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Cyclerion Therapeutics Reports Full Year 2020 Financial Results and Corporate UpdateNovel mechanism of CY6463 demonstrated desired blood brain barrier penetration, target engagement, favorable safety and tolerability profile as well as evidence in multiple independent biomarkers associated with cognitive impairment, including neuroinflammatory biomarkers; MELAS Phase 2a study underway with top-line data anticipated in mid-2021; Phase 2a study Alzheimer’s disease with vascular pathology expected to initiate in mid-2021; Transformation to a nimble and efficient CNS organization with leading clinical and scientific advisory boards to accelerate novel approaches to restore cognitive function for patients CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function, today reported financial results for the full year 2020 and provided general corporate and pipeline updates. “The highly encouraging clinical data from our lead asset, CY6463, is guiding our clinical strategy and we expect 2021 to be an exciting year as we begin to explore the impact of modulating a key node in a fundamental CNS signaling network in patients,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “This positive momentum in the clinic includes the initiation of clinical studies in patients with Alzheimer’s disease with vascular pathology (ADv) and Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes (MELAS). Given the broad potential associated with this novel mechanism in the CNS for a range of patients, we will continue to assess additional indication opportunities for CY6463 and differentiated molecules to deliver the full potential of our pipeline.” Recent Program and Business Updates
About CY6463 CY6463 is the first CNS-penetrant sGC stimulator to be developed as a symptomatic and potentially disease modifying therapy for serious CNS diseases. Nitric oxide (NO) is one of several fundamental neurotransmitters, but it has yet to be leveraged for its full CNS therapeutic potential. CY6463 stimulates sGC, a signaling enzyme that responds to the presence of NO, to enhance the body’s natural ability to produce cyclic guanosine monophosphate (cGMP), an important signaling molecule that regulates diverse and critical biological functions in the CNS including neuronal function, neuroinflammation, cellular bioenergetics, and vascular dynamics. An impaired NO-sGC-cGMP signaling pathway is believed to play an important role in the pathogenesis of neurodegenerative diseases and is critical to basic neuronal functions. Agents that stimulate sGC to produce cGMP may compensate for deficient NO signaling. About Cyclerion Therapeutics Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion’s lead program is CY6463, a novel, first-in-class, CNS-penetrant, sGC stimulator that modulates a key node in a fundamental CNS signaling network. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. CY6463 has shown rapid improvement in biomarkers associated with cognitive impairment and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion). 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. 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. 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. Investors
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