CymaBay Therapeutics Inc.

Good day, ladies and gentlemen, and welcome to the CIMA-based third quarter 2023 financial results and business update conference call. At this time, all participants are in 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 CIMA-based website at www.simabay.com. Now, I would like to turn the call over to Mr. Paul Quinlan, General Counsel at Simabay. Mr. Quinlan, please proceed.

Thank you, Operator, and good afternoon, everyone. I hope that you've had a chance to review the press release we issued announcing our third 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 Harish Shantaram, Chief Financial 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 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 a forward-looking statement are based on reasonable assumptions, actual outcomes and results are subject to risks and uncertainty 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 Sujal.

Thank you, Paul, and good afternoon. We appreciate everyone taking the time to listen to our updates at SEMA Bay in the midst of a busy earnings period. 2023 has been a remarkable year for SEMA Bay, And the third quarter was especially momentous with the achievement of multiple significant milestones advancing us towards our goal of improving the lives of people living with PBC. First, Celadalpar met its primary and two key secondary endpoints with high statistical significance in the phase three pivotal response trial for patients with PBC. The consistency and depth of the clinical data set generated from phase two, enhance, and now response, demonstrates that Celadalpar has the potential to be the first ever approved treatment for patients with PBC to significantly reduce both markers related to the risk of disease progression and symptoms. Reaching this milestone required focus, resilience, and perseverance by our team here at SEMA Bay, but it would not have been possible without the commitment of our partners, including the patients who participated in all our clinical trials, their family members and caregivers, investigators and patient advocacy groups who were part of this journey. The reactions from all quarters on the response results have been very positive. and Louis will provide color on some of the feedback we've received from the medical community and patient advocacy groups later in his remarks. Our team is now working with singular focus to deliver high quality regulatory applications for approval as soon as possible and are actively engaged with FDA, MHRA, and EMA. We were very encouraged by the FDA's granting of a revised breakthrough therapy designation for Celadalpar in PBC that now covers the treatment of PBC, including puritis, in patients who are inadequate responders or intolerant to UDCA without cirrhosis or with compensated cirrhosis. The unmet needs for people living with PBC today are for treatments that provide a significantly lower risk of disease progression while also reducing symptoms, across a broad spectrum of patients, including those with compensated cirrhosis. We believe that Celadelpar is the only drug in development for PBC that has received a breakthrough designation that includes puritis and compensated cirrhosis. We look forward to working with the FDA and other regulatory agencies as they conduct their regulatory review post-completion of our submissions. Our commitment to PBC runs deep, and we will continue to add to what we believe is already the largest clinical development program in PBC. The ideal study that we announced earlier in the third quarter targets partial responders to first-line treatment with alkaline phosphatase levels between 1 and 1.67 times the upper limit of normal who continue to have higher risk of disease progression and negative outcomes. We believe that this study has the potential to be transformational for this neglected population, potentially resetting expectations for second-line treatment. In September, we also announced the initiation and design of our long-term outcome study, affirm, that will serve as our post-marketing regulatory commitment. Leveraging years of dialogue with regulators, and work interrogating rich data sets gathered by the global PBC study group, we designed a unique, event-driven, fixed-duration study evaluating CeladalPAR in patients with compensated cirrhosis, assessing its benefits on outcomes relative to placebo. The design of AFIRM attempts to also address the challenges inherent in recruiting placebo-controlled outcome trials in PBC. These studies demonstrate our unwavering commitment to advancing care for people living with PBC. We are too early in startup for us to comment on the timelines for enrollment and results, but Chuck will provide more detail on these studies during today's call. We now have a majority of our U.S. medical field team in place, and they are actively engaging with the community on disease education and Cell at Alpar clinical data. and have initiated additional collaborations with the scientific community to fully understand the potential of Cell at El Par. We have also made significant progress this year with pre-commercial planning efforts and will be accelerating these activities with positive phase three pivotal results now behind us. We are currently determining the size and structure of our commercial field team to optimize its reach for effective coverage of healthcare providers. while also enabling patient activation in preparation for a potential CeladalPAR launch. On the manufacturing and distribution front, we have now established our commercial supply chain and will soon finalize our distribution channel partners in the US. In summary, I'm extremely proud of our achievements to date. With a quality team we have put in place and a strong balance sheet, we are ready to execute on our key near-term deliverables and continue to march towards our goal of helping people with PBC live potentially longer and better lives. With that, I will turn the call over to Chuck.