Immunovant, Inc.

Good morning. My name is Melissa, and I will serve as your conference operator today. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. Joining me on the call today will be Dr. Pete Saltzman, Chief Executive Officer of Immunivint, and Dr. Frank Torti, Executive Chairperson of Immune Events. Before we begin, I'd like to remind everyone that today's conference 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 Immune Events product candidate and Immune Events expectations regarding the timing, design, and results of its clinical trials, including the timing of future data readouts and announcement of future indications. These forward-looking statements are not guarantees of future performance and are subject to various risks 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 Amendment'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 Salsman. Thank you. Dr. Salsman, 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 30th, 2021. R&D expenses. Research and development expenses were $18.7 million for the three months that ended June 30th, 2021 compared to $16.9 million for the three months that ended June 30th, 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 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 Immunivant. I'm joined today by Dr. Frank Tordy, the executive chairman of Immunivant, 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. And this investment not only is the executive chair of Immunovans, but also is a representative of the Roivant management team. As a member of Roivant's senior leadership team, I know the rigor with which Roivant's investments are assessed. And this significant investment is further evidence of Roivant's continued confidence in and commitment to Immunovans, 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 two and three trials across numerous studies and sponsors. There's been 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-SDRM market, exceptionally attractive due to a wide range of indications that the mechanism could 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 Immunobant describes in June and in other analyses that 14.01 is even more potent than we initially expected, which opens up a path for us to be uniquely flexible in our dosing and dose strategies to address the myriad of diseases that can be impacted by FCRN. In particular, the flexibility of dosing not only enables Immunobant to design programs to target the ideal level of IgG suppression in a particular disease, But we believe also will enable a new event to design dosage regimens where changes in albumin and LDL outside of normal limits will be mostly either modest or of short-term duration during an induction phase, for example. In addition, when you think of a signal like lipid elevation, our ability now to consider things like dose, dose interval, induction and maintenance, inclusion-exclusion criteria, baseline lipid levels, treatment with antilipid therapy, et cetera, and just generally bring a degree of thoughtfulness to the issue is, of course, much different now. than it was when this was an unexpected signal first emerging. So I think you'll see design elements that take advantage of 1401's flexible profile from our trials in the future. With that said, this is a landscape that is moving fast with well-capitalized competitors pursuing indications aggressively. For example, Argenix raised about a billion dollars in February to aid in the advancement of their drug, and in now six different indications, and they said they plan to have 15 by 2025. J&J is likewise moving aggressively post their acquisition of Momenta. And in a field with that degree of investment, taking a serial and stepwise approach is not the strategy we at Royvan thought would best position the company for long-term success. So our investment was really designed to allow the company to move forward in an unencumbered way and let the team really be aggressive with their clinical development approach. You know, in particular, we fully appreciate the unique features this antibody offers in terms of a very broad therapeutic window with its convenient low volume, subcutaneous injection form factor. So we think Immunovant's 1401 can really make a big difference for many, many patients. But to realize that potential, we know Immunovant's going to need to execute an ambitious clinical development plan. In some cases, Immunovant is already ready to run a pivotal trial and include design elements that will differentiate 1401 versus competing assets in the class. In other cases, Immunovant will be running first-in-class proof-of-concept studies and new indications. And to be a leading anti-XCRN, which we definitely believe Immunivant can be and 1401 can be, we'll need to execute many of these trials in parallel. And that's where the incremental $200 million investment really made a lot of sense to ensure we can drive long-term value creation. You know, when you step back, drugs with validated mechanisms, very large market opportunities, and transformative potential in markets this big just don't come around very often. And with approximately $575 million now on the balance sheet, Immunobant is well equipped to focus on the execution of their trial, as well as expanding into new indications. Now, Roivant is incredibly excited about the prospects of 1401, and we're eager to support Immunobant through this investment and through broader engagement. And I also look forward to personally continuing to work closely with Pete and the Immunobant team to help develop 1401 to help maximize the benefits for patients and to drive future value for all of our shareholders. So, thanks for having me on the call today, and with that, I'll turn it back to Pete for some additional comments.