Roivant Sciences Ltd Unveiling New Pipeline Program: Mosliciguat Summary

The following is excerpted from the question-and-answer section of the transcript.

Question: David Risinger - Leerink Partners - Analyst : Thanks very much and congrats on the update, and thank you, Mayukh, for the very detailed presentation. So I have a couple of questions. I'm going to ask mainly high-level questions. The presentation was quite comprehensive and helpful. So Matt, I know that you've been excited to share this news for a long time. Can you just step back and review how you decided to keep this drug confidential over the past year and developments in recent months? And just what activities you've been engaged in -- obviously, that's included designing the Phase 2. But additional color would be helpful.

Question: David Risinger - Leerink Partners - Analyst : Great. And then you studying a single dose in Phase 2?

Question: David Risinger - Leerink Partners - Analyst : Great. And then with respect to the trial design, I mean, obviously, you're moving very rapidly, and it's only a 120-patient study, which is great. But could you have considered conducting an adaptive Phase 2/3 study to go even faster into Phase 3, given the unmet need and the profile of the drug? Or is that just not possible? You have to run the Phase 2, complete it, have an end of Phase 2 meeting and then start Phase 3 separately.

Question: David Risinger - Leerink Partners - Analyst : Excellent. And then one final one. Could you comment on your consideration of potential development in PH COPD?

Question: Allison Bratzel - Piper Sandler - Analyst : Congrats on the update. And -- maybe just two quick ones from me. First, could you just clarify for us the time lines and Catalyst what we should be looking for with respect to Mosli and PH-ILD . Given the Phase 1b data we've seen, I would think you would see pretty rapid enrollment and PHocus and an eventual Phase 3. So just thought there would be helpful. And then maybe building on that last question. I know you're initially focusing on Group 3 and PH-ILD for Mosli. I guess -- at what point do you explore other PH expansion opportunities? Is PHocus data gating factor? Or what's gating there? Just maybe just kind of bigger picture plan for the asset would be helpful.

Question: Dennis Ding - Jefferies - Analyst : Maybe a question around the Phase 2 design. Can you talk about your target enrollment criteria, you're slightly elevated based on PVR, but is there a specific cutoff -- and -- maybe if you can comment on the number of background therapies and other things like a mix of naive or experience, that would be helpful.

Question: Yaron Werber - TD Cowen - Analyst : Congrats on this program. A couple of questions. Number one, just kind of systemically, are you seeing any exposure at all on any systemic vasodilation. And then secondly, our understanding is that Merck's program in PAH didn't have great data. I don't know if you have any insights on that. And then maybe just finally, give us a little bit of a sense, when is the composition of matter expiring. I see that the overall patent status until 2042.

Question: Louise Chen - Cantor Fitzgerald - Analyst : Congratulations on the progress this week. It's only Tuesday and you've announced a lot. So first question I had for you was, Roivant has always been very good at spotting trends early. And what really peaked your interest in this opportunity? And what do you think -- the Street hasn't caught on to yet? And then secondly, any physician feedback you can offer from your ERS presentation.

Question: Brian Cheng - JPMorgan - Analyst : Just a couple from us. Can you give us a sense of the duration of the titration period in the Phase 2? What are the doses that you'll be testing going into this titration period? Are those the same doses that we have seen in the Phase 1? And any trigger that you can discuss -- you can disclose on what you would need to see to further escalate the dose. And I have a follow-up.

Question: Brian Cheng - JPMorgan - Analyst : Okay. And when we look at your ERG presentation, it seems like you already got decent PVR reduction in patients with high 400s and low 700s PVR at baseline. Mayukh, I don't know if you can discuss a little bit about how you envision to assess when it comes to PVR change from baseline, which is your primary end point into Phase 2.

Question: Andy Chen - Wolfe Research - Analyst : So activators have been around for a while, even though some of them may have been terminated. Why is it that they haven't entered PH-ILD? And then on a related note, because you've been hiding the asset, if your competition should enter PH-ILD with an activator, are there certain pharmacological or molecular properties that make Mosliciguat better than other activators? The only thing I see on this slide is half-life and convenience. Curious if there are other advantages. The reason I'm asking is because if your competition also pursues PH-ILD, will they be immediately at a molecular disadvantage?

Question: Corinne Jenkins - Goldman Sachs - Analyst : Maybe a couple of questions for me. Maybe first, I mean you just mentioned they are sort of an expert in the space. So what's your understanding for why they'd be willing to sort of part with this drug and let you take over the development there? And then you mentioned, I think, that you'd be willing to talk about expansion opportunities, albeit you see the Group 3 PH-ILD here is compelling on its own. But would you run this proof-of-concept-type studies kind of in parallel to Phase 2? And when would you aim to have like more clarity on a broader development strategy for this program?

Question: Yatin Suneja - Guggenheim Partners - Analyst : Just maybe two for me. With regard to the dose response, could you maybe articulate for us, what did you see in preclinical model? Are you seeing a similar effect where you're seeing a plateauing effect around 2 milligram -- so that's one. And then the second question is around this activator versus stimulator. So the question is how variable are the levels of NO and heme in PH-ILD, in other words, are there patients that might respond to stimulator better versus an activator?