Tricida, Inc.

Good day and thank you for standing by. Welcome to Trasita's fourth quarter 2021 financial results conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to Jackie Kosman with Trasita. Please begin.

Thank you, Norma. Good afternoon, and thank you for joining the Tricita Fourth Quarter 2021 Financial Results and Business Update Conference Call. In today's call, Garrett Klarner, our founder, CEO, and president, will provide an update on our ongoing VALORCKD Renal Outcomes Trial and discuss our business progress. Jeff Parker, our COO and CFO, will discuss our financial results for the fourth quarter and review our financial guidance. Please note that in today's call, we will be making forward-looking statements various statements that include forward-looking statements as defined under applicable securities laws. Forward-looking statements include our anticipated activities related to our ongoing VALORCKD renal outcomes clinical trial, including early termination of the trial and the estimated timing for receipt of top-line data, and 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 fourth quarter and year-end 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. 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're making good progress on the execution of Valid CKD. Against the backdrop of a pandemic and a war, we have managed to remain on track with our projections for primary endpoint events in the valid CKD trial. Enrollment was completed at the end of 2021 with 1,480 subjects randomized. As of March 28th, randomized subjects had an average treatment duration of approximately 24 months. The trial has accrued 217 subjects that positively adjudicated primary endpoint events defined as renal death, end-stage renal disease, or greater than or equal to 40% reduction in estimated glomerular filtration rate. 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. We'll continue to cool our primary endpoint events into the third quarter. We anticipate reporting top-line results from the valid CKD trial early in the fourth quarter of 2022, which would allow for approximately six months of financial runway following the announcement. We continue to believe that the valid CKD trial will provide interpretable data to evaluate how treatment with Avirama impacts slowing of CKD progression in patients with metabolic acidosis and CKD. Our calculations show approximately 80% power, assuming a hazard ratio of 0.70. And given the results from prior literature, we believe that even with a fewer number of primary endpoint events than originally contemplated, we have a chance to reach our main trial objectives. With that, I'll turn the presentation to Jeff for an overview of our financial results for the quarter.