Business
Cyclerion Reports Corporate Update and Full Year 2022 Financial Results
CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) today announced corporate updates including advances in its
About this update from Cyclerion Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) today announced corporate updates including advances in its zagociguat (formerly CY6463) mitochondrial disease program. The Company previously reported clinical data in adult patients with MELAS* that indicate that zagociguat may have potential as a first-ever therapy for patients with this rare, genetic mitochondrial disease. In Q4 2022, Cyclerion met with the United States Food and Drug Administration (FDA) and incorporated feedback from regulatory and mitochondrial disease clinical experts to refine the design of a Phase 2b study to evaluate zagociguat in patients with MELAS. More recently, Cyclerion filed a request with the FDA for Orphan Drug Designation and manufactured drug product to support the Phase 2b study. Given the significant capital and capabilities necessary to ensure that the Phase 2b study is executed efficiently and with the highest quality, and the currently unfavorable capital market conditions, the Company is actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat and its other clinical development candidates and to maximize shareholder value. Cyclerion is working expeditiously to deliver this potential treatment to help address the immense unmet needs of patients with MELAS, a patient population in desperate need of therapies. The Company is also working to develop and execute on the optimal strategy to advance its other wholly-owned assets: CY3018, a next-generation CNS-penetrant sGC stimulator that preferentially targets the brain and has demonstrated a unique pharmacological signature and promising profile for neuropsychiatric diseases, and olinciguat, a vascular-targeted sGC stimulator which has attractive profile in cardiovascular and cardiopulmonary diseases, areas where sGC stimulators have previously demonstrated clinical benefit. Financial Position Cash, cash equivalents, and restricted cash balance on December 31, 2022 was approximately $13.4 million, as compared to approximately $20.4 million on September 30, 2022.Research and development expenses were approximately $31.5 million for the full year 2022, as compared to approximately $37.6 million for the full year 2021. The decrease of approximately $6.1 million was ...