Tisento Launches with $81 Million From Top-Tier Investor Syndicate and Promising Cyclerion Assets
– Asset Purchase Agreement Closed; Cyclerion Received Equity Ownership in Tisento and Upfront Cash Payment –
– Tisento Developing Zagociguat in MELAS*, a Rare Primary Mitochondrial Disease with No Approved Therapies, Leveraging Extensive Preclinical and Clinical Data Generated by Cyclerion –
Zagociguat is a first-in-class, brain-penetrant sGC stimulator that modulates the nitric oxide-cyclic guanosine monophosphate (cGMP) pathway, a fundamental cell-signaling pathway, and has shown potential to treat both central nervous system (CNS) and peripheral symptoms of mitochondrial diseases. Phase 2a clinical data, generated by Cyclerion, showed rapid improvements in disease-associated biomarkers in patients with MELAS who received zagociguat for 28 days. In the study, zagociguat exhibited an excellent safety profile, exposure in the CNS and throughout the body consistent with once-daily oral dosing, and improvements across key domains of the disease pathophysiology including neuronal function, mitochondrial function, cerebrovascular hemodynamics, and inflammatory processes.
“Tisento is launching with a Phase 2b-ready asset, compelling clinical data, an experienced team led by CEO
Major Cyclerion shareholders participated in Tisento’s Series A financing, including
In the transaction, Tisento acquired from Cyclerion zagociguat and CY3018, a CNS-targeted sGC stimulator in IND-enabling studies. Cyclerion received 10 percent equity ownership in Tisento with anti-dilution protection through
“We are very pleased to have found a good solution to advance our promising brain-penetrant sGC development programs on behalf of patients with significant unmet medical needs,” said
* MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like episodes)
About Cyclerion Therapeutics
Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments for serious diseases. Cyclerion acquired 10 percent equity ownership in Tisento Therapeutics as part of an asset purchase agreement in which Tisento acquired the brain-penetrant sGC stimulators zagociguat and CY3018. Cyclerion’s current portfolio includes novel sGC stimulators, namely praliciguat and olinciguat, as well as multiple research stage molecules. Praliciguat is a systemic sGC stimulator that is exclusively licensed to Akebia and is being advanced in rare kidney disease. Olinciguat is a vascular sGC stimulator that Cyclerion intends to develop itself or out-license for cardiovascular diseases. Concurrently, Cyclerion is also evaluating other activities aimed at enhancing shareholder value, which potentially include collaborations, licenses, mergers, acquisitions and/or other targeted investments.
About Tisento Therapeutics
Tisento Therapeutics is developing novel medicines to treat diseases with significant unmet medical needs. Tisento’s lead candidate is zagociguat, a Phase 2, first-in-class, brain-penetrant sGC stimulator, which is advancing in MELAS and other genetic mitochondrial diseases. Zagociguat is ideally suited to treat mitochondrial diseases with both CNS and peripheral symptoms, such as cognitive impairment, fatigue, and muscle weakness.
Forward Looking Statement
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should”, “positive” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding the potential of zagociguat for the treatment of MELAS and other mitochondrial diseases, any future value creation to the Company from the sale, and other trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the risks that the referenced transactions may not be successful in generating future value for Cyclerion shareholders; that zagociguat and CY3018 may not demonstrate the desired safety and efficacy in ongoing and future clinical trials; the ability of Tisento to successfully develop and/or commercialize zagociguat and CY3018; the receipt of regulatory approvals and adequate financing for Tisento to develop or commercialize any of its products, the risk that the Company may be deemed an investment company and required to register as such; and other risks described in the Company’s Form 10-K for the fiscal year ended
Cyclerion Investor & Media Relations
Tisento Media Relations
Source: Cyclerion Therapeutics, Inc.