Altimmune Inc Phase 2b Topline 48-Week Data Conference Call Transcript

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

Question: Yasmeen Rahimi - Piper Jaffray Inc - Analyst : Good morning, team. Congrats on the data and really a big win of getting all to the regulatory alignment to you move to an AI-based biopsy reading. So team, I guess, if you could help us understand as you think about these really profound liver fibrosis benefits that you're seeing, which continues to get at 48 weeks. Can you help us understand like would you contemplate doing a longer Phase III study to capture that? And maybe just squeezing that the question will come up is, given that's AI-based, could there be an opportunity that the size of the Phase III could be smaller given that you use variability or biased in any way? Or is it just going to have to be over 1,000 patient data given the safety data requirement? I appreciate any color, and I'll jump back in the queue. LSEG STREETEVENTS | www.lseg.com | Contact Us consent of LSEG. 'LSEG' and the LSEG logo are registered trademarks of LSEG and its affiliated companies.

Question: Annabelle Samimi - Stifel, Nicolaus & Company Inc - Analyst : Hi, thank you for taking my question. Congratulations on the really consistent data. So a few questions here. Just going back to the design of the study, realizing this is going to be a 52-week study. Anything that you're doing to t pake in an endpoint that's going to demonstrate the rapidity of effect because I think that's one of the standout characteristics here. And then you mentioned that you're adding a 2.4 milligram dose for maintenance only. Is this only maintenance? Or are you considering it as one of the actual arms of the study? Thanks.

Question: Annabelle Samimi - Stifel, Nicolaus & Company Inc - Analyst : And if I could just ask a quick follow-up. Obviously, the discontinuations were very impressive, barely any dropout actually. So can you actually talk about that relative to the other MASH drugs, what you typically see, not just from the GLP-1s, but also from the FGF21s? How does it compare?

Question: John Wallabin - Citizens JMP Securities - Analyst : Thanks for taking the questions. Two for me. You mentioned you saw consistent safety in the diabetic population included. I wonder if you could talk a little bit about any differential responses you've seen on any of these efficacy measures. And then for Phase III, when you're jumping into the 2.4 milligram dose, can you talk about expectations for response rates at that higher dose? How do you think about your statistical projections and modeling for the Phase III? Thanks. LSEG STREETEVENTS | www.lseg.com | Contact Us consent of LSEG. 'LSEG' and the LSEG logo are registered trademarks of LSEG and its affiliated companies.

Question: Michael DeFor - Evercore ISI - Analyst : Thanks so much for taking my question and congrats on the very impressive data. Two questions from me. For Phase III for the 1.8 milligram dose, will it incorporate titration given the relatively high nausea rates seen in Phase II? And the second question is the FDA's openness to using PathAI. It sounds like they still need, I guess, more convincing on the variability of this modality. Has there been any change in the expected timing of Phase III given this -- the openness to use? Or is the base case still that the agency needs more data to fully embrace it? Thank you.

Question: Corinne Jenkins - Goldman Sachs - Analyst : Good morning, everyone. I was hoping you could be a little bit more specific about the number of patients you anticipate in the Phase III program, given some of these considerations around both efficacy and safety. And then I also wanted to just follow up on a point you made a bit earlier about using a maintenance phase for outcomes, assuming that's in the F2/F3 patient population. I'm curious if you anticipate also doing outcomes in an F4 population and how long you'd kind of anticipate it will take to generate that outcomes data depending on the patient populations you're looking at? Thank you.

Question: Fiona Gia - Jefferies LLC - Analyst : Hi, this is Fiona on for Roger. Congrats on the data and also the regulatory advancement. Just a clarifying question on the Phase III design for the primary endpoint. Is the understanding the conversation with the FDA is still evolving. Is your current goal using the non-invasive measurements or PathAI data for the primary endpoint?

Question: William Wood - B. Riley Securities Holdings Inc - Analyst : Hi, thanks for taking our questions and congratulations on the results this morning. I think the first question I have sort of centers around the NIT that you look to incorporate. The field has been essentially coalescing around this dual VCTE endpoint, which you've now increased to sort of come in line with your VCTE now at less than -- or greater than 30% improvement. But I'm just curious, given that while VCTE and now MRE are in -- they've had LOIs accepted from the FDA, we haven't seen that type of movement for ELF. And so the question really centers around where is the FDA or what's the FDA thinking in terms of a potential approvable NIT, are you looking at more this dual endpoint? Is that the correct area? Or is it going to be just VCTE or liver stiffness in general or just ELF? And then I have a follow-up. Thank you. LSEG STREETEVENTS | www.lseg.com | Contact Us consent of LSEG. 'LSEG' and the LSEG logo are registered trademarks of LSEG and its affiliated companies.

Question: William Wood - B. Riley Securities Holdings Inc - Analyst : Just one last one, if I can. In terms of the AIM-MASH AI tool, you incorporated this into your 24-week endpoint, but only for fibrosis. Is there a means to go back and reevaluate those original biopsy slides at 24 week for your dual primary endpoints and sort of give an adjustment post hoc wise on how that may change your original solely hepatologist read? You already presented the responder rate analysis, but you didn't actually provide -- I don't know if that's an option. That would be very interesting to see how that could improve or change in general, the solely hepatologist based.