Takeda and HemoShear Therapeutics Enter into Exclusive Drug Discovery Partnership in Liver Diseases

OSAKA, Japan & CHARLOTTESVILLE, Va.

Takeda Pharmaceutical Company Limited (TSE: 4502) and HemoShear Therapeutics, LLC, a privately held biotechnology company, today announced a partnership to discover and develop novel therapeutics for liver diseases, including nonalcoholic steatohepatitis (NASH).

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“The ability to study pathophysiology in a human multi-cell system is crucial for our understanding of disease and how to develop best-in-class therapies,” said Gareth Hicks, Ph.D., Head of the GI Drug Discovery Unit at Takeda. “We see the HemoShear platform as an integral component in our overall liver disease strategy that focuses on a ‘human first’ approach to the identification and validation of novel targets in NASH and other liver diseases.”

HemoShear’s proprietary disease modeling platform, REVEAL-Tx™, applies principles of physiological blood flow to tissue derived from patients. REVEAL-Tx™ allows drug candidates to be studied at human concentrations and provides valuable insights into complex pathophysiological pathways by replicating human disease with great accuracy. REVEAL-Tx™ was recognized recently at the American Association for the Study of Liver Disease annual meeting where its NASH model received four Presidential Awards based on publications demonstrating the platform’s ability to replicate many clinical observations from clinical stage drugs.

“We are excited about our collaboration with Takeda,” said Jim Powers, HemoShear’s CEO. “From the beginning, Takeda has recognized the value and potential of our platform and its ability to identify and validate therapeutic targets in liver diseases. Our ability to replicate NASH and other liver diseases for drug discovery, coupled with Takeda’s expertise in developing and commercializing therapeutics, can yield safer and more effective therapies for NASH and potentially other liver diseases.”

Under the terms of the agreement, HemoShear will receive upfront payments and R&D funding, and Takeda will receive exclusive access to HemoShear’s proprietary disease modeling platform to discover and develop best-in-class therapeutics for specific liver diseases. HemoShear is also eligible to receive milestone payments of potentially $470 million and royalties. Further financial terms were not disclosed. Liver diseases may progress to end-stage disease requiring liver transplantation and represent a serious unmet medical need. One of the leading causes of transplantation, NASH, is a serious, chronic liver disease that is estimated to impact over 16 million people in the United States alone. NASH is characterized by inflammation and excessive fat accumulation in the liver that may progress to fibrosis, cirrhosis, liver cancer and eventually liver failure. There is currently no FDA approved therapeutic available for NASH and liver fibrosis.

Cowen acted as financial advisor to HemoShear in this transaction.

About HemoShear Therapeutics

HemoShear Therapeutics discovers novel biological targets and advances drug programs to treat metabolic disorders with significant unmet patient need. HemoShear’s proprietary drug discovery platform, REVEAL-TX™, enables HemoShear to create best-in-class, biologically relevant human disease models to uncover and explain the underlying mechanisms of disease, translate those discoveries into drug candidates, and predict which drug candidates will treat patients successfully. HemoShear’s current drug discovery programs are focused on nonalcoholic steatohepatitis (NASH) and propionic and methylmalonic acidemias, rare genetic metabolic disorders. For more information visit www.HemoShear.com.

About HemoShear’s REVEAL-Tx™ Platform

Existing human experimental disease models do not reliably represent human biology. HemoShear has developed a transformational platform, REVEAL-Tx™, which applies principles of physiological blood flow to tissue from patients to recapitulate disease. REVEAL-Tx™ provides unprecedented insights into complex pathophysiological pathways by replicating human disease with great accuracy. HemoShear’s human disease models, in combination with its advanced proprietary computational biology tools, identify novel treatment approaches and reduce risk of failure by enabling HemoShear’s scientists to deeply interrogate disease pathways, test hypotheses and select meaningful targets in physiologically accurate disease conditions.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in Emerging Markets, are currently fueling the growth of Takeda. Takeda’s 30,000 employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information visit www.takeda.com/news.

Takeda’s Commitment to Gastroenterology

More than 70 million people worldwide are impacted by gastrointestinal (GI) diseases, which can be complex, debilitating and life-changing. Takeda is driven to improving the lives of patients with GI diseases through innovative medicines, dedicated patient disease management support and the evolution of the healthcare environment. Takeda is leading in gastroenterology through the delivery of innovative medicines in areas associated with high unmet needs, such as inflammatory bowel disease, GI acid-related diseases and GI motility disorders. Our GI research & development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies. With more than 25 years of experience in this area, our broad approach to treating many diseases that impact the GI system and our global network of collaborators, Takeda aims to advance how patients manage their disease.

Takeda’s Forward-Looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as “anticipate,” “expect,” “project,” “continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,” “assume,” “will,” “may,” “should,” and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.

The forward-looking statements contained in this press release speak only as of the date of this press release, and neither HemoShear Therapeutics nor Takeda undertake any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.

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