Cyclerion Therapeutics: Pioneering New Era in Neuropsychiatric Therapies

Cyclerion Therapeutics is pioneering a new era in neuropsychiatric therapies with a relaunch as a neuropsychiatric company, backed by an MIT licensing agreement securing foundational intellectual property. The company plans to build a new era in neuropsychiatric therapies and highlight opportunities ahead, with a clinical and corporate roadmap.

Cyclerion Therapeutics, Inc. has announced a significant strategic shift with the licensing of key intellectual property from the Massachusetts Institute of Technology (MIT). This agreement marks the company's relaunch as a neuropsychiatric company, focusing on the development of innovative therapies for neuropsychiatric conditions, starting with treatment-resistant depression (TRD). The move is aimed at addressing the substantial unmet medical need for the estimated 3 million Americans suffering from TRD.

The licensing agreement secures intellectual property that will serve as the foundation for Cyclerion's new pipeline of neuropsychiatric therapies. The company's lead program utilizes known anesthetics combined with a novel delivery system to resynchronize communication between key brain regions and restore functional connectivity in patients with TRD. This approach offers a potential alternative to current limited treatment options for TRD patients.

Cyclerion's relaunch is supported by a world-class team of experts in neuropsychiatry, anesthesiology, machine learning, and therapeutic delivery. The company's operating model is designed to maximize value creation and advance programs through de-risked inflection points. A Phase 2 proof-of-concept trial for its lead program is expected to initiate in 2026, with an initial data set anticipated in 2027.

The company plans to expand its pipeline into other neuropsychiatric diseases, building a pipeline of novel, improved, or first-in-class therapies that combine clinical efficacy with commercial differentiation. Cyclerion aims to deliver precision neuropsychiatric solutions beyond TRD, potentially bringing forward additional therapies that are safe, effective, and accessible.

Cyclerion will host a webcast on September 24, 2025, at 10:30 a.m. ET, to discuss this milestone and its future plans. The webcast will be available on the company's website under the “Events” page.

The strategic relaunch positions Cyclerion to make a significant impact in the underserved therapeutic area of neuropsychiatric conditions while creating sustainable value for all stakeholders. However, the company has acknowledged substantial doubts regarding its ability to continue as a going concern, which may raise concerns among investors about its financial stability.