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Good day, and thank you for standing by. Welcome to Roivant First Quarter 2026 Earnings Conference 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. To ask a question during the session, you need to press star one and one on your telephone. Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today, Stephanie Lee. Thank you. Please go ahead.

Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant. For those dialing in via conference call, you can find the slides being presented today, as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. With that, I'll turn it over to Matt.

Thank you, Steph, and good morning, everybody, and thank you for joining. This is a little bit of a calm before the storm moment for us, and so a pretty quiet quarter and maybe not the most interesting of our earnings calls in recent memory. Nonetheless, a lot of great progress in the business. Certainly, we're expecting a jam-packed second half, as I'll get to in a moment. I'll be relatively brief in my remarks, and then we'll go to Q&A. I'd like to start on slide four. This is a slide we took from our own prior deck. This is from the investor day that we did in December of last year, and this was a list of our priorities for the year. We're sitting here a little bit more than halfway through the year.

Just wanted to highlight that it's gone well for us, that we feel really good about the setup. On slide five, looking across the list here, we've got brepocitinib expected to launch by the end of September. Obviously, we got priority review and our PDUFA date, as you said, is this quarter. We had great data from IMVT-1402 in D2T RA study that we presented on our last quarterly call. Probably the most notable update for today, the top center of this slide, is that we've now enrolled patients in the phase III study in cutaneous sarcoidosis for brepocitinib, which follows on the positive results that we had in our phase II data, which I think we announced on our first quarterly call of this year or earlier in the calendar year.

We've now received the initial payment from Moderna in the settlement, the 1498 part of that case is progressing, and we filed international proceedings against Pfizer and BioNTech in that case. Finally, earlier this year, we added LPP as a fourth brepocitinib indication, and as I'll remind people later today, that study is continuing to enroll as well. As I mentioned at the top of the call here on slide six, I'll just say this is a quiet quarter and this is a quiet day. I don't know exactly how the following statement could be true, but I think it is. The next 6-12 months are in many ways busier than the prior 6-12 months for us, we just have an enormous amount coming up.

Starting, as I mentioned, with the upcoming potential brepocitinib launch in DM, which should happen imminently, assuming everything goes as we hope and expect it will with FDA. We've got top-line data in brepocitinib from the NIU study, an indication that could easily be as large as aromatase inhibitors. That data is coming in the second half of this year. We also have top-line data coming shortly in the second half from mosliciguat, the phase II study in PH-ILD. I know that's being closely watched and we're looking forward to getting that data and presenting it.

We will provide further updates on the D2T RA program at Immunovant in the second half of this year, including hopefully a download on a conversation we hope to have with FDA about that program as well as the results from the second part of the study and a little bit more about our plans going forward. Finally, probably the smallest of these, we're expecting top-line data from the PoC study in CLE also in the second half of this year, and looking forward to finding out what we've got there when that comes in as well. Just a jam-packed second half and even more coming in 2027 with the Graves' data and beyond. Just a lot in the here. I'll just hit a couple of highlights in terms of pipeline updates in a little more detail here before, again, turning to our Q&A.

Starting on slide eight with a reminder because it's been a few months since we talked about it. The initiation of this cutaneous sarcoidosis phase III study is a pretty exciting event. It's a little bit ahead of schedule in terms of what we're able to do here. This is a disease that we're just privileged to be able to work in here. It's a high morbidity, very difficult disease with a high urgency to treat. You can see on slide eight some of the photos we've shared before, but these are patients who are really sick and have very few treatment options. On slide nine, as a reminder of the data that we generated in our phase II study, we had set for ourselves a goal of a sort of five-point benefit on the CSAMI scale for clinical meaningfulness.

In the study in the top left of this chart, we showed a greater than 20-point benefit compared to roughly nothing on placebo. Just a huge benefit to those patients in the phase II study and really excited to carry that forward into the pivotal program. A reminder on slide 10, we think this is a pretty decent-sized indication, again, with high unmet need, probably about 40,000 patients in the U.S., and reasonable overlap with some other organ systems, including optical sarcoidosis or eye sarcoidosis, where that overlaps with NIU. That is one of the types of NIU that we're studying, as well as pulmonary sarcoidosis, which is a big potential indication as well, and where we hope to be able to treat some of those patients via either tracheal sarcoidosis or OCS.

The phase III study that we've now begun, the design is laid out on slide 11. I know there were some questions after the phase II about what exactly this study would look like. It is designed to take all of the learnings from the phase II study that was successful. It is a 16-week study with the primary endpoint of CSAMI greater than or equal to 50% response rate. It's a 140-patient study across about 70 sites, 3:2 randomized with patients either on 45 milligrams of brepocitinib or placebo and with a mandatory steroid taper going from week two to week eight, down to zero. Which is roughly consistent with what we did in the phase II, and generally consistent with what we think is appropriate for patients in this indication. That study, as I said, has already begun enrolling patients, and we expect top-line data in 2028.

Which just adds to the list of potential registrational indications for brepocitinib coming up. I'll reiterate on slide 12, the other ongoing registrational program, is the brepocitinib study in lichen planus or LPP that we announced earlier this year. That study is enrolling, I'll say, extremely well. There's a lot of enthusiasm from physicians and patients for that. Speaks to the high unmet need in the indication. Speaks to the quality of the work being done by Ben and the Priovant team. I'm looking forward to sharing more about that as soon as we've got it. That's also moving along nicely. Finally, I'm sure there will be questions about this in Q&A and lots of opportunity to talk about it hopefully with regulatory approval and beyond. One of the major events in the near term here is the potential launch of brepocitinib in dermatomyositis.

I think we're in a phenomenal position here in terms of what we've got and in terms of what we hope to be able to do. Starting with the quality of our clinical data, which as you know from the multiple times we've talked about it from the publications, including "The New England Journal of Medicine" and so on, just a phenomenal data set taken across all 10 endpoints, big clinical benefit, a lot of enthusiasm from the doc community. This is a really tough disease, a large addressable population, most of them on sort of polypharmacy, trying a lot of different things, and frankly, most of them still dissatisfied with the available treatments. We feel like we have an opportunity to do something big and different for this patient population.

Our team has been out spending a lot of time with the physician, the patient communities on overall education, and I think the enthusiasm for a new therapy is coming out loud and clear, including with all the academic presentations that have been done and so on. Commercial launches, there's not much to say today other than that it's on track. We're ready to launch on time, having received priority review. The sort of commercial and base support teams are built out, trained, ready to deploy. We feel really great about the hires we've made there, really great about the organizations we've built there. We think we're doing this in a way that is both capitalizing on all the learnings from successful launches at other companies in recent years and doing it in a Roivant private way.

There's nobody in the world that'd be more excited to oversee this than the team we've got at Priovant with Ben and Daniel and others, and I think we're going to be fully ready. Everything's on schedule. We'll have much more to say about that with the potential approval, and after, but looking forward to it. I'll say one more thing about the commercial franchise overall of brepocitinib on slide 14. We get a lot of enthusiastic questions from investors around pace of launch, and we've been pretty consistent that our answer to that question is sort of slow and steady, is what we're looking to build there. I think there's a bunch of reasons for that. Some of them are DM is a new indication and no one's launched a novel therapy basically ever, or at least a targeted therapy, basically ever.

It's just hard to know exactly what work will need to be done to get everyone comfortable and excited and on drug. Although I think we're fully prepared. Also to me, it's because brepocitinib is a lot more than just dermatomyositis. To me, what we're really doing here is not just trying to make that launch as fast as possible. We're trying to lay the groundwork for the overall opportunity, which goes beyond DM into first NIU and then CS and LPP with the data coming thereafter.

I think as you think about that layering, to me, it's much less about what week one or month one or quarter one look like, and much more about making sure that the foundation around access, the foundation around patient support, the foundation around the institutional activities, the foundation around our communication with the scientific and physician community and our communication with patients are all set up to deliver the maximum opportunity for brepocitinib across all of these indications. I think slow and steady isn't just about sort of guidance. Slow and steady is about the approach that we're taking with the program to make sure we have maximum reach across everything that we're doing there, including indications that we're excited about beyond the ones we've already announced. A lot to come. As I said, on track for that launch.

You all hear the same thing we do, which is a ton of enthusiasm from the patients and physician community for new options in all of these indications. I'm looking forward to sharing more when we know about it. Our guidance is going to continue to be slow and steady because that's what we think we're building. Final business update here is we got the upfront payment in the settlement with Moderna. That $950 million has come in, 770-ish of it to Genevant and the rest to Arbutus. That's done. There'll be progress in terms of return of capital, et cetera, of that via Arbutus and so on. The '498 sort of appellate ruling is that process is ongoing at the Federal Circuit. That'd be another $1.3 billion if we got a favorable outcome there. We continue to advance our litigation against Pfizer and BioNTech.

We filed three international lawsuits, notably in Canada and the UPC, in July, just last month, continue to progress that case as fast as we can. Not all of it in our control, but equally enthusiastic about the potential there in terms of what we could get. I'll wrap up just with our usual financial update on slide 17. Overall, most importantly, we are spending in areas that we're excited to be spending. We're excited about all of our R&D programs, about $200 million of R&D expense for the quarter of just under $100 million of non-GAAP adjusted G&A or $166 of GAAP G&A expense. Cash just under $4 billion, and that's before the receipt of the $772 million. Notably, pretty significant share repurchase activity, about $200 million in the quarter, a bit more than that when you include March.

What we did there was we accelerated our share repurchase program upon the announcement of the Moderna settlement so that we could get those shares in. Remember, the shares that we bought by kind of the first round of this, the billion and a half that we had bought back sort of up through mid last year, we bought back at around $10 a share. I think the average price at which we've been able to buy back stock since we kicked off the second round of this in earnest in March has been in the high 20s. Feeling good overall about retiring those shares and getting that capital back to shareholders. Going to continue doing that according to our authorizations for now. All of it ahead of, on slide 19, a really rich catalyst calendar ahead with a lot coming.

Looking forward to all of that with just an incredibly busy stretch ahead. On slide 20, again, incredible for the people around Regeneron who have to do this work. By the end of calendar 2028, we'll have had hopefully three or more commercial launches, nine full multiple studies readouts, four plus NDA or BLA filings, a number of proof of concept studies. Just a ton coming up in the near term. With that, I'm going to wrap up my prepared remarks for the day. I will hand it back over to the operator for Q&A in just a moment. Thank you again for listening this morning and looking forward to taking your questions.

Thank you.

Operator, over to you.

Certainly. We will now begin the question-and-answer session. As a reminder, to ask a question, please press star one and one on your telephone. If you'd like to cancel your request, you can also press star one and one again. Our first question comes from the line of Brian Cheng of JPMorgan. Your line is open. Please go ahead.

Hey, guys. Good morning. Thanks for taking our question. Maybe just thinking through the DM launch map, can you give us a quick sense of what metrics we could be receiving way out of the gate to help us better track the initial launch? Secondly, on PH-ILD, as we think about the baseline characteristics here in PHocus, it seems that more patients are on [batoclimab]. We're curious if there's any implication in terms of the fibrosis versus erythema ratio in the populations, and then further down the line, whether there's any implication towards the bar for success for both six-minute walk and also PVR. Thank you.

Yeah, perfect. Thanks. I appreciate both questions. Look, on DM, a thing I've gotten fond of saying as I've watched other companies with commercial launches is that you all don't deserve our guidance, which isn't quite fair. Look, I think other than sort of a slow and steady launch, and obviously the sort of top-line metrics will be plainly visible in our financials each quarter. I don't know that we're going to provide a ton of detail in the early days. I think it's important for us mostly to spend our time focused on understanding those dynamics ourselves, getting out, talking to patients, talking to physicians, doing the work we need to do. We'll give a little more color on what that's going to look like on a call with potential approval, and then we'll start to flesh out the package that we share with each successive quarter.

I don't have a lot to say right now about metrics. I'll say, I think typical with these launches, I'm not sure a ton is going to be visible in the early days, just given how the commercial apparatus is set up for practical purposes. We'll provide more guidance on that as it gets closer and is here. On PH-ILD, I guess, first of all, we've obviously been watching, for example, the treprostinil data in IPF and trying to understand a little bit better what's been going on with these PH-ILD patients in treatment of PH-ILD for fibrosis and for lung disease.

It's been a view of ours for a while that one of the things to look out for in treatment of PH-ILD with vasodilators is emphysema, the study was designed with care around the amount of emphysema allowed in the study overall, and that was an important part of the guiding philosophy of the study to make sure that we could serve the patient population broadly, but also while maximizing the potential benefit of the therapy. That was considered from the beginning. Those are, I think, things we're keeping an eye on. I know there is a local cohort that believes the treprostinil has anti-fibrotic benefit. Look, I think our view is if you treat PH-ILD patients well for their pulmonary hypertension, you may well deliver a benefit overall on their lung disease.

I think our view is probably that vasodilation is driving a lot of the activity there. We also have some evidence from some non-clinical models of anti-fibrotic activity for Overall, on six-minute walk and PVR, I'm sure I'll get versions of this question more today. Look, I think it's consistent with what we said before. We're hoping to see a clear signal on PVR. We expect if the drug is at all active, we will. We don't expect to see very much disparity on six-minute walk. The study is not powered for six-minute walk. It would be nice to see some separation, but I don't think that's essential for our sort of go, no go decision from here. We'll know what we've got once we get a closer look at it, including the full balance of that data. Thanks, Brian.

Thank you, Matt.

Thank you for the questions. Next question comes from the line of David Risinger from Leerink Partners. Your line is open. Please go ahead.

Thanks very much, and thanks for all the updates, Matt. I have three questions, but rather than rattling them all off right now, maybe if it's okay, I'll go one by one. First, on mosliciguat, you commented just now on six-minute walk distance. If you were to run a large trial, what type of six-minute walk distance would you be hoping for? I.e., what would be relevant to the clinicians and to the patients? That's my first question.

Yeah. Thanks, Dave. Look, I think obviously we'll have a slightly better answer to these questions overall once we have a sense of what we saw in phase II. The truth is that PH-ILD patients are really sick. There are not a lot of options for these patients. As we saw in group 1 in PAH, when you have more treatment options, first of all, patients go on multiple options, multiple lines of therapy. Second of all, most importantly, the actual, not from a clinical trial perspective, from a real-world evidence perspective, survival and mortality rates go down as new classes of drugs are introduced in PAH over time. I think it's less about a number on six-minute walk and more about having an approvable therapy. Remember, these are patients that are trying to walk to the car. They're trying to walk to the bathroom.

They're trying to live their daily lives. I don't know that I think it's correct scientifically to describe a specific numerical bar that matters versus just being able to get a new therapy. Some of that's frankly because six-minute walk in clinical settings is an artifact that is complicated and noisy and a little bit difficult to translate into daily lives. Whereas if these drugs really effectively vasodilate and improve lung function and improve PVR, I think you wind up seeing a lot of benefit for these patients. I don't know that we're going to articulate or have a specific numerical bar versus a successful study. Obviously, we will be judged, especially by the investor community, based on competitor data. I don't think we even need to be per se better than any other mechanism in order to have a big benefit to patients. Thanks, Dave.

Great. That's very helpful. Regarding the forthcoming brepocitinib DM launch, could you discuss the cadence of formulary reviews for rare disease drugs? I ask because for mass-market drugs, P&T committees often wait until six months after launch before putting drugs on formulary.

Yes. Thanks. Look, I don't have a ton to say about that right now other than we're having all of the normal engagement with the payer community that you'd expect us to have at this stage. I think this is a critical point about all of these launches, we are super focused on making sure that the physicians who want to write this drug and patients who want to get on this drug are going to have access. I think that's going to be really important for our engagement with the community for access generally. I think in terms of literal formulary, it's probably not so different. It's not like there's a separate committee for different kinds of diseases. There's lots of medical exception procedures and other things that you can do to get patients covered.

We have a whole team of people built out of Priovant that's dedicated to making sure whether the formulary work has happened yet, whether the P&T committee has happened yet, is not something that our patients and physicians have to spend a lot of time thinking about as they're deciding how to use the drug.

Excellent. That's really helpful context. Finally, beyond the list of programs on slide nineteen, could you remind us about pipeline or product opportunities for your portfolio, including specific products that you could announce initiation of new studies for over the next year or so?

I think every single one of the programs that the world is aware of in our pipeline, as well as potentially ones that the world is not yet aware of in our pipeline, in all of those cases, we could announce new trials, new indications in the next year. I think every one of those are eligible and all of our molecules could be put into indications beyond the ones we've talked about. I think it's fair to say in each case, we have specific ideas of indications we're excited about. We've done active work and are, in fact, preparing to initiate programs to varying degrees, depending on how busy those teams are today versus next month or the month after, but real progress.

I think the answer is we are actively working on that all of our products are, as you called them, pipe limited products, that we're excited to share more indications as we start those studies.

Excellent. Thanks so much.

Thanks. Thank you.

Thank you for the questions. The next question comes from the line of Samantha Semenkow from Citi. Please go ahead.

Hi. Good morning. Thanks very much for taking the questions. I also have two, one on mosliciguat, one on brepocitinib. For mosliciguat, I'm wondering if you could just talk about the translatability of PVR reductions in patients with PAH to those with the PH-ILD population that you enrolled in PHocus. Are there any aspects of either disease that could influence the magnitude of PVR that you could see in the mosliciguat data? I have a follow-up.

Look, thanks for the question. I appreciate it. I think the translation from PAH to PH-ILD is the fundamental question being answered by our study. The first unfortunate answer to that question is we're just going to have to see what we see. Yeah. It is the risk of the program at some level that we find some risk. Again, the phase I data, including in PAH patients, looks very good on the PVR basis. One of the main "risks" of this program is that there's something, I would call it unexpected, in the PH-ILD translation. Obviously I use the word unexpected because I think scientifically it seems relatively straightforward that inhaled vasodilation is an effective mechanism in PH-ILD, but we'll find out. Obviously, the lungs of PH-ILD patients are different than the lungs of PAH patients.

You might expect some difference in sort of the pharmacodynamics of the drug in those patients. Overall, it seems pretty clear that when you take an inhaled vasodilator in PH-ILD patient, you get drug to the healthy lung tissue and it matters. That's what I'd say.

Got it. Thank you. That's very helpful. Just on brepocitinib and DM, in your conversations that you've been having with physicians for education, I'm wondering if you could just talk about the reception to brepocitinib given the JAK class safety concerns. Obviously, the safety profile on VALOR was quite favorable, from a class perspective, it would just be helpful to hear how the physicians are thinking about safety, particularly since DM patients already tend to have a higher underlying risk for cancer. Thanks very much.

Yeah. We've said a few times that when we first in-licensed brepocitinib, we didn't exactly know what the reception to JAK inhibitors was going to be following the addition of black box warnings and a whole slew of two indications where the safety profile of JAKs was going to be much less of a focus. I think dermatomyositis is a poster child for this, in that while JAK inhibitors are at this point extremely widely used in diseases with much less morbidity, many more alternative therapies. In dermatomyositis there's really no other options available, I don't think physicians therefore are going to be particularly focused on this question.

Remember, these patients are, first of all, I think you sort of alluded to the profile in the trial, dermatomyositis patients are inherently at risk of many of these concerns, malignancies, cardiometabolic events, treating them well makes them healthier and reduces those risks. On top of that, the therapies that they are currently on for dermatomyositis are things like high-dose steroids, which in themselves add meaningfully, in fact, in many cases, much worse than JAK inhibitors to those very same risks. Yeah, I think in general, physicians are not going to spend a lot of time worrying about this, especially when reminded of the inherent risk of steroids and immunosuppressants that they're on anyway.

It's clear from our conversations with docs across different prescriber bases that it was very comfortable using these agents, including prescriber bases, as we said, for patients with significantly less severe disease. As a reminder, we fully expect that our label is going to look like the labels for other JAK inhibitors. It's going to have the black box warnings, it's going to talk about experience with JAK inhibitors from other indications. Like I said, I think docs expect that and I think are not going to be too concerned about it because these patients are, A, very sick, and B, on other drugs, in many cases, significantly worse safety concerns.

Thanks, Matt. Very helpful.

Questions. Our next questions will come from the line of Prakhar Agrawal from Cantor Fitzgerald. Your line is now open.

Hi. Thank you so much for taking my questions, congrats on the continued execution. Maybe a couple of questions from my side as well. Firstly, on brepocitinib and DM, could you remind us what percentage of DM patients are on off-label JAKs based on your latest primary or secondary research? Would you expect rapid switches from these patients who are on off-label JAKs to brepocitinib? If not, why is that the case? Secondly, for brepocitinib in NIU trial, what do you see as the biggest risk for phase III given the phase II was really strong? Is this geographic variation, which has been a key risk for this drug, which could drive some of the baseline variability that has been flagged as one of the risk factors by some of the table checks that we have done? Thank you. Really appreciate it.

Great. Thank you. So, in terms of your first question on brepocitinib and DM around who's on off-label JAKs and what does that look like. Look, first of all, there's just variability in physician practice, and some physicians use more JAKs and some physicians use less JAKs. That has more to do, I think, with the docs in many cases than with any specific subcategory of patient. I think what we've said publicly is a low single-digit percentage or mid-single-digit percentage of dermatomyositis patients have experience with these things. Some of the docs who are involved do use. Some docs don't use off-label drugs full stop. Some of the docs who use off-label JAKs have said they expect to switch patients over, and I hope they do, and obviously we'll be working to help them where that's appropriate, facilitate those switches.

It's just going to be down to the preference and practice of each individual doc. One of the things that our team is finding in talking to physicians is that different docs have different sort of ideals in mind for who their sort of first patients might be. It just varies based on the patient experience, the physician. Obviously we'll be able to have much more of these conversations pending a potential approval. Medically we'll see a wide variety of different phenotypes. On NIU, what is the biggest risk in phase III? It feels funny to call placebo a risk in these trials, and that's not quite exactly what I mean, but the variability in placebo response rates in immunology trials is significant.

If you're asking me what keeps me up at night, it's that we don't know exactly what placebo response rates will be in that study, and that just makes it hard to know exactly what the trial's going to look like on outcomes. Obviously, the phase II data was quite compelling, and the level of drug activity seems good. I'm pretty optimistic about the study. But this is biotech, you can lose sleep over anything. Is geography a risk? There may be geographic variation, just as there is in many other indications, and some of that's literally driven by geography and some of it's driven by physician practice, and some of it's just noise. I don't know that it's a risk in the sense that it's unanticipated or whatever. It's just a feature of running immunology studies.

Overall, the team is doing a great job with the study, and I hope it's going to come out well. Thank you.

Thank you.

For the questions. Our next question comes from the line of Andy Chen of Wolfe Research, your line is now open.

Hey, thank you for taking the question. I don't think this has been talked about yet, but for the brepocitinib launch, can you maybe talk about a few launch analogs that you're assessing right now, either patient curve or market share curve? What are the historical products with the most resemblance to brepocitinib in DM? Thank you.

Well, thanks. It's a good question. The truth is, there has never been a launch of a targeted therapy in dermatomyositis before, so there is no good, quote-unquote, analog in the sense that you can point to lots of other launches of lots of other kinds, and some have been faster and some have been slower, and some have been slow and steady, and some have been It's quite different versions of different things. I think it's hard to say, there have been successful products with all kinds of different launch phases. I think the short answer is, I don't have a specific analog for another drug that we're watching as evidence of our own penetration. I think what we're really focused on here is the dermatomyositis opportunity itself, these docs, these patients.

The benefit and the cost of being a pioneer in the indication is that you don't get to look at others. You have to chart your own course. I don't have an analog to point to. Thanks, Andy.

Thank you for the questions. One moment for our next question. Our next question comes from Yatin Suneja from Guggenheim. Please go ahead.

Hey, guys. Thank you for taking my questions. Just a quick one on difficult to treat RA. Could you maybe talk about the strategy there? Would you need one more study, two more studies? How are you thinking about that? What should be our expectations for the randomized withdrawal phase that we're going to get data on? Thank you.

Yeah, thanks. Great question. Look, on study designs, we're going to come back later this year with a full update on that program, that includes we don't yet have the randomized withdrawal period data yet, I can't speak to what's in it or how it will or will not inform strategy from here. I think at some level, the results of that study may inform whether it is usable or not as one of our pivotal studies, et cetera. I think we designed it to serve potentially as one of two, obviously it's got to hit for that to work. As we said when we announced the data, the quality of the response rates in the open label period have set a somewhat higher bar for hitting a P value we want to randomize the withdrawal section.

I think we've got to sort of see all that, take an aggregate look at the patient level data, understand what's going on, and we are planning for an FDA conversation this fall that will inform both the exact design of that study as well as help us answer those questions. I don't have a specific guidance to give on exactly what those studies are going to look like now because we don't know, but I'll say the team's working on it hard. The data was obviously exciting. It has gotten noticed. We've got a lot of enthusiastic reception, including from the doc community on it. We're excited to finalize those plans and bring them back to you later this year. Thank you.

Thank you for the questions. Our next question comes from Yaron Werber from TD Cowen. Yaron, you may ask.

Great. Thanks so much. I have a couple of questions. The first one with mosliciguat, once you release the data this year, would you release both the mono and the combo data at the same time? Secondly, for CS, the trial design is super interesting and makes obviously a lot of sense. The primary endpoint is CSMI more than a 50% response. Can you maybe translate the phase II data into the same context? Because I think the phase II looked at CSMI over 10 points and the change from baseline. I'm just trying to get a sense of the apples to apples, kind of what to expect. Thank you.

Great. On mosliciguat, I think the short answer to your question is we will not release the monotherapy data and the combo data at the same time because the combo study started much later and is enrolling now, whereas the monotherapy study obviously will read out pretty soon in the second half. I think the answer is they won't come out at the same time, and we'll put out the combo data when we've got it. The combo study, remember, it's an open label study. The truth is, I think a lot of the information that we could want will come out of the monotherapy study anyway, such that the combo study won't provide that much incremental.

I think it was designed in part to give us really good Safety experience in the combination as well as a little bit of information about incremental efficacy, just so that we can get a sense for inclusion criteria and management in the phase III. I'm not sure it's going to be a super informative outcome. That's what I'll say on mosliciguat. I think data are going to come at separate times. On CS, I don't have to give right now the exact delta. I'll say we saw meaningfully higher rates of greater than 50% CSAMI in the treatment arm than in zero. The delta was wide.

I think in the press release that may have gone out around the initiation of the CS study, it almost said well north of 50% of the patients in the treatment arm of the phase II had a CSAMI response rate of greater than 50% compared to I think the zero on CS. It should be a good bar to set for us in terms of the endpoint. I don't know that we're going to replicate exactly what we saw in the phase II. I think the point is it's well powered for population success given what we saw on the phase II.

Right. If I can just sneak in the phase III NIU, do you have a sense, is the percent HUMIRA experience going to be the same as the phase II, given that the data looked pretty good overall? It must have been pretty good in that segment too. Thank you.

I don't think we've said, thank you, what the percentage of patients in the phase III have HUMIRA experience. I don't have that number on the top of my head. I'll have to check into it. I think the answer is there's no reason to expect it to be very different than what we've seen. There are a meaningful number of HUMIRA-experienced patients in the phase III, which matters in terms of ability to go into all of those patients. I think the short answer to your question is I wouldn't expect it to be a major driver and I wouldn't expect anything markedly different about the patient population from the phase II. Thanks, Yaron.

Our next question comes from Thomas Smith from Leerink Partners. Your line is now open.

Hey, good morning. Thanks so much for the updates and for taking our questions. On the IMVT-1402 difficult to treat RA program, I just wanted to clarify how you're approaching the disclosure in the second half of the year. Should we expect to see the Part 2 randomized withdrawal data prior to your meeting with FDA, or are you planning to share the data and the regulatory feedback and next steps simultaneously? On Graves', just wanted to get your thoughts on the competitive landscape. Obviously, you're the first advanced therapy there with really solid phase II data, and you'll have the first pivotal readout next year with IMVT-1402. There are a number of different approaches targeting various segments of the Graves' patient population. Just wondering if you could comment on the competitive landscape.

As you see some of the approaches some of these competitors are taking with respect to the patient population, wondering how you're thinking about potential future studies for IMVT-1402 in Graves'. Thanks so much.

Yeah, perfect. Those are both really great questions. On the first one, I think what we said when we put the date out still holds. I think my dream, our dream for the second half of this year is that we can come back with everything tied as nicely into a bow as possible, which is to say the Period 2 data, the FDA conversation, maybe some further analysis of patient experience through both periods in the RA study, all shared at the same time. Obviously, until we have the Part 2 data in hand, we can't sort of specifically know whether there's anything in there that requires earlier disclosure. In general, I think the answer is our hope and expectation would be to give a fulsome update later this year on everything all at once for D2T RA.

On Graves', look, I think first of all, I cannot say enough times that discussion of competition in Graves' disease among therapeutic categories is just misplaced in the sense that you've got so many patients with unmet need that have had no option. The last time a novel therapy was developed in Graves' disease was like the 1950s or 1960s. There's so many patients who have need of novel therapy that it's not about outrunning a bear. It's not about beating some specific competitor. It's about changing doc behavior in an indication that badly needs new options. IMVT-1402 will have been studied in lots of patients. It's a safe and well-tolerated drug. Graves' is going to have room for lots of mechanisms and lots of products.

Among the other mechanisms, some will have specific either safety liabilities where they'll mimic a thyroidectomy and they'll require treatment with SYNTHROID, or there's lots of different approaches and most patients may be appropriate for those drugs may be appropriate for later line patients or a different subset of the patient population. Over time, I'm sure that segmenting will occur. First of all, we're going to be first out in the marketplace there long before anybody else. We're going to get to have some influence over the treatment paradigms and also just get an option out to patients and physicians before some of those other choices are available. Second of all, I think it's mostly about building the market, not about any specific alternative and so on.

Look, we're tremendously excited to be in our position in Graves' to be first to be able to offer hopefully a new option here. The only other thing I will say is you learn a lot running these studies. You learn a lot engaging with this physician community. I do think there is nuance to the patient population, and I think there is nuance to the prescriber behavior. I think there's a lot of heterogeneity in terms of how these patients are managed around the world and around the U.S. I think one of the things that we're going to be able to do is to take advantage of those learnings in future studies, in these studies, in commercial prep. I think that will be a big benefit to us in being in the first place here.

Thank you.

Our next question comes from Yasmeen Rahimi of Piper Sandler. Your line is now open.

Hi, this is Shannon on for Yasmeen Rahimi. Congrats on the great quarter. Maybe just one more from us about clarity with the readout in second half of 2026. Could you give us just maybe what you might be thinking about narrowing guidance, if you expect to do that, and then how you're thinking about the bar for success? Timing post-data, would you expect to file an sNDA, and what would be the cadence on that? Thanks.

Thanks. Look, I doubt that we're going to provide more specific timing guidance at this point than we have. We announced, I think, when the study was fully enrolled, I think we're just going to read the study out when it's done and we have the data cleaned. The truth is, NIU is another one of these diseases where there's a lot of unmet need. HUMIRA leaves a lot of room on the table. Frankly, a lot of patients aren't even getting it. I think the truth is that the bar for success is successful studies that would support registration. I think if we get that, we will have a big opportunity to help lots of patients who need it. I don't think there's a numerical bar.

Obviously, better data is better. The more we look like phase II, the happier I'll be about that. Phase II was really great data. Overall, I think as long as we have a successful clinical trial, a successful outcome, we're going to get what we need, and we have a lot of patients we can reach. I don't want to put Ben on the spot right now on exactly when that sNDA goes in, but we got the DM one in nice and quickly. I know the team is enthusiastic for NIU's indications if that study's positive. You got to believe that team's going to be working really quickly to get that sNDA in as fast as possible. Thank you.

Our next question comes from Douglas Tsao from H.C. Wainwright. Please go ahead. Douglas, your line is open. You can unmute locally. In that case, we'll move on to our next questions. One moment, please. The next question comes from Sam Slutsky from LifeSci Capital. Please go ahead.

Hey, thanks for taking the questions. Two quick ones from me. I guess, for the proof of concept readout in CLE, there's a few parts to that study, just remind me what we'll be getting in that initial release this year. For the initial launch in dermatomyositis, remind me how many clinics you're targeting and the concentration of patients at those clinics. Thanks.

Yeah, thanks. On CLE, again, I think we've said this before in other settings, but it bears mentioning. I think CLE is an interesting indication. This is a small study. It's really a fact-finding proof of concept study. We've been watching the competitive landscape in CLE closely. There's a lot of other exciting therapies in development as well. The early data from the couple of patients that we have dosed was encouraging. We're really sort of overall just looking to understand what our treatment benefit looks like, how we could conceptually stack up in the future treatment landscape, I think that will all be super informative to what we do from here and whether we go forward. I think the primary, as a reminder, is 12 weeks, 600 versus placebo, then in period two, all patients go out to 600 at 52 weeks.

The thing that we'll be reporting first is that 12 weeks for 600 versus placebo. That's what we'll see. Then, obviously, a bunch of other data beyond just the specific primary endpoint. On the DM launch, I'm not going to share today exactly what our sort of targeting strategy is, but as a reminder, there's about 200 myositis referral centers that treat approximately half of the U.S. patient population. Obviously those clinics, those docs, those centers are an important part of the overall picture. There are other important physicians as well. I think Ben and the team have done a really great job overall engaging with the physician community. I'm excited about what we've done there, excited about the sort of medical publication strategy. Obviously, The New England Journal publication was a great outcome.

Feeling good overall about that plan, we're going to talk to as many docs and get out there as much as we can at [audio distortion] Global. Thank you. Great questions.

Further questions? We will now take the last questions from Alex Thompson of Stifel. Please go ahead.

Hey, great. Thanks for taking our question. Maybe two more on IMVT-1402. Going back to the questions around placebo responses. How are you thinking about managing placebo response in the Graves' studies, particularly in the backdrop of ATD down titration, and the potential for waxing and waning of disease in that context over longer periods of time? Secondly, what's your current thinking on sort of where IMVT-1402 could fit within MG and CIDP as that landscape continues to evolve? Thanks.

Yeah. Thank you. Great questions. Appreciate it. Look, on Graves', I think the short answer to this question is, if you set the bar high enough on the endpoints, these are just not patients who are spontaneously remitting. If you're looking at patients who are getting to proper thyroid hormone levels and off ATDs, I think the simple truth is placebo should be pretty manageable here. Without saying much more about exactly how the ATD titration works and so on, different other studies being run by different companies are taking slightly different approaches there, I'm not going to say too much about exactly what we're up to. Overall, I think this is something that is likely manageable.

I think as far as MG and CIDP are concerned, it's pretty rare that you have a great drug where you can run a clinical trial and be just very confident that the trial is going to work. FcRns have been studied many times in MG at this point. IMVT-1402 really should work in MG. The data that we generated in batoclimab, although I know there was plenty of debate over the deeper is better question, we think showed a real treatment benefit, especially on things like MFR and sort of clinical remission that other FcRns, in our view, have not been quite as compelling on. I think we have an opportunity to deliver really great data, and I think that data will translate to adoption. I'll say two other things.

One is that the MG market has just shown itself to be extremely large. There's room for lots of different classes. There's room for multiple FcRns. There's a little bit of cycling going on. There's differences in dosing paradigm and so on. I think no matter what share we take, even a relatively modest share of a market that size is a big opportunity. I think argenx SE has done a really great job establishing that market, establishing themselves in that market, becoming the drug of choice that people reach to for a next-generation therapy. I think they may very well remain the class leader there. I think we will find lots of operating room around them with hopefully incremental meaningful benefit to patients beyond what they can deliver and just with another option, with different route of administration and so on.

I think in MG, we'll be out there. I think we'll have a big opportunity just given the size of the overall market and then exactly what our share is and where we fit in will depend on the clinical data that we generate in the study. CIDP, my one comment is, I think in CIDP, class leadership has been less concretely established at this point. It's a more recent launch. I think there's probably a little bit more room for improvement on treatment paradigm. I think what we showed with batoclimab in the CIDP study was pretty encouraging, and I hope we're able to do something similar with IMVT-1402, and I think there will be a lot of enthusiasm if we can for our role there.

I think we have an opportunity to be a major driver in that market. Overall, I think the level of success that argenx SE se has had with things like MG and CIDP makes me tremendously excited about Graves' and about D2T RA and the other indications where we are first, in that the first-mover advantage that argenx SE se has been able to develop in their indications are significant, and I expect to build a similar moat for ourselves. Look, I think ultimately these docs are going to be sensitive to clinical data, focused on clinical data. I think if our data is phenomenal, we'll be able to lead in every indication where we have that kind of data. I think docs are going to follow the quality of the evidence.

Great. Thanks, Matt.

Appreciate the question.

Thank you for the questions. With that, I would like to hand the call back to management for closing.

Thank you, everybody, again. Thank you for the thoughtful questions. I appreciate how much work it is to come up with good questions in a quiet quarter. I promise there'll be lots coming in the coming weeks and months to give you more substrate in the future. In the meantime, we appreciate it. We appreciate everyone for listening. As always, I'm super appreciative of everybody who works for Roivant and our advancements, who are working just super hard on all of these programs to move them forward. I've been very proud of our execution and pleased with the progress we've made. I want to thank the physicians and investigators and patients in our studies who trust us with their care. I couldn't be more excited for the 12 months ahead.

One way or another, this is the last boring quarter we're going to have for a while. Looking forward to the more exciting ones ahead and moving swiftly over them until we get there. Thank you, everybody. Have a good day.

That does conclude today's conference call. Thank you for your participation. You may now disconnect your line.

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 going into the session, you'll need to press star one one on your telephone. You will then hear an automated message asking if your 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. Please go ahead.

Good morning. Thanks for joining today's call to review business updates from Roivant's fourth quarter and fiscal year ended March 31st, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant, and Drew Fromkin, CEO of Pulmovant. For those dialing in via conference call, you can find the slides being presented today, as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. With that, I'll turn it over to Matt.

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, so 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 D2T RA, as well as a planned spotlight we've been planning to do for a while on mosliciguat getting into that data, which Drew will take us through, and some smaller updates on the brepocitinib program, although exciting. A lot to cover. 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. Happy birthday, Dad. He sometimes listens in on these calls. I don't know if he's listening in now.

If not, he'll catch it on the replay. Into the important topics now. Starting on slide five. This has been a pretty wild 12 months for Roivant. We continue to see just tremendous execution and 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 brepocitinib was awarded breakthrough designation and a rare therapy designation for cutaneous sarcoidosis, which just underscores indication selection and development there in terms of what that could mean for those patients. We announced LPP as an indication for brepo, and that study is already enrolling, and we're excited about how that's going.

A ton of work ongoing in commercial prep for the launch in 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, ACR50, and ACR70 in the D2T RA study in the open label portion. We'll talk more about that's obviously encouraging data that we're looking forward to spending some time on. We're also fully enrolled on CLE with top-line data expected in that study in the second half.

Earlier in this quarter, we announced the failure of the batoclimab studies in TED, but also that the hyperthyroid patients showed normalization, which was supportive of our Graves' studies, which are ongoing and continue to enroll well also. Finally, hard to believe it was this quarter, but earlier this quarter, we also announced our $2.25 billion settlement with Moderna, and we expect to receive the first portion of that payment, the $950 million upfront, in July. 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 Roivant. None of that, though, is to say on slide six that we're done. The next 12 months are also incredibly exciting.

Obviously, one of the most important things going on, we will hopefully be launching brepocitinib in dermatomyositis by the end of September. The phase III study in cutaneous sarcoidosis we expect to begin this year as well and we expect the NIU phase III top line data in the back half of this year. A transformative year for brepo as all of that comes around. We'll spend time on this today, but the mosliciguat PH-ILD phase II-B top line data is expected in the second half. That also will potentially underscore that as a really important program and hopefully looking forward to that data and just talking more about it.

Obviously, D2T RA, 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 some 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. Obviously we'll get the CLE PoC top line data as well. Next year is a huge year with 1402 data in Graves and MG coming in. A ton to look forward to, and frankly, as much in the windshield as in the rear view 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 D2T RA data, which I would call surprisingly good.

We were pretty excited to see what we saw here is 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 eight 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. Most commonly, that's two of, for example, TNFs, JAK, and IL-6s. 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 positivity.

We had a criteria on ACPA+ above a certain level. That was also specific to the study and the design. 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, 600 mg, 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 mg, some go down to 300 mg, 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 effect from Period 1.

Period 2 is still ongoing, with more than half of patients still being dosed in the study. We don't have any data or information about Period 2 to share today. Even for Period 1, there's a whole bunch of data like IgG, for example, that we haven't analyzed fully and are not ready to share. Nothing to say about it other than that we're going to be sharing a pretty limited subset of this data today. On slide nine, you can see baseline characteristics for the patients in the study. We wound up with 165 evaluable 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.

For example, if you look at the DAS28 CRP score of 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. 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. That's very different than either the [NIPPON] study or really any of the later line RA studies that have been run. Actually, one thing that we're highlighting today, which I think is particularly interesting, 65% of these patients roughly have failed, specifically JAK inhibitors.

Notably, and we'll highlight this elsewhere as well, basically every single one of the patients who failed a JAK inhibitor also failed a TNF. This is a TNF and JAK refractory patient population that we're focused on. Look, slide 11 is the headline here. The headline is, with all the appropriate caveats for an open label study, these numbers are high. We saw 73% of patients roughly with ACR20 responses. Not just that, but we saw quite deep responses. We saw over half of patients with an ACR50 and over 1/3 of patients with an ACR70. Notably, once you get onto the deeper end of that with ACR50s and ACR70s, you just don't see a lot of placebo response in that level of responder analysis.

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. 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. One of the things that I think is maybe most exciting about this data is it's basically fully preserved in that subset.

As you think about that opportunity where these patients have really failed all of the most advanced options available to them, we're 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 positivity is an orthogonal mechanism to some of the other anti-inflammatory options, and that for ACPA+ patients, this could be an effective treatment option. 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 to see how they evolve through the rest of this study and on deeper patient-level analysis. Notably, this is the largest patient population dosed with IMVT-1402 to date. It was safe and well-tolerated in the study. Nothing new drug-related from a safety signal perspective identified. A clean data set overall and further underscoring what we think we've got with 1402. Fast-forward from here. Obviously, you look at this data and you feel pretty good about what this could be. Significant potential benefit, a differentiated mechanism, a difficult to treat population with not a lot of options. 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. As you'll recall, the randomized withdrawal period, the primary endpoint of Period 2 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've been fine if we had seen more marginal benefit on ACR20. The truth is, once you're looking at ACR50 and ACR70 responders, I think the bar has actually gotten a fair amount higher for Period 2. Paradoxically I think we still have a good shot of success there, but in some ways, Period 2 was less meaningful than it might otherwise have been.

I think there are plenty of scenarios where we don't see a P value in Period 2 and continue forward with the drug given the overall quality of this data. Conversely, depending on FDA's feedback, potentially situations where we do see a P value in Period 2 and just need to make sure we're comfortable with the plan forward. 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. We expect to share all of that in the second half of this year. We're working on it right now. 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 some data at our investor day suggesting this is at least a 70,000-patient population and some more specific revised commercial analysis that 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. With that, I actually 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 about obviously what Priovant's been able to do with brepocitinib from a clinical enrollment perspective. We're excited about the speed of enrollment for mosliciguat. Obviously, the quality of that data we'll find out soon. look, we're really excited about what we've been able to do across the portfolio on clinical execution. So much appreciation for the enormous number of people who are working towards those goals. Cool. I'm going to pivot now to mosliciguat 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. we wanted 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 brepo in dermatomyositis.

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 unmet medical need. These patients, in the extreme, a significant proportion of them die. They're very sick. There's currently only one approved mechanism with two therapies, and we think there's probably 200,000 patients across the U.S. and Europe. That one mechanism for prostanoid underscoring multiple really great launches at this point. We're excited to see the commercial enthusiasm and excited to see these patients have access to something that provides real benefit already, and we're hoping to add to that. Mosliciguat has a completely differentiated mechanism of action for the disease. It's an sGC activator. It's an inhaled sGC activator.

It is potentially the first non-prostanoid that could be available for these patients. We expect this to be a polypharmacy combination therapy market as PAH has been, and we think mosliciguat 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 and moving forward there. In our phase I 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. one of the things 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 shown 20+% PVR reductions has been able to deliver clinically meaningful benefit.

I think it's true that there has not been any class of drug showing a 20+% PVR reduction that has not gone on to be a commercially successful class of drugs. 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 a 135-patient study. 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?

That's great.

Thank you.

Thanks a million, Matt. I can tell you there's a lot of excitement about mosliciguat. Mosliciguat 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-ILD, nitric oxide may be reduced and the sGC binding site can become impaired, leading to sGC dysfunction. Now, typically, sGC is activated when nitric oxide engages sGC in the presence of heme, and cGMP is then produced. Unlike cGMP sGC stimulators that requires nitric oxide and heme to activate the sGC, inhaled mosliciguat 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.

We know many pulmonary diseases are heterogeneous in nature, and that fact can make patient treatment complex. To start, there's disease of the pulmonary vasculature and disease of the lung parenchyma. 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 II PHocus study. We believe mosliciguat has the potential to address both the pulmonary vascular and the lung parenchymal diseases experienced with patients with PH-ILD. Mosliciguat. Next slide. I want to make sure that-

What I'm going to do is call out the slide numbers. Everyone's got-

Okay. I'll call out. You call out the slide numbers for me.

You can call them out.

Okay.

Thank you.

Thank you very much. I appreciate that. I want to make sure we're advancing. Okay. Mosliciguat preclinical properties led Bayer to take mosliciguat into phase I trials in a total of 170 patients, including healthy volunteers and patients with Group I PAH and Group IV CTEPH. In the phase I study, Bayer studied mosliciguat in 132 healthy volunteers and 38 PH patients. The healthy volunteers underwent studies with single and multiple dose formats, and mosliciguat proved to be well-tolerated, active, and have an extended half-life of approximately 40 hours. In the phase I-B ATMOS study, 38 patients with PH were dosed in a single ascending dose format, and mosliciguat again proved to be very active, producing deep PVR reductions, and was very well tolerated. On to slide 20.

Given mosliciguat's mechanism of action inhaled route of administration, one would expect to see notable reductions in pulmonary vascular resistance associated with hemodynamic changes. With one dose of mosliciguat in PH patients, that's exactly what we saw. A single dose of mosliciguat reduced PVR in these patients early and sustained through the three-hour observation period with a mean PVR reduction of greater than 30% and a mean peak PVR reduction of approximately 38%. This places mosliciguat's PVR reductions amongst the highest reductions seen in single and multi-dose trials in PH treatment space. With one dose of mosliciguat, 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 mPAP of up to 20% and mean increase in cardiac output of up to 25%. Slide 21. Mosliciguat was also well-tolerated in phase I patients, in healthy volunteers, and patients with PH, with treatment-emergent adverse events being mild to moderate in intensity across both groups. All doses were well-tolerated, and we did not see significant cough, which is often exacerbated by inhaled treprostinil. We did not see clinically relevant systemic side effects, which we believe in great part was due to the inhaled direct delivery of mosliciguat to the lungs and the limited bioavailability of mosliciguat in circulation. Slide 22. With mosliciguat's phase I tolerability and clinical profile, we look to take mosliciguat into phase II development, an indication where there exists a major unmet medical need.

We felt that PH-ILD was an exciting opportunity for development. Given the primary site of PH-ILD, 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. Mosliciguat lines up really nicely in this moment. Since it was delivered directly to the lungs as a once-daily dosing, that's been very well tolerated and produced limited incremental cough and systemic side effects in phase I, and has the potential to address both the pulmonary vascular and lung parenchymal diseases. Slide 23. 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 U.S. and Europe, likely underdiagnosed 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-ILD represents an increasingly poor prognosis compared to each alone. I mentioned previously the lack of treatment, as there are currently only two approved FDA treprostinil drugs, leaving room for significant improvement. Slide 24. Now the core field of drugs in development for the treatment of PH-ILD is rather sparse. There are three companies, all with treprostinil treatments in different formulations, and all of these treprostinil treatments continue to have a range of challenges.

Seralutinib, with its different mechanism, has also run into recent challenges as Gossamer's phase III PROSERA trial in PAH did not meet its primary endpoints, coming off challenges in phase II as well. The result of the recent PROSERA trial outcome, Gossamer has paused its planned studies in PH-ILD. Mosliciguat 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 I studies. This really positions mosliciguat to be a leader in the treatment of patients with PH-ILD upon its approval. This is slide 25. I also wanted to share our thoughts about how we see PH-ILD and the market and how it's going to develop. We actually think the PAH market provides a likely roadmap for that development.

In the early days, supportive care was the only option for patients with PAH. This is what we currently see, and that's the reality of PH-ILD patients in most regions outside of the U.S., where there are limited treatment options. Over time, drugs with newer mechanisms were approved, and combination therapy involving multiple mechanisms of action became more common. As the median survival of these PH patients has also steadily increased as time went on from 2.5 years to where they are today at 12-15 years, the treatment guidelines evolved alongside the data, which reinforced the evolution of the treatment paradigm.

Today, revenue in the 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 PAH. Finally, key takeaway is that today over 40% of patients with PAH initiate their treatment with dual therapy, and 15% of these patients will add a third therapy by the end of the year. This combo therapy, as Matt said, is really the norm. We are currently deep into our phase II study exploring mosliciguat in our blinded phase II placebo-controlled and randomized study in adults in PH-ILD. The study is a multicenter study across the globe. We're targeting 120 patients. We ended enrollment with 135 patients.

During the screening period, the investigators looked hard to find patients to confirm ILD, elevated baseline 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, drug to placebo, and then they go through a rapid uptitration, and that moves from 1 mg-2 mg to 4 mg. 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 mg dose and sustaining well through the week 16 period. That's been very attractive and positive. At week 16, the primary endpoint is change from baseline PVR, and that's determined at 16 weeks alongside the secondary endpoint of change from baseline six-minute walk and change from baseline NT-proBNP.

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. very importantly, and as we get closer to data in the second half of this year, we've focused very heavily in designing our phase II study and defining our patient population. we carefully designed around the Seventh World Symposium on Pulmonary Hypertension, and these guidelines are crucial for PH-ILD patient selection. We targeted patients with worsening symptoms of PH, mild to moderate impaired lung function based on pulmonary functional testing, elevated 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.

On slide 28, as you can see, this effort is reflected in our baseline data in PHocus. Our mean PVR came in at 7.1 Wood 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 for emphysema both in number of patients and level of severity as determined by the CAT scan. This was very important from all of those learnings. We also explored background therapy, including exploring PDE5i on background, and this is also consistent with real-world practice. This careful patient selection and enrichment gives us confidence we've enrolled the right population to detect meaningful treatment effect, and are very much looking forward to our phase II data in the second half of this year. Matt, back to you.

Awesome. Thank you. Thanks, Drew. Look, a lot to be excited about on the program here. Just 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 II programs across a variety of other PH-ILD studies or mechanisms or drugs. We're doing the same thing, following a well-trodden path there. We will then, in phase III, 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, and what we're really looking for is affirmation of dosing, affirmation of safety, affirmation of PVR in this patient population, and we will obviously look for interesting trends in patient-level data on six-minute walk. 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 as 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 to the Pulmovant 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 PH-ILD 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. This is a great thing for safety. It's a great thing for the opportunity. As Drew said, 95% of the participants reached 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 allowed people to run the study.

Obviously, there's lots of things that don't get revealed until the data's unblinded, but it certainly gives us comfort that the patients are achieving high dose and that things are moving as they should be. 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. 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 brepo. Brepo has been the focus of so much of our conversation for the past 10 months. It's less of a focus today as we're in execution mode there. Just as a reminder on slide 25 here. Sorry, I'm looking at the wrong slide numbers.

As a reminder on the next slide, on the first slide of the brepo 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 12-24 months between the potential approval, obviously, in dermatomyositis, but also the NIU data, the potential for the NIU launch, the ongoing program that we'll start enrolling soon in cutaneous sarcoid, the currently enrolling study at LPP, and potentially more indications to come. Just a lot of great stuff coming for brepo 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 mg a day for a good portion of the year. Beyond that, it's a combination of IVIG, which, as a reminder, the sort of established treatment paradigm for IVIG in dermatomyositis is somewhere between four and five days a month consecutive in an infusion center. A really arduous path. 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. We feel really great looking forward here to our ability to bring a new option to these patients. 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 steroid 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. 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. 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. I'm excited to see what we're able to do there later this year and beyond. We've also been moving along on the scientific and medical side. If you look at slide 36, this is a small subset of the presentations that have been made of this data, but the data's been presented all over at this point and continues to be presented all over, both at the major medical meetings as well as at a whole host of regional myositis meetings and rheumatology meetings.

Notably, in March, the phase III 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 brepocitinib. It's a highly morbid disorder with no FDA-approved therapies. 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 II/III pivotal that's designed to give us endpoint validation and is going to get us into, hopefully, registration there. We're really looking forward to that. There's just a ton of reasons to be excited about the program on slide 39. The high unmet need in LPP. The mechanistic rationale for brepo is strong. It's a Th1-dominant disease where dual JAK1/JAK2 inhibition should work specifically well. We think we've got the right trial design, and there's obviously some overlapping prescriber base and KOL community with our existing indications. 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&A.

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 equivalents as of 3/31 before the Moderna settlement. No debt. We continue to retire shares. We purchased a fair amount in this quarter. We continue to have an active program. Spend continues to be sort of as it has been. Over time, R&D has grown a bit as 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. 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.

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 of that play through. With that, I'm going to say thank you again. I'm going to say thank you to, obviously, all of you for listening. Thank you to all of our teams, Pulmovant, Priovant and 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. Obviously, a great thank you to the investigators and the patients who work with us and make this happen. Thank you to everybody who makes this work. I'm going to pass it over to the operator for Q&A so that we can get to it.

As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced and to withdraw your question, please press star one one again. We do ask that you please limit to one question. Our first question is going to come from Corinne Johnson with Goldman Sachs. Your line is open.

Good morning, and happy birthday to Papa Gline 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, there's a 24-week reporting timeline. 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.

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 II sort of randomized withdrawal period. 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 we were done. I think there's certainly a possibility for continued improvement with therapy over time. We'll find out as we look at that part of the patient population. Thanks, Corinne. Appreciate the question.

Thanks.

Thank you. The next question is going to come from Yasmeen Rahimi with Piper Sandler. Your line's open.

Congrats team and congrats to Papa Gline for also achieving a major milestone of 75 years. Happy birthday to him as well. Quick question on mostly congrats. 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 are sort of tracking in alignment with what you're seeing? I'll jump back in the queue.

Yeah, thanks. I appreciate it. Look, I think the short answer to that question is we are largely blinded to all of that data and don't have a lot of information about it, so it's hard to say. I think given the patient population we enrolled, we feel pretty good about where the study's headed, and we think we've got an efficacious drug. We don't have a lot of information about sort of ongoing distributions because the way the study has been blinded. Thank you.

Thank you. The next question will come from Andy Chen with Wolfe Research. Your line's open.

Hey, thank you for taking the question. Matt, I'm aware that you said with Immunovant you haven't analyzed IgG reduction, but that's still my biggest question. Other FcRn drugs, they don't seem to be able to achieve this level of efficacy in 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 2 data? Do you expect ACPA reduction to be less than IgG reduction? Thank you.

Look, I don't have that data now, as I said, so I can't answer the question. We know from our phase I studies that IMVT-1402 suppresses IgG quite deeply relative to other drugs. Given the quality of the clinical data we've seen on ACR, I think it's certainly a thing to speculate on that the overall profile of 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. 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 what you're going to see before or after the Period 2 is unblind. I think we will provide more information about what we've seen, about what our analysis looks like, when we're sort of 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 wonder if this data is going to also establish a leadership role for us along the lines of which others may follow. I do think we're going to be a little bit conservative on what exactly we say from a competitive perspective.

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 continued able to see that as the data mature. Thanks, Andy.

Thank you. Our next question will come from David Risinger with Leerink Partners. Your line is open.

Yes, thanks very much. Congrats on the phenomenal data this morning. My question is on mosliciguat. If the phase II PHocus study surprisingly shows a statistically significant benefit on six-minute walk. Could it represent a pivotal study? What would the requirements be in that scenario for a future NDA filing? Then just one other on mosliciguat. Is the company considering development of mosliciguat in any additional indications? Thanks so much.

Thanks, Dave. On [stat sig] at six-minute walk, I think it's impossible to say exactly what we would do until we saw the data. If the data looked good enough to support a productive conversation with FDA, I think we would have a conversation with FDA. The FDA has been aggressive lately on conversations about single pivotal designs. 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. Look, I think given where we're at, we'll certainly take that as we go. On other indications, I'll say every sign around mosliciguat 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. We have some of our own that others haven't shown us yet. I think there are absolutely opportunities for indication expansion. Although, I remember we got this question about 40 times when we first unveiled mosliciguat, and our comment then, which is still our comment now, is PH-ILD is an area with a lot of unmet need. Even if it were the only thing we ever did with mosliciguat, it's a big opportunity with a lot of value to deliver to patients. I think there's a lot of different ways to go there.

Thank you.

Thank you. Our next question will come from Yaron Werber with TD Cowen. Your line's open.

Great. Thanks so much, and also congrats on that difficult-to-treat RA study. Question actually about that. Is there any chance you can amend that protocol and essentially run Period 1 and then sort of get new patients completely into Period 2, so you're not going to have that step-down issue? Secondly, based on our analysis, we think that about 75% of patients are ACPA+. Is that still kind of what you think the data shows? Thank you.

Thanks, Yaron. 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 2 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. 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. 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. I think we'll have a pretty clear sense. Then, look, we've done some commercial analysis of the market in various settings.

There's an updated version of analysis actually in Immunovant's 10-K that was filed today. I think your number is within the range of what we have seen in the literature for ACPA+ patients generally.

Thank you.

Thanks, Yaron.

Our next question comes from Brian Cheng with JPMorgan. Your line's open.

Hey, guys. Thanks for taking our question. In this RA Explore trial, since there's no washout period between Period 1 and 2, 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 2 might be less meaningful. Are you saying that 12 weeks may not be enough to fully drive the separation? Thank you.

Yeah, thanks. I appreciate the question, Brian. Just to reiterate, 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. That's one piece of this. Obviously, Period 2 is blinded, so we don't know now anything about what's in there. 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 2, it just takes some time to give up that level of response.

That's where I'd say the quality of the data in Period 1 is in some ways counting against Period 2, irrespective of the pharmacokinetic effects of withdrawal of the drug. I think remember, every ACR70 responder is an ACR50 responder, is an ACR20 responder. It just takes time to come off that hill. We have people who've achieved a lot of benefit. That's that. Thank you.

Thank you. Our next question will come from Dennis Ding with Jefferies. Your line's open.

Hi. Good morning. Thanks for taking our questions. For PH-ILD, I'm curious what are your thoughts around the phase I-B data and the interpretability of that data in the small number of patients. Specifically, why did the 4 mg cohort outperform so much relative to the 2 mg dose on cGMP, and also cardiac output? I wonder if you should expect a big increase in cardiac output since mosliciguat is locally delivered to the lungs and it's not really a systemic. Thanks so much.

Thanks, Dennis. I appreciate the question. I think the first answer is 4 mg is twice 2 mg, 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. While the specific study that you're referring to may have had a smaller patient, we have a large body of evidence at this point across mosliciguat being administered in a lot of different settings. 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. I think we generally think we know what we've got.

I think with a single dose-

You saw real robust growth and 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 result, and that was really important for us. I think we'll see that as we go forward. 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. 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 II.

Thanks, Drew. Yeah, the other thing I'll say, it just 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.

Yeah.

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 vasodilation. We feel that gives us an advantage as well and frankly increases the level of need for the patients. Look, I think it is all setting up in that way. Thanks, Dennis. Appreciate the question.

Perfect. Thank you.

Thank you. As a reminder, please limit to one question. Our next question comes from Derek Archila with Wells Fargo. Your line's open.

Good morning. This is Jacob on for Derek. Thanks for taking our question and congrats on the 1402 data. Real quick on safety, just want to clarify, confirm there were no LDL changes or other events of interest observed, right? Secondly, given the strong activity in period one, how is this informing your trial design strategy in the future? I know you mentioned that this is likely one of a couple registrational trials, do you think this data changes that?

Thanks, Derek. Great questions both. I'll remind politely for the other analysts we're trying to keep to one given the number in the queue. I appreciate both questions and I'll take both of them. On safety. 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. 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. Look, given the level of activity in Period 1 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. That's why 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. 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.

Cool. Thanks.

Thank you. Our next question comes from Samantha Semenkow with Citi. Your line's open.

Hi, good morning. Thanks for taking the question and congratulations on the data this morning and all the progress. Now that you have this first data in RA for 1402, I'm wondering also how we should be thinking about the CLE 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? What magnitude of treatment effect do you think would be meaningful here? Thanks very much.

On 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. That's what we'll be able to share. 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. I think the bar for us is not just sort of per se clinical meaningful. I think the bar is do we think our data is good enough to support a program in the face of where the landscape is headed?

We're going to look closely at that data. We're going to look at what we see, and we're going to make a decision based on the totality of the data. I think the bar there is pretty high, and I think we knew that going in. Thanks for the question.

Thank you. Our next question is going to come from Thomas Smith with Leerink Partners. Your line's open.

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 respect 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. 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.

Thank you. 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 Graves' disease. I think we can now say enrollment's going great. We're on track. We'll have the data in 2027 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. I think overall really happy with how that program is evolving. I'll again take the opportunity to say I think all of our main teams at this point are executing at a really high level from a clinical enrollment perspective, and I think that's been a real driver of value for us. Thank you.

Thank you. Our next question is going to come from Alex Thompson with Stifel. Your line's open.

Hi, guys. Congrats on the data. This is Patrick Culliton on for Alex. I guess just building on the path forward here in RA. Looking at Period 2, I guess if your 300 mg performs just as well as 600 mg, how are you guys thinking about your dosing strategy going forward in phase III?

It's fun to sit here and think about what happens if in the phase II study we see as good. First of all, it's a randomized withdrawal study, so I was trying to figure out exactly what it would look like for the 300 mg and 600 mg to perform equivalently. 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 to say without a lot in development is an understatement. I think basically we are plowing a new course with 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 mg and 600 mg the study was important because FDA, especially in new indications, especially an indication like RA, is likely to want some dose-ranging information.

I think we're going to have some flexibility, and we're going to get to see. Historically, there has been separation in IgG reduction, obviously between 300 mg and 600 mg. We'll see how that translates in this population. I think we got a lot of options here. Thanks for the question. I appreciate it.

Thanks.

Thank you. The next question comes from Prakhar Agrawal with Cantor Fitzgerald. Your line's open.

Hi. Thanks for taking my questions, and congrats on these impressive data. 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. Maybe just if you can expand if you have any data on some of the 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 in a registration trial? Thank you.

Yeah, thanks. 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 ACR50 and ACR70 responses and just ACR20 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 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. That's about all we're able to say at this point because that's about all we know at this point. One other thing is the way the study is designed, the people doing the joint assessments are blinded.

They are doing the assessments without knowing anything about the study, what patients are on, where in the study they are, or 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.

Thank you. Our next question comes from William Pickering with Bernstein. Your line's open.

Hi. Congrats on the updates, thanks for the question. On mosliciguat, you also have a phase II open label with patients on background treprostinil. What are you hoping to see in that study? How are you thinking about broader evidence generation strategy to support reimbursement of mosliciguat in combination with treprostinil? Thanks.

Yes. I think in the combo study, we have patients on background treprostinil. Obviously, in the main phase II-B, we don't have patients on background treprostinil. The reason we set this up this way is because we know that polypharmacy is going to be a part of the landscape. In the subsequent study that we run, we're likely to have some proportion of patients on background treprostinil 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. 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 the information that will help us design the stratification rules, help us understand better who's going to be on what in the subsequent study. I think beyond that, it's hard to say at this point, and the combo study's still in pretty early days, so we don't have much to say about it. Drew, anything to add to that?

I think that's exactly the case. We decided not to go on top of inhaled treprostinil in the first PHocus study. We were initially looking at our drug in single agent activity in PH-ILD, and we wanted to have some time to understand that population, understand mosliciguat. 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. With that, in the later days, we decided with the team to go a little deeper and look at mosliciguat on top of inhaled treprostinil, given the confidence we had in mosliciguat after seeing it in our PHocus study, of course, in an aggregated setting.

With that as a backdrop, as Matt said, we're early in the days, but we actually don't expect there to be much of an issue there. We definitely want to understand that from a dosing and safety perspective.

Thanks, Drew.

Thank you. The next question is going to come from Douglas Tsao with H.C. Wainwright. Your line's open.

Hi. Good morning. Thanks for taking the questions and congrats on the data progress. Matt, I'm just curious, in terms of the RA data, if you've had a chance to sort of talk with some of the KOLs, clinicians on the data. I'm just curious what their sort of feedback is on, and if they were more focused on the depth of response than you saw, or the breadth of response. Obviously you've kind of had both, so you don't necessarily have to choose. If there's anything that was striking to them from the initial data set? Thank you.

Thanks, Doug. Look, we have obviously a bunch of KOLs involved with the study. 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 ACR70s like this." That's the opinion of one physician. I think it's true at some level. Ultimately we'll have to see what the rest of the studies show. Look, I think docs are excited. They're excited about the depth of responses. They're excited about what this could mean. 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. Obviously this is beating that bar handily. I think there's a lot of enthusiasm. Thanks, Doug.

Great. Thank you.

Thank you. Our next question will come from Dina Ramadane with Bank of America Securities. Your line is open.

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 1? Was there anything you can 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. 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. That's exactly the kind of analysis that we're running. You said non-responders. Just a reminder, 72% or 73% were ACR20 responders. We're also looking at some of whom got to ACR20 but not ACR50 and just trying to get a better sense of what happened there. Thank you.

Thank you. Our next question will come from Iris Gao with Guggenheim. Your line is open.

Good morning. This is Iris on for Yatin. 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-IL-6 in these MOAs are relevant in seropositive patients? Would like your feedback with you. Thank you.

Yeah, thanks. I don't have that in front of me. It's a good question. We have cleaned some of that data. We had a bunch of IL-6 refractory patients. Rituximab, I don't know. Look, overall, we don't have that to share right now, but I think the answer is that the population is consistent with a heavily pretreated population. They've been on multiple lines of therapy. Many of them have failed things in addition to JAK and TNF. All of those different mechanisms are in. We may eventually share more data on sort of what those different subsets look like. I think we're particularly enthusiastic about the JAK and TNF combined failures. Remember that over 10% of these patients had failed more than three lines of these advanced therapies. Thank you.

Thanks, Matt.

Thank you. Our next question will come from Sam Slutsky with LifeSci Capital. Your line's open.

Hi. Good morning. This is Kate on for Sam. I appreciate you taking the question. I know the strength of Period 1 data has made Period 2 all the more challenging, particularly on ACR20. Looking to Period 2, is there a delta versus placebo potentially on other endpoints that would excite you commercially?

I don't think phase II is really about commercial value at this point. I think phase II is about better understanding the characteristics of the patients, seeing erosion of efficacy, starting to understand, to separate out drug effects from other things. I think it's not so much that we're looking for some commercial bar in phase II. I think the quality of this headline data is such that even if it degrades, we're happy with it. 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.

Makes sense. Thank you.

Thank you. That will conclude today's Q&A session. I will now turn the call back over to Matthew Gline for closing remarks.

Great. Look, thank you everybody again. Appreciate it. There were a lot of questions there, I appreciate everyone's forbearance in helping us get through it all and in limiting the 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. Thank you again to everybody for playing along with that. An exciting day for us and exciting data to be able to put out. Thank you again to everybody who made that happen, from the Vant and Roivant 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. Once again, happy birthday to my dad. Thank you everyone for listening, and we'll talk again soon. Have a great day.

This concludes the conference call. Thank you for participating, and you may now disconnect.