Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage
biopharmaceutical company on a mission to develop treatments that
restore cognitive function, announced today clinical development
progress for CY6463, its lead program, and first quarter 2022
financial results.
“We are building on three previously reported
clinical studies that demonstrated a favorable safety and
tolerability profile for CY6463 with exposure in the brain that led
to neurophysiology changes associated with cognition, by continuing
to characterize the novel neuropharmacology of NO-sGC-cGMP signal
modulation and advancing CY6463 toward data readouts in three
exploratory clinical studies in CNS diseases associated with
cognitive impairment.” said Peter Hecht, Ph.D., Chief Executive
Officer of Cyclerion Therapeutics. “We have recently closed
enrollment on our CY6463 studies in MELAS and CIAS and look forward
to obtaining topline clinical data from these exploratory studies
in Q2 and Q3 2022, respectively. We expect that these pending data
may provide further evidence supporting the optimal clinical
utility for our most advanced CNS penetrant sGC stimulator and
refine our plans for further development efforts, including dose
and patient selection, and study endpoints. We have also continued
to enroll our CY6463 study in Alzheimer’s Disease with vascular
pathology, while efficiently driving Cyclerion’s earlier stage
research programs forward.”
Clinical Pipeline Updates
Mitochondrial Encephalomyopathy, Lactic
Acidosis, and Stroke-like episodes (MELAS)
The MELAS trial (NCT04475549) is an open-label,
single-arm study of oral, once-daily CY6463 in adults aged 18 or
older with MELAS. The study includes measures of safety,
tolerability, pharmacokinetics, and exploratory pharmacodynamic
effects, including MRI and various disease-relevant biomarkers.
Study enrollment has closed, and topline data are expected in Q2
2022.
Cognitive Impairment Associated with
Schizophrenia (CIAS)
The CIAS trial (NCT04972227) is a randomized,
placebo-controlled, multiple-ascending-dose study of oral,
once-daily CY6463 in adults aged 18-50 diagnosed with
schizophrenia. The study includes measures of safety, tolerability,
pharmacokinetics, and pharmacodynamics, including a broad battery
of EEG-based assessments and a computerized battery of cognitive
performance tests. Study enrollment has closed, and topline data
are expected in Q3 2022.
Alzheimer’s disease with vascular pathology
(ADv)
The ADv trial (NCT04798989) is a randomized,
placebo-controlled study of oral, once-daily CY6463 over a
twelve-week dosing period. Study participants must have confirmed
Alzheimer’s disease pathology as assessed by PET or CSF biomarkers,
cardiovascular risk factors, as well as mild-to-moderate
subcortical small-vessel disease as assessed by MRI. The study will
evaluate safety, tolerability, and pharmacokinetics as well as
explore the impact of CY6463 on various disease-relevant
pharmacodynamic biomarkers (e.g., EEG, MRI, neuroinflammatory
biomarkers) and cognitive performance. The ADv study is active, and
enrollment is ongoing.
First Quarter 2021 Financial
Results
- Cash Position: Cash, cash
equivalents, and restricted cash balance on Mar. 31, 2022 was
approximately $41 million, as compared to approximately $54 million
on Dec. 31, 2021.
- Research & Development
Expenses: R&D expenses were approximately $9.7 million for the
first quarter of 2022, as compared to approximately $8.0 million
for the first quarter of 2021. The increase of approximately $1.7
million was driven by increases in external research costs,
partially offset by decreases in employee-related expenses and
facilities and operating costs.
- General and Administrative
Expenses: G&A expenses were approximately $4 million for the
first quarter of 2022, as compared to approximately $5.4 million
for the first quarter of 2021. The decrease of $1.4 million was
driven by decreases in employee-related expenses and facilities and
operating costs.
- Net Loss: Net loss was
approximately $13.0 million for the first quarter of 2022, as
compared to $13.4 million for the first quarter of 2021.
About CY6463
CY6463 is the first CNS-penetrant sGC stimulator
to be developed as a symptomatic and potentially disease-modifying
therapy for serious CNS diseases. The nitric oxide (NO)-soluble
guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP)
signaling pathway is a fundamental mechanism that precisely
controls key aspects of physiology throughout the body. In the CNS,
the NO-sGC-cGMP pathway regulates diverse and critical biological
functions including neuronal function, neuroinflammation, cellular
bioenergetics, and vascular dynamics. Although it has been
successfully targeted with several drugs in the periphery, this
mechanism has yet to be fully leveraged therapeutically in the CNS,
where impaired NO-sGC-cGMP signaling is believed to play an
important role in the pathogenesis of many neurodegenerative and
neuropsychiatric diseases and other disorders associated with
cognitive impairment. As an sGC stimulator, CY6463 acts as a
positive allosteric modulator to sensitize the sGC enzyme to NO,
increase the production of cGMP, and thereby amplify endogenous NO
signaling. By compensating for deficient NO-sGC-cGMP signaling,
CY6463 and other sGC stimulators may have broad therapeutic
potential as a treatment to improve cognition and function in
people with serious CNS diseases.
About Cyclerion
Therapeutics
Cyclerion Therapeutics is a clinical-stage
biopharmaceutical company on a mission to develop treatments that
restore cognitive function. Cyclerion is advancing novel,
first-in-class, CNS-penetrant, sGC stimulators that modulate a key
node in a fundamental CNS signaling pathway. The multidimensional
pharmacology elicited by the stimulation of sGC has the potential
to impact a broad range of CNS diseases. The most advanced
compound, CY6463, has shown rapid improvement in biomarkers
associated with cognitive function and is currently in clinical
development for Alzheimer's Disease with Vascular pathology (ADv),
Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like
episodes (MELAS), and Cognitive Impairment Associated with
Schizophrenia (CIAS). Cyclerion is also advancing CY3018, a
next-generation sGC stimulator. 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
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Our forward-looking statements are based on
current beliefs and expectations of our management team that
involve risks, potential changes in circumstances, assumptions, and
uncertainties, including statements about the anticipated timing of
release of topline results of our clinical trials, the progression
of our clinical programs, and the business and operations of the
Company. We may, in some cases use terms such as “predicts,”
“believes,” “potential,” “continue,” “anticipates,” “estimates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,”
“will,” “should” or other words that convey uncertainty of the
future events or outcomes to identify these forward-looking
statements. Each forward-looking statement is subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied in such statement. Applicable risks
and uncertainties include the risks listed under the heading “Risk
Factors” and elsewhere in our 2021 Form 10-K filed on February 24,
2022, and our subsequent SEC filings. Investors are cautioned not
to place undue reliance on these forward-looking statements. These
forward-looking statements (except as otherwise noted) speak only
as of the date of this press release, and Cyclerion undertakes no
obligation to update these forward-looking statements, except as
required by law.
Investors
Carlo Tanzi, Ph.D.Kendall Investor
Relationsctanzi@kendallir.com
MediaAmanda SellersVerge Scientific
Communicationsasellers@vergescientific.com
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