Tricida, Inc.

Good day and thank you for standing by. Welcome to the Troisida Second 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 the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Jackie Kosman. Please go ahead.

Thank you, May. Good afternoon, and thank you for joining the Tricita Second 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 the recent results from our new market assessment of Aviramer as a potential therapy for slowing CKD progression, provide a summary of 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 the applicable securities laws. Forward-looking statements include our anticipated activities related to our ongoing Valor CKD Renal Outcomes Clinical Trial our plans for interactions and communications with the FDA, our plans and expectations regarding potential pathways to approval of Viveramer by the FDA, our assessment of potential clinical development pathway for Viveramer, the future market potential of Viveramer, 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. 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 press release this afternoon just after the close of the market. For copies of the 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. In today's call, we'll provide a status update on our continued progress for the valid CKD trial. We'll also provide highlights on a new commercial market assessment based on the Verimer as a potential therapy to slow CKD progression. And then we'll provide a brief overview of future development opportunities for VARIMA that we believe could unfold with positive Valid CKD data. Finally, we will provide a recap of our second quarter financial results and cash position. Now, turning to Valid CKD. On slide five is a summary of the Valid CKD trial design. We plan to randomize 69 subjects to VARIMA or placebo, and the trial will end when the Independent Blind and Clinical Endpoint Adjudication Committee has positively adjudicated 511 subjects with DD40 events, defined as renal death, ESRD, or confirmed greater than or equal to 40% reduction in EGFR. And as you saw in our press release, we now have one interim analysis that will occur when we have accrued 250 subjects with primary endpoint events. We anticipate that this will occur around mid-2022. If the criteria for early stopping for efficacy are not met at the interim analysis, the trial is scheduled to conclude at 511 DD40 events. We recently removed the 150-event interim analysis from the Valid CKD protocol. We chose to eliminate this early analysis to preserve statistical and regulatory optionality for the trial. Overall, the Valid CKD trial is designed to have 87% power to show a 24% difference in primary endpoint events. Said another way, the assumed hazard ratio for the powering of Valid CKD is 0.76. And on slide six, you can see that we are making good progress in the conduct of the Velocity trial. As of August 6, 2021, the trial had randomized 1,455 of the planned 69 subjects with an average treatment duration of approximately 17 months, and 127 of the targeted 511 primary endpoint events have been accrued. With respect to the overall trial enrollment rate, the change in our geographic focus and the impact of COVID-19 has slowed the rate of the enrollment somewhat, We now anticipate completion of enrollment in the first half of 2022. On slide 7, there have been 32 additional primary endpoint events since our last quarterly call. Based on our event accrual projections for valid CKD, we believe that we are still on track for the 250-event interim analysis in mid-2022. Now, on slide 8, before I turn to the assumptions around our interim analysis and final analysis, I want to provide some perspective around the assumed hazard ratio of the valid CKD trials. You can see that epidemiological studies analyze the relationship between serum bicarbonate level and risk of CKD progression results in an estimated hazard ratio of 0.76, whereas several published prospective studies of the effect of increasing serum bicarbonate on CKD progression in patients with metabolic acidosis and CKD reported hazard ratios in the range from 0.2 to 0.5. As we've previously described, when discussing our valid CKD powering assumptions, we took a conservative approach and used epidemiologic data to apply a 0.76 hazard ratio to estimate the power of valid CKD. On slide nine, if we assume the true hazard ratio is in fact 0.76, we have a 22 percent probability of meeting the criteria for stopping the trial early for efficacy at 250 events. And as I said, the overall power at the final analysis is 87 percent. However, given the risk reduction from slowing CKD progression from some of the published prospective trials, patients treated with Vivarumab may experience greater benefit in viral CKD than the epidemiological models might suggest. For example, if we were to assume a two-hazard ratio of 0.70 instead of 0.76, the probability of stopping viral CKD early for efficacy at the interim analysis doubles from 22% to 47%. If instead the two-hazard ratio were 0.6 or 0.5, the probability of stopping early at the interim increases to 88 or 99.6% respectively. At the bottom of the slide, expressed another way, an observed hazard ratio of less than 0.67 at the interim analysis would result in meeting the criteria for early stopping of the trial for efficacy. We believe the interim analysis will be an important milestone for valid CKD and alpha well spent. It will be conducted by an independent, unblinded interim analysis committee, and if this committee does not recommend stopping early for efficacy, we'll receive no information from the interim analysis. The interim analysis was to yield a statistically significant result for the primary efficacy endpoint, and the committee recommends early stopping for efficacy. It could potentially form the basis for resubmission of the NDA through the traditional approval pathway. Now, turning to slide 10, we may find ourselves in a situation where we must stop the trial early for administrative reasons. As you are aware, conducting clinical trials is expensive, and uncertainties can arise at any time. If we are unable to ensure that we have adequate resources to complete the trial in accordance with the protocol, or if other events occur which diminish our likelihood of reaching 5-11 events, we may be compelled to stop the trial early for administrative reasons, which could occur either prior to or following the plan's interim analysis. Any such decision would be made in the future based on a range of considerations, including our ability to responsibly stop and wind down the trial consistent with our regulatory and ethical obligations, and within the confines of our financial runway. If we were to stop the trial for administrative reasons, the primary endpoint would be analyzed using all alpha remaining at that time. As an example of what we estimate the power of the trial would be under an administrative sub-scenario, we have laid out two hypothetical time points after either 150 or 250 primary endpoint events have occurred. Assuming a true hazard ratio of 0.76, the trial is 39% or 58% power at 150 or 250 events, respectively. To provide you with a sensitivity analysis, if the treatment effect is larger and the true hazard ratio is 0.70, the power increases to 59% at 150 events and to 81% if stopped at 250 events. And as we move to hazard ratios of 0.6 or 0.5, the estimated power goes up significantly. On the last line, expressed another way, if the trial was terminated early for administrative reasons at 250 events, The data from the trial would show statistical significance if the observed hazard ratio is less than 0.78. And if that occurs, could potentially form the basis for an NDA resubmission through this additional approval pathway. As a reminder, we've highlighted on slide 11 the key CRL and ADL issues from our initial NDA. We believe outcomes data from VALOR-CKD will be very important in determining the regulatory path for approval of the VERIMR and could address the regulatory concerns expressed by the FDA in the CRL and ADL. Regarding the applicability of the trial results, the U.S. population and practice of medicine, while we expect that few primary endpoint events will come from U.S. patients, 10 to 20 percent of patients are expected to be enrolled in the U.S., Canada, and Western Europe, we'll conduct subgroup analyses of the primary endpoint by geographic region. In addition, we plan to conduct sensitivity analyses to assess the effects of country and other baseline variables on the primary and secondary endpoints of the trial. We also intend to ensure that no single site in the viral CKD trial provides credit for 5% of the total number of trial subjects. I would note, however, that FDA's acceptance of the viral CKD data in support of the NDA resubmission, including the acceptability of the data from non-U.S. countries or regions, will ultimately be a review issue. As always, in presenting new data to the FDA, new issues can arise. On slide 12, to summarize our reason and plan into FDA interactions, We have submitted a protocol amendment to eliminate the 150-event interim analysis and provided the FDA with an update on the VALOR-CKD trial and potential future development activities for Reverma. The timing of future substantive interactions with the FDA will ultimately be dependent on the availability of VALOR-CKD data. If VALOR-CKD is stopped early for efficacy at the 250-event interim analysis in mid-2022, resubmission of the NDA could occur in 2023. If the trial must be stopped early for administrative reasons, it could occur prior to the Plan 250 event interim analysis, and in that case, if the data demonstrate efficacy, resubmission of the NDA could occur as early as late 2022. We believe our submission will be classified as a resubmission under the original NDA and, as such, will qualify for a six-month review. Clearly, the specifics related to any NDA resubmission and related timing will be determined for our future FDA interactions. I'll turn the presentation over to Jeff for an update on the Bavaria Market Opportunity.