Cyclerion Therapeutics Announces Global Licensing Agreement with Akebia Therapeutics for Praliciguat
June 04 2021 - 8:00AM
Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) today announced that it
has entered into an exclusive, global license agreement with Akebia
Therapeutics, Inc., a leading biopharmaceutical company focused on
kidney disease, for the development and commercialization of
praliciguat, an oral sGC stimulator.
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.
“We are very pleased to license praliciguat to
Akebia, whose demonstrated leadership in kidney disease and
extensive R&D and commercialization capabilities make it an
ideal partner for the future development of praliciguat. This
transaction provides Cyclerion with meaningful participation in any
potential near and longer-term value creation and enables us to
focus on our mission to develop treatments for cognitive
impairment, including our foundational assets CY6463 and CY3018,
where we see enormous clinical promise,” said Peter Hecht, Ph.D.,
Chief Executive Officer of Cyclerion.
“We are pleased to expand our clinical
development pipeline with the in-licensing of praliciguat, which is
highly complementary of our strategy to identify and efficiently
develop novel therapeutics for people impacted by kidney disease,”
said John P. Butler, Chief Executive Officer of Akebia
Therapeutics, Inc. “We look forward to leveraging our capabilities
to explore development and commercialization of praliciguat.”
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 StatementThis
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.
Statements in this press release that are not purely historical are
forward-looking statements. Such forward-looking statements
include, among other things, the uncertain utility, development,
promise, and commercialization of praliciguat; and whether any of
the referenced or other development, regulatory, and
commercialization milestones or royalty payments provided for in
the license agreement with Akebia will be achieved. Actual results
could differ from those projected in any forward-looking statements
due to numerous factors. Such factors include, among others, the
ability of any party to raise the funding needed to pursue business
and product development plans; the inherent uncertainties
associated with developing new products or technologies; the
ability to develop, complete clinical trials for, obtain approvals
for and commercialize any product candidates, including the ability
to recruit and enroll patients in appropriate studies; the ability
to address the requests of the U.S. Food and Drug Administration
and similar regulators in other jurisdictions; and market
conditions. 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, and our subsequent SEC filings including the Form 10-Q
filed on April 30, 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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