Cyclerion Therapeutics Reports Third Quarter 2021 Financial Results and Corporate Update
November 09 2021 - 4:01PM
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage
biopharmaceutical company on a mission to develop treatments that
restore cognitive function, reported today results for the third
quarter 2021 and provided general corporate and pipeline updates.
“Cyclerion has made pipeline progress with three
ongoing clinical studies related to CY6463, our lead
investigational candidate. CY6463 development program is supported
by completed clinical studies including a translational
pharmacology study that demonstrated efficient entry into the brain
and positive effects on multiple measures of brain neurophysiology
associated with cognition. Our strategy is to pursue small
concurrent signal-seeking studies to evaluate CY6463 in multiple
CNS diseases where effective treatment options are lacking today.
We plan to review the clinical data from our ongoing exploratory
studies to determine how to optimally advance to later stages of
development,” said Peter Hecht, Ph.D., Chief Executive Officer of
Cyclerion.
“We are pleased to have recently initiated
enrollment in our CY6463 clinical study in patients with Cognitive
Impairment Associated with Schizophrenia (CIAS), a debilitating
aspect of schizophrenia that affects over two million patients in
the U.S. alone. There is a tremendous societal need for new
treatment options for schizophrenia, especially for its cognitive
aspects. In addition, we’ve continued to make progress with our
clinical studies in Alzheimer’s disease with vascular pathology
(ADv) and Mitochondrial Encephalomyopathy, Lactic Acidosis, and
Stroke-like episodes (MELAS). We believe that CY6463 has the
potential to provide a much-needed new treatment option for each of
these serious diseases that affect cognition, and we intend to
aggressively advance each of our ongoing development studies and
evaluate the data” said Cheryl Gault, Chief Operating Officer of
Cyclerion.
Recent Program and Business
Updates
Cyclerion continues to develop CY6463 with
signal-seeking studies in CIAS, ADv, and MELAS:
- The CIAS trial (NCT04972227)
is a randomized, placebo-controlled, multiple-ascending dose study
of oral once-daily CY6463 in up to 60 adults aged 18-50 with
schizophrenia. The study will evaluate safety, tolerability,
pharmacokinetics, and pharmacodynamics over 14 days of dosing and
includes a broad battery of EEG-based tests and computerized
battery of cognitive tests. Clinical sites are actively recruiting,
and the first participants have been enrolled into the study.
- The ADv trial (NCT04798989) is a
randomized placebo-controlled study of oral CY6463 in approximately
30 adults older than 65 years of age to evaluate safety,
tolerability, and pharmacodynamic effects (EEG, MRI, CSF
biomarkers, cognition). CY6463 will be administered once-daily for
12 weeks. Participants must have confirmed AD pathology as assessed
by PET and/or CSF biomarkers, cardiovascular risk factors, as well
as mild-moderate subcortical small-vessel disease as assessed by
MRI. The study is active and patient screening is underway.
- The MELAS trial (NCT04475549) is an
open-label, single-arm study in up to 20 participants aged 18 or
older to evaluate safety, tolerability, pharmacokinetics, and
pharmacodynamics of oral CY6463 in MELAS. CY6463 will be
administered once-daily for up to 29 days. Enrollment in the MELAS
study has been slowed by several factors, including COVID-19 and
disease-specific operational challenges. Cyclerion has implemented
measures to improve enrollment and will continue to work with the
participating centers of excellence to enroll participants through
the end of 2021. Clinical data are expected in H1 2022.
In September, Cyclerion announced a publication
in the Journal of Neuroinflammation demonstrating that
administration of a small molecule soluble guanylate cyclase (sGC)
stimulator reduced markers associated with neuroinflammation in
multiple preclinical models. Neuroinflammation is a hallmark of
numerous CNS diseases, including Alzheimer’s disease and other
neurodegenerative diseases, and targeting this pathology is a
promising drug development strategy.
Investor Conferences
In September, Cyclerion presented at two
investor conferences: H.C. Wainwright 23rd Annual Global Investment
Conference and Cantor Fitzgerald Virtual Global Healthcare
Conference.
Cyclerion will participate in the upcoming
Jefferies London Healthcare Conference. The corporate presentation
will be available on-demand beginning on Thursday, November 18 and
will remain available for 30 days in the investor section of the
Cyclerion website.
Third Quarter 2021 Financial
Results
- Cash Position:
Cash, cash equivalents, and restricted cash balance on September
30, 2021 was approximately $63 million, as compared to
approximately $70 million on June 30, 2021. The Company’s operating
discipline, including workforce and leased space reductions,
decreased cash burn rate in 2021 compared to 2020.
- Research &
Development Expenses: R&D expenses were approximately $7.0
million for the third quarter of 2021, as compared to approximately
$13.7 million for the third quarter of 2020. The decrease of
approximately $6.7 million was driven by a decrease of
approximately $3.9 million in salaries and other employee-related
expenses, a decrease of approximately $2.8 million of facilities
and operating costs and a decrease of $2.0 million related to
completion of the STRONG-SCD study in October 2020, a decrease of
$0.5 million in discovery, offset by increases of $1.5 million
associated with CY6463 clinical trials (MELAS, CIAS, and Adv) and
$1.0 million for CY3018 preclinical development costs.
- General and
Administrative Expenses: G&A expenses were approximately $4.6
million for the third quarter of 2021, as compared to approximately
$8.0 million for the third quarter of 2020. The decrease of $3.4
million was driven by a decrease of approximately $1.4 million in
salaries and other employee-related expenses, a decrease of
approximately $1.5 million in fees associated with 2020 company
financing, and a decrease of approximately $0.5 million in
facilities and operating costs.
- Net Loss: Net
loss was approximately $11.3 million for the third quarter of 2021,
as compared to $18.8 million for the third quarter of 2020.
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 for the treatment of 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. 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 2020 Form 10-K filed on February 25,
2021, our Form 10-Q filed on November 9, 2021, and our other
reports filed with the SEC. 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.
InvestorsCarlo Tanzi,
Ph.D.Kendall Investor Relationsctanzi@kendallir.com
MediaAmanda SellersVerge Scientific
Communicationsasellers@vergescientific.com
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