Cyclerion Therapeutics Reports Full Year 2020 Financial Results and Corporate Update
February 25 2021 - 7:00AM
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage
biopharmaceutical company on a mission to develop treatments that
restore cognitive function, today reported financial results for
the full year 2020 and provided general corporate and pipeline
updates.
“The highly encouraging clinical data from our lead asset,
CY6463, is guiding our clinical strategy and we expect 2021 to be
an exciting year as we begin to explore the impact of modulating a
key node in a fundamental CNS signaling network in patients,” said
Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “This
positive momentum in the clinic includes the initiation of clinical
studies in patients with Alzheimer’s disease with vascular
pathology (ADv) and Mitochondrial Encephalopathy, Lactic Acidosis,
and Stroke-like episodes (MELAS). Given the broad potential
associated with this novel mechanism in the CNS for a range of
patients, we will continue to assess additional indication
opportunities for CY6463 and differentiated molecules to deliver
the full potential of our pipeline.”
Recent Program and Business Updates
- CY6463 Program
Updates: Cyclerion announced promising results from
its Phase 1 translational pharmacology study of CY6463, the first
soluble guanylate cyclase (sGC) stimulator in clinical development
for CNS disorders.Treatment with CY6463 in the 15-day, 24-subject
crossover study confirmed and extended results seen in the earlier
Phase 1 study: once daily oral treatment demonstrated
blood-brain-barrier penetration, desired CNS exposure levels,
target engagement, and showed CY6463 to be safe and generally
well-tolerated. In this study, several neurophysiological and
objective performance measures associated with age-related
cognitive decline and neurodegenerative diseases improved in
subjects receiving CY6463 including increased alpha and gamma
power, improved mismatch negativity (MMN) latency, faster saccadic
eye movement (SEM) reaction time.CY6463 administration resulted in
improvement in the levels of various neuroinflammatory biomarkers,
including alpha-2-macroglobulin (A2M) and Complement C3 (C3). A2M
and C3 have been associated with CNS pathology, cognitive decline,
and the development of Alzheimer’s disease.
- ADv Clinical Trial Initiation: The
Company anticipates initiating a 12-week Phase 2a clinical trial in
patients with ADv midyear. This exploratory trial is designed to
evaluate safety, tolerability, and pharmacodynamic effects
including impact on disease-specific biomarkers.
- MELAS Clinical Trial Advancement:
Cyclerion has initiated clinical activities for a 29-day open label
Phase 2a pilot study in patients with MELAS and anticipates
beginning enrollment imminently. A collaboration with a leading
MELAS academic center of excellence has also been initiated to
further characterize the effects of sGC stimulation in preclinical
models of mitochondrial disease and will include assessments of
brain health, neuromuscular function, and biochemical markers of
mitochondrial dysfunction.
- Clinical and
Scientific Advisory Boards: The Company expanded its expert
networks and announced advisory boards comprised of an accomplished
and diverse group of academic leaders with expertise that spans
neurology clinical development and translational science, as well
as CNS disease biology. The advisors’ expertise will support the
continued development of the company’s clinical programs and the
pipeline.
- Leadership
Transitions: Effective January 1, 2021, the Company announced the
promotions of Cheryl Gault to Chief Operating Officer and Anjeza
Gjino to Chief Financial Officer. Bill Huyett, the Company’s prior
CFO, continues to work part-time as a Strategic Advisor providing
strategic, operational, and organizational development support.
Dr. Mark Currie, Cyclerion’s prior President and Chief
Scientific Officer (CSO), also transitioned to become a Senior
Advisor and Chair the Scientific Advisory Board. Dr. Andreas
Busch has assumed the Chief Scientific Officer
responsibilities.
- Praliciguat
Update: The Company is working to out-license rights to
praliciguat, its investigational orally administered, once-daily
systemic sGC stimulator.
- Organization
Revamping and Strategic Alignment: The Company has made substantial
progress revamping its organization and aligning its capabilities
with its CNS focus. With a leaner more externally networked
organization, Cyclerion expects significantly reduced operating
cash use in 2021, including exiting its current laboratory and
office facilities in early 2021, from which it expects annual cash
savings of about $10 million.
Full Year 2020 Financial Results
- Cash Position: Cash, cash equivalents, and restricted cash
balance on December 31, 2020 was approximately $58
million, as compared
to approximately $71 million on September
30, 2020.
- Research & Development Expenses: Research and
development expenses were approximately $56.4 million for the full
year 2020, as compared to approximately $95.1 million for
the full year 2019. The decrease of approximately $38.7
million was driven by a decrease of approximately $18.0
million in external research costs, primarily related to the
completion of praliciguat trials in the prior year, a net decrease
of approximately $12.5 million in personnel and related
costs due to lower headcount, and a decrease of
approximately $8.2 million of facilities and operating
costs primarily from our reduced lease footprint.
- General and Administrative Expenses: General and
administrative expenses
were approximately $28.8 million for the full
year 2020, as compared
to approximately $34.4 million for the full
year 2019. The decrease of approximately $5.6 million was primarily
driven by a decrease in personnel and related cost primarily due to
lower average headcount.
- Net Loss: Net loss
was approximately $77.8 million for the full
year 2020, as compared to $123.0 million for the full
year 2019.
- Headcount: The Company had 34 employees as of December 31,
2020, not including employees who were impacted by our recent
workforce reduction and who are transitioning out by the end of Q1
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. Nitric oxide (NO) is one of several
fundamental neurotransmitters, but it has yet to be leveraged for
its full CNS therapeutic potential. CY6463 stimulates sGC, a
signaling enzyme that responds to the presence of NO, to enhance
the body’s natural ability to produce cyclic guanosine
monophosphate (cGMP), an important signaling molecule that
regulates diverse and critical biological functions in the CNS
including neuronal function, neuroinflammation, cellular
bioenergetics, and vascular dynamics. An impaired NO-sGC-cGMP
signaling pathway is believed to play an important role in the
pathogenesis of neurodegenerative diseases and is critical to basic
neuronal functions. Agents that stimulate sGC to produce cGMP may
compensate for deficient NO signaling.
About Cyclerion Therapeutics
Cyclerion Therapeutics is a clinical-stage
biopharmaceutical company on a mission to develop treatments that
restore cognitive function. Cyclerion’s lead program is CY6463, a
novel, first-in-class, CNS-penetrant, sGC stimulator that modulates
a key node in a fundamental CNS signaling network. The
multidimensional pharmacology elicited by the stimulation of sGC
has the potential to impact a broad range of CNS diseases. CY6463
has shown rapid improvement in biomarkers associated with cognitive
impairment and is currently in clinical development for Alzheimer's
Disease with Vascular pathology (ADv) and Mitochondrial
Encephalomyopathy, Lactic Acidosis and Stroke-like episodes
(MELAS).
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. 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
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