Hi, everyone. I'm Yigal Nochomovitz. Next session is with Travere Therapeutics, CFO Chris Cline. Great to see you.
Great to see you as well. Thank you for having us.
Of course. Just as a reminder, if you have a question, there's a microphone in the back, and then we can send you the mic, and you can ask the question. So with that, welcome. Maybe a lot has happened with the company, a lot of very good developments, full approval, progress on your other indication, FSGS. So maybe just set the stage, expand a little bit on those points, and we'll dig in there from there.
Great. Well, thanks again for having us, Yigal. It's great to be here. And just taking a step back for a second, for those who may not know us quite as well, at Travere, we're a San Diego-based biotech company that is exclusively focused on identifying, developing, and delivering life-changing therapies for people living with rare diseases. And as you mentioned, Yigal, we've had a number of great milestones this year, really with our lead program, sparsentan or Filspari, which recently gained full approval for IgA nephropathy. And we've been very pleased with how our launch has gone to date, both in the accelerated approval time of that, but now also in full approval. We're seeing a nice inflection as to what we had expected.
We were also seeing, as you mentioned, good progress on an additional indication, FSGS, which is another rare kidney disorder where there really is nothing that's been approved, and we've had a lot of developments on the regulatory side of things where we believe we may have a path forward here in the near term to submit an SNDA for a second indication, so that's a very exciting development that we're looking forward to in 2025. We also have another program in development, pegtibatinase, and that's an enzyme replacement therapy that is for something called classical homocystinuria, and this is a rare metabolic disease where there are no approved treatment options that are disease-modifying, and we've generated very strong phase one and two data and have started a phase three program with some very compelling data.
That's another area where we're investing a lot of our time and energy and we're excited about in the future.
Okay, so let's start with the full approval for Filspari. Just remind everybody what was required to get that approval and how you believe that's going to inflect the launch in IgA. And are you seeing evidence of that inflection to the extent you can comment? Obviously, you can't talk about 4Q, but you can talk about 3Q a little bit.
Sure, sure. Yeah, and maybe it's worth taking a quick step back on how the IgAN space has evolved. Because if you go back to even 2018, when we started the PROTECT study, there were no approved medicines. You had only two drugs that were in late-stage development. And you look at the KDIGO guidelines and those sorts of things, that they weren't really getting updated because there wasn't much investment in the field. There wasn't much new that was coming to fruition. And now you fast forward to today where you have, and I know you know the story all too well, you've got three approved medicines, and you've got excitement around the field where you have a lot to update.
And so for us, we were very fortunate in the fact that we had both the full approval come through and the KDIGO guidelines update, which were favorable for Filspari at the same time this year. And so your question as to what was required, under the construct of how FDA has looked at IgA and similar rare kidney disorders, for accelerated approval, what you have to do is you have to have an interim assessment on proteinuria that is successful and then confirm that with a two-year endpoint that has been historically based on eGFR. And so what we had seen at 36 weeks that got us to accelerated approval was a reduction in proteinuria of about 50%. And then we later showed data reported out last year and then got the accelerated approval, or sorry, the full approval just this year based off of eGFR.
Our eGFR, what we showed was an accrual of benefit over time, which is not something that any other medicine yet has been able to show. Really, that's going from a difference between an active comparator and showing 1.9 mL per minute per year at one year growing to 3.8 mL per minute per year at two years. That change in eGFR was the basis for full approval and getting to a new label. I think there's two important components that go into how we think about growth, and specifically to your question, fourth quarter, but then also beyond. The first is with the full approval, we're able to talk about new and important things with Filspari. Under accelerated approval, we had a label that was generally indicated for patients at risk of IgA progression at 1.5 grams or greater in proteinuria.
And we could not talk about any of the two-year data, right? So all of the efforts that were done from February of 2023 until September of this year, we're on that limited basis and really geared towards physicians were really gearing that towards their patients who are probably more at risk or progressive of the disease. And so now what we're able to do with the full approval is talk about the new label, which reflects no threshold, no 1.5. So now it just says for patients generally at risk of IgA progression. And then we're able to, for the first time, talk about the two-year data, which is critical. So the two-year data, as I mentioned, it's the only medicine that has been able to show an accrual of benefit on eGFR and long-term kidney function preservation so far.
Then we also have shown a durable effect on both proteinuria and a durable safety profile. We know and we knew going into this that there was going to be a physician or a part of the physician community that was waiting for the full approval, waiting for the two-year data, and then waiting for us to be able to educate on it for the first time. We're seeing the excitement of that come through now. The other piece of it is the KDIGO guidelines. The KDIGO guidelines, as I mentioned previously, there hadn't been much evolution in those because there wasn't much done in the space to really include. Now we're seeing for the first time the new draft KDIGO guidelines came out around the Labor Day timeframe.
What you see there is a reflection of, first and foremost, probably a greater ambition for physicians to treat their patients. Historically, the goal had been to get your patients to around a gram per day. Now what we're seeing is that the data tells you that you need to get patients below 0.5 or really to complete remission or 0.3 if you can. That's critical because not only is that going to drive earlier treatment in patients, but it's also going to drive physicians to really treat ambitiously and use medicines like Filspari and others.
And so alongside that information coming out and also the reflection of Filspari and the KDIGO guidelines that points to it being foundational placement for the overactivation in the kidney and the only medicine that's been able to show superiority over the historical standard of ACE inhibitors and ARBs, we saw and we're seeing a continued momentum. And so to your point in 4Q, we're not in a position where we're giving numbers like you mentioned, but we're very pleased with the inflection that we're seeing. And so that had been our expectation all along was that with this broader label, with the two-year data, with the KDIGO guidelines, we'd see a meaningful inflection in demand, and that's exactly what we're seeing.
Okay, gotcha. So a couple interesting follow-ups there. So number one, people may be wondering, was it just happenstance that the KDIGO guidelines happened to coincide essentially with the full approval, or was that some grand plan? Tell us.
It would be great if it was a grand plan, but we have no control over that.
That was just on a separate clock. Okay.
It was on a separate clock, and as you would imagine, that's working with the broader nephrology community. So you're working with a lot of nephrologists who are busy, and it takes time to get all that through, and it just happened to coincide with where we were at.
And then the second part of that, relatedly, is you're dropping the threshold from the 1.5 to the 0.5. So which do you think is driving more of the uptake now, the two-year data or the drop in the proteinuria cutoff, or is it the synergy of both those data points?
Sure.
Yeah.
I think there's definitely some synergy. If we had to point to one right now, it's probably more tied to the label change and to having the full two-year data. And I say that for a couple of reasons. The first is that we know that there was a group of physicians, and we've said historically that there was around 1,000 or more physicians who were waiting for that two-year data. And that's based off of our visibility into things like REMS certification, but not yet having a treated patient, and then also through our market research. And so we know that there is a pocket of physicians who are going to write once they saw the two-year data. And we're seeing that come through. We're seeing increased breadth and depth.
The other piece of it is that the KDIGO draft guidelines, while we obviously have visibility to them, we talk about them, we are able to get feedback on them, I don't think it quite gets to all of the, for example, the community nephrologists right away, right? So I think that you do see some impact out of the gate, but that's something that I expect to be more sustainable as we go forward and to really drive the field over time and continue the number of patients getting treated earlier and to be more ambitious.
So for the two-year data, I mean, obviously, it was only formally in the label on September 5th.
5th.
Okay. But I mean, it was out there before. So what was stopping a physician from absorbing that information? Your salespeople couldn't say it, but they could read the internet and see it. So I'm just asking, couldn't that have shown some sort of an uptick before the official change, or that just didn't work that way?
We did see some impact of that in a positive way. For example, after we had our simultaneous dual publications and late-breaker presentations at ASN, not this past year, but the previous year. What we saw following that was an increase in the number of academic or key opinion leaders writing scripts. There was some impact in that way. I think that that's logical, right? Because those are the docs that are going to be at more of those medical congresses. They're going to be more forward-thinking and reading more of the literature and dedicating time to that. Where I think you have a little bit of a difference is with, again, the busy community nephrologists, right?
So they are ones that may not have the ability to go to the big medical meetings or have the time to dedicate to reading the publications or whatever else it may be. And so that education from our reps going in and having that engagement with them really moves the needle in terms of their understanding of the profile for Filspari.
So in the U.S., I forgot how many nephrologists there are, but what's your hit rate as far as how many you've got a sales rep in the door to see?
Sure. So what we've said is that there's a community of, call it, more than 10,000 nephrologists. We call on about 6,000 nephrologists, and we think that that gets us to about 85% of the overall addressable population. We haven't said specifically what the number of docs is that we've gotten in to spend time with, but you can imagine that with the vast majority of them, we have spent time. I think we're making good headway into the 1,000 nephrologists that I mentioned earlier that our chief commercial officer has pointed to for being good prospective writers following the full approval. We're making good headway into that as well.
Okay, let's talk a little bit about combinability of Filspari with other mechanisms. What work have you done there, for example, with, say, the SGLT2s?
Sure. So when we started the development of Filspari, our vision all along has been that there's going to be a combination therapy market that comes out in IgA. And I think we're already seeing that play out not only in the real-world setting, but also in the KDIGO guidelines. So the KDIGO guidelines say that IgA nephropathy is essentially a disease of two areas that need to be addressed, the overactivation in the kidney and the overactivation in the immune system. And so with that perspective and vision, we set in motion quite a while ago studies that would help us understand what the effect would be of adding Filspari to an SGLT2 and then also adding an SGLT2 onto Filspari use. And so we did that both within our phase three study and then a sub-study.
We've also done work to look at Filspari in combination with general immunosuppression. With all of that work, what we've shown is that when you combine Filspari with either of those modalities, first off, it's safe. Second off, you see an increase in benefit on proteinuria reduction when you add Filspari. It's further adding evidence to our belief that Filspari should be used as that foundational position and be able to be used in conjunction with a patient who has a flare-up on the immune system or anything else that may be needed to have one of those other modalities. The other thing that we've done in terms of additional evidence generation is looking at patients who are treatment naive.
We're the only ones that have to date done a treatment naive study in which we've looked at. It's about 12 patients' worth of data that's repeat biopsy. So as you would imagine, that's a tough thing to sign up for, but we have patients who are signing up to do that. What we've seen is that you get a proteinuria reduction of about 70% in stable eGFR in those patients. Not only have we looked at Filspari to make sure that we're providing evidence so that physicians understand how to combine it with other modalities, but also how to use it earlier. I think all the evidence to support that has come up consistently.
Okay. Now you're a fixed combination, correct?
Yes.
Right. So one of the pieces of feedback I've heard from some physicians is that that has its advantages, but it may also have drawbacks in terms of combinability. How do you see things?
Well, I think that there's always going to be a pocket of, I'll call it the academic institution areas that will say, "Well, we would like to play with different modalities," right? And I think that there may be some validity to that. But at the end of the day, what you want to do, especially in IgA, and our data have shown this, you need to inhibit both endothelin and angiotensin together, right? So if you are adding risk to not inhibiting both of them together, then you're either going to have lower efficacy or potentially some safety side effects, right? And you're even seeing that in, for example, some of the other data that's come out from endothelins, where if they're not on max dose of angiotensin, they don't have the same level of efficacy.
So for us, we think that not only do you get the maximum efficacy from having both maximally inhibited angiotensin and then the endothelin component, but it's also an important component of being convenient for patients going forward. And when you think about an IgA patient, you're already talking about taking other medicines, right? So this isn't the only pill that they'll be taking. And adding another one to that, if you don't have it both in one modality, makes that more challenging. And especially as you look forward, as the field continues to evolve and we have other modalities that come down the pipeline, you're going to want to have the simplicity of being able to combine with those as well.
And so when you look at it that way, and then when you also think about, again, the busy either patient or the busy community nephrologist, you don't want to add complication. And adding complication is having two things and trying to individually titrate and then hoping you keep the same compliance with both and that you have a static regimen of therapy and experience. It's not only more efficacious and better understood to have them together, but it's also more convenient.
I don't know how much of this you've disclosed so you can speak in vaguish terms, I guess, but so I'm just curious, what % of your treated population are new to therapy at all? Like you mentioned, you have a study. What % are coming on to Filspari from a period of steroids? What % are switchers from, say, Tarpeyo? Can you give some color on that?
Yeah, we haven't given the specific numbers, but I can talk directly for it. And what I would say is, first, on the patients that are treatment naive, we are hearing physicians go through the process of not only writing the script, but then getting through reimbursement and getting access. I think that that's one where just given the label and how the payer plans have been put into place, we're not seeing as much of that yet. But what we have seen is the combination, right? So we're seeing a combination of use with Tarpeyo. We're seeing a combination use with SGLT2s and even newer modalities. And so I think from an overall dynamic perspective, we're seeing patients start earlier on Filspari. And maybe one of the important things to highlight here would also be we're seeing the baseline or the average proteinuria level come down, right?
So when we were under accelerated approval, it was greater than 1.5, as you would expect.
When you start.
Yep. Yep. And so now it's coming down, which is what you expect. So that tells you that new patients coming in are moving down the paradigm, which is exactly what you want to see. And so we're seeing that dynamic. We're seeing patients that are being used in combination, and we are seeing some switching from the different medicines that are available.
Do you also capture starting eGFR, I assume, too?
We do. We do.
But that's maybe a little more complicated to plot that out.
It's a bit more complicated. You've got more variability in it. You've got a host of different factors. I think that's one where it's probably not as much or not as easy as a leading indicator as the proteinuria levels are. But we would anticipate that we'll continue to see that evolve over time as well.
Okay. Now, as far as just the basics on commercial, you gave some guidance yet or no? You have not?
No.
No. Is that in the cards for 2025, or you still want to test the waters a little more?
It's something that we're continuously talking about, right? I think we've made great progress both through last year and now this year, and we expect to see significant growth, not only beyond the inflection we're seeing here post-full approval in the fourth quarter, but next year and the years ahead. I think what we want to make sure that we're doing when we get to the point of providing guidance is that it's a reliable number for investors and for everybody to be able to work around. Because we're in the early stages still of having that full approval and the KDIGO guidelines, we're trying to make sure we have the best understanding of that before we get there. It's something that we're continuously talking about.
Okay. And then just one more on Filspari, and then we'll go to the other topics. I've been asking all the companies this, given the change in the administration potential for this increased protectionist policy in terms of the tariffs, what's your level of exposure to that risk? Meaning, where do you manufacture the drug and the API, the finished, so on?
Yeah. What I can say about that is that we have designed our system for a number of years to be able to have optionality. So we do have some supply that comes out of the areas that could potentially be involved in that, but we have also a second supplier strategy that we can enact if we need to. So I would say that overall, our exposure there is not something that we're materially concerned about at this point, and we need to see where all that legislation evolves.
Okay. And anything you want to throw in in terms of the potential changes in the leadership of some of the important divisions of government, HHS, CMS, FDA, or you want to leave that one alone?
I'll leave that one to the government at work.
Okay. All right. So the next one, FSGS. So that was kind of on the back burner. And then you had PARASOL, which is this academic working group in Sweden or where they're.
They're global.
They're global, but they had meetings in Scandinavia, right?
They had a summer meeting in Iceland.
Okay. I was close. Anyway, so that was a fruitful initial summit that they did in, I think, June, maybe, right? And then there was another one on October 7th- 8th. And I think Aliza Thompson showed up for both. And then they presented some of that at ASN. So tell us what all this means for you.
Yeah, sure. All right. Let me begin with the origins of PARASOL. And this kind of goes back to when we had our phase 3 DUPLEX study readout with the two-year data. That was the largest controlled study ever done in FSGS, still is, the largest controlled study done in FSGS. And the hypothesis all along has been similar to IgA nephropathy, where if you show a significant benefit on proteinuria at 36 weeks, that should translate to a beneficial change in eGFR. And what we saw in our study at two years with DUPLEX was we had the significant benefit in proteinuria at 36 weeks that translated to a significant benefit at two years in proteinuria and a 50% difference versus active control. But what we saw in eGFR was that it was clinically meaningfully different, but it wasn't statistically significant.
And the reason for that was there was far too much variability in the eGFR measurements. So our view at that point, and this was back over a year ago, was, "Well, if we can't do this with the largest study, how do you get there?" And I think that quickly became the same view amongst the nephrology community. And that's where I think PARASOL really came to formation. And as you mentioned, it's a number of thought leaders, and you've got regulatory agencies involved, but it's also got a very large patient advocacy organization that is spearheading a lot of the work, which is very important because the FSGS community has had nothing, for there hasn't been anything approved. And you're talking about one of the most progressive kidney disorders and a leading cause of end-stage kidney disease.
You've got a very motivated group that was helping bring together FDA, EMA, all the thought leaders in glomerular disease and nephrology community. What they came together to do was pool data so that they could answer the question of what are the best endpoints to pursue for an FSGS approval. As you mentioned, they had a number of meetings along the way. They actually had weekly telecons, and then they had a checkpoint in the summer in Iceland, and then they had the PARASOL workshop this fall. What we learned from that work was a few important things. One, eGFR is too variable. They looked at 1,600 patients' worth of data, which is a lot for FSGS.
What they saw and what the conclusions came to was to be able to show statistically significant difference at 1 ml/min/year, you would require 900 patients per arm. So that's a very difficult thing to do in a disease like FSGS. It was very clear, and there was consensus that eGFR was not the endpoint that should be used for FSGS.
It's difficult because of the prevalence. It would be too high a bar to enroll quickly. It'd just be not a feasible situation.
Exactly. I mean, 1,800 patients in a clinical study for multiple years is difficult to do for we think of FSGS as 15,000- 30,000 patients as the addressable market.
In the U.S.
In the U.S., right?
Okay. So that's a huge, huge chunk of the.
Exactly. And so I think that there was very clear recognition that that doesn't make sense. The other way you could look at it was, "Okay, well, how long would it take to have that variability sort of become more static?" And there you're talking five to seven years, right? So that doesn't make sense for patients who have.
You see your patient swim by you.
Well, and even more importantly, you have patients that are on placebo, right? Or in our case, it was an active control. But for the whole community, that's a very tough choice to make for that long period of time, right? So I think it was very clear to the overall group that eGFR was not the endpoint. And so they then went through the data to say, "What is the right endpoint?" And they very clearly aligned on proteinuria. And what they showed was at two years, reductions in proteinuria below certain thresholds. And really, this begins at 1.5. If you can get patients below 1.5 grams, that is clearly tied to better outcomes on kidney survival. And so what they did was evaluate a number of different thresholds, and the majority of the conversation came from or landed on 0.7 grams.
Now, when you look at 1.5 down, you can show that there's a very clear benefit on kidney survival. But 0.7 seemed to be the one that it would require a meaningful difference from baseline because most of the studies in FSGS are enrolling patients that are 1.5 grams or higher. And it would get patients to a threshold that was tied very clearly to kidney survival. So when they did that, there was a very robust data set that showed, "Okay, well, this isn't by chance. This is real. If you can get patients to this level, you're delaying end-stage kidney disease by a significant matter.
Do you mean below 0.7 on an absolute basis or dropping on average of 0.7?
No, dropping them to on an absolute basis below 0.7, right?
Okay. Yeah.
So essentially, if you were coming in at 1.5, it's a 50% reduction in proteinuria, roughly. And that's actually very clearly aligned with our FPRE endpoint in our phase three, which was a 40% reduction from baseline and getting patients below 1.5. And we showed a statistically significant difference on that. So the conversation really landed on, "Okay, proteinuria is now the target that we need to get to, and 0.7 is likely a good threshold to look to." FDA throughout the discussion, both at the workshop in October and then again at ASN, didn't point to a specific number. I think what their guidance has been on official guidance has been is this is going to be a sponsor discussion. So each individual sponsor needs to come in and present the biologic plausibility. So how is the drug working and why does this make sense?
And then what is the threshold that really does make sense for whatever modality you're using? And they said at the end of the workshop, they were asked very candidly, "Will you be using proteinuria going forward?" And they said that they will be approving products on our new endpoint. So it's very encouraging, certainly for us, but for the field as a whole and being able to have a future for FSGS treatments.
But you're still going to talk to the FDA, or?
Yep.
But what you just said was the conclusions from PARASOL.
Right.
Right. But as I mentioned earlier, there were representatives of the FDA voicing that opinion.
Yeah, there were. So one of the key people amongst the PARASOL group was Eliza Thompson, the lead reviewer from Cardio Renal. And I think that she's been consistently there along the way with all of the work and having her team involved is obviously very helpful for the group as a whole to have alignment, right? And so what we had been watching was, "Okay, where does this land? Is it similar to what we believe the case to be with FSGS based off of our own data set?" And now we're at the point where it aligns very well. So when we look at our data set from DUPLEX, for example, every which way we look at proteinuria reduction, it's significantly better for Filspari over irbesartan.
We've looked at the data with pre-specified endpoints at getting patients below 1.5, getting patients below 1, getting patients below 0.5, and getting patients below 0.3. And on all of those measures, we have a statistically significant difference in favor of Filspari. So when you think about that, it shows a very clear picture that aligns with where PARASOL landed. What we need to do now is go and have that conversation with FDA in the context of this work and see how they think about our data, right? So it's easy for us to look at it and say, "We have a very clear data package," but we need to go and see where they are now that they've had the insight and the work done.
Our expectation is that we should be able to have a path towards an SNDA submission, and we're doing all the work now to make sure we can move very quickly after that meeting.
The base case is you shouldn't need to have to run another study because you have the relevant data. If the conclusions of PARASOL are accepted by the FDA, then everybody's in alignment, yeah?
That's our belief, right? So our belief is we have the pre-specified endpoints that are all based off of the proteinuria reduction of the thresholds that PARASOL landed on. And it's a very consistent data set. What we want to do, again, is make sure that we're on the same page with FDA before we go in there and do it. But our expectation is that we have the data set. We really shouldn't have to run another study. And it's kind of difficult because are you going to run another study to show the same answer, right?
Now, by the way, when they did their, was it a meta? I don't know whether it's called a meta-analysis. Did they put the DUPLEX data in there, or that was jackknifed out?
No. So this is, and I think that's a good point because it's independent data. I think that's an important part of the discussion because when we first went to FDA last year and talked to them about the DUPLEX data set, the answer was, "Don't file now. Work with the community," and so I think at that point, that was under the mindset of you have to show a link between proteinuria and eGFR, well, we've since learned that you can't actually show that link between proteinuria and eGFR, at least in a statistically significant manner, and so now we're going to go and have that conversation with this new view in place.
Now, by the way, the other thing, which is kind of interesting, is I mean, you proved that or they proved, or they concluded that eGFR was a no-go, it was too variable, and then they turned to proteinuria, but I mean, honestly, that's the only other, isn't that the only other option? I mean, it wasn't like there was a whole array of possibilities. It was, yes?
Yeah, I think you're right. I think the question probably was specific to proteinuria.
What the cutoff was?
What is the cutoff? Exactly, right? Because there was guidance out there, or there still is guidance out there, that if you can get patients to complete remission, so below 0.3, then that's an approvable endpoint. I think the challenge had been prior to this is people didn't know whether they could actually get there in a study. And actually, what we saw was, and this was shown in the PARASOL data as well, the lower you go on those cutoffs, the data strengthens in terms of the signal. And that's in part because you can't get patients who are on background ACE or ARB or even placebo. You can't get them to have that big of a response, right? They can't get below 1.5 without some sort of intervention. They can't get below 1 and further.
And so I think that the goal was to find a cutoff that wasn't quite so stringent as complete remission, but that was still very clearly tied to the outcomes that they wanted to see, especially when thinking about it for full approval.
So was it done, was it sort of qualitative, or did they run models and sort of use some predictive algorithm to determine that 0.7 was the best discriminant between a bolus of patients with abnormally high risk versus in a good zone?
They looked at it at a number of different ways, and they certainly did a lot of modeling around it. They have the lead statistician, I believe he's from U-Michigan, and has been working in the field for quite some time. And the interesting thing was that the FDA also brought their statisticians into the discussion. And so the whole way through, I think they were looking at it from a number of different lenses to make sure that it was a robust data set. And no matter how they looked at it, it came to the same or similar conclusions. So I think it's a very good indicator of where things should head.
By the way, speaking of variability, and I know we're running out of time, but eGFR can move around a lot. With proteinuria, does it tend to, if we measured my proteinuria, say, now and then in 24 hours, what's the variability? Is it tight? I mean, just in terms of, because if you're close to the 0.7, you're either in or out, right?
Yeah. Well, I think it's far less variable than eGFR. You can have some variability in it, but you can also do 24-hour urine tests, which.
Oh, so you average.
Yeah. You can do it that way. And then there's also the first morning void that you sort of can level set things. And so over time, you generally don't see the same level of variability with proteinuria and eGFR.
And then I left this, so HCU quickly. It's a bit further out. But there was some news recently where you had to reset expectations on timelines. So can you just run through that super fast?
Sure, so just real quick on the background for HCU. This is a disease where, again, there are no therapies that are approved that are disease-modifying, and we've shown great data with Pegtibatinase that we're really excited about. To your point, we did recently announce that we need to make some improvements in our CMC process, and so we paused enrollment in our phase three study. What I can say is that we are making good progress there, and we've got great CDMO partners and great internal expertise to work through it. It's more from our perspective, it's a when, not an if, and so we're making good progress there. Our guidance right now is that we expect to restart enrollment in 2026. Of course, if we make progress ahead of that, then we're going to provide an update.
But our view is that we're going to get it back into the clinic, and it will be an important medicine for patients in the future.
And we've done a lot of clinical discussion, but since you are the CFO, there is a piece of, is it a convert that's due in 2029?
There's a small tranche in 2025, and then a large one in 2029.
Right. So what's the thinking around how to manage that? Are you just going to let the debt holders play it out, or are you going to pay it off early, or what can you say there?
What I can say is we've got flexibility, right? After we reported our 3Q earnings, we had $277 million in cash. We recently completed a financing where we brought in another $144 million in gross proceeds. The business is strengthening from an operating standpoint where our revenues are growing. Filspari and IgA is expected to continue to grow. Our operating expenses have been coming down. I think it provides us with plenty of flexibility to manage the notes in the best way possible for us and holders.
All right, well, thank you so much, Chris.
All right. Thanks, Bill.
Good luck with the FDA meeting.
Thank you.