Altimmune, Inc. (ALT) September 2026 Conference Transcript

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 all the 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 us today.

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 the journey, your journey as a CEO and the story for those who are not familiar.

Thanks. So at Altamune, 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 pembidutide, 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 a 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 with PEMBDUTIDE. 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 Pembidutide. And again, the important differentiation that we think Pembidutide 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 MASH 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, Mohai, 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 of 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 Pembid that can bring multiple pull 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 a robust segment of patients where we think the benefit of PEMV 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 PEMDUTAS.

It's basically GLP plus.

Glucagon plus.

Okay, glucagon plus, sorry.

It's the importance of Glucagon. 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 glucagon 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 mass. 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 efficacious dose, suppressing the cause, treating the liver. And pemfitidite is really designed to be able to do that.

Makes sense. So the other question is that with the PERFORMA study, when so what should investors be looking at when the data read out obviously mesh resolution and all those things are there but like are there particular attributes you would ask you would make you ask us to focus on from this study that the data is out right so we have designed the study in a fairly conservative manner because that's a study that using biopsy as an endpoint We will look at mesh 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 is an AI generated approach to reading the biopsy, which should decrease the variability. We also compare to our phase two 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 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. We'll, 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 2 trial, So we'll get a sense of a higher dose in a MASH population. And I guess the other thing which is interesting, we know from our obesity experience that in Phase II, penvidutide 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 III 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 glucagon could be better in terms of muscle 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 could be a really positive aspect that pemvidutide is bringing. Got it. And you're using DEXA scans or MRI? So we're going to use MRI and there is a number of aspects because it's great to use to look at just the some biomarkers etc 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 performa study at this point? Timelines for performa data readout?

The timelines for So the data readout, 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.

Very helpful. Thank you. And then you also shared 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 issue 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's a population that is much more representative of the real world population than some of the recent study 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 pathism 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 we the consistency between all these measures was very striking I think the importance as Jerry mentions the AUD and the mass patients are slightly different however we know that there is met ALD in the mass population so some of those there's patients that are drinking also in the mass populations and we know that there is advanced liver disease already in the in the AUD, ALD populations. So this overlap between these different causes of advanced liver disease is really critical because pemvidutide 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 glucogon could play a role for the liver side of things but how like what glucagon adds to the alcohol use disorder per se like does it cause a little bit more inhibition than then just the GLP like what does glucagon add to that?

So the glucagon impact is currently unknown or very poorly studied. It's a great questions because we are obviously very interested in this. Everybody knows the GLP-1 and how it works through the dopamine repression, et cetera. But there are glucagon receptors all over the CNS, even in the regions, the same regions that the GLP-1 is affecting, whether it's appetite or the alcohol occurring in the real world 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 a one-day improvement, for example, and we saw actually more than this. Whether it is due to the glucagon, whether it is due 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 it's 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 severe 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 PEMV can have the most impact, In fact, 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 PENVI.

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 you think about it right now?

Yeah we are in the planning of this we are preparing to interact with regulatory agencies we're putting the different pieces together for this and and we are our concept is to try as Jerry highlighted not only to get the patients that have what I would call it more typical type of AUD but also we have the opportunity with penviditide 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 AUD. So Pemvigetide will be suited in our phase three approach. We'd like to target both of those populations.

Got it. So the interesting data from other GLP glucagon came out, Cervigetide from New Zealand earlier this year. So not in MASH yet, but they have some NAFLD data in there. So talk about, like, 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. I mean, 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 silver detide, that's a good validation of the dual agonism. They have different ratio. They're seven to one. They have a high discontinuation rate due to the tolerability, which is extremely different than what we see with pemviditide. 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 pemviditide. 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. And 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 outcomes. So we're gonna 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 right. 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 servodetite that lost one out of four patients in their study, with pemvidetite, we keep more than 80, 90% in our study. So we're in good shape so far from what we've observed. than we have experienced 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 penvidutide 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 two, You know, more patients stayed, less patients discontinued on PEMV due to AEs than did on placebo, which is a really different picture from what we see in the MASH phase two on cervidutide. 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 retitutrile, right? So retitutrile 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 retitutrile to Manjaro. 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 retatridide is a very different molecule. So the affinity it's mostly focused on the GIP. The EC50 for the GIP is 0.06. The EC50 for the GLP-1 is ten times higher, I want to say 0.8, and then the glucagon side is another ten times with close to 5.6, 5.8, which means there's a hundredfold difference between the GIP and the glucagon affinity, which means that this is really heavily focused on the GIP side of things and the glucagon 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 a clinician, I mean, if you want to treat diabetic patients, but you add dysastasia, 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 PEMVD-Tide or experienced anything similar to this. So it's a little, it's a bit of a different molecule than 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 Restore 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 two trial. We will read out at 12 months. Fibra scan is the primary endpoint. so we'll really be able to assess in this population the impact on FibroScan both at 12 and at six months. 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'll 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 PEMV brings the impact on liver scan measurement at 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.

Yeah, just on the regulatory side, it strengthens our propositions now when we go to have an indication that address AUD, whether you have ALD or not. And I think for the phase three and vis-a-vis the regulator, our current thinking is that having those data enhanced and our phase three 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 II. 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 II, 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 what do you have to get a buy-in from the FDA before you start the trial at this point?

Yes it's a registration all the people to 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 with the FDA and obviously we'll have also discussions with other European regulatory agencies like we've done for MASH basically it's it's aligning on our approach for registration.

Who treats these patients? Is it primary care? I'm sorry? For AUD is it primary care or liver doctors?

So it's a mix right as as patients get more advanced the higher the probability they're with GIs or with with hepatologists we know that a considerable number of GPs and 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 think about 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 two's, ALD, it'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 seat 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 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. Fast forward one year, Wells Fargo Healthcare Conference 2027. I hope you are 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 going to 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. Anything to add?

No, the time moves quickly. We'll be here a year ago like this. But there's a lot of hard work going on. And I'm very proud of the team and the progress being made here. Pretty impressive.

On that high note, thank you very much for coming and all the best. Thanks, Mark.

Thank you very much.