Good morning. Thanks for joining us for another session at the 42nd JP Morgan Healthcare Conference. I'm Brian Cheng, one of the senior biotech analysts here. Joined by my associate, Sean Kim, who's in the audience. On stage, we have Protagonist CEO, Dinesh Patel. I'll pass the mic to Dinesh for a short presentation, followed by a live audience Q&A. If you're joining us live, you can submit the question for the team through our conference portal. Dinesh, the stage is yours.
Thank you, Brian. Good morning, everybody. Thanks for the kind intro. It's always a pleasure to be at the JP Morgan Healthcare Conference. Just a quick reminder that we'll be making forward-looking statements in today's presentation and Q&A. So at the core level, Protagonist is a peptide therapeutics-based company. We have a platform. We have two late-stage clinical assets, rusfertide and JNJ-2113, which is completing clinical studies and, eyeing over the coming years, NDA filing and, commercialization. And the genesis of this mature assets is our core technology platform, which has the wonderful ability to discover peptides in a de novo fashion against almost any biological target of interest, including the protein-protein interaction targets, which typically, as you know, are not amenable by small molecule approaches.
Today, the new thing that we are announcing is that through the use of our platform, we now are acknowledging our presence in the oral IL-17 program. And as you know, this is a very validated target with a huge commercial opportunity and an oral peptide antagonist of IL-17 could be creating a huge differentiation from anything and everything that is out there. So our product pipeline, as you see, has multiple assets. We believe each asset has a multi-billion-dollar potential in its own right. Rusfertide is a mimetic of hepcidin that is being evaluated for polycythemia vera. The phase III pivotal study, the VERIFY study, is ongoing, and we expect enrollment completion by the end of the quarter.
We have completed numerous phase II studies, including the phase II REVIVE study, where, based on the outstanding data that we achieved recently, we have had a very constructive dialogue with the FDA. And we are of the belief that the cumulative data package that we will have from these phase II studies and the phase III VERIFY study upon its completion, is gonna be an adequate data package for NDA filing. JNJ-2113 is our oral IL-23 receptor antagonist. This has been partnered with Janssen last year, and Janssen is now renamed as J&J Innovative Medicine. Last year, they reported the phase II data from the Frontier psoriasis study, and based on the outstanding data that was achieved over there, they have launched a very comprehensive psoriasis clinical program comprised of four different phase III studies.
In addition, we also have a phase IIb ulcerative colitis study that is ongoing with JNJ-2113 as well. So now, inspired by the success of these two assets, clearly we are inclined to do more in the heme space and the I&I space as well. And in that context, oral IL-17 is the new announcement right now. Hopefully, during the year, we'll have something to say in the heme arena as well. But we are super excited about oral IL-17 peptide antagonist program. It's a first-in-class kind of approach, and we believe we should have a development candidate by the end of the year. So now talking about rusfertide for polycythemia vera. Polycythemia vera, as you know, it's a myeloproliferative neoplasm, and its characteristics is excessive red blood cell production.
It's a rare disease, but it is a serious chronic disease. It's associated with increased mortality rates, largely stemming from increased thrombotic and cardiovascular risks. Around 100,000 patients are treated in the U.S. alone, with almost an equal number in Europe as well. The average population age is 50- 70 years for these patients, and they do survive with the disease for almost two decades. We believe that PV is very underserved. The current standard of care is suboptimal at best, and there is a very significant unmet need that could be filled by an agent like rusfertide. So I would like to make four points. One is that this is a disease where maintaining hematocrit below 45% is very critical, and it is as per the NCCN guidelines.
And if you do not control hematocrit, that has serious consequences, including increased mortality from these cardiovascular events. And then, of course, you know, the primary treatment is phlebotomy. If you're struggling to control your hematocrit, you have excessive phlebotomies, then you become iron deficient, and then you have the symptom burden, and that's really a quality-of-life issue. So clearly, that there are those consequences as well. So in spite of this importance of controlling hematocrit, the real-world data shows that the majority of patients, over 75% of them, do not control the hematocrit, and that's just a reflection of the suboptimal standard of care that is out there.
I mean, if we think about it, this is a disease where controlling hematocrit is sort of the mainstay, but there is no RBC treatment, specific treatment option that is out there. So in that context, rusfertide, which is a mimetic of the natural hormone hepcidin, and hepcidin is the, you know, our natural iron homeostasis regulator in charge of erythrocytosis, right? So, it's just logical to see then, like, how rusfertide could be an RBC-specific agent that could come to the rescue of these patients. We have done numerous studies, but we will highlight the phase II REVIVE study very quickly over here. The inclusion criteria has been those patients who require excessive phlebotomies in spite of their current standard of care, reflecting that, you know, their hematocrit is not being controlled.
The 12-week randomization part of the study is the blinded portion of the study, where the patients are distributed equally between a placebo arm or a treatment arm, and that data was presented as a late breaker at EHA last year. I'll share some of the highlights of that data. Obviously, we achieved wonderful efficacy over there. But the second outcome that we get from the study is the durability of response with our drug, and that data is sort of summarized over here. What you can see is that this is really impressive durability, 37 out of 70 patients, meaning more than 50% of the patients, they are continuing with the drug for over two years now.
In fact, initially when we had the study planned, we had only one year of open-label extension. But then based on the level of interest that we saw from the patients and the investigators, we increased that time period to three years, and now we have several patients moving beyond three years. So, we have decided to add on this a separate long-term extension study, the THRIVE study, where the patients are now going to get the drug available for an additional two years. So talking about the randomization data, basically, rusfertide met its primary endpoint with just excellent statistical significance, with a P value of 0.0003. In the treatment arm, we had 26 patients. About 70% of them were responders by the technical definition.
We had 8 non-responders out of the total of 26. But if you look at the data more carefully, only three patients fulfilled the fulfilled the phlebotomy eligibility criteria. The other five patients, they just discontinued the treatment per patient investigator discretion, and then immediately went into the open-label extension arm of the study. And seven out of these eight patients are continuing the the open-label extension. So, the big highlight over here is that besides achieving an excellent P value, I mean, we are keeping the patients essentially phlebotomy-free with our drug. And that is very important because that is kind of like the cornerstone of our primary endpoint in the phase III study. In terms of safety, the drug is very well tolerated, and there are no new safety signals, even with the longer duration of follow-up.
In fact, now the median duration of exposure with rusfertide per patient is over two years. The majority of adverse events are grade one or two nature, the most common one being injection site reactions, which is localized and transient, and it also decreases both in severity and frequency over a period of time. There were 14 SAEs reported, but most of these were assessed as being unrelated to rusfertide by the investigators. Keep in mind that PV is a disease where the prevalence of secondary cancers, including skin cancers, and the prevalence of thromboembolic events, is just higher, significantly higher than what you would normally find. So then the nature and extent of the SAEs that we are observing, that is very consistent with the co-morbidities that exist for this patient population.
The phase III study design is sketched out over here. The primary endpoint is at the 30-week week time period, and as you can see, the primary endpoint is freedom from phlebotomy, very similar to what we had in the phase II study, where we got outstanding results. The phase II study was a 70-patient study, and we got excellent P value. So of course, this 250-patient study is kind of overpowered for efficacy. But the idea over here is, like, maybe this will allow us to have a good score in the symptom improvement as well, which is one of the key secondary endpoint.
So now, as we start completing the phase III studies and we go towards NDA filing and those sort of things, this is the right time to come up with a commercial strategy for our drug. So in that context, what we would like to propose is this, that this is a drug that could be ideally suited for patients with moderate treatment burden. So what is the definition of moderate treatment burden? Well, these are the patients who require too many phlebotomies to control their hematocrit and to control the disease. And irrespective of, like, you know, whether they are on other concurrent therapy like HU or not.
We have done our own homework in terms of looking very carefully at the you know, real-world patients' databases that are out there, and we believe that almost 60% of the patients fall in this moderate treatment burden category. So clearly, this is a rare disease. Our drug has orphan drug status, fast track status, and we believe being an RBC-specific agent this could have a very prominent role to play in the future in the potential treatment of the PV patients. So now let's switch to JNJ-2113, our oral IL-23 receptor antagonist peptide. So this is a drug that is being developed in partnership with J&J. This is a partnership that's seven years old but still going very strong. The drug is jointly discovered by the two companies.
In general, in the collaboration, there has been a division of labor and effort, so to speak. So we are responsible primarily for discovery, the preclinical activities, the phase I activities, and then Janssen takes over and does the heavy lifting of the phase II studies, phase III studies, the regulatory filings, and ultimately the commercialization. Now, it was the positive data from the Frontier-2 psoriasis study that was really an inflection point over here in the program, and I'll talk about some of the data in the next few slides. But the big outcome is, like, you know, what is happening going into the future? Well, that there is a bold, comprehensive phase III registration program with not one or two, but four different phase III studies in psoriasis.
The idea over here is really to make a claim that this is the best oral psoriasis treatment that could possibly be out there. Of course, in parallel, the phase 2b UC study is going on also. As you know, with IL-23 intervention, you can combat not just psoriasis, but psoriatic arthritis, ulcerative colitis, and Crohn's disease. In fact, at the recent Enterprise Review Day that was hosted by J&J, they described JNJ-2113 as a first and best-in-class targeted oral IL-23 antagonist with unprecedented potential across multiple indications. No surprise that, you know, this has been now placed in the category of promising drug candidates. They have their pipeline with potential peak sales of over $5 billion.
And of course, you know that, you know, J&J has the injectable antibody STELARA and TREMFYA franchise, which in 2022 alone, generated over $12 billion in revenues for them. JNJ-2113, the magic in JNJ-2113 is that it's an oral peptide with some oral bioavailability that works in an indication like psoriasis. It's a peptide with outstanding potency, picomolar level, similar or better to than the antibodies that are out there. Extremely orally stable. Preclinical POC with amazing data, both in the skin inflammation model and the rat and PS colitis model. PD-based POC studies in phase I, and of course, ultimately, the phase II B Frontier study psoriasis results. So this is the study design.
There are five different dosing regimens over here, comprised of both once daily and twice a day dosing, and then, of course, the placebo arm. Here are the results. There are kind of multiple key takeaways over here. The primary endpoint was the PASI 75 at week 16, and statistical significance in the context of primary endpoint was achieved at all five doses. The second thing is, if you can see that it's a very clean, clear, and linear dose response. The higher the dose, the higher the efficacy. The best efficacy being achieved at 100 mg BID dosing. However, the study was designed in such a way that you're also allowed to do a comparison of QD versus BID dosing.
So when you look at the 50 mg QD versus 25 BID, you would conclude that the QD dosing is more effective. So combine these two observations, and then you would conclude that instead of 100 BID, you would take a 200 mg daily dose, and that is what Janssen is doing, and they are moving a dose 200 mg QD dosing regimen in all the four phase III studies. The other thing is, like, you know, when you look at the efficacy data, the PASI 75 is like an understatement. Instead, why not raise the bar to a higher efficacy level? The drug does very well, even under the more stringent criteria of PASI 90 and 100.
So no surprise that now going forward, you know, J&J is opting for PASI 90 as the primary endpoint in most of these phase III studies. Here what we have done is, like, we have taken the liberty of doing cross-trial comparison of the phase II data of the various drugs that are out there. And what you see on the left is our drug, JNJ-2113. The three bars next to it are the various oral psoriasis agents that are out there, including the two TYK2 inhibitors, one approved. The one in orange is SOTYKTU, and the gray is TAK279. And then on the left are STELARA and TREMFYA, the injectable antibody drugs.
At a visual level, you will see that when you look at the PASI 75, our drug is very much out there with efficacy easily in the range of the antibodies that STELARA and TREMFYA. But you know, this is an oral drug. This is a first of its kind oral targeted therapy, so it stand on its own in our opinion and especially in the oral agent space. And that is where you can start seeing the superiority of our drug versus other things that are out there. And especially now, when you look at the PASI 90 or the PASI 100, that is where the differentiation is even bigger. So no surprise, PASI 90 is the primary endpoint of choice over here.
Of course, out of the four phase III studies, the two studies are the ones where the J&J is opting to do a head-to-head comparison with the only approved oral TYK2, which could be considered as the best-in-class oral for now. So the head-to-head comparison with SOTYKTU is there in the two phase III studies. Now, of course, it is always great when you can see a nice translation of excellent R&D performance into some dollars and cents. So here we are. We have already received over $170 million in different forms of payments. There is another close to $800 million that we could be fetching from future milestones.
We believe that out of this 800, at least 215 million, which are sketched in the table here, are achievable over the next 12-36 months, and those are listed over here. Then ultimately, the big piece of the pie is the royalty component, 6%-10% royalty, which is upward tiered and the 10% kicking in at sales over $4 billion. You can do the math, and I'm sure you will come up with numbers that you like. So, that's basically around JNJ-2113, and as I mentioned before, inspired by our own success, we said, "Hey, if you have done something well, then the simplest thing to do is go for repeat performance." So here we are.
Oral IL-17, it's a very pro and target. The commercial appeal is huge. If you look at the IL-17 antagonist, I mean, over here, you can reach out to indications like HS, spondyloarthritis, psoriasis, psoriatic arthritis. In 2021 alone, these indications that could be treated with IL-17 agents, you know, the global sales were around $29 billion, and the market is supposed to grow very significantly. So in by 2031, the anticipation is that it would be over $50 billion. Of course, what we are doing over here is like we are leveraging our oral peptide technology platform, and that's why we are going for a very ambitious and very well-differentiated target product profile.
With the oral approach, the peptide approach, we believe we are the first in class, in that category. From the preliminary results that we have had, we believe that, we have at least similar, most likely better potency than versus the approved antibody drugs like Cosentyx and Taltz. And, we are aiming for trispecificity, because the data that is out there with, you know, the antibodies and the nanobodies suggest that the trispecificity may play an important role, in terms of overall best efficacy and safety, right? So, we have been working on this for a while. This is a very high priority project.
You can expect more to hear from us during the year about this program, and we are predicting that we should have a development candidate here by the end of the year. In terms of cash runway, we are fortunate to have a cash runway through Q1 of 2026. I would like to point out that this does not include the $215 million in potential milestones that we expect from Janssen, that I showcased on the table a few slides ago, over the next 12-36 months. So, in a way, the cash runway is up to Q1 2026, plus potentially the $200 million-plus we could be getting from Janssen.
So then, in terms of the summing up the major catalysts that lie ahead, I mean, the big picture scenario is that we have two drugs, rusfertide, fully owned by us, and JNJ-2113 in partnership with a wonderful partner like JNJ. These are the drugs that are moving towards commercialization by 2026 or early 2027 time period. And for these drugs to be stemming from our nascent de novo discovery peptide technology platform, it's really a very satisfying outcome. But if you focus on 2024, then, I mean, clearly, we'll continue with our habit of highlighting the rusfertide data at major medical conferences. We will also have the completion of the two year carcinogenicity study.
We are completing the enrollment in the phase III study by the end of this quarter. With JNJ-2113, there are four studies that will kick off. Two have already started, and the first two phase III studies are based on the information on ClinicalTrials.gov. The primary endpoint phase of the study will be completed by the end of the year, by November of this year. So clearly after that, you know, the data and the news flow will be there in terms of what was the outcome of those studies. And then, of course, last but not least, this is also the year where we hope to that before the year ends, we will have our own oral first-in-class peptide antagonist, IL-17, as a development candidate.
So with this, I would like to thank the broad Protagonist team, which comprises of the excellent employees at Protagonist. I'm also grateful to their dedication and commitment to excellent science and creating wonderful assets. We would also be thanking the investigators and patients who are collaborating with us to give us these wonderful results. And of course, thank you all for your attention, and we will be happy to answer any questions.
I'll invite the Protagonist team to join us on the table. We have their CMO, Arturo Molina, Clinical Development Advisor, Samuel Saks, and Chief Scientific Officer, Scott Plevy. I'll kick off with one or two questions, if I may, and then I'll turn it over to the audience, if they have any questions. Maybe focusing on your new oral IL-17 program. How do you view your oral trispecific IL-17 antagonist differentiate from some of the competitors out there, Acelyrin and MoonLake? They all have seen some proof of concept early in some of the autoimmune indications. You know, how do you view the differentiation? And why those specific indications that you listed out on the slide?
Yeah. I mean, our big differentiation at the end of the day is going to be that we are oral, and even with an oral approach, we would like to fetch all the specificity and the potency that the injectable antibodies or the nanobodies are achieving. I guess that's the simplest answer. Scott, would you like to add anything?
Yeah, and there's IL-17 small molecule programs there. And just to reiterate what Dinesh said, we have exquisite potency and exquisite specificity, like a monoclonal antibody. So, we are absolutely not concerned about off-target effects.
Any questions from the audience? Do you expect this program to be partnered off? How do you think about IL-17 in your portfolio, given, you know, how well you have done with IL-23 receptor antagonists?
Yeah, I think, look, it's an excellent question, and the way I would answer this is like, you know, when we did the partnership with J&J, that was in 2017. Protagonist was a different company at that time, and it just made so much sense to do a preclinical stage deal at that time. And as you can see, the outcome has been wonderful, well, wonderful. But I would like to claim we are a little bit grown up now, and we have the luxury of continuing the development of IL-17 in our own shop a little bit longer. So over here, under one scenario, you could envision us developing an oral IL-17 peptide antagonist up to phase II clinical POC on our own.
So IL-23 receptor antagonist, your peptide program definitely had its, you know, multiple challenges in the past, and you finally got to a really good one with JNJ-2113 that's shown success in PSO. When you think about oral IL-17 today, it's still preclinical, you still haven't selected the DC. Is it going to be harder to get an oral IL-17 peptide antagonist from where you stand today, or is it easier? Or and also, is there any learnings from the past as well?
Yeah, it's an excellent, excellent question. And what I would say is that, look, there have been a lot of learnings during our seven-year journey in the IL-23 program. As some of you may recall, in the initial years, we were focused on oral gut-restricted peptides, and the hard way we learned that, you know, it's probably not the best idea in the world to be gut restricted. So that is where we took on the difficult task of getting some oral bioavailability with our drugs. So I think that's just a learning that will go a long way also. So we will clearly...
I mean, our anticipation would be that based on our learnings of this kind of nature and several others, the journey over here should be faster than what it was with the IL-23 program.
Are there going to be two different inhibitors that roll out from this program, targeting I&I and Heme? And do you anticipate that one would move faster than the other, just given, you know, where our competitors are today?
So you're talking about the discovery programs-
Yes.
-in general?
'Cause you have a slide that says, you know, I think you have one slide where you have I&I and Heme underneath. So do you anticipate two individual programs, two different assets, or do you think that one will can, you know, address both of the indications?
Yeah, I would want Scott to elaborate a bit, but the short answer is, yeah, two different programs, one in the I&I space, one in the Heme space.
Yeah. So IL-17 is our initial new foray into the I&I space. With the heme space, I would just say at this point, stay tuned this year, and we're confident that we should be announcing what that program looks like at some point.
Any questions from the audience? Okay, so maybe we'll move on to 2113. When you think about 2113, I think there's always that potential that you can monetize the royalty stream. I think we spoke a little bit about that last year, right, right when we were about to get the Frontier-1 data in Singapore. And where do you stand on that today? Do you think that, you know, based on your current cash runway, does it make sense to do it now? And also just kind of, you know, also the market condition as well. I think, you know, it has improved quite, quite a bit since we last spoke on this. So where do you stand on that today?
Yeah, no, I think, look, we are really fortunate that to be in a very respectable financial position. And so we can pull many different levers, the royalty stream or its monetization or partial monetization is only one of them. Right now, our attitude is that we are in a comfortable financial situation, so the best thing to do is to do nothing. You know, as Charlie Munger said, "In financial investments, don't be lazy. Just be super lazy." So not doing anything is a difficult thing, but that is what we'll be doing. Don't do anything on the royalty monetization.
How confident are you that your QD dose, the 200 mg QD dose, will perform better than 100 mg BID, that was tested in the Frontier-1? You know, in your slide, you're hinting that you should be, you should be able to get there, you know, some delta, versus the, the BID dose. But, how confident are you today that you can beat it? And also, and also, like, commercially, how viable is it compared against, Sotyktu?
Yeah, absolutely. But QD dosing is always preferred over BID, so it's as simple as that. In any of our phase II study, the 50 mg QD was better than 25 BID. So that's just the empirical observation, which you can translate in theory to 200 mg QD from 100 BID. But Scott, why don't we provide a more scientific explanation for our optimism?
Okay. Well, you were pretty scientific, but just to expound on that, what the phase II B data showed us was that since a QD dose is better than a BID dose at the same daily exposure, it's a Cmax-driven phenomenon rather than trough levels. So this is why we would expect, or at least hypothesize, that 200 QD might be better than 100 BID. The other factor that plays into this is that Janssen has now discussed that, in fact, there is a food effect. It's not an on/off switch, but in the presence of food, there might be some decreased absorption. Now, think about this in the context of a clinical trial where patients are taking twice daily doses.
What Janssen is going to move forward with is 200 milligrams QD, the dose to be given in the morning, and then nothing by mouth, for 30 minutes after. So clinically, for patients, no big deal. But in the context of the clinical trial, imagine a second fast, both before and after, for the second daily dose. This sets up a minefield for compliance, patients taking it when there's still food on board. So, in the context of the clinical trial, one can also speculate that the 100 BID, because of that second daily dose, could have minimized efficacy.
That is the situation we will not be encountering with the QD dose, right? It's like you take the drug first thing in the morning, and after 30 minutes, you can have your breakfast.
That's the dosing that you're doing in the phase 3-
Yeah.
Across all the phase three?
Across all the four phase III studies, 200 QD.
Yeah.
Yep.
Any questions from the audience? Maybe just one more on 2113. On, on the IBD side, you're—I think you're, you'll have data in 2025. How quickly can you roll into a pivotal, is, is... And then also, it's just UC, right? So how do you think about Crohn's as well?
Well, you know, Scott is an IBD KOL from his former life. So, Scott, go ahead.
Sure. I led the J&J IBD programs for almost six years before coming here. So I'm not telling you what they're going to do, but I can tell you a little bit about how they think. So we're using ulcerative colitis as a dose-finding exercise. And they are testing, the study's ongoing, three doses versus placebo. Ulcerative colitis is essentially a go, no-go for registrational trials in both ulcerative colitis and Crohn's disease. So based on the dose that's found in an ulcerative colitis trial and given the validation of the IL-23 target in IBD, we feel really good about the probability of success here. Our anticipation is that Janssen could move quickly into registrational studies in both UC and Crohn's, without really doing any extensive dose-finding in Crohn's.
Just to clarify, we are not saying those are the decisions. This is like, you know-
Yeah.
We are just giving you logical scenarios.
We're speculating, yes.
All right.
In the last couple minutes, I want to touch on rusfertide. We're running out of time, so I'm gonna talk a little bit faster. So on rusfertide, what's the latest on enrollment? Are you still on track to complete enrollment for the pivotal VERIFY trial in the first quarter?
Yes. Absolutely, yes.
Can you provide some color on where you are in enrollment?
We have a lot of activities ongoing, and the enrollment has just picked up. We've opened up a lot of new sites in the fall quarter that are now screening patients. As a reminder, this is a global or international study with sites in Canada, U.S., Mexico, South America. We have Eastern, Western European sites in Israel and Hungary. So definitely, and then we have focused digital and TV ad campaign that's been very effective-
Right.
in getting patients into the screening programs. So yep, we are on target.
When we think about the interim analysis at week 32, for the VERIFY, are you going to top line when you have—when you pass that point of the interim? And, and if not, what does, what does that, what does that mean, you know, for, for the success or, for the success and probability of success for the study?
Yeah, I mean, maybe that's, you know, Sam, you can take that question.
Sure. So, it's really not an interim analysis. It's the primary endpoint. So just to clarify, the primary endpoint in the U.S. for the FDA is the phlebotomy freedom from week 20 to 32. The additional 20 weeks are meant to be a durability check in the active group to see that the people who are phlebotomy-free in the 12-week period maintain that phlebotomy freedom for the additional 20 weeks. So we will stay blinded during that period. But to your point, if it turned out that we failed the primary endpoint at 32 weeks, it's likely the independent data safety monitoring committee would end the study because it wouldn't be ethical to continue a negative experience. So, we'll be, will remain blinded till the 52 weeks, but, no news is good news.
Let me just add that the patient population in the VERIFY study is very similar to the patient population in the REVIVE study, with respect to inclusion, exclusion criteria, high phlebotomy burden requirement. So if the REVIVE study is any predictor of the success of VERIFY, it looks very promising.
Do you need the THRIVE study, THRIVE data to support a filing? And how important is that, from a regulatory perspective and also, commercial perspective?
Okay.
So the focus of the discussion that we had with the FDA was to review the REVIVE data, and they basically indicated that this is a positive data. It counts. It's an adequate, well-controlled study. And we also discussed the PACIFIC study, which is a single-arm study of rusfertide in patients with uncontrolled hematocrit, the VERIFY study, assuming it's positive. And the THRIVE study is for patients who graduate or finish treatment on REVIVE. So the totality of the data package is potentially adequate for an NDA, and that was reviewed with the FDA. The other thing we discussed with the FDA is the adequacy of the safety database and exposure, and they've also agreed in principle with what we have proposed.
Great. I think that concludes the end of our presentation with Protagonist. Thanks for joining us. Thank you.