sGC) stimulators zagociguat and CY3018 acquired from Cyclerion. Cyclerion’s current portfolio includes novel sGC stimulators, namely praliciguat and olinciguat, as well as multiple research stage molecules. Praliciguat is a systemic sGC stimulator that is exclusively licensed to Akebia and is being advanced in rare kidney disease. Olinciguat is a vascular sGC stimulator that Cyclerion intends to out-license for cardiovascular diseases. Concurrently, Cyclerion is also evaluating other activities aimed at enhancing shareholder value, which potentially include collaborations, licenses, mergers, acquisitions and/or other targeted investments. Forward Looking StatementCertain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should”, “positive”, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements about pursuing collaborations, licenses, mergers, acquisitions and/or other targeted investments aimed at enhancing shareholder value. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including, those under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 22, 2023 and in our Form 10-Q filed with the SEC on July 28, 2023, as well as our subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. ContactsInvestor & Media RelationsPhone: 857-327-8778Email: IR@cyclerion.com

Cyclerion Therapeutics had taken its lead drug candidate into the clinic, obtaining encouraging data in a rare disease. But the company was running out of cash to support that program and others in its pipeline. A key Cyclerion financial backer stepped in with a deal to acquire that asset and continue its development in a new biotech company. That startup, the mitochondrial diseases-focused Tisento Therapeutics, formally launched on Monday, nearly three months after the deal was first announced. Cambridge, Massachusetts-based Tisento is backed by $81 million in Series A financing. Tisento’s lead program is zagociguat, a small molecule previously known as CY6463 under Cyclerion. This drug is designed to penetrate the brain to stimulate soluble guanylate cyclase (sGC), an enzyme key to the nitric oxide signaling pathway. This pathway controls aspects of physiology throughout the body, including mitochondrial function. Cyclerion was developing zagociguat for mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes, a rare disease typically shortened to “MELAS.” This disorder affects the energy-producing components of cells called mitochondria and leads to central nervous system problems, cognitive impairment, fatigue, and muscle weakness. In mid-2022, Cyclerion announced data from an open-label Phase 1 study showing encouraging effects were observed on various aspects of MELAS in six of the eight patients in the study. Last October, Cyclerion announced it would hone its focus on mitochondrial disease, a strategy shift that led to the layoff of 45% of its staff. But cash continued to be problem. CEO Peter Hecht was part of a group that tried to buy some of Cyclerion’s assets to continue their development. The company’s independent board of directors unanimously turned down that proposal. This past March, in its report of 2022 financial results, Cyclerion reported a cash position totaling just $13.4 million. In May, Cyclerion announced a deal to sell zagociguat and another asset, the preclinical CY3018, for $8 million cash and another $2.4 million to cover employee and development expenses for zagociguat. Cyclerion also received a 10% equity stake in Tisento as well as the right to purchase additional equity in the future. Hecht, who is also CEO of Tisento, personally invested $5 million in Cyclerion. Tisento’s Series A financing includes participation of major Cyclerion shareholders, including Invus, Hecht, Polaris, and others. They are joined in the Tisento investor syndicate by Sanofi Ventures, Venrock, J. Wood Capital, and other unnamed investors. Meanwhile, Cyclerion says it now has enough cash to last into 2025. Errol De Souza, chair of Cyclerion’s board, said in a prepared statement that the company will continue an “externalized business model” in which it targets later-stage, de-risked CNS assets that can be quickly advanced in development. In parallel, the company will explore ways to advance its systemic sGC stimulator drugs. The remaining pipeline includes praliciguat, a systemic sGC stimulator that is licensed to Akebia Therapeutics and is in clinical development for treating rare kidney diseases. Olinciguat is a clinical-stage vascular sGC stimulator that the company intends to out-license for cardiovascular diseases. “We are very pleased to have found a good solution to advance our promising brain-penetrant sGC development programs on behalf of patients with significant unmet medical needs,” De Souza said. “In the midst of this extremely challenging financing climate for the biotech industry, we’re honored to partner with an excellent syndicate of investors.”