Altimmune Inc Q3 2025 Earnings Call Transcript

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

Question: Yasmeen Rahimi - Piper Sandler - Analyst : And congrats on the RECLAIM enrollment completion. I guess the first question is based on sort of discussion with the key opinion leaders in the space, do you have any idea in like, I guess, the probability of the different scenarios of potentially using NITs or AI-based histological reading. If you could just maybe help us understand based on the three scenarios, which one they think has a high probability of being able to get a sign-off. That's question one. And then question two is, help us understand, I guess, the advantages of using AI-based biopsy reading versus traditional histology reading and especially when it comes to Phase III studies and if any other sponsors have implemented that? And then the third question is on RECLAIM, maybe help us conceptualize what would be considered a clinically meaningful endpoint in the primary endpoint there. And I'll jump back in the queue.

Question: Yasmeen Rahimi - Piper Sandler - Analyst : That's right.

Question: Yasmeen Rahimi - Piper Sandler - Analyst : Thank you. I'm good. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2025 / 1:30PM, ALT.OQ - Q3 2025 Altimmune Inc Earnings Call

Question: John Wallabin - Citizens JMP Securities - Analyst : I was hoping you could talk a little bit about alcoholic use disorder and alcoholic liver disease as distinct opportunities. It just seems like there's going to be significant overlap in the advantages or disadvantages of running one program versus both.

Question: Annabelle Samimi - Stifel, Nicolaus & Company Inc - Analyst : Just going back to the product profile and pricing and payer discussions, maybe for Linda. I mean, how -- I understand the potential differentiation, how exciting that could be for MASH. I guess the landscape is shifting a little bit now with obviously, with semaglutide possibly having MASH some combinations that are in development or seeking development with FGF21. So, I guess maybe you can talk about how you think about MASH pricing when we have some of these other alternatives that could potentially help on the liver side, but indirectly and longer term. I just want to think about that because some physicians are really starting to think about payer pushback and cost. So how should we think about that? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2025 / 1:30PM, ALT.OQ - Q3 2025 Altimmune Inc Earnings Call

Question: Annabelle Samimi - Stifel, Nicolaus & Company Inc - Analyst : Great. That's great context. Just a couple more for me. Just going into AASLD, I know that raising awareness of pemvi is very important. So, can you just give us some color around how you're going to be doing that at the upcoming meeting and how you're going to raise awareness among KOLs? And just on one other quick question, RECLAIM, obviously, enrolled very quickly. How is the ALD enrollment going?

Question: Unidentified Participant - - Analyst : This is William on for Mayank. Congratulations on a very nice quarter. Looking forward to seeing the upcoming AASLD presentation. Two for us. In terms of your Phase II 24-week biopsy results, I was curious if you could talk to any new or incremental analysis that you may have performed that we may get. And specifically, do you know if there's, by any chance, any F2 or F3 analysis that you did on the study? And in regards to F4 patients, by chance upon sort of reevaluation of the biopsies were any included in the study and how the data from your F3 patients might inform how pemvi may perform in the F4 population? And then I have a follow-up.

Question: Unidentified Participant - - Analyst : Got it. And then in terms of RECLAIM, as it's been said, it's obviously enrolled pretty far ahead of plan. I was curious if there's been any type of baseline analysis that's been compiled. And if so, could you touch on how those baseline characteristics may compare to the original plan? And then also how that informs to your interest in your RESTORE ALD trial, where you're also looking at these liver-specific endpoints such as VCT and ELF? And maybe what's the broader data package that you're looking for to collect that would help qualify as Phase III enabling?

Question: Michael DeFor - Evercore ISI - Analyst : I have three. The first one, since you said that Europe has approved AI biopsy reads and that you intend to propose the PathAI platform to the FDA later this quarter, what are the practical steps -- next steps once the clearance comes? Like for example, are your imaging and workflow systems already validated for PathAI? Or would there be a ramp-up period before you could implement the AI read in Phase III? And then I have two follow-ups. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2025 / 1:30PM, ALT.OQ - Q3 2025 Altimmune Inc Earnings Call

Question: Michael DeFor - Evercore ISI - Analyst : Okay. And relatedly, how will NIT tracking actually be implemented operationally in Phase III in terms of frequency, imaging cadence, data interpretation? Any color you could offer on that?

Question: Michael DeFor - Evercore ISI - Analyst : Got it. And my final question is regards to Lilly's Retatrutide. I know it's very early and a lot needs to happen between now and then. But any thoughts on pemvi's competitive positioning? Should pemvi and Retatrutide compete against each other in the MASH space?

Question: Unidentified Participant - - Analyst : This is [Kelsey Lucerne] on for Andy. We had a question around the preclinical development program for the oral formulation of pemvidutide. Just curious if you could share next steps and time lines for advancing this candidate and any sort of thoughts around positioning relative to the injectable? Will it also be progressing in MASH as an alternative to the injectable form and who you might see as your competitors for this program?