CBAY CymaBay Therapeutics Inc.

6.51
+0.15  (+2%)
Previous Close 6.36
Open 6.33
52 Week Low 1.21
52 Week High 7.09
Market Cap $448,454,969
Shares 68,887,092
Float 68,467,232
Enterprise Value $281,501,968
Volume 987,110
Av. Daily Volume 4,224,134
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Drug Pipeline

Drug Stage Notes
Seladelpar
Primary biliary cholangitis (PBC)
Phase 2
Phase 2
Phase 2 open-label data presented at EASL August 27, 2020.
Seladelpar
Non-alcoholic steatohepatitis (NASH)
Phase 2b
Phase 2b
Clinical hold released July 23, 2020.
Arhalofenate
Gout
Phase 3
Phase 3
Phase 3 planned - to be initiated by Kowa Pharmaceuticals.

Latest News

  1. MONTREAL and CHARLOTTE, N.C., Sept. 22, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the appointment of Lisa Giles and Robert Wills to its Board of Directors, effective October 1, 2020. Ms. Giles will serve as a member of the Audit Committee of the Board and Dr. Wills will serve as a member of the Nominating & Corporate Governance Committee of the Board. 

    "On behalf of the entire Board of Directors, it is a pleasure to welcome Lisa and Rob, two highly accomplished industry veterans, to our team," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Their…

    MONTREAL and CHARLOTTE, N.C., Sept. 22, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the appointment of Lisa Giles and Robert Wills to its Board of Directors, effective October 1, 2020. Ms. Giles will serve as a member of the Audit Committee of the Board and Dr. Wills will serve as a member of the Nominating & Corporate Governance Committee of the Board. 

    "On behalf of the entire Board of Directors, it is a pleasure to welcome Lisa and Rob, two highly accomplished industry veterans, to our team," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Their collective experience across a range of diverse strategic roles will be highly instrumental as we continue to advance our Phase 3 program of etripamil for the treatment of paroxysmal supraventricular tachycardia, prepare for commercialization, and build out our pipeline. I look forward to working with them and leveraging their unique expertise."

    Ms. Giles brings to the Milestone Board of Directors over 35 years of experience in the pharmaceutical industry, including strategic planning, operations, and business development. She is the founder, managing director and Chief Executive Officer of Giles & Associates Consultancy, Inc. (GAC). From 2013 until 2020, Ms. Giles served as Chief Executive Officer of Optivara, Inc., a cloud-based software and predictive analytics company serving the life sciences industry. Prior to founding GAC and Optivara, Ms. Giles was the Vice President of Strategy Development at G.D. Searle Pharmaceutics, Monsanto; and held various leadership roles with Abbott Laboratories. She currently serves on the Board of Directors of GenMark Diagnostics, Inc. (NASDAQ:GNMK) and the Northwestern Memorial Hospital Foundation, and previously served as a member of the Board of Directors of Durata Therapeutics, Inc. (NASDAQ:DRTX) and Intranasal Therapeutics, Inc. She received her B.S. in Economics from Juniata College, and completed executive management programs at Stanford University and the University of Chicago.

    Dr. Wills joins the Board with over 35 years of experience in the pharmaceutical industry, including preclinical and clinical research and development, business development, and strategic partnering. Prior to his retirement in 2015, Dr. Wills spent over 25 years in a variety of executive roles at Johnson & Johnson, most recently as Vice President, Alliance Management, where he was responsible for managing worldwide strategic alliances. Prior to Johnson & Johnson, he spent ten years in drug development roles at Hoffmann-La Roche Inc. Dr. Wills currently serves as Chairman of the Board of Directors of CymaBay Therapeutics, Inc. (NASDAQ:CBAY) and is on the Board of Directors of Oncternal Therapeutics, Inc. (NASDAQ:ONCT), Parion Sciences, Inc., and Go Therapeutics, Inc. He was previously a member of the Board of Directors of GTx, Inc., where he served as Executive Chairman and Chair of the Scientific and Development Committee. Dr. Wills holds a B.S. in Biochemistry and a M.S. in Pharmaceutics from the University of Wisconsin and a Ph.D. in Pharmaceutics from the University of Texas.

    About Milestone Pharmaceuticals

    Milestone Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines. Milestone Pharmaceuticals operates in Canada and the United States. For more information, visit www.milestonepharma.com and follow the Company on Twitter at @MilestonePharma.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate,", "continue" "estimate," "potential,", "prepare", "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding, Milestone's future board members, Milestone's ongoing clinical trials and Milestone's preparations to commercialize etripamil for PSVT.  Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process, uncertainties related to the timing of initiation, enrollment, completion and evaluation of clinical trials, and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, as well as risks related to pandemics and public health emergencies, including those related to COVID-19,  and risks related the sufficiency of Milestone's capital resources and its ability to raise additional capital. These and other risks are set forth in Milestone's filings with the U.S. Securities and Exchange Commission, including in its quarterly report on Form 10-Q for the quarter ended June 30, 2020, under the caption "Risk Factors." Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    Contact:

    David Pitts

    Argot Partners

    212-600-1902

    (PRNewsfoto/Milestone Pharmaceuticals)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/milestone-pharmaceuticals-strengthens-board-of-directors-with-two-new-appointments-301135061.html

    SOURCE Milestone Pharmaceuticals, Inc.

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  2. NEWARK, Calif., Sept. 03, 2020 (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 management will participate in three virtual investor conferences including Citi's 15th Annual BioPharma Conference taking place September 9-10, 2020, the H.C. Wainwright 22nd Annual Global Investment Conference taking place September 14-16, 2020 and the Cantor Global Healthcare Conference taking place September 15-17, 2020.

    Citi's 15th Annual BioPharma Conference 
    Date:Wednesday, September 9
    Time:1-on-1 meetings only
      
    H.C. Wainwright 22nd Annual Global Healthcare Conference 
    Date:Monday, September

    NEWARK, Calif., Sept. 03, 2020 (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 management will participate in three virtual investor conferences including Citi's 15th Annual BioPharma Conference taking place September 9-10, 2020, the H.C. Wainwright 22nd Annual Global Investment Conference taking place September 14-16, 2020 and the Cantor Global Healthcare Conference taking place September 15-17, 2020.

    Citi's 15th Annual BioPharma Conference 
    Date:Wednesday, September 9
    Time:1-on-1 meetings only
      
    H.C. Wainwright 22nd Annual Global Healthcare Conference 
    Date:Monday, September 14
    Time:1:30 pm Eastern Time
    Webcast:http://ir.cymabay.com/events
      
    Cantor Global Healthcare Conference 
    Date:Wednesday, September 16
    Time: 10:40 am Eastern Time
    Webcast: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 and PRIority MEdicines status from the EMA for PBC.

    Cautionary Statements

    Any statements made in this press release and at the investor conferences referenced above 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 intended future interactions with the FDA, 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 or to potentially restart clinical trials. 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 Silver

    Lazar-FINN Partners

    (973) 818-8198

    Investor Relations Contact:

    Hans Vitzthum

    LifeSci Advisors, LLC

    (617) 430-7578

    Primary Logo

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    • Sustained anti-cholestatic and hepatoprotective effects observed in patients with and without cirrhosis
    • Self-reported pruritus improved at one year for patients in highest categories of baseline itch
    • Selected for inclusion in the "Best of ILC" presentation
    • Results mirror recently reported ENHANCE Phase 3 data confirming anti-cholestatic and anti-pruritic effects of seladelpar

    NEWARK, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced final results from a previously completed open-label Phase 2 study of seladelpar in patients with primary biliary cholangitis…

    • Sustained anti-cholestatic and hepatoprotective effects observed in patients with and without cirrhosis

    • Self-reported pruritus improved at one year for patients in highest categories of baseline itch
    • Selected for inclusion in the "Best of ILC" presentation
    • Results mirror recently reported ENHANCE Phase 3 data confirming anti-cholestatic and anti-pruritic effects of seladelpar

    NEWARK, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced final results from a previously completed open-label Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC). These data will be made available as an electronic presentation through the Digital International Liver Congress™ 2020 of the European Association for the Study of Liver (EASL) which will be held online August 27th – 29th and were selected for inclusion in the "Best of ILC" presentation.

    The presentation titled "Durability of treatment response after 1 year of therapy with seladelpar in patients with primary biliary cholangitis (PBC): final results of an international phase 2 study," was delivered by Dr. Cynthia Levy, MD, Professor of Medicine, University of Miami. This electronic presentation highlights the efficacy, safety, and tolerability of seladelpar over 1 year of open-label treatment. Eligible PBC patients with either an inadequate response (alkaline phosphatase [ALP] ≥1.67 x upper limit of normal [ULN]) or intolerance to ursodeoxycholic acid (UDCA) were either sequentially assigned or randomized to daily seladelpar at 2 mg, 5/10 mg (initial 5 mg with an option to adjust to 10 mg) or 10 mg groups and treated for 1 year. At 1 year, the mean decreases in ALP were 41% and 45% in the 5/10 mg and 10 mg groups, respectively. A key secondary endpoint was the composite responder rate measured at 1 year and defined as a patient with ALP <1.67 x ULN, ≥ 15% decrease in ALP, and total bilirubin ≤ULN. At 1 year, 55% and 69% of patients met the composite responder endpoint in the 5/10 mg and 10 mg groups, respectively. Mean decreases in ALT, AST, and GGT were observed in all treatment groups. Normalization of ALP levels at 1 year occurred in 14% and 33% in the 5/10 mg and 10 mg, respectively. Pruritus was evaluated at baseline through 1 year for patients in the 5/10 mg and 10 mg groups using visual analogue scale (VAS: 0-100), 5D-itch scale (5 domains: 1-5 each) and PBC-40 questionnaires. Substantial improvement in pruritus (VAS ≥20-point decrease) at 1 year in patients with moderate to severe pruritus (VAS ≥40 at baseline) was seen in 58% and 93% of patients in the 5/10 mg and 10 mg groups, respectively. Seladelpar in doses up to 10 mg appeared safe and well-tolerated in patients with and without cirrhosis. Of the 119 patients that received at least one dose of seladelpar, 14 serious adverse events were documented and none were related to seladelpar. Four patients discontinued the study due to an adverse event. Nine patients had liver biopsies performed during the long-term study after treatment with seladelpar ranging from 15 – 33 months. Post-treatment liver biopsy findings were consistent with expected features of PBC.

    "These findings suggest that seladelpar treatment in a high-risk PBC patient population promotes clinically significant improvement in biochemical markers of cholestasis and provides a potential benefit on pruritus. Additionally, seladelpar treatment appeared safe and well-tolerated which is encouraging given the unmet need that exists in this high-risk population," said Dr. Levy.

    Sujal Shah, CEO and President of CymaBay Therapeutics, commented, "We are extremely encouraged by the sustained anti-cholestatic effects and improvement in markers of liver injury observed with seladelpar treatment in this study. We believe the results from this Phase 2 PBC study have now been confirmed in the placebo-controlled ENHANCE study, which demonstrated clinically meaningful and statistically significant differences in anti-cholestatic, hepatoprotective, and anti-pruritic effects from placebo after only 3 months of treatment. These data and data from ENHANCE strengthen our confidence in the potential for seladelpar to be a breakthrough therapy for patients with PBC. We want to thank the patients and investigators who have participated in our clinical studies and look forward to the re-initation of a Phase 3 registration study for seladelpar in PBC."

    CymaBay's presentations from The Digital International Liver Congress™ will also be made available on the CymaBay website (www.cymabay.com).

    About PBC

    Primary biliary cholangitis (PBC) is a serious and potentially life-threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids. There is an accompanying inflammation and destruction of the intrahepatic bile ducts, which can progress to fibrosis, cirrhosis and liver failure. Other clinical symptoms of PBC include fatigue and pruritus, which can be quite disabling in some patients. PBC is primarily a disease of women: 1 in 1000 women over the age of 40 lives with PBC.

    About Seladelpar

    Seladelpar is a potent, selective, orally active PPARδ agonist that has been in development for the treatment of the liver diseases PBC and nonalcoholic steatohepatitis (NASH). For 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 and PRIority MEdicine status from the EMA for PBC.

    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.

    Cautionary Statements

    The statements in this press release 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 intended future interactions with the FDA, 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 or to potentially restart clinical trials. 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 Silver

    Lazar-FINN Partners

    (973) 818-8198

    Investor Relations Contact:

    Hans Vitzthum

    LifeSci Advisors, LLC

    (617) 430-7578

    Primary Logo

    View Full Article Hide Full Article
  3. NEWARK, Calif., Aug. 20, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced that two seladelpar presentations will be delivered during the Digital International Liver Congress™ 2020 of the European Association for the Study of Liver (EASL) which will be held online August 27th – 29th.

    The presentation titled "Durability of treatment response after 1 year of therapy with seladelpar in patients with primary biliary cholangitis (PBC): final results of an international phase 2 study,"1 will be delivered by Dr. Cynthia Levy, MD, Associate Professor of Medicine, University…

    NEWARK, Calif., Aug. 20, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced that two seladelpar presentations will be delivered during the Digital International Liver Congress™ 2020 of the European Association for the Study of Liver (EASL) which will be held online August 27th – 29th.

    The presentation titled "Durability of treatment response after 1 year of therapy with seladelpar in patients with primary biliary cholangitis (PBC): final results of an international phase 2 study,"1 will be delivered by Dr. Cynthia Levy, MD, Associate Professor of Medicine, University of Miami. This electronic presentation will highlight the efficacy, safety, and tolerability of seladelpar treatment over 1 year.

    In addition, a preclinical oral presentation2 will highlight the effects of seladelpar in a mouse model of ethanol-induced liver disease from Professor Bernd Schnabl and collaborators at the University of California, San Diego.

    Sujal Shah, CEO and President of CymaBay Therapeutics, commented, "We are excited to share the final results from an open-label Phase 2 study of seladelpar in PBC. The data demonstrate that seladelpar retained efficacy and appeared safe and tolerable after 1 year of treatment in patients with PBC. We believe the observed response in this study along with recently reported data from the placebo-controlled ENHANCE study support the evaluation of seladelpar in a new Phase 3 registration study in PBC. We want to extend our sincere gratitude to the patients who have participated in our clinical studies, their families, and the investigators and clinical research team members that support them."

    Poster Presentation

    August 27th 12:30 PM CEST

    FRI133:

    1"Durability of treatment response after 1 year of therapy with seladelpar in patients with primary biliary cholangitis (PBC): final results of an international phase 2 study"

    Cynthia Levy, Christopher Bowlus, Guy Neff, Mark G. Swain, Michael Galambos, Marlyn J. Mayo, Aparna Goel, Palak Trivedi, Gideon Hirschfield, Richard Aspinall, Andreas E. Kremer, Stuart C. Gordon, Brian Borg, Stephen Harrison, David Jones, Paul Thuluvath, Yvonne Doerffel, Carmen Stanca, David Sheridan, Bruce Bacon, Christoph Berg, Douglas Thorburn, John Vierling, Mitchell Shiffman, Joseph Odin, Tarek Hassanein, Adam Peyton, Aliya Gulamhusein, Charles Landis, David Bernstein, Lynsey Corless, Marcus-Alexander Woerns, Peter Buggisch, Sandrin Bergheanu, Wendy Chen, Frances Seput-Dingle, Lily Mao, Yu Li, Ke Yang, Elena Muslimova, Yun-Jung Choi, Monika Varga, Klara Dickinson, Pol Boudes, Charles McWherter, Alexandra (Sasha) Steinberg

    Oral Presentation

    August 27th 12:00 – 12:15 PM CEST

    AS083:

    2"The selective PPAR-delta agonist seladelpar reduces ethanol-induced liver disease by restoring gut barrier function and bile acid homeostasis in mice"

    Huikuan Chu, Bei Gao, Yanhan Wang, Lu Jiang, Edward Cable, Bernd Schnabl

    A full list of presentations can be found on The Digital International Liver Congress™ 2020 website. 

    The presentations will also be made available on the CymaBay website.

    About PBC

    Primary biliary cholangitis (PBC) is a serious and potentially life-threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids. There is an accompanying inflammation and destruction of the intrahepatic bile ducts, which can progress to fibrosis, cirrhosis and liver failure. Other clinical symptoms of PBC include fatigue and pruritus, which can be quite disabling in some patients. PBC is primarily a disease of women: 1 in 1000 women over the age of 40 lives with PBC.

    About Seladelpar

    Seladelpar is a potent, selective, orally active PPARδ agonist that has been in development for the treatment of the liver diseases PBC and nonalcoholic steatohepatitis (NASH). For 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 and PRIority MEdicine status from the EMA for PBC.

    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.

    Cautionary Statements

    The statements in this press release 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 intended future interactions with the FDA, 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 or to potentially restart clinical trials. 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 Silver

    Lazar-FINN Partners

    (973) 818-8198

    Investor Relations Contact:

    Hans Vitzthum

    LifeSci Advisors, LLC

    (617) 430-7578

     

    Primary Logo

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  4. FDA lifts all clinical holds on seladelpar

    Positive topline data announced from ENHANCE

    Company to reinitiate clinical development of seladelpar for patients with PBC

    Cash sufficient to fund current operating plan into 2022

    Conference call and webcast today at 4:30 p.m. ET

    NEWARK, Calif., Aug. 10, 2020 (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 second quarter and six months ended June 30, 2020.  

    Specifically, in the second quarter and through early August 2020, CymaBay achieved significant progress in its ongoing efforts…

    FDA lifts all clinical holds on seladelpar

    Positive topline data announced from ENHANCE

    Company to reinitiate clinical development of seladelpar for patients with PBC

    Cash sufficient to fund current operating plan into 2022

    Conference call and webcast today at 4:30 p.m. ET

    NEWARK, Calif., Aug. 10, 2020 (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 second quarter and six months ended June 30, 2020.  

    Specifically, in the second quarter and through early August 2020, CymaBay achieved significant progress in its ongoing efforts to review its strategic options, one of which included completing a scientific investigation and working with the FDA to lift the clinical holds on the seladelpar INDs in nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), the three liver diseases in which CymaBay had terminated clinical studies late last year.      

    Sujal Shah, President and CEO of CymaBay, stated, "We are thrilled with the significant progress made to date in our efforts to conduct a review of strategic options, one of which was to pursue the reinstatement of our seladelpar program.  Specifically, in May, we convened a panel of expert liver pathologists and hepatologists that unanimously concluded after a thorough, independent investigation, that there was no clinical, biochemical, or histological evidence of seladelpar-induced liver injury for patients enrolled in our Phase 2b NASH study.  We discussed the panel's findings and related information with the FDA and submitted complete responses to the agency, and in July, the FDA notified us that all clinical holds on seladelpar were lifted.  In addition to this favorable outcome, we evaluated and announced last week positive topline results from our ENHANCE study of seladelpar in PBC which, despite being terminated early, provided sufficient data which appear to support seladelpar's efficacy and tolerability in this patient population.  After receiving notification from the FDA, and reviewing the latest clinical data from the ENHANCE study, we stopped our review of strategic options having decided to focus on reinstating the clinical development program for seladelpar in PBC and to continue to evaluate seladelpar for other indications. We have also been very successfully at minimizing our operating expenses through the first half of the year and expect our cash to fund our current operating plan into 2022."

    Recent Corporate Highlights

    • In May 2020, a panel of eight of the world's foremost expert liver pathologists and hepatologists, whose collective experience relevant to CymaBay's investigation includes drug-induced liver injury, NASH and cholestatic liver diseases, completed a four-day independent review analyzing findings from CymaBay's NASH Phase 2b study, and the results of independent pathologist's reviews of the study biopsies, which included a blinded unpaired review and a paired review blinded to chronologic order of the biopsies. The panel unanimously supported lifting the clinical hold for seladelpar and re-initiation of clinical development pending approval by the FDA. In June 2020, CymaBay discussed the data and the panel's conclusions with the FDA and submitted complete responses to the agency.  In July 2020, the FDA lifted clinical holds on seladelpar in all indications with open INDs (NASH, PBC and PSC). 

       
    • In August 2020, CymaBay announced positive topline results from ENHANCE for seladelpar in patients with PBC.  Topline data for patients through 3 and 6 months demonstrated anti-cholestatic, anti-inflammatory, and anti-pruritic activity.  Notably, 78.2% of patients on seladelpar 10 mg versus 12.5% on placebo achieved the primary composite outcome after only 3 months (p<0.0001).  In addition, 27.3% of patients on seladelpar 10 mg versus zero on placebo experienced normalization of ALP by 3 months (p<0.0001).  Treatment with seladelpar 10 mg also resulted in a statistically significant improvement in pruritus (p<0.05) for patients with moderate-to-severe itch versus placebo.  Overall, seladelpar appeared to be safe and well-tolerated in this study.

       
    • CymaBay intends to reinitiate the long-term study, a Phase 3 study and other NDA-enabling studies to confirm the potential of seladelpar to be a best-in-class treatment for patients with PBC and to further evaluate suitable strategies to advance seladelpar in other indications.

       
    • CymaBay held $168.9 million in cash, cash equivalents and short-term investments as of June 30, 2020 and had no outstanding debt.  Cash and investments are deemed sufficient to fund CymaBay's current operating plan into 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. To date, these developments have not had a significant impact on CymaBay's financial condition or its ability to execute its business plan.  CymaBay will continue to closely monitor pandemic developments and their associated risks to the business, including plans to restart clinical development of seladelpar, and will continue to take actions available to mitigate them where possible. Further, all CymaBay's actions will be guided by a commitment to taking all steps possible to ensure the health and safety of its employees as well as patients enrolled in its clinical studies.

    Second Quarter and Six Months Ended June 30, 2020 Financial Results

    • Research and development expenses for the three months ended June 30, 2020 were $7.9 million, compared to $21.1 million for the three months ended June 30, 2019.  Research and development expenses for the six months ended June 30, 2020 were $17.5 million, compared to $39.7 million for the six months ended June 30, 2019.  Research and development expense in the three and six months of 2020 was significantly lower than the corresponding periods in 2019 primarily due to declining clinical trial activities related to the Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, as efforts continued to shut down these studies which were early-terminated as a result of the FDA's clinical holds that were placed on the seladelpar program in the fourth quarter of 2019.

       
    • General and administrative expenses for the three months ended June 30, 2020 were $3.4 million, compared to $4.5 million for the three months ended June 30, 2019. General and administrative expenses for the six months ended June 30, 2020 were $7.7 million, compared to $10.2 million for the six months ended June 30, 2019. General and administrative expenses in the three and six months of 2020 were lower than the corresponding periods in 2019 due to lower employee compensation and other administrative expenses incurred as a result of a December 2019 reduction-in-force and restructuring effort that was undertaken to reduce costs in response to the FDA's clinical holds on the seladelpar program.

       
    • Net loss for the three months ended June 30, 2020 was $10.7 million, or ($0.16) per diluted share, compared to a net loss of $24.0 million, or ($0.35) per diluted share in the three months ended June 30, 2019. Net loss for the six months ended June 30, 2020 was $23.8 million, or ($0.35) per diluted share, compared to a net loss of $47.1 million, or ($0.72) per diluted share in the six months ended June 30, 2019.  Net loss was lower in the three and six months of 2020 compared to the corresponding periods in 2019 primarily due to a decrease in operating expenses, including clinical trial and labor related expenses, as a result of the early-termination of our seladelpar studies and our cost reduction efforts undertaken in response to the FDA's clinical holds that were placed on the seladelpar program in the fourth quarter of 2019.

    Conference Call Details

    CymaBay will host a conference call today at 4:30 p.m. ET to discuss second quarter 2020 financial results and provide a corporate 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# 13706143. 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 and PRIority MEdicines status from the EMA for PBC.

    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 intended future interactions with the FDA, 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 or to potentially restart clinical trials. 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 Silver

    Lazar-FINN Partners

    (973) 818-8198



    Investor Relations Contact:

    Hans Vitzthum

    LifeSci Advisors, LLC

    (617) 430-7578

     
    CymaBay Therapeutics, Inc.
    Financial Results
    (In thousands, except share and per share information)
             
      Quarter Ended  Six Months Ended
      June 30, June 30,
       2020   2019   2020   2019 
      (unaudited) (unaudited) (unaudited) (unaudited)
             
    Operating expenses:        
    Research and development $7,942  $21,119  $17,451  $39,707 
    General and administrative  3,398   4,529   7,745   10,192 
    Restructuring charges  (188)  -   (117)  - 
    Total operating expenses  11,152   25,648   25,079   49,899 
             
    Loss from operations  (11,152)  (25,648)  (25,079)  (49,899)
    Other income:        
    Interest income  426   1,610   1,265   2,786 
    Total other income  426   1,610   1,265   2,786 
    Net loss $(10,726) $(24,038) $(23,814) $(47,113)
             
    Basic net loss per common share $(0.16) $(0.35) $(0.35) $(0.72)
    Diluted net loss per common share $(0.16) $(0.35) $(0.35) $(0.72)
             
    Weighted average common shares        
    outstanding used to calculate        
    basic net loss per common share  68,885,108   68,697,735   68,883,783   65,312,988 
    Weighted average common shares        
    outstanding used to calculate        
    diluted net loss per common share 68,885,108   68,697,735   68,883,783   65,312,988 
             
        
    CymaBay Therapeutics, Inc.   
    Balance Sheet Data  
    (in thousands)  
             
        June 30, December 31,  
         2020   2019   
        (unaudited)    
             
    Cash, cash equivalents and marketable securities $168,907  $190,945   
    Working capital  164,624   185,287   
    Total assets  176,597   205,727   
    Total liabilities  10,989   19,379   
    Common stock and additional paid-in capital  815,108   812,140   
    Total stockholders' equity  165,608   186,348   

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