CymaBay Therapeutics Inc.

Good day, ladies and gentlemen, and welcome to the SEMA Bay's first 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 up 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'd 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've had a chance to review the press release we issued announcing our first quarter 2022 financial results and business update. You can access that release on our website under the Investors tab. Joining me on the call today are Sujal Shah, Chief Executive 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 trial enrollment 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 upon 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-based 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. Good afternoon and thank you for joining us today. As it is less than two months since our 2021 year-end call, our updates today will be brief as we turn our attention in the second half of this year to key milestones in our unwavering journey to bring Celadelpar to patients with primary biliary cholangitis, or PBC. Our phase three development program for Cell at LPAR in PBC includes ongoing NDA-enabling PK studies, ASURE, a long-term safety study to complete a comprehensive patient safety database, and RESPONSE, our second phase three efficacy and safety study to support marketing approval. We believe this program is the most extensive program for any investigational drug currently in development for the treatment of PBC. These clinical studies draw from the extensive experience we gained from our prior phase two and phase three development, where data have continued to support the potential for Celadalpar to address many of the unmet needs faced by patients with PBC. Results we previously shared from our 52-week open-label Phase II study in over 100 PBC patients dosed with Celadalpar were published last month in the Journal of Hepatology. The opportunity to have these data featured in one of the world's preeminent medical journals for liver diseases elevates Celadalpar's visibility as a differentiated drug candidate for patients with PBC. We continue to believe Celadelpar has the potential to address three important unmet needs for patients with PBC. First, many patients need therapies with improved activity against the disease, as exhibited in the incomplete responses commonly observed in their liver lab tests for cholestasis and liver injury. These tests include levels of alkaline phosphatase, bilirubin, and transaminases, biomarkers that have been associated with histological progression and poor outcomes for patients with PBC. We believe that offering patients an improved biochemical response and especially the opportunity to achieve biochemical normalization should be the aspiration of therapy in PBC. Second, many patients with PBC suffer from significant burden of symptoms, including puritis. Currently approved therapies have not addressed this need, and the only approved second-line treatment, abetacolic acid, has been associated with new onset or exacerbation of puritis. A therapy that can provide symptom relief would improve patients' lives, potentially improving acceptability and adherence to therapy. Lastly, PBC patients encompass a spectrum of disease stage ranging from those without cirrhosis to those with compensated cirrhosis, including with portal hypertension. A leading treatment option should be safe across this spectrum of non-cirrhotic and compensated cirrhotic stages of disease. These data, along with data from our prior Phase III enhanced study that we have presented at past medical meetings, continue to excite and motivate investigators and their patients to participate in our ongoing clinical studies. Central to our clinical development program for Cell at LPAR and PBC is response. Our second global Phase III registration study targeted to enroll 180 PBC patients who have had an inadequate response to or are intolerant to first-line treatment, ursodeoxycholic acid. Since our last call, we have made steady progress toward completing enrollment. However, the COVID-19 pandemic continued to have an impact on screening and enrollment at clinical sites globally. A cycle of implementing then easing restrictions as variants emerged and subsided and lingering resource issues at clinical sites have been primary factors affecting our projected timeline for response. Timelines for enrollment have also been affected by our suspension of activities in Ukraine and halting of further enrollment in Russia. Our efforts to mitigate the delay have included increased in-person visits with investigators at their sites, additional investigator meetings for US, Latin American, and European investigators, implementation of patient referral initiatives, and activation of additional sites. This has resulted in consistent progress over the past few months, despite ongoing global challenges. We now have over 150 sites activated across 26 countries. As we approach what we project to be the final month of screening, we have greater visibility into monthly metrics and now forecast completion of enrollment occurring in the third quarter. We remain confident in our ability to execute given our extensive clinical and operational experience with Celldell PAR development in PBC globally. Importantly, we continue to expand the clinical experience with Celadelpar in the Assure long-term open-label study. We have now begun to roll over patients completing response into Assure. Together with patients that entered into Assure from prior studies with Celadelpar, there are approximately 140 patients in this study taking Celadalpar daily. This level of investment underscores our commitment to collect data on the long-term safety and durability of efficacy of Celadalpar. We believe this is fundamental to our success in seeking approval and eventually in marketing Celadalpar. In addition to fueling our ongoing clinical efforts, Our prior experience has provided us rich data sets that have been featured at major medical meetings since we began development of CellDelPAR for patients with PBC in 2015. Through the remainder of this year, we are excited about multiple opportunities to feature data and analyses at upcoming GI and hepatology congresses. In two weeks, Celadalpar will be featured in three abstracts presented at the annual Digestive Disease Week held in San Diego from May 21st to the 24th. The first is an oral presentation in the Presidential Plenary Session by Professor Bettina Hansen from the University of Toronto. The presentation, entitled Celadalpar Treatment of Patients with Primary Biliary Cholingitis for two years improves the GLOBE PBC score and predicts improved transplant-free survival, supports that long-term treatment with Celadalpar was associated with improved prognosis, and supports an emerging view regarding the promise of earlier intervention in disease. Two additional oral poster presentations will also be made. The first by Dr. Stuart Gordon, Professor of Medicine at Wayne State University and Director of the Division of Hepatology and GI Research at the Henry Ford Health System, describes a pooled analysis of phase two and three data on the efficacy and safety of Celadalpar in PBC patients with compensated liver cirrhosis. The second presentation by Dr. Aliya Ghulam Hussain assistant professor at the University of Toronto Center for Liver Disease, describes an analysis of the efficacy and safety of Celadalpar in PBC patients who have had prior treatment with abetacolic acid or fibrase. We look forward to these presentations and further engagement with many of the key experts supporting our ongoing work with Celadalpar in PBC. Before I ask Dan to review our first quarter financials, let me provide a brief update on our second clinical program. Last year, AdventHealth initiated patient dosing of MBX2982 in a two-period crossover pharmacology study using a hypoglycemic clamp technique to evaluate the levels of counterregulatory glucagon release under conditions of low blood sugar. MBX2982 is a GPR119 agonist discovered and developed by CIMA Bay. It has completed five previous clinical studies, including in subjects with prediabetes and type 2 diabetes. The product concept being investigated for MBX2982 in the current study is as an agent to potentially prevent or minimize hypoglycemia in patients with type 1 diabetes. The study is being conducted by AdventHealth Translational Research Institute in Orlando, Florida, and is fully funded by the Leona M. and Harry B. Helmsley Charitable Trust. SEMA Bay retains all rights to MBX 2982. In addition to safety and tolerability, the primary endpoints are maximal glucagon release and glucagon area under the curve for MBX 2982 versus placebo treatment periods. These results will guide our decision on whether to pursue further development for hypoglycemia associated with diabetes. This 28-day study is targeted to enroll up to 29 participants. We are projecting to have these data prior to year end if recent progress in enrollment continues in the coming months. Turning our attention to financial results for the first quarter, we have remained diligent with managing our expenses and focusing our activities where we have near-term opportunities to create significant value. The current market environment has been as challenging as we have seen in our industry over several years. The capital we raised last year gives us a balance sheet that allows us to advance our global clinical activities for CELADELPAR and report top line data from response in 2023. We believe we are well positioned to weather the pressures of the global markets, as well as those facing the biotech industry today. Before taking questions, I'll ask Dan to review our first quarter financials. Dan?