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

Patrick Trucchio: Thanks, and good afternoon. Just a few follow-up questions. The first one is just around the ARO-RAGE chronic tox data. Can you just clarify, is this data would it be expected in the third quarter or fourth quarter of calendar 2023? And how would you expect it to differ for that, which was reported from ARO-ENaC just in terms of how are the doses for these compounds compared to ENaC in these studies specifically? And then separately, just also regarding the pulmonary programs in clinical development, there are several three programs in clinical development, at least one in preclinical development. Can you give us an idea of what targets you could include for your pulmonary platform as it expands — and to what degree would you be looking at targets with genetic or clinical validation as you look to build out this pulmonary pipeline going forward?

Chris Anzalone: I’ll take the second, and Jim can take it first. I’ve got the easy one. The answer is we can’t give you too much guidance on undisclosed targets. We are – I get your point that, of course, we will be looking at genetically validated targets and clinical validated targets, and that is always our preference. You’ve heard us say before, our goal here is to take as little target risk as we can. And one way to do that is to work on the most validated targets that we can. And so we will certainly be doing that. Will we expand beyond that into some targets that have less validation? Probably, but my hope is that we will — in the near to mid-term, at least, the targets we’re focusing on will be well validated. James, do you want to address the top?

James Hamilton: Yes, sure. Hi, Patrick, thanks for the question. Regarding tox, so the doses are across the board lower for the new pulmonary programs, lower in terms of exposure. I think most importantly, less frequent. If you recall, we used a day one, two, three, every two-week dosing regimen for ENaC and then for our current programs, the dose frequency is spread out much less frequent. We’re dosing either monthly or every two months in the chronic tox studies.

Chris Anzalone: And if you look — if you compare the exposure, I want to say it spans from ENaC being four times to ENaC being 20 times the amount of material compared to the various newer compounds we’re working on. And that is entirely a testament to – to how much more potent these follow-on compounds are.

Patrick Trucchio: Great. Thank you so much.

Chris Anzalone: You’re welcome.

Operator: Thank you. One moment, while we queue our next question. Next question is from Keay Nakae of Chardan.

Keay Nakae: Hi, thanks. Question about partnering specifically for the CV assets. You’re going to go it alone initially with some of these Phase IIIs, but you do have an outcome study out there planned, if you see success going in alone, does that make it more or less likely that you want to partner to do an outcome study?

Chris Anzalone: So, we are planning on doing the outcome study for ARO-APOC3 by ourselves. We see that as a very interesting asset and the data have been very compelling. So we are happy to take that on ourselves. It doesn’t mean that we’re not going to partner that at some point, geographically, potentially, who knows, but we are happy to take on the CVOT risk ourselves. And so that’s our plan right now.

Keay Nakae: Okay. Thanks.

Chris Anzalone: You’re welcome.

Operator: Thank you. One moment for your next question. Our next question comes from Edward Tenthoff of Piper Sandler.