CymaBay Therapeutics Inc.

Good day, ladies and gentlemen, and welcome to CIMA Bay's first quarter 2023 financial results and business update conference call. At this time, all participants are in a listen only mode. Following the formal remarks today, we will open up the call for your questions. Please be advised that the call will be recorded at the company's request. It is also being webcast live on the investor section at the SEMA Bay website at www.semabay.com. At this time, I would like to turn the call over to Mr. Paul Quinlan, General Counsel at SEMA Bay. Mr. Quinlan, please proceed.

Thank you, Operator, and good afternoon, everyone. I hope that you have had a chance to review the press release we issued announcing our first quarter 2023 financial results and business updates. You can access that release on our website under the Investors tab. Joining me on the call today are Sujil Shah, Chief Executive Officer, Chuck McWhorter, Chief Scientific Officer and President of R&D, Louis Stewart, Chief Commercial Officer, and Dan Minold, VP Finance. Following our prepared remarks, we will open 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 CIMA Bay's expected future performance, business prospects, events or plans, including clinical plans, regulatory approvals, funding and repayment schedules, anticipated timelines and data release dates, cash runway, and planning for commercialization 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 on 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 SEMA Bay'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 SEMA Bay, and any recording or rebroadcast is expressly prohibited without the written consent of SEMA Bay. At this time, I'd like to turn the call over to Sujil.

Thank you, Paul. Good afternoon and thank you for joining us today. 2023 continues to be an exciting year for SEMA Bay with only a few short months before we report results from the response phase three study of Celadalpar in patients with primary biliary cholangitis or PBC. Conducted across five continents, The CeladalPAR development program embodies our commitment to advancing care for patients with this rare autoimmune liver disease. In service of their need for improved treatments, we have worked in close collaboration with patient advocacy groups and the world's leading disease experts to ensure that the design of the CeladalPAR program evaluates those aspects most important for patient needs. Our early Q1 accomplishments included licensing of rights to develop and commercialize Celadal PAR in Japan to Kaken Pharmaceutical Company and a follow on equity offering. The capital we raised will fund our operating plan through Q3 of 2024. Our update today will describe our key activities, progress and accomplishments made since our last call and will share catalysts expected in the months ahead. Last week, we announced the appointment of Harish Shantharam as our Chief Financial Officer. For almost 20 years, Harish led various financial functions in commercial biotech companies with a particular focus on setting strategy and building financial planning and accounting operations to prepare companies for commercial drug launch. Harish spent 11 years at Gilead Sciences, last serving as Vice President and Head of Global Commercial Finance. Prior to Gilead, he served in various roles of increasing responsibility, driving forecasting, commercial analytics, and business development at Amgen. Over the course of his career, Harish has supported multiple product launches and brings his operational leadership capabilities as well as his strong strategic, finance, and commercial experience to FEMA Bay as we embark on a transformation to becoming a fully integrated commercial biotech company. We are thrilled to have him on our team and look forward to his impact on our mission to deliver Celadal PAR to patients with PBC. Since our last update call, we have continued to collaborate with PBC stakeholder communities. In April, we had the opportunity to be a sponsor and participant in the 10-year anniversary meeting of the Global PBC Study Group that assembled experts, advocacy groups, regulators, and industry with a theme on the future of treating PBC. Emerging concepts included advancing treatment goals to include normalization of cholestatic and inflammatory markers of disease, addressing clinical symptom burden, particularly fatigue and pruritus, and leveraging inherent knowledge within real-world data to better understand risk parameters and effects of treatment on long-term outcomes. Thanks to the advances by so many around the world, we are convinced that an important inflection point is at hand for treating patients with PBC. Novel improved treatments and growing investments by the collective community is increasing awareness and diagnosis of PBC. Our goal is to increase the number of patients treated with therapies that for the first time have the potential to both reduce the risk of disease progression while also improving quality of life. Today, I will ask Chuck McWhorter, our Chief Scientific Officer and President of Research and Development, to provide important updates on our clinical progress. Louis Stewart, our chief commercial officer, will then share a brief summary of our pre-commercial planning activities before handing the call to Dan Minold, VP of Finance, to review our financials for the first quarter. Chuck?