– Important step toward launching two independent, publicly-traded
companies –
– Separation on track for first half 2019 –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ:IRWD) today announced the filing by
Cyclerion Therapeutics, Inc. (Cyclerion) of a Form 10 Registration
Statement with the U.S. Securities and Exchange Commission (SEC). The
Form 10 reflects Ironwood’s plan for a tax-free spin-off of Cyclerion as
a publicly-traded company, which is on track to be completed in the
first half of 2019.
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“Today’s filing is a critical step toward creating two differentiated,
innovative and productive companies, each with promising foundational
assets and the opportunity to build industry-leading businesses,” said
Peter Hecht, chief executive officer of Ironwood and future chief
executive officer of Cyclerion following completion of the planned
separation. “With strong competitive positions and flexibility to pursue
their distinct growth opportunities, we believe both Ironwood and
Cyclerion are positioned well to enhance value for patients and
shareholders.”
Cyclerion expects to be a clinical-stage biopharmaceutical company
harnessing the power of sGC pharmacology to discover, develop and
commercialize breakthrough treatments for serious and orphan diseases.
The company plans to advance five differentiated sGC stimulator programs
that are designed to target tissues of greatest relevance to the
diseases they are intended to treat: olinciguat (Phase 2) for sickle
cell disease, praliciguat (Phase 2) for heart failure with preserved
ejection fraction (HFpEF) and for diabetic nephropathy, IW-6463 (Phase
1) for serious and orphan central nervous system diseases, and two
late-stage tissue-targeted discovery programs targeting serious liver
and lung diseases.
Dr. Hecht continued, “Cyclerion intends to advance breakthrough
treatments for serious and orphan diseases. We believe Cyclerion will
have an experienced team with a track record of discovering, developing
and commercializing important therapies, and we look forward to working
to unlock the full therapeutic potential of its sGC development
pipeline.”
Following the planned separation, Ironwood expects to build a leading
gastrointestinal (GI)-focused healthcare franchise, leveraging its
commercial success to-date with LINZESS® (linaclotide) and advancing its
late-stage, first-in-category development candidates for persistent
gastroesophageal reflux disease (GERD) and abdominal pain toward the
market. Ironwood plans to focus on driving further innovation within the
GI market and delivering differentiated therapies to patients through
its robust portfolio of GI assets and its strong global network of
partnerships.
Ironwood plans to distribute 100% of the outstanding shares of Cyclerion
common stock to Ironwood’s stockholders on a pro-rata basis and,
immediately following the distribution, Cyclerion is expected to close a
private placement in which certain investors will make a cash investment
in Cyclerion in exchange for newly issued shares of Cyclerion common
stock. The Form 10 filing provides important information on the business
strategy and historical financial data relating to Cyclerion and will be
updated with additional information in subsequent amendments in
conjunction with the SEC review process. For more information, the full
Form 10 can be viewed at http://www.sec.govand Ironwood’s Investor Relations site at http://investor.ironwoodpharma.com/.
Ironwood is on track to complete the planned separation in the first
half of 2019, subject to customary conditions, including effectiveness
of the Form 10, a favorable opinion with respect to the tax-free nature
of the transaction, and final approval of Ironwood’s Board of Directors.
About Cyclerion Therapeutics
Cyclerion Therapeutics expects to be a clinical-stage biopharmaceutical
company harnessing the power of sGC pharmacology to discover, develop
and commercialize breakthrough treatments for serious and orphan
diseases. Cyclerion plans to advance its portfolio of five
differentiated sGC stimulator programs with distinct pharmacologic and
biodistribution properties that are designed to target tissues of
greatest relevance to the diseases they are intended to treat. These
programs, each of which are expected to have important milestones in
2019, include olinciguat in Phase 2 development for sickle cell disease,
praliciguat in Phase 2 trials for heart failure with preserved ejection
fraction (HFpEF) and for diabetic nephropathy, IW-6463 in Phase 1
development for serious and orphan central nervous system diseases, and
two late-stage discovery programs targeting serious liver and lung
diseases, respectively.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq:IRWD) is a commercial biotechnology
company focused on creating medicines that make a difference for
patients, building value for our fellow shareholders, and empowering our
passionate team. We discovered, developed and are commercializing
linaclotide, the U.S. branded prescription market leader for adults with
irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic
constipation (CIC). Our pipeline priorities for linaclotide include a
Phase IIIb trial evaluating its efficacy and safety on multiple
abdominal symptoms, including abdominal bloating, pain, and discomfort
in adult patients with IBS-C, as well as research into a formulation of
linaclotide designed to relieve abdominal pain associated with IBS.
We are also advancing a pipeline of innovative product candidates in
areas of significant unmet need, including persistent gastroesophageal
reflux disease, and the product candidates that Cyclerion expects to
advance following completion of the planned separation of Ironwood and
Cyclerion into two independent, publicly-traded companies. The
separation is expected to be completed in the first half of 2019.
Ironwood was founded in 1998 and is headquartered in Cambridge, Mass.
For more information, please visit www.ironwoodpharma.com
or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
Forward-Looking Statements
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including statements about the proposed separation of our
operations into two independent, publicly traded companies, including
the status, structure, completion and timing of the separation; the
business and operations of Ironwood and Cyclerion and any benefits or
costs of the separation, including the tax treatment; the business and
operations of each company and the benefits of a potential separation,
including with respect to Ironwood’s and Cyclerion’s competitive
position, attractiveness to investors and enhanced operational,
commercial and scientific effectiveness; and Cyclerion’s leadership
following the separation, the strength and value thereof, and the
leadership’s anticipated impact on Cyclerion’s businesses, growth,
business strategies, pipeline advancement and productivity. 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
those related to the possibility that we may not complete the separation
on the terms or timeline currently contemplated, if at all, that neither
Ironwood nor Cyclerion may achieve the expected benefits of a
separation, and that a separation could harm the business, results of
operations and financial condition of Ironwood and Cyclerion; the risk
that we may be unable to make, on a timely or cost-effective basis, the
changes necessary to operate as independent companies; Cyclerion’s lack
of independent operating history and the risk that its accounting and
other management systems may not be prepared to meet the financial
reporting and other requirements of operating as an independent public
company; the risk that a separation may adversely impact Ironwood’s and
Cyclerion’s ability to attract or retain key personnel; the risk that
the management of the Ironwood and Cyclerion will be different than
currently contemplated; the risks listed under the heading “Risk
Factors” and elsewhere in Ironwood’s Quarterly Report on Form 10-Q for
the quarter ended September 30, 2018, and in Ironwood’s subsequent SEC
filings; and the risks listed under the heading “Risk Factors” and
elsewhere in Cyclerion’s Registration Statement on Form 10 filed on
January 28, 2019, and in Cyclerion’s subsequent SEC filings, including
SEC filings related to the proposed separation. These forward-looking
statements (except as otherwise noted) speak only as of the date of this
press release, and Ironwood and Cyclerion undertake no obligation to
update these forward-looking statements.
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Media and Investors:
Meredith Kaya, 617-374-5082
Vice
President, Investor Relations and Corporate Communications
mkaya@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.