Tricida, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Tricita Second Quarter 2022 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, please press star 1 on your telephone keypad. If you would like to withdraw your question, press star 1. As a reminder, today's call is being recorded. I will now hand today's call over to Jackie Kosman of Tricita. Please go ahead.

Thank you, Tamika. Good afternoon, and thank you for joining the Tricita Second 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 Valor CKD Reno Outcomes Trial and discuss our business progress. Jeff Parker, our COO and CFO, will discuss our financial results for the second 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 the Valor CKD Renal Outcomes Clinical Trial, including 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. Tri-Cita 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 second 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 like to note that we've 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'll turn the call over to Garrett.

Thank you, Jackie, and thank you all for joining us today. As we reported in May, we've stopped the valid CKD trial early for administrative reasons as permitted by the existing study protocol to allow for six months of financial runway following the reporting of top-line results. We've continued to accrue primary endpoint events as clinical trial subjects complete their participation in the study. As of today, the 1,480 subjects who were randomized in the valid CKD trial had an average treatment duration of approximately 26 1⁄2 months, And the trial had accrued 281 subjects with positively adjudicated primary endpoint events, defined as renal death, end-stage renal disease, or greater than or equal to 40% reduction in EGFR. Given the current event rate trend, we are increasing our estimate for positively adjudicated primary endpoint events in the final analysis. We now anticipate between 285 to 295 subjects with primary endpoint events in the final analysis, which is up from our prior estimate, last quarter of 250, 270 events. We anticipate that the last subjects will complete their participation in this trial in the third quarter, and we plan to report top-line results from ValorCKD in October 2022. We have reviewed various hazard ratios and corresponding powering assumptions for ValorCKD in prior calls. These calculations are also in our investor presentation on our website. To recap, Assuming a true hazard ratio of 0.70, which corresponds to a 30% reduction in variable versus placebo 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, the trial is expected to meet its primary endpoint 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 the VARAMER impacts slowing of CKD progression in patients with metabolic acidosis and CKD. And before I turn the presentation over to Jeff, I'd like to say that we are really proud of our Atricida team. along with our partner CROs who are doing a fabulous job ensuring an orderly completion of the VALOR CKD trial at almost 200 sites in over 30 countries to enable top-line data in October. With that, Jeff will now provide an overview of our financial results for the quarter.