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: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: That's perfect. Thank you. Yes. I mean maybe just to start high level, and there's several FcRn assets out there. And if you could just outline how
you see yourself being differentiated?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: And then one thing you've obviously seen is some LDL elevation. And so can you talk about whether you think that's unique to batoclimab or
whether you think there's any evidence of it with other assets so that it would likely appear at some point?
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MAY 23, 2022 / 5:15PM, IMVT.OQ - Immunovant Inc at UBS Global Healthcare Conference
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: So as we think about -- I mean, the MG, for example, in the Phase III trial design, you're excluding patients with high LDL. And so -- I mean, a couple
of questions around this. What size of the population do you expect to exclude? And then is that something we should expect to see in other trials
in terms of high LDL exclusion? Or would dosing or duration of dosing be short enough that you think that wouldn't be necessary?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: And just as you think about this in the future for more chronic dosing, what and how do you plan to collect data, potentially dosing concomitantly
with the statin?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: And you're still on track for a first half '22 initiation?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Yes, just checking. And what's the threshold for success in this trial? Like, what do you want to see at the 12-week endpoint?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Just with regards to one of the points of differentiation being the subcu dosing, I think we recently saw some subcu data from argenx. And I'd just
be curious on your thoughts there.
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Okay. The -- obviously, your Phase III design and path forward here in MG has been blessed by FDA. Any early discussions with ex U.S. regulators
on the path forward just given the LDL changes and with regards to what they would see -- they would need to see to feel comfortable and how
you're factoring that into your development plan?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Okay. That's great. Maybe switching gears to WAIHA and TED. In WAIHA, you -- I don't think we've seen the study data accumulated prior to the
study termination. So any plans to share that at a conference or just publicly?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: And then the buckets you outlined in TED, the buckets of opportunity, obviously, post teprotumumab, which one of those you're seeing as your
sort of most optimal chance of success? Or is it just you're simply going to go after all 3 and you think they're all completely viable?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Okay. Great. So you showed us a slide, we've got 2 -- MG, TED, WAIHA and then 2 other indications. And 2 out of those 4 are going to be pivotal
trials or the next step is a pivotal trial, correct? What is the -- what are we waiting, or what are you waiting on there? Is it discussions with FDA? Is
it that they -- or is it you already know and you're just waiting to disclose them? Is it resources that you're going to pick 2 of the 4? What's the
processes going on behind the scenes?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Has the thought process around subsequent indications changed since the discovery of the LDL issues? Or were the next 2 indications you're
following, have they -- were they just happened to be the same?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: And you previously mentioned that the -- you were going to kind of run it through the LDL issues with 1 division and then you hope that there will
be sort of cross-talk between the others. In your subsequent interactions with these other divisions, have you found evidence of that cross-talk?
Or have you kind of -- how efficient has that been?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Okay. From a timeline perspective and a sort of event path for the company, I guess all we know right now is MG trial initiation first half '22, data
2024. And then we're kind of waiting on the -- you too kind of open the (inaudible) and tell us what the other 2 indications are and what's starting?
What can you tell us about potential data updates between now and 2024?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Maybe switching gears just quickly on funding, obviously, an important consideration for the space, especially where things are right now. Just
remind us where you are and what that -- what the runway that gives you is?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Okay. So do you think that will get us -- would that get you through to approval in MG, do you think? Or do you think we would -- there may be
additional funding required between Phase III data to an approval?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Sure. And maybe just on the healthy volunteer program with the statins. I think we're in a follow-up period right now. Should we expect to see any
data from that follow-up period publicly?
Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst
: Okay, fantastic. And I presume you'll let us know when MG trial initiates, right?
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