Good day, and thank you for standing by. Welcome to the mosliciguat and PH-ILD PHocus Study Topl ine Results 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 will need to press star one one on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Stephanie Lee. Please go ahead. Good morning, and thanks for joining today's call to review the results from the PHocus study of mosliciguat and PH-ILD. 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 will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we 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 thank you everyone for joining this morning. These are always the fun ones. Great data is always good to report on, so I appreciate everyone making time for us, and I'm looking forward to taking you through the results from the PHocus study in PH-ILD. I'm going to do a little bit of frame-up and then I'll get to the data. Starting on slide three. This is a slide that we've been showing, I think since our investor day late last year, laying out that we have a busy couple of years ahead, and I'm happy to report we continue to add check marks to this slide as we move forward. Obviously, this one is particularly great, first of all, coming so closely on the heels of the approval of what's now LISRAYA in DM, but also I think properly standing mosliciguat up as a third leg of the stool, which feels really awesome. I'm looking forward to talking more about it. I'm not going to spend time on slide four because I'm going to go through the data in great detail in just a moment once I get through some background. The one thing I will say is, look, this is a great day. This is a phenomenal data set. It is robust across both the primary endpoint PVR, functional endpoints like six-minute walk, exploratory pre-specified analysis out to 24 weeks showing improvements even beyond what was possible at the primary at 16. We were not powered for a p-value at six-minute walk, but we got a really nice one. Just a great data set all along. It is supported by hemodynamic measures and overall consistent with the disease state, obviously, but a picture on safety and tolerability that feels really good. This is a great data set. Obviously, and I will do this again at the end, there are a bunch of people who need to be thanked here, including the Roivant team, the Pulmovant team for running a great study, and always, most importantly, the investigators and the patients who trusted us with their care. That is actually a pretty good segue to. Again, I think many folks on this call are likely familiar with pulmonary hypertension and with PH-ILD, but I just want to spend two seconds on background. This is, in short, a terrible disease. These patients on slide five here are very sick. PH-ILD, these are patients with pulmonary hypertension that comes from lung disease. They often have lung function issues associated with underlying lung disease, and then also issues with blood flow to the lung from the pulmonary hypertension. They have horrible shortness of breath on exertion, so really great difficulty in activity to daily life. Lots of negative sequelae, including, frankly, just a ton of mortality. These patients are really sick. Lots of comorbidities. Things like pulmonary circulation disease, congestive heart failure, vascular disease of other kinds. Just a really, really tough prognosis. Now options. Within the last few years, there has been the introduction of inhaled treprostinil, which has been a big step forward for the field here, but we feel strongly that another option is a real benefit and one that delivers this kind of efficacy as well as the tolerability and safety that we have shown here is something we think could make a big difference for these patients. We are truly thrilled here. PH-ILD on slide six. I talked a little bit about this just a moment ago, but again, a really bad disease. 1.5 year Median Survival despite best available standard of care treatment, which as I said, includes inhaled treprostinil. We said in other settings about 200,000 patients between the U.S. and Europe. It is a big patient population with a lot of people with high need. Again, other than sort of the really old stuff, really nothing other than treprostinil approved for this patient population. A lot of opportunity to deliver some value. mosliciguat, which we have talked about at length on some earlier calls, we thought from a sort of mechanistic rationale perspective, a really great fit for the disease, especially in the format we have got here, which is on an inhaled basis, where delivered directly to the lungs to activate impaired sGC. We think this could be the first non-treprostinil treatment option. sGC is a key enzyme in the pathway here, essential for vascular homeostasis. We activate both impaired as well as native sGC and restore cGMP production. In short, we are an inhaled vasodilator, and we think that has some real benefits, and then we have potential reduction of fibrosis and inflammation as well. We think a really good mechanism, and again, obviously borne out with the data. The study here on slide eight was a large double-blinded multicenter global trial, 135 patients in PH-ILD across close to 90 sites in 20 countries. Primary endpoint was PVR at week 16, with key secondaries including six-minute walk and NT-proBNP, and then some pre-specified 24-week exploratory endpoint, six-minute walk, NT-proBNP, and TTCW at week 24 as well, or 20 week TTCW. A robust study, and we will talk more about the data in a second, but obviously set up for hopefully this kind of outcome. We had talked a little earlier in June about the blended baseline characteristics. We show them by arm on slide nine. In short, pretty well-balanced across the arms in most respects, and I think a fair test of the drug. Not too much else to say about it other than it was a pretty sick patient population in the study, which I think speaks to the quality of the data that we have been able to generate here. I do not want to spend too much time on preamble. I really just want to get to the highlights. By the way, this data was also just presented at ERS in Europe this morning as well. So excited to get it out to the academic community, and I think it hopefully will have made a splash there. My understanding is there were a lot of docs in the room. On slide 11, in short, this is the primary endpoint data. I believe this is the largest reduction in PVR from baseline ever observed in any pulmonary hypertension study, regardless of which type of pulmonary hypertension. It is in the box on the upper right-hand corner here, but 100% of patients on drug saw a reduction in their PVR. We had a placebo-adjusted change in PVR at 56.3% reduction with a obviously quite low p-value. This is, on an objective endpoint, a commanding outcome and one that we think speaks to the potency of the drug and the effect that we are having in these patients. So a great, obviously primary. This on slide 12, I just said this, but this is we think the deepest or among the deepest PVR reductions ever seen in pulmonary hypertension. It is a very deep reduction, and it speaks to the breadth of outcomes that we are going to talk about today, including on hemodynamic measures and otherwise, that we are able to deliver this kind of reduction in PVR. I think it hangs in harmony with the rest of the data that we are going to share. On slide 13, this was actually an analysis that I found really interesting, and I think it speaks to the breadth of what we are going to be able to do with mosliciguat from here. We saw a huge benefit relative to placebo in every pre-specified subgroup. There were a whole bunch of them ranging from age and sex subgroups to patients with and without emphysema, patients on or not on anti-fibrotic therapy, patients with different levels of pulmonary fibrosis, patients with different levels of baseline PVR, baseline six-minute walk, different forms of PH-ILD. Again, across the board, we saw really, really big benefits. Some of these are relatively small subgroups, but really big benefits in PVR. I think this is helpful for a bunch of reasons. One is it really underscores the robustness of the data for this patient population. The other is it opens the door to all kinds of other potential forms of pulmonary hypertension, et c., for mosliciguat. So we think there's a whole lot of opportunity here, and obviously, the robustness of this data across subgroups feels really good. On slide 14, one of the sort of greatest bits of intrigue going into this dataset is we had said it a bunch of times. This was not a study that was powered to deliver in six-minute walk. Six-minute walk is a finicky endpoint, and you just never know what you're going to see with that kind of variability. We had a really great outcome in six-minute walk. We showed a 35 m change from baseline delta to placebo at week 16. You can see that on slide 14. I think it's the highest six-minute walk change from baseline seen in a large placebo-controlled study in PH-ILD, certainly among them. So we feel really good about that data as well, and it gets to the crux of the matter here. By the way, one just note. Often in the trough studies, there's discussion of purchased trough PVR, and we don't have the trough data to share today. This was measured at "peak." But one of the things about mosliciguat that's interesting is it's got this sort of long deposition in the lung. We talked about a 40-hour half-life before, and actually, our peak and trough measures are nearly identical, very similar to one another. So I think, again, it just speaks to the unique profile of the drug. One of the things that I was most excited to see on slide 15 is that, obviously, six-minute walk at week 16 was a key secondary endpoint, but we measured it all the way out to week 24, and this is a really sort of nice-looking chart. It just shows that the placebo-adjusted benefit on six-minute walk continues to grow over time. We obviously don't know what would have happened beyond week 24, but these are patients who are continuing to improve against a backdrop of placebo patients who are continuing to deteriorate. This is, again, just underscores the big impact that mosliciguat could potentially have for these patients, and it ultimately, at week 24, was over 50 m with, again, a very low p-value separation from placebo. So this is a great outcome. Now I'm going to move to some of the "more objective" measures relative to PVR, starting with NT-proBNP on slide 16. Again, an equally attractive picture through week 24 with continued improvement through the duration of the study. Very low p-values, early separation, NT-proBNP. These are patients who are definitely getting better on drug, and we get up to greater than 75% improvement by week 24. On slide 17, one of the other sort of interesting things here is this data just like fully hangs together. This is not just a pulmonary arterial pressure benefit. There's also increased cardiac output for these patients. And obviously, those components add up together to a significant portion of the PVR number. So you sort of figured it had to look like this, but seeing it across both of these sort of fundamental hemodynamic measures, again, just gives you confidence that this is really sort of working to improve the overall health of these patients in an exciting way. Again, just gets to the robustness of the dataset. Again, really low p-values with significant benefits on both pulmonary arterial pressure and cardiac output. We also did, on slide 18, an exploratory pre-specified analysis on time to clinical worsening. We had a relative risk reduction of 37%. Not quite a p-value here, but 0.09 is still not bad. Again, a significant improvement in time to clinical worsening, which is an important endpoint and something that we would think about as mattering potentially in the phase III as well. Then one other point on slide 19, one of the "issues" with current standard of care, which is these inhaled treprostinil, that are good drugs that are important to options for these patients, is treprostinil has a generally on-target effect of inflaming the airway and causing cough. Which again, these are patients who already have a high level of cough because of their underlying lung disease, and it's one of the sort of common issues associated with use of treprostinil. You can see our cough levels, and this sort of makes sense for the mechanism, right? There's no on-target cough effect from sGC activation. In fact, mostly patients had less cough than placebo patients on drug. By the way, I haven't said this, I think, yet on this call, but one notable thing. This is a single puff on a DPI once a day, so these are one puff once a day therapy here. With less cough than placebo, and obviously significantly less cough than what you see on the treprostinil, given the nature of those drugs. Otherwise, on safety and tolerability on slide 20, overall a clean picture. Again, these are sick patients and the overall rates of AEs here are consistent with the sick patient population. They look different generally than what you see in like a PAH study, for example, but fully consistent with what we've seen generally in other studies in PH-ILD. Overall, the kinds of things you might have worried about, given some of the history of sGC and the mechanism, no significant AEs on hypotension that were meaningfully different from placebo. We don't have data on oxygenation to share in detail today, but I can say, overall, supplemental oxygen use both at rest and with exertion, basically exactly the same between placebo and drug. Oxygen saturation at rest looked good on both placebo and drugs. So I'd say overall a data set that's encouraging relative to some of the questions we might have gotten going in. Certainly, we think with an attractive risk-benefit profile relative to the level of clinical benefit we've been able to show with the data set. It's always hard to do cross-trial comparisons on slide 21, but we're really proud of this data set. We think it matters a lot to patients. We think across the board, these are measures that stand out from the competitor profile across a bunch of different measures from obviously PVR and the 24-week six-minute walk number, which is really exciting to NT-proBNP to the difference in cough profile and the fact that we're one puff, once a day. This is a phenomenal, robust data set. Again, I couldn't be more excited for what this is going to mean for the PH-ILD community and what it's going to mean for patients. This gets me to the last thing I want to cover today. We obviously didn't know what this data set was going to look like, but we were sort of sitting thinking about it earlier this year and decided to accelerate the path to phase III. We put some dollars and some time and effort at risk. Long story short, the phase III PHrontier study is now underway. It is actively screening and enrolling patients. So the phase III program is already up and running. It's currently set up as a 375-patient PH-ILD study. Obviously, one of the things that we're going to do now is take this phase II-B data to FDA and have a conversation with them about the design of PHrontier. Any changes that need to be made, we can make on end and so on based on powering, based on what we now know. It's a down the fairway, large placebo-controlled, double-blinded, multicenter study in PH-ILD with a primary endpoint at week 24 of six-minute walk with key secondaries, TTCW, PVR, NT-proBNP, et c. We're really just trying to look to replicate what we've been able to see in the PHocus study. As a reminder, we also have an ongoing combo study with TYVASO that's an open label study. We will allow some amount of background treprostinil use in PHrontier. Obviously, we'll use the data we get from the ongoing combo study to titrate a little bit some of the parameters of that. Overall, again, as a reminder, treprostinil are not approved outside the U.S. anyway, so there will be some mix of patients in that study. We'll know more about how that looks as the combo study comes together. We're really excited that that study is ongoing. On slide 24, just to sort of wrap up overall sort of the picture here. Obviously, PH-ILD has been a big and growing market for TYVASO, and now with Yutrepia on the market as well. It's been a really exciting commercial opportunity. Again, speaking to a global unmet need, and with this data set, we think we're going to be able to play a really big role for these patients. The other thing I'll say on slide 25, I'll just reiterate. I'm sure we'll get questions around line of use. I'm sure we'll get questions around how we play vs the others. One thing I'll just say that I think is an important point. PAH is a polypharmacy market. These patients are on multiple classes of drug. They are really sick. They want to use everything that they can. And one of the most amazing things as a story for the biopharma industry is that over time, as you look through the history of treatment of PAH, each time a new class was introduced, life expectancy for these patients materially increased. I hope, obviously, we cannot say anything about that from this data today, but I hope that the same thing is true in PH-ILD, that as new options come to market, as new classes come to market, we can materially improve outcomes for these patients. I fully expect that we are going to be used alongside treprostinil, and hopefully that will make the lives of pulmonary hypertension patients better over time. It is the reason we are obviously allowing some amount of inhaled treprostinil use in the phase III study as well. I will not hammer this too hard again on slide 26. I think a lot of this data speaks for itself, but we could not be more pleased with the outcome here across all of the endpoints, across safety, across tolerability, and obviously thrilled to have the phase III program already underway and excited to talk to the agency about where to go from here. So really pleased. This, as a reminder, although I think most people are aware of this on slide 27, is only one of our programs. LISRAYA is now on the market in DM, and we have got more to come near future on NIU, as well as a number of important late-stage data sets, phase III data sets coming for brepocitinib, a whole bunch of data coming starting later this year and then next year for IMVT-1402 on the FcRn side. And excited to talk about both more about PH-ILD as well as indications beyond PH-ILD for mosliciguat in the relatively near future as we get everything going. So a phenomenal outcome, always a great way to get in front of people with data like this on the Tuesday after Labor Day. So excited to take some questions. I just want to say again, and I will say it one more time at the end of the call, a big thank you to everybody involved in this program from the Roivant team who brought it in and stewarded it, to Drew and the clinical team at Pulmovant who ran this great study. And again, obviously to the investigators and patients, really sick patients in many cases, who entrusted us with their care here as we tested out a new medicine. We are glad to have been able to show something for it. So with that, I will wrap up, and I will pass it back to the operator for some Q&A. Thank you, everybody. Certainly. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile our Q&A roster. Our first question will come from the line of Yaron Werber of TD Cowen. Your line is open. Great. Thanks so much. Really amazing outcome. I have a couple of questions, Matt, and I think you kind of touched on them. The first one is the six-minute walk distance gets better as you dose longer, and the phase III is looking at 24 weeks, and you're on top of inhaled treprostinil. What do you expect? Do you expect any synergy with the drugs or no difference in terms of better efficacy on the background? What percent of patients would have inhaled treprostinil in the study? I assume it's going to be stratified. Thanks, Yaron. Yeah, it'll be stratified on inhaled treprostinil. I don't have an answer right now to what percentage of patients will be on. Obviously, it's only going to be U.S. patients who are on inhaled treprostinil. Some proportion of the patients. We may very well cap enrollment for inhaled treprostinil patients, depending on what we find out in the combo study. So we'll see more about that. Look, I think mechanistically, I think you would expect some synergistic benefit between the drugs, but what that means on the combined outcome, I think we'll just have to wait and see what the combo data show, and that study is open label and ongoing. But look, generally what we've seen in PAH and what I would expect here is that highly active agents are additive, and so I would hope to see the same here. Thanks for the question. Our next question will be coming from the line of Brian Cheng of JPMorgan. Your line is open. Hey, guys. Congrats on the data, and thanks for taking questions this morning. Matt, can you give us a sense of the dose escalation, the titration up to the optimal dose here? How are patients experiencing dose escalation? Can you talk about the titration up to the optimal dose in the phase III? Is that the same also as the phase II? With quick follow-up. Thank you. Great. Thanks. Look, great questions. Appreciate it. In the phase II-B, the short answer is the vast majority of patients were able to get to the highest dose and to tolerate it, which is obviously a great outcome. It is obviously what we were hoping to see, and certainly the outcome speaks for itself in terms of both efficacy and safety and tolerability. I think in general, the phase III is similar. It is slightly quicker titration to the high dose in the phase III, but I don't think the details are not even that important here. I think the point is that we hope to be able to replicate that a high proportion of the patients are going to get to the high dose. We saw pretty good outcomes there in the phase II-B. Okay. A quick one on the potential beyond PH-ILD. It seems like you're waiting for feedback with the regulator to get a sense of the next step for mosliciguat. Can you give us a sneak peek there? How many mutations are you thinking of, and how should we think about the steps beyond PH-ILD? I think many people would shoot me if I gave a number of indications. Look, it's a great question. I think the short answer is, first of all, I would say we're not waiting for the regulator per se on indication expansion. Obviously, we're going to meet with FDA to make sure we've got the cleanest, fastest path forward, specifically in PH-ILD. We've also got lots of other ideas that we're working on right now. With data this good, especially across all the different subgroups, I think you got to believe every form of pulmonary hypertension is on the table for consideration. Obviously, even before this, we had looked very closely at the TETON data and been thinking a lot about IPF. Frankly, I think, as you'd want with a data set like this, our imaginations are running a little wild as we think about all the possibilities. I think, like I said, I think this becomes a real leg of the stool for us. I think there is more for us to do. We have IP into the 2040s, and the ATMOS data in phase I-B, which was in PAH patients in part was really good and also sort of compelling PVR reduction, and that was with a single dose. I think there's a lot of opportunity in that indication as well. I think going in our commentary on PAH had reflected the competitive dynamic in PAH. I think with data this good, we may very well find a role to play in indications that are more competitive. Stay tuned, but I think there's a lot of opportunity from here. Thanks, Brian. Congrats on the data again. Thank you. Thank you. Our next question will come from the line of Prakhar Agrawal of Cantor. Your line is open. Hi. Thank you for taking my questions and congratulations on the excellent data. Maybe on the six-minute walk test, any differences you noticed across the subgroups? I saw that you had a chart on PVR, but was wondering if something similar on the six-minute walk test, specifically looking for patients who had DPLD. Did they have any difference vs other subgroups? For patients who were on background PDE5, how did they perform, given there is some overlapping hemodynamic mechanisms with mosliciguat here? Finally, given these strong data sets, how quickly can you enroll phase III, given that it took some time for some of the inhaled treprostinil trials in phase III and the timing of the readouts? Thank you so much, and congrats again. Yeah, perfect. Great question. As a reminder, in the deck on slide 13, we talk a bunch about different subgroups, including with and without PDE5s. So you can see we saw pretty similar effect regardless of PDE5 therapy, which is great. It is exactly what you would want. On six-minute walk, as you are asking your question, with no shade on the question, I was thinking about this, sort of what have you done for me lately, and that we came in with a study that was not powered for a p- value on six-minute walk, and now we are being asked about subgroups on six-minute walk. Look, I think six-minute walk is a noisy endpoint, but I think given what we saw on PVR just as well as given the data set overall, I think the general view here is that nothing stood out to us around subgroups in terms of performance here. This drug seems to work just across the board consistently. Again, obviously not powered for comparative analysis on six-minute walk, but feel really good about the breadth of it. In terms of enrollment on the phase III, look, stay tuned, and I do not have guidance to give, but I think the fact that we are presenting this data at ERS is helpful, and I expect it will make an impact in the doc community. I think these are sick patients and frankly, we were pretty happy with how these patients did on level 12, so I hope we can move very quickly from here. Thanks for the questions. Thank you. Yeah. Our next question will be coming from the line of David Risinger of Leerink Partners. Your line is open. Thanks very much, and congrats, Matt and team, on the spectacular results. My questions are related to the future potential of the drug. Could you just talk a little bit about the design of phase III in some more detail, specifically what percentage of patients you expect to enroll ex U.S. where treprostinil is not typically used? Do you see an opportunity to be more than just an add-on therapy to treprostinil in the U.S. in the future, i.e., be an alternative to treprostinil? Thanks so much. Yeah, thanks, David. Those are both good questions. On the second one first, because that's the easy one. Look, I think with data this good, you got to expect that we have lots of opportunity to occupy lots of different lines of therapy in PH-ILD, including frontline therapy. I think overall, I think we absolutely have an opportunity to be there. I think if we get used first, we will be used with treprostinil on top of us eventually. If treprostinil is used first or if patients are already on treprostinil, we will be used on top of treprostinil. But I think we absolutely have a shot here at frontline therapy. It's convenient. It's got one puff once a day with significantly lower cost than you see with the inhaled treprostinil. I think we have an opportunity to exist on top of existing therapies, before existing therapies, on top of new therapies that will come in the future, et c. I think that everything's on the table here. On the first question on the phase III design, without getting into too much detail, I think we aren't expecting any differences between the phase III and the phase II in terms of the impact on results. I think overall, the phase III at this point is being designed with that in mind. I think we are hopeful we're going to be able to replicate that. Like I said, I think on the concurrent treprostinil, which is the only meaningful change, in a way that we expect to allow the phase II to fully translate to the phase III. Thanks, David. Our next question will be coming from the line of Samantha Semenkow of Citi. Your line is open, Samantha. Hi, good morning. Congratulations on the great data as well. I have two hopefully quick questions. I am wondering, Matt, if you have any immediate feedback from KOLs following the ERS presentation that is worth sharing with us? Then also just another question on capital allocation. With this great data, your expansion opportunities have just expanded, but you also have really great brepocitinib data and lots of indications there, and IMVT-1402 has a similar problem. Just how do you think about allocating your capital across these three pillars of your business? Thanks very much. Thanks. Both good questions. On the KOL question, as you may know, Drew, who has been on some of these calls in the past, is not on this call because he and I are doing a little bit of a divide and conquer here. He is working the room at ERS and talking to the docs, and I am sitting in the Encore in Boston at a conference. So I do not have the direct KOL feedback myself. But what I am told is that the ERS room was packed to the gills despite being quite a large room. I know that the KOLs that we managed to speak to, the docs we managed to speak to about the data before today were incredibly enthusiastic, as you would expect for this kind of data set. I know the professor who presented it was thrilled to be able to present it. So I think the doc feedback so far has been very positive, and I expect we will know a lot more by later today. But that is what I would expect to hear. On the capital allocation question, I will say, first of all, we have been fortunate up until now and continue to be fortunate not to have to make the toughest of those decisions. We are spoiled for choice, and I think expect to sprint at indication expansion here while continuing to sprint at indication expansion for brepocitinib and to continue to sprint at indication expansion for IMVT-1402 in the FcRn world. So I think we have great opportunities and we have capital left aside even after all of that for in-licensing opportunities for BD. I feel like a broken record on this point, and we have said the same thing for a while now, but there are some opportunities on our racket that we are really excited about that I hope we are going to be able to complete and talk about in the relatively near future. There is nothing to say that a stool can only have three legs, so I am excited to see where we go from here as well. Thank you, Samantha. Our next question will be coming from the line of Yasmeen Rahimi of Piper Sandler. Your line is open. Team, congrats to the outstanding data. Looking at the baseline population, it seems like a pretty sick group of patients, right, with baseline six-minute walk test of 260- 285 and PVRs of 580. Makes me think about as you're designing a phase III study or the study phase III is up and running. What is the requirement of the minimum six-minute walk test and PVR that they need to have to be eligible for this study? Yeah, perfect. Great question. Look, it is a sick patient population. Not a sick. PH-ILD in general is a sick patient population, so this is representative of the PH-ILD patient community generally. I think the only thing that we've said so far about enrollment criteria in the phase III is PVR of greater than or equal to 4 Wood units. I think that gives you a sense. I think in general, like I said, this is a representative patient population of what the PH-ILD patient experience is like. My hope and expectation is that the phase III population will be similarly representative. Okay. Thank you. Thanks, Yasmeen. Our next question will come from Dennis Ding of Jefferies. Your line is open. Hi. Good morning. Thanks for taking my questions. I have two, if I may. For the phase III six-minute walk, it's really impressive that delta continues to get better from week 16-week 24, but you guys didn't break out how drug vs placebo did at 24 weeks. Can you comment on the shape of the curves between mosliciguat and placebo at 24 weeks? Basically, with the bigger delta driven by mosliciguat doing better and placebo doing worse, sort of consistent as to what you saw at week 16? Or maybe was it from placebo doing much worse? Question number two, on time to clinical worsening, can you give a little bit more color on why mosliciguat did a little bit worse early on? Maybe it's just small numbers, but just talk a little bit more about that and how important is this endpoint from a regulatory perspective in phase III from the FDA as well as the EMA? Thanks so much. Yeah. Thanks, Dennis. Those are both really good questions. On the first one on six-minute walk, I will say three things. One is we have to leave something for future academic conferences, so I am sure more of that data will come out. The second thing is, and this is not our fault, the way the field works on six-minute walk in pulmonary hypertension is the sort of interpolation models are complicated in a way that makes this question slightly complicated to answer. But the short answer is it is clear from our data that both drug effect is consistent and increasing over time through week 24 and that placebo patients are getting worse. So it is not just one or the other and the magnitude of, in fact, in the academic presentation this morning out to week 16, this was showed. You can clearly see just like a consistently improving drug effect as well as a consistently worsening placebo and that were sort of smooth in both directions. And that continued out through week 24. Sort of smooth worsening of drug and, sorry, smooth improvement on drug and a smooth worsening of placebo patients all the way out to week 24 across the board. So I think anyway, short answer to your question on that is both the drug effect keeps getting better and placebo patients getting worse. On TTCW, I will say increase for TYVASO also had a similar early crossover effect. I do not have a clear answer sitting here right now as to why that seems to be the way it works in these studies. But obviously by week eight, mosliciguat is ahead and it continues to do better and better from there. As far as the regulatory significance of TTCW, obviously six-minute walk is a regulatory approvable endpoint in pulmonary hypertension and has been used repeatedly in pulmonary hypertension studies. TTCW is looked at especially in some other geographies. I think both are helpful measures and obviously we are measuring both in the phase III and in a properly powered study, I think they are both going to be useful outcomes measures that we should be able to deliver on. Knock on wood. Thank you. Great. Thank you. Our next question will be coming from the line of Andy Chen of Wolfe Research. Your line is open, Andy. Hi, this is [Jason] taking it for Andy and thank you for taking my question. I just wanted to ask really quickly about the TEAE-related discontinuation rate. Was there any concerns about that and what maybe drove it to be a little higher? Also, was there any concerning effects on oxygenation, oxygen requirement and blood pressure or hypotension? Thank you. Yeah. I'll take the second question first because I'm going to pull up some data on the situation while I'm talking. But the short answer is no. I know there's a lot of data we will eventually have on oxygen saturation and stuff like that. We just don't have it all clean for now. So I can't speak to the full detailed data set, but we took a look in anticipation of getting this question and the short answer is we have some oxygen saturation at rest data that was basically consistent between drug and placebo. We have supplemental oxygen data both at rest and with exertion that are basically the same on drug and placebo. There's not any significant imbalance of hypotension as an AE between the arms. So I think overall that looks good. Look, on discontinuation, I think the short answer is we're not particularly concerned. The slightly longer answer is this is just what PH-ILD studies look like, and so our TEAE discontinuation rates look quite similar to what we've seen in the other programs that have been run here. Obviously, they are generally higher in PH-ILD studies than they are in PAH studies, and I think that's reflective of a sicker patient population in some ways and just different set of situations. But I think overall, as we look across the board, I think our discontinuation rate is a little bit lower than what we're seeing overall, on increase. Similar. Just overall, in the same general bucket as what you see in other PH-ILD studies. So we feel relatively unconcerned. Obviously, the fact that so many of the patients made it to high dose is a useful fact for us. Awesome. Thank you. Our next question will come from the line of Chi Fong of Bank of America. Your line is open. Hey, guys. Good morning. Thanks for taking our question. Matt, in the past, you have talked about taking a look at the FVC data in the subset of patients with IPF. Granted, it is a very small number. I think it is about 25 patients on drug and 15 on placebo. Is there any learning that you can talk about today? I have a follow-up after that. Thanks. Yeah, thanks. Look, the first thing I will say is, like I said, we have to save some things for academic conferences. We have just started to peek at the FVC data and at the IPF subset. It is early days. Look, I think overall, given the magnitude of the effect, given the breadth of the effect across different subgroups, I think we continue to have the belief that anything anybody else can do, we can also do with this drug. We are obviously well aware of the IPF data that has been generated by treprostinil by TYVASO so I think we are excited to continue to think about and explore that as an opportunity. I think our data points in a similar direction. But in terms of the specifics on FVC or on the IPF subset, give us a minute and we will definitely be back with more presentations on that topic as we lay out our future plans. Thanks, Chi. And my follow-up question, if I may, is regarding your phase III population. Do you have any thoughts of exploring mosliciguat in milder pulmonary hypertension, more specifically between the two to 3 Wood units? I understand that the phase II data and the phase III enrollment is focused on the above four, which is in line with the treatment recommendation. But if we were to go by the diagnostic criteria from the World Symposium of PH, there is quite a bit of patients in the two to 3 Wood unit. So I am curious if you have any sort of thoughts about pursuing mosliciguat in those milder patients, maybe perhaps in a separate phase III or subsequent study. Yeah. Look, I think I will say things. One is obviously our top priority right now in PH-ILD is to get this drug approved as quickly as we can and to run a study that is going to replicate the data that we have seen here as closely as we can. So I think in PHrontier, we are focused on what we are doing. Again, the data is new, and so we are still processing it, but I would be surprised if we made major changes to that kind of inclusion criteria. That said, I will reiterate what I said earlier, which is with data this good, I think every form and severity of pulmonary hypertension is on the table in terms of things we would consider. And I absolutely think we will think about earlier line studies in other forms of pulmonary hypertension, et c. So I think all of that is absolutely on the table. Thank you. Okay. Thanks so much, Matt. Our next question will come from the line of Yatin Suneja of Guggenheim. Your line is open. Hey, guys. Let me add my congratulations as well. Not very often that you see practicing data gets replicated in phase III, so congrats to the team. Two quick questions from me. First one is on the PH-ILD population in the U.S. Could you maybe provide a little bit more color in terms of, I know you mentioned 200,000 patient total, but just in the U.S., what numbers do you come at? What is the eligible number? Then just one quick one on the study, on the phase III study. Could you talk about or are you able to share what magnitude of six-minute walking distance effect you are powering it to? I mean, obviously pretty strong result in phase III. How should we think about modification there, if at all? Thanks. Yeah. Thanks. Look, great question. On the second one, the study is 375 patients as currently set up, but we will reevaluate size and powering now that we have the phase II-B data in hand, and it could change modestly from there. So in terms of powering, stay tuned, but I think certainly given that the phase II-B saw such a robust p- value, the phase III is healthily powered for a six-minute walk. On the market size in the U.S., there are a variety of estimates in the world ranging from mid tens of thousands to very low six figures is probably the current range out there. Diagnosis is increasing over time now that there are more therapies on the market, and our view is that trend will continue. So look, PH-ILD is, in short, it is a big patient population with a lot of really sick patients. We will see. Also, look, I think duration of therapy will increase over time as mortality comes down and as patients are on multiple things that keep them healthier longer. I think there is a whole bunch of reasons to expect this, whatever. It always feels strange to call a patient population a market, but to expect this patient population to grow over time. It feels good to be here at this moment. Thank you. I would now like to turn the call back to Matt for closing remarks. Thank you very much. Look, I will just say again, thank you everybody for joining this morning. This is a tremendous outcome for patients, for the investigators. There is a ton of people it takes to make this happen. The clinical team at Pulmovant ran hard at this study to get it enrolled quickly and run well. Drew obviously overseeing it all. The Roivant team across the board from the investment team who brought the asset in to the government team who oversees it. Then, thanks to our partner, Bayer, who got this program off the ground, and I am happy to take the torch from them and continue to run with it, and it is really great to be here. Look, I am excited to get back together over the balance of this year. We have a lot more coming and hopefully great things to say. I am excited to talk much more about PH-ILD and all the great talking this morning, and we will speak to you again soon. Thanks, everyone. This concludes today's conference call. Thank you for participating. You may now disconnect.