Altimmune Inc Q4 2023 Earnings Call Transcript

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

Question: Yasmeen Rahimi - Piper Sandler Companies - Analyst : Good morning team and thank you for all the updates. I think my first question in mind we have been getting, given the continued desired product profile of pemvidutide a lot of investors would like to get a little bit more update on where you are with partnership discussions currently? That's question number one. Question number two is have you had the opportunity to engage with the agency negates the Phase 3 design line for obesity and what they would look like. And then the third one, how could we think it showed really compellingly MASH preservation results at week 48, how can we think about this magnitude to be further improved over time in patient? And thank you for allowing me to ask these questions.

Question: Yasmeen Rahimi - Piper Sandler Companies - Analyst : Thank you so much team. I'll jump back into the queue.

Question: Seamus Fernandez Fernandez - Guggenheim Securities LLC - Analyst : I think So Tom, I appreciate the opportunity to ask questions here. The partnering discussions, Vipin, you mentioned scientific and technical discussions, but also business discussions. It seemed to me this is predominantly a business discussion at this point. So I'm just trying to better understand the commentary of differentiating those two. If there are a scientific and technical discussions, what are the scientific and technical debates that remain for pemvidutide in the context of a obesity program? And in the past on partnering, you've commented that that perhaps there will be separation of the opportunity for obesity being with a partner, but perhaps having NASH or MASH move forward exclusively with Altimmune. Do you still believe that, that is a realistic partnering discussion, given the fact that we've now seen that tirzepatide has an opportunity potentially to impact fibrosis, and we have another competitor molecule in survodutide in the near term with regard to their own potential fibrosis benefits and both programs have a very robust obesity program, either planned or well underway?

Question: Seamus Fernandez Fernandez - Guggenheim Securities LLC - Analyst : Great. And maybe just to follow up on on the MASH program. Can you just remind me the doses? My recollection was that the plan was to explore only up to the 1.8 milligram dose, but where we saw more meaningful weight loss in the obese, the program was at the 2.4 milligram dose. So just wanted to I see where the sort of dose range is going. And then you mentioned weight loss in MASH patients. But my recollection is that there was very limited weight loss in the MASH sort of Phase 1b/2 program that you ran previously outage 12 weeks. Just trying to get a better understanding because my recollection is you explore the 1.8 milligram dose there, but we didn't see much weight loss and that I guess was partially attributed to the patient population recruited. But just trying to get a better understanding of how this Phase 2 will differ from your initial Phase 1b/2 program?

Question: Seamus Fernandez Fernandez - Guggenheim Securities LLC - Analyst : Great. Thanks. I'll drop back in the queue.

Question: Roger Song Song - Jefferies LLC - Analyst : Great. Thanks for sharing the new data and the uptake and take our questions. So another question related to the partnership. Maybe a little bit more specific. Can you let us know how much discussion is contingent upon this more detailed Phase 2 obesity MOMENTUM data at the way your Phase 2 MASH data on kind of upcoming on, and just remind us the discussion is combination of both program moving forward or are you well different partner have different interests in certain program? Thank you.

Question: Roger Song Song - Jefferies LLC - Analyst : Got it. Thank you. Another mechanistic question. So it seems very compelling this muscle preservation, which is very interesting. So how do you think about and whether that can be differentiated in the maintenance or the rebound kind of mechanism given you are more liver, liver care or your additional liver, liver care targeting versus the GLP-1 molecule of the hypocaloric mechanism? Thank you.

Question: Roger Song Song - Jefferies LLC - Analyst : Excellent. Thank you.

Question: Liisa Bayko - Evercore ISI - Analyst : I think most my questions have been answered, but maybe you could give us a little more on, I guess, the color on some of that kind of feedback you're getting from potential partners as it relates to dose and Phase 3 strategy. And just wanted to confirm that on our plan is to wait for a partner before proceeding to Phase 3 for obesity. Thanks.

Question: Liisa Bayko - Evercore ISI - Analyst : And how are they thinking about on your titration schedule? I know you're only doing that for the highest dose of hotels that you have any interest in the low dose. Like what is the thinking on kind of your dosing approach and how much of a differentiating feature is no dose titration arm? Or might you actually consider does titrating team and tolerability mark?

Question: Liisa Bayko - Evercore ISI - Analyst : Great. Thank you so much.

Question: Corinne Jenkins - Goldman Sachs - Analyst : Finally, I guess maybe as partners, it's obviously been a focus that is using about time lines are kind of goals for the management team. Is there anything you can share with respect to when you'd hope to have to make establishment? And maybe if you could comment on whether you might have something in place by the time you get to Phase 3 conversation the FDA later this year. And the other question that we had was just how many patients are included in the body composition analysis? And is that something you've looked at embarrassingly? Just curious how on how many patients and how robust that data set is? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 27, 2024 / 12:30PM, ALT.OQ - Q4 2023 Altimmune Inc Earnings Call

Question: Corinne Jenkins - Goldman Sachs - Analyst : Got it. Thank you.

Question: Mayank Mamtani Mamtani - B. Riley Securities, Inc. - Analyst : Good morning team, and thank for taking the questions. Appreciate the comprehensive update here. Just a few more of exercise, technical follow-up there. So regarding the new baseline normalization data up to 79%, which is a little higher than what you saw in NAFLD study, what's the sample size? And I assume it's a pooled analysis from dose levels. Could you please clarify that?

Question: Mayank Mamtani Mamtani - B. Riley Securities, Inc. - Analyst : Got it, Scott. And a related question I have on the body fat composition data the methodology used here, you just clarified that MRI-based, but there are additional approaches like (inaudible), that could be helpful to also compare against what we have for (inaudible). Are those analysis being conducted and could be presented in the future? Or was that not part of the protocol?

Question: Mayank Mamtani Mamtani - B. Riley Securities, Inc. - Analyst : Okay. Understood. And then on the IMPACT MASH trial execution, any color you can provide on pace of enrollment and if you'd expect later in the year doing a placebo-controlled study could be impacted now that an approved MASH therapy is on the market? And to the prior commentary you had that some of the approved drugs will start showing more pronounced anti-fibrotic effect than we've seen before. Anything on the MASH trial execution through the course of the year we should be aware of?

Question: Mayank Mamtani Mamtani - B. Riley Securities, Inc. - Analyst : And just maybe staying with you, Scot, final question on that preclinical anti-fibrotic study data you report, I think 33% level fibrosis in less than 2 weeks. In the same experiment, chemical experiment with incident and non-incident drugs, are you able to comment on what you've seen? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 27, 2024 / 12:30PM, ALT.OQ - Q4 2023 Altimmune Inc Earnings Call And then also lastly, an update on the oral formulation of pemvi, I believe you were pursuing a couple of technologies there. Is there any early (inaudible) data emerging that you can talk about of the overall peptide format. And thanks again for taking our questions.

Question: Mayank Mamtani Mamtani - B. Riley Securities, Inc. - Analyst : Thank you.

Question: Jonathan Wolleben Wolleben - JMP Securities, LLC - Analyst : Good morning and thanks for taking the questions. A couple of follow-ups on the body composition study. I'm wondering if you could give some context for how what you're seeing with pemvidutide compares to semaglutide and tirzepatide? And if you expect to see similar changes with other dual and triple agonist that include glucagon work this is specific to pemvidutide. Thanks.

Question: Patrick Trucchio Trucchio - H.C. Wainwright & Co., LLC - Analyst : Thanks. Good morning. Just first a clarification on the lean mass data. I'm wondering if the -- how the lean mass preservation and body composition compared across dose levels of pemvidutide or if it was consistent across the doses? And then separately, I'm wondering if the updated preclinical or clinical data reported today has impacted the way you're thinking about a potential Phase 3 program in obesity in terms of trial design, such as dosing titration or end points? And separately, can you tell us how the data reported today would be expected to read through to the IMPACT program

Question: Patrick Trucchio Trucchio - H.C. Wainwright & Co., LLC - Analyst : Great. Thanks so much.