Altimmune Inc Q1 2025 Earnings Call Transcript

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

Question: Yasmeen Rahimi - Piper Sandler - Analyst : Good morning team. Thank you so much for all the great updates and very much looking forward to the IMPACT study reading out here in 2Q. Two questions. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 13, 2025 / 12:30PM, ALT.OQ - Q1 2025 Altimmune Inc Earnings Call The first one is Scott, you mentioned that you guys are analyzing the baseline biopsies again. Have you had a chance to maybe provide some commentary around what the distribution F2 and F3 are and sort of how representative this Phase 2b population baseline characteristics are versus maybe some of the other Phase 2b successful Phase 2bs that we have seen? That's question one. Question two is directed to Vipin. I think speaking with investors we always find that they are excited about pemvidutide but may need help to think about post impact. What is the ideal population within MASH obese that would be ideal for pemvee? If you could provide color there that would be really helpful. And then the third one is obviously upon positive data from the IMPACT study you do have the opportunity to think about partnering this asset if you could provide also Vipin and team some commentary around how you're thinking about partnership opportunities. So appreciate if you could tackle these three part questions and I'll jump back in the queue.

Question: Yasmeen Rahimi - Piper Sandler - Analyst : Thank you so much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 13, 2025 / 12:30PM, ALT.OQ - Q1 2025 Altimmune Inc Earnings Call

Question: Liisa Bayko - Evercore ISI - Analyst : Hi there. Thanks for taking the questions and congratulations on the progress. Can you talk a little bit about, what you're seeing in the study in terms of discontinuations, how you're handling the discontinuations in terms of the data, and how should we think about any loss from the re-reads and things like that? Curious. Thanks.

Question: Liisa Bayko - Evercore ISI - Analyst : Okay, great. And then just one more question. I've been getting some questions on the importance of weight loss in this study because it really is obviously a MASH first study and weight loss is sort of secondary. So I guess how do you see the importance and how do we think about benchmarking weight loss in this study? I know you said to expect something like semaglutide, but what does that actually really mean? And I know this study will have a combination of patients with MASH diabetics. They won't be encouraged necessarily on lifestyle and other factors. So taking that all together, how should we think about how much weight loss to expect in a study like this? Thank you.

Question: Liisa Bayko - Evercore ISI - Analyst : Very helpful, thank you. And then just final question from me. As you think about phase 3 and I know you'll be pending, all this data meeting with FDA towards the end of the year is taking the higher dose into phase 3 consideration. And also I know you're really focused on kind of like how rapid the response is and how are you thinking about a potentially earlier six month endpoint? Thank you.

Question: Liisa Bayko - Evercore ISI - Analyst : Thank you so much for answering all my questions.

Question: Roger Song - Jefferies - Analyst : Excellent. Thanks, team, for the update. And then taking our question, I have a couple questions related to the IMPACTS study as well. The first one is understanding the trial is well overpowered for both endpoints, but just curious how you think about which endpoints are a bit harder to hit based on all the historical data. And then that's number one. Number two is your recent ESO data regarding this MASH resolution index, the translation to the MASH biopsy. So how you think about that index will correlate with the fibrosis improvement as well. Thank you.

Question: Roger Song - Jefferies - Analyst : Excellent. Thank you. Thank you, Scott.

Question: Annabel Samimy - Stifel Financial Corp - Analyst : Hi, thanks for taking my questions. I just want to follow on. The comments about the Phase 3 program. We all know that one of the issues that plagues mass development is the long development pathway. So if you're successful here in achieving the fibrosis response in six months and realize that you're going to design the phase 3 program with a 6-month program. But do you see any avenue to tighten the development timelines or will FDA be still sticking with its typical years long pathway? And how do you see this evolving over time, especially as we see additional movement on these biomarkers at the recent conferences? Do you see greater acceptance from the FDA from that? And I guess I have to ask a follow up question to that. Just generally speaking, how have your interactions with FDA changed with all the movement there? Anything to the positive or negative that you are seeing? Thanks.

Question: Annabel Samimy - Stifel Financial Corp - Analyst : Fantastic. Thank you.

Question: Jasmine Fels - UBS Securities LLC - Analyst : Hey this is Jasmine on for Eliana. Thanks so much for taking our question. So when you meet with the FDA for your end of Phase 2 after IMPACT, do you expect to discuss MASH F4 Cirrhosis with them at that time? And just what can you say about your latest plans and timelines there? And then second question. Can you just confirm for us your cash running Runway at the Hercules facility? And are there any specifics that you can share on what that Runway includes? Thanks.

Question: Jasmine Fels - UBS Securities LLC - Analyst : Okay, Super helpful. Thanks so much.

Question: Mayank Mamtani - B. Riley Securities - Analyst : Good morning, team. Thanks for taking your questions and congrats on the recent progress. Scott, I don't know if I heard from you. Could you comment on the range of placebo responses you are expecting on fibrosis and MASH resolution endpoints? As you mentioned, we've seen a relatively broad range in prior trials and if you're able to comment at all, sorry to push you here on the female to male ratio and what baseline weight is relative to your prior Phase 1b MASLD study, if you could maybe comment on that and then I have a follow up.

Question: Mayank Mamtani - B. Riley Securities - Analyst : Yes. Sorry, yes. The female to male ratio and then the baseline weight relative to your priority Phase 1b MASLD study. So both baseline demographics questions.

Question: Mayank Mamtani - B. Riley Securities - Analyst : Understood, thank you. And with secondary endpoints you may include as part of your top line release next month and obviously want to understand which NIT should be focused on at this 24 week time point versus maybe the 48 week because the 48 week could be important as you also think about powering the long term outcomes trial as part of your end of Phase 2 FDA discussion. So if you could maybe segment that, that would be helpful.

Question: Mayank Mamtani - B. Riley Securities - Analyst : Understood. And lastly, could you touch on the impact you believe based on pemvi's mechanism would be on bone and muscle health and or muscle health. Thanks for taking a question.

Question: Mayank Mamtani - B. Riley Securities - Analyst : Thank you. Look forward to the data update. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 13, 2025 / 12:30PM, ALT.OQ - Q1 2025 Altimmune Inc Earnings Call

Question: Andy Hsieh - William Blair - Analyst : Great. Thanks for taking our question. Just one quick one for us. We are just wondering about the overlap between clinical sites that you use for obesity and MASH compared to potential sites for AUD and ALD that you look to activate in the coming quarters. Thank you.