CymaBay Therapeutics Inc.

Ladies and gentlemen, and welcome to SEMA Bay's second quarter 2023 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 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 second 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 Sujul Shah, Chief Executive Officer, Chuck McWhorter, Chief Scientific Officer and President of R&D, Louis Stewart, Chief Commercial Officer, and Harish Shantaram, Chief Finance Officer. 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 CIMA 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 Sujal.

Thank you, Paul. And good afternoon, everyone. We are confidently advancing towards what is a key and exciting milestone this fall when we expect to report top-line results from response our global phase three registration study of Celadalpar in people with primary biliary cholangitis, or PBC. We anticipate releasing top line results from response by the end of September, and will then plan to submit for regulatory approval as soon as feasible. Our update today includes the announcement of IDEAL, an important new clinical study in the development program of Celadalpar for PBC, and an overview of our pre-commercial planning activities for Cell at El Par. Before we get to these updates, let me welcome our new CFO, Harish Shantharam, to this call. Harish joined us in May and brings over 20 years of experience driving 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. We are delighted to have Harish during this time of critical growth for the company, as we plan for the completion of our Phase III study, regulatory filing, and commercialization of Celadelfar for patients with DVC. His operational leadership capabilities as well as his strong strategic, finance, and commercial experience will be critical as we embark on a transformation to a fully integrated commercial biotech company. Turning to our progress with CeladalPAR, we continue to execute on what we believe is currently the largest clinical development program in PBC. Between our phase two studies, prior Phase III enhanced study, the ongoing Phase III response study, and the open-label Assure study, the development program for Celadalpar is one of the most robust ever conducted in patients with PBC, with over 600 participants, including over 300 currently receiving treatment with Celadalpar in our ongoing studies. It is the depth of clinical data that gives us the confidence in CeladalPAR's potential to offer a clear, differentiated second-line treatment option for patients who are either intolerant or have an inadequate response to ursodeoxycholic acid, the approved first-line agent. At the EASL Congress in Vienna in June, there was considerable discussion among PBC thought leaders, industry sponsors, and patient advocacy groups that centered on revisiting treatment goals for PBC. We noted a consistent theme in the dialogue to consider adjusting treatment goals to include normalization of cholestatic and inflammatory markers and the need to include improving symptom burden. Earlier today, we announced the initiation of IDEAL, a study that will compare the effects of Celadalpar on normalization of ALP versus placebo in patients who continue to have persistent elevations of ALP above normal, but below 1.67 times the upper limit of normal, a level that has been often used as a lower cutoff in clinical trials for PBC. In several publications, this population has been identified to be at continued risk for disease progression. However, they do not meet current guidelines for recommending second-line treatment and are not typically included in clinical research. We believe that IDEAL has the potential to be transformational for this neglected population, potentially resetting expectations for second-line treatment. We are optimistic for the potential results in IDEAL, given CeladalPAR's previous rates of alkaline phosphatase normalization and enhance, a population that had much higher levels of ALP than will be recruited to IDEAL. We are excited that this study is now actively recruiting, and while it is too early for us to comment on timelines for enrollment and data, Chuck will provide more detail on this study during today's call. Beledelpar is the first in the Delpar class of drugs that targets PPAR-Delta in the liver. Study results to date suggest that it has a differentiated profile for efficacy on cholestatic markers of disease, including the registration endpoint of primary composite response of ALP and total bilirubin, and on ALP normalization. Unique among agents approved or in development for PBC, prior studies have suggested that a key feature of Celadalpar's profile might be improvement in quality of life by reducing pruritus in those patients with clinically significant itch. If Celadalpar's profile is confirmed in the ongoing pivotal response study, and if the safety is consistent with that seen today, we believe Celadalpar could be an important step forward in patient care. If in the future we are able to confirm our expectation of positive results in IDEAL, this would be important to advance our aspirations to remake the landscape for treating PBC to far more than those that are treated with second-line therapy today. On the operational front, we continue to make good progress with our medical affairs organizational build, including both leaders and field members having years of experience, including in PBC. We have also been successful in assembling key talent for our commercial infrastructure in line with our pre-commercial priorities. Louis will provide more details later in the call. Before that, let me hand the call over to Chuck, who will provide updates on our clinical progress.