CYP7A1

Seladelpar Treatment of PBC Patients for Two Years Predicts Improved Transplant-Free Survival NEWARK, Calif., June 22, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced encouraging seladelpar data in patients with primary biliary cholangitis (PBC) that are being presented at The International Liver Congress™ 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd – 26th. In a poster presentation titled, “Seladelpar Treatment of Patients With Primary Biliary Cholangitis (PBC) For 2 Years Improves the GLOBE PBC Score and Predicts Improved Transplant-Free Survival,”1 Bettina Hansen, PhD, Associate Professor Toronto Centre for Liver Disease, University of Toronto, will be reporting the improvement in GLOBE score following seladelpar treatment over two years and predicted transplant-free survival. The GLOBE score is a validated risk-assessment tool providing an estimate of transplant-free survival for patients with PBC. Patients with PBC having an incomplete response or intolerance to UDCA (defined as alkaline phosphatase (ALP) ≥ 1.67xULN) had completed an open-label one-year phase 2 study of daily oral seladelpar therapy (NCT: 02955602). After 1 year, patients were eligible for an open label long-term study (NCT: 03301506). Treatment of 50 patients with oral seladelpar 5 mg or 10 mg daily for 2 years resulted in a mean (SD) change from baseline in GLOBE score of -0.417 (0.269), resulting in a corresponding hazard ratio of 0.66 for transplantation or death compared to no prior treatment with seladelpar (baseline). The improvement in GLOBE score and predicted survival did not depend on age. However, an analysis of subpopulations of high risk patients by GLOBE score (> 0.3) revealed that while patients of all ages improved, the younger patients tended to have numerically greater improvements, although these differences did not achieve significance. “These findings demonstrate that seladelpar treatment over 2 years resulted in a sustained decrease in GLOBE score for patients with PBC. These results provide an estimate of seladelpar’s treatment effect on transplant-free survival for patients with PBC supporting its continued long-term evaluation in patients with PBC,” said Dr. Bettina Hansen. An oral presentation2 by Dr. Bernd Schnabl, Professor of Medicine at the University of California San Diego, will describe the suppression of bile acid synthesis by seladelpar and reveal the role of FGF-21 signaling, a previously known regulator of bile acid synthesis. These results provide new insights into the anti-cholestatic mechanism of seladelpar. Dr. Dennis Kim, Chief Medical Officer of CymaBay Therapeutics, commented, “We continue to be encouraged by the potential key role seladelpar can play in providing benefit to patients with PBC. We look forward to our continued collaboratation with our academic partners and investigators to further explore how this first and only delpar in development for the treatment of PBC can advance the care and quality of life for patients with PBC over time. We want to extend our sincere gratitude to the patients and investigators who have participated in our clinical studies and look forward to completing our RESPONSE global Phase 3 study for seladelpar in PBC. Presentations at The International Liver Congress™ 2022 include: Poster Presentations: June 23rd 9:00 – 18:30 BST1529: 1“Seladelpar Treatment of Patients With Primary Biliary Cholangitis (PBC) For 2 Years Improves the GLOBE PBC Score and Predicts Improved Transplant-Free Survival”Bettina E. Hansen, Elaine Watkins, Ke Yang, Yun-Jung Choi, Charles A. McWherter, Gideon M. Hirschfield, for the Seladelpar Long-Term Study Investigators June 24th 9:00 – 18:00 BST1518: “Comparative fibrosis-reducing activities of farnesoid X receptor (FXR), peroxisome-proliferator activated receptor delta (PPAR) and thyroid hormone receptor (THR) agonists in the carbon tetrachloride mouse model” Edward Cable, Jeffrey Stebbins, Yun-Jung Choi, Jiangao Song, Prasad Manchem, Sanjay Pandey, Charles A. McWherter Oral Presentation: June 25th 9:00 AM BST2726: 2“The selective PPAR-delta agonist seladelpar suppresses bile acid synthesis by reducing hepatocyte CYP7A1 through the FGF21 pathway” Tetsuya Kouno, Xiao Liu, Tatiana Kisseleva, Edward E. Cable, Bernd Schnabl Congress attendees can visit CymaBay throughout the meeting at booth 93. A full list of presentations can be found on The International Liver Congress ™ 2022 website. The presentations will be made available on the CymaBay website. About PBCPBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000) over the age of 40. PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of alkaline phosphatase (ALP) and total bilirubin. The most common early symptoms of PBC are itching (pruritus) and fatigue, which can be very debilitating for some patients. Progression of PBC is associated with an increased risk of liver cancer and liver-related mortality. About SeladelparSeladelpar is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need. Preclinical and clinical data support its ability to regulate genes involved in bile acids synthesis, inflammation, fibrosis and lipid metabolism, storage and transport. 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. Cautionary StatementsAny statements made in this press release regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease and the potential benefits to patients 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; and effects observed in trials to date that may not be repeated in the future. 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, its Quarterly Reports on Form 10-Q 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) 818-8198Glenn.silver@finnpartners.com Investor Relations Contact: Hans VitzthumLifeSci Advisors, LLC(617) 430-7578Hans@LifeSciAdvisors.com

NEWARK, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that multiple seladelpar presentations will be delivered during The International Liver Congress™ 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd – 26th. A poster presentation1 in collaboration with Dr. Bettina Hansen, PhD, Associate Professor of Biostatistics at the University of Toronto, Toronto, CA and Erasmus University Medical Center, Rotterdam, NL, will be made highlighting the improvement in GLOBE score following seladelpar treatment over two years and predicted transplant-free survival. The GLOBE score is a validated risk-assessment tool providing an estimate of transplant-free survival for patients with PBC.A preclinical poster presentation2 will compare the fibrosis-reducing activities of the Farnesoid X Receptor (FXR) agonist, obeticholic acid; the Peroxisome Proliferator-activated receptor delta (PPARd) agonist, seladelpar, and the Thyroid Hormone Receptor (THR) agonist, resmetirom in the carbon tetrachloride (CCl4) mouse model.An oral presentation3 in collaboration with Professor Bernd Schnabl at the University of California San Diego, will describe the suppression of bile acid synthesis by seladelpar and reveal the role of FGF-21 signaling, a previously known regulator of bile acid synthesis. Dr. Dennis Kim, Chief Medical Officer of CymaBay Therapeutics, commented, “We are excited to have the opportunity to present once again this year at the International Liver Congress™. We are honored to collaborate with our academic partners and investigators and to share clinical data that highlights the potential key role seladelpar can play in improving the lives of PBC patients.” Presentations at The International Liver Congress™ 2022 include: Poster Presentations: June 23rd 9:00 – 18:30 BST1529: 1“Seladelpar Treatment of Patients With Primary Biliary Cholangitis (PBC) For 2 Years Improves the GLOBE PBC Score and Predicts Improved Transplant-Free Survival”Bettina E. Hansen, Elaine Watkins, Ke Yang, Yun-Jung Choi, Charles A. McWherter, Gideon M. Hirschfield, for the Seladelpar Long-Term Study Investigators June 24th 9:00 – 18:00 BST1518:2“Comparative fibrosis-reducing activities of farnesoid X receptor (FXR), peroxisome-proliferator activated receptor delta (PPAR) and thyroid hormone receptor (THR) agonists in the carbon tetrachloride mouse model” Edward Cable, Jeffrey Stebbins, Yun-Jung Choi, Jiangao Song, Prasad Manchem, Sanjay Pandey, Charles A. McWherter Oral Presentation: June 25th 9:00 AM BST2726: 3“The selective PPAR-delta agonist seladelpar suppresses bile acid synthesis by reducing hepatocyte CYP7A1 through the FGF21 pathway” Tetsuya Kouno, Xiao Liu, Tatiana Kisseleva, Edward E. Cable, Bernd Schnabl Congress attendees can visit CymaBay throughout the meeting at booth 93. A full list of presentations can be found on The International Liver Congress ™ 2022 website. The presentations will also be made available later this month on the CymaBay website. About PBCPBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000) over the age of 40. PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of alkaline phosphatase (ALP) and total bilirubin. The most common early symptoms of PBC are itching (pruritus) and fatigue, which can be very debilitating for some patients. Progression of PBC is associated with an increased risk of liver cancer and liver-related mortality. About SeladelparSeladelpar is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need. Preclinical and clinical data support its ability to regulate genes involved in bile acids synthesis, inflammation, fibrosis and lipid metabolism, storage and transport. 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. Cautionary StatementsAny statements made in this press release regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease and the potential benefits to patients 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; and effects observed in trials to date that may not be repeated in the future. 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, its Quarterly Reports on Form 10-Q 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) 818-8198Glenn.silver@finnpartners.com Investor Relations Contact: Hans VitzthumLifeSci Advisors, LLC(617) 430-7578Hans@LifeSciAdvisors.com

Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 Pipeline Review, H1 2017 Summary Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 pipeline Target constitutes close to 24 molecules. Out of which approximately 23 molecules are developed by companies and remaining by the universities/institutes. The latest report Fibroblast Growth Factor Receptor 4 Pipeline Review, H1 2017, outlays comprehensive information on the Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action MoA, route of administration RoA and molecule type. Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 Fibroblast growth factor receptor 4 is a protein encoded by the FGFR4 gene. It plays a role in the regulation of cell proliferation, differentiation and migration, and in regulation of lipid metabolism, bile acid biosynthesis, glucose uptake, vitamin D metabolism and phosphate homeostasis. It is required for normal downregulation of the expression of CYP7A1, the ratelimiting enzyme in bile acid synthesis, in response to FGF19. It phosphorylates PLCG1 and FRS2. Ligand binding leads to the activation of several signaling cascades. The molecules developed by companies in PreRegistration, Phase II, Phase I, Preclinical and Discovery stages are 1, 10, 5, 5 and 2 respectively. Similarly, the universities portfolio in Preclinical stages comprises 1 molecules, respectively. Report covers products from therapy areas Oncology, Metabolic Disorders, Gastrointestinal, Central Nervous System and Musculoskeletal Disorders which include indications Hepatocellular Carcinoma, Solid Tumor, Bile Duct Cancer Cholangiocarcinoma, Type 2 Diabetes, Breast Cancer, Esophageal Cancer, Gastric Cancer, Lung Adenocarcinoma, Lymphoma, Melanoma, NonAlcoholic Steatohepatitis NASH, NonSmall Cell Lung Cancer, Obesity, Ovarian Cancer, Recurrent Glioblastoma Multiforme GBM, Adrenocortical Carcinoma Adrenal Cortex Cancer, Chronic Lymphocytic Leukemia CLL, Constipation, Endometrial Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Fibrosis, Glioblastoma Multiforme GBM, Head And Neck Cancer, Head And Neck Cancer Squamous Cell Carcinoma, Hematological Tumor, Metastatic Biliary Tract Cancer, Metastatic Melanoma, Metastatic Transitional Urothelial Tract Cancer, Nasopharyngeal Cancer, NonSmall Cell Lung Carcinoma, Osteosarcoma, Peritoneal Cancer, Primary Biliary Cirrhosis, Primary Sclerosing Cholangitis, Prostate Cancer, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Renal Cell Carcinoma, SmallCell Lung Cancer, Spinal Cord Injury, Thymic Carcinoma, Thyroid Cancer and Transitional Cell Cancer Urothelial Cell Cancer. Furthermore, this report also reviewsalso reviews key players involved in Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 targeted therapeutics development with respective active and dormant or discontinued projects. Driven by data and information sourced from proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industryspecific third party sources. Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data. Scope The report provides a snapshot of the global therapeutic landscape for Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 The report reviews Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industryspecific sources The report covers pipeline products based on various stages of development ranging from preregistration till discovery and undisclosed stages The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, RD brief, licensing and collaboration details other developmental activities The report reviews key players involved in Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 targeted therapeutics and enlists all their major and minor projects The report assesses Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 targeted therapeutics based on mechanism of action MoA, route of administration RoA and molecule type The report summarizes all the dormant and discontinued pipeline projects The report reviews latest news and deals related to Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 targeted therapeutics Reasons to buy Gain strategically significant competitor information, analysis, and insights to formulate effective RD strategies Identify emerging players with potentially strong product portfolio and create effective counterstrategies to gain competitive advantage Identify and understand the targeted therapy areas and indications for Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 Identify the use of drugs for target identification and drug repurposing Identify potential new clients or partners in the target demographic Develop strategic initiatives by understanding the focus areas of leading companies Plan mergers and acquisitions effectively by identifying key players and it's most promising pipeline therapeutics Devise corrective measures for pipeline projects by understanding Fibroblast Growth Factor Receptor 4 CD334 or FGFR4 or EC 2.7.10.1 development landscape Develop and design inlicensing and outlicensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope