Pad Chivukula: No. Again, just to reiterate some of the earlier, we haven’t seen any SAEs or severe AEs associated with Phase 1 or, Phase 1b to date. And obviously, we’re monitoring that closely. And in terms of lung biopsies, we are not currently, or we’re looking at the actual function in patients. So we’re not doing that.
Joe Payne: With respect to the phase one data, there is a European CF conference in June that we’re preparing to present out.
Unidentified Analyst: Okay. Got it. That makes sense. And just one quick follow-up on the OTCD data that you’re going to present soon. What do you need to see there to make a go-no-go decision there?
Joe Payne: A go-no-go decision for the Phase 1b readout?
Unidentified Analyst: The OTC data.
Joe Payne: Oh, for the OTC readout, sorry. Yes, we’d like to make sure we maintain a safety and tolerability of multiple doses. That’s going to be about most importance because that’s one of the challenges that many other competitors and people that have tried to do lipid nanoparticle mRNA therapeutics for OTC deficiency have failed in the past due to toxicity. So this is going to be a significant hurdle to jump through, but that would be the primary objective. Something that we’d be very encouraged by is to show safety and tolerability of multiple treatments in a spectrum of OTC deficient patients. Having said that, do we also want to see some biomarker changes? Absolutely. It is a placebo-controlled trial, so there would be increased confidence in these readouts as long as we have sufficient numbers. We would be looking for that sort of detail as well to give us confidence going to the next step.
Unidentified Analyst: Okay. Got it. Great. Thank you very much for taking our questions.
Joe Payne: Thank you.
Operator: Our next question comes from Pete Stavropoulos with Cantor Fitzgerald. Please proceed with your question.
Pete Stavropoulos: Hi, Joe, Andy – and Andy. So just a question about ARCALIS, can you leverage that facility for other pipeline candidates and perhaps distribution outside of Japan? And if not already, I don’t know if you mentioned it or if I missed it, when do you expect the facility to be operational? And what will be the manufacturing capacity?
Joe Payne: Andy, do you want to grab that?
Andy Sassine: Yes, sure. Thanks, Pete. Yes, we’ve kind of highlighted the time line for ARCALIS in terms of drug substance. They’re currently in production right now in getting GMP qualified. So that is pretty exciting. And there’ll be some news coming out of them to update the status of what they’re doing and are they going to be participating in the orders from Japan for this year. So those are all the things you want to listen for carefully. And obviously, the drug product is going to be online probably either later on this year or early next year. And then the plasma business should be on within a couple of years. So within 2.5 years, they should be vertically completely integrated. But in the meantime, we can certainly fail the void with our global CDMO partners in terms of Catalent in the United States and Aldevron and Recipharm in Poland and in Europe.
So we have a really strong core of partners to help us fill a void, where until ARCALIS is able to get up to speed. Obviously, if they can make up to 1 billion doses, they — CSL and Meiji have certainly a lot of opportunity to determine whether it’s going to be a chance to export the vaccine to other countries. And so that will be a decision that will be made by certainly CSL and Meiji with respect to Japan. Hopefully, that helps.
Pete Stavropoulos: Yes, it does. Thank you. And so a question on the CF program. So you’re having two doses. Just curious on the perspective of how much do two doses actually derisked, I guess, from a safety perspective, drug. That’s one question. And the other one is any learnings from the cystic fibrosis program that you can potentially develop an inhaled vaccine to a respiratory virus either a loan or in partnership with OCSL?
Joe Payne: Yes. Good follow-on questions there, Pete. With respect to the – Pad, do you want to address those questions?
Pad Chivukula: Yes, sure. In terms of CF, the safety, what we really want to see is even with the single or two doses, we want to make sure that there’s no respiratory side effects like coughing, chest discomfort, et cetera. We also want to look at some secondary safety endpoints like fever, for example, right? So I think we can tell all of those things from just two doses. So we’re looking forward to collecting that data.
