CymaBay Therapeutics Inc.

Good day, ladies and gentlemen, and welcome to SEMA Bay's fourth quarter and full year 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. And now I would like to turn the call over to Mr. Paul Quinlan, General Counsel at CIMA Bay. Thank you, 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 fourth quarter and full year 2022 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, President of Research and Development and Chief Scientific 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 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 manufacturing and commercialization are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although CIMA Bay 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. CIMA Bay 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 CIMA Bay, and any recording or rebroadcast is expressly prohibited without the written consent of CIMA Bay. At this time, I'd like to turn the call over to Sujal.

Thank you, Paul. Good afternoon, and thank you for joining us today. We finished 2022 with significant progress in our Phase III program for CELDELPAR in patients with primary biliary cholangitis, or PBC. In parallel, we were establishing our readiness for its commercial manufacturing and also creating our pre-launch infrastructure and go-to-market plans. Importantly, we delivered through presentations and publications on our foundational commitment to understand the science of CeladalPAR's potential for action on disease, improvement in symptoms, and confirming its effects after long-term treatment on serum biomarkers linked in the literature to improve transplant-free survival. We didn't rest on our laurels with those 2022 accomplishments. We came fast out of the blocks in 2023 with licensing Japan rights to sell at LPAR, providing significant upfront cash, followed closely by a significant capital raise at a favorable valuation. By the end of January, we had strengthened our balance sheet by over $125 million. to meet our planned operating cash needs 12 months beyond top line phase three response results expected in the third quarter of 2023. In short, we've set the stage to execute on our 2023 objectives to potentially transform the company by placing us on the doorstep of an NDA submission, and if successful, approval of our first product. Our prepared remarks today will be focused on key business updates centered around substantial advancements in the company's clinical development program of Cell at LPAR for patients with PBC, organizational growth and focus necessary to bring Cell at LPAR to patients, and financial position to support value creation for all of our stakeholders. At the core of our clinical activities are two active global clinical trials, Response and Assure, that are part of one of the most robust development programs ever conducted for patients with PBC. I'll ask Chuck McWherter, our Chief Scientific Officer and President of Research and Development, to start the call today with an overview of our clinical accomplishments over the past year including presentations made at DDW, EASL, and ASLD last year, and the latest progress on development activities. In addition to clinical progress, the past year was importantly defined by critical infrastructure and organizational growth necessary to enable the transition of our Celadal PAR clinical program to a commercial effort aimed at improving the lives of patients with PBC. I will speak today about our business development efforts that led to our partnership with Kaken in Japan, CMC regulatory and quality priorities to enable NDA filing, and balance sheet growth positioning us with a cash runway beyond key catalyst in the second half of this year. I will ask Louis Stewart, our Chief Commercial Officer, to also outline critical progress in pre-commercial planning that kicked off in 2022 and will continue through this year. We'll end today's call with Dan Minold, our VP of Finance, who will provide an overview of our financials during the fourth quarter and full year 2022 before taking questions. Chuck?