Altimmune, Inc. (NASDAQ:ALT) Q1 2024 Earnings Call Transcript

Vipin Garg: In terms of your question about the right kind of partner, we’ve always maintained that the compound that we are developing semaglutide had very compelling data both in obesity as well as in MASH. And if you think about it MASH and obesity really intersect each other. It’s going to be hard to differentiate in these patient populations down the line, because most people with MASH also need to lose weight. So we think we bring a perfect combination of these two things. Our focus has been — in terms of the right partner, has been on partners that value both of these indications and our goal is to find a partner that will help us develop both of these indications in parallel.

Q –Unidentified Analyst: All right. Thank you so much.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Corinne Jenkins from Goldman Sachs.

Q –Unidentified Analyst: Good morning. This is Mario [ph] on for Corinne. So, a couple of questions for us. Could you provide an update on how the partnership discussions are progressing and do you plan to bring in a partner for the new indication you want to pursue with pivotal data?

Vipin Garg: Thanks for the question. In terms of the partnership discussions that continues to be a topic of interest. What I can say is that our partnering efforts are ongoing. We have the numerous factors that come into play in finalizing a partnership discussion. So stay tuned. Those efforts are ongoing and we expect to have a partner before we go into Phase III development for obesity. As we mentioned earlier in the call, we are getting ready for the end of Phase II meeting. We think that’s going to be very value-driving having that information, as well as additional data. In terms of the additional indications, yeah, I mean these indications really are an extension of obesity and match for some of the broader indication in obesity and mass, and we’re trying to figure out where does our compound has the maximum value creation opportunity, differentiation opportunity relative to other compounds that are mainly GLP-1 focused.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Alana Lelo from Guggenheim.

Alana Lelo: Hi there. Thanks for the question. I just wanted to circle back a little bit on the potential outcome of the synergy NASH study and back to the partnerships again. So with facility NASH, from my understanding, it was said that they had a clinically meaningful benefit on fibrosis, but there was no direct commentary on whether that was statistically significant or not. If it turns out that tirzepatide does lead to statistically significant fibrosis benefit. How do you see that impacting the prospects of NASH?

Scott Harris: Well, thanks for the question Alana. So as we’ve continued to state these drugs do not have the same liver defining effect or effects on fibrosis improvement that the compound rich and glucagon has. So it is possible that they could have meaningful results potentially statistically significant. These drugs will eventually have a direct effect on fibrosis if you have enough patients and you follow them out long enough. And we know that from bariatric surgery were that simply a reduction of caloric intake. So eventually they would hit an endpoint given enough patients and enough time. But I think you’ve seen from our original data that the speed and the robustness of the effects are tremendously enhanced in the presence of glucagons, such that we can get a better treatment effect.

And actually we did that in an earlier time point. So we would congratulate them if they achieved statistical significance. But we would also highlight the fact that we believe that we will do better.

Alana Lelo: Great. Thank you for that clarification. And then just very quickly on the partnerships. With respect to timing, are you still confident that a partner can be secured this year? Are you thinking that it might be more likely after the NASH data hit 1Q 2025?

Vipin Garg: Yeah. Thanks for the question Alana. Look it is difficult to pinpoint the time line for partnering. As I’ve said our efforts are ongoing. We would love to have our goal remains to have a partner before the end of the year, before we start the obesity Phase III program. But let’s see how things develop on that front as our discussions progress we’ll know better. But at this point, we are committed to having a partner on board before the start of Phase III in obesity.

Alana Lelo: Great. Thanks so much for taking my question.

Vipin Garg: Welcome.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Mayank Mamtani from B. Riley Securities.

Mayank Mamtani: Good morning, team. Thanks for taking my questions; and good to see the end of Phase II meeting being calendared. So maybe just on that quickly, are you able to share how your specific plans could vary relative to say a step in SURMOUNT program. I believe Amgen may also be having similar FDA correspondence around same times. So, I wonder if any guidance from an FDA standpoint on this next wave of weight-loss drugs could be relevant here. And also if you are able to can’t comment on the outcome trial commitment how big that could be given obviously you have a big lipid benefit and then I have a couple of follow-ups.

Scott Harris: Well, thanks for the question. Mayank. I’m not sure I heard the entirety of the first question, so please persist if I don’t answer it completely. So look, this meeting that we’re going to have come later this year is going to be extremely value enhancing for the Company. And there are a lot of great things that we can get done at this meeting that really enhance our goals and objectives specifically around glucagon and what glucagon brings to the table in the treatment of obesity. So we’re expecting that there will be certain things in place that our expected safety database of 5,000 subjects in probably distributing those subjects across three to four trials. We’re going into the meeting with that expectation and more than likely that will be a trial without diabetics and with diabetics.

But there’s still room for creating trials with endpoints and populations that enhance the value proposition of penveu tied in the role of glucagon in the treatment of obesity and provide differentiation as the obesity market becomes more substance becomes more segmented. So, as we know the obesity population right now is not well differentiated. Right now, there’s not great certainty about what those segments will look like. We know that it will become more segmented the same way hypertension became differentiated over time. So our goal is to ride that wave and to find ways that we can really stress differentiation based on the mechanism. And as I pointed out before, that could include choosing the best population for example to enrich in the liver that lipid effects, looking at body composition changes over time, looking at different durations of treatment in order to maximize the amount of weight loss because since as you know the weight loss was steeply continuing at 48 weeks and trial and the improvement of body composition.