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CymaBay Therapeutics, Inc. (CBAY)

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Previous Close4.1900
Open4.1800
Bid4.2100 x 1800
Ask4.2200 x 2200
Day's Range4.1650 - 4.3000
52 Week Range1.5000 - 9.0600
Volume479,475
Avg. Volume1,166,340
Market Cap290.608M
Beta (5Y Monthly)1.18
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
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  • CymaBay Appoints Thomas Wiggans and Janet Dorling to Board of Directors
    GlobeNewswire

    CymaBay Appoints Thomas Wiggans and Janet Dorling to Board of Directors

    NEWARK, Calif., April 05, 2021 (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 the appointment of biopharma veteran Thomas Wiggans and commercial leader Janet Dorling to its Board of Directors. Concurrently with these appointments, CymaBay announced that Paul F. Truex has resigned from the Board of Directors effective as of April 1, 2021 to focus on his new role as Chief Executive Officer of LQT Therapeutics. “We are truly excited to be welcoming Tom and Janet to the Board. Tom’s experience leading biopharma companies, such as Dermira, Peplin and Connetics, through development to commercialization makes him a perfect addition to guide us through our next phase of development and commercialization,” said Dr. Robert Wills, CymaBay’s Chairman of the Board. “Janet was formerly our Chief Commercial Officer and is now the Senior Vice President, Global Commercial Product Strategy at Gilead. Over the course of her career at Gilead, CymaBay, Achaogen, Roche and Genentech she has extensive senior executive experience in global marketing, commercialization and strategic planning across multinational biopharmaceutical companies, something that will be critical to the company as it moves forward. On behalf of the entire Board I also want to extend our gratitude to Paul for his work over the past five years at CymaBay. His advice and counsel have been key in guiding the Company through critical periods of strategic transition and we wish him success in his new role.” “I’m delighted to be working with the CymaBay Board at such an exciting time for the company,” said Mr. Wiggans. “I look forward to partnering with the executive team and the Board as we prepare the company for its next stage of transition and growth in bringing novel treatments to patients.” “I’ve had an opportunity to see first hand the potential that seladelpar has to significantly advance patient care in PBC,” said Ms. Dorling. “I’m excited to once again play a role in the important work that lies ahead for the company.” “We are incredibly fortunate to be able to add such extensive experience and critical skill sets to our Board as we move through key inflection points at CymaBay including advancing our lead program, seladelpar, from the final stages of clinical development to commercialization and expanding our pipeline,” added President and Chief Executive Officer, Sujal Shah. “Tom has had a distinguished career as an operator and director across numerous biopharma companies. In addition to her leadership as a commercial executive at two of the most successful biotech companies in the world, Janet has unique insight into the potential opportunity seladelpar has to significantly advance patient care in PBC having previously served as Chief Commercial Officer at CymaBay. I’m confident that both will have an immediate impact on our mission to bring novel treatments to patients with chronic inflammatory diseases.” About Mr. WiggansMr. Wiggans is a veteran biopharmaceutical executive, having founded Dermira, Inc. in 2010 and served as its chairman and chief executive officer until it was acquired by Eli Lilly and Company in February 2020. Prior to founding Dermira, Mr. Wiggans served as chairman and chief executive officer of Peplin, Inc. until Peplin’s acquisition by LEO Pharma A/S in 2009. He also served as chairman of the board of directors and chief executive officer of Connetics Corporation until it was acquired by Stiefel Laboratories, Inc. in 2006. Prior to Connetics, he served as president and chief operating officer of CytoTherapeutics Inc. and in various management positions at Ares-Serono S.A., including as president of its U.S. pharmaceutical operations and managing director of its U.K. pharmaceutical operations. He began his career with Eli Lilly and Company. Mr. Wiggans has served on the boards of numerous public and private companies including Excaliard, Somaxon, Corthera, Sangamo and Onyx. He is a long-standing member of the board of directors of BIO, as well as a member of the board of trustees of the University of Kansas Endowment Association. He holds a B.S. in pharmacy from the University of Kansas and an M.B.A. from Southern Methodist University. About Ms. DorlingMs. Dorling has been the Senior Vice President, Global Commercial Product Strategy at Gilead Sciences Inc. since May 2020. She was the Chief Commercial Officer at CymaBay Therapeutics, Inc. from August 2019 to December 2019 and the Chief Commercial Officer at Achaogen from 2017 to 2019. Previously she served as Vice President, Breast Cancer Franchise, Global Product Strategy from 2015 to 2017 at Roche and from 2003 through 2015 served in various marketing and commercial roles at Genentech. Throughout her career, Ms. Dorling launched numerous products across multiple therapeutic areas including ophthalmology and oncology. Ms. Dorling received a M.S. from Duke University and an M.B.A. from the University of California, Berkeley. About CymaBayCymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. CymaBay is developing seladelpar, a potent, selective, orally active PPARδ agonist for patients with primary biliary cholangitis (PBC). Seladelpar has received an orphan designation from the US Food and Drug administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA for early stage PBC and PRIority MEdicines status from the EMA. CymaBay is currently commencing a global, Phase 3 registration study of seladelpar for PBC. This study is a 52-week, placebo-controlled, randomized, phase 3 study to evaluate the safety and efficacy of seladelpar (RESPONSE) in patients with PBC. For more information about RESPONSE, please visit: www.pbcstudies.com. Cautionary StatementsThe statements in this press release regarding the potential for seladelpar to treat PBC, the potential benefits to patients, CymaBay’s expectations and plans regarding product development and its current and future clinical trials, 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) 818-8198Glenn.silver@finnpartners.com Investor Relations Contact: Hans VitzthumLifeSci Advisors, LLC(617) 430-7578Hans@LifeSciAdvisors.com

  • CymaBay Reports Fourth Quarter and Year End 2020 Financial Results and Provides Corporate Update
    GlobeNewswire

    CymaBay Reports Fourth Quarter and Year End 2020 Financial Results and Provides Corporate Update

    Actively recruiting patients in two global, clinical studies evaluating seladelpar in primary biliary cholangitis (PBC): RESPONSE, a 52-week, randomized, placebo-controlled, Phase 3 registrational studyASSURE, an open-label, long-term study Two pipeline programs also in clinical development in 2021: Phase 2a study of MBX-2982, a GPR119 agonist, for the prevention of hypoglycemia in patients with type 1 diabetesPhase 1 single and multiple ascending dose study of CB-0406, a non-agonist ligand of PPARγ Conference call and webcast today at 4:30 p.m. ET NEWARK, Calif., March 25, 2021 (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 corporate updates and financial results for the fourth quarter and fiscal year ended December 31, 2020. In the fourth quarter of 2020 and through early March 2021, CymaBay made significant progress reinitiating the development program for seladelpar in primary biliary cholangitis (PBC). With multiple clinical sites activated, patient recruitment is underway in RESPONSE, a global Phase 3 registrational study evaluating seladelpar in patients with PBC. In addition, we have also initiated ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional safety data to support registration. Sujal Shah, President and CEO of CymaBay, stated, “One year ago today, our work towards finding novel treatments for patients with chronic, inflammatory and metabolic diseases was on hold as we completed the important work of ensuring patient safety before moving forward. Today we have four active clinical studies ongoing across three programs. We continue to make great progress towards restarting our seladelpar development program with RESPONSE as we execute on a focused strategy to complete late-stage development of seladelpar for patients with PBC. Results from our previous Phase 3 study in PBC, ENHANCE, presented at The Liver Meeting® 2020, highlighted the anti-cholestatic, anti-inflammatory and anti-pruritic effects of seladelpar in patients with PBC that we believe support the potential for seladelpar to address key unmet needs for patients suffering from this disease. In addition to our core focus in PBC, we continue to evaluate seladelpar for other indications and are excited about our early-stage pipeline maturing in the coming months.” Recent Corporate Highlights Initiated RESPONSE, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study will target enrolling 180 patients, who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary.Initiated ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration. The first subjects will consist of patients who have participated in CymaBay’s prior studies of seladelpar in PBC, including the patients who completed the open-label Phase 2 study and enrolled into the previous long-term study and ENHANCE. Patients who complete RESPONSE, and potentially other future PBC studies with seladelpar, will also have the opportunity to enroll in ASSURE.Presented results from two separate studies of seladelpar in patients with PBC and NASH at The Liver Meeting® 2020 as follows: Oral, late-breaking presentation by Professor Gideon Hirschfield, MD, on November 16 highlighting results from ENHANCE, a Phase 3 study of seladelpar in patients with PBC“Poster of Distinction” presentation by Dr. Stephen Harrison, MD, featuring results from a Phase 2 paired-liver biopsy study of seladelpar in patients with NASH In November 2020, we announced a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes (T1D). The study is being conducted by the AdventHealth Translational Research Institute (TRI) in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982. TRI commenced startup activities in early 2021 and topline results are currently anticipated in late 2021.Initiated a single and multiple ascending dose study of CB-0406 in healthy subjects to establish its pharmacokinetics, safety and maximum tolerated dose. CB-0406 is a non-agonist ligand of PPARγ that attenuates the expression of inflammatory genes.Held $146.3 million in cash, cash equivalents and short-term investments on December 31, 2020. We believe that cash and investments are sufficient to fund CymaBay’s current operating plan into mid-2022.Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. CymaBay continues to closely monitor pandemic developments and their associated risks to the business, including the restarting of its clinical development of seladelpar, and will continue to take actions available to mitigate them where possible. Further, all CymaBay’s actions will continue to be guided by a commitment to ensuring the health and safety of its employees as well as patients enrolled in its clinical studies. Fourth Quarter and Year Ended December 31, 2020 Financial Results Research and development expenses for the three and twelve months ended December 31, 2020 were $10.7 million and $35.9 million, respectively. This compared to R&D expenses of $20.9 million and $83.8 million for the three and twelve months ended December 31, 2019, respectively. Research and development expenses in the three and twelve months ended December 31, 2020 were lower than the corresponding periods in 2019 primarily due to a decline in clinical trial activities related to the termination of our Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, after the seladelpar development program was placed on hold from November 2019 through July 2020. Clinical development of seladelpar in PBC was resumed in late 2020, and these clinical expense reductions were offset in part by increases in clinical trial costs associated with the commencement of RESPONSE and ASSURE, our two new global late-stage clinical trials in PBC.General and administrative expenses for the three and twelve months ended December 31, 2020 were $5.2 million and $17.4 million, respectively. This compared to $4.5 million and $19.2 million for the three and twelve months ended December 31, 2019, respectively. General and administrative expenses in the year 2020 were lower than in 2019 due to lower employee compensation costs following the completion of a reduction-in-force plan in late 2019. General and administrative expenses in the three months ended December 31, 2020 were higher than the corresponding period in 2019 due to higher employee compensation associated with the hiring of additional personnel upon resumption of development of seladelpar in the second half of 2020. Net loss for the three and twelve months ended December 31, 2020 was $15.8 million, or ($0.23) per diluted share, and $51.0 million, or ($0.74) per diluted share, respectively. This compared to net loss of $29.4 million, or ($0.43) per diluted share, and $102.8 million, or ($1.53) per diluted share, in the three and twelve months ended December 31, 2019, respectively. Net loss was lower largely due to decreases in clinical operating expenses which resulted from the temporary clinical hold placed on the seladelpar development program. With development of seladelpar restarted during the second half of 2020, we expect our operating expenses to increase in 2021 as we continue to execute on our clinical development plans. Conference Call Details CymaBay will host a conference call today at 4:30 p.m. ET to discuss fourth quarter and fiscal year end 2020 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13715944. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company's website at http://ir.cymabay.com/events. About CymaBay CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. CymaBay is developing seladelpar, a potent, selective, orally active PPARδ agonist for patients with primary biliary cholangitis (PBC). Seladelpar has received an orphan designation from the US Food and Drug administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA for early stage PBC and PRIority MEdicines (PRIME) status from the EMA. CymaBay is currently commencing a global, Phase 3 registration study of seladelpar for PBC. This study is a 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar (RESPONSE) in patients with PBC. For more information about RESPONSE, please visit: www.pbcstudies.com. Cautionary Statements Any statements made in this press release and accompanying conference call regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease, the potential benefits to patients, CymaBay’s expectations and plans regarding its current and future clinical trials, CymaBay’s ability to fund current and planned clinical trials and CymaBay’s anticipated cash runway 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) 818-8198Glenn.silver@finnpartners.com Investor Relations Contact: Hans VitzthumLifeSci Advisors, LLC(617) 430-7578Hans@LifeSciAdvisors.com CymaBay Therapeutics, Inc. Financial Results(In thousands, except share and per share information) Quarter Ended Year Ended December 31, December 31, 2020 2019 2020 2019 (unaudited) (unaudited) Operating expenses: Research and development$10,688 $20,937 $35,882 $83,837 General and administrative 5,186 4,532 17,425 19,238 Restructuring (benefit) charges (1) 5,075 (705) 5,075 Total operating expenses 15,873 30,544 52,602 108,150 Loss from operations (15,873) (30,544) (52,602) (108,150)Other income: Interest income 122 1,131 1,616 5,342 Total other income 122 1,131 1,616 5,342 Net loss$(15,751) $(29,413) $(50,986) $(102,808) Basic and diluted net loss per common share$(0.23) $(0.43) $(0.74) $(1.53) Weighted average common shares outstanding used to calculate basic and diluted net loss per common share 68,917,646 68,749,075 68,893,127 67,033,046 CymaBay Therapeutics, Inc.Balance Sheet Data(in thousands) December 31, December 31, 2020 2019 Cash, cash equivalents and marketable securities $146,323 $190,945 Working capital 141,728 185,287 Total assets 153,825 205,727 Total liabilities 11,119 19,379 Common stock and additional paid-in capital 819,556 812,140 Total stockholders’ equity 142,706 186,348

  • ACCESSWIRE

    CymaBay Therapeutics, Inc. to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / March 25, 2021 / CymaBay Therapeutics, Inc. (NASDAQ:CBAY) will be discussing their earnings results in their 2020 Fourth Quarter Earnings call to be held on March 25, 2021 at 4:30 PM Eastern Time.