Good morning. My name is Melissa, and I will serve as your conference call operator today. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. Joining me on the call today will be Dr. Pete Salzmann, Chief Executive Officer of Immunovant, and Frank Torti, Executive Chairperson of Immunovant. Before we begin, I'd like to remind everyone that today's conference call will include certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, for example, statements regarding the potential efficacy and safety of Immunovant's product candidate and Immunovant expectations regarding the timing, design and results of its clinical trial, including the timing of future data readouts and the announcement of future indications. These forward-looking statements are not guarantees of future performance and are subject to various risk and uncertainties, assumptions, known or unknown, which could cause actual results to differ materially from those indicated or anticipated. For more information, investors are encouraged to review Immunovant's most recent quarterly report on Form 10-Q filed with the SEC on August 9, 2021. Now, I'd like to turn the call over to Dr. Pete Salzmann. Thank you, Dr. Salzmann. You may begin.

Thank you, Melissa. I want to take this opportunity to thank everyone for joining the call today. I realize that we do not always do quarterly earnings calls, but because we've been more limited in our ability to interact with the investment community over the last several months than typical, we wanted to take the opportunity to have a call today to highlight the results from the quarter and engage in a dialogue around our go-forward strategy. I will start the discussion today with a brief recap of our financial results and close with some comments on our programs. With that, I'd like to begin by briefly reviewing our financial highlights for fiscal first quarter ended June 30, 2021. R&D expenses. Research and development expenses were $18.7 million for the three months that ended June 30, 2021, compared to $16.9 million for the three months that ended June 30, 2020. The year-over-year increase primarily reflected higher personnel-related expenses and increases related to clinical activities for analyzing data and the program-wide data review, partially offset by lower contract manufacturing costs. G&A. General and administrative expenses were $11.2 million for the three months that ended June 30, 2021, compared to $9.7 million for the three months that ended June 30, 2020. The year-over-year increase was primarily due to higher personnel-related expenses. Net loss. The net loss was $30.5 million or $0.31 per common share for the three months that ended June 30, 2021, compared to $26.7 million or $0.38 per common share for the three months that ended June 30, 2020. Net loss for the three months that ended June 30, 2021 and 2020 included $3.9 million and $4.0 million, respectively, related to non-cash stock-based compensation expense. In addition to the first quarter results that I just briefly reviewed, we announced last week a $200 million direct investment by Roivant into Immunovant. I'm joined today by Dr. Frank Torti, the Executive Chairman of Immunovant, who is also a member of Roivant's senior leadership team. Frank, I believe you are in a unique position to put this investment into perspective, which I'd like to ask you to do.

Thank you. And it's a pleasure to join you today on the call and be able to express my excitement and support for the company in this investment, not only as the Executive Chair of Immunovant but also as a representative of the Roivant management team. As a member of Roivant senior leadership team, I know the rigor with which Roivant investments are assessed, and this significant investment is further evidence of Roivant's continued confidence in and commitment to Immunovant, both now and, importantly, in the future. Fundamentally, we believe 1401 is a unique asset. In our view, the mechanism is validated, with successful Phase II and III trials across numerous studies and sponsors. There's a proof-of-concept in multiple indications. And we have the potential in 1401 to deliver the most flexible and patient-friendly dosing experience with the best form factor in the class. And we've always found the class, the anti-FcRn market, exceptionally attractive due to a wide range of indications that the mechanism can potentially address. Now that's something that's been said before, but if you look at the pace of new indication announcements from all the companies in the field, the interest and development intensity around the mechanism is only increasing. There are now, for example, companies targeting approximately 15 or more distinct indications with anti-FcRn therapies, with at least five of those indications being disclosed only over the last several months. And these indications are characterized by a high unmet need with a still outdated standard-of-care, often consisting of broad spectrum immunosuppressants and IVIg. And so the opportunity to take share and remake multiple existing markets, as well as to create new ones is really remarkable. We've now observed from the data Immunovant described in June and in other analyses that 1401 is even more potent…

Thanks, Frank. That's a great overview. Before I get to the $200 million investment from Roivant, I'd like to discuss Myasthenia Gravis from both a strategic angle and in terms of execution. Let's start with execution. I believe we are on track to gain alignment on our pivotal MG design with the FDA in Q4 of this calendar year. In fact, we have communicated with FDA regarding a meeting early in Q4 to review modifications to our pivotal Phase III study in MG. These modifications are based on the agency's advice and feedback obtained during our previous end of Phase-II meeting and are also based on our recently communicated program wide review. Contingent upon the FDA feedback we received in Q4, we plan to initiate our study in the early part of 2022, and we're very excited about how this program is shaping up. Gaining alignment with the FDA and getting back into the clinic will be an important catalyst for Immunovant, especially given the remaining opportunity we see for patients and for 1401 based on our understanding of patient needs and 1401's potential. I also think the strategic opportunity for 1401 is underappreciated by the market. Not surprisingly, Immunovant's market research highlights the enthusiasm that neurologists have for the anti-FcRn class generally. The rapid onset of symptom control and the percentage of deep responders have been impressive, especially given that studies reported to-date have involved short term dosing. Recently, our marketing and medical teams dug deeper with patients and with physicians who treat large populations of patients with Myasthenia Gravis. This research highlights something very important, specifically that patients strongly desire to avoid relapse. When patients with Myasthenia Gravis relapse, weakness in symptoms can occasionally get much worse very quickly. Relapse can be a crisis. So patients want study…

Thank you. [Operator Instructions] Our first question comes from the line of Robyn Karnauskas with Truist Securities. Please proceed with your question.

Hey, guys. Good morning. Thank you so much for taking my call. This is Trepan [ph] for Robyn. So the PR mentioned plan to initiate clinical trials in at least two indications. Maybe you can talk - you talked about all the 15 indications that FcRns are being investigated in. Can you talk a little bit about the rationale behind selection of these indications? And just a little confused, you said that at least one of these trials will be a pivotal trial. Is that beyond MG, TED and WAIHA? And then maybe it's a little too early to talk about it, but if 1401 plays out the way you expected to in TED, how do you see the market evolve in TED? Thank you.

Thanks, Trepan. A great set of questions there. So first, your first question related to our selection criteria. And I mentioned that there are 15 different indications now posted to clinicaltrials.gov across the entire anti-FcRn class. How will we select which indications we're going to pursue next? I think that's a pretty classic type of analysis that we're doing, with probably the two most important elements being the probability of technical success, how good of a fit is the anti-FcRn mechanism for the particular disease in question, as one element. And then secondly, the degree of unmet need, how much opportunity is there to benefit patients. In addition, of course, we'll consider the unique features of 1401 that I discussed, including the broad therapeutic window and the really simple subcutaneous form factor. And then some other logistical factors, like the clarity of regulatory endpoints. So all that goes into our decision-making. Ultimately, we want to have a set of indications, some of which we have an opportunity to be best-in-class, where there's already been clinical validation perhaps by another asset, and then some indications where we can be first-in-class. So I think that's for your - for your first question. With regard to the statement around a - and one of our indications beyond MG being pivotal, that could apply to WAIHA, TED or one of the new indications. So we're thinking about those four indications as a group. And we believe that one of them will begin with a pivotal trial in 2022. And then we'll also have the previously announced pivotal trial in MG. So that's two pivotal programs in 2022. Finally, with regard to Thyroid Eye Disease, I think it's just a really, really interesting market. It's a - like many of the auto antibody conditions, for…

Great. Thank you so much.

Yeah.

Thank you. Our next question comes from the line of Thomas Smith with SVB Leerink. Please proceed with your question.

Hey, guys. Good morning. Thanks for taking the questions and thanks for the update. I guess, first, in terms of 1401 dosing, are there any additional analyses that are being conducted on the previously collected data? And if so, when can we expect to see these analyses communicated?

Yeah. Thanks, Tom, for that question. So we are taking the totality of data that we have from all the patients who were dosed with 1401 prior to the pause in dosing and continuously refining our models to give us an understanding of how dosage regimens that we haven't yet studied might perform. That's obviously, as you know, the rationale for PK/PD modeling. So yeah, we're looking at a lot of different potential dosage regimens and we expect those to inform our protocols going forward. And I would expect that detailed information regarding the output of our models and the design of our protocols, including any new dosage regimens, would be part of our R&D Day in the first quarter of 2022.

Okay. That makes sense. Thank you. And then it sounds like you're relatively close to having a pretty good idea of the trial design for the pivotal MG study. I guess what else would you be able to share with us both in terms of details around that study? And then, I guess, what the - what you feel are the major outstanding, perhaps gating, factors to starting that study and gaining alignment with the agency?

Right, right. So in terms of the protocol itself, I mean, I think as I've indicated, I see a lot of opportunity for an induction in maintenance type of approach. So I think the protocol that we ultimately achieve alignment with the FDA on, which of course is dependent on any final feedback they have, will have a - will have that flavor. In terms of gating factors, it's really just the logistics of the back and forth and gaining alignment with the FDA that we have to work through at this point.

Okay. And then maybe one last question, Pete. In terms of, I guess, your overall engagement with the agency across three different divisions, if you can maybe speak to, I guess, any other gating factors that you feel like are outstanding in terms of being able to restart the WAIHA and Thyroid Eye Disease programs?

Right, right. It's really the same element as what I just mentioned for Myasthenia Gravis. Obviously, we have the most data in Myasthenia Gravis. And so that is - that's a good place to start, having completed an end of Phase-II meeting with the division previously. And so that interaction will be the first one, and then the interactions with the other divisions will follow. And there's obviously a whole host of background information that is the same for any interaction and a lot of that will be reviewed first with the agency via the interactions with the neuro division.

Okay, great. Thank you. Appreciate for taking the questions.

Yeah. No problem, Tom.

Thank you. Our next question comes from the line of Douglas with H.C. Wainwright. Please proceed with your question,

Hi, good morning. Thanks for taking the questions. Just, Pete, as you think through indications and prioritization, is there been any change or thinking, just given sort of some of the flexibility, in terms of dosing and managing albumin levels and LDL levels that will be needed? Thank you.

Yeah, I think the big insight came just as we were doing our final preparation for the June 1st call and finalizing our 10-K. And that was really rooted, honestly, in optimizing efficacy within immunology conditions. And what we came to realize, Doug, is that across a wide variety of immunology indications, you want to optimize efficacy by treating hard upfront with induction and then minimize the patient's long-term immunosuppression by tapering down a little bit in the maintenance phase. So this induction and maintenance phase is really used across a wide variety of mechanisms and indications to optimize the efficacy. So I think efficacy is always one of the most important things for any new asset. We then realized that this approach was also attractive from an albumin and LDL standpoint, primarily because, as I mentioned earlier today and previously, the PK/PD models are different for IgG and for albumin. So you get a much steeper fall-off [ph] of the albumin impact, as you step down the dose as compared to the reduction in the IgG. So that allows for a sort of a sweet spot to be achieved for chronic dosing with a more mid-range dose that still have really good IgG reduction. Remember, we reported a 62% median reduction in IgG for the 255 dose, while having a much more modest impact on albumin and, therefore, LDL, where that dose had a 15% decrease in albumin and a 15% increase in LDL, speaking about the 255 dose. So that's really fundamentally what I think is going to provide us a great path forward in a lot of indications.

Okay. And so just to clarify, so you don't really see this being sort of a limiter in terms of what indications you may or may not pursue at this point?

I don't because, again, in the short term, when you're in that induction phase, the goal of the physician and the goal of the patient is really to get the symptoms under control, it's really around efficacy. There will certainly be some small percentage of patients who - for whom a medication that changes the albumin or LDL even for a short term may not be appropriate, but that's going to be true of any asset. There'll be a small percentage of patients that aren't ideally suited. And then there'll be a large majority of patients who - for whom this can be a really nice option. Maybe I'll ask Frank to make a point as well. I know he's thought a lot about this topic. Frank, we're not hearing you yet. You might be muted.

Thank you. I think the - the other thing we're aware of, obviously, is others in the field are thinking about some of these issues, right. And if you see how this manifests, for example, in the nipocalimab Phase III design that has just been released by J&J. They didn't change much from the protocol they wanted to go forward with other than adding an exclusion criteria for patients who have had myocardial infarction, unstable angina, heart disease or stroke within 12 weeks of screening. So clearly, other companies are grappling with us in the field kind of similar kind of issues with the FDA and thinking about how they go forward. And we're taking the lessons obviously from those points.

Great. Thank you so much.

Thanks, Doug.

Thank you. Our next question comes from the line of Sam Slutsky with LifeSci Capital. Please proceed with your question.

Hey. Good morning, everyone. Thanks for the presentation. Just one question for me. In terms of resuming development in WAIHA and TED, are you able to discuss what the general design and size of next studies might look like? And then for TED, can we expect to see data from the Phase II study prior to next steps?

Yeah. Great question, Sam. So the $200 million investment from Roivant obviously allows us a lot of flexibility in our thinking. So we're thinking about the best way to approach both of those conditions in terms of next steps in the context of what we've learned so far and in the context of what we ultimately want to achieve, which is a differentiated approval in those indications. So I'm not yet able to get more specific beyond that. In terms of the releasing the Thyroid Eye Disease data in greater granularity prior to gaining alignment with the FDA on our next trial, I don't think we'll do that. I think right now we have a lot of information that we're poring over confidentially with some advisers and design - using that to design our next trial in Thyroid Eye Disease. And then probably at the time that we announced that, the design for that next trial that would be a good time to share more detail on what we've observed.

Okay. Got it. Thanks.

Thank you. Our next question comes from the line of Yatin Suneja with Guggenheim. Please proceed with your question.

Hi. This is Evan on for Yatin. Thank you for taking our questions. You know, what specific steps would you take to mitigate the LDL issue in the TED trial that you're starting up again? Is there anything that you're doing beyond potential adjustments in the dosing regimen? And then I have a quick follow-up.

Yeah. Thanks for that, Evan. So Thyroid Eye Disease is a little bit unique in that it's likely a shorter duration of therapy. So this is a condition that may just have induction, and then the maintenance phase could be off medication. That's essentially the teprotumumab design, which makes sense in a condition that is somewhat self limited. Thyroid Eye Disease resolves over a period of years versus many, many - versus the other conditions which don't resolve spontaneously. So I think given that the dosing in Thyroid Eye Disease is likely to be of a shorter term duration, then it may be that there is nothing particular that needs to be done for lipid management, given that shorter term excursions in LDL for the vast majority of patients, particularly with some modest inclusion, exclusion criteria changes, won't really be an issue. That said, we are considering the kinds of things that you'd imagine and Frank highlighted briefly in his prepared remarks, which is dosage modification or anti-lipid therapy that could play a role in Thyroid Eye Disease programs as well. So all that stuff is things we're looking at and will get finalized over the next six months here.

Got it. And then just one quick follow-up. Are there indications or subsets of patients within a particular indication across the 15 indications that you mentioned that are currently being investigated in the FcRn space you know, where these lipid issues are not that big of a deal?

Yeah. There's a wide variety of comorbidities. For most of the autoantibody conditions, the comorbidities are not actually that significant. And that may be because for many of the autoantibody conditions, there's not as significant of a sort of total body inflammatory data as there are in some of the more general autoimmune conditions. But certainly, if you look across all 15, you'll find some variability. I think maybe the most important point though, just to kind of keep hammering at home [ph] is that short term changes in LDL are not concern for the vast majority of patients. So when there's a short term change associated with induction, I think that's not going to be such an important consideration, particularly if that short term excursion is associated with higher efficacy because of the deep reduction in IgG that can be achieved with induction with 1401.

Got it. Thank you.

No problem.

Thank you. Ladies and gentlemen, this concludes our question-and-answer session. I'll turn the floor back to Dr. Salzmann for any final comments.

Thanks, Melissa. Well, I appreciate everyone joining today's call. I'm sure you can really hear our enthusiasm based on a remarkable market opportunity, 15 announced indications across the class, it's just really, really unique, I think. Our enthusiasm is also based on 1401 differentiated profile with a broad therapeutic window and a simple subcutaneous injection form factor. And based now on a strong balance sheet, enabling us to pursue an ambitious parallel development program. Thanks, everyone. Have a good day.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.