Cylerion Therapeutics, Inc. (NASDAQ: CYCN), a biopharmaceutical company whose mission is to develop treatments that restore cognitive function, recently reported financial results for 2Q2021 and provided general corporate and pipeline updates.
The company’s cash and cash equivalents at the end of the second quarter were approximately $70 million, compared to $45 million at the end of the first quarter. In addition, R&D expenses in the second quarter were approximately $12.1 million, compared to $13.8 million in a similar period last year. The company also recorded a loss of $16.2 million, an improvement from $19.5 million from a similar period in 2020.
According to Peter Hecht, P.h.D., C.E.O. of Cyclerion, during the first half of the year, the company has made significant progress in advancing its lead program CY6463 into clinical development for multiple neurological indications where they believe they could have meaningful therapeutic impact. This positive momentum in the clinic includes the advancement of the clinical studies in patients with Mitochondrial Encephalomyopathy, Lactic acidosis, Alzheimer,s Disease Vascular pathology (ADv) and Stroke-like episodes (MELAS) and the initiation of start-up activities for a clinical study in patients with Cognitive Impairment Associated with Schizophrenia (CIAS). In addition, the company has also conducted additional preclinical work to support the development of CY3018, a differentiated, next-gen, CNS-penetrant sGC simulator, into clinical development for several serious neurological complications.
The U.S. Food and Drug Administration (F.D.A.) reviewed the Investigational New Drug (IND) application for CY6463 in ADv and informed the company that it may proceed. As a result, Cyclerion has initiated a 12-week Phase 2a clinical trial in patients with ADv. The F.D.A. also notified the company that its Ph1b clinical trial in participants with CIAS might proceed, and study start-up activities are ongoing.
Partnership with Beacon
The company also announced an extended and expanded strategic partnership with Beacon Biosignals. This collaboration is expected to identify disease-relevant biomarkers to improve patient selection and endpoints to guide the clinical development of Cyclerion’s investigational therapeutics for neurological diseases associated with cognitive impairment. Meanwhile, the company’s exploratory 29-day open-label Phase 2a pilot study in patients with MELAS is ongoing, and data is expected to be released by the end of 2021.