The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jayed Momin - Stifel, Nicolaus & Company Inc - Analyst
: Hi, this is Jayed on for Annabelle. Thanks for taking our question. I have two the first one related to the MASH development plan. You've had some
time to digest the data and we did see fibrosis improvement not reach statistical significance, but to what extent could you still leverage the other
improvements and a PathAI analysis at week 24? How does the FDA view these new measures and could you potentially get it into the label by
including those endpoints in a Phase three?
Question: Jayed Momin - Stifel, Nicolaus & Company Inc - Analyst
: Thank you. I had one more question. It's related to the AUD and ALD trial. I could be wrong about this, but I do recall you guys mentioning that
you would test different doses, like 1.2, 1.8, 2.4 with titrations. But it looks like you're only testing the 2.4 milligrams in these trials. Is there a particular
reason for that?
Question: Catherine Okoukoni, MD, PhD - Citizens JMP Securities LLC - Analyst
: Hi, this is Katherine on for John. I have a quick question about the T1 responses and how the results from IMPACT compared to other programs. I
know that you said kind of best-in-class, but if you could kind of give us some kind of ranges from the other competitor programs. Thanks.
Question: Mayank Mamtani - B. Riley Securities Holdings Inc - Analyst
: Hi, thanks for taking our questions. This is William on for Myong today. Two from us. Maybe I'll start with the first. So now that we know that Lily.
Has gotten positive FDA buy in on pursuing high risk masld, a high risk MASLD trial for their Retta and Tirzepatide. They're using NITS for patient
screening and then foregoing biopsies completely for primary FSP endpoint and looks like even in the trial looking more of an outcomes type trial.
How do you see this as an opportunity for PENVI to execute on a capital efficient Phase 3 trial? And is your understanding that this still only biopsies
are a way to secure subpart H accelerated approval? And then I have a follow up.
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Question: Mayank Mamtani - B. Riley Securities Holdings Inc - Analyst
: Got it. And then also again, I was sort of thinking of Crosstown Pier. Merck has their efinopegdutide readout coming out shortly and they're looking
at biopsy results at 48 weeks. Slightly different glucagon ratio here. But what could their data mean in terms of your 48 week data potentially in
Phase 3 or obviously just your NIT data coming up the end of the year? And what may you be specifically looking for to bring you additional
confidence in Phase 3 sort of going forward? And what will guide you, help guide you in development of that Phase 3?
Question: Corinne Johnson - Goldman Sachs Group Inc - Analyst
: Good morning. Maybe just one from us. How should we think about the cadence of research and development spend from here as these AUD and
ALD studies studies get up and further running and enrollment increases? Thanks. Thanks. Appreciate the call.
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