Altimmune Inc R&D Day Transcript

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

Question: Yasmeen Rahimi - Piper Sandler & Co. - Analyst : On presentation and all the color. I guess I think investors are trying to understand as we go into the impact data readout. Obviously, this robust effect or showing a histological and benefit across MASH resolution at 1 point improvement of fibrosis at 24 weeks, as you know to Dr. Noureddin is the first one at that time point. But I guess, let's say, impact, achieve that, how will you and your colleagues prioritize pemvidutide's utility versus other agents that are either approved or in development. So where does that put that in your choice of agents that you could work with? If you could share some color around that, that would be really helpful. And then secondly, as a MASH physician, how much emphasis is there to control weight in conjunction to the liver manifestations present?

Question: Eliana Merle - UBS Investment Bank - Analyst : So can you just first maybe walk us through the time lines for the biopsy rereads, is that ongoing now for the MASH Phase 2b? And then into that data, I guess, how should we think about what would be competitive from a tolerability perspective, particularly to get use in, say, the F2 patients. And in terms of the wet loss, I guess, how much weight loss do you want to see or if they are expecting from this, MASH study?

Question: Annabel Samimy - Stifel, Nicolaus & Company, Incorporated - Analyst : Maybe for Dr. Aronne, how would you consider the use of timidity in your population. I mean, I think you're treating mostly of these patients. But given the overlap 80% to 83% would that simulate you to conduct further diagnostics to identify whether these patients have liver disease and try to seek usage of pemvidutide over some of the other incretins, obviously, given the overlaps. So I'm just trying to think about from a -- from an obesity specialists, looking at patients who may have a significant amount of liver disease and not having been fully diagnosed. How would you approach these patients?

Question: Annabel Samimy - Stifel, Nicolaus & Company, Incorporated - Analyst : Just as a follow-up, does that, I guess, make you wish that there was a potentially higher dose to the 2.4 milligrams, even though it's not maximum -- does it concern you that it's not maximized for weight loss as opposed to maximized for liver fat reduction, which you like the option to be able to have greater weight loss? Louis Aronne - Altimmune Inc - Member of Obesity Scientific Advisory Board, Professor of Medicine at Weill Cornell Medical College I think that we may have the higher dose at some point. So it may be that the higher dose is available as indicated in obesity. And so if someone has both obesity and liver disease, we might progress to the 2.4 milligram. So it's not that I don't think it will be available. You'd have to ask company, but I think that they will ultimately make it available for obesity. And if we had both of those conditions, we would go to the 2.4 mg if necessary.

Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst : I would like to ask a little bit more about your choice of methodology for analyzing the biopsies. I know you've chosen a three radar approach. And it seems like we've seen very different placebo rates. That's really what I wanted to get to. And sort of, I guess, first question is kind of what was your rationale for choosing this particular way of analyzing the biopsies? And then, I guess, for the physicians on the panel, how do you -- when you kind of look at these different MASH drugs across the landscape, how do you kind of compare and contrast is think about accuracy in the context of pretty wide differences in placebo rates. And what do you think is the best method?

Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst : And appreciate the level of detail here. Maybe for Dr. Noureddin quickly, if you could put in context the correlation of liver fat normalization with what we've seen on histology endpoints with other agents and your expectation for pemvi here. And I'm just thinking Also, if you think of this as induction and maintenance both? Or are you thinking of this more position for induction given the depth of liver fat. And then I do have a follow-up to Dr. Noureddin.

Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst : Yes. for maybe Dr. Aronne, I was just curious, how does having a drug like this, have you more proactively look for active liver disease among your obese patients, Dr. Aronne? And I wonder how many of the early F1 F2 patients get missed in the system, where obviously being overweight and type 2 diabetes could help sort of the early diagnosis piece. Louis Aronne - Altimmune Inc - Member of Obesity Scientific Advisory Board, Professor of Medicine at Weill Cornell Medical College So the short answer is we're not looking actively for liver disease in our patients. We sit right next to the hepatologists who have their own program. So when someone comes to us, we know that getting them to lose weight will be able to do the best we can with the compounds that we currently have. So we are not actively looking. But again, being on this panel, I'd start to actively look and change our protocol in the future.

Question: Jonathan Wolleben - Citizens JMP Securities - Analyst : Just a simple one for me for Dr. Noureddin and Dr. Loomba. If we're talking about treating F2-F3 patients, do we -- do you guys care at all about MASH resolution rates? Or are we only focused on fibrosis improvement? And how should we think about interpreting MASH resolution data when we're looking at clinical trials these days.

Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst : I want to better understand a little bit more about sort of the induced disease liver versus the MASH liver. Are these like kind of very distinct? If you see, we've seen tremendous benefit in MASH with pemvidutide and some of the other drugs as well in the category. I've always thought that this makes a ton of sense to go into alcoholic liver disease, but I'm wondering about the kind of common ground there and what is different? And if you see like how much read-through should we expect to see.

Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst : Can I ask a follow-up?

Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst : Yeah. I'm wondering -- what have you seen -- I'm assuming you've looked through the data collected so far about cravings for alcohol use. Have you seen reports of reductions in cravings and that kind of thing? I was curious about that. And then also, how are you going to manage that in the study? Is that going to be sort of like lifestyle intervention kind of double along? It's just kind of like you do on the obesity side. I was curious.

Question: Liisa Bayko - Evercore ISI Institutional Equities - Analyst : And Altimmune in the [pemvidutide] data specifically.

Question: Yasmeen Rahimi - Piper Sandler & Co. - Analyst : Yes. I think both of these indications as you guys highlighted, high unmet need. I guess I would love to understand in both studies, what is considered a clinically meaningful difference in both in the change in the heavy drinking in days as well as in the liver stiffness measures that sort of one in terms of what POC data could establish warranty moving forward to Phase III? 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 13, 2025 / 4:00PM, ALT.OQ - Altimmune Inc R&D Day And then part B, what is the regulatory framework for both of these indications? Are they determined? Or is that something that you would need to work with the agency closely post positive data? If you could just opine on both of these? -- for success as well as next steps registrational path. It would be very grateful.

Question: Yasmeen Rahimi - Piper Sandler & Co. - Analyst : Thank you.

Question: Annabel Samimy - Stifel, Nicolaus & Company, Incorporated - Analyst : Just for Dr. Loomba and Dr. Kranzler. Maybe you can help explain the rationale for the inclusion criteria. I believe it was DMI of greater than 25%? Or did I hear that incorrectly? And how did you push it that low?

Question: Eliana Merle - UBS Investment Bank - Analyst : I guess how are you thinking about development next step after the Phase II studies. So I mean I think the clinical rationale is sort of straightforward. So I think you end up showing this reduction in heavy drinking and AUD and the reduction in liver stiffness and ALP. I guess, do you then move both into Phase III. I guess, which of these two would be the priority. And I guess how was the scale of those folks like these potential Phase III programs here look, I guess, relative to obesity? Is ALD in space that you could say, pursue on your own.

Question: Eliana Merle - UBS Investment Bank - Analyst : Great. And just a follow-up question. And so I guess what's the proportion of patients that you expect in that ALD Phase II to be cirrhotic. And I guess how do you expect sort of the efficacy of the glucagon component to be in patients, let's say, a cirrhotic liver versus, say, F2, F3?

Question: Jonathan Wolleben - Citizens JMP Securities - Analyst : Wondering what percentage of NASH patients trying to get in the study that are excluded because of over alcohol use? And then can you discuss any specific challenges in running clinical trials in an alcoholic population and how to mitigate those specific challenges?

Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst : And to keep it short. If you could quantify event rates per year for MET-ALD versus what we have for MASH F2, F3 and also F4 MASH, I think it's like low single digits. And glad to hear, obviously, F4 MASH is part of the pemvi program. And maybe specifically, if you could comment on enrollment timelines for the AUD versus ALD study. I know the number of patients are different and time points are also different. If you could provide some color on that would be helpful.

Question: Mayank Mamtani - B. Riley Securities, Inc. - Analyst : First part was the event rates per year in ALD versus NASH, F2, F3, and F4. And yeah, that was the first part.