Q2 2022 Tricida Inc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the Tristate, Our second quarter 2022 financial results Conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you'd like to ask a question during that time. Please press star one on your tele.
I'll keep at it feel about withdraw your question press Star one.
As a reminder, today's call is being recorded.
Now how today's call over to Jacky Cosman of Tri Seta. Please go ahead.
You can make a good afternoon and thank you for joining the Tracy the second quarter 2022 financial results and business update conference call and today's call Garrett clearance of our founder CEO and President who will provide an update on the ongoing valor TKD renal outcomes trial and discuss our business progress Geoff 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 she called the renal outcomes clinical trial, including anticipated endpoint event accrual.
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.
Tracy they 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 Dot Tracey to Dot 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 Gary.
Jackie and thank you all for joining us today.
As we report them they stopped the valor <unk> trial early but administrative reasons as permitted by the existing study protocol to allow for six months a financial runway following the reporting of top line results.
We've continued to accrue primary endpoint events.
What type of trial subjects complete their participation in this study as of today. The fortunate 80 subjects were randomized and that obviously could he tried an average treatment duration of approximately 26 and a half months.
In the trial had accrued 281 subjects with positively adjudicated primary endpoint events.
Finally, as we know that end stage renal disease, but greater than or equal to 40% reduction.
The GFR.
Given the current event rate trend, increasing our estimate for positively adjudicated primary endpoint events in the final analysis.
Now anticipate between 285 to 95 subjects 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 with complete their participation in this trial in the third quarter. We plan to report top line results from <unk> in October 2022.
We've reviewed various hazard ratios and corresponding powering assumptions for the us They get you in prior calls these.
These calculations are also in our investor presentation on our website.
Weekend, assuming a true hazard ratio of <unk> seven.
Which corresponds to a 30% reduction versus placebo in point events, because there are 250 events in the final analysis.
78% and if they are 300 event and the final analysis the trial is 85%.
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 <unk> 78 Aloha.
And with 300 events, if the observed hazard ratio is <unk> 79.
Believe that device. He can he tried to provide interpretable data to evaluate how treatment is a very minor impacts, Florida seek any progression in patients with metabolic acidosis and <unk>.
And before I turn the presentation over to Jeff I'd like to say that we are really proud of how much I see that team.
Along with our partners heroes, who are doing a fabulous job, ensuring an orderly completion of device. He can he trial at almost 200 sites in over 30 countries to enable topline data in October .
Cause that Jeff will now provide an overview of our financial results for the quarter.
Thanks, Garrett our second quarter results were in line with our expectations with R&D expense of $16 9 million and $19 8 million for the three months ended June 32022, and 2021, respectively.
The decrease in R&D expense was primarily due to a decrease in clinical development costs related to our valor <unk> trial. Following the administrative staff announced in May 2022.
G&A expense was $9 8 million and $9 6 million for the three months ended June 32022, and 2021, respectively.
The increase in G&A expense was primarily due to higher stock based compensation expense.
Net loss was $28 5 million and $33 6 million and non-GAAP net loss was $21 3 million.
And $24 $6 million for the three months ended June 32022, and 2021, respectively.
As of June 32022, cash cash equivalents and investments were $98 $7 million.
We believe our current financial resources will fund our planned operations into early in the second quarter of 2023, which is approximately six months from the anticipated October announcement of topline results for valor <unk>.
With that I will turn the call over to the operator for questions operator.
Thank you at this time, if you would like to ask a question press star one on your telephone keypad, if you like.
Remove yourself from the queue. Please press star one.
Our first question comes from the line up EBIT Perretta from Cowen.
Hi, Congrats on the execution of the trial and thank you for taking our questions. So the event accrual seems to be happening faster than what was previously guided which is great.
But what do you think is accounting for this faster rate and is it still within the range of what you had previously modeled.
Yes.
So the question is good.
Yes, it's spot on it's right and I think in the in the middle of what we expected.
Over over time, there was some uncertainty.
We bring people in for the last visit and shorter intervals. If you would still see the same number of events that we've seen pretty consistently over the last year or year and half the trial, but thats clearly the case. So we will continue to stay on track.
Excellent. Thanks.
Second question so.
You you list, a 0.76 hazard ratio and that's based on the serum Bicarb is I've seen in the 301 trial and the Tango model developed a few years back.
There was a paper published last year by each hangry that that draws from a larger database of patients.
Is zero point 706, still kind of the base case assumption.
Or have you made any can you point us to anything to.
0.2, possibly different hazard ratio I think we have a I think we have a couple of different buckets here that we draw from right and one you just described and that was very important in the context of accelerated approval, where we obviously wanted to connect the serum bicarb effect and then ultimately the expected.
Outcome benefit.
The other bucket are really sort of some of the smaller academic trials. The <unk> study in Kenya, where interventions.
Like all of the alkali or extreme low protein diets.
And patients with the tolerate these interventions were studied in singles into trials in their warehouse hazard ratios that were much much lower that's also now.
On slide deck, our investor slide deck, and they're basically youre looking at hazard ratios in the 0.25% to five range and then of course, we had our own study, where we had a pre specified safety analysis that is quite different from the renal endpoint, but had all cause mortality.
And 50% Egfr decline.
<unk> 300, 131 <unk> study.
And there we saw basically.
Also a failure.
Significant smaller.
Hazard ratio of I think it was 65% reduction in those CD 50 events again, not a renal endpoint in very very small numbers, but the way we think about it we look at all three.
I think that gives us comfort that.
We ultimately when we take a look that we are below the point 787 nine in terms of hazard ratio.
That's very helpful. Thank you.
Your next question is from the line of Sara Dame Legwork from Needham.
Hey, good afternoon.
Just a couple for me I guess first just.
Just looking forward to October .
And thinking of the data readout or are we just going to see the <unk>.
Topline that the primary endpoint or should we.
Also see some of the secondary endpoints at that time, and then thinking of the secondary endpoints.
Which ones are the most important for the.
Do you project the label to be core programmer.
Given the stoppage of the Taylor trial.
Just curious whether you think we are.
The study is powered well enough to see a stat Sig difference on some of the secondary endpoints.
Yes.
Got it thanks for the question, yes. So we again we are right now so we're busy really taking down obviously the trial in orderly manner and then.
Ultimately locking the database analyzing the data and then.
Obviously sort of communicating.
As soon as possible.
The primary endpoint is really it but let's be very clear in terms of.
In terms of FDA approval in terms of the claim for slowing of <unk> progression.
We are really.
Our laser focus.
On the <unk> endpoint about we do have other endpoints that describe the slowing of <unk> progression is obviously the <unk> 50.
The individual components.
Egfr slope and I think they're all important.
And the idea is hopefully that.
If we are successful on the primary theres a good chance we also.
You can see some interesting things.
On the individual components and some of the other renal related endpoint. So to me personally at least those are.
That's really from a labeling perspective from an FDA discussion perspective that this is really where the rubber hits. The road now we do have endpoints on physical functioning.
And obviously, that's really really important for patients and.
Think we.
Of course interested indicated QL, which is the patient reported outcome and also the repeated chair stand test.
I think its less clear those are not basically the same in terms of proven endpoints from a regulatory perspective, but they obviously really really important for patients and how our patients.
So those are really the two that the two buckets that we we are we are focused on and that are important to us.
Others around mortality and hospitalization.
To be clear those are all I think important endpoints.
We did run this against the backdrop of the pandemic.
So.
I think that's always a question in terms of what type of noise generated in terms of hospitalizations and overall mortality, but that's why we are paying a lot less.
Less attention at least at this stage to some of those other endpoints.
Thank you.
The human data.
Thank you by the way.
Your next question is from the line of Jessica Fye with JP Morgan.
Hey, guys. Good afternoon. Thanks for taking my question, maybe asking the first question a little bit of a different way.
How much separation between arms on serum Bicarb do you think is needed to have an impact large enough to achieve that hazard ratio no higher than Europe point of nine.
[laughter].
Yes ill try to answer that if we were still pursuing accelerated approval.
Yes.
<unk> basically.
We expect you know.
Obviously.
This is a significant difference.
In serum bicarb between between active and placebo patients, but but I think this overly quantitative view.
As I said before is a very important too.
To get initial approval on the basis of the surrogate, which we didn't.
And so I think that.
That to US I think it's it's much more important to to have.
A larger number of events that we're observing right now so that if we were sitting here just with 200 events or so a 330 events.
That would make me that would make me I think.
A bit more nervous than.
Then sort of unexpected serum bicarb defense because you have random there are fewer events do you have the more random variability plays into this and so with us having 281.
Events as of today, I think that really gives us a chance to to truly see the effect.
We stopped right around the time of the Sierra or the Ada.
We stopped kind of having this very quantitative view of serum bicarb and outcomes.
Got it and just say that I understand when in the third quarter might you finally stopped counting events. It seems like every update we got the projected number of events cause a little bit higher and so I want to make sure I'm thinking about that potentially happening one more time.
No that won't happen because this is the last call before data.
Okay. Thank you.
Yeah.
Our final question comes from the line of Matt <unk> Tomorrow.
Goldman Sachs.
Hey, guys.
Rob on for Madhu, Thanks for taking our question.
<unk>.
So I was just wondering what information will be disclosed in the valor <unk> topline data and then beyond the topline data are there any other gating factors for NDA submission.
Probably as I said.
<unk>.
We basically so obviously, we're going to dispose the primary endpoint.
Depending on how many we get to analyze.
The secondary endpoints as well.
And ultimately I think the.
The important piece here is also the primary endpoint in the individual components. So for me everything else has.
<unk> is interesting, but but not critical but.
And then of course safety I mean, I think this is.
It's a multiyear study in.
And a large group of patients and so we will have oh.
Safety data and as you know ultimately what this comes down to from from an approval perspective benefit. So I think at top line. Our goal is to give a clear picture.
<unk> safety and efficacy. So I think this will ultimately that inform the risk benefit that is underlying.
The approval decision.
And as you know we are.
We have a data driven and we move very quickly. So we will basically include as much as we can at this at this time point of communicating top line data.
Thanks.
At this time there are no panel there are no questions I will hand, the call back over to the presenters for any closing remarks.
Thank you all for joining us today and as always if you have additional questions don't hesitate to E Mail us at IR at <unk> Dot com, Thank you and goodbye.
This concludes today's call. Thank you for joining you may now disconnect your lines.
Yeah.
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Yes.
Yes.
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