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spk00: 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.
spk02: 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.
spk04: 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.
spk01: Thanks, Garrett, and thank you all for joining us today. Our fourth quarter results were in line with our expectations, with R&D expense of $36.8 million and $27.3 million for the three months ended December 31, 2021, and 2020, respectively. The increase in R&D expense was primarily due to increased activities in connection with our Veramer development program related to manufacturing process optimization and the manufacturing of drug substance. G&A expense was $9.1 million and $21.8 million for the three months ended December 31, 2021 and 2020, respectively. The decrease in G&A expense was primarily due to restructuring costs incurred in 2020 and to decrease administrative activities, including reduced pre-commercialization and medical affair activities in 2021. Net loss was $50 million and $54.8 million, and non-GAAP net loss was $41.1 million and $37.4 million for the three months ended December 31, 2021, and 2020 respectively. As of December 31, 2021, cash, cash equivalents, and investments were $150.6 million. We believe our current financial resources will fund our planned operations into early in the second quarter of 2023, which is anticipated to be approximately six months from the announcement of top line results for Valor CKD. With that, I will turn the call over to the operator for questions. Operator?
spk00: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Sergey Ballinger from Needleman Company. Your line is open. Sergey, your line is now open. Our next question comes from Jessica Fye. Your line is now open.
spk03: Hey there. Good afternoon. Thanks for taking my question. Can you just recap the number of events you expect to have when you conduct the administrative stop, and when you expect that to occur?
spk04: Yeah, Jessica, I think obviously the administrative stop is determined by our cash balance and not by a particular number of events. And I think given our cash balance, I think we expect to accrue approximately 240, 250 events. I think with 217, we're pretty close. We've been, I think, accruing on average over the last 15 months between 10 and 11 events, and we expect to accrue into the third quarter. So we feel pretty good about our ability to reach, you know, that number of approximately 240 to 250 patients with primary endpoint events.
spk03: Great. Thank you.
spk00: Thank you. Our next question comes from Sergey Ballinger with Needham & Company. Your line is now open. Sergey, are you there? All right, our next question comes from Phil Nadeau with Calwin. Your line is now open.
spk05: Good afternoon. Thanks for taking our questions. Just a few from us. First, on the situation in Eastern Europe, I think when we talked last, you were assuming that no more events were going to be accrued from the Ukraine due to the unfortunate war there. What is the most recent update? Have those events, in fact, stopped accruing from Ukraine, or are you actually still seeing some patients go to the clinic?
spk04: I think in our projections, we are not counting on any additional events. from Ukraine. I think, you know, as you've said, sort of, you know, it's a very unfortunate situation. It's a very serious situation. And we, I think, sort of, you know, we see bravery from the Ukrainian people across the board. We do have some patients actually showing up for study visits. I don't think we have accrued any additional events, and that's a longer process. And again, we don't rely on on any event from Ukraine. That would be pure upside. And I think we're comfortable with a 240 to 250, 55 number without any events coming from Ukraine.
spk05: That's very helpful. And what about the neighboring countries such as Poland? Are there any disruptions due to the refugee crisis or any other issues in those countries?
spk04: We haven't seen any impact, and we would hope that NATO wouldn't get involved because then we have a bigger problem at hand. But again, I think so far we've seen the disruption really limited to Ukraine.
spk05: Perfect. Second question is on, I guess, the process of the administrative stop. I think you said in your prepared remarks you're going to stop this study in Q2. but continue to accrue events through Q3 with the data on Q4. So I guess technically, what does the stop mean and how do you continue to accrue events post-stopping the study?
spk04: I think that at the study stop, we would basically ask the sites to have the patients come in for a final study visit. And obviously, during those visits, you know, patients can have either confirmatory events or additional index events. And I think the way we've structured it is that, you know, shortly before the database lock, we would still allow for those, you know, visits to happen and for those events to be confirmed to maximize, really, the amount of follow-up that we're getting from the study. And so we... I think it's pretty common practice, even under a normal wind down, that sort of up to a month or two before database lock, you do basically events and collect data.
spk05: Perfect. Third question is on the true hazard ratio. In your prepared remarks, you mentioned 80% power to detect a hazard ratio of 0.7. We're curious to get your updated thoughts, if there are any, on what you think the true hazard ratio is based on the academic literature and your own experience. Is 0.7 approximately where you think it's likely to fall out, or is there a chance it could be even lower?
spk04: Yeah, I think some of the academic studies, you know, those were obviously single-center trials that were not necessarily double-blind or randomized in all cases. They showed hazard ratios that were significantly smaller. And as we've said, we would not rely on that. So we're quite comfortable with 0.7. And I think it could be lower than that. But from a statistical perspective, that's, I think, an important threshold. Also from a clinical significance perspective, I think this is the right threshold. And so we're still very confident that that's the bar we can reach
spk05: Perfect. The last question for Maz is on the FDA filing process. Once you have the data, should they be positive? How long would it take you to put together the filing? Are there additional conversations you'd have to have with the FDA in order to be able to file?
spk04: Yeah, I think we continue to look at that. Obviously, the clearer and the more positive the data, I think the less need to delay the submission, and as part of the submission, obviously, there's a, you know, there's a pre-NDA submission meeting that has, it's more mechanical, but so I think sort of the clearer the results, the more we're going to run towards resubmission.
spk05: Male Speaker 1 Perfect. Thanks for taking our questions.
spk00: Thank you. As a reminder, to ask a question, that's star 1. And I'm currently showing no further questions at this time. I'd like to hand the conference back over to Jackie Kostman for closing comments.
spk02: Thank you, Norma, and thank you all for joining us today. As always, if you have additional questions, don't hesitate to email us at ir.tricita.com. Thank you, and goodbye.
spk00: Ladies and gentlemen, thank you for your participation in today's conference. You may now disconnect. Everyone have a wonderful day.
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