All right. I think we're ready to get started. Thanks, everyone, for joining us again at our conference this year, the inaugural Healthcare Innovation Conference for Guggenheim Securities and I'm here in Boston, day two, about halfway through, I guess, the three-day conference. I'm Vamil Divan, for those of you who don't know me, one of the biopharma analysts here at Guggenheim Securities and I'm joined by Daniel Crossett, up here on stage, also from the Guggenheim Securities and my side. And next up in this room, we have Savara. And next to me, we have Matt Pauls, the CEO. And on the far left, Braden Parker, the CCO of the company. Also, a couple other members of the team with us in the room. So yeah, so first of all, thanks so much for joining us. Congrats on all the progress you guys have shown over the course of the year. I know you guys just reported earnings this morning, had a little update. I don't know if you want to maybe make any opening comments and just sort of where things stand, and then we'll go right into the Q&A after that. Sounds great. Thank you. Yeah, so Matt Pauls, Chair and CEO of Savara. Thanks to the Guggenheim and its team for the invitation to participate. We did report earlier today third quarter earnings, and a couple of key updates. The first is we completed a successful, productive pre-BLA meeting with the FDA recently, and coming out of that, we have refined our BLA filing timelines, so the rolling submission will commence by the end of this year. So in the near future, we'll initiate the rolling submission, and we will complete the BLA submission in full by the end of the first quarter. That is a change from the previous guidance, which we kept a little more broad, which was 1H 2025. We've also included an update today on Europe. The MAA filing timeline will be by the end of 2025. So that's really, I think, the first time that we've put a stake in the ground with regard to MAA filing. We're excited to talk more about what we think to be the underappreciated opportunity in Europe for Molbreevi and the potential there. We also updated our cash runway guidance. We reported $219 million-ish or so on the balance sheet and extended cash runway through Q2027. Okay, great, so maybe why don't we just take one step back for people who might be newer to the story and just kind of give an overview on sort of Molbreevi, the progress you've had, the data to date. And then I did want to dive a little deeper into sort of aPAP as a condition, too, so let me just start with kind of how that's currently managed and what you're hoping Molbreevi will bring to the table here. Yeah, sure. So Savara, a single-asset company in orphan rare pulmonary respiratory diseases. Our single asset is a novel inhaled biologic, molgramostim inhalation solution. We just completed a long three-year global phase three study of 164 subjects in IMPALA-2. And we reported those data at the end of June of this year. Positive results. Won on the primary endpoint among other stat-sig wins, key secondary endpoints. And we're, as I mentioned earlier, we're marching towards BLA filing and MAA filing, both in 2025. And so aPAP currently, maybe you can talk through just the condition and how it's currently managed. I know there's also some lung lavage and some of these other therapies or options that are out there for patients. Maybe you can talk through that just for people who are still learning the story. Yeah, so aPAP is a rare lung disease. The diagnosed prevalence in the literature ranges from between six or seven per one million to mid-20s per one million. So rare, but we think underdiagnosed, without question. aPAP. It's autoimmune pulmonary alveolar proteinosis. We will go with aPAP for the rest of the fireside chat. It is a biological signaling issue in the alveolus. It's where the alveolus in the lung, it ultimately just misbehaves and does not effectively clear surfactant from the lung. So there's surfactant buildup and surfactant burden. And it's based on autoantibodies that cause it to do that. And so Molbreevi goes, the science and the biology is that it turns a signal on and helps start to reduce the surfactant burden. And so then, therefore, of course, activities of daily living, physical symptomatology of breathlessness and lethargy and other symptoms improve. And so we saw the IMPALA-2 data you mentioned in June and then some presentations since then. As you've talked to the sort of community, aPAP community, the thought leaders treating the condition, are there certain endpoints that seem to resonate more or less? In terms of what the doctors, what the patients are really sort of, what's really appealing to them in terms of what they're seeing here? Yeah, so the primary endpoint in IMPALA-2 was a measure of gas exchange that's very well accepted in the pulmonary respiratory community. And that's DLCO. And the primary endpoint win to deem a winning study was that it was a 40-week study. It was at week 24. It was stat-sig positive compared to placebo. And it maintained that statistical significance through 48 weeks, which is an important point to which I'm happy to come back to. So what we saw objectively was that Molbreevi outperformed placebo at both 24 and 48 weeks, maintaining durability of effect. I think what's important to note is that when you look at SGRQ, both total and activity at 24 weeks, Molbreevi was stat-sig on SGRQ total and nominally stat-sig on SGRQ activity at 24 weeks. And numerically maintained good separation from placebo through 48, although did not maintain statistical significance. Importantly also was a functional measurement of performance of Molbreevi versus placebo. And that was exercise treadmill test. And at six months, numerically started to see separation from placebo. But interestingly, at 48 weeks, it was statistically significantly better than placebo. So when you take the gestalt of all of the data, both the primary endpoint of DLCO at 24 and 48 weeks, and you cross-reference it with the key secondary endpoints of SGRQ total activity and exercise treadmill test, it's a compelling data set. And we think I have a high probability of regulatory approval in the U.S. and around the world. A couple of questions around what you mentioned, the pre-BLA meeting they just had. A few questions around sort of the regulatory side and the label. As you think about the label and the indication, you mentioned the 24-week data, the 48-week data. What do you expect all of that to be sort of presented in the label for doctors to see as they're prescribing? And then the second part, the communication from here. You're starting the rolling submission. Should we expect any updates from you along the way or just sometime near the end of the first quarter we'll hear that the filing is submitted? Yeah, so with regard to the label, I think it's premature for us to comment on what we think it could be. Of course, we aspire to have a broad, inclusive label that's as informative as possible for clinicians so that they can practice the best medicine possible. And then with regard to regulatory updates, given the fact that rolling submission will commence at the end of this year, and then it's just a few short months to completing the submission, that's I think you should just assume that you'll hear when we've completed the submission. That's all done? Yeah. Okay great. Let me turn to Daniel and ask a few on the more commercial side. Yeah, exactly. So maybe moving over to the commercial opportunity a little bit. So you guys went over this in detail on the commercial webinar back in September, delivered at the CHEST annual meeting in October. You kind of characterized the current aPAP population as well as the likely underdiagnosis in this indication. So maybe starting with the currently diagnosed patients, you guys just had around 3.6 thousand. Can you go into a little more detail about how you plan on profiling these centers to gain this line of sight to 100, I mean, sorry, to 1,000 aPAP patients at launch? Yeah, thanks for the question. And I'll ask Braden to take that one. Sure. As Matt mentioned earlier, the literature had a broad range on epidemiology. So we went and conducted our own claims database analysis and identified through ICD-9 and ICD-10 codes the 3,600 diagnosed patients today. So these are known diagnosed patients where we have physical addresses of the people that are managing them. So as you mentioned, the next step now is to begin going out, profiling those accounts, learning about the practice, the management of those patients, and other factors in preparation for launch. We've set out a goal of having line of sight to 1,000 of those patients by the launch, which you mentioned. And we're systematically going about that right now. And we're doing it in a couple of different ways. One is through the building of a field presence pre-launch where you can begin to do that profiling, some disease awareness education, some education around testing and the availability of the test, as well as some supplemental efforts where we're using tele-education to go to a broader population overall. While those 3,600 were identified within 1,100 accounts or so, what we've gone about doing is really prioritizing those accounts. So when you start thinking about centers of excellence where there might be a key opinion leader, high level of expertise and experience treating aPAP patients, there's a couple dozen of those, perhaps. And then you go to the next layer of interstitial lung disease clinics. You get to about 50 or so of those that also have enriched populations that might have aPAP patients in that. There’s a third tier of broader pulmonology centers that we're targeting as well. When you take the top 200 or so of those centers, you have more than enough to get to that 1,000-patient line of sight. We're systematically approaching each one of those accounts along that pyramid, if you will, in order to get to that number. OK, great. And I think last time we heard from you, you said you guys were adding around 300 patients as of now. I guess should we be expecting what kind of regular updates on how many patients you have line of sight to as we lead up to the launch? Yeah, we will certainly, it's a metric that we're tracking internally. And I think at the appropriate times between now and launch, we'll provide updates as to the progress that we're making. OK, great. So maybe moving over to those more unconfirmed patients that you guys have identified through the machine learning of these claims database. So maybe can you discuss these patients and maybe kind of broadly discuss why there is this likely under- or misdiagnosis in this indication? Sure. So as I mentioned, the 3,600 were those that had specific ICD-9 and ICD-10 coding for aPAP. And so what we did was take some artificial intelligence, machine learning, and apply it to the rest of the population within the data set. And we scored patients based on their claims history and how closely it resembled those that were diagnosed to have aPAP. And so based on that scoring system, you were either classified as likely to have aPAP or highly likely if you had something along the lines of a whole lung lavage or bronchoscopy or something along those lines would give you a higher score and make you more likely. When you look at that data set, it's another 3,700 patients, so a potential to double the size of the market overall. We also know where those patients lie in terms of the management and their practice. We'll be approaching those accounts as well with the disease education and starting to learn and educating around testing as well to see if they're good candidates that their physician identifies for our ClearPath test to identify aPAP. OK, great. Do you think maybe you could expand upon these efforts you guys are making towards expanding it with the ClearPath test as well as I believe you guys are doing this ILD pilot study? Can you maybe expand on these? Sure. So we launched the serum test, antibody test, I think at the end of last year at risk before the data reveal of IMPAALA-2, as Matt mentioned. And really what we've done since the data reveal is start to think about being smart about how we apply the testing. So leveraging ILD clinics. In this case, our pilot is down in Florida, that kind of southeast region where we believe ILD clinics have an enriched population of highly likely or likely aPAP patients. And that's a good population to start with to say, maybe if we do some additional testing here, we'll identify patients more quickly and more efficiently than might otherwise be identified out in the general population. So that is the nature of this pilot study. I think as we evolve the test to be more dried blood spot, and we're looking to launch that sometime in the first half of next year, a little bit simpler test than the serum test where you just a finger prick, you put the blood on the card and send it in, and seven days later, seven business days later, you can have an answer. That'll now allow us to take this pilot program and kind of more broadly spread it across the country in a more simple way that will hopefully help identify patients over the long term. OK, that's amazing, and Savara spent a good amount of time discussing this U.S. opportunity at your commercial webinar, but maybe can you expand a little bit and discuss the ex-U.S. opportunity and maybe generally talk about your plans to, are you guys going to host another sort of webinar to discuss it in more detail similarly to how you did in the U.S.? Or just generally, how are you going to communicate this? Yeah, I'll take the second part of the question, and then I'll turn the first part over to Braden. Yeah, at the appropriate time, we'll provide additional color and detail with regard to the European opportunity in more detail. That's forthcoming. As we've said today, we announced today that the MAA will be filed by the end of next year. So more to come on that. I think the takeaway on Europe is that it's been somewhat understated from our perspective. And it's a real opportunity. And we do look forward to sharing much more detail with regard to European plans, opportunity, et cetera. But in the meantime, Braden, do you want to provide some additional color? Sure. As Matt mentioned, we do think there is a significant opportunity over there. Traditionally speaking, Europe is roughly the same size from a patient perspective as the U.S. market, and at least our early landscape work would suggest that as well. In addition to the fact that it's very structured and centralized, so we have a sense for where the patients are and where they're going for expert treatment as well, so we think those factors lend itself very similar to the U.S. in the sense that it's a market that we can approach in a very capital efficient way in order to identify those patients and pull them through eventually post approval. Maybe I'll jump in. So it sounds like you're leaning towards doing this on your own at this point, not necessarily having someone partner with you? Yeah. So we are actively preparing to launch Molbreevi on our own in Europe. Now, there's a lot of distance between now and time and distance between now and when we launch in Europe. So we'll continue to be open-minded about how we do that. But I think what's important is that we have a team who have been there and done it. And we think there is a thoughtful, capital efficient way that from a kind of a bottom-up perspective that there's a clear path forward to go on our own in Europe. But I think we've also proven, this team's proven to be pragmatic and open-minded in the past, and we will continue to be going forward. But we have to prepare, and we are to go along. OK. And maybe you can talk a little bit about the competitive dynamics. So whole lung lavage obviously available now, potential competitor, I guess, approved in Japan not too long ago. What do you see as the competitive dynamics in the U.S. and in Europe? Yeah, so in the United States and in Europe, we actually, from a competitive perspective, don't see anything on near, mid, or long-term horizon with regard to a competitor. Nothing in development. So that's in the U.S. and Europe, we think that it's just wide open for Molbrivi for really over the long term. In Japan, Sargramostim was approved earlier this year. And so, but we still believe that there's an opportunity for us in Japan. And so we're moving forward. And we'll be providing more detail in the future on that. But in the U.S. and in Europe, whole lung lavage will always be a rescue therapy available as it should be for patients. But there is a real need clearly for a chronic therapeutic that helps address or at least attempt to address the biology of the problem. And then maybe coming back, another question we commonly get from investors is around the testing that you offer now and sort of the progress you're making there. I'm just curious sort of what your plans are to just share with the street any updates on how many of the tests have been done, how much has the testing helped find new patients that maybe weren't previously diagnosed. So just the plans at this point in terms of it. I think just the sort of educating the market is a key part of getting investors behind the story. So what are your plans between now and maybe the next 12 months before you launch to show the progress you're making there? Interestingly, based on the revised regulatory timelines that we provided this morning, if in fact priority review is granted, that would actually put PDUFA at the end of next year. So then therefore, what's critically important is that the 3,600 patients, the knowables, the patients with confirmed diagnosis, it's preparing the confirmed, already diagnosed patients for potential approval and therapy. We want to show a really strong uptake curve right out of the gate. In parallel, what's very important also is this group of likely or highly likely 3,700 patients, bringing them into the market over time. But when you look at analogs like LAM, or you look at Alpha-1, or there's plenty of others, the earlier you can get in and get this free diagnostic platform in place, the faster you can grow the market over time. The great news here is with 3,600 patients in the U.S. confirmed diagnosed, we have plenty to work with right now out of the gate, plenty of patients that are in need right now. Anything else there? Yeah, it's a significant opportunity that's right in front of us that we have to capture. And success will be determined by how well we penetrate the 3,600 to Matt's point. I think we view the testing as a long-term commitment to the community and really beginning to grow that over time. So placed in the proper context, more on the long-term horizon. Therefore, that's why you see so much focus from us on what the 3,600 looks like in the market opportunity today. OK. I think we only have about one minute left. You touched on this before at the start. But so you did a raise early third quarter, just maybe again sort of restating kind of your capital position, the runway, and kind of how should we think about. Sure. Yeah, so we reported today approximately $219 million on the balance sheet and extended cash runway now through Q2 of 2027. And so very well funded. We've been capital efficient and will continue to be. And we're now heads down just preparing because now it's very real. And sooner than maybe we or the market we're thinking. So it's great news for everybody. Yeah. OK. All right, congrats on all the progress. Thanks again for joining us. Thank you very much.