Cyclerion Announces CY6463 Clinical Pipeline Progress and Second Quarter 2022 Financial Results
09 Agosto 2022 - 3:00PM
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage
biopharmaceutical company on a mission to develop treatments that
restore cognitive function, today announced second quarter 2022
financial results and a business update.
“The data generated from our recent CY6463 CIAS
and MELAS studies demonstrate highly encouraging therapeutic
activity and favorable safety and tolerability in two distinct
patient populations. The results from these studies provide further
evidence of the pro-cognitive and anti-inflammatory effects of
CY6463 observed in preclinical studies and prior clinical trials.
We also continue to enroll a Phase 2a study in Alzheimer’s Disease
and look forward to seeing topline results in 2023.” said Peter
Hecht, Ph.D., Chief Executive Officer of Cyclerion.
Dr. Hecht continued: “The promising clinical
results we have seen to date strongly support the advancement of
CY6463, a first-in-class, CNS-penetrant sGC stimulator. We are
preparing to meet with the FDA to align on the development path for
CY6463 in MELAS, including potential opportunities to accelerate
development in this rare disease. We are also evaluating potential
partnerships that would support our objective to fully explore the
broad therapeutic potential of CY6463 as a novel treatment for CNS
disorders.”
Clinical Pipeline Updates
- In June, the Company announced
positive topline data in its signal-seeking clinical study of
CY6463 for the potential treatment of Mitochondrial
Encephalomyopathy, Lactic Acidosis and Stroke-like episodes
(MELAS). Results from the study were also presented at the United
Mitochondrial Disease Foundation (UMDF) Mitochondrial Medicine 2022
Symposium. In this open-label, single-arm study of the oral,
once-daily sGC stimulator in eight adults with MELAS, improvements
were seen across a range of assessments, including mitochondrial
disease-associated biomarkers such as lactate and GDF-15, a broad
panel of inflammatory biomarkers, cerebral blood flow, and
functional connectivity between neural networks. CY6463 was well
tolerated with no AEs leading to treatment discontinuation, and
pharmacokinetics (PK) were consistent with Phase 1 studies in
healthy volunteers.
- In July, the Company announced
positive topline data from its clinical study of CY6463 for the
potential treatment of Cognitive Impairment Associated with
Schizophrenia (CIAS) in individuals with stable schizophrenia on a
stable, single, atypical antipsychotic regimen. Study data from the
14-day, double-blind, randomized, placebo-controlled,
multiple-ascending-dose study demonstrate a strong effect on
cognitive performance after two weeks of 15mg once-daily dosing.
Positive movement on inflammatory biomarkers was also observed.
Data also demonstrate that CY6463 was safe and well tolerated, with
no reports of serious adverse events (SAEs), severe adverse events
(AEs), or treatment discontinuation due to AEs.
- In July, the Company announced the
appointment of Steven E. Hyman, M.D., to its Board of Directors
effective July 25. Dr. Hyman is a Distinguished Service Professor
and the Harald McPike Professor of Stem Cell and Regenerative
Biology at Harvard University and a Core Institute Member of the
Broad Institute of MIT and Harvard. Dr. Hyman also serves as
Chairman of the Board of Directors of the Charles A. Dana
Foundation. He is founder of Emugen Therapeutics, a Director of
Voyager Therapeutics and Q-State Biosciences, and serves on the
scientific advisory boards of Janssen Pharmaceuticals and F-Prime
Capital.
- The Company continues to enroll its
ADv study (NCT04798989), 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.
Second Quarter 2022 Financial
Results
- Cash Position: Cash, cash
equivalents, and restricted cash balance on June 30, 2022 was
approximately $30.3 million, as compared to approximately $41.1
million on Mar. 31, 2022.
- Research & Development
Expenses: R&D expenses were approximately $10.2 million for the
second quarter of 2022, as compared to approximately $12.1 million
for the second quarter of 2021. The decrease of approximately $1.9
million was driven by decreases in facilities and operating costs,
partially offset by increases in external research costs and
employee-related expenses.
- General and Administrative
Expenses: G&A expenses were approximately $3.5 million for the
second quarter of 2022, as compared to approximately $6.2 million
for the second quarter of 2021. The decrease of $2.7 million was
driven by decreases in facilities and operating costs and
employee-related expenses.
- Net Loss: Net loss was
approximately $13.4 million for the second quarter of 2022, as
compared to $16.2 million for the second 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’s lead molecule 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
function and is currently in clinical development for Alzheimer's
Disease with Vascular pathology (ADv) and 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
(http://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 potential for CY6463 in the treatment of CNS
diseases, including CIAS and MELAS, the potential for any
successful development of CY6463, the sufficiency of our resources
and other abilities to pursue the development of CNS, 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, our ability
to continue with sufficient liquidity and capital resources to
pursue our business plan regarding CY6463 or any other product
(including without limitation our ability to fund additional
clinical trials); our ability to successfully demonstrate the
efficacy, safety and therapeutic effectiveness of CY6463; the
success, timing and cost of our ongoing or future clinical trials
and anticipated clinical trials for our current product candidates,
including statements regarding the timing of initiation and
completion of the trials, futility analyses and receipt of interim
results, which are not necessarily indicative of or supported by
the final results of our ongoing or subsequent clinical trials; any
results of clinical studies not necessarily being indicative of or
supported by the final results of our ongoing or subsequent
clinical trials;; the timing of and our 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,
our product candidates; the potential for the CY6463 clinical trial
to provide a basis for approval for treatment of MELAS and CIAS;
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 Company’s 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.
InvestorsCarlo Tanzi,
Ph.D.Kendall Investor Relationsctanzi@kendallir.com
MediaAmanda SellersVerge Scientific
Communicationsasellers@vergescientific.com
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