Tricida, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Tri-City Third Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star 1 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 turn the call over to our speaker today, Jackie Kusman of Tricita. You may begin.

Thank you, Marjorie. Good afternoon, and thank you for joining the Tricita Third 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 the ongoing Valor CKD renal outcomes trial and discuss our business progress. Jeff Parker, our COO and CFO, will discuss our financial results for the third 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 outcomes clinical trial, including early termination of the trial, and our expectations regarding our financial runway. Management's assumptions and 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 then or implied by such forward-looking statements. TRICEDA 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 third 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. At this time, I'll turn the call over to Garrett.

Thank you, Jackie, and thank you all for joining us today. I'd like to first turn to our announcement today regarding our plans for a future administrative stop of Valid CKD. We have spoken previously about the potential need to stop the trial early based on insufficient financial resources. As you saw on the press release, we believe that there is a substantial likelihood that we will not have adequate resources or be able to obtain such resources on reasonable terms in the necessary timeframe to continue Valid CKD to reach the current target of 511 subjects. that positively adjudicated primary endpoint events, which we anticipate would not be reached until 2024. As such, we have considered various options to terminate valid CKD early. Triceida requested and was granted a Type A meeting with the FDA to discuss approaches to stopping the trial early based on financial resources and the procedures for study closeout. We believe that we received clear and helpful feedback in the FDA's preliminary comments which allowed us to cancel the actual type A meeting. Among the alternatives considered, FDA indicated that stopping valid CKD for administrative reasons pursuant to the existing protocol is likely to provide the most complete and interpretable data, reduce the risk of missing data required for key efficacy analysis, and maintain the integrity of the trial. While the exact timing of the administrative stop will be determined by our financial runway, we anticipate that an administrative stop would occur in the first half of 2022. Our goal is to have approximately six months of financial runway upon receipt of the biosecurity data. Also, based on feedback from the FDA, we will halt enrollment of additional patients in the trial in order to focus resources on maximizing the duration of follow-up in subjects who are currently enrolled in the trial. I would like to emphasize that the timing for stopping the trial has not yet been determined. We are evaluating our financial runway and should have additional information on when we will stop the trial as we move into the new year. We believe that even with an early termination, we can address the most important valid CKD trial objectives. We've made good progress to date in the accumulation of primary endpoint events and intend to continue our focus on successful execution of the trial. As a reminder, VALOR-CKD is a renal outcomes trial designed to show that treating metabolic acidosis visits the very American slow CKD progression. The primary endpoint of the trial is the time to first occurrence of a confirmed DD40 event, defined as renal death, ESRD, and a greater than 40% reduction in EGFR. We've made very good progress in the trial. To date, we have randomized over 1,470 subjects with an average treatment duration of approximately 19 months. We have accrued 159 subjects with positively adjudicated primary endpoint events. This puts us on track with our event rate projections, and we still anticipate that we will reach 250 subjects with primary endpoint events by approximately mid-2022. However, we anticipate that an administrative stop will occur in the first half of 2022. Accordingly, we are not likely to conduct the protocol-specified 250 event interim analysis. Overall, we remain excited about the prospects of LRTKD. Given the results from prior literature and our own studies, even with the fewer number of primary endpoint events that were originally contemplated, we believe that we have a chance to reach our main trial objectives. First and foremost, our goal is to show slowing of progression of chronic kidney disease . With that, I'll turn the presentation to Jeff for an overview of our financial results for the quarter.