Cyclerion Therapeutics Reports Second Quarter 2021 Financial Results and Corporate Update
July 29 2021 - 5:00PM
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 second quarter 2021 and provided general corporate and pipeline
updates.
“During the first half of the year we have made significant
progress advancing our lead program CY6463 into clinical
development for multiple neurological indications where we believe
we could have a meaningful therapeutic impact. This positive
momentum in the clinic includes the advancement of the clinical
studies in participants with Alzheimer’s disease with vascular
pathology (ADv) and Mitochondrial Encephalomyopathy, Lactic
Acidosis, and Stroke-like episodes (MELAS) and the initiation of
start-up activities for a clinical study in participants with
Cognitive Impairment Associated with Schizophrenia (CIAS),” said
Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. “We have
also conducted additional preclinical work to support the
advancement of CY3018, a differentiated, next-generation,
CNS-penetrant sGC stimulator, into clinical development for
specific serious neurological conditions.”
Recent Program and Business Updates
- ADv Clinical Trial
Advancement: The U.S. Food and Drug Administration (FDA) reviewed
the Investigational New Drug (IND) application for CY6463 in ADv
and notified the Company that the study may proceed. Cyclerion has
initiated a 12-week Phase 2a clinical trial in patients with
ADv.
- CIAS Clinical Trial
Start-up: The Company received notification from the FDA that its
Ph1b clinical trial in participants with CIAS may proceed and study
start-up activities are ongoing.
- MELAS Clinical
Trial Advancement: The exploratory 29-day open-label Phase 2a pilot
study in patients with MELAS is currently enrolling and data are
expected by year end 2021.
- Beacon Partnership:
In July, Cyclerion and Beacon Biosignals announced an extended and
expanded strategic partnership between the two companies. This
collaboration is expected to identify disease-relevant biomarkers
to refine patient selection and endpoints to guide the clinical
development of Cyclerion’s investigational therapeutics for
neurological diseases associated with cognitive impairment.
- Equity Raises: In
June, Cyclerion closed a direct private sale of approximately $18
million of Cyclerion shares of common stock to EcoR1 Capital, LLC,
Slate Path Capital LP, MFN Partners, LP, Invus, Peter Hecht, Ph.D.,
Lincoln Park Capital Fund, LLC and Polaris Partners. In addition,
the Company received net proceeds of approximately $12.5 million in
Q2 2021 for shares sold under the ATM Offering.
- Praliciguat
Out-license: In June, the Company entered into an exclusive,
global license agreement with Akebia Therapeutics, Inc. for the
development and commercialization of praliciguat. Under the terms
of the agreement, Akebia has obtained an exclusive license to
research, develop, and commercialize praliciguat globally and will
be solely responsible for these activities going forward. Cyclerion
is eligible to receive up to $225M in pre-commercial milestones,
including up to $15M in the first 18 months. Total potential future
development, regulatory, and commercialization milestone payments
could result in up to $585M. Cyclerion is also eligible to receive
tiered, sales-based royalties ranging from single-digit to
high-teen percentages.
- Scientific
Conferences and Publications:
- In July, Cyclerion
presented a poster at the Alzheimer’s Association International
Conference 2021 (AAIC) highlighting the clinical trial design for a
Phase 2a study of CY6463 in participants with Alzheimer’s disease
with vascular pathology. In addition, Anna Marin, a researcher in
the laboratory of Dr. Andrew Budson and Dr. Katherine Turk in the
Department of Neurology, Boston University School of Medicine and
Center for Translational and Cognitive Neuroscience, VA Boston
Healthcare System, presented results from the Cyclerion-sponsored
study highlighting alpha peak frequency and N200 latency as
predictors of neuropsychological performance in a memory disorders
clinic.
- In May, Cyclerion
announced the publication of preclinical data for CY6463 in
Frontiers in Pharmacology. The publication includes preclinical
pharmacology data with CY6463 and, along with decades of research,
highlights the crucial role of the sGC pathway in brain physiology
and cognition. Across a range of preclinical models, administration
of CY6463 resulted in physiologically relevant drug levels in
cerebrospinal fluid and led to improvements in neuronal function,
neuroprotection, and cognitive performance.
- In April, Cyclerion
hosted a webinar and provided an update on its clinical programs
for its first-in-class, CNS-penetrant sGC stimulator, CY6463, in
ADv, MELAS and CIAS. The event included neuropsychiatric key
opinion leader, Andreas Reif, M.D., Chair, Department of
Psychiatry, University Hospital Frankfurt, who discussed the sGC
pathway and its role in cognitive function and CIAS. Cyclerion
also introduced its latest development candidate, CY3018, a
differentiated, next-generation, CNS-penetrant sGC stimulator.
- Board of Directors
Transitions: In April, the Company announced that Errol De Souza,
Ph.D., was appointed to the Company’s board of directors. Dr. De
Souza is currently a member of the board of directors of Royalty
Pharma and Catalyst Biosciences and executive chairman of Bionomics
Limited. Previously, Dr. De Souza founded Neurocrine Biosciences,
Inc., served as CEO of numerous publicly traded and private
companies, including Biodel, Inc., Synaptic Pharmaceutical Corp.,
Archemix Corp. and Neuropore Therapies, Inc. In addition, he led
CNS R&D at DuPont Merck and US R&D at Aventis. Dr. De Souza
received a B.A. in physiology and a Ph.D. in endocrinology from the
University of Toronto.
Second Quarter 2021 Financial Results
- Cash Position:
Cash, cash equivalents, and restricted cash balance on June 30,
2021 was approximately $70 million, as compared to approximately
$45 million on March 31, 2021.
- Research &
Development Expenses: Research and development expenses were
approximately $12.1 million for the second quarter of 2021, as
compared to approximately $13.8 million for the second quarter of
2020. The decrease of approximately $1.7 million was driven by a
decrease of approximately $4.2 million in salaries, stock-based
compensation, and other employee-related expenses due to lower
average headcount, a net increase of approximately $2.3 million of
facilities and operating costs allocated to research and
development primarily due to $4.2 million of non-cash write-off of
leasehold improvements partially offset by $1.9 million reduction
in the Company’s total leased premises expense, and a net increase
of approximately $0.2 million in external research costs, primarily
related to the start-up costs for CY6463 in CIAS and ADv, offset by
the completion of praliciguat and olinciguat trials in the prior
year.
- General and
Administrative Expenses: General and administrative expenses were
approximately $6.2 million for the second quarter of 2021, as
compared to approximately $6.6 million for the second quarter of
2020. The decrease of approximately $0.4 million was primarily
driven by a decrease of approximately $1.3 million in salaries,
stock-based compensation, and other employee-related expenses due
to lower average headcount, and a decrease of approximately $1.2
million in facilities and other operating costs, partially offset
by an increase of approximately $2.1 million of non-cash write-off
of leasehold improvements.
- Net Loss: Net
loss was approximately $16.2 million for the second quarter of
2021, as compared to $19.5 million for the second 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. 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. Impaired NO-sGC-cGMP
signaling is believed to play an important role in the pathogenesis
of many neurodegenerative and neuropsychiatric diseases. 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 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
and include, among other things, whether the praliciguat
out-license will result in the creation of any therapies for the
treatment of patients with kidney disease; the uncertain utility,
development, promise, and commercialization of praliciguat; and
whether any development, regulatory and commercialization
milestones or royalty payments provided for in the agreement with
Akebia will be achieved. 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, and our subsequent SEC
filings including the Form 10-Qs filed on April 30, 2021 and July
29, 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
MediaAmanda SellersVerge Scientific
Communicationsasellers@vergescientific.com
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