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

Daniel Vitt: Good question. So expectations, I think we had this R&D day call everybody on this line here had a chance to listen to that so far. Even it’s available as a recording on the home page by the way. We think that in that design, we’re treating for 4 weeks and half of the time without gluten challenge and then we follow in the second half of the trial for another 14 days with a gluten challenge. And I think the most robust expected readout would be to look whether to what extent we can block the IL-2 sequence after starting the gluten challenge and this is typically done 4 hours after starting the gluten challenge. You measure then the CR based IL-2 levels. And if we are able to restore barrier function and block basically the settling of gluten and the derivatives of gluten to the immune system, then we should see a reduced amount of IL-2.

So that’s the first thing. Yes, there was a second question, MOA. As you know, we have been very quiet on that and just to make sure we have little bit of — we maintain our advantage over potential competitors on the knowledge of the target and how it works. But we plan to disclose the target during this year, but of course we would like to do that in the context of a scientific presentation or conference so that it has the right surrounding of a scientific environment. So likely after the release of the data not too long after that we will come out with the target and maybe more details on the mode of action. Despite we have I think shown some aspects of the mode of action for example gene regulation affecting globin proteins, and the tier assay system where we have shown that the drug is able to restore barrier function in quite importantly moments.

Unidentified Analyst: Got it. That makes sense. And then with the interim data from the CALLIPER in PMS expected in second half, like what would that asset look like in your perspective and what data gives you the most confidence in the potential of vidofludimus calcium in this indication?

Daniel Vitt: Yes. Thank you for that question. It’s important to know what are we reading out. I think the focus of this readout is clearly on biomarkers. We will have a couple of those. And as you know, progressive MS is something where not a lot of things worked so far. It’s a huge unmet need. So seeing a difference between placebo and the different subsets of PMS in this trial would be a success from my point of view. This is not an interim analysis which is prop for any statistical readout. It’s really just looking do we see a signal here. And there’s a typical more important question is it medically meaningful segment we see there. But the focus is clearly here on the biomarkers. To remind you the primary endpoint of the trial will be change in brain atrophy between placebo and active and that is then expected to be read out at the end of ’24.

So all of these pieces I think are important to at the end judge to what extent the potential of vidofludimus goes beyond the RMS Phase III program, which we’re running in parallel.

Jessica Breu: The next one is Matt Kaplan from Ladenburg Thalmann.

Matthew Kaplan: Just some follow-ups on your kind of near-term clinical milestones. Just first was 935 as you analyze that data there from the psoriasis cohort, what are your expectations in terms of looking at the drug’s impact on IL-17 and reductions there that would get you excited about moving the drug forward?