Tricida, Inc.

Good day and thank you for standing by. Welcome to the Tricita First Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Jackie Kosman of Tricita, and please go ahead.

Thank you, Didi. Good afternoon, and thank you for joining the Tricita First Quarter 2022 Financial Results and Business Update Conference Call. In today's call, Garrett Klarner, our founder, CEO, and president, will provide an update on the ongoing Dollar CKD Renal Outcomes Trials and discuss our business progress. Jeff Parker, our COO and CFO, will discuss our financial results for the first quarter and review our financial guidance. Please note that in today's call, we will be making various statements that include forward-looking statements as defined under applicable securities laws. Forward-looking statements include our anticipated activities related to our ongoing Valor CKD renal outcome clinical trial, including early termination of the trial, anticipated endpoint event accruals, and the estimated timing for receipt of top-line data, as well as our expectations regarding our financial runway. Management's assumptions, expectations, and opinions reflected in these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from any future results, performance, or achievements discussed in or implied by such forward-looking statements. Tricita can give no assurance that these statements will prove to be correct, and we do not intend and undertake no duty to update these statements We also urge you to read the risks and uncertainties associated with our business that are described in our filings with the Securities and Exchange Commission. We issued our first quarter financial results press release this afternoon just after the close of market. For copies of our press release, please go to www.tricita.com and follow the link to our investor relations page. I would also note that we have posted an updated slide presentation on the investor relations portion of our website that includes updated information from our press release and call. At this time, I'd like to turn the call over to Gary.

Thank you, Jackie, and thank you all for joining us today. We continue to make good progress on the execution of our valid CKD renal outcomes trial. As of May 9th, the 1480 subjects randomized in the trial had an average treatment duration of approximately 25 months. The trial has accrued 233 subjects with positively adjudicated primary endpoint events defined as renal death, end-stage renal disease, ESRD, or greater than or equal to 40% reduction in estimated glomerular filtration rate, EGFR. As we previously reported, based on our financial runway, we intend to stop the Valid CKD trial early for administrative reasons in the second quarter of 2022, with continued accrual of primary endpoint events into the third quarter of 2022. Based on the current event rate trend, we are updating the anticipated number of subjects with positively adjudicated primary endpoint events in the final analysis to 250 to 270. We anticipate reporting top-line results from the Valley Seeker Detroit early in the fourth quarter of 2022, which will allow for approximately six months of financial runway following the announcement. Assuming a true hazard ratio of 0.70, which corresponds to a 30% reduction in the very most possible endpoint events If there are 250 events in the final analysis, the trial has 78% power. And if there are 300 events in the final analysis, the trial has 85% power. Switching from power to observed hazard ratio statistics, we could be successful with 250 events if the observed hazard ratio is 0.78 or lower, and with 300 events if the observed hazard ratio is 0.79 or lower. We believe that the VALOR CKD trial will provide interpretable data to evaluate how treatment with VAMR impacts slowing of CKD progression in patients with metabolic acidosis and CKD. With that, I'll turn the presentation to Jeff for an overview of our financial results for the quarter.