Altimmune Inc Q4 2024 Earnings Call Transcript

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

Question: Roger Song - Altimmune Inc - Analyst : Hi, this is Fionaar rager. Congrats on the year and, a lot of new, developments exciting for this year. Just, ques questions on the new indications. I was wondering if you're going to announce the details like the pre-clinical data at the R&D day and whether if you're going to start the two, phase two trials simultaneously, mid-year.

Question: Roger Song - Altimmune Inc - Analyst : Thank you, yes, looking forward to the R&D Day and congrats on the year.

Question: Yasmin Rahimi - Piper Sandler - Analyst : Good morning team. Thank you for the great updates and, I can't believe you're retiring. You have another 20 years and you not more so, but I'm happy to know that I get to work with you for another year. So when I when I when I say that, and it's been a pleasure working with you H1stly. I think one of the questions that we would love to understand is post the C2B data as you guys are going to be engaging with the agency. Is there anything, is there an opportunity to think about, given the profound defatting of the liver and a lot of data supporting MRI PDFF as a histological response? Should we be thinking about the phase three design very like the typical studies we have seen based on histology, or is there going to be some flexibility on some innovative NIT incorporation into the study? And then also if you're thinking about would you be concurrently starting a cirrhosis study in conjunction, just want to love to understand how you're thinking about on sort of the phase three development and what sort of strategy you want to implement, and I'll jump back in the queue. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 27, 2025 / 1:30PM, ALT.OQ - Q4 2024 Altimmune Inc Earnings Call

Question: Yasmin Rahimi - Piper Sandler - Analyst : Thank you so much. I'll jump back in the queue.

Question: Annabel Samimy - Stifel - Analyst : Hi everyone, thanks for taking my question, questions and great progress. I guess could you going into this impact trial, can you talk about what your expectations are? To consider this not just a clinical success but a competitive success, and just to follow on from that, we've heard a lot about how the obesity market might evolve, but maybe you can talk about how you expect the mash market to evolve with some glut tides essence data and ROSIFRA and FGF 21. So can you just talk about how you think all those Programs as well as some of the dot will play in with each other. Thank you.

Question: Annabel Samimy - Stifel - Analyst : Great. And if I could just ask one more question, are you going to be releasing any of, any other exploratory or secondary end points, on this top line readout?

Question: Lisa Baco - Evercore - Analyst : Hi there, I'm wondering if you could just talk through the overall strategy of, pursuing, pivotal studies for, pemidaldehyde in the MASHpopulation as well as bringing on some new indications. How do you prioritize it and fund all of this stuff, from here just curious about your thinking and prioritize, prioritizing all of that as well with the I know the obesity is kind of lingering their background waiting for partnership, but just love some clarity and thoughts on prioritization there. Thank you.

Question: Lisa Baco - Evercore - Analyst : Okay, and then for the upcoming phase to be data and MASH, can you give us a sense of what you kind of think the bar is to have a competitive profile both on weight loss and fibrosis reversal?

Question: Lisa Baco - Evercore - Analyst : And how do you think of Served tide and tide as constant at this juncture?

Question: Lisa Baco - Evercore - Analyst : Okay, great. And then just would, should we expect any update at your R&D Day on your oral form of pemvadutide and is there been any progress there? That's my final question. Thanks.

Question: Unidentified Participant 1 - - Analyst : Hi everyone, this is, Jasmine on for Ellie. Thanks so much for taking your question. So for the additional indications, I just want to get confirmation. So for the two phase 2s starting this year, would these be cases where we can potentially see proof of concept data next year? And then I think you know previously you said you were thinking about up to 3 additional indications so would that potential third one be something we could also see in IND from this year and will we learn more about this or any others of the R&D day? Thanks.

Question: Unidentified Participant 1 - - Analyst : Great, thank you.

Question: Unidentified Participant 2 - - Analyst : Hi, yes, and thank you for taking our questions. This is William on from Maun. Congratulations on a very nice year and definitely looking forward to some of the data and events that are coming up. So, I did just want to dig in just a little bit more on the top line data at at impact. I know that we'll be expecting sort of the fibrosis and liver fat reduction, and please correct me if I'm wrong there, but I was also curious if we would be, if we should be expecting fibrosis improvement and MASH resolution sort of that combined endpoint, and then, on statistical significance. Could you speak to what treatment effect you're thinking that you'll need to hit that STATs Diego and fibrosis endpoint? and then have a follow up?

Question: Unidentified Participant 2 - - Analyst : Okay, thank you. And then just to curious about the two new indications. Is it safe to assume or maybe give us some colour if you could, will these, should we be expecting these indications to be sort of based on or in the obesity subgroup, or could they be something more akin to even a mash or cardiovascular or something outside of obesity directly that may actually surprise us a little bit when we, when you actually unveil this.

Question: Unidentified Participant 2 - - Analyst : Excellent. Thank you and congratulations again on a very nice year and Scott, best of luck for you going forward. Congratulations.

Question: Jonathan Wollevin - Citizens JMP - Analyst : Hey, thanks for taking the questions. 2 for me. In the past we've talked a little bit about potentially seeing reduced weight loss in MASH patients due to metabolic dysfunction for the same drugs than in a non-MASH population. I was wondering. Your current thinking there if it's evolved since we've seen some more data from other drugs and programs and then I guess the elephant in the room is, real world adherence. We've seen pretty low discontinuations in phase 3 programs from other inertons, but the real world use not being, sustained long term. How do you think you could buck that trend if there's anything in the data that could suggest, you'll have a different profile in the real world?

Question: Jonathan Wollevin - Citizens JMP - Analyst : Okay thanks appreciate it.

Question: Patrick Trucchio - H. C. Wainwright and Company - Analyst : Thanks. Good morning. A few follow ups on mash first on impact, specifically, I was just, I was wondering if you could elaborate a little bit more on that triple reader model technique and blinded rereads. How does that compare to approaches used in prior mass trials to control placebo effects? Secondly, regarding the phase 3 timing, at the end of phase 2 meeting occurs by year end, when could the registration of phase 3 trial and mash begin? And last on MASH regarding phase 3 planning, will you design the Phase 3 MASH program run in parallel with additional trials and other metabolic indications? How would you prioritize the sequence of development?

Question: Patrick Trucchio - H. C. Wainwright and Company - Analyst : Great. Thanks so much.