Cyclerion Reports Corporate Update and Full Year 2022 Financial Results
March 22 2023 - 04:40PM
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 driven by decreases of
approximately $1.0 million in non-cash stock-based compensation,
approximately $0.3 million in salaries and other employee-related
expenses, and approximately $6.8 million of facilities and
operating costs, partially offset by increases of approximately
$2.0 million related to zagociguat and CY3018 external research and
development costs.
- General and administrative expenses
were approximately $14.5 million for the full year 2022, as
compared to approximately $20.6 million for the full year 2021. The
decrease of approximately $6.1 million was driven by decreases of
approximately $2.3 million in non-cash stock-based compensation,
approximately $1.0 million in salaries and other employee-related
expenses, approximately $2.1 million in facilities and operating
costs, and approximately $0.7 million in outside professional and
corporate expenses.
- Net Loss: Net loss was
approximately $44.1 million for the full year 2022, as compared to
$51.6 million for the full year 2021.
About Cyclerion Therapeutics
Cyclerion Therapeutics is a 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
StatementCertain 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 U.S. Food and Drug
Administration (“FDA”) or other regulatory authority approval of,
or other action with respect to, product candidates; the Company’s
ability to successfully defend its intellectual property or obtain
necessary licenses at a cost acceptable to the Company, if at all;
the successful implementation of the Company’s research and
development programs and collaborations; the success of the
Company’s license agreements; the acceptance by the market of the
product candidates, if approved; and other factors, including
general economic conditions and regulatory developments, not within
the Company’s control. The factors discussed herein could cause
actual results and developments to be materially different from
those expressed in or implied by such statements. The
forward-looking statements are made only as of the date of this
press release and the Company undertakes no obligation to publicly
update such forward-looking statements to reflect subsequent events
or circumstance.
* MELAS (Mitochondrial Encephalopathy, Lactic
Acidosis, and Stroke-like episodes syndrome)
Investors and Media
InquiriesCyclerion Investor RelationsPhone:
857-327-8778Email: info@cyclerion.com
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