Cyclerion Therapeutics and Beacon Biosignals Announce Expanded Strategic Partnership

Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) and Beacon Biosignals today announced an extended and expanded strategic partnership between the two companies. This collaboration is expected to identify disease-relevant biomarkers to refine patient selection and endpoints to guide the clinical development of Cyclerion's investigational therapeutics for neurological diseases associated with cognitive impairment.

Beacon Biosignals' EEG neurobiomarker platform is engineered to discover and scale new clinical paradigms for patients with neurological and psychiatric disease. Beacon Biosignals brings a world-class clinical electroencephalogram (EEG) database coupled with proprietary, artificial intelligence-based algorithms and analytical capabilities to identify neurological biomarkers of drug action and efficacy. Distinct EEG profiles are associated with neurodevelopmental status and various neurological diseases, and can be affected by neurologically active therapeutics. The platform rapidly characterizes these effects and guides dose selection in humans to help overcome the challenges of translating PK/PD models from preclinical animal studies.

Beacon Biosignals and Cyclerion previously collaborated on the analysis of data from a Cyclerion clinical translational pharmacology study of CY6463 which demonstrated clear effects on EEG parameters associated with aging and disease. These data were recently presented at the annual meeting of the American Academy of Neurology (Glasser et al., 2021). Incorporation of the Beacon Biosignals approach in ongoing and planned Cyclerion patient studies is expected to support the continued clinical development of CY6463, the Company's lead clinical program, as well as CY3018, a next-generation preclinical program.

CY6463 is an oral, first-in-class, central nervous system (CNS)-penetrant sGC stimulator that is being developed for neurological diseases associated with cognitive impairment. CY6463 was designed to address multiple pathophysiological features of neurodegenerative and neuropsychiatric diseases associated with cognitive impairment. Results from initial CY6463 clinical studies have demonstrated favorable safety and tolerability and pharmacologically relevant drug exposure in the cerebral spinal fluid. In addition, CY6463 resulted in promising impacts on EEG measures, neuroinflammation, and other neurophysiological measures that support continued clinical development.

Patient studies to further evaluate CY6463 safety and signals of clinical activity in studies in Alzheimer's disease with vascular pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) are ongoing, and a study in individuals with Cognitive Impairment Associated with Schizophrenia (CIAS) is expected to initiate shortly. Analysis of EEG and other neurological biomarkers will be an important aspect of these studies.

"Beacon Biosignals is the leader in the identification of disease-relevant EEG neurological biomarkers. We believe that the application of this technology to our innovative pipeline may be quite powerful in guiding efficient drug development, and we look forward to a productive partnership focused on successfully advancing CY6463 for diseases associated with cognitive impairment," said Andy Busch Ph.D., Chief Scientific Officer of Cyclerion Therapeutics.

"We are eager to apply our proprietary AI-based analytical capabilities to support the development of Cyclerion's promising therapeutic candidates. We believe that our platform has the capacity to identify novel disease-relevant biomarkers that may help guide patient selection or endpoint identification for future clinical development," said Jacob Donoghue, M.D., Ph.D., Chief Executive Officer of Beacon Biosignals.

About Cyclerion Therapeutics

Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments that restore cognitive function. Cyclerion is advancing novel, first-in-class, CNS-penetrant, sGC stimulators that modulate a key node in a fundamental CNS signaling pathway. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of CNS diseases. The most advanced compound, CY6463, has shown rapid improvement in biomarkers associated with cognitive function and is currently in clinical development for Alzheimer's Disease with Vascular pathology (ADv), Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS), and Cognitive Impairment Associated with Schizophrenia (CIAS). Cyclerion is also advancing CY3018, a next-generation sGC stimulator.

About Beacon Biosignals

Beacon's machine learning platform for EEG enables and accelerates new treatments that transform the lives of patients with neurological and psychiatric disease. Through novel machine learning algorithms, enormous datasets, and advances in software engineering, Beacon Biosignals is changing the way patients are treated for disorders of the brain.