Linda Burkly: Yes. In vivo, our in vivo approach is aimed at functional up-regulation of gene expression in genetically determined diseases. And this strategy positions us very well to be differentiated from others in terms of our targets and our target editing strategies. And what this means, is that we can go after targets that others can’t go after. And so from an indication perspective, we can go after indications that perhaps others can’t go after. And so we could have a first in class strategy. Also, within a given indication, we could devise a targeting strategy that would be best-in-class, if you will. So we can have first in class strategies as well as best-in-class opportunities. I hope that answers your question.
Yanan Zhu: Yes. Thank you. Very helpful. Thanks for all the answers.
Operator: Our next question comes from Luca Issi from RBC Capital. Please proceed.
Luca Issi: Oh, great. Thanks so much for taking my question and congrats on all the progress. Maybe just a quick one on reni-cel and the filing strategy. What’s the vision here for the BLA? Are you planning to file adults and adolescents concurrently or sequentially? Any color there, much appreciated. And then maybe quickly on the Middle East. Can you just talk about the opportunity for sickle cell disease in the Middle East? Vertex seems really, really excited about that market. So wondering what’s your strategy there to potentially tap that market? Are you still focused on partnership? Can you potentially access that via distributor? Again, any thoughts there, much appreciated. Thanks so much.
Gilmore O’Neill: Happy to do. Thanks very much, Luca. So I’ll ask Baisong just to talk about our regulatory strategy as far as we have shared it. And then Caren can talk about just how we’re looking at and thinking about the Middle East. And frankly, in the context of the rest of the world.
Baisong Mei: Yes, yes. Thanks, Luca. We are very pleased with the interaction with the agency and continued interaction with the agency about the reni-cel and for the RUBY study as a Phase 3 study to support the BLA, and all the front of the Phase 3 study, we have alignment on that. And we have continued conversation with FDA on this route. We have not shared the specifics about the date of the BLA, or the indication of adult alone or adolescent. But as we shared, we are very pleased with the enrollment for both adult cohort as well as adolescent cohort. So that gives us a great position for this molecule. Thank you.
Caren Deardorf: Great, Luca. Thanks for the question about Middle East and certainly just the populations outside the United States. And there’s absolutely a number of geographies where there is a significant population of sickle cell patients, and really high unmet need beta cell ischemia as well. What I’d say is our continued drive to execute in the U.S., and to move reni-cel forward with differentiation, just continues to support the opportunity for us to partner at the appropriate time. And that’s certainly something that we’ve said we are open to and will certainly provide more color in the future as appropriate.
Luca Issi: Thanks so much.
Operator: Our next question comes from Steve Seedhouse from Raymond James. Please proceed.
Unidentified Analyst: Hi, thank you. This is [Nick] on for Steve. We actually had a longer term question. To what extent can you leverage the infrastructure that Vertex is already building out for CASGEVY will EdiTHAL won’t be able to plug into the existing authorized treatment centers once launched? Thank you.
Gilmore O’Neill: Thanks very much. And Nick. I’m going to ask Caren to address that.
Caren Deardorf: Yes, thank you, Nick, for the question. First, we’d say – I’d say that I’m really pleased to see some of the initial progress for the other therapies and being able to get patients started. We always anticipated that it would be a dipping, many centers starting to dip their toe. As they build the infrastructure and they gain the confidence. So to answer your question, absolutely. We’ve always said that in this kind of market of the complexity, of the ex vivo, being a fast follower is absolutely an advantage. We also, on our own, have a really strong base of over 20 clinical sites in the U.S. with very strong enrollment and relationships that we’re leveraging. And those relationships and the guidance they’re giving us will be really pivotal for us as well.
But this is a field that will benefit, from the increase in education with patients, which Baisong mentioned, also helps with our enrollment and just building the infrastructure. But we are engaged on the KOL, the patient advocacy, as well as on the payer front to ensure that we’re prepared. So thanks for the question.
Unidentified Analyst: Thank you. Our next question comes from Jack Allen from Baird. Please proceed.
Jack Allen: Great. Thanks so much for taking the quick follow-up here. I just wanted to touch on reni-cel one more time, and ask when we might hear a little bit more about the differentiation, as it relates to the treatment process. Have you provided any color on the number of apheresis cycles, and how editing efficiency of the Cas12a enzyme may allow you to be more efficient in manufacturing the process?
Gilmore O’Neill: Thanks very much, Jack. So I’m going to ask Baisong to talk about that.
Baisong Mei: Yes. Thank you. We have not shared specifics about the number of cycle and the apheresis. What I mentioned before was since I joined, we actually work together with our internal as well as a apheresis external – apheresis expert. We actually have protocol amendment, to improve the apheresis cycle and also provide assistance to study site for the apheresis cycle, which is significant, because it’s reduced the patient burden. It’s a smoother manufacturing process. We’re very pleased to see the progress in that front. And just to add on that, we are hoping this clinical experience will be very much helpful for commercial endeavor.
Operator: Our next question comes from Mani Foroohar from Leerink Partners. Please proceed.
Mani Foroohar: Hi. Thank you for taking our follow-up question. Kind of similar to the last question, you previously talked about optimizing the vein-to-vein process. Would you be able to walk us through how reni-cel could provide advantages from either both operational or logistics perspective? Thank you.
Gilmore O’Neill: So Baisong I’m going to ask, I’ll ask Baisong to address that.
Baisong Mei: Yes. Happy to. We are over this process, really working together that with the study sites to optimize this process. And that coming from multiple factors. One of the factors just mentioned is bio- apheresis. The other factor is the logistics. And we provide support on that. The third factor is actually patient condition. As we know that we are treating the severe sickle cell disease. And before the reni-cel treatment, they can have multiple VOE per year. And that also can impact the vein-to-vein time.
Caren Deardorf: Mani, this is Caren. I would just add that, again, in the fast follower position, one of the things that it gives us the opportunity to do is to really understand as the first two therapies are commercialized, what’s working, what’s not working, what they need to see differently, and really making sure that Editas sets ourselves up as the partner of choice. And so, we’re working very hard on that. And we’ll certainly talk about that at a later time.
Mani Foroohar: Great. Thanks so much for taking questions.
Operator: Ladies and gentlemen, this concludes today’s call. Thank you once again for your participation. You may now disconnect.
