Cyclerion Announces Corporate Updates and Q1 2023 Financial Results
Definitive agreement reached with new company (“NewCo”) established by certain Cyclerion shareholders and new investors
Cyclerion to receive
Definitive agreement signing triggers previously announced
Definitive Agreement Signed
Go Forward Strategy
Previously, Cyclerion out-licensed the peripherally active sGC stimulator praliciguat to Akebia Therapeutics, Inc. (“Akebia”), a leading biopharmaceutical company focused on kidney disease. Under the terms of that agreement, the Company is eligible to receive up to
These external development deals make up a growing diverse portfolio of upside value for our shareholders and the potential for non-dilutive funds from upfront and milestone payments and/or monetization of equity positions and royalties. The externalization of the initial sGC assets means that Cyclerion now has the opportunity to bring in new assets to develop using its highly efficient and externalized model. The Company will initially target assets in the CNS therapeutic area that are at a later stage of development and can be advanced to approval more quickly.
Upon approval of the current transaction by Cyclerion shareholders,
Board of Directors
Current independent board member
“I am excited to have a unique platform from which to exercise my passion for finding underappreciated and undervalued neuro assets. I’ve been fortunate to have had multiple successful opportunities to uncover important neuro therapies through approval that are having profound impacts on patients’ lives, and I’ve done so in a variety of circumstances, including small biotechs” said
ADv Study Results
Cyclerion recently completed the analysis of its signal-seeking clinical study of zagociguat for the potential treatment of Alzheimer’s disease with vascular pathology (ADv) (NCT04798989). This exploratory, randomized, placebo-controlled, study of oral once-daily zagociguat was designed to evaluate safety, tolerability, and pharmacokinetics as well as explore the impact on biomarkers and cognitive performance over a twelve-week dosing period. The total number of participants in the study was capped at 12 participants due to challenges associated with enrollment. Data from this study show that the safety and tolerability profile of once-daily zagociguat was consistent with prior studies. Given the small number of participants Cyclerion is unable to draw any conclusions from the data generated in the study.
Signing of the definitive agreement today triggered the previously announced
- Cash, cash equivalents, and restricted cash balance on
March 31, 2023was approximately $7.2 million, as compared to approximately $13.4 millionon December 31, 2022.
- Research and development expenses were approximately
$3.8 millionfor Q1 2023, as compared to approximately $9.7 millionfor Q1 2022. The decrease of approximately $6.0 millionwas primarily driven by decreases of $3.1 millionin external research and development costs related to zagociguat and CY3018, $1.6 millionin employee-related expenses, $0.6 millionin non-cash stock-based compensation, and $0.6 millionin professional services.
- General and administrative expenses were approximately
$3.3 millionfor Q1 2023, as compared to approximately $4.0 millionfor Q1 2022. The decrease of approximately $0.7 millionwas primarily driven by a decrease in non-cash stock-based compensation.
- Net Loss: Net loss was approximately
$7.0 millionfor Q1 2023, as compared to approximately $13.0 millionfor Q1 2022.
Cyclerion Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop treatments for serious diseases. Cyclerion’s portfolio includes novel sGC stimulators that modulate a key node in a fundamental signaling network in both the CNS and the periphery. The multidimensional pharmacology elicited by the stimulation of sGC has the potential to impact a broad range of diseases. Zagociguat is a CNS-penetrant sGC stimulator that has shown rapid improvements across a range of endpoints reflecting multiple domains of disease activity, including mitochondrial disease-associated biomarkers. CY3018 is a CNS-targeted sGC stimulator in preclinical development that preferentially localizes to the brain and has a pharmacology profile that suggests its potential for the treatment of neuropsychiatric diseases and disorders. Praliciguat is a systemic sGC stimulator that is licensed to Akebia and being advanced in rare kidney disease. Olinciguat is a vascular sGC stimulator that the Company intends to out-license for cardiovascular diseases. For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on Twitter (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).
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 assessment of the best combination of capital, capabilities, and transactions available to it resulting in the Company pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms, the success of any such potential transactions in delivering any future value to the Company, the sufficiency of any expected revenues to provide liquidity and capital resources to pursue any of our go-forward business plans regarding any product candidate, the potential for zagociguat in the treatment of mitochondrial diseases, the potential for CY3018 in the treatment of CNS diseases, the potential for olinciguat in the treatment of cardiovascular and cardiopulmonary diseases, the potential for any successful development of any of our assets, 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 success of any transactions in delivering any future value to the company, our ability to succeed with any go-forward business, the sufficiency of any expected proceeds to provide liquidity and capital resources to pursue any of our go-forward business plans regarding any product candidate (including without limitation our ability to fund additional clinical trials); any ability to successfully demonstrate the efficacy, safety and therapeutic effectiveness of any product candidate; any results of clinical studies not necessarily being indicative of or supported by the final results of subsequent clinical trials; the timing of and ability to pursue, obtain and maintain
* sGC (Soluble guanylate cyclase)
** PAH (Pulmonary arterial hypertension)
*** HFrEF (Heart failure with reduced ejection fraction)
Investors and Media Inquiries
Cyclerion Investor Relations
Source: Cyclerion Therapeutics, Inc.