Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) Q3 2023 Earnings Call Transcript

Edward Tenthoff: Great. Thank you very much. Summer is going on and excited about the progress. As we look at the pipeline, what should we be expecting from C3? I know that we’re in these patient cohorts now of these neuropathy and maybe IgA nephropathy. When could we get data from those? And what would be your ultimate view for advancing AROC3 further? Thanks.

Ken Myszkowski: Yes. In terms of when we should get data, we’re probably looking at end of next year, so end of 2024. And what was the other part of the question?

Edward Tenthoff: Just how would you anticipate progressing from there?

Ken Myszkowski: Yes. I mean, I think it depends on what the data show us. I think there are several other examples out there of Phase III programs that are ongoing for IgA nephropathy and C3 glomerulopathy with biomarkers as primary endpoints. So, I think our late-stage programs would probably look something similar to those.

Edward Tenthoff: Okay. Great. Thank you.

Ken Myszkowski: Thank you.

Operator: Thank you. One moment for our next question. Our next question comes from Mani Foroohar of Leerink Partners.

Mani Foroohar: Hey guys, thanks for taking the question. A quick one around, how you think about building the CD side of the franchise. Could you lay out what your estimation is for what is that CVOT should cost for cascade now? Presumably, given that you plan to go it alone, I would assume that you’ve got a reasonable budget estimate for what that might cost. And can you walk us through sort of how we should think about sort of expansion in OpEx, as you build out the infrastructure to support, what will be a larger study than you guys have ever done stand-alone before?

Chris Anzalone: Sure. So we can’t give you — yes, we are putting together estimates about what that’s going to cost. However, we still haven’t had our end of Phase II meeting with the FDA. We are putting together our proposal and so, I expect that we’ll be speaking with them this year. Until we have that conversation, until we have feedback from them, it’s going to be very difficult for us to give you good numbers, just because, we want better clarity. We will be happy to give you some estimates on some guidance, once we have those discussions. But at this point, it’s a bit premature.

Mani Foroohar: Okay. So, we should expect some — like we should expect some numerical guidance around that. Post the end of Phase II meeting, is that a reasonable expectation for us to have?

Chris Anzalone: Yes. I think that is reasonable. We need to have feedback from the FDA. We need to incorporate that into our plans and then have that build it down into our budget. So sometime over the next couple of quarters, we should have a good estimate for you and then we’ll be happy to chat about it at that point.

Mani Foroohar: Okay. That’s helpful. Thanks guys.

Chris Anzalone: You’re welcome.

Operator: All right. Thank you. One moment for our next question. Next question comes from Mike Ulz of Morgan Stanley.

Mike Ulz : Hey, guys. Thanks for taking the question. Maybe just a follow-up on the pulmonary program specifically to the MMP7 program. Can you just remind us when we might see the initial clinical data there? And should the focus be just on target knockdown, or are there other data points that we should be focused on as well? Thank you.

Chris Anzalone: Yes, I think — so as we had stated at the Analyst Day meeting we really think the focus there should be on the patients since those are the population that has regulated MMP7 in the BALF and in the serum. So that’s what we’ll be focusing on. We’re still in the healthy volunteer component of the study, and so we don’t know how the patient cohorts will enroll just yet, depending on enrollment, it’s conceivable we could have some data by end of next year.