Roivant Sciences Reports Q4 2026 Results: Full Earnings Call Transcript

Roivant Sciences (NASDAQ:ROIV) reported fourth-quarter financial results on Wednesday. The transcript from the company's fourth-quarter earnings call has been provided below. This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/. The full earnings call is available at https://edge.media-server.com/mmc/p/6w4qcx9w Summary Roivant Sciences reported strong execution momentum with multiple strategic updates, including a $2.25 billion settlement with Moderna and advancements in their drug development pipeline. Financially, the company maintains a robust position with $4.3 billion in cash and no debt, and they continue active share repurchase programs. Key clinical developments include promising data from the 1402 study in a difficult-to-treat rheumatoid arthritis population, and ongoing progress in launching Brepocitinib for dermatomyositis by September, pending FDA approval. The company highlighted its strategic focus on Moseli, an inhaled SGC activator, with upcoming Phase 2 data expected in the second half of 2026, targeting PH-ILD with a potentially first-in-class treatment. Roivant Sciences remains optimistic about future data releases and indicated a strong pipeline with significant upcoming milestones in multiple therapeutic areas. Full Transcript OPERATOR Ladies and gentlemen, thank you for standing by. Welcome to the Roivant fourth quarter 2025 earnings call. At this time, all participants are in a listen only mode. After the speaker's presentation there will be a question and answer session and to ask a question during the session you will need to press Star one one on your telephone. You will then hear an automated message advising your hand is raised. We ask that you Please limit to one question and to withdraw your question please press Star one one again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Stephanie Lee from Roivant Sciences. Please go ahead. Stephanie Lee Good morning and thanks for joining today's call to review business updates from Roivant's fourth quarter and fiscal year ended March 31, 2026. I'm Stephanie Lee with Roivant Presenting today we have Matt Glein, CEO of Roivant and Drew Frumpkin, CEO of Pulmovant. For those dialing in via conference call, you can find the slides being presented today as well as a press release announcing these Updates on our IR website at www.investor.roivant.com. We will also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that We will be making certain forward looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the U.S. Securities and Exchange Commission for more information regarding these forward looking statements and related risks and uncertainties. And with that I'll turn it over to Matt. Matt Glein (CEO) Thanks Stephanie. Thank you everyone for dialing in this morning. I'm glad to be talking. We have an unexpectedly busy agenda with a bunch of topics. I'm looking forward to going through all of it, including obviously what we announced this morning, which is the preliminary open label period Data from the 1402 study in D3TRA as well as a plan spotlight we've been planning to do for a while on Mosely, getting into that data, which Drew will take us through and some smaller updates on the PrEP Sentinel program. Although exciting, so a lot to cover. I want to, before I get into all that, use one small bit of executive privilege and wish my father Jerry a happy 75th birthday. Today is his 75th birthday, so happy birthday dad. He sometimes listens in on these calls. I don't know if he's listening in now. If not, I'll catch it on the replay. Okay, into the important topics. Now starting on important business topics. Now starting on Slide 5. Look, this has been a pretty wild 12 months for Roivant and We continue to see just tremendous execution momentum across our development portfolio. An update that will get drowned in some of the other things for today, but is actually pretty great is that PrEP Citinib was awarded Breakthrough designation Breakthrough Therapy designation Sarcoidosis, which just underscores indication selection and development there in terms of what that could mean for those patients. Obviously also in this quarter we announced LPP as an indication for Brevacitinib and that study is already enrolling. We're exciTED (thyroid eye disease) about how that's going. And then a ton of work ongoing in commercial prep for the launch for DM which assuming FDA goes as we expect it to, will launch by the end of September. Obviously the bIgGest data update for today in the FcRn franchise is what I mentioned earlier, which is that 1402 showed we think clinically meaningful, pretty exciting ACR response rates across ACR20, 50 and 70 in the D3TRA (dual therapy for refractory arthritis) study in the open label portion. We'll talk more about that, but that's obviously encouraging data that we're looking forward to spending some time on. We're also fully enrolled on CLE (cutaneous lupus erythematosus) with top line data expecTED (thyroid eye disease) in that study in the second half. And earlier in this quarter we announced the failure of the bapineuzumab studies in TED (thyroid eye disease), but also that the hyperthyroid patients showed normalization which was supportive of our Graves' studies which are ongoing. Continue to enroll. Well also and then finally hard to believe it was this quarter. But earlier this quarter we also announced our two and a quarter billion dollar settlement with Moderna and we expect to receive the first portion of that payment, the $950 million upfront, in July. So just an incredibly busy quarter of execution for us and an incredibly busy fiscal year for us. It's really hard to believe how much has changed in a year for Roivantt. None of that though is to say on slide 6 that we're done. And the next 12 months are also incredibly exciting. Obviously one of the most important things going on, we will hopefully be launching brevacitinib for primary, hopefully launching brevacitinib in Dermatomyositis by the end of September. The phase three study in cannium sarcoidosis we expect to begin this year as well and we expect The NIU (non-infectious uveitis) Phase 3 top line data in the back half of this year. So a transformative year for brepo as all of that comes around. We'll spend time on this today, but the Moseli PHLD (pulmonary hypertension with interstitial lung disease) Phase 2B top line data is expecTED (thyroid eye disease) in the second half. That also will potentially underscore that as a really important program and hopefully look forward to that data and to talk more about it, obviously D3TRA (dual therapy for refractory arthritis), some of the data is around today, but we're looking forward to providing a pretty significant update later this year with a little bit more data as well as detailed analysis we're doing at a patient level and hopefully with some feedback from FDA on a go forward plan given what we've now seen. And then obviously we'll get to see all the PoC (proof of concept) topline data as well. And then next year is a huge year with 1402 data enGraves's and MG coming in a ton to look forward to and frankly as much in the windshield in the rearview mirror. I think I've got the car analogy right there. Great. Okay, I'm going to go in now without spending any more time on the preamble and talk a little bit about this D3TRA data, which I would call surprisingly good. We were pretty exciTED (thyroid eye disease) to see what we saw here. It has slowly been a little bit hard to process just how exciting this data is and so we're still doing a lot of work on it. As a reminder on slide 8 of what we're talking about today, this was a unique study design in a few ways. First of all, as I think everyone's aware, this was a study in heavily refractory patients. Every patient in this study, in addition to failing steroids and DMARDs, also had to fail at least two advanced lines of therapy. So most commonly that's two of for example TNs, JAK inhibitors and IL-6 inhibitors and we'll talk a little bit about that. There's obviously some other things that could be in that bucket as well. The study also had a pretty strict entry criteria on autoantibody-positive. We had a criteria on aqua-positive above a certain level and that was also specific to the study of design. And then the other way in which the study was unique is it was a randomized withdrawal study with two periods. First, an open label active treatment period of 16 weeks at high dose 1402 600mg followed by a period two 12 week re randomization where ACR20 responders at week 14 and 16 both are re randomized into a 12 week randomized withdrawal period where some of them stay on 600, some go down to 300 and some go down to placebo. What we have to share today is preliminary data. We're still actually cleaning and finalizing it all, but it shouldn't move very much from here on the top line treatment Vect from Period One, Period Two is still ongoing with more than half of patients still being dosed in the study. So we don't have any data or information about period two to share today. And then even for Period One, there's a whole bunch of data like IgG, for example, that we haven't analyzed fully and are not ready to share. So nothing to say about it other than that we're going to be sharing a pretty limiTED (thyroid eye disease) subset of this data today. On slide 9 you can see baseline characteristics for the patients in the study with 165 valuable patients. I'm not going to go through all of this in detail other than say this is quite a sick patient population. Obviously by design it's refractory and we'll talk more about that in a second. But for example, if you look at the DAS28-CRP score 6.1, that's quite high for a study like this. There's a bunch of measures on here that suggest a quite sick population, which was the goal. Right. This is the population that we set out to enroll. And so we feel good about who's in the study on prior lines of therapy, specifically on 10. So you can see on the right hand side, we succeeded with our entry criteria. That is basically all of these patients have failed more than two advanced therapy mechanisms. And that's very different than either the Nippon study or really any of the later line RA studies that have been run. And actually one thing that we're highlighting today, because I think it's particularly interesting, 65% of these patients roughly have failed specifically JAK inhibitors. And notably, and we'll highlight this elsewhere as well, basically every single one of the patients who failed a JAK inhibitor also failed the tnf. So this is a TNF and JAK refractory patient population that we're focused on. So look, Slide 11 is the headline here. And the headline is, with all of the appropriate caveats for an open label study, these numbers are high. We saw 73% of patients roughly with ACR20 responses. And not just that, but we saw quite deep responses. We saw over half of patients with an ACR 50 and over a third of patients with an ACR 70. And notably, once you get onto the deeper end of that with ACR 50s and ACR70s, you just don't see a lot of placebo response in that level of responder analysis. And so it feels to us like looking at this data there's something going on that's meaningful and interesting with this drug and something that merits enthusiasm and a lot of further investigation. And we're certainly doing all that work now as we get ready to take the program forward. I'll Highlight on slide 12 the one other bit of interesting data from the study that we're able to present today, which is we pulled out the subset of patients who are JAK-experienced. Remember those patients, 107 of them are both JAK and TNF experienced. All of them, Some of them have also failed something else as well. And one thing that I think is maybe most exciting about this data is it's basically fully preserved in that subset. And so as you think about that opportunity where these patients have really failed, all of the most advanced options available to them were able to deliver in an open label setting. Pretty exciting response rates for those patients, which I think bodes well for the exact biological thesis with which we ran the study to begin with, that autoantibody-positive is an orthogonal mechanism, some of the other anti inflammatory options, and that for aqua-positive patients this could be an effective treatment option. So look, I think on slide 13, just to reiterate what we're showing here, look, these are sick patients, a difficult to treat patient population who have failed a lot or all of the available options and come in with highly active disease. We showed really great response rates in the data that we're exciTED (thyroid eye disease) to see how they evolve through the rest of this study and on deeper patient level analysis. And also notably, this is the largest patient population dosed with IMVT-1402 to date. It was safe and well toleraTED (thyroid eye disease) in the study. Nothing new drug relaTED (thyroid eye disease) from a safety signal perspective identified. So a clean data set overall and further underscoring what we think We've got with 14.02 path forward from here. Obviously you look at this data and you feel pretty good about what this could be. Significant potential benefit, a differentiaTED (thyroid eye disease) mechanism, a difficult to treat population with not a lot of options. So we're actively working right now to get ready to talk to FDA about this data and plan a path forward. The data is encouraging, I'll make one comment about it, which is the depth of responses is exactly what's exciting about the data set. It's exactly what makes us believe there is something beyond placebo happening in the data set. But as you'll recall, the randomized withdrawal period, the primary endpoint of period two is do patients taken off drug lose their ACR20 response in 12 weeks, which was a relatively short period to begin with and almost certainly would have been fine. If we had seen more marginal benefit on ACR20. But the truth is, once you're looking at ACR 50 and 70 responders, I think the bar has actually gotten a fair amount higher for period two. And so paradoxically, I think we still have a good shot of success there. But in some ways, period two was less meaningful than it might otherwise have been. And I think there are plenty of scenarios where we don't see a P value in period two and continue forward with the drug, given the overall quality of this data. And Conversely, depending on FDA's feedback, potentially situations where we do see a P value period too, and just need to make sure we're comfortable with the plan forward. So I think much more interesting than the period 2 data at this point is more patient level analysis as well as the results of those FDA discussions. And we expect to share all of that in the second half of this year. We're working on it right now. And my hope, given the quality of this data, is that we'll be coming back to you with an enthusiastic update about next steps here that lay the groundwork for just a really big opportunity. Remember, we presenTED (thyroid eye disease) some data at our Investor day suggesting this is at least a 70,000 patient population and some more specific revised commercial analysis, but Immunovant has now done that. Looks like that number could be 85,000 or higher. It's a big patient population in need. And I think underscoring that the speed with which this trial enrolled, the enthusiasm that physicians have for putting patients on study, is just further evidence that there's really something interesting here. And with that, actually, I just want to also just give a shout out to the Immunovant team who have continued to execute really well. Obviously the data itself is strong, but also the speed of enrollment, the speed with which we're moving through these studies, the full enrollment on cle, and I think that spans all of our programs. I think we're exciTED (thyroid eye disease) about what obviously what Private's been able to do with Brev sitting in from a clinical enrollment perspective. We're exciTED (thyroid eye disease) about the speed of enrollment for Moseley. Obviously the quality of that data. We'll find out soon, but look really exciTED (thyroid eye disease) about what we've been able to do across the portfolio in clinical execution. So much appreciation for the enormous number of people who are working toward those goals. Cool. I'm going to pivot now to Moseley Cigarette and do a little bit of a data preview there because the next time we get together, that data could potentially be very close in front of us. And so we wanTED (thyroid eye disease) to get out ahead of that and give people a chance to just ground themselves in what's coming, as we did last year around this time or a little later for Brevacitinib in drivenomystitis. Look, I'll do a little bit of an introduction here. And then you all heard from Drew back at Investor Day in December. He's in the room with me and is going to talk through a little bit more about the program, look intense on that medical need. These patients, in the extreme, a significant proportion of them die. They're very sick. There is currently only one approved mechanism with two therapies. And we think there's probably 200,000 patients across the US and Europe. And that one mechanism for prosthenol is underscoring multiple really great launches at this point. So we're exciTED (thyroid eye disease) to see the commercial enthusiasm and exciTED (thyroid eye disease) to see these patients have access to something that provides real benefit already. And we're hoping to add to that. Mosely has a completely differentiaTED (thyroid eye disease) mechanism of action for the disease. It's an SDC activator, it's an inhaled SCC activator. It is potentially the first non verprostenol that could be available for these patients. We expect this to be a polypharmacy combination therapy market, as PAH has been. And we think Mosely has a chance to be first line, has a chance to be a major part of the treatment paradigm. And we're just looking forward to getting this data moving forward there in our phase one data across healthy volunteers and pulmonary hypertension patients. And Drew will remind us of this data. Specifically, we saw among the best PVR reductions to date. And one thing we're going to remind people of today is that although we saw a 38% PVR reduction in some of those patients, that basically anything that has ever showed 20 plus percent PVR reductions has been able to deliver clinically meaningful benefit. I think it's true that there has not been any class of drugs showing a 20 plus percent PVR reduction that has not gone on to be a commercially successful class of drugs. And then finally, as a reminder, unsurprisingly, the top line data from that study is on track and we expect to get it in the second half of 2026. It's 135 patients studied. So with that, I'm going to hand it over to Drew, who's going to take you through the next handful of slides here on the program and then I'll come back for a little summary at the End and the rest of the presentation. Drew Frumpkin (CEO) Drew, that's great. Thank you. Thanks. Amelia, Matt and I can tell you there's a lot of excitement about Moseli ciguat. So Moseli is an inhaled SGC activator that's delivered directly to the lungs to activate SGC and restore impaired SGC function. SGC is a key enzyme in the NO-SGC-cGMP pathway. And in oxidative stress environments like pH, I, L D, nitric oxide may be reduced and the SGC binding site can become impaired leading to SGC dysfunction. Drew Frumpkin (CEO) Now, typically, SGC is activated when nitric oxide engages SGC in the presence of hemet and CGMP is then produced. Unlike cgmp SGC stimulators that requires nitric oxide and heme to activate the sgc. Inhaled Mosasigua binds to the heme pocket independent of the need for NO and heme producing cgmp, which results in vasodilation of the pulmonary arteries and potential reduction of fibrosis and inflammation of the lung tissue. Next slide. So we know many pulmonary diseases are heterogeneous in nature and that fact can make patient treatment complex. Drew Frumpkin (CEO) To start, there's disease of the pulmonary vasculature and disease of the lung parenchyla. The combination of these two disorders is embodied in pulmonary hypertension with interstitial lung disease, which is the first indication we're exploring in our phase two focus study. We believe Moseley has the potential to address both the pulmonary vascular and the lung parenchymal diseases experienced with patients with ph I L, D. Moseley, next slide. I want to make sure that all I'm going to do is call out the slide numbers. If everyone's got. Okay, okay, let me pull out the slide numbers. Okay, thank you very much. I appreciate that. I want to make sure we're advancing. Okay. Most of these preclinical properties led Bayer to take mosase into phase one trials and and a total of 170 patients including healthy volunteers and patients with group one pulmonary arterial hypertension (PAH) and group four CFAP. In the phase one study, Fire studied Moseley, CGWAT and 132 healthy volunteers and 38 pH patients. The healthy volunteers underwent studies with single and multiple dose formats and Moseley proved to be well tolerated, active and have an extended half life of approximately 40 hours. And in the phase 1b at most study, 38 patients with pH were dosed in a single ascending dose format and Moseley again proved to be very active, producing deep PBR reductions and was very well tolerated on to slide 20. So given Moseley Seed Watt's mechanism of action and inhaled route of administration, one would expect to see notable reductions in pulmonary vascular resistance associated with hemodynamic changes and with one dose of Moseli in PH patients that's exactly what we saw. A single dose of Mosel ciguat reduced pulmonary vascular resistance (PVR) in these patients early and sustained through the three hour observation period with a mean pulmonary vascular resistance (PVR) reduction of greater than 30% and a mean peak pulmonary vascular resistance (PVR) reduction of approximately 38%. This places Moseley's PBR reductions amongst the highest reduction seen in single and mostly dose trials and PH treatment space. With one dose of Mosasiguat. We also saw CGMP levels rise as measured in plasma with no associated clinically meaningful systemic side effects including systemic blood pressure and heart rate. We also observed the desired impact on other hemodynamic measures including mean reduction in mean pulmonary arterial pressure (mPAP) of up to 20% and mean increase in cardiac output of up to 25%. Slide 21 Moseli was also well tolerated in phase one patients in healthy volunteers and patients with PH with treatment emergent adverse events being mild to moderate in intensity across both groups and all doses were well tolerated and we did not see significant cough which is often exacerbated by inhaled treprostanols and we did not see clinically relevant systemic side effects which we believe in great part was due to the inhaled direct delivery of Moseley to the lungs and the limited bioavailability of Moseley in circulation. Slide 22 so with Moseley's phase one tolerability and clinical profile we look to take Moseley into phase two development, an indication where there exists a major unmet medical need and we felt that PH ID was an exciting opportunity for development given the primary site of PH ID it's in the lungs involving the pulmonary vasculature and the lung parenchyma and the currently approved treprostinil treatments have high treatment burden as well as tolerability challenges with highly variable efficacy. Moseley lines up really nicely in this moment since it was delivered directly to the lungs as once daily dosing that's been very well tolerated and produced limited incremental cough and systemic side effects in phase one and has the potential to address both the pulmonary vascular and lung parenchymal diseases. Slide 23 so to go a little deeper into PH ILD patient populations and the opportunity PH ILD represents a large and underserved market where new drugs are sorely needed for these patients. There are up to approximately 200,000 patients in the US and Europe likely under diagnosed given the lack of treatment options. In particular, this is a sick population and severe subgroup of pH less than a five year median survival and the combination of PH and ILD represents an increasingly poor prognosis compared to each alone. And I mentioned previously the lack of treatment as there are currently only two approved FDA comprosenil drugs leaving room for significant improvement. Slide 24 now the core field of drugs in development for the treatment of PHLD is rather sparse. There are three companies all with treprostinil treatments in different formulations and all of these treprostinol treatments continue to have a range of challenges. Ceralutinib with its different mechanism has also run into recent challenges as Gossamer's Phase 3 Procera trial in pulmonary arterial hypertension (PAH) did not meet its primary endpoints coming off challenges in Phase two as well and the result of the recent Procera trial outcome, Gossamer has paused its planned studies in Ph I lp so mostly on the other hand with its first in class opportunity as an inhaled SGC activator has once daily dosing positive tolerability and positive activity in its profile from Phase one studies and this really positions Moseley to be a leader in the treatment of patients with Ph I L D upon its approval. I also wanted to share about and this is slide 25 I also wanted to share our thoughts about how we see Ph ID and the market and how it's going to develop. We actually think the pulmonary arterial hypertension (PAH) market provides a likely roadmap for that development. In the early days supportive care was the only option for patients with pah and this is what we currently see and that's the reality of PHLD patients in most regions outside of the US where there are limited treatment options. Over time, drugs with newer mechanisms were approved. Combination therapy involving multiple mechanisms of action became more common as a median survival of these PH patients has also steadily increased as time went on from two and a half years where they are today at 12 to 15 years. And treatment guidelines evolved alongside the data which reinforce the evolution of the treatment paradigm. Today, revenue in the pulmonary arterial hypertension (PAH) market has really reached a stellar level at $100 billion in aggregate sales and a robust $7 billion per year with 15 drugs approved. And there remains a good pricing environment and commercial opportunity for these newer therapies because this is driven by the complex nature of pulmonary arterial hypertension (PAH). And finally key takeaway is that today over 40% of patients with pulmonary arterial hypertension (PAH) initiate their treatment with dual therapy. 15% of these patients will add a third therapy by the end of the year. The combo therapy, as Matt said, is really the norm. And so we are currently deep into our phase 2 study exploring mosa ciglot in our blinded phase 2 placebo controlled and randomized study in adults in pH ID. The study is a multi center study across the globe. We're targeting 120 patients. We ended enrollment with 135 patients during the screening period. The investigators look hard to find patients to confirm ild, elevated baseline pulmonary vascular resistance (PVR) indicative of PH and limits on the level of fibrosis and emphysema as determined by CAT scan. If eligible for the study, the patients then randomized two to one placebo drug to placebo and then they go through a rapid up titration and that moves from 1mg to 2mg to 4mg and Matt may have spoken about it but we've seen really great progress there with the vast majority over 95% of our patients achieving that 4 milligram dose and sustaining well through the week 16 period. So that's been very attractive and positive. And at week 16 the primary endpoint is change from baseline pulmonary vascular resistance (PVR) and that's determined at 16 weeks alongside the secondary endpoint of change from baseline 6 minute walk and change from baseline NT-proBNP and then the patient moved on to week 24 secondary and exploratory endpoints and then they all go on drug if they weren't on drug into the long term extension slide 27 so very importantly and as we get closer to data in the second half of this year, we focused very heavily in designing our phase two study and defining our patient population and we carefully designed around the 7th World Symposium on Pulmonary Hypertension and these guidelines are crucial for PH I L D patient selection. We targeted patients with worsening symptoms of physical mild to moderate impaired lung function based on pulmonary functional testing. Elevated pulmonary vascular resistance (PVR) and mean pulmonary arterial pressures were crucial and also we excluded severe emphysema to ensure a cleaner ILD population. The result is that the study population closely mirrors the recommended guidelines in more severe patients and on slide 28. As you can see, this effort is reflected in our baseline data in focus. Our mean PBR came in at 7.1 woods units, so very elevated mean pulmonary arterial pressures of 39.3 consistent with our desired thresholds and confirming we enrolled patients with significant hemodynamic involvement. The lung disease mix also looks well balanced and we protected framzysema both in number of patients and level of severity as determined by the CAT scan. And this was very important from all of those learnings. And we also explored background therapy, including exploring PDE5s on background. And this is also consistent with real world practice. So this careful patient selection and enrichment gives us confidence we've enrolled the right population to detect meaningful treatment effect. They're very much looking forward to our phase 2 data in the second half of this year. Matt, back to you. Matt Glein (CEO) Awesome. Thank you. Thanks, Drew. So look, a lot to be excited about on the program here. I just want to a couple quick reminders and a summary on slide 22 and 23 here on slide 22. So Drew talked about this in detail, but just as a reminder, the primary endpoint of this study is pvr. That is the same as the primary endpoint for the phase two programs across a variety of other PHLD studies or mechanisms or drugs. And so we're doing the same thing, following a well trodden path there. We will then in phase three move to a six minute walk and other clinically relevant endpoints as the way that the trial is measured. I want to remind everybody this study is not powered to achieve a P value on six minute walk. We may or may not achieve a P value. What we're really looking for is affirmation of dosing, affirmation of safety of PVR in this patient population. And we will obviously look for interesting trends in patient level data on six minute walk. But I want to make sure we've been clear ahead of time. This is not a study designed to achieve a P value on six minute walk. And that's not what we're looking for, is our own criteria to go from here. That's the point I wanted to highlight. I wanted to highlight it now while having not seen any of that data, so that I can't possibly be telegraphing anything about the study other than how it was designed on slide 23. Just to recap what Drew has said here, first of all, again with appreciation of the FOMovant team, this study enrolled very quickly, with all the patients enrolled within 12 months of the first patient being dosed. Early discontinuation rates compare favorably to what we've seen in previous PHLD studies. Look, with this and 20 bucks, you can buy two pizzas at Domino's. But our investigators are enthusiastic about the program. They're excited, the feedback's good. I think we're feeling great about how the study is being run. And then this is A great thing for safety. It's a great thing for the opportunity. As Drew said, 95% of the participants reach the maximum dose during their titration. And all of the blinded safety reviews and the ongoing assessments by the DMC have continued to affirm the safety of the program and allow people to run the study. Obviously, there's lots of things that don't get revealed until the data is unblinded, but it certainly gives us comfort that the patients are achieving a high dose and that things are are moving as they should be. So, again, thank you to Drew. Happy to provide this update. Now, ahead of that data, I'm really looking forward to seeing the outcome from this program in just a few short months at this point. So looking forward to it. Lastly, in terms of the pipeline updates today, I'm just going to give a brief recap of where we are on Brevacitinib. Brevacitinib has been the focus of so much of our conversation for the past 10 months. It's less of the focus today as we're in execution mode there. But just as a reminder on slide 25 here. Sorry, that's. I'm looking at the wrong slide numbers. As a reminder on the next slide, on the first slide of the Brevacitinib section, it's slide 32. Sorry. Look, this is a huge opportunity for us. There's possibly close to 300,000 patients addressable by the existing indications and just a ton of data coming over the next 12 to 24 months. Between the potential approval obviously and derventomyositis, but also the NIU (non-infectious uveitis) data, the potential for the NIU (non-infectious uveitis) launch, the ongoing program that will start enrolling soon in Katie Sarcoid, the currently enrolling study at lpp, and potentially more indications to come. So just a lot of great stuff coming for Brevacitinib and a really exciting moment from here on slide 33. We've put this up a few times just to remind people, first of all, these are sick patients and there are really very few options for them in dermatomyositis. As a reminder, 75% of these patients are on principally steroids and in many cases on very high doses of steroids, over 10 milligrams a day for a good portion of the year. And beyond that, it's a combination of ivig, which, as a reminder, the established treatment paradigm for IVIG and dermatomyositis is somewhere between four and five days a month consecutive in an infusion center. So a really arduous path and then other than that, it's off label stuff. Much of which has not been successful in studies but is used because there's no other option. So we feel really great looking forward here to our ability to bring a new option to these patients. And on slide 34, further underscoring. And again, this is not new. We've presented this before, further underscoring the need here. These patients are treated as with ph, for that matter with polypharmacy, on multiple lines of therapy, they're bouncing around, they have accumulated organ damage with high systemic corticosteroid exposures. It's just a tough experience for these patients and we think a new option is going to go far. We're not saying a lot on slide 35 about our commercial progress. First of all, it is a and will become a more competitive field. And second of all, we're mostly just head down in execution mode. But I'll just say, suffice to say we're doing all the things that you would expect us to be doing at this stage. We're in the thick of payer engagement. We're working with the physician community, we're partnering with specialty pharmacies to make sure distribution is effective for these patients. We've built a strong commercial team that we're really excited about and we continue to do unbranded patient engagement. We talked about dermatomyositis.com, when we got together in December and I'm super pleased with the work that team is doing. I think they are executing on the commercial side with the same vigor that they executed on the clinical side and I'm excited to see what we're able to do there later this year and beyond. We have also been moving along on the scientific and medical side. As you look at slide 36, this is a small subset of the presentations that have been made of this data, but this data has been presented all over at this point and continues to be presented all over the both at the major medical meetings as well as at a whole host of regional myositis meetings and rheumatology meetings. And notably in March the phase three data was published in nejm, which is a testament to how exciting the data is, a testament to the importance of the study, the quality of the study, and we couldn't be more excited for that publication as well. Finally, just a super quick recap on lpp, which we announced just about a month and a half ago. A fourth indication for Repcitnib. It's a highly morbid disorder with no FDA approved therapy. These patients are miserable. They are in a ton of pain It's a really tough disease that in addition to pain, causes itch, burning, redness, scaling, generally irreversible hair loss. There's probably 100,000 or so such patients in the U.S. it's been growing in prevalence over time and there's nothing approved. So we have an opportunity to do something really interesting for these patients. Our trial design on slide 38 we talked about when we first unveiled the program is a sort of continuous enrolling phase two B3 pivotal that's designed to give us endpoint validation and is going to get us into hopefully registration there. So we're really looking forward to that and there's just a ton of reasons to be excited about the program. On slide 39, the high unmet need in LPP (lichen planopilaris). The mechanistic rationale for Brevacitinib is strong. It's a TH1 dominant disease where dual JAK1 tick 2 innovation should work. Specifically well, we think we've got the right trial design and there's obviously some overlapping prescriber based and KOL community with our existing indications. So it all sort of fits together and we're excited to see how that program continues from here. Great. Okay, I'm going to wrap up quickly with the financial update and then we'll get to Q and A. So I'm not going to spend a ton of time on this. Financial quarter was relatively straightforward. We continue to be in a strong position from a cash perspective. 4.3 billion in cash and cash equivalents as of 331 before the Moderna settlement. No debt. We continue to retire. Shares repurchased a fair amount in this quarter. We need to have an active program and you know, spend continues to be sort of as it has been over time. R and D has grown a bit and the scope of the programs have increased. But that's all for the good and looking forward to the future. There is a couple of slides in here that I'm not going to talk to now, but we've gotten a few questions on accounting treatment as the launch gets closer. And so there's some good reference material in here on slides 44 and 45. If you're trying to build models or understand our financial statements in the future. And look, I've talked about this, a fair amount already, but on slide 46 and 47 we just have a great run ahead of us here. We got a lot to do. Obviously we've been fortunate and have had high quality execution so far with the quality of our data. It sets a high bar for the stuff coming next. Which I couldn't be more excited for. So a lot of really great data coming in, our existing programs and new programs and looking forward to sharing all of it in the period to come as well as obviously getting back on the commercial arena and watching all that play through. So with that I'm going to say thank you again. I say thank you to obviously all of you for listening. Thank you to all of our teams, polemamp, Roivant Immunovant, for continuing to run high quality studies, executing well, generating quality data. Couldn't ask more of these drugs, couldn't ask more of these teams. And obviously a great thank you to the investigators and the patients who work with us and make this happen. So thank you to everybody who makes this work. And I'm going to pass it over to the operator for Q and A so that we can get to it OPERATOR as a reminder to ask a question. Please press star 11 on your telephone and wait for your name to be announced and to withdraw your question, please press star 11 again. And we do ask that you please limit to one question. And our first question is going to come from Corinne Johnson from Goldman Sachs with Goldman Sachs. Your line is out. Corinne Johnson (Equity Analyst) Good morning and happy birthday to Mr. Klein as well. Maybe you could just contextualize the ACR responses you saw here at 16 weeks. First I think more kind of typical in later-stage studies is a 24 week reporting timeline. And how would you expect those responses to trend with more time on therapy with kind of implications then towards the randomized withdrawal phase? Thank you. Matt Glein (CEO) Yeah, perfect. Appreciate it. Look, I think the first answer to that question is we don't know. This is the first time patients have been treated with this drug and first time this patient population has been studied this way in detail. Sicker people tend to need more time to get better in general. And that's why I made the comments I made about the Phase Two sort of randomized withdrawal period. But in terms of Week 16 versus Week 24, I don't know. I'll say. I don't think there was anything specific about the data leading into week 16 that suggested and I think there's certainly a possibility for continued improvement with therapy over time. But you know, we'll find out as we look at that part of the patient population. Thanks Sharon, Appreciate the question. OPERATOR Thank you. And the next question is going to come from Yasmeen Rahimi from Piper Sandler with Piper Sandler. Your line's open. Yasmeen Rahimi (Equity Analyst) Congrats team. And congrats to Mr. Klein for also achieving a major milestone of 75 years. So happy birthday to him as well. Quick question on Moseli ciguat. We're very much looking forward to the data. You've been very granular on sort of the baseline as well as what you're seeing of up titration and safety. Have you been able to look at whether your assumptions for standard deviation in PVR and six-minute walk test are sort of tracking in alignment with what you're seeing? And I'll jump back in the queue. Matt Glein (CEO) Yeah, thanks, I appreciate it. So look, I think the short answer to that question is we are mostly blinded to all of that data and don't have a lot of information about it. So it's hard to say, but I think given the patient population we've enrolled, we feel pretty good about where the study's headed and we think we've got an efficacious drug. But we don't have a lot of information about ongoing distributions because the latest study has been blinded. Thank you. OPERATOR Thank you. And the next question will come from Andy Chin from Wolf Research with Wolf Research. Your lines open. Matt Glein (CEO) Hey, thank you for taking the question. So, Matt, I'm aware that you said with Immunovant you haven't analyzed IgG reduction, but that's still my biggest question. So other FCRN drugs, they don't seem to be able to achieve this level of efficacy in rheumatoid arthritis (RA) and people blame it on FAB glycosylation. Do you somehow have ACPA antibody reduction data or will we see that data before you unblind the Period Two data? And do you expect ACPA reduction to be less than igg reduction? Thank you. I don't have that data now, as I said, so I can't answer the question. We know from our phase one study that imvt1402 suppresses igg quite deeply relative to other drugs. And given the quality of the clinical data we've seen on acr, I think it's like certainly a thing to speculate on that the Overall profile of IMVT-1402 is part of what's contributing to our ability to deliver this data. Obviously it's also a different patient population that has been studied and it could also be partially patient selection and I think that could certainly be playing a role here. So I think those are both important. Look, I think we will continue to analyze this data. I don't know at this stage exactly when we're going to present what data. So I don't have a good answer to like what you're going to see before or after the period two is unwinded. I think we will provide more information about what we've seen, about what our analysis looks like when we're prepared to talk about the full future of the program. I'll say I think mostly this has been a blessing, but also it's a curse. We've been a leader, wondered if this data is going to also establish a leadership role for us along the lines of which others may follow. So I do think we're going to be a little bit conservative on what exactly, exactly we say from a competitive perspective. But overall, I think the data are starting to speak for themselves here in terms of the quality of what we're able to do. And I hope we are continuing to see that as the data mature. Thanks, Andy. OPERATOR Thank you. And our next question will come from David Reisinger from Learning Partners with Learning Partners. Your line is open. David Reisinger Yes, thanks very much. So congrats on the phenomenal data this morning. My question is on Moseli ciguat. So if the Phase two Phase Two FOCUS study surprisingly shows a statistically significant benefit on Six Minute Walk, could it represent a pivotal study and what would the requirements be in that scenario for a future NDA filing? And then just one other on Moseli ciguat, is the company considering development of Moseli ciguat in any additional indications? Thanks so much. Thanks, Dave. On Statsiga, Six Minute Walk, Matt Glein (CEO) I think it's impossible to say exactly what we would do until we saw the data. And so if the data looked good enough to support a productive conversation with fda, I think we would have a conversation with fda. And the FDA has been aggressive lately on conversations about single pivotal trial designs. So never say never is the answer. I want to be clear, it's not the base case expectation and the study is not powered to show a benefit on Six Minute Walk. So we'll see what we see. But look, I think given where we're at, we'll certainly take that as we go. And in other indications, I'll say every sign around Mosley is pointing to an effective, exciting agent with a lot of things we could do with it. As we watch the field around us, others are showing us good ideas all the time in terms of how these mechanisms might work. And we have some our own that others haven't shown us yet. And so I think there are absolutely opportunities for indication expansion, although I remember we got this question about 40 times when we first unveiled Mosely. And our comment then, which is still our comment now, is, man, ph ild is an area with a lot of unmet need. And even if it were the only thing we ever did with Mosely, it's a big opportunity with a lot of value to deliver to patients. So I think there's a lot of different ways to go there. OPERATOR Thank you. Thank you. And our next question will come from Yaron Werber from Tzco with Tzco. And your line's open. Yaron Werber (Equity Analyst) Great, thanks so much. And also congrats on the difficult to treat our study. So question actually about that. Is there any chance you can amend that protocol and essentially run Period One and then sort of get new patients completely into period two? So you're not going to have that step down issue? And then secondly, based on our analysis, we think that about 75% of patients are ACPA-positive. Is that still kind of what you think the data shows? Thank you. Yeah, thanks, Jeroen. Look, I think on your first question, there's a lot of things you could imagine doing. I think the truth is between this data and detailed patient level analysis of this data, plus the period two data, we're going to have a pretty good sense for what we've got and a pretty good sense for what we need to do going forward. And so I don't know that we would gain that much from dragging this study out given the quality of the data we're seeing here. So I think we're going to do that analysis in detail. I think we're going to have the conversation with FDA and I think we're going to plot a course forward, but I think we'll have a pretty clear sense. And then look, we've done some commercial analysis of the market in various settings. There's an updated version of that analysis actually in immunovance 10K that was filed today. I think your number is within the range of what we have seen in the literature for aqua positive patients generally. OPERATOR Thank you. And our next question comes from Brian Chang from JP Morgan with JP Morgan. Your line's open. Brian Chang (Equity Analyst) Hey guys, thanks for taking our question in this Race Explore trial. Since there's no washout period between period one and two, I'm curious if you have some thought around the tail of the efficacy from those going from drug to placebo? You said that period two might be less meaningful. Are you saying that 12 weeks may not be enough to fully drive the separation? Thank you. Matt Glein (CEO) Yeah, thanks. I appreciate the question, Brian. And just to reiterate, I just like, look, I think first of all, it's hard to know exactly what the tail will be at the end of dosing at the end of Week 16. So that's like one, that's like one piece of this. Obviously Period Two is blinded, so we don't know now, anything about what's in there. So that's all sort of a part of that. Look, I'll say the other thing is, and just to reiterate what I said earlier, I think given that the period 2 primary endpoint is losing an ACR20 response. If you imagine a patient who has achieved an ACR50 or an ACR70 response, even if they start worsening on the first day of Period Two, it just takes some time to give up that level of response. And so that's where I'd say the quality of the data in Period Two is. The quality of the data in period one is in some ways counting against Period Two, irrespective of the pharmacokinetic effects of withdrawal of the drug. So I think it's, remember, every ACR70 responder is an ACR50 responder, is an ACR20 responder. So it just takes time to come off that hill. We have people who've achieved a lot of benefit. So that's that. Thank you. OPERATOR Thank you. And our next question will come from Dennis Singh from Jeffries with Jeffries. Your line's open. Dennis Singh (Equity Analyst) Hi, good morning. Thanks for taking out questions for pH, ILB. I'm curious, what are your thoughts around Phase 1B data and the interpretability of that data in the small number of patients? Specifically, why did the 4-milligram cohort outperform so much relative to the 2-milligram dose on cGMP and also cardiac output? And, you know, I wonder if you're expecting, you know, you should expect a big increase in cardiac output since Moseli is locally delivered to the lungs and it's not really a systemic. Thanks so much. Matt Glein (CEO) Thanks, Dennis. I appreciate the question. Look, I think the first answer is four is twice two. So there's just a lot more drug being delivered. The second point I'll make is, remember, there are 170 patients across the Healthy Volunteers program. And so while the specific study that you're referring to may have been a small number of patients, we have a large body of evidence at this point across mostly being administered in a lot of different settings. And I'd say the dose dependent improvements in CGMP were broadly consistent across all of that data. The dose dependent improvements in PVR were broadly consistent across all that data. So I think we generally think we know what we've got. I think with single dose, you saw real robust growth immediately, right away in cgmp. I think the thing that was exciting for us is it demonstrated that the inhaled approach was really buffering us from A systemic effects. And that was really important for us. And I think we'll see that as we go forward. Drew Frumpkin (CEO) This inhaled approach is so important because you can get the drug to the well ventilated parts of the lung without worrying about those systemic effects. And so I think that's the biggest takeaway was we saw cardiac output, we saw MPAP reductions. These are the things you want to see. But these were single dose studies, so now we'll see them much more robust fashion in our phase two. Thanks, Drew. Yeah, the other thing I'll tell you, just because it occurred to me as Drew was answering that question, is, look, I think one of the things that makes PH-ILD exciting as a commercial opportunity is it really requires inhaled therapy precisely because of this effect. And so the competitive landscape will be thinner and the ability to develop drugs for this market will be more challenging because you need to sort of thread the needle on systemic effects of vasodilation. And so we feel that gives us an advantage as well and frankly increases the level of need for the patients. So, look, I think it's all setting up in that way. Thanks, Dennis. Appreciate the question. OPERATOR Perfect, thank you. Thank you. And as a reminder, please limit to one question. Our next question comes from Derek Archilla from Wells Fargo with Wells Fargo. Your line's open. Jacob Munford Good morning, this is Jacob Munford. Derek, thanks for taking our question and Congrats on the IMVT-1402 data. So, real quick, on safety, just want to clarify, confirm there were no low-density lipoprotein (LDL) changes or other events of interest observed. Matt Glein (CEO) Right. And then secondly, on the given the strong activity in period one, how is this informing your trial design strategies in the future? I know you mentioned that this is likely one of a couple registration trials, but do you think this data changes that? Thanks, Derek. OPERATOR Great questions, both. Although I'll remind politely for the other analysts, we're trying to keep to one given the number in the queue. But I appreciate both questions and I'll take both of them. First of all, on safety, in fact, what I can say here is not just in this study, but across now hundreds of patients dosed across 1402 studies. The DMC has been watching that issue and we have seen no impact on albumin or LDL across the hundreds of patients dosed with 1402. So while I don't have the very specific data to share for this study, numerically, I think the answer is we've seen literally nothing on albumin OR LDL from 1402. And then look, given the level of activity in period one on trial design, I think the Answer is we're going to have to take this data when we get it, we're going to have to look closely at it and we're going to have to have a conversation with FDA about where we stand and what we need to do. Obviously, the stronger the data from the first study or from this study overall, the more compelling that conversation is. And so I think we're excited about this data. Our belief is that we should be able to run a lean program from here given the patient population we're focused on, given the level of need in this patient population. But that's a conversation we're going to have to have together with FDA in the months to come. Thanks for the question. Awesome. Thank you. Samantha Simenco Thank you. And our next question comes from Samantha Simenco with your lines open. Matt Glein (CEO) Hi, good morning. Thanks for taking the question and congratulations on the day this morning and all the progress. Now that you have this first data in rheumatoid arthritis (RA) for 1402, I'm wondering also how we should be thinking about the CLE (cutaneous lupus erythematosus) data coming up in the second half. Will that readout include the entire 52 week study or will that just be the 12 week randomized portion? And what magnitude of treatment effect do you think would be meaningful here? Thanks very much. OPERATOR On the first question. Thank you. Appreciate the questions. On the data, that will just be the 12 week period. That's what we'll have by then, so that's what we'll be able to share. And in terms of what treatment effect will be meaningful, look, I'll say two things. One is we will have an opportunity to continue to talk about what we expect to see from that study over time and we'll probably do a little preview of that data before it comes. Secondly, CLE is a little bit different than some of these other indications in that it is commercially more competitive and there's other mechanisms coming. And so I think the bar for us is not just sort of per se clinical meaningful. I think the bar is like do we think our data is good enough to support a program in the face of where the landscape is headed? And so we're going to look closely at that data. We're going to look at what we see and we're going to make based on the totality of the data. But I think the bar there is pretty high and I think we knew that going in. Thanks for. Thanks for the question. Thomas Smith (Equity Analyst) Thank you. And our next question is going to come from Thomas Smith with Larynx Partners. Your line's open. Matt Glein (CEO) Hey guys. Good morning. Congrats on the really stellar RA data here for 1402. Just wanted to ask one if I could on the pivotal GRAVES program, any updates you can share with to patient enrollment? I think you were initially kind of gating some of the scale up activities and trying to get a sense for how the early enrollment trends were going, but just wondering if there's anything that you could share there in terms of pace cadence and maybe patients being enrolled, anything differing from initial expectations. Thanks so much. OPERATOR Thank you. Patrick Olson Yeah, it's a great question. Look, I think the short answer is we had a pretty high bar for ourselves when we started the study and we didn't exactly know because there hadn't been a lot of development in grave disease. I think we can now say enrollment's going great. We're on track. We'll have the data in 27 as we previously discussed. And a lot of enthusiasm and a growing amount of enthusiasm as we continue to add sites as docs continue to get comfortable with the study. So I think overall really happy with how that program is evolving. And I'll just again take the opportunity to say I think all of our teams at this point are executing at a really high level from a clinical enrollment perspective. And I think that's, that's been a real driver of value for us. Thank you. Matt Glein (CEO) Thank you. And our next question is going to come from Alex Thompson with Steve. Will your lines open? OPERATOR Hi, guys. Congrats on the data. This is Patrick Olson on for Alex. I guess just kind of building on the path forward here in Ra, you know, looking at period two, I guess if your 300 milligram arm performs just Prakar Agrawal as well as 600 milligram. How are you guys thinking about your Matt Glein (CEO) dosing strategy going forward in Phase Three? OPERATOR It's fun to sit here and think about what happens in the phase two study we see as good. First of all, it's a randomized withdrawal study. So it's trying to figure out exactly what it would look like for the 300, 600 to perform equivalently. But look, I think overall it's just too early to say we've got to look at the data. This is a patient population with extremely significant unmet need and without, I mean, to say without a lot in development is an understatement. I think like basically we are plowing a new course for this patient population. So I think we've really got to look at that data and get an outcome from it. I think the inclusion of 300 and 600 in the study was important because FDA, especially in new indications, especially indications like RA is likely to want some dose ranging information. But I think we're going to have some flexibility and we're going to get to see, you know, historically there has been separation in IGG reduction obviously between 300 and 600. So, you know, we'll see how that translates in this population. But I think we got a lot of options here. Thanks for the question. I appreciate it. Drew Frumpkin (CEO) Thank you. And the next question comes from Prakar Agrawal with Cantor Fitzgerald. Your line's open. Hi, thanks for taking my questions and congrats on these impressive data. So maybe on the RA front, given the sample size is quite large, but ultimately this trial was open label and some of the ACR responses can be susceptible to open label nature of the trial. So maybe just if you can expand if you have any data on some of these secondary endpoints which might be less susceptible to open label design of the trial. And how much efficacy degradation would you assume as you move from an open label to more of a placebo controlled trial into registration trial? Thank you. OPERATOR Yeah, thanks. This is, look, it's a great question. It's obviously what was on our mind from the day we first saw the data. I think it is certainly helpful that we're talking about ACR 50 and ACR 70 responsiveness to ACR 20 responses. I think once you get to that level, sort of spontaneous placebo style, remissions of those kinds are less frequent. We don't have any of the secondaries or additional, you know, markers to share. We've been looking at that data hard and we feel excited about the data based on what we've seen in terms of everything hanging together. But that's about all we're able to say at this point because about all we know at this point. One other thing is we have the way the study is designed, the people doing the joint assessments are blinded. So they are doing the assessments without knowing anything about the study, what patients are on or where in the study they are, whether they're on drug or placebo. That's obviously only one component of the total here. But it is one way for us to get a little bit of objectivity into a study that is otherwise at this stage, open label. And that is helpful and pretty objective. Thank you. Douglas Thank you. And our next question comes from William Pickering with Bernstein. Your line's open. Matt Glein (CEO) Hi, congrats on the updates and thanks for the question on Moseli. You also have a phase two open label with patients on background to Prostanol. What are you hoping to see in that study. And then how are you thinking about broader evidence generation strategy to support reimbursement, mostly in combination with treprostenol. OPERATOR Thanks. Yes. Dina Ramadane (Equity Analyst) So I think in the Tombo study we have patients on background. Obviously in the main phase iib, we don't have patients on background prostanol. And the reason we set this up this way is because we know that polypharmacy is going to be a part of the landscape. And so in the subsequent study that we run, we're likely to have some proportion of patients on background to prostanol as well. And it felt like going into that state study with no experience treating patients on both drugs was, for a variety of pretty obvious reasons, a liability. And so I think the combo study is in part really a safety study. It's just designed to make sure these things can be administered safely. Together we will learn from it, information that will help us design the stratification rules, help us understand better who's going to be on what in the subsequent study. But I think, you know, beyond that, it's hard to say at this point and that's the commerce setting is still in pretty early days, so we don't have much to say about it. Drew, anything you'd add to that? Matt Glein (CEO) I think that's exactly the case. We decided not to go on top of nhltropostanil in the first focus study. We were initially looking at our drug in single agent activity in Ph I L D and we wanted to have some time to understand that population, understand Moseli. Also, as you know, treprostinils do have a sticky issue with cough and we wanted to make sure that our drug would have a clear path to be able to demonstrate its tolerability profile, which I think has been relatively impressive. So with that in the later days, we decided with the team to go a little deeper and look at Moseley on top of inhaled treprostinil, given the confidence we had in Moseli after seeing it in our focus study, of course, in an aggregated setting. So with that as a backdrop, as Matt said, we're only in the days, but we actually don't expect there to be much of an issue there. But we definitely want to understand that from a dosing and safety perspective. OPERATOR Thanks, Roll. Iris Gao Thank you. And the next question is going to come from Douglas. So with Datesy Wainwright, your line's open. Matt Glein (CEO) Hi, good morning. Thanks for taking the questions and congrats on the data. Matt, I'm just curious, in terms of the RNA data, if you've had A chance to talk with some of the key KOL clinicians on the data. Just curious what their sort of feedback is and if they were more focused on the depth of response that you saw were both aggressive response and obviously you kind of had both, so you didn't necessarily have to choose. But if there's anything that was striking to that for the initial data set. Thank you. OPERATOR Thanks, Doug. So, look, we have obviously a bunch of KOLs involved with the study. Therefore, we have those conversations continuously and with some of the important ones for the field who have been on multiple of these studies as well. I think in general, the answer is they're super impressed. I think one KOL told our team roughly as a quote, you can't fake ACR 70s like this. That's the opinion of one physician. I think it's true at some level, but ultimately we'll have to see what the rest of the studies show. But look, I think docs are excited. They're excited about the depth of responses. They're excited about what this could mean. And look, I think the most important thing is these are physicians who they're treating these patients. They have no options. Many of these patients are very uncomfortable and in a lot of pain. I think they see a new option for this population and they were hoping for something that worked even a little. And obviously this is beating that far handily. So I think there's a lot of enthusiasm. Matt Glein (CEO) Thank you. And our next question will come from Dina Ramadane with Bank of America securities. Your line's open. OPERATOR Good morning. Congrats on the data this morning, and thanks for taking our question. Just a quick one from us on the non responders. Could you provide maybe some more color on these non responders in period one, Was there anything you could maybe point to, such as prior lines of failed therapy or baseline characteristics, such as maybe antibody levels that were the reason for not responding to 1402. Thank you. Yeah, so we're looking at that in detail now just to try and get some further comfort and understanding about what's going on. I don't have anything to say about it now, but that's exactly the kind of analysis that we're running. And, you know, you said non responders. Reminder, 72 or 73% were ACR 20 responders. So we're also looking at some of the people who got to 20, but not 50. And just like trying to get a better sense of what happened there. Thank you. Matt Glein (CEO) Thank you. And our next question will come from Iris Gao with Guggenheim. Your line is Open. OPERATOR Good morning. This is Iris Anfayaten. Thank you for taking my question. Congratulations on the data and happy birthday to Matt's father. My question is also on 1402. Are there any more colors on what proportion of patients were refractory to rituximab and maybe anti RSA? These MOAs are relevant in seropositive patients. So I get back with you. Thank you. Yeah, thanks. B Thank you. And our next question will come from Sam Slutsky with Lifesack Capital. Your line's open. C Hi, good morning. This is Kate on for Sam. I appreciate you taking the question. So I know the strength of period one data has made period two all the more challenging, particularly on acr20. But looking to period two, is there a delta versus placebo potentially on other endpoints that would excite you commercially? A I don't think phase two is really about commercial value at this point. I think phase two is about better understanding the characteristics of the patients, seeing erosion of efficacy, starting to understand, you know, to separate out drug effects from other things. So I think, you know, I think it's not. It's not so much that we're looking for some commercial bar in phase two. I think the quality of this headline data is such that even if it degrades, we're happy with it. And I think even in subsequent studies, I don't know that we're shooting for this bar per se. This is just a great foundation from which to build something pretty exciting in RA B Thank you. And that will conclude today's Q and A session. And I will now turn the call back over to Matthew Glein for closing remarks. A Look thank you everybody. Again, appreciate it. There were a lot of questions there. So I appreciate everyone's forbearance in helping us get through it all and in limiting a number of questions, which is a great favor to the people lower in the queue who need to come up with questions if theirs has already been asked. So thank you again to everybody for playing along with that. An exciting day for us and exciting data to be able to put out. So thank you again to everybody who makes that happen, from the Vant and Roiven teams to the patients and investigators. It takes a village and it's a great outcome and something that we can really build from here. And once again, happy birthday to my dad. Thank you everyone for listening, and we'll talk again soon. Have a great day. B This concludes the conference call. Thank you for participating, and you may now disconnect. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.