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Cyclerion Announces Translational Research Award from the Alzheimer’s Association Part the Cloud-Gates Partnership Grant Program

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CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing treatments for serious and orphan diseases, today announced that it has been awarded a grant from the Alzheimer's Association’s Part the Cloud-Gates Partnership Grant Program. This award will support the Company’s upcoming Phase 2 trial of IW-6463 in Alzheimer’s Disease with vascular pathology (ADv). The award provides Cyclerion with $2 million of funding over the next 2 years.

“We are very pleased to have won this highly competitive award from the Alzheimer’s Association Part the Cloud-Gates Partnership Grant Program. Human genetic evidence and preclinical data suggest that stimulation of soluble guanylate cyclase (sGC) with IW-6463 can alleviate neurodegenerative pathology at the cellular level and thereby restore neuronal health and function. The clinical work supported by this grant will further our understanding of treatment potential of our approach and inform our efforts to find meaningful new treatments for dementias,” said Andy Busch, Ph.D., Cyclerion’s Chief Innovation Officer

“As a practicing neurologist I have seen first-hand the devastating impact that dementias have on patients and their families. Patients and physicians are eager for better therapies and we need to explore new mechanistic approaches. We believe that IW-6463 has the potential to improve cognitive symptoms of dementia and may also be disease modifying – changing the course of many neurodegenerative diseases via potential neurovascular, neuroprotective, cellular bioenergetic, and neurophysiological benefits,” said Chris Wright, M.D., Cyclerion’s Chief Medical Officer.

IW-6463 has successfully completed a Phase 1 study and is now being studied in a translational pharmacology study in elderly participants. Top line data from this study are expected in September 2020. Cyclerion R&D leaders and independent experts reviewed the company’s CNS program in a webcast investor event on July 9, 2020. The presentation and transcript from that event are available at the “Investors and Media” section of the Cyclerion website: https://ir.cyclerion.com/news-events/presentations

About Cyclerion Therapeutics
Cyclerion Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of sGC pharmacology to discover, develop, and commercialize breakthrough treatments for serious and orphan diseases. Lead programs include its vascular-targeted olinciguat in Phase 2 development for sickle cell disease and IW-6463, a pioneering CNS-penetrant sGC stimulator in clinical development for Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) and Alzheimer's Disease with Vascular pathology (ADv).

For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).

About Alzheimer's Association and its Part the Cloud-Gates Partnership Grant Program
As the world’s largest nonprofit funder of Alzheimer's research, the Alzheimer's Association is committed to accelerating the global effort to eliminate Alzheimer's. The Association’s Part the Cloud program aims to accelerate the translation of possible therapeutics in the clinical setting. Bill Gates and Part the Cloud have partnered to accelerate research exploring specific areas of neurodegeneration, neuroinflammation, and immune responses that contribute to the development of Alzheimer’s and dementia.

For more information, visit http://www.alz.org

About IW-6463

IW-6463, a CNS-penetrant sGC stimulator, is being developed as a symptomatic and potentially disease modifying therapy for neurodegenerative diseases. In preclinical studies, IW-6463 has been associated with increased cerebral blood flow, reduced markers of neuroinflammation, enhanced cognition, neuroprotection and enhanced cellular bioenergetics. Nitric oxide is one of several fundamental neurotransmitters, but it has yet to be leveraged for its full CNS therapeutic potential. sGC stimulators work synergistically with the nitric oxide naturally produced in the body to boost the positive effects of nitric oxide, even when the body is not producing enough. Extensive human genetic and preclinical data implicate nitric oxide signaling defects in neurodegenerative diseases. Evidence indicates that nitric oxide dysregulation leads to vascular contributions to neurodegenerative disease (e.g. endothelial cell damage, decreased blood flow and impaired vascular reactivity) and may also directly increase inflammation, neuronal dysfunction/loss and cognitive impairment. sGC is expressed widely throughout the CNS and CNS vasculature. IW-6463 has successfully completed a Phase 1 study and is now being studied in a translational pharmacology study in elderly participants.

Forward Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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 Cyclerion. 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. Investors are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Cyclerion undertakes no obligation to update these forward-looking statements, except as required by law. Applicable risks and uncertainties include the risks listed under the heading “Risk Factors” and elsewhere in our 2019 Form 10-K filed on March 12, 2020, and in Cyclerion’s subsequent SEC filings, including the Form 10-Q filed on May 4, 2020 and the Form 10-Q filed on August 3, 2020, including without limitation that we will need to raise additional funding to further advance our product candidates, including IW-6463 and olinciguat, which funding may not be available on acceptable terms or at all, and that there can be no assurances that we will demonstrate safety and efficacy of such product candidates under regulatory requirements or for various other reasons ever commercialize any such product candidates.

Carlo Tanzi, Ph.D.
Kendall Investor Relations