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

Mike Ulz : Got it. Thank you.

Operator: All right. Thank you moment for our next question. Our next question is from Mayank Mamtani of B. Riley Securities.

Mayank Mamtani : Good afternoon, Dean. Thanks for taking our questions. So maybe just on the FeNO high asthma patient cohorts that you’re just starting to enroll. Could you clarify the dose levels being looked at and sort of what initial number of patients you intend to have before you may look to disclose something externally? And if you could comment how this could be same or different relative to your execution on the mild to moderate asthma MAD patient cohort? And then I have a quick follow-up.

Chris Anzalone: Sure. So there are the two highest dose levels is what we’re looking at in the FeNO cohort. So that’s the 92 and the 184 milligram dose levels that we studied in the healthy volunteers, we’ll investigate those doses in the FeNO cohorts as well. And we’re doing a 16 per cohort in terms of how many we’d have to have enrolled before we disclose data. I can’t really give you a clear answer to that.

Javier San Martin : Yes. So let’s just assume that we’ll disclose those once those cohorts are complete. It wouldn’t make much sense for us to feed that out dribs and drabs. I think we’ll wait until that study’s over

Mayank Mamtani : Got it. And in terms of your asthma cohort data before the end of the year, could you just clarify, would you also include some valve bronchoscopy data also in addition to serum data on the higher dose levels? Could you just clarify that?

Javier San Martin : The asthma patients actually don’t undergo bronchoscopy, so we don’t have a valve data from the asthma patients. It’s only the only sRAGE measure we get is from the serum in the asthma patients.

Mayank Mamtani : Got it. And just lastly, on the financials, the two milestones earned from GSK and the data could you just clarify how they will be sort of modeled on your P&L in terms of recorded revenue amortization schedule?

Ken Myszkowski: So, those milestones have already been recorded in revenue. They are not amortized over time. We actually recorded those — the quarter before last, we received the cash in this past quarter.

Mayank Mamtani: Understood. Thanks for taking our questions.

Ken Myszkowski: Thank you.

Operator: Okay. Thank you. One moment for our next question. The next question comes from Ellie Merle of UBS.

Ellie Merle: Hey, guys. Thanks so much for taking the question. Just a follow-up on the pulmonary patient cohort timing, I guess for RAGE, just where are you in the enrollment of those high-pheno cohorts? I think you just mentioned you had 16 per cohort. And then for MUC5AC, I guess, where are you in enrollment of the asthma patient cohorts? And have you started enrolling in the COPD cohort? And then just for MUC5AC, what should we expect in terms of the timing of potential patient data there?

Chris Anzalone: So on the phenol-cohorts, those — the amendments to add those cohorts, I think, are just — they’ve been filed and so they’re working their way through the various regulatory bodies and ethics committees. And we haven’t enrolled any pheno patients just yet. And then the MUC5AC patient cohorts were enrolling into the — actually, all the cohorts are open. So that all of the asthma patient cohorts are currently open from MUC5AC. And we’d be looking, assuming enrollment goes well, probably having data mid to late next year as well. And then your last question, I believe, was on the COPD cohorts from MUC5AC, that’s a similar situation to the pheno cohorts we’ve got the amendments filed and so those are working their way through to get ethics and regulatory approval. So we’d expect to have those being enrolled later this year, aiming to have data maybe end of next year.