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May 8, 2019, 4:12 p.m. EDT

CymaBay Reports First Quarter 2019 Financial Results and Provides Corporate Update

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

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NEWARK, May 08, 2019 (GLOBE NEWSWIRE via COMTEX) -- CymaBay Therapeutics, Inc. /zigman2/quotes/201917619/composite CBAY +0.63% , a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced financial results and a corporate update for the quarter ended March 31, 2019.

"The first quarter of 2019 was highlighted by significant clinical and regulatory accomplishments that continue to accelerate and support the development of seladelpar in PBC and NASH," said Sujal Shah, President and CEO of CymaBay. "In February, we completed enrollment one quarter ahead of schedule in our 52-week, dose-ranging Phase 2b study of seladelpar in patients with NASH, putting us in a position to announce topline data for changes in liver fat, lipids and transaminases at week 12 before the end of the second quarter. Also in February, we announced the FDA granted seladelpar Breakthrough Therapy Designation for patients with early stage PBC. Our progress supported a successful capital raise in March that will now allow us to advance clinical development of seladelpar into a third inflammatory liver disease, primary sclerosing cholangitis (PSC) in the second half of this year. We could not be more pleased with the progress we have made to date and the depth of our overall development program for seladelpar."

First Quarter Business Highlights

-- Enrollment was completed in a Phase 2b dose-ranging, paired liver biopsy study of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH).

    -- A total of 181 patients enrolled with elevated liver fat and biopsy-confirmed NASH.

    -- A total of 181 patients enrolled with elevated liver fat and biopsy-confirmed NASH.

    -- Topline data on the primary efficacy outcome, the change from baseline in liver fat content at 12 weeks as measured by magnetic resonance imaging using the proton density fat fraction method (MRI-PDFF) as well as changes from baseline to 12 weeks in alanine aminotransferase (ALT), low-density lipoprotein C (LDL-C) and triglycerides are expected before the end of 2Q 2019.

    -- The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for seladelpar for the treatment of early stage primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adult patients with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

    -- Continued enrollment of ENHANCE, a global, Phase 3 registration study of seladelpar for the treatment of primary biliary cholangitis (PBC).

      -- ENHANCE is being conducted in more than 150 centers in over 20 countries. The study is intended to establish the efficacy and safety of seladelpar for the treatment of PBC to support the submission of a global registration dossier with health authorities to obtain approval.

      -- ENHANCE is being conducted in more than 150 centers in over 20 countries. The study is intended to establish the efficacy and safety of seladelpar for the treatment of PBC to support the submission of a global registration dossier with health authorities to obtain approval.

      -- The study is expected to be fully enrolled by the end of 2019 with the 52-week treatment period targeted to be completed by the end of 2020 and top-line data in 2021.

      -- Data from an ongoing Phase 2 study of seladelpar in PBC and certain preclinical studies were presented at the International Liver Congress(TM) 2019 hosted by the European Association for the Study of the Liver in Vienna, Austria.

        -- An interim analysis of data from the ongoing Phase 2 study in PBC highlighted comparable anti-cholestatic and anti-inflammatory effects as well as comparable safety and tolerability for seladelpar in non-cirrhotic PBC patients and those with Child-Pugh A cirrhosis.

        -- An interim analysis of data from the ongoing Phase 2 study in PBC highlighted comparable anti-cholestatic and anti-inflammatory effects as well as comparable safety and tolerability for seladelpar in non-cirrhotic PBC patients and those with Child-Pugh A cirrhosis.

        First Quarter Ended March 31, 2019 Financial Highlights & Results

        -- Raised $107.7 million in net proceeds through our March public offering of common stock.

        -- Held $264.8 million in cash, cash equivalents and marketable securities at March 31, 2019. Existing cash is expected to fund the current operating plan into 2021.

        -- Research and development expenses were $18.6 million in the first quarter of 2019 as compared to $9.5 million in the same period of 2018. The increase was primarily driven by increases in seladelpar-related clinical trial expenses including:

          -- start-up and enrollment activities related to our ENHANCE PBC Phase 3 clinical study

          -- start-up and enrollment activities related to our ENHANCE PBC Phase 3 clinical study

          /zigman2/quotes/201917619/composite
          US : U.S.: Nasdaq
          $ 6.43
          +0.04 +0.63%
          Volume: 552,419
          July 18, 2019 4:00p
          P/E Ratio
          N/A
          Dividend Yield
          N/A
          Market Cap
          $438.97 million
          Rev. per Employee
          N/A
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