Cyclerion Therapeutics Reports Third Quarter 2020 Financial Results and Recent Corporate Updates

Positive IW-6463 translational pharmacology study in healthy elderly subjects showed significant improvements in multiple measures associated with age-related cognitive decline and neurodegenerative diseases

Company revamping its organization to focus on critical IW-6463 CNS program priorities; expects 2021 average cash use reduction of approximately 50% from Q3 2020 levels

Company anticipates that its current cash will be sufficient to fund its current CNS priorities, including the MELAS and ADv studies, and further characterization of IW-6463 novel pharmacology

MELAS study expected to initiate in Q4 2020 with top-line readout in mid-2021 and the ADv study expected to initiate in 2021

CAMBRIDGE, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing innovative medicines for people with serious diseases of the central nervous system (CNS), reported financial results for the third quarter ended September 30, 2020 and provided general corporate and pipeline updates.

“We are highly encouraged by the data from our IW-6463 translational pharmacology study showing robust and consistent positive effects on multiple measures of brain neurophysiology that are associated with age-related cognitive decline and neurodegenerative diseases,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “IW-6463 is a promising new approach for CNS diseases that have very limited therapeutic options today. Building on the exciting IW-6463 translational pharmacology study results and leveraging our team’s neuroscience expertise, the Company will concentrate on developing meaningful treatments for serious CNS diseases. Our immediate priority is to rapidly and efficiently further assess the clinical profile of IW-6463, and we look forward to initiating enrollment in our MELAS study this quarter and in our ADv study in 2021.”

Recent Program and Business Updates

• IW-6463 Program Update: Cyclerion announced promising results from its Phase 1 translational pharmacology study of IW-6463, the first soluble guanylate cyclase (sGC) stimulator in clinical development for CNS disorders.
  
  Treatment with IW-6463 in the 15-day 24-subject crossover study confirmed and extended results seen in the earlier Phase 1 study: once daily oral treatment demonstrated blood-brain-barrier penetration, desired CNS exposure levels, target engagement and showed IW-6463 to be safe and generally well-tolerated. In this study, subjects receiving IW-6463 showed improvements in several neurophysiological and objective performance measures that are associated with age-related cognitive decline and neurodegenerative diseases. Effects on cerebral blood flow and markers of bioenergetics were not observed in this study of healthy elderly subjects.