The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Ellie Merle - UBS Securities LLC - Analyst
: Before we jump into the specifics around obesity and NASH, maybe just high-level from a competitive standpoint, how are you thinking about the
other GLP-1/glucagon agonist being developed such as [mazdutide] and the Survodutide. How should investors compare and contrast your data
to these programs?
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MAY 23, 2024 / 2:00PM, ALT.OQ - Altimmune Inc at UBS Obesity Therapeutics Day (Virtual)
Question: Ellie Merle - UBS Securities LLC - Analyst
: Absolutely, a common investor your question that we got. From the glucagon side is around safety and tolerability, particularly for some of the
potential changes in heart rate and risk of arrhythmia. I guess what is your view on the safety tolerability of the class and how your molecule
compares to some of the other datasets that have been reported?
Question: Ellie Merle - UBS Securities LLC - Analyst
: That's helpful contest. In terms of assessing the potential for differentiation based on this safety and less decrease or less of an increase in the heart
rate relative to some of the other glucagon containing compounds.
How should we think about that threshold for which an increase in heart rate is too much when we're assessing the competitive landscape? it's a
difficult one.
Question: Ellie Merle - UBS Securities LLC - Analyst
: Maybe let's talk about some of your data. Can you talked about the Phase 2 momentum study and the 48 week data that you shared to date.
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MAY 23, 2024 / 2:00PM, ALT.OQ - Altimmune Inc at UBS Obesity Therapeutics Day (Virtual)
Question: Ellie Merle - UBS Securities LLC - Analyst
: Maybe can you elaborate a little bit more on the mechanism behind why you think you have a favorable profile in terms of I'm preserving lean
body mass and maybe a little bit more in terms of how you think this compares with some of the other novel incredence and development.
Question: Ellie Merle - UBS Securities LLC - Analyst
: You've said that you're expecting to have your end-of-Phase 2 meeting with the FDA in the third quarter. What are you hoping to come away from
this meeting with?
Question: Ellie Merle - UBS Securities LLC - Analyst
: What specific populations or how will this differ from maybe the standard overweight or obese population enrolled in the obesity studies?
Question: Ellie Merle - UBS Securities LLC - Analyst
: Absolutely. And how are you thinking about the potential dose selection and also the potential titration regimen and how those might differ versus
some of the other titration regimens that have been studied in the space?
Question: Ellie Merle - UBS Securities LLC - Analyst
: And before we move to NASH, and I think we talked about some of the efficacy comparisons and safety in terms of arrhythmias and potential blood
pressures, heart rate increases, but can u talk a little bit about from a tolerability perspective, maybe how you see yourself fitting into the landscape.
And so certainly a big focus of the space?
Question: Ellie Merle - UBS Securities LLC - Analyst
: What do you think is driving this, is this the more stable PK and I guess lower C-max? Or is this due to the balanced agonism of GLP-1 and glucagon
or a mix of both? How are you thinking about the driver here?
Question: Ellie Merle - UBS Securities LLC - Analyst
: Let's talk about NASH. What do you view as the rationale for your compound in NASH and maybe how this might compare to some of the others
and the landscape such as FGF-21s.
Question: Ellie Merle - UBS Securities LLC - Analyst
: We're certainly eager to see a histology data in the first quarter next year, maybe just to ask a high level, a really obvious question.
What's your expectation in terms of the effect size and maybe just starting with fibrosis and how we should think about that? Relative to others in
the class. I mean, you mentioned that the deep liver fat reductions and some potential independent, effects on inflammation. How do you think
this will stack up to what we've seen say with FGF-21?
Question: Ellie Merle - UBS Securities LLC - Analyst
: How you're thinking about your effects on MASH resolution relative to fibrosis in the context of the space? Do you expect to be maybe more potent
on MASH resolution and fibrosis benefits might take more time see. How are you thinking about what we could see on fibrosis at 24 weeks?
Question: Ellie Merle - UBS Securities LLC - Analyst
: What is the methodology for the readers using a consensus method and how you're doing that?
Question: Ellie Merle - UBS Securities LLC - Analyst
: You mentioned having direct anti-fibrotic mechanism as well as direct anti-inflammatory mechanisms. Can you elaborate on that?
Question: Ellie Merle - UBS Securities LLC - Analyst
: An investor question that I get for a cure on 89. As if you guys are successful in the first quarter and F2-F3, what this might mean for your potential
to compete in F4, where we're also getting longer-term F4 data from [Macau] in the first quarter of next year as well. How are you thinking about
your program and the potential. Does it make sense and F4 and how do you think about the approach there?
Question: Ellie Merle - UBS Securities LLC - Analyst
: At easel there's been a lot of conversation around the presentations from Tirzepatide and Survodutide and MASH. What are you looking for in these
presentations and how might this inform how you're thinking about your competitive positioning?
Question: Ellie Merle - UBS Securities LLC - Analyst
: And in terms of the development path forward, how are you thinking about the degree of you know, Is there a certain level of efficacy you'd want
to see that have a competitive profile going forward and how you're thinking about prioritizing between obesity relative to NASH?
Question: Ellie Merle - UBS Securities LLC - Analyst
: Last question, just in terms of thinking about the commercial landscape, there's a lot of conversation about combinations. I know emphasized that
your program essentially is its own combination. But how would you think about how your profile in NASH might compare to say a combination
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