Ironwood Announces Filing of Form 10 Registration Statement in Connection with Planned Business
Separation
– Important step toward launching two independent, publicly-traded companies –
– Separation on track for first half 2019 –
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.gov and 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.
Media and Investors:
Meredith Kaya, 617-374-5082
Vice President, Investor Relations and Corporate Communications
mkaya@ironwoodpharma.com
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