CymaBay Therapeutics Announces Collaboration with Kaken Pharmaceutical Co., Ltd. to Develop and Commercialize Seladelpar in Japan for Primary Biliary Cholangitis

Advances strategy to partner seladelpar for PBC outside U.S. Brings in approximately $34.0 million upfront payment Japan represents an important market with no currently approved second line treatment NEWARK, Calif. and TOKYO, Jan. 08, 2023 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY) (“CymaBay” or the “Company”) announced today that it has entered into a collaboration and license agreement with Kaken Pharmaceutical Co., Ltd. (“Kaken”) for the development and commercialization in Japan of CymaBay’s investigational drug seladelpar for the treatment of primary biliary cholangitis (“PBC”). Under the terms of the agreement, Kaken receives an exclusive license to develop, commercialize and market seladelpar in Japan for PBC. Kaken will make an upfront payment to CymaBay of ¥4.5 billion (approximately $34.0 million at current exchange rates) with additional potential milestone payments to CymaBay totaling up to ¥17.0 billion (approximately $128.4 million at current exchange rates) for the achievement of certain regulatory and sales milestones in addition to 20+% royalties. Kaken will be responsible for development, regulatory approval and commercialization of seladelpar in Japan. There are currently no approved second line treatments for PBC in Japan, representing a significant unmet medical need for PBC patients in Japan. “We are honored to collaborate with Kaken, a company that shares our passion and dedication to working together to bring to market novel therapies targeting serious rare diseases,” said Sujal Shah, Chief Executive Officer of CymaBay. “Kaken is a well-regarded leader in development and commercialization in Japan with a proud history of scientific and medical innovation. By working together, we believe that if approved, we can potentially make seladelpar broadly available to Japanese patients to complement CymaBay’s efforts to provide access in the U.S. and other parts of the world. This collaboration is an important next step in achieving our vision of becoming the global leader in treating cholestatic liver diseases.” “We are pleased to begin a collaboration with CymaBay, a company with a strong passion toward developing novel therapeutics for cholestatic liver diseases,” said Hiroyuki Horiuchi, President and Representative Director of Kaken. “With this collaboration, we hope we can help improve the lives of patients with cholestatic liver disease in Japan.” About CymaBayCymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. Our deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped us receive breakthrough therapy designation (U.S. Food and Drug Administration), PRIority MEdicines status (European Medicines Agency) and orphan drug status (U.S. and Europe) for seladelpar, a first-in-class treatment for people with primary biliary cholangitis (PBC). Our evidence-based decision-making and commitment to the highest quality standards reflect our relentless dedication to the people, families and communities we serve. To learn more, visit www.cymabay.com and follow us on Twitter and Linkedin.  About KakenKaken (Tokyo Stock Exchange: 4521) is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals in the fields of orthopedics and dermatology. Kaken concentrates its R&D resources in areas such as immune system, nervous system, infectious diseases and rare diseases with unmet medical needs. Kaken, in its philosophy, strives to improve the quality of life of patients through the development and distribution of superior pharmaceuticals. For more information, please visit http://www.kaken.co.jp/english/. Cautionary StatementsThe statements in this press release regarding the potential for seladelpar to treat PBC, the potential payments that may be received as a result of the Kaken collaboration and CymaBay’s ability to fund current and planned clinical trials are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay’s product development activities, including clinical trials; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay’s product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay’s filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law. For additional information about CymaBay visit www.cymabay.com. Public Relations Contact:                                     Glenn SilverLazar-FINN Partners(973) [email protected] Investor Relations Contact: Hans VitzthumLifeSci Advisors, LLC(617) [email protected]