Immunic, Inc. (NASDAQ:IMUX) Q4 2022 Earnings Call Transcript

Daniel Vitt: I think it’s not only IL-17, it’s also looking on overall biomarkers impact on relations we are looking at. The other thing what I would like to see is kind of like a difference between the groups to guide us forward and to be able to conclude some ideas on potential dosing and so forth going forward. So that would be my expectation. But that’s all I can tell right now I think, I can’t dig into more details on the ongoing work here. Sorry for that.

Matthew Kaplan: No, perfect. That’s helpful. And then in terms of just a follow-up on the ENSURE interim analysis. What are the potential outcomes of the interim? Is this a futility analysis or what type of analysis will go on there?

Daniel Vitt: Yes, that is not pursuing a futility analysis. It’s more looking on what do we see when we reached half of the events and giving us the ability to do sample size adjustment in that timepoint. So that’s the pre-designed plan here. So it will not be handled as a termination reading or something like that. It’s really looking at…

Matthew Kaplan: It’s more of a powering or sizing analysis. Okay. Now I think some of the other questions have been covered already. But thanks and congrats on the progress.

Jessica Breu: . The next one is Andreas Argyrides from Wedbush.

Andreas Argyrides: They’ve actually more or less all been asked at this point, but maybe a quick follow-up on just 935. Do you see any potential to dose higher in the Phase I or extended treatment period? And are there going to be any changes to the patient population that could be implemented in terms of modifying exclusion including criteria?

Daniel Vitt: Yes, all of those are things on the team. So when we started this trial, for the first 2 dose strengths we were limited on the dosing for 28 days because of the preclinical package. We meanwhile completed the 3-month safety package and are in principle able to follow on the treatment to 12 weeks, which is something which we would consider doing. Once again it’s not decided, but it’s some of the options on the table. Second thing is dosing higher of course. That is something we can do, which we have the ability to increase doses. And on the other primates, of course that’s an important exercise here to understand what was the reason for the high placebo activity we have seen. And that of course is something we need to look on the patient characteristic and baseline, what is different there and where are potential risks on getting a bias or a wrong placebo activity.

And that’s something we are looking on every stone and flipping every stone that we have here. And that also is part of the reason why the team needs to spend some time on really carefully evaluating all of these things.

Andreas Argyrides: Okay. Great. Congrats on all the progress.

Jessica Breu: And we have one more person in the queue, which is Mayank Mamtani from B. Riley.

William Wood: This is William Wood on from Mayank Mamtani today. Really nice to see the continued great work here. Congrats on everything. I’ve got a couple of questions, more follow-ups on what others have asked. For the interim look for CALLIPER, you stated that you’ll be providing some biomarker data. I believe you mentioned NFL and GFAP before, we’ll probably also get safety. Maybe if you could just provide a little extra color on what we might be expecting? Is it just going to be those 2 biomarkers? Are we going to get any functional data? And then also just to verify, will these same biomarkers be provided also in the top line full data set sort of to give us an idea of mid and then end of term progression?