Cyclerion Reports Corporate Update and Full Year 2022 Financial Results
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
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.
- Cash, cash equivalents, and restricted cash balance on
December 31, 2022was approximately $13.4 million, as compared to approximately $20.4 millionon September 30, 2022.
- Research and development expenses were approximately
$31.5 millionfor the full year 2022, as compared to approximately $37.6 millionfor the full year 2021. The decrease of approximately $6.1 millionwas driven by decreases of approximately $1.0 millionin non-cash stock-based compensation, approximately $0.3 millionin salaries and other employee-related expenses, and approximately $6.8 millionof facilities and operating costs, partially offset by increases of approximately $2.0 millionrelated to zagociguat and CY3018 external research and development costs.
- General and administrative expenses were approximately
$14.5 millionfor the full year 2022, as compared to approximately $20.6 millionfor the full year 2021. The decrease of approximately $6.1 millionwas driven by decreases of approximately $2.3 millionin non-cash stock-based compensation, approximately $1.0 millionin salaries and other employee-related expenses, approximately $2.1 millionin facilities and operating costs, and approximately $0.7 millionin outside professional and corporate expenses.
- Net Loss: Net loss was approximately
$44.1 millionfor the full year 2022, as compared to $51.6 millionfor the full year 2021.
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, 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 MELAS, 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
* MELAS (Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like episodes syndrome)
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Source: Cyclerion Therapeutics, Inc.