Altimmune at Leerink’s Global Healthcare Conference: Strategic Insights on Pemvidutide

On Monday, 10 March 2025, Altimmune Inc (NASDAQ: ALT) presented at Leerink’s Global Healthcare Conference 2025, highlighting the potential of its GLP-1/glucagon dual agonist, pemvidutide. The company emphasized its innovative approach to treating MASH and obesity, showcasing promising trial results. While the strategic path forward appears robust, challenges remain, particularly in securing partnerships for further development.

Key Takeaways

• Altimmune’s pemvidutide targets both MASH and obesity, showing significant liver fat reduction and weight loss in trials.
• The company plans to independently advance its MASH program to Phase III, with an end-of-Phase II FDA meeting on the horizon.
• A partnership is sought for the obesity program, with manufacturing and supply chains secured through early commercialization.
• Pemvidutide demonstrates class-leading lean mass preservation and no cardiac safety concerns, differentiating it from competitors.

Operational Updates

MASH Program:

• Phase 2b trial enrollment complete; data readout expected in Q2.
• Preparing for an end-of-Phase II meeting with the FDA.
• Plans to independently move into Phase III for the MASH program.

Obesity Program:

• Phase 2b MOMENTUM study showed 15.6% weight loss at the 2.4mg dose after 48 weeks.
• Seeking a partnership to advance to Phase III.

Manufacturing and Supply:

• Clinical supply secured through Phase III and early commercialization.
• Collaborating with leading CDMOs for manufacturing.

Regulatory Interactions:

• Received FDA feedback aligned with updated obesity guidance.
• No cardiac safety trial required for the obesity program.
• FDA confirmed the compound’s safety profile.

Future Outlook

MASH:

• Aiming to set a new standard by combining liver fat reduction and weight loss.

Obesity:

• Focus on treating obesity comorbidities, such as liver fat reduction and high LDL.
• Considering additional indications for pemvidutide targeting serious diseases with obesity as a comorbidity.

General:

• Planning an R&D Day to discuss additional indications for pemvidutide.
• Advancing programs targeting serious diseases with obesity as a comorbidity.

Q&A Highlights

MASH Trial Design:

• Phase 2b IMPACT study designed to minimize placebo response by rereading biopsies and scrambling order.

Weight Loss and MASH Treatment:

• Altimmune aims to provide a comprehensive solution by addressing both liver effects and weight loss in MASH treatment.

Dose Titration:

• The absence of dose titration in the MASH trial is due to the drug’s slow release, leading to fewer side effects.

Readers are encouraged to refer to the full transcript for a detailed understanding of Altimmune’s strategic initiatives and trial results.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Tom Smith, Senior Biotech Analyst, Leerink Partners: All right. Good afternoon, everyone. Thanks for joining us here at the Leerink Partners Global Healthcare Conference.

My name is Tom Smith. I’m one of the senior biotech analysts here at Leerink. And it’s my pleasure to welcome our next company to the stage, Altimmune. And happy to be joined up here by CEO, Vipin Garg and CMO, Scott Harris. Gentlemen, thanks for joining us.

Thank you. Thank you for having us. Certainly an exciting time in the metabolic space, and Altimmune’s advancing their GLP-one glucagon dual agonist pemidutide, in both obesity and MASH. So a lot to talk through. Maybe, Vipin, if you could just kick us off here with a brief overview of, Altimmune for those in the audience who may be less familiar with the story.

Vipin Garg, CEO, Altimmune: Yes, absolutely. So as you mentioned, we are developing a GLP-one glucagon dual agonist called family deutide. It’s unique. It’s been rationally designed to have one to one ratio of GLP-one and glucagon. This molecule because it’s really pipeline in a product, you can develop it for multiple indications.

We have recently completed enrollment in a Phase 2b MASH trial and that data readout we’re expecting here fairly shortly in the second quarter coming up of this year. So we’re very excited about that. We’ve also completed a Phase II obesity trial. We’ll talk more about that. And finally, we’ve recently received clearance from the FDA for two additional INDs, two additional indications for PENNDU diet.

And we’ll discuss those at our upcoming R and D Day here in two days on Thursday, March 13. So looking forward to it.

Tom Smith, Senior Biotech Analyst, Leerink Partners: That’s great. Yes, thanks for the intro there. And I guess first on pamidutide, you alluded to the one to one agonism between GLP-one and glucagon. Maybe you could just talk about, I guess, what drove the decision like that selectivity profile and then how that ends up comparing to some of the other GLP-one glucagon dual agonists that are out there, things like sirobototide. Scott?

Scott Harris, CMO, Altimmune: That decision came out of a series of studies that were performed by Richard DeMarkey and Merck when he was associated with that company where they looked at different ratios of GLP-one and glucagon. And they determined based on animal studies that the one to one ratio was optimal for maximizing the effects of glucagon while maintaining glycemic control. And we’ve carried that forward since then. And since that time, we’ve now had over 500 patients in completed studies. We’ll add a couple of hundred more to that with the recent studies that we’re completing.

We had the end of a Phase two meeting with the FDA where that safety experience was reviewed and FDA agreed with the design specifically of the molecule that glycemic control was being maintained while the glucagon effect was being maximized. So we distinguish ourselves from other molecules in the field by having the highest amount of glucagon. We think that drives this differentiation, it drives this effects on liver fat reduction, on serum lipids, on preservation of lean mass. These are all glucagon effects. And again, we think that we have the most potent dual agonist in development with glucagon.

Tom Smith, Senior Biotech Analyst, Leerink Partners: That’s great. Okay. And, yes, let’s dig in a little bit on the MASH side of the story. We have very important readout coming up here rather imminently in Q2. I know you guys have completed a Phase 1b study in presumptive NASH.

Maybe you could talk about, I guess, the data that you generated there. What gives you confidence as you went about designing the Phase 2b study? And then start to tie in, I guess, some of the data that we’ve seen from cerbututide, which now advanced to Phase three, as you mentioned, more of a glucagon effect with your compound. But what are your expectations here as we start to think about the Phase

Scott Harris, CMO, Altimmune: 2B? So in that study, we took patients not with biopsy proving MASH, but with Maslow D. The definition was a high liver fat content. In this study, it was ten percent. And in that study, we saw a very dramatic reduction of liver fat at twenty four weeks, which is the time point that most drugs are compared.

We actually had a 76% reduction in liver fat. That’s class leading among the drugs that are still as we know it in mesh development. We also saw this effects at twelve weeks. In fact, we even saw signs of it occurring at six weeks, not only potent, but also rapid. And that speed indicates the potency of the molecule.

We also had a number of other readouts in that trial that we could talk about later in our discussion today. But specifically in designing the MASH trial, it’s liver fat reduction, which drives the biopsy effects. That’s been shown repeatedly in studies. So not only with MASH resolution, but fibrosis improvement is driven by the degree of liver fat reduction. The greater the liver fat reduction, the better effects you have on these endpoints.

So we felt very good about going into the trial with the likelihood of success. So we found that there was a dose response plateauing at the one point eight milligram dose. And even though the two point four milligram dose might have offered greater weight loss for the efficiency of a Phase two trial, which is meant to be smaller, more efficient than a Phase three trial, we topped the dose at the one point eight milligrams. We also have the one point two milligram dose, which allows us to look at a dose response, which conspicuously has been absent in many readouts in mass trials and you worry about the biological plausibility without the dose response. So we have those doses in there.

We are not including the two point four milligram dose, but we certainly have the opportunity that that in the Phase three program because what differentiates here differentiates us here is not only the master effects, but the weight loss as well, which makes us unique. So we looked at that liver fat reduction and we decided that we were in the potent class of MASH agents. What do we mean by that? The drugs that have direct effects on the liver. In our case, it’s glucagon, that component of the molecule with the FGF 21 also in that class of potent direct acting agents, which also have rapid readouts.

They had readouts at twenty four weeks that were successful with liver fat reductions that were less than what we’ve seen. So we felt very comfortable with reading for twenty four weeks. We found that it was a great opportunity to differentiate us from the incretins that had failed even at seventy two weeks in the semaglutide original semaglutide Phase two study three times longer the same number of patients failed. But these drugs are now reading out with much more greater number of patients at forty eight and seventy two weeks. They would not imagine trying to read out twenty four weeks.

So we differentiate from the other inkrotin drugs on the basis of potent mash effects that are readable, Tom, at week twenty four. But now we face off against the FGF 21s. What do we offer there? Weight loss. None of these drugs have any meaningful weight loss.

So if successful in our readout and we can talk about the assumptions and the power, we will be the first Incretin agent to read out successfully in twenty four weeks and the first drug of any class to have both potent effects on MASH at week twenty four, but also weight loss. Now with regards to your third question, which was servadutide, that molecule has much less glucagon in it. Our ratio, as you mentioned is one:one. Their ratio of GLP-one to glucagon is eight:one meaning they have if you would oneeight the amount of glucagon. They get good effects on liver defacing that’s due to their glucagon effects but to do that they have to go to much higher doses.

They have to be much more aggressive with dosing to see that glucagon effect and the price they pay is for tolerability. And as you know they have very high dropout rates even at their lowest dose, which is representative of the fact they’re pushing the doses to the extreme of the expense of tolerability. They had to titrate over twenty weeks to see that and they had 12 titration steps something we couldn’t imagine at two of our doses in our trials. In fact, in our upcoming mesh trial readout in the second quarter, we have no dose titration at all. And also with regards to servadutide, we went to the FDA with a full portfolio of our safety information.

They looked at that and they said we don’t see a safety signal. We agree with you that you have glycemic control. We agree with you that you don’t have any cardiac signal. You don’t have a meaningful increase in heart rate. You don’t have any arrhythmias that we’re seeing.

But we know with servadutide they were asked to do something which is inefficient in a Phase three drug development program which should take of their 6,000 patients to commit 5,000 to studying cardiac safety. What that implies us is that a signal was seen in the discussion with the FDA and FDA wanted more information. I would emphasize that we were not asked to do that. But even comparing to servadutide, just on the efficacy parameters, we have greater liver fat reduction and we think also greater potency.

Tom Smith, Senior Biotech Analyst, Leerink Partners: That’s great. Maybe, building off of some of that where we’re calling out the the safety tolerability. Just remind us, I guess, what you saw in the phase 1b MASH experience. And then on this decision to not titrate, obviously, suggests a good amount of confidence in safety tolerability and not needing to stepwise increase the dosing there. Just kind of walk us through I guess the rationale, behind the dose selection in the Phase 2b.

Scott Harris, CMO, Altimmune: Yeah. The dose response in obesity is different from the dose response in MASH and liver fat reduction. We think liver fat reduction is a great biomarker for MASH endpoints. But we saw the liver fat reduction and many other endpoints plateauing at the one point eight milligram dose. To us it meant there wouldn’t be good efficiency by using the 2.4 in that trial.

And that contrast with obesity where the more you give the better. And I’m sorry I didn’t capture the second part of your question.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yeah. Just, you mentioned the lack of those titration, which I think, yeah, would be quite differentiated from a lot of other ingredients that are out there. Just talk through a little bit of the dose selection rationale and why you don’t need that titration.

Scott Harris, CMO, Altimmune: Well, it relates to the medicinal chemistry. It’s the lipid side chain that gives the drug longer half life. That drug is specifically organized to be polar on one end and act very much like a surfactant. What it does is that it aggregates the way micelles would form under the skin and slowly releases into the bloodstream. What differentiates us is the slower release into the bloodstream.

It’s the time, it’s the peak concentration that drives all the side effects and probably even some of the safety like heart rate. Our drug does not peak until seventy hours after dose administration. Instead of getting a peak, we get a hill, a soft hill. With other drugs, we’re seeing peaks that are occurring at fourteen hours or similar to that, which results not only in tolerability issue, but safety issues as well. So based on that we felt that we could administer the drug without dose titration.

In almost all of our studies we have not titrated at the 1.2 or the one point eight milligram dose. If we recall at the two point four milligram dose we had a short titration of four weeks but that’s short in comparison to the sixteen to twenty weeks used with other compounds. So we would say with comparable safety data and tolerability that we have the best tolerated drug in the class. Now moving ahead, we’re doing some modifications of dosing. As you know in our obesity program, we’ve talked about titrating for a slightly longer period of time.

We’ve not titrating in the IMPACT trial, which is the MASH biopsy trial, but that’s something we could do in Phase three. One thing that we didn’t do in our MOMENTUM obesity trials, we did not allow for dose reduction. We had not seen adverse event discontinuations of any sort in earlier trials. Other companies have had as many as thirty percent of patients who have dose reduced or they stopped dosing before they got to the upper dose because of intolerance. So we thought to as we go into Phase three and improve the tolerability of the compound in the prescribing information that we would allow dose reduction and we’ve done that in the impact program.

But there is no currently no dose titration in the Phase two study, which is in contrast to most other incretin studies.

Tom Smith, Senior Biotech Analyst, Leerink Partners: But we are allowing for dose reduction

Vipin Garg, CEO, Altimmune: as stated.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay, understood.

Vipin Garg, CEO, Altimmune: And just to reemphasize in our Phase 1b MASH trial, there was actually very good tolerability and very low discontinuation rate. So the data was very clear that we didn’t need to make we didn’t need to have dose titration on top of reducing dose and we believe that’s going to work out really well in the MASH patient population.

Scott Harris, CMO, Altimmune: Yes, I would add to that that we saw in our MASS LD or if you would our MASH trials and diabetes trial very low adverse event discontinuation rates. We saw the low adverse events in general. In the diabetes program for example, we had no zero adverse event discontinuations at all at any dose. And even at the one point eight milligram dose, we had no nausea and vomiting. That’s unique among intrusions drugs.

And the moral of the story is that when you’re in disease populations like MASH or diabetes, people report lower adverse events and they have lower rates of adverse event discontinuations. The bottom line is now that we’re going into a MASH readout where approximately fifty percent of the patients could have diabetes. Up to that, we don’t know yet because we haven’t seen the demographics. But also the fact that they have a disease match, we think a very, very good tolerability profile will be seen.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Great. Let’s talk about the design of impact a little bit more. And it is, I think, very uniquely designed certainly amongst the ingredients, but even kind of beyond that looking at that twenty four week paired biopsy time point. So, yeah, if you could elaborate a little bit on how you powered the study, what you’re expecting in terms of treatment effect, and, your expectations here as we head into the top line data in Q2?

Scott Harris, CMO, Altimmune: It’s difficult to pick an actual treatment effect because the placebo response varies so much from study to study. An example being with the same placebo treatment effect of twenty weeks comparing thirty percent to fifty percent that’s very different comparing seven percent to twenty seven percent in terms of the power and the conclusion. In the first example the improvement over placebo was sixty percent second example it’s fourfold, right? And that also drives the statistical power. So there are a lot of moving parts here that make it very difficult to say what the treatment effect should be, but if you hit statistical significance that’s going to be very meaningful.

Now we’re not going to hit statistical statistical significance with a 5% difference. We’ve designed the trial to have a lower placebo response rate because we’ve learned from the experience of other trials how to get the placebo response rate down and the principal way of doing that is to reread the biopsies at the end of the trial and avoid the bias that occurs when pathologists know the sequence with which they’re reading biopsies for example early in the trial they’re going to upgrade the severity to allow the patient to get into the trial later on expecting the patients going to get treated they downgrade the severity. A patient with no change in the biopsy can have an improvement simply because of the time when the biopsies were read, and this probably accounts for the twenty percent to thirty percent placebo response rate that’s been seen in other trials. When you reread the biopsies the experience has been in the seven percent to twelve percent range and that’s going to drive statistical power, but that may also bring down the actual absolute treatment effect, but to get statistical significance is the major difference here and I also say that we’re getting then the placebo response by using three readers and what’s called the mode method and importantly we’re scrambling all the biopsy so that the pathologist reread the biopsies without having any idea of when the biopsy

Vipin Garg, CEO, Altimmune: was done.

Tom Smith, Senior Biotech Analyst, Leerink Partners: That makes sense.

Vipin Garg, CEO, Altimmune: One thing I would add Tom in terms of our expectation here, if we are able to show statistically significant improvement in fibrosis combined with date loss, we will clearly set a new standard for treatment of NASH. I mean, that would be the new standard because there’s no other drug that can do that. We have drugs that have direct effect in the liver, fibrosis improvement at twenty four weeks, and we have drugs that have weight loss, but not this combined both effects in the same drug. And that’s really what we’re trying to, put, get get going here in terms of the the next phase of the trial. Yep.

Tom Smith, Senior Biotech Analyst, Leerink Partners: That makes sense to me. Have we have you implemented, I guess, plans to evaluate the biopsies using, AI or machine learning to give you more of, like, a quantitative scale of of the actual fibrosis changes rather than the, pathologist interpretation of what you’re doing on the biopsies?

Scott Harris, CMO, Altimmune: Yes, we will do that. But the primary readout that we’ll have in the second quarter will be based on the pathologist reads.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay. Got it. So that is a subsequent analysis that we can expect some at some point in the future?

Scott Harris, CMO, Altimmune: Yes. Okay.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Great. And then, maybe if you could just take a step back, think about the mash landscape here. I mean, today, we have resmediram that’s approved. We have semaglutide most expected to be approved, towards the end of this year, probably. And then a number of other kind of late stage treatments.

Vipin, I thought you you framed it quite well. You could have potentially a very unique dataset and potentially set set the standard here in terms of weight loss plus the study benefit? Like how are you guys thinking about how this market shapes up over the next three to five years?

Vipin Garg, CEO, Altimmune: Well, as you said, it’s a good news that we have a drug already approved in the market. We’re seeing that that drug is doing very well. So that’s a good sign. But it’s a very modest effect and it’s very clear that there’s a lot of room for improvement, particularly if you combine direct effect in the liver with weight loss because that’s really the complete solution for treating MASH. You want to treat MASH and you want to take away the reason in the first place that resulted in MASH, which is obesity and overweight.

So by combining these two effects, we would be, you know, even with other drugs coming on the market, we think we’re going to be the treatment of choice. Why wouldn’t you want to treat both of these conditions at the same time? So again, we will set a new standard in terms of treating MASH. It’s really think of it as MASH with obesity. That’s really the treatment, that indication that we are going after.

These patients, people with MASH have eighty to ninety percent of the subjects are overweight or obese and will benefit from losing weight. So we are combining these two things. So think of it as a MASH with obesity. We’re treating MASH and obesity at the same time.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Right. Okay. That makes sense to me. And maybe last last question on MASH, just to bring it back to the IMPACT study and I guess your expectations. Do you is is it a requirement that you show statistically significant improvement on fibrosis in the space to be study to warrant advancing it into a phase three program?

Or is it something you’re you need to evaluate sort of totality of the data showing NASH resolution alone? Obviously, you can get approved in in The US, we think, on the basis of NASH resolution alone. But how are you guys thinking about, the minimum requirement out of the space TV study?

Scott Harris, CMO, Altimmune: Yeah. I think it’ll be based, Tom, excuse me, on the totality of the data.

Vipin Garg, CEO, Altimmune: Yeah. But based on everything we know, we are very confident that we should hit both of these endpoints. I mean, again, we’ve talked about we have the best in class liver fat reduction. And that’s really the driver of MASH resolution of fibrosis improvement. So So we should hit that.

And clearly, we should hit the MASH resolution based on everything we know. And weight loss, we have already produced significant amount of data to show that we’re getting very, very significant weight loss after twenty four weeks of

Tom Smith, Senior Biotech Analyst, Leerink Partners: treatment. Understood. Okay. Yeah. Let’s switch gears and talk about obesity.

And you have results from the Phase 2b MOMENTUM study. Maybe if you could just sort of hit the highlights of that dataset and then, and then we can talk through some of the recent regulatory interactions potential for phase three.

Scott Harris, CMO, Altimmune: Right. So that was a forty eight week trial in patients with obesity and overweight. The drug was given for forty eight weeks. At the two point four milligram dose at the end of forty eight weeks, we had fifteen point six percent weight loss, but most importantly the trajectory of weight loss was still steep and had we continued dosing out to the say the seventy two week time point that there is Epitide trial, we would have had very competitive weight loss. Importantly, all three doses were potent, even the lowest dose which was the one point two milligrams which was given without those titration still yielded 10% weight loss as a drug given without titration which has an adverse event profile similar to placebo very attractive in primary care.

Remember obesity is going to move into the primary care prescribing space. It has to be to be a $100,000,000,000 indication. This is a drug that can be administered without uptitrating through inactive doses to get there. It doesn’t have to be reimbursed with each step separately. You give it, you don’t have to titrate or have your physician extend or follow the patient.

Now it was not only positive in terms of the weight loss, but the other parameters. In patients who came into the study with elevated LDL, we had a 21% reduction of LDL cholesterol. We even saw that effect in patients taking statins. It opens up the whole opportunity to use weight loss to drive better LDL reductions as you’re aware thirty percent to fifty percent of patients who take statins failed to achieve their LDL goals for a variety of reasons, but to combine it with the desire of the patient to lose weight to drive additional weight loss, we now have a pattern of synergy, which when we described to the FDA they were very excited. We also saw eighty percent of patients normalizing their liver fat, something that we would expect.

And in addition, we also saw a class leading preservation of lean mass. We did an MRR sub study of 67 subjects. We showed that of the total weight loss that was realized that only twenty one point nine percent was attributable to lean mass. By comparison, semaglutide was forty percent. And by the way, in their prescribing information, the association of that lean loss with higher rates of bone fractures of women in the elderly four to seven fold.

That was very notable. But retrutide was about thirty eight percent, even tirzepatide was twenty six percent and finally, the ratio with historically reported with diet and exercise was twenty five percent. So we’ve actually beaten pharmacologically diet and exercise, which is really exciting. We’ve designed a Phase three program around these parameters. We could talk about that with time, but each of the pivotal studies addresses one of these described attributes of pempedeutide.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Yes, that’s great. And yes, let’s talk about the phase three design because in November, you engaged with with FDA. You have some regulatory feedback. Maybe just talk about that that feedback. And, you know, this all came in proximity to the FDA’s updated obesity guidance.

I guess, what’s the level of alignment between the the feedback you received in November and obviously, like, the updated guidance documents for obesity?

Scott Harris, CMO, Altimmune: The alignment was incredible. We’ve joked internally that they were writing the guidance as they were meeting with us, but the guidance reads very much the way the meeting went. For example, we came in and said this is not a drug designed to lower hemoglobin A1c. However, we will have an adequate number of diabetics in the program so that you can assess safety and they agreed and that was reflected in the guidance. We were told importantly that we had no safety signals.

That’s extremely important. We were told specifically we didn’t have a cardiac safety signal and we were specifically told that we did not have to conduct a cardiac safety trial. So all of our trials, the four trials accounting for five thousand patients are efficacy trials. And we had a very, very interesting discussion with the agency about lean mass preservation and it’s reflected in some of the language and the guidance. They asked us how we expect to get the information in lean mass into Section 14 of the prescribing information because in obesity drugs are used to seeing weight loss, weight circumference, blood pressure, lipids and heart rate.

So how do you incorporate lean mass? And the conclusion was this is very exciting. We and the conclusion was this is very exciting. We increasingly recognize the importance of this. We’re seeing these morbidities.

We’re seeing fractures. We’re concerned about loss of function in the elderly population using these drugs. Let’s have further discussions and find a way to get the sense of the prescribing information.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Great. That makes sense. And in in the velocity, program that you’ve laid out, it does seem like you’re enrolling a or targeting a pretty broad swath of patients. I think you’ve kind of specifically called out patients comorbidities, high LDL, liver fat, sarcopenia. Maybe just talk about, like, how how broad do you think you can go with this program and, how that’s the basis for that is is is, the data that you’ve generated so far in momentum.

Scott Harris, CMO, Altimmune: Well, this was an innovative program. We didn’t come in with step one, step two, step three, step four, surmount one, two, three, four. We know what that template looks like, what that boiler plate looks like. We came in with an original innovative program where each pivotal trial highlighted an attribute of glucagon, LDL reduction in the presence of absence of statin that’s velocity two, liver fat reduction as a risk factor for cardiac disease, velocity three, lean mass preservation effects on function, rates of bone fractures, velocity four. So the FDA called this program refreshing and innovative because they were not seeing a repeat what had been given to them before and it was addressing new concepts.

But most importantly, each of the studies reflected an attribute of glucagon. But most importantly, the FDA confirmed the safety profile of the confound, which is a tremendous platform for going forward with all of our studies in the future.

Vipin Garg, CEO, Altimmune: And that actually cuts across all our programs where we are trying to treat not just obesity in general, but actually comorbidities of obesity. So serious diseases with obesity and you’ll see that even as we talk about the additional indications, it’s the same theme that we are developing. Because of the dual mechanism, we are trying to capture these both benefits at the same time. So disease conditions where patients would benefit by improving their liver health, but also losing weight at the same time is that’s how we are focusing on it. And that keeps the obesity indication alive in this specialized patient population.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Got it. That makes sense. I guess in in tying all of that together, could you just talk about how you’re thinking about next steps and advancement as it relates to business development and partnerships? And I think you’ve talked about a partnership for obesity would be ideal, but just how you’re thinking about partnering across the broad opportunities that you could go after with PEMDI?

Vipin Garg, CEO, Altimmune: Yes. So we’re moving full speed ahead with the MASH program. We’re actually preparing for our end of Phase II meeting as we speak. We think we can have that meeting on the back of the twenty four week data. And then our plan is to move into a MASH Phase III program on our own.

With obesity, we’ve been very clear that, you know, we’re looking for a partner. You know, the only way we’ll move it forward from here is to have a partner. The whole landscape in changing in obesity, the pricing pressure is very much downwards. You know, people are already discounting these drugs, whereas if you go after a serious disease condition with obesity as a comorbidity, that’s a simpler route because because you have pricing flexibility, you’re really treating that serious disease and this losing weight is an added benefit, a desirable outcome, but it’s an added benefit. So that’s really how we are looking at it.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Understood. And can you, I think an increasing focus here sort of like non clinical, but key to thinking about scaling this up has been focused on manufacturing and supply. How are you guys manufacturing today and how are you thinking about scaling that up for future clinical studies in commercial?

Vipin Garg, CEO, Altimmune: Yes. So we are working with world class CDMOs who are very well known in this space. They’re working on other programs. So and right from the very beginning, so we are all set. We have plenty of material to do Phase III trials that we are talking about, even any additional studies as well as launch the drug.

And as we are moving forward, we have relationships with commercial manufacturers that we will need down the line when we commercialize the drug.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Okay. So we have clinical supply that’s secured. We’re secured, we think, through Phase III and then commercial And

Vipin Garg, CEO, Altimmune: early commercial is the same.

Tom Smith, Senior Biotech Analyst, Leerink Partners: And early commercial. Okay. Got it. And then that’s great. And, yes, unfortunately, we’re up against time, so we’ll have to leave it there.

But looking forward to the R and D event a couple couple days from now and we’ll stay tuned to the Ultimin story.

Scott Harris, CMO, Altimmune: Thank you. Thanks.

Vipin Garg, CEO, Altimmune: Thanks for the invitation.

Tom Smith, Senior Biotech Analyst, Leerink Partners: Thank you, guys.

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