Joseph Payne: Well, with respect to what we want to do strategically is position ourselves with the right approvals and the manufacturing slots and timelines to address what the market desires or wants. So if we have an approval of approvals in place then we can proceed to provide an updated monovalent vaccine. If the monovalent 154 gets approved then we’ll be in a stronger position to provide an updated monovalent vaccine, if that’s what the — if that’s where the orders come.
Padmanabh Chivukula: And hey, this is Pad. And just one other thing to add is, we — Joe mentioned on his call earlier that we filed for in the EMA approval with our partner, CSL. Once we get the approval, I think, CSL will be looking at what the commercial launch looks like, right? So I think they are in charge of that. But as Joe mentioned, we’re currently focused on getting the approvals in the various jurisdictions now.
Unidentified Analyst: Got it. Thanks for all the color.
Joseph Payne: Thank you.
Operator: The next question comes from Pete Stavropoulos with Cantor Fitzgerald. Please proceed.
Pete Stavropoulos: Hi, Joe, Andy, and team. Nice to hear all the updates for the quarter. First question I have for our 154, what are your expectations of when you may hear back from the EMA sort of rough timelines?
Joseph Payne: Oh, with respect to hearing back from the EMA, this is going to be a considerable process. We haven’t provided any type guidance on when approval is expected. I can refer to our partner, CSL, has guided that in 2024, we anticipate approval with the EMA.
Pete Stavropoulos: All right. And then in terms of ARCALIS, just curious if you could just discuss a little bit, if you can leverage that venture for manufacturing other pipeline candidates. And perhaps you know distribution of drug outside of Japan. And if not already, when do you expect the facility to be operational and what will be the manufacturing capacity?
Joseph Payne: Yeah, I can answer that question for you, Pete. We’ve kind of guided that the drug substance facility has been completed. And we’ve kind of given a timeline for drug product and in-fill finish is probably going to be next year in that timeframe. So in the meantime, we’re going to be supplying Japan and any other country through our current CDMO group that we’ve been working with which includes Catalent, Aldevron, Recipharm in Europe. So until that plant is up and running and able to support not only Japan but any other mRNA product that we may be working on our therapeutics. We certainly would be delighted to have that diversification of manufacturing opportunity in the Far East, like that. So it’s going to be a very strategic asset for Meiji, for us, and for CSL. And certainly want to be able to utilize it to the best of the opportunity to address whatever the demand may be on a global basis. So hopefully that will help answer your question.
Pete Stavropoulos: It does. Thank you very much. And just one last question for 032 for cystic fibrosis. For the Phase 1b patients, I know, we’re going to receive two doses. Will you be looking at any pharmacodynamic markers or clinical outcomes, again it’s only two doses to sort of gauge 032 activity.
Joseph Payne: Yes, the primary objective of the Phase 1b study — just to understand, safety and tolerability and in actual CF patients with two administrations. And to understand further what type of administration regimen will be ideal for a nice proof of concept study. That’s to follow assuming success of course. But that’s the — now are we looking at other potential markers of success? Yes. But our expectation at this point and the purpose of the study is just to show safety and tolerability in CF patients. We’d be very excited to see if multiple administrations are well tolerated, because of the recent data that we shared in CF ferret that are very indicative or important data that we bolt-on to the human experience that increases the likelihood of success for this program.
Pete Stavropoulos: All right. Actually throw one last question, if you don’t mind. So this isn’t inhaled products. Is there any potential to actually develop some type of inhaled vaccine to respiratory viruses either alone with growth partner CSL.
Joseph Payne: Well, it’s a great segue to the opportunity, the overall platform opportunity for our technologies. If we’re showing proof of concept in large vaccine trials and in therapeutics, it does present the opportunity to potentially combine these. We haven’t provided any guidance on this, but it does give people some sense of excitement of the platform, in general, that there is so lot of opportunity in the future.
Pete Stavropoulos: All right. Thank you for taking my questions.
Joseph Payne: Thanks.
Operator: The next question comes from Ed Arce with H.C. Wainwright. Please proceed.
Thomas Yip: Hi, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. Perhaps a first question for pay tenant. In OTC you mentioned the Phase 2 data from the study in Europe are expected in the first half of 2024. Can you discuss what about the Phase 1b single ascending dose study in the US with 60 patients, when should we expect to see some data from that study?
Joseph Payne: Correct. We’ve gone through database lock is later this year. Once we’ve gone through that process will then strategically think at the right time to communicate the data because we need to understand the timing of the interim Phase 2 data, so we may present these at the same time, we may present them separately. But we haven’t made that strategic decision yet. But we have informed the market now that the database is getting locked this year for Phase 1 and Phase 1b.
