CymaBay Therapeutics Inc.

Good day, ladies and gentlemen, and welcome to the SEMA Bay second quarter 2022 financial results and business update conference call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open 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. Now, I would like to turn the call over to Mr. Paul Quinlan, General Counsel at CIMA 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 second quarter 2022 financial results and business updates. You can access that release on our website under the Investors tab. Joining me in the call today are Sujil Shah, Chief Executive Officer of Chuck McWhorter, Chief Scientific Officer, Dennis Kim, Chief Medical Officer, 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 SEMA 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. I'm excited to start our call today highlighting the achievement of a significant milestone in the development of Celadalpar for patients with the rare autoimmune liver disease primary biliary cholangitis, or PBC. Last week, we announced the completion of enrollment in response. Our global phase three registration study evaluating Celadelpar in PBC patients who have had an inadequate response to or are intolerant to first-line treatment, ursodeoxycholic acid. As a result of the tireless efforts of our team here at SEMA Bay, the commitment of our patients and their family members, the expertise of our investigators and their staff, and the support of our investors, we have been able to bring CELADELPAR a step closer to our goal of improving the lives of patients with PBC. We believe our development program for CELADELPAR is one of the most robust ever conducted in patients with PBC, with over 600 participants, including over 325 currently receiving treatment in our ongoing study. We have explored a broad range of doses between two and 200 milligrams and have studied a wide spectrum of patients, including non-cirrhotics and compensated cirrhotics with and without portal hypertension. Our current experience includes patients who have been on treatment for between three months and up to three years. Today, I'll ask our chief medical officer, Dr. Dennis Kim, to provide an overview of our progress in response, as well as across the entire PBC development program. Over the years, a key element of our development program has been to publish and present our findings at major medical meetings. Since beginning development in PBC in 2015, we have consistently shared data with the medical community And today, our Chief Scientific Officer, Dr. Chuck McWhirter, will review some of our most recent data presented at the International Liver Congress sponsored by Eazl this past June. Finally, as we look forward to completing response and reporting top-line results from the trial in the third quarter of 2023, we will continue our pre-commercial work to identify strategies that maximize the impact Celadelt Park can have in PBC. Our Chief Commercial Officer, Louis Stewart, will briefly discuss the work that is ongoing and that will be expanded on during a virtual investor event we are planning to hold in September. Before taking questions, we will wrap up our paired remarks with our VP of Finance, Dan Minold, reviewing our financials for the past quarter. Let me first turn the call over to Dennis.