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Awesome. Thank you very much for joining us today. My name is Mohit Bansal. I'm one of the biotech and pharma analysts at Wells Fargo, and I'm very happy to have Altimmune Management team with us today, so we are joined by Jerry Durso, the chief executive officer, Greg Weaver, the CFO of the company, and Christophe, the Chief Medical Officer of the Company. Thank You very much for joining. Thanks for having us, Mohit. Awesome. So why don't we start with, you know, those who are new to the story. There have been some changes in the story since last year. So talk a little bit about your journey as a CEO and the story for those who are not familiar. Thanks. So at Altimmune, we're a company focused on liver disease. I've been the CEO since the beginning of 26. The main focus of our efforts is around Pembedutide, which is a balanced glucagon GLP agonist, and again, we think is well-positioned for liver diseases based on the overall clinical profile that's evolved. We spent quite a bit of time this year as we've transitioned to a late-stage development company. Really happy last month to announce that our phase three in MASH is enrolling after a lot of work to deliver the phase two data, and to raise appropriately to transform the balance sheet in order to support execution of the phase three trial in MASH, which is called Performa. And then also importantly, recently we announced very positive phase two data from our AUD trial, alcohol use disorder, again, another opportunity with a high unmet need in the market and real important differentiation that we're beginning to see with Pemba Dew Tide. So we think we're positioned well as we, again, continue to really focus on the execution now. Maybe Greg can touch a minute on the balance sheet, which is an important part of where we are. And then hopefully through the conversation, we can talk about why we're excited about PemBA Dew TIDE and, again. the important differentiation we think PemBa Dew Tides can bring. We've had, I think, a great amount of progress to date as we think about the year. It's been a busy year, but we're clear on the work to do ahead. Got it. Very, very interesting. So talk a little bit about, you know, like this is where for match market, the question is because as of now, there are two different agents out there. So obviously you have approaches which do not lower weight, and then you have JLP1 approaches as well. What your agent brings to the table and how differentiated it is from what is out there? So, Mohan, as you know, we've been talking for a long time in MASH about the complexity of the disease. It's a multifactorial disease. And for a Long Time Now, the KOLs, the investigators have talked about the importance of potentially bringing combination therapy to the Table. Why? because the disease is complex. You have different manifestations ultimately leading to liver complications. A combination approach like pembidutide is where you're bringing, again, the direct action on the liver, and Christoph can go into some detail perhaps, along with the benefits of GLP, the metabolic benefits. We know that we're driving weight loss. We see good indicators in phase two are the impact on fibrosis and MASH resolution. And also, importantly, when you think about chronic therapy, the real need to keep patients on the drug at the right dose, we think we saw in our phase two MASH trial that the profile of pembidutide probably is well suited to the real world, where we know patients have difficulty staying on some of the existing therapies. So as the MASH market evolves, we think that drugs like Pembe that can bring multiple benefits to the table, but do it in a balanced and patient-friendly way are going to be important. And again, we Think that the phase two data that we've generated thus far starts to talk about that differentiation. I've always believed that the MESH market treatment will end up maturing like every other big chronic class where you have multiple mechanisms at play as patients progress in severity of diseases. So we always think about the opportunity for PEMV for, you know, a robust segment of patients where we think the benefit of PEMVR is different than some of the other options that are out there. But the importance to bring the benefits of both the direct liver effects and the metabolic effects in GLP we think is one of the important dimensions of Pemidutide? It's basically GLP plus. Glucagon plus. Okay, Glucogon plus, sorry. It's the importance of Glucegon. So first, we know that GLP takes a long time to have the effect because it's an indirect effect. So the direct effect of Gleucogon on the liver is important in these patients early on so that they can see the benefits of this. And then the GLP-1, it's also treating the cause for what's driving that mesh. So when you suppress the cause and you treat directly the liver impairment aspect, either the steatosis, the inflammation, or clearly the fibrosis, now you see the full benefits of what you can bring for these patients. In addition, again, the adherence, as Jerry was highlighting, is critical because it's a chronic disease. So if the patients cannot, because the titration is difficult, cannot reach an efficacious dose, or these patients drop out after six months, fibrosis is not something that you get rid of in just a few weeks. It takes a long time. So you need to keep your patients at an effic gracious dose, suppressing the cause, treating the liver, and penvidutite is really designed to be able to to do that. Makes sense. So the other question is that with the PERFORMA study, so what should investors be looking at when the data read out? Obviously, match resolution and all those things are there, but are there particular attributes you would ask us to focus on from this study when the read data readout? Right, so we have designed a study in a fairly conservative manner, because that's a study that's using biopsy as an endpoint. We will look at mass resolution and fibrosis improvement, both for FDA and European regulators. But what we've built in this study is a number of aspects that are unique, that we believe, one, will facilitate the enrollment. For example, we have the two cohorts, So for PIs, that helps because they can recycle their patients in the second cohorts, and it's a very attractive feature. Now, for the efficacy of the trials, we are the first phase three registrational trials in that performance study that uses the AMASH, which assist, ASSIST, which is an AI-generated approach to reading the biopsy, which should decrease the variability. We also compared to our phase 2 data, where we had already a very strong efficacy at 1.8 milligram. We added the 2.4 milligram dose because our titration scheme is very simple, one or two steps, and the drug is very well tolerated that allows us to do this. And then And the weight loss didn't plateau at 48 weeks. So this combination of things give us an approach that is conservative in its nature, but also give us the upside to read the trials and the full potential of pemvidutide on the fibrosis biopsies. So we'll look at the classic efficacy markers, as you mentioned, will importantly the adherence rate. We anticipate a low discontinuation. Christophe, I think, has underscored how important that is in the context of chronic therapy. We'll look at the 2.4 milligram dose, which will be important. That was not part of the phase two trial, so we'll get a sense of a higher dose in a mass population. And I guess the other thing which is interesting, we know from our obesity experience that in In phase two, pembidutide seemed to do a good job in the obesity population, sparing lean muscle mass loss. We'll look at that in a MASH population in the phase three study, which, again, could be another important element as we look about treating these patients over time. So it'll be a robust, really robust data set and, again for us, the good signal that we were able to start the trial quickly and now heavy focus on the execution and enrollment. And I'm sure over the coming months and quarters, we'll be talking more about the progress of the study as we execute. Very helpful. In terms of muscle loss, is there a scientific reason why glucogon could be better in terms of mussel preservation versus a GLP, GIP, and all those approaches which promised, new approaches promised, but they did not deliver on the muscle preservation part of things. So the quality, this is a topic that's evolving in the scientific clinical community that's of great interest because MASH patients are at risk. The population itself, as we've shown in our phase two, is actually a population that's on average 55, so these are patients that are at-risk and in the AUD or ALD it's even more critical there. We have observed in our obesity study some beneficial effect that seems to suggest that we are preserving this lean mass. So that's a combination that's important to keep in mind. We will be studying this in our phase three. We are planning to have a much more rigorous approach in studying this, in order to be able to, at the end of the 52 weeks, for example, look at what kind of weight loss happens on pemvidutide. But this is something that seems to, that quality weight loss, that seems, that could be a really positive aspect that pemviducide is bringing. Got it, and you're using DEXA scans or MRI? So we're gonna use MRI, and there is a number of aspects because it's great to use to look at just the, some biomarkers, et cetera, or MRI, but it's also the functional aspect of what that means for the patients, and I think that's an important factor too. Makes sense. Thank you. And so what are the timelines for performance study at this point? Timelines for performance data readout? The timelines for the data readouts, yes. So it's a five-year study. For the accelerated approval, it's going to be 52 weeks, and we've shared that in 2029 we're expecting the data to read out. Got it. Very helpful. Thank you. And then you also share results from the RECLAIM study, the alcohol use disorder study. Talk a little bit about the data you have seen and also like how much comfort it gives you in the mesh from that data readout. Yeah, I guess first, and Christoph can go into the data, but we were really encouraged by what we saw. We think it's the most robust data set in AUD based on the consistency of the effect on drinking across all of the endpoints, including the two potentially registrational endpoints. I think it gives us a good indicator of what we could be doing in an AUD population. I think It also is a different population than MASH. And so I wouldn't say it's necessarily the transferable read over. However, there is some consistency on what we see in terms of what the drug is doing that as we look more and more, and this is, again, the third phase two that we've read out, we do see, again every reason to believe that pembidutide can have a broad effect across a multitude of liver diseases, which is why you hear us talk about now of a franchise opportunity that we have in liver disease as we get more phase two data. Yeah. So the study was designed. It's a multicentric study. It uses different sites. It is a population that is much more representative of the real world population than some of the recent studies that have been published. And in these data, we show a very clear reduction in heavy drinking days per week. We also show the WHO RDL risk decrease by 2.2 levels and zero heavy drinking days improvement in this population. The consistency of these patients' reported outcome is very striking, especially on the abstinence part, which is very difficult to achieve. And then we also have a more objective measure like the PATH that we were able to demonstrate. The PATH is a test that looks at the alcohol intake in the past four to six weeks, a little bit like HbA1c represents glucose in diabetic patients. So we've had those, the consistency between all these measures was very striking. I think the importance, as Jerry mentions, the AUD and the MASH patients are slightly different. However, we know that there is MET-ALD in the MOSH population, so some of those, there's patients that are drinking also in the mosh populations, and we know there is advanced liver disease already in the AUDALD populations. So this overlap between these different causes of advanced liver disease is really critical because pemvigutide, through the direct effect on the liver and through the impact on the causes, either metabolic or alcohol, can really target this population specifically. Got it. That makes sense. So I understand that glucagon could play a role for the liver side of things, but how, like, what glucagons adds to the alcohol use disorder per se? Like, does it cause a little bit more inhibition than just the GLP? Like, what does glucagone add to that? So the glucagoin impact is currently unknown or very poorly studied. It's a great question because we are obviously very interested in this. Everybody knows the GLP-1 and how it works through the dopamine, the repression, et cetera. But there are glucagon receptors all over the CNS, even in the regions, the same regions that the GLT-1 is affecting, whether it's appetite or the alcohol accrearing in the reward system. So it is potential possible that there could be an effect of glucagon, we don't know. In our study, we plan originally to see an effect that was similar to what we saw in this one study with semaglutide around the one day improvement, for example, and we saw actually more than this. Whether it is due to the glucagone, whether it is you to other factors, It's currently unknown, but it's very encouraging, and again, this population is not only having an addictive issue per se, but is having also already some liver disease. It's having liver steatosis or inflammation at minimum, but also sometimes even early fibrosis. So targeting this, those two aspects are important. Got it. So we were really encouraged by what we saw with the data set. Again, the population in the study was moderate to severe AUD. We think that, again, that's where we're going to focus on the more moderate to sever population. And then we know that those patients are at highest likelihood of going on to have liver issues, and that many of them, many of the AUD patients are already suffering from ALD. So when we think about where a drug like Pembe can have the most impact, it's going to be on the more advanced population. Again, where the liver, the direct liver action, the potential liver benefit in addition to the impact on drinking can be most important. So when we think about the marketplace that's ultimately out there, you know, there's about 12 million patients in the U.S. with moderate to severe AUD, 6 million with ALD. So it's a sizable population. We know the unmet need is high. And again, we know that the importance of impacting both the drinking and the consequences of that on the liver are going to be really important. And that's how we think about ultimately pursuing phase three and starting to think about the value proposition ultimately in the marketplace for Pembe. So maybe alcohol companies should start investing in your companies as well, right? 12 million is a big number. So you are in the planning phase of phase three? Like, how are you thinking about it right now? Yeah, we are in planning of this. We are preparing to interact with regulatory agencies. We're putting the different pieces together for this. And we, our concept is to try, as Jerry highlighted, not only to get the patients that have what I would call a more typical type of AUD, but also we have the opportunity with penvidutide to target the patients that have AUD and ALD, and we know that it's a sizable group of patients because 50% of these ALD patients have AUT. So penvidetide will be suited, and our phase three approach would like to target both of those populations. Got it. So the interesting data from another GLP-glucagon came out, Cervodutide from New Zealand earlier this year. So not in MASH yet, but they have some NAFLD data in there. So talk about what did you learn from those trials? And then also, there's a phenomenon of controlling the placebo nowadays because people don't want to stay on placebo for a long time. Especially in your case, it's a long trial. So how do you plan to manage all those aspects of the trial? Yes, so just those different molecules, so servodetide, it's a good validation of the dual agonism. They have different ratio. They're 7 to 1. They have a high discontinuation rate due to the tolerability, which is extremely different than what we see with pemvidetide. So I think that dual mechanism becomes more and more accepted. Also, there will be differences in molecule that so far from what we've seen favor pembidetide. With regard to your question more on the placebo side, clearly it is something that we are looking into and working very hard with the site to keep the patients. There is a number of incentivization for patients to stay in our trial. First, they have two chance out of three to get the active drug, which is already a good point. The second is that there is, in our trials, there are, as mentioned, like this AMASH assist. So the first 52 weeks is probably the one that is the most difficult to keep those patients. After that, it's mostly hard outcome, liver-related outcome. So we're going to be looking at these in these populations. So I think we see a very good response so far from our sites, extremely high interest in bringing patients in the study. And we haven't heard any concerns around placebo retention, but we'll see throughout. It's also an indirect measure of efficacy. So if you lose your patients in the placebo more than in your active arm, it shows that you're, so this will play as you would see in the real world. But we have a clear efforts. Retention is a key aspect. And unlike servodutide that lost one out of four patients in their study, with pemvidutide, we keep more than 80, 90% in our study. So we're in good shape so far from what we've observed, and we have experience with 48 weeks in the phase two. So we'll see when we see their MASH data, but we feel good at this point about the potential differentiation. We know that the ratio matters, and so you have a balanced ratio with Pemvidutide that we think plays in our favor. The molecule matters, and so the Uport domain is probably having an impact on this tolerability and why in the MASH Phase II, you know, more patients stayed, less patients discontinued on Pemvi due to AEs than did on placebo, which is a really different picture from what we see in the MASH phase 2 on servodutide. So we'll, of course, learn more, but we think the compounds are very different, and we like what we're seeing thus far in terms of the differentiation, which we know ultimately when you think of it fast forward to these drugs in market, the differentiation is going to be critical. Right. That's fair. That is fair. Then, the other question, obviously you get a lot as well is probably retratratide, right? So retratatide is a three mechanism combo here. So would love to learn about the differences there versus your molecule. And then also, they're running a very interesting trial. So they are comparing retratrate to Monjaro. So that'll probably be the most definitive trial. Maybe it'll help you as well to show that glucagon is important or not. So talk a little bit about that aspect of things. So ratatridide is a very different molecule. So the affinity, it's mostly focused on the GIP. The EC50 for the GEP is 0.06. The EC 50 for the GLP-1 is 10 times higher, 0.8, and then the glucagon side is another 10 times on side is another 10 times with close to 5.6, 5.8, which means there's hundred fold difference between the GIP and the glucagon affinity, which means that this is really heavily focused on the GEP side of things. And the glocagon is actually much less important. We are really on the glucagon and the GLP-1 directly with a very high affinity up front, so pemvidutide is different. They are moving forward and all the effect that they have, I agree that it could help us in that direction. I think, again, some of the things that we need to look at is the tolerability, and clearly there's some differences. There is also those, and as clinicians, I mean, if you wanna treat diabetic patients, but you add dysesthesia, and those patients could have diabetic neuropathy, that's an issue that I would be concerned about, so it's a little different. We haven't seen this with pemvidutide or experienced anything similar to this. So it's little, it's bit of a different molecule And then PEMV that has that one-to-one ratio with very high affinity both on the GLP-1 and on the glucagon. Got it. Very helpful. I also want to touch upon the alcoholic liver disease trial that you are running, the RESTRO trial. So same question, like what aspects of reclaimed trial that make you comfortable about ALD? Some patients already have liver disease there as well. And then, again, talk us about the timeline and how should we set the stage for the data data, like what should we expect there? Yeah, so we announced last month that we were fully enrolled in the ALD Phase 2 trial. We will read out at 12 months. Fiberscan is the primary endpoint, so will really be able to assess in this population the impact on FibroScan, both at 12 and at six months. Okay, so we'll read at 12, but we'll have a chance to look at both time points. And again, those patients are drinking at a considerable rate, so we will also assess the impact in that more advanced ALD population on the drinking levels, on weight, on tolerability, on all the usual suspects. So we think this is going to be a really important incremental learning that will help support a population that we'll also look to include in our AUD trial. Again, because of this important overlap in the two diseases, we think that this is an important differentiator because we think, again, because of the mechanism that PEMVI brings the impact on liver scan measurement that 12 and 6 months could be an important differentiator against other compounds, that might be more on the GLP side and won't bring the direct liver. Just on the regulatory side, it strengthens our propositions now when we go to have indications that address AUD, whether you have ALD or not. And I think for the phase 3 vis-a-vis the regulator, our current thinking is that having those data enhanced and our phase 3 in that subpopulation should give us a very strong differentiated package. So are you measuring biopsy-driven liver disease or not? We're not measuring biopsies in the current phase two. As you know, ALD path regulatory-wise is more complicated. You need an outcome study. But through the AUD indications, we know that 50% of those patients have AUD. So we want to strengthen that package through our phase two, as Jerry said, at week 24 or at week 48. and, in addition, include that subpopulation in our phase three. Got it. Very helpful. One more on AUD, going back to AUD trials. So, like, obviously, you're playing the trial and everything. So, do you have to get a buy-in from the FDA before you start the trial at this point? Yes, it's a registrational pivotal study. So, we're going to get an end of phase two meeting, and we will have, we will propose our approach. We'll have the discussions with the FDA, and obviously we'll have also discussions with other European regulatory agencies, like we've done for MASH, basically. It's aligning on our approach for registration. Who treats these patients? Is it primary care? I'm sorry? For AUD, is it primarycare or liver doctors? So it's a mix, right? As patients get more advanced, the higher the probability they're with GIs or with hepatologists. We know that a considerable number of GPs end psychiatry often for the addiction side of things. So there's a mix of physicians that are out there. As Christoph mentioned, that end of phase two meeting is going to be important for us to finalize, size the scope of what a potential phase three trial may look like in AUD as we do the kind of commercial thinking along the way in terms of the treaters, how to think about it. And then that input from the end of phase two will be important as we think about potential funding mechanisms for a phase three. And maybe Greg can touch on how we thinkabout that dimension of our AUD approach. Yeah, thanks, Jerry. Mohit, we've got first of the balance sheet today at the end of June reported out 519 million in cash. So that's a runway that takes us full on through the readout in MASH in 2029, importantly. And we mentioned the two phase twos, ALD, that's ongoing, AUD that just read out. We're in position for an AUD phase three that's going to need a requirement for some funding on top of today's balance sheet. We have some prospective look at non-dilutive options there that we're confident we can pull off. I think that's the approach. And I think investors are looking to the solid balance sheet and the leadership team. And I just should mention our internal team doing just a yeoman's work in execution day in, day out on these trials. So I'm happy about that. And as we go into later in the year, we'll get more guidance around what that phase three scope and scale would look like. Awesome. So one last question for all of you. So fast forward one year, Wells Fargo Healthcare Conference 2027. I hope you are here. I am here. What would make you look back at the year and say it was a great year for us? So a lot of work ahead of us. And I think if we think about a year from now, you know, look, we're going to monitor closely and we anticipate the execution of the perform a trial. We're goingto be progressing well. Those are large studies. The enrollment clip is important, and so we'll be anticipating that the fast start that we've had in terms of getting up in the trial is translating to a robust and rapid enrollment because that's going to be critically important. We anticipate we could be in a position, again, if all things progress, where we could be in phase three for a second program. We'll think about timing around that. Again, we've got to size the trial. We have to work through some of the elements that Greg mentioned, but every reason to believe that there's a really unique opportunity and we'll be, you know, in the window of a lot of learning on our ALD readout. So, again, when you think about progress in terms of execution on two major indications as well as more data coming with good, strong execution and clear understanding of how we want to ultimately differentiate Pemba-Dutite in the market, a lot of progress forward to look front of. And if we're getting the invitation from you now, we say we'll be back. September 8th to 10th next year. This is your invitation. Awesome. Awesome. Anything to add? No. The time moves quickly. Yeah. We'll be here a year. It'll go like this. But there's a lot of hard work going on, and very proud of the team and the progress being made here. Pretty impressive. Awesome. On that high note, thank you very much for coming, and all the best. Thanks, Mahat. Thank you very, very much.