Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) Q1 2024 Earnings Call Transcript

Jason Gerberry: Got it. Okay, thank you.

Operator: One moment for our next question. And our next question comes from Patrick Trucchio with H.C. Wainwright. Your line is open.

Patrick Trucchio : Thanks. So I’ve a couple of follow up questions. The first is just on the CMO role if you can maybe discuss the reasoning behind the decentralizing the Chief Medical Officer function and what impact this is expected to have as well as potential advantages of this decentralized approach? And then secondly, just on the CNS platform, can you talk a bit more about what went wrong with ARO-SOD1 more specifically? Was it a decision based on market potential or with the SRA or something else? Maybe just give us an idea of how you expect the platform to build out going forward.

Chris Anzalone: Sure, so with the slight restructuring of R&D, look we just thought that we needed, good leaders with deep expertise in our chosen verticals. So far that’s going to be cardiometabolic. We expect pulmonary to be the next vertical. We just need a deep expertise there. We expect those not to be the last verticals that we’re going to create, we’re probably going to have several others going forward. And they just needed their own leaders and so for us, it made sense to restructure towards that. Regarding SOD1, look, there is nothing within ARO-SOD1 that pushed us off it to be honest. We liked ARO-SOD1, we liked the opportunity because it gave us a good chance to interrogate the platform. It was going to give us a good, we thought proof-of-concept the platform is working or is not working.

The problem with SOD1 is that it was becoming — it was appearing to be increasingly commercially unviable. So the good news is we can see what’s working, the bad news is it didn’t make economic sense to develop that drug we thought. And we a fast follower, at least one that we think, at once gives us the ability to interrogate the platform. It gives us good proof-of-concept of platform, but also will be a more commercially viable drug. So it just made sense to allocate resources to it and to others. And so it was less of SOD1 failing than a lack of confidence in the SOD1 ALS market.

Patrick Trucchio : Got it. That’s helpful. Thank you very much.

Chris Anzalone: You’re welcome.

Operator: One moment for our next question. And our next question comes from Mani Foroohar with Leerink Partners. Your line is open.

Mani Foroohar: Hey, thanks for taking the questions. A couple of quick ones. We talked about $100 million step down in operating expenses, which obviously buys a lot of wiggle room for the company and allows you to maximize return on investment. Could you give us any sort of color on the tempo at which we’ll see that flow into OpEx over the course of this year just for our own modeling? And then I’ve got a couple of quick pipeline questions to follow.

Ken Myszkowski: So I think you should expect those results immediately. If you look at what our burn was in the current quarter, it was high compared to previous quarters, but we think it will go back to a normalized spend, like I had mentioned before of about $80 million to $100 million, and you can expect that beginning the second fiscal quarter.

Mani Foroohar: Okay, and hopping over to the pipeline, for ARO-INHBE or INHBI, how are we going to pronounce it? That’s a target for which we’ve seen some evidence in non-human population studies etc., for a change in adipose phenotypes, into the distribution into the hip to waist ratio, even after one accounts for BMI? So should we be thinking of that as a place where we’re going to eventually see data that targets weight loss, adipose distribution? Like what are the endpoints we should be thinking about in humans? And then what are the endpoints we should be thinking about in earlier stage studies as we sort of– as this asset gets progressively de-risked?

Chris Anzalone: Yeah, sure. I think all of the above for at least in terms of our initial clinical study, we’ll look at all of that and investigate not just changes in body weight loss, but we’ll evaluate body composition, loss of lean mass distribution of adipose tissue. They are the visceral fat stores shrinking, what happens to lean mass. And we’re also interested in what happens to measures of glycemic control like A1C, or oral glucose tolerance testing. So I think there are quite a few endpoints that we can study in even a Phase 1 study and learn a lot about our drug and about that particular target.

Mani Foroohar: Great, and as a follow-up, is there an opportunity in initial human dataset to see this asset tested both in patients who are on and off with GLP1, given how broadly they’re taken amongst the population of the U.S. and other places where you guys have done clinical trials.

James Hamilton: Yeah, I think so. I think that would be — we’re still a little ways away from the clinic. But would anticipate a study design that first starts in obese patients that are not on those drugs. And then also investigates the combination of the GLP1 agonist with INHBE knockdown and see how the combination plays out.

Mani Foroohar: Right, I’m going to hop off, I know a couple of others are still waiting on the queue. Thanks, guys.

Operator: One moment for our next question. And our next question comes from Brendan Smith with TD Cowen. Your line is open.

Unidentified Analyst: Hi, this is Jenna on for Brendan. Thanks for taking our question. I just want to ask, which of your non [technical difficulty] relation partnership and which would be the highest priority. Thank you.

Chris Anzalone: Yeah, sorry. You’re breaking up. Can you repeat that?

Unidentified Analyst: Of your non-core pipeline programs would you consider for a development commercialization partnership and which of these would be the highest priority for you?

Chris Anzalone: Yeah, so unfortunately, we don’t do that entirely. We need a counterparty that’s going to be interested as well. Look, there are — we would certainly be happy to talk about C3 for instance. We’d be happy to talk about the muscle assets. We think those are all good assets. But at least right now, don’t fit neatly into a planned vertical. One would think that muscle would be a natural vertical for us. And it could morph into that. But right now, we are happy to talk to the right partner about one or both of those assets. PNPLA3, potentially, could be something that that we are interested in. NASH is a bit in flux right now. But that’s something that we that we could consider discussing as we partner HSE to GSK, we can talk about that as well. That’s sort of what it feels like right now in our existing clinical pipeline.

Unidentified Analyst: All right. Thank you so much.

Chris Anzalone: You’re welcome.

Operator: One moment for our next question. And our next question comes from Mike Ulz with Morgan Stanley. Your line is open.

Mike Ulz: Hey, guys, thanks for taking the question. And maybe just a quick follow-up here in terms of BD. You mentioned maybe one or two potential deals this year. Could they potentially include the core areas like cardiometabolic and pulmonary? Or are those going to be excluded from potential royalty deals? Thanks.

Chris Anzalone: Let’s deal with those separately. So cardiometabolic, we are full speed ahead with zodasiran and plozasiran right now. And so we are not actively looking to partner those. On the pulmonary side, we are not actively seeking the partners for our three clinical assets. We could be — we would be happy to discuss with a potential partner, a platform partnership whereby somebody would bring in a target, one that we may not be working on for us to together build a drug candidate. But at least right now, we are not looking at partnering those existing clinical assets.