Roivant Sciences Ltd. Common Shares Wells Fargo 21st Annual Healthcare Conference

That's right, yeah. Thanks for having us. It's great. We put out some data in PH-ILD this morning that was pretty extraordinary, so it's exciting to be here.

Yeah. Taking just like a 2-second step back first, just in case anyone's not familiar. Roivant now, just under a $30 billion market cap company. At this point, a leg with three stools, such as it were. brepocitinib is our lead product, just got approved a couple weeks ago in dermatomyositis under the brand name LISRAYA. We have an FcRn that Derek Archila knows extremely well, and I'm sure we'll spend some time talking about today at Immunovant. The third of them, which had been third in line until this morning, is mosliciguat. mosliciguat is an inhaled sGC activator. This is a mechanism, it's effectively a potent vasodilator, among other things, and it's a mechanism. sGC-targeted therapies have been studied.

In fact, in one case, there's a systemically administered sGC called Adempas that was a Merck-Bayer collaborative project in PAH, so it was about a $2 billion drug at peak. PH-ILD, for those who are unfamiliar with it, is pulmonary hypertension that comes from having lung disease. It's been a tough indication because systemic vasodilation for these patients is dangerous. You wind up all the benefit you get from vasodilating the healthy lung tissue, you give up by vasodilating the unhealthy lung tissue. It's been a tough indication to study. In the last few years, inhaled treprostinils, most notably Tyvaso from United Therapeutics, but also YUTREPIA from Liquidia and coming TPIP from Insmed, all different formulations of treprostinil have been successful at treating these patients. We took mosliciguat, this inhaled sGC activator, into PH-ILD with the hope of replicating that idea.

PHocus was a large, 100 some, 120-ish patient, phase II-B study in PH-ILD that was designed to demonstrate that we could treat these patients, and boy howdy, that was a really nice outcome. We got the deepest ever observed PVR, pulmonary vascular resistance, measured by right-hearted cath, I think in any pulmonary hypertension study ever. We had about a 56% placebo-adjusted improvement in PVR. We were not powered for a P value on the functional endpoint 6-minute walk, but we delivered a P value on the functional endpoint 6-minute walk. Just a really, really good set of data all around. I don't know how familiar people are with PH-ILD. This is a terrible disease. These patients are dying, and so it's phenomenal to be able to deliver this kind of outcome.

Yeah. A few months ago or earlier this year, we were kind of looking at each other and realized that we had pretty good conviction and that we wanted to move fast, and we started the phase III earlier this year. The phase III is enrolling patients now. I think the next step is to finish that study, which should then be sufficient for approval. That is what is ongoing now.

Basically, no, with one key exception, which is in the phase II-B study, we did not allow for concurrent use of treprostinil of Tyvaso, and in the phase III, we are allowing for some measure of concurrent Tyvaso. We have an open label study that is a combo study that we have not read out yet, but will allow for some concurrent Tyvaso use. It will be stratified, and we will probably cap it at some level. That way, we will not have any label restrictions, which pulmonary hypertension, for those that follow it, is a polypharmacy market where these patients go on every available drug. Actually, in PH-ILD specifically, because these patients have lung disease, treprostinil is an irritant and it causes cough in these patients, which is lousy for a patient with already a coughing disease. We had less cough on drug than in placebo.

We're one inhalation of a DPI once a day. I think we should have a pretty compelling value proposition, but ultimately, these patients are very sick, and I expect they will also wind up on a combination of these drugs over time.