Cymabay Therapeutics, Inc. (NASDAQ:CBAY) Q3 2019 Earnings Conference Call - Final Transcript

Nov 05, 2019 • 04:30 pm ET


Cymabay Therapeutics, Inc. (NASDAQ:CBAY) Q3 2019 Earnings Conference Call - Final Transcript


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Good day ladies, and gentlemen and welcome to CymaBay's Third Quarter 2019 Financial Results Conference Call. [Operator Instructions] Please be advised that the call will be recorded at the company's request. It is also being webcast live on the Investors section at the CymaBay website at

Now I would like to turn the call over to Mr. Dan Menold, Vice President of Finance at CymaBay. Mr. Menold, please proceed.

Dan Menold

Thank you, operator and good afternoon everyone. I hope that you had a chance to review the press release we issued announcing our third quarter 2019 financial results and business update. You can access that release on our website under the Investors tab. Joining me on the call today are Sujal Shah Chief Executive Officer; and Dr. Chuck McWherter Chief Scientific Officer. They'll provide an update on our financial position and clinical programs and review upcoming milestones before we open up the call for Q&A. Before we begin I'd like to remind everyone that statements made during this conference call including the Q&A session, relating to CymaBay's expected future performance business prospects events or plans including clinical plans and anticipated data release dates and cash runway are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995.

Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecast due to the impact of many factors. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information future events or otherwise except as required by applicable law. Participants are directed to the cautionary statements set forth in today's press release as well as the risk factors set forth in CymaBay's quarterly and annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. This conference call is the property of CymaBay and any recording or rebroadcast is expressly prohibited without the written consent of CymaBay.

At this time I would like to turn the call over to Sujal.

Sujal Shah

Good afternoon and thank you for joining us. I begin our call today with today with several exciting updates related to seladelpar our highly selective and potent PPAR-delta agonist currently in development for multiple inflammatory liver diseases including primary biliary cholangitis or PBC; primary sclerosing cholangitis or PSC; and nonalcoholic steatohepatitis or NASH. Yesterday almost one year to the day since its initiation we announced that we had reached target enrollment of 240 patients earlier than expected in ENHANCE our global Phase three registration study of seladelpar in patients with PBC. We now expect to complete randomization by the end of this month and to report top line Phase three data in early 2021. As a reminder ENHANCE is a double-blind randomized placebo-controlled 52-week study evaluating the safety and efficacy of five and 10 milligrams of seladelpar versus