Okay, we'll continue with the next session. Hi, everyone. My name is Paul Choi, and I cover the Mid-Cap Biotech Sector here at the firm. It's my pleasure to welcome Gossamer Bio to this session. We'll spend some time obviously talking about the pipeline as well as the PAH market and sort of developmental opportunities there. But joining us from the management team to my immediate left is the, sorry, my brain's frozen.
Faheem Hasnain.
Faheem, sorry. Faheem-
It's okay.
To my immediate left, and to my far left is Rob Roscigno, who heads up clinical development for seralutinib. Maybe what we'll do for, you know, people who are new to the Gossamer story, Faheem, is start with maybe just an overview of the company, how it... How maybe what was the genesis of it and how you got into seralutinib, and just then we'll maybe get into a little bit of the data and the clinicals after that.
Sure, Paul. Well, the company was formed in 2018. We took it public approximately a year later. One of the centerpieces of the assets that we brought in at that time was seralutinib. We ended up acquiring that asset from a company called Pulmokine, which was formed by an academic founder, practicing cardiologist named Larry Zisman. It was Larry's idea to actually take the IMPRES data with imatinib and really try to improve upon that concept, because obviously there was a fairly good modicum of validation around the pathway. So what Larry defined was a molecule that would have greater specificity against the targets that we think are most meaningful in PAH, meaning CSF1R, PDGF, and c-KIT.
But it wasn't just about the specificity, it was also about hitting those targets with greater potency. So we have hit those targets with much greater potency, double the potency that we see with imatinib, and hitting both isoforms of PDGF, both the alpha and beta. So that was kind of part of the premise, and then the last piece of the premise was then putting this into a molecule that would be uniquely designed to be inhaled. So what that uniqueness is, certainly vis-a-vis imatinib, is that we end up not only have a compound and a molecule that gets deep into the lung but also rapidly cleared from the systemic circulation. So that was the premise, and here we are now in the PROSERA study in phase III. And we're pretty excited about getting this study enrolled and looking at the results.
Okay, great. Maybe if we could, like, review some of the data to date from your phase II program and help us contextualize what you've seen so far. I think, you know, part of the part of the investor in diligence into seralutinib is understanding, you know, how it did in the overall populations versus certain subsets and just understanding the performance there. And maybe if you want to just review for us, you know, what the phase II data showed with TORREY and the OLE data that's been generated subsequently.
Sure. Let me top line that, and then I'll turn it over to Rob to kind of give a little deeper description. But what we saw in the TORREY data was, first up, we saw a statistically significant effect on PVR, which was the primary endpoint. And we also saw a trend in six-minute walk, but it was not powered for six-minute walk, so that really wasn't kind of that surprising that we didn't hit stat sig on that. I think probably most people know this story, Paul. We enrolled a study in the midst in the heart of the pandemic, and we had clinics closing down for you know, months on end. So in the end, what we ended up with in TORREY was an unprecedented, less sick patient population.
What that did is when you bring in patients who are less sick, there's less room for improvement on both PVR as well as six-minute walk. So I would argue that the result was somewhat muted because of the skew in the patient population. But as we looked at the patient populations that we would be studying in a phase III, which is exactly what we're studying now, the functional class, the functional class III, and the patients who are at a higher REVEAL risk score, as we look at that data, we saw substantive effects both on six-minute walk and PVR. And I would argue, kind of in the functional class III, as an example, a 30+ meter improvement in six-minute walk, which is sotatercept-like. So that was really encouraging to us.
In addition to that, when we looked at all of the data, the concordance of the data, the impact on the biomarker, and the impact on an NT-proBNP, the impact that we saw through our imaging data on the lung, what we think might be evidence of remodeling, the impact that we saw via echo on right heart, as well as the safety profile, and then into the Open Label Extension. Rob, do you want to just comment on the Open Label Extension data?
Sure. We actually designed the Open Label Extension a little differently, because typically, Open Label Extension studies are looking at, if you will, some durability of treatment, but really safety and tolerability over the long haul, because physicians treat their patients for years, not for weeks or months. We designed the Open Label to capture additional efficacy data. So what's unique about our Open Label is that we actually have right heart catheterization data at week 48 or one year into the Open Label. So patients who continued seralutinib would have an exposure of 72 weeks, if you will, and those that crossed over from placebo, 48 weeks. And what you'd like to see in these drugs, and I've been working on this, this development, in PAH for 27 years now, you wanna see not only... You'd like to see a durability of effect.
Well, not only did we see a durability of effect, which you don't see with a lot of the approved drugs, usually you see a waning over the time as the disease progresses. We saw a continued improvement in one of the most important endpoints, and that is change in pulmonary vascular resistance. We saw a further improvement in pulmonary vascular resistance between weeks 24 and week 72, and this occurred in both groups and a substantial number of patients in both the active group and the placebo crossover group. In addition, we saw increasing six-minute walk over time and also improvement in echocardiographic and other clinical measures as well. Importantly, we also saw no change in the safety and tolerability profile.
The types and severity of the adverse events, which we saw during the double blind, which were mostly mild to moderate in nature of the adverse events observed in the TORREY study, were also observed in the Open Label, and we have safety data now out to 127 weeks. So the take home message is that the longer you stay on seralutinib, you have the continued, if you will, ability to show continued improvement in your pulmonary hypertension symptoms, if you will, and the safety and tolerability profile is intact as well over the long haul.
I want to maybe dive into that a little deeper. If we could, and just, you know, as you look at the sort of patient subgroups, particularly as you think about either NYHA or risk scores and stratification, you're also seeing a separation, you know, based on those populations, and maybe you could elaborate a little more on that as well?
Well, I think with regards to the Open Label data set, what we saw is there was really improvement in both groups, the sicker patients at baseline, as well as the less sick patients, and I think that's the story here. Typically, with these PAH drugs, you see activity in the sicker patients. If you're going to see something, you see it in the class III patients. But we saw that in TORREY, and we continue to see that durability in the Open Label. What's unique about the Open Label data set is a number of the patients who were less sick at baseline actually showed the ability to further improve.
We're able to take these folks who are heavily managed on two or three background therapies, including parenteral prostacyclin, and show further improvement over time, and really taking them to a better place than the currently approved treatment options are taking them, with no additional risk in terms of safety and tolerability.
Great. For people who may not be deep in the PAH field, how predictive are these sort of baseline characteristics typically of clinical responses, whether across some of the established, you know, categories like PDE5, prostacyclins, and so forth, and just generally? You mentioned you're seeing more responses in the sicker patients as one would normally anticipate. But just generally, how predictive are these of potential outcomes here?
Well, when you look at REVEAL risk scores and risk scores in general, they're predictive in terms of you want a lower risk score because a higher risk score is related to a morbidity, mortality, vulnerability, if you will. And being able to take somebody and keep them either at a low risk or take them to a lower risk, has direct impact on their long-term survival. So, the risk score is an important determinant. Also, their functional class as well, because as we know, as you progress in your functional class, you have right heart failure involvement, and patients don't die of a high risk score. They don't die of a low six-minute walk. They die of right heart failure.
What we've been able to show in the TORREY data set and continue to show in the Open Label is that not only are we having impact on the human six-minute walk, but also parameters.
Great. I want to maybe turn a little bit towards the PROSERA study and just, you know, maybe, you know, probably a question you guys commonly get is just how to think about the landscape now that Merck has gotten approval for sotatercept, and just maybe just sort of what that impact and sort of demand in the patient community might be for that both here in the U.S. and Europe, and just sort of what that potentially means for your enrollment timelines and capabilities?
Yeah. I'll start off with just commenting a little bit about enrollment. Of course, we'll talk about specific numbers at this point, but certainly, we're really pleased with the way it's going, Paul. When we are completed with site initiations, we'll have about 170 sites up globally. We anticipated the sotatercept launch, and in that anticipation, we made sure that we had a good number outside of the U.S. that would be able to contribute quite significantly to the enrollment of the study. And I think that we can safely say that's playing out. So we're ahead on our enrollment. I think we've been saying that. Sorry, on the site initiation. We're absolutely thrilled with the response we're getting from the treating and the investigator community.
Certainly, I feel like I live in two different worlds when I go talk to the docs and then when I see what Wall Street's reaction is. You couldn't have a further divergent opinions. So that is really encouraging to us, and so we continue to be very optimistic about the enrollment landscape. Now, as it relates to sotatercept being approved, which was in the March timeframe, of course, there's tremendous demand. You know, this is a, stating the obvious, this is a progressive disease. Every patient will progress, and we see a 50% mortality in five years. And so the concept that sotatercept, of course, is hugely anticipated and much, much needed, but the concept that that is all that's needed is just completely erroneous and kind of silly.
And all you need to do is talk to any treating physician, and they will tell you that sotatercept will work really well in about approximately 30% of patients, and then there's going to be a significant number of patients that it will not work well, and it's not a cure, nor is seralutinib. We will certainly, there is a certain subgroup of patients—some of the longer-term safety implications that seem to be connective tissue disorder.
Yeah, bleeds.
But beyond that, there is tremendous commitment among our U.S. physicians where sotatercept is available. Of course, they've got a number of patients that they want to get immediately onto sotatercept. These are the really high-risk, really progressed patients. But that leaves plenty of opportunity for, for seralutinib. In the context of the commercial opportunity, by the time we get to market, there's going to be a good number of patients that have tried sotatercept. It's worked for a while. We don't know what the durability looks like At this point in time. That will then creating next solution, and that will be the cycle.
That's right. So to your point, I mean, it's available and approved in the U.S. Obviously, availability in ex-U.S. markets is, you know, it's just not there yet.
Right.
And so that provides you, you know, certainly an opportunity to recruit heavily in those markets.
I'll say, Paul, we've also. We're about to open up a significant presence in South America, Latin America, as an example. Of course, we're going to be in Japan as well, and Saudi Arabia. So we've got a lot of sites where sotatercept really won't be available for, quite frankly, the duration of the PROSERA study.
Okay. Maybe just given the geographic mix of your enrollment, you can maybe just remind us, relative to the population you enrolled in TORREY, sort of what standard of care and just availability of approved therapeutics is like in those markets. Just to maybe help us think about how baseline differences might eventually show up in terms of the enrollment for the patient baseline characteristics.
Great. Rob, you want to?
Sure. So in all the countries we're in, and we're in over 30 countries, they have the oral, approved oral agents, the PDE5s and the ETRAs. In some of the countries, they don't have access to prostacyclin, especially the parenteral prostacyclin. And, you know, having seralutinib and the PROSERA study as an option is hugely important to these places, and it gives us a good patient mix, if you will, for looking at, you know, the impact of seralutinib on top of these, I call it foundational combination therapies, if you will, to look at changes in the six-minute walk. So we're pretty diverse and also the patient population we have exposure to. South American countries and some of these other countries, globally, we see patients who have less comorbidities. They're a little younger as well.
So in the U.S., we tend to be a little larger. We tend to have other diseases, and, you know, we want to have as diverse a population, but again, a homogeneous population in terms of their pulmonary hypertension, and we think we have that sweet spot with our, global.
I'll also just remind you that, in PROSERA, we are absolutely targeting a more sick patient population. A much lower cap on six-minute walk, 450 meters, whereas TORREY was-
550 meters.
550 meters .
Okay.
And of course, using the REVEAL Lite risk score, we're stratifying. So what we will end up with in the context of the patient population, will be a patient population that very much looks like what, sotatercept enrolled in, in their.
Okay, great. Given what you just described in terms of availability of background therapies, your thoughts on, you know, polypharmacy approach here in this category. I think it's been relatively well established that you layer on therapies as you progress from one class to another here. I guess, just as we think about the KOL feedback that you've received on TORREY, in terms of layering it on, seralutinib on existing therapies, how does this sort of... How easily, I guess, does it fit ultimately into the current treatment paradigm, whether it's U.S. or ex-U.S. markets?
I think if you polled physicians, and Rob, please jump in, but if you polled physicians today about sotatercept and seralutinib and the positioning, I think what you would hear kind of quite loudly is the desire to push out prostacyclin use as far as they possibly can. And, of course, the questions now that they're starting to mull through are: Do we use these agents earlier in the course of therapy to try to prevent longer-term disability? And, again, what Rob just walked you through in terms of the Open Label Extension, the fact that not only do we see durability, but continued improvement out to week 72 really begs that question. And then there's a, I think, also a tremendous interest in the combination of sotatercept and seralutinib. Rob?
Yeah, I think you have to also look at the dynamics of what the therapy is you're asking patients to live with. So we've had parenteral prostacyclin for 30 years now. That's the most potent drug we have. One could argue, if you really want to be proactive, you should give that drug as a first-line therapy. There are practical limitations of doing that, including patient acceptance and feasibility. I think with our drugs, with the seralutinib and the convenience... Our long-term now establish an emerging safety and tolerability profile. There's an argument that there'll be more patient acceptability to start this sooner than, than later, as Faheem was mentioning, especially with these longer-term effects and the tolerability.
With sotatercept, while it's a very promising therapy, you're asking patients to get an injection, and also the safety and tolerability burden over the long run may not make everyone an acceptable candidate for that therapy. But I also agree with Faheem, that really the new frontier is combining these remodeling agents together and perhaps put off or eliminate the need for some of these other therapies, which have a high management burden and/or tolerability burden, such as the prostacyclin class of drugs.
Okay, great. Maybe turning to the near to intermediate term, for even Rob, just as you think about, how you're going to communicate to the Street progress on PROSERA here, and just sort of what you want to lay out in terms of whether it's 2024 or 2025 expectations, and just sort of what milestones you'll be communicating to the Street on, on PROSERA.
Yeah. I think the most important milestone is our guidance around top-line data. Our guidance all along has been seeing top-line results by 5. So, we've kind of remained to that guidance and feel confident that that will be in place. We will be presenting some data at ERS around our echo, further echo work. Rob, if you want to-
Sure. We have, if you will, an enduring response cohort of patients from the Open Label study that shows significant benefit in their pulmonary vascular resistance, six-minute walk, et cetera. That will be presented at ERS. In addition, we have our phase II biomarker data, which is important to kind of link the mechanism of action with the potential for remodeling as well as, other, if you will, interesting scientific aspects of the compound. And we also have, if you will, data in human pulmonary vascular smooth muscle cells showing the remodeling effects of seralutinib.
Again, continuing to just kind of layer on further evidence of, of activity of this drug. And then, of course, we'll be giving updates on our progress towards getting our PH -ILD phase III up and running. Said we expect to have it up and running by here, but we'll be going through regulatory authorities, getting design approval, and the like.
Okay. Maybe just on PROSERA, apart from the top-line results, which you're shooting for, for end of next year, can you remind us if the study trial design builds in an interim look for any subset of patients or anything like that, that you'll communicate prior to the top?
No interim analysis.
Okay, great. I do want to touch on PH-ILD in a moment, but I want to also talk a little bit about Chiesi-
Yeah
And your collaboration there with them. Can you maybe talk to us a little bit about the genesis of that collaboration? Who courted who, or who asked who out and so forth, and just sort of in terms of the dating. And then maybe, you know, how does this, you know, in your mind, advance the strategy and the prospects for maximizing value with seralutinib?
Since you used the courting analogy, I won't give you too many intimate details, but I will tell you that it's been a long conversation. I mean, Chiesi approached us before the TORREY data. And so we've had a long ongoing dialogue with them. And then, you know, that dialogue started to intensify as they got more and more interested in what we were doing. Of course, they did a lot of homework with the clinical community. So look, the headline here is, I am absolutely thrilled about this relationship, and it's because of what it does for us at a strategic level and, and, and certainly in the context of value creation.
So the highest premise I'll start with, and then we can talk about some of the nuances of the deal, is that this now gives us capital to be able to do PH-ILD 4-5 years earlier than we otherwise would have been able to anticipate. We just would not have had the capital to be able to start a PH-ILD study in advance of getting the PAH data. So it turns us from a binary readout to now a company that has two significant readouts potentials for readouts. And it is important to note that the PH-ILD market is at least double the size of the PAH market, with very low competitive intensity. The only drug that's approved for PH-ILD is TYVASO, and only in the U.S.
So we've got essentially a vasodilator that will probably end up being combined with, which really leaves us unfettered in a massive market with huge unmet need. These patients are really sick. They're sicker than PAH patients. And so we think the validation that we've seen thus far with our TORREY data actually really gives us an opportunity to jump right into a phase III. And the community, the PH-ILD treating community, is very excited about this, and I think somewhat noted by the fact that Steven Nathan, who's arguably one of the biggest voices in PH-ILD in the treating community, joined our board. So I think that's kind of emblematic of the enthusiasm there. So the Chiesi deal brings in the capital. The cost sharing of our R&D programs as we go forward is hugely beneficial to us.
It puts us in a really strong financial situation, but an opportunity to grow our pie much bigger than we would have been otherwise.
And faster.
And faster. And then the nuances associated with this is that, it is... You know, some people have said, "Oh, does this take M&A off the table now?" It absolutely does not, and we were very specific about this. We lead global clinical development for PAH and PH-ILD worldwide, and we have a final say provision. We lead commercial in the U.S., and we have a final say provision, and we book sales in the U.S. And U.S., of course, being the biggest market in the world for these two indications. So that in itself represents, and all I need to say is think Pharmacyclics. But I had a personal experience, Paul, when I was CEO of PDL, and I spun out Facet Biotech a number of years ago.
Yeah.
I was partnered with Biogen Idec, and we sold to AbbVie, even in the face of that partnership. And I can tell you that that contract was a lot less clear than the contract that we've generated here. So M&A is clearly a no-no.
Okay. I want to speak a little bit on the commercial piece in terms of the potential synergies that Chiesi brings here. They do have some respiratory products and franchise here established both in the U.S. but it's maybe not as particularly well known, given that they're a European pharma and just sort of like, maybe you can remind us where they're already touching in terms of the cardiopulmonary or respiratory space.
Sure. So Chiesi is a really fascinating company. They do about $3 billion in sales worldwide. They've got about 7,000 employees. Their heart and soul, I will call it, is from the respiratory area, the pulmonology. They have a very significant, what they call an air business, which with a very strong footprint in Europe and the rest of world, which, of course, made them an ideal Europe, rest of world partner.
Yep.
In the context of the U.S., they're less well known, but they are really already creating a beachhead in the U.S. with their rare disease business and about to be creating a splash with their portfolio in pulmonology as well. So that made them ideal, and it also gave us the opportunity to really take the lead in the U.S., which arguably, if we had done this deal with a big pharma company, that would've been a very difficult thing to negotiate.
Sure. If memory serves, they have a footprint in CF and asthma to some degree.
Correct.
And so they're already-
And so already bringing great ideas because, you know, there is, as you know, our priorities, PAH, PH-ILD, but it's not inconceivable, it's viable to think that we might be looking at PH-IPF in the future, PH-COPD, IPF in general, and of course, those are real interests of Chiesi as well. So you know, obviously we'll walk before we run, but conceivably, you can think about this as a potential pill in a bottle.
In terms of-
Or an inhaler in a bottle.
An inhaler in a bottle. I want to ask maybe a little bit, in terms of how your collaboration works with regard to regulatory alignment and just who, who's in the driver's seat with regard to the U.S. FDA filing, a potential EMA filing, and, just, you know, where are the regulators, I guess, more broadly speaking, in terms of aligning on, on, you know, how, how to interpret PROSERA and use it as a registrational trial?
We have strong concordance between FDA and EMA on our trial, and kind of as it, as it sits now, six-minute walk will be the endpoint for both. So, we developed that, acceptance and concordance, before we'd started the PROSERA study. So we will continue, Gossamer will continue to drive the regulatory interactions. It would make sense to kind of do a handoff there. Certainly, as it relates to PH-ILD, we will continue to drive the regulatory discussions, both with EMA as well as the FDA.
Okay. And also, I want to touch on Japan and just given an opportunity there, how the framework with the PMDA and so forth is going there.
Yeah, so that was an interesting one that, quite frankly, really just showed up a number of months ago, where we had heard new guidance from Japan that we had never heard before around certain rare diseases, where typically they would ask for a bridging study, and they've really waived those requirements, which, which is a tremendous opportunity. And so of course, we jumped on that right away. I think we're gonna have somewhere in the neighborhood of 6-8 sites?
Eight sites in Japan. They'll be participating in TORREY. There's a lot of connectivity between the Japanese KOLs and our European KOLs, so we're looking forward to their contribution to PROSERA.
Okay, great. In our remaining time, I want to spend a little bit of time on PH-ILD and, you know, maybe first from Tori, how to think about the inferences, you know, particularly in a sicker patient population, as you said, that sort of has a phenotype, more of a, potentially of a PH-ILD type patient. And just maybe help us think about bridging, interpreting the data you've generated so far to this new and more sick population. Is that right?
Sure. So if we think about PH-ILD, there have been a lot of drugs tried that have worked in Group 1 , that didn't work in Group 3 . I think, to be fair, United cracked the code a little bit with TYVASO, and I had some experience with TYVASO, being the principal developer of that back in the day, and we learned a lot from their registration study. What we've learned is the population to study and also, if you will, that the inhaled route of delivery is really probably key to getting the drug to where it needs to go to treat the pulmonary hypertension component in the background setting of the lung disease.
I think we have a lot of experience with our current PROSERA sites and with Steven Nathan on board as well, to apply those learnings to really have a well-thought-out phase III registrational study as well. Add a little more?
Oh, well, just the important thing that Rob was pointing out is that we are treating PH, right?
Yeah.
And I think the validation comes in and the effect that we've seen in the context of TORREY on the pulmonary hypertension component of the disease. And so we think that the biology that we're attacking in context of PAH is exactly relevant in the context of PH-ILD.
Okay.
Patient selection will, of course, be absolutely important here. You've got a more heterogeneous patient population, and so we're spending a lot of time with our advisors right now on thinking through that. As Rob said, we've got a really good template to go by, which is the TYVASO study. So it kind of tells us that code has been cracked, and I think with careful trial design, we think we stand a pretty good chance.
So I know you and your SAB and advisors are thinking about it a little, very, very carefully. But to your point, and maybe just to play devil's advocate here, you know, in terms of a small POC study, given the heterogeneity of the population, is that something you'd consider in terms of your trial design? Whether it's like a run-in period for a set number of patients or something along those lines that might, you know, give you increased comfort before really putting your foot down on the gas and going full ahead with a pivotal trial later next year.
Yeah. Well, I'll start off by saying we have a lot of confidence running into a phase III pivotal trial, and we've thought pretty deeply about it and of course, we've spent a lot of time with the advisors in the field around that. The actual mechanics of how we do that is still, we're still working through, so more, more on that to come, and quite frankly, we're looking at all of those choices. Do we run right into a phase III? Do we do a small run-in to that phase III? Some more details on that to come.
Okay, great. With regard to the analog that you mentioned in just terms of the TYVASO study and the precedent or analog there, just in terms of sizing and thinking about, you know, study enrollment sizing and timelines and so forth, in terms of, like, establishing a clear treatment effect size and so forth, just can you maybe help us understand what is the framework? What does the historical precedent show there, and just sort of what, what sort of like, you know, is considered meaningful in terms of a treatment effect size?
In terms of the size of the study, I mean, if you point to the TYVASO study, I think there were about 160 patients per arm in that study.
300.
So, I think, you know, that probably gives us a rough estimation of what ballpark we'll be in, Paul.
Okay.
The treatment effect.
Treatment effect, these folks are either on, you know, in the upcoming seralutinib study, they'll either be on no background therapies or they'll be on TYVASO. So, you know, with a six-minute walk, these folks at baseline typically walk in the 200s, you know, so they're sicker coming in. I'm not going to speculate on what a clinically meaningful treatment effect is. We do see them, you know, 20-meter improvement in six-minute walk. I'm sure will be powered statistically to show a robust effect, and given the population, these are sicker folks, as Faheem mentioned, so the placebo group over, you know, the duration of the study, we would expect to show a decline in the, you know, the seralutinib arm obviously would show, you know, some sort of a treatment effect.
But in some ways, I'd say it's less complicated because compared with PROSERA, where we have two or three background therapies, I think that the treatment effect of seralutinib will easily, you know, shine through in this patient population.
Okay, great. This is a little further downstream, but as you think about, you know, both regulatory alignment and sort of the regulatory path there for approving seralutinib in this population, you know, how does that look like in your mind upon completion of study?
First off, in the endpoint, well, the approvable endpoint will be likely six-minute walk.
Yeah.
Certainly in the context of the FDA, we're pretty confident of that. I think probably as well as EMA, but more conversations need to be had about that. So that will kind of be the approvable.
Okay. We have less than a minute left. I just want to maybe touch just on commercialization in terms of your relationship with Chiesi, and just kind of how does PH-ILD fall into that? Is that something that's carved out specifically for you, or does that also fall under the umbrella of your collaboration?
It also falls under the umbrella, but again, just to reiterate, we will be and are taking the lead on global clinical development. Obviously, we're gonna do things very collaboratively because it wouldn't make sense to not to. They've got a lot of expertise that we can tap into, but we are at the lead. And then in the context of commercial, we're actually working on those commercial plans as we speak with them in terms of how we attack the U.S. market. But clearly, we will be in the lead and also have final say on how that path plays out. But I think together will end up being a stronger entity.
Okay. Last one for you, I guess, is, you know, for me, frustration as an analyst, I think it's just you have a de-risked asset. You know, I think that may not be reflected, you know, fully in your share price, but, you know, you as a management team, I guess, as you speak to the Street, you know, what is, you know, what do you communicate to investors and say, "You know, our data is not coming till next year, but what else is happening apart from the timing to catalysts?
Well, look, we have really been trying to educate the Street in terms of everything we've just talked about today. I think you've hit on all the really salient points, Paul. You know, you talked about frustration as an analyst. You know, it's really quite fascinating to us because we certainly believe what you just said. We have a de-risked asset. We've got an asset where every data point shows concordance. We clearly have an asset that not only is it safe, but it appears to be extremely active and in the right trial design, which is what we think we have now with PROSERA. We think that we've got a very decent, better than decent probability of success.
So, you know, in the context of where our stock price sits, you know, that, that certainly is, is kind of an interesting, interesting position. I think the Wall Street perspective started with a, just the, the TORREY data, the top-line TORREY data, without kind of digging into it. And then sotatercept, there was a narrative for a while, and may still exist, that, you know, with sotatercept being approved, there really isn't room for anything else. That, of course, we've already discussed, is, is just erroneous, quite frankly. And, and then I think, to be fair, everybody's waiting for the Aerovate data as well, which will be coming up soon.
Yeah.
I think, you know, those things will be a bit of a brush-clearing exercise for us, and in the end, the data will speak for itself, and we feel pretty good about that.
Okay, great. We'll have to end it on that note.
Thanks.
My thanks to Faheem and Rob for joining us.
Thanks, Paul.
We'll end the session. Thank you.