Altimmune Inc at Goldman Sachs Global Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Corinne Johnson - Goldman Sachs - Analyst : Great. I think we'll definitely have some time on MASH, particularly given some recent updates. So maybe we'll start with obesity. You talked about this, but you reported Phase 2 data last December. Maybe you could walk through some of the key details from those results as you see them through. Unidentified Company Representative So we achieved at the end of 48 weeks, 15.6% weight loss, but the shape of the weight loss curve or its trajectory was downward pointing. We think that at the end of 72 weeks, which is where tirzepatide read their data, we can have substantially more weight loss rivaling the numbers they came up. And patients who had high lipids at baseline. We saw very profound reductions in serum lipids, LDL cholesterol reduction of 21% while not directly looked at in that trial we also saw great reductions in liver fat. This was not enough of the population, but 80% of their people die fat in their liver, which is very important for cardiovascular risk. One of the more important readouts from that study was body composition. We have best-in-class preservation of lean mass. We're still looking at that data, we think there's some potential of getting even better effects as we mine the data more will make a presentation of that in a meeting later this year. But this is extremely important for something that's not gotten enough attention right now in the minds of investors, which is maintenance and safe and effective maintenance of body weight. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 12, 2024 / 1:20PM, ALT.OQ - Altimmune Inc at Goldman Sachs Global Healthcare Conference The focus has been on how much weight loss you have in a year, but some of these drugs are having profound loss of lean body mass. Semaglutide, for example, was associated with bone fractures in the elderly and in women, that's not really going to cut the mustard in terms of long-term treatment. So as a cosmetic drug getting weight loss that may really suit a lot of people, but for effective long term management, when you safely reduce cardiovascular risk while also preserving lean body mass, that's very important. Our lean body mass preservation is commensurate with and probably even better as we see it now than diet and exercise. So we're really gearing our program right now towards safe maintenance of weight loss. We'd like to have that discussion with the FDA and build it into our studies when we talk to the FDA at our endof-Phase 2 meeting, which will be in the late in the third quarter of this year.

Question: Corinne Johnson - Goldman Sachs - Analyst : Okay. You mentioned the body composition data, obviously early signals an intriguing there. I guess could you talk to us about the mechanistic basis. You think that's providing that benefit within the Pemviduitide. Unidentified Company Representative Glucagon, which is the key component in pemvidutide, [shift] metabolism from carbohydrate to fat. We know that we saw that in our data and we saw a rise in ketone bodies in our studies. So glucagon acts by inducing what you might say is a ketogenic diet. We know that's preserving for lean mass. So what it does is it takes away the reliance of muscle to provide the substrate for glucose in the liver and therefore, Rob's deliver if it's amino acids in protein in order to supply carbohydrate shift that over to fat and it puts the burden on fat. And we think that's the mechanism of preserving the lean mass. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 12, 2024 / 1:20PM, ALT.OQ - Altimmune Inc at Goldman Sachs Global Healthcare Conference

Question: Corinne Johnson - Goldman Sachs - Analyst : Okay. As you look across all the data and think about next steps for the program. I guess what are your priorities going to be anything maybe you alluded to this in your first comments. That what are your priorities going to be as you go speak to regulators to this year? Unidentified Company Representative I think the most important thing going to bring out are the attributes and the benefits of glucagon. So we could take the approach that we're going to just target the entire obesity population. That's going to be a huge population, there's really no need for this. We saw hypertension divide into 10 drug classes each having its own role. We think that we need to concentrate in this huge marketplace and what glucagon actually brings to the table, which is going to make it desirable for doctors to prescribe. So things like lipids, liver fat, body composition. So it's important for us to identify for the marketplace where this is going to fit in the treatment paradigm and to actually design studies and get agreement with the FDA on those studies in order to drive home that value. Based on that, we think that with the studies that we're going to propose to the agency and discuss with them at the end of Phase 2 meeting, which will concentrate on those glucagon specific attributes. We think that meeting will be confirming of our statements about glucagon and actually drive a value of tremendously.

Question: Corinne Johnson - Goldman Sachs - Analyst : As you like look forward then anything about what kind of like outcome studies that you could run successfully, was an asset of this profile what are some of the most interesting outcomes you think you could be proving out here? Unidentified Company Representative Well, I think a long-term rise to show that we're preserving lean mass in susceptible populations better than other drugs, but also relating to outcomes with enough patients. And as we have mentioned, these pivotal studies are large enough to look at outcomes like bone fractures. You know, for example, the obverse were seen in the semaglutide program where they had a 40% loss of lean mass. We're at about 25% were about diet and exercise at this point, but they actually had in their label and increased risk of bone fractures. So it is possible within the pivotal program to show an impact on bone fractures. Obviously, we would have tried to show the opposite and tried to get that into our label. So we think that's really what we wanted to design into our program really take a focus towards the long term in terms of the safe and effective maintenance of weight loss. And also the safe and effective maintenance of reduction in serum lipids and liver fat. Yes, I just wanted to add that to date, there's been a lot of focus on acute weight loss. What happens in 12, 24, 48 weeks. That's not what's going to be about, it's really going (technical difficulty) about weight management and weight maintenance. So we think again, a glucagon containing compound is really going to shine (technical difficulty) long-term lipid profile and actually (technical difficulty). Yeah, let me add to that Corinne, right now (technical difficulty) I firmly believe -- we firmly believe that in near future, three, five years approvals will also be based on safe and effective maintenance of weight loss. We saw this in other indications, for example, in croninson ulcerative colitis, it could be in the 1990s, you could get an approval for induction of remission of one of those diseases by the mid part of the first decade that shifted to you have to show maintenance of effect, you couldn't just get an effect on inducing remission in Crohn's disease, you have to show maintenance of remission to get approval. So we think that, right now the field is still young drugs are getting approved in acute weight loss, but I think in the future there will be a shift to showing maintenance of weight loss safely and effectively as well. And we think (technical difficulty) near future.

Question: Corinne Johnson - Goldman Sachs - Analyst : Okay. Maybe another question here, obviously, and on one level, obesity is quite crowded. There's tons of different products in development and the other slices of the market based on mechanism and delivery, et cetera. Does you look within decisively glucagon and (technical difficulty) program? Unidentified Company Representative Well (technical difficulty) there going to be multiple classes of obesity drugs. This marketplace is not fully differentiated. I'd like to quote little Rony from Weill Cornell, who says that obesity is a new hypertension. I think that's exactly correct. Back in the [19] (technical difficulty), we had four drugs for hypertension. Now we have a multitude of drugs and turn classes, very differentiated attributes known to primary care, primary care docs, use it. Obesity is going in that direction as well. I think the easiest differentiation right now is between the compounds that (technical difficulty) the compounds that don't have glucagon. Because (technical difficulty) Amlin, you're really look same effect, which is reducing appetite just by different mechanisms. So all of the effects in obesity or by timing, caloric intake and all of the effects we're seeing are related to weight loss. If you don't get weight loss, you don't get the effects. So it's really a pursuit of weight loss. Now you shift over to glucagon and you get other attributes, as mentioned body metabolic rate, energy expenditure which could have effects on the metabolic set point, chronically the lipids, liver fat reduction, and now we know body composition. So we see that our part in the marketplaces and the glucagon space. And we think that based on a variety of readouts, we have the best Glucager containing molecule.

Question: Corinne Johnson - Goldman Sachs - Analyst : Okay. So maybe with those two data points in mind, can you walk through the Phase 2 trial design and some of the key parameters you're evaluating with the update in the first half of next year. Unidentified Company Representative Sure. So we have two endpoints in the trial. NASH resolution or fibrosis improvement. It's a dual endpoint trial, meaning to be successful. You hit either in the statistics or or develop that way to give success for either. We are looking at a typical MASH population with F2 and F3 fibrosis. We're not looking at F1. We don't really think the benefit is there an F1. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 12, 2024 / 1:20PM, ALT.OQ - Altimmune Inc at Goldman Sachs Global Healthcare Conference Also the ability to hit fibrosis improvement is better in the more severe stages of fibrosis. So we're requiring at least 50%, F3 to be in (technical difficulty). We're taking the 1.2 and 1.8 milligram doses forward. They're not titrated at all, the reason we didn't take the 2.4 milligram dose forward was that we saw the effects plateauing at 1.8 milligrams. We thought that was enough into this trial. We could always take 2.4 into Phase 3, if we feel that that's going to add additional benefit. The trial has 190 subjects. As you mentioned, Karin is supposed to read out in the first quarter of next year. Enrollment in this trial has been excellent. I think we're going to enroll this trial faster than any other MASH trial. I think the reason is that patients want to come in and get to weight loss, [MASH them] as a silent disease, like cigarette smoking I'll try to stop next month. But for weight loss, it's right in front of people that want to lose weight immediately. So we've had no problem getting people into the trial, and we think that reflects the market opportunity as well as when this drug gets out when the pen hits the pad. And I've been there before for many years as a prescribing physician, and you talk to the patient and ultimately prescriptions and negotiation with the patient if you've ever been in the other side of the discussion. People want to get the weight loss and they're going to see that first, and we think that this drug is going to be a winner.

Question: Corinne Johnson - Goldman Sachs - Analyst : In terms of the powering. I guess what are you looking to see in terms of delta with respect to fibrosis and or NASH resolution? Unidentified Company Representative You got to be a bit careful when you're taking week 52 endpoints and translating it to week 24, because obviously your absolute changes at week 24 will only be better at week 48. So if I give a number and you compare to the 52-week data you're going to get confuse. The important point is that it's statistically significant. It means it didn't happen by chance. So we hope to have the best treatment effect possible, but the more important readout will be that is statistically significant. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 12, 2024 / 1:20PM, ALT.OQ - Altimmune Inc at Goldman Sachs Global Healthcare Conference

Question: Corinne Johnson - Goldman Sachs - Analyst : I guess what's your view on the role that noninvasive test can play in NASH space within the joint development. And then as you get into patient kind of monitoring cases. Unidentified Company Representative Will they are very helpful to help predict effects and the absence of biopsy where they stand in terms of approval o1f the FDA. I think we're years away from that. I think the FDA made it very clear in this symposium several months ago that noninvasive tests are not ready for approval. We can talk about the rationale for that. But these noninvasive tests are very useful like at week 48 to see the progression. To look it populations where a biopsy may or may not be readily available. It will give you guidance as to what's actually going on in the liver.

Question: Corinne Johnson - Goldman Sachs - Analyst : Okay. And as you think about next steps like post Phase 2 data, I guess, what will come after that? And would you be able to initiate and have between the 24 and 48 week endpoint or do you need to get through 48 weeks? Unidentified Company Representative We'll have the discussion with the agency and see what their feelings are, but you know that data can be coming in as we speak to the FDA and roll them. But we clearly think it all adds up and talk to the financials on this that this is in our wheelhouse that we can execute a Phase 3 study in MASH because the spend is not as acute and is focused in such a short period of time with no outcomes trials. So that's an indication that we can actually execute on our own. So we believe and I'll let him comment on this as well that after that readout, we will progress to an end-of-Phase 2 meeting and start Phase 3 right after that. Yes. I mean, look, our strategy has always been to pursue MASH on our own. Obviously, as we have said for obesity, we are looking for a partner, but MASH can continue on its own path forward. We think by combining these two mechanisms, both weight loss and add a direct effect on the liver. We have a unique profile, and I think our tolerability is also going to shine. It's going to add to that profile as the data becomes available. So we have a unique drug for MASH, best-in-class liver fat reduction that's going to show up in long-term studies as well. So we think we should we will move forward very aggressively. As Scott said, we'll actually trying to meet with the FDA soon after the 24 week data and in parallel to collecting the 48 week data will begin to plan for the Phase 3 program in March.

Question: Corinne Johnson - Goldman Sachs - Analyst : As you think about the adjacent indications, you've started talking about the NASH data next year. To what extent could those kind of help inform partners conversations from a more robust full pipeline perspective? Unidentified Company Representative Yes, that's a that's a good question because most partners are really looking at Pemvidutide more like a cardio metabolic drug, obesity, MASH and some of the co-morbidities, dyslipidemia, hyperlipidemia, they all fit that category. So some of those discussions are centered around what are the other indications because just going after the broad obesity market is a very significant undertaking for anybody. So as a result, there is interest in trying to explore some of the benefits in smaller indications. So those discussions are also part of our partnership discussions. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 12, 2024 / 1:20PM, ALT.OQ - Altimmune Inc at Goldman Sachs Global Healthcare Conference

Question: Corinne Johnson - Goldman Sachs - Analyst : And remind me how COGS compares to the other like GLP-1 only is in space. Unidentified Company Representative Very similar. There's really not a significant difference. We're using similar devices in terms of weekly injection of the drug as well as the peptide manufacturing is very similar.