Jay Olson: Congrats on the new additions to your team and — can you provide an update on the number of patients enrolled in the sickle cell and thalassemia trials to date? And since you’re on track to dose 20 patients in sickle cell by year-end, do you have a similar dosing goal for thalassemia? And if so, how many? And then separately, can you talk about the ex-U.S. opportunity for sickle cell and thalassemia.
Gilmore O’Neill: So, I’d ask Baisong to address your first question on enrollment.
Baisong Mei: Thanks, Jay. So we are — have great momentum, have been rolling patients dosing patients, as I just mentioned, we’re on track to those 20 patients at year-end. And we previously announced we actually have 20 patients already enrolled in the last quarter we eased. So we will provide an update on the enrollment in the coming months. And so that we can share more information on that end. And regarding the goal of the number of patient doses cell, we have not disclosed the goal for the dosing not going yet.
Gilmore O’Neill: And then with regard to the ex U.S. opportunity, we see actually a substantial — a real opportunity there. And we also see that and believe that the best way to maximize the value for patients and, frankly, for us and our shareholders is to seek a partner with a large footprint. And there are a number of partners in that space that are potentially very interesting to us. But as I say, the opportunity is large and we want to make sure that we optimize the delivery to that opportunity which is why we’re seeking a large partner. Thanks very much, Jay.
Operator: Our next question comes from Manny [ph] with Leerink Partners.
Unidentified Analyst: Obviously, a lot of questions on this call have been around for clinical trial execution, enrollment, et cetera. I want to dig into endpoints, if we could. You’ve discussed earlier on this call, pain and other sort of fatigue, some quality of life issues is important area of potential differentiation. As clinical trial endpoints, these are pretty notoriously variable and has some element of subjectivity. What efforts have you made, if any, to ensure comparability between your data on these endpoints and that your competitors who are likely to have an ADCOM approval prior so that we can clearly differentiate — sorry, clearly demonstrate differentiation, if any.
Gilmore O’Neill: I’m going to ask Baisong to address that.
Baisong Mei: Yes. Thanks for your question, Manny. Very good question about end points and maybe I’ll just step back a little bit on that. So after I joined Editas in the middle of last year. And one thing what we’re doing was actually to manage the protocol, we actually changed the primary endpoint as the complete remission of the severe VOE that is consistent with other Phase III clinical trials in a similar setting. So that’s kind of the primary end point expected. Then as I mentioned, there are many end points we are looking to including the end organ functions and the PROs in that too. You have absolutely very good point about possible variations and especially the PROs in there, too. So we’re looking into that direction that will be — we have more data on that and method understanding.
But we feel that this is an area that we have publications in the myself [ph]. We will have more information about the X and other data and will allow us to have an understanding of where we stand for those end points.
Unidentified Analyst: Great. I guess one quick follow-up. You talked a little bit about how to understand where you guys are on those endpoints. Do you have any average components to in the literature or based on experience in publicly disclosed data from other companies or your own around what duration of follow-up we would need to be able to compare across trial statistical caveats notwithstanding and kind of provide clear evidence of where you guys are versus where your competitors are? Like how long follow-up would we need to clearly differentiate on pain, on fatigue, on quality of life?
Baisong Mei: Yes, very good question. That’s something we are looking into that. First of all, we say there are some information already published, for example, in the allogeneic transplant perspective for scarce disease, their publication in multiple dependent on that to see how patients improve after the moves stem cell transplant for those patients. And then in terms of specific endpoints, some will take longer and the other will take shorter time. For example, we already see the [indiscernible] increase and ratio of time period. So that’s kind of probably taking shorter time wise. And so far for some point of life, it may take 6 months or 12 months ago and for the analog damage and that’s actually a space that we’ll continue to learn.
They are actually publication, for example, to say from central nervous system and after the allogeneic transplant, they see improvement hydrodymic improvement in blood vessel in the brain. So there’s a lot of studies in this space. But again, we are steering a new territory, we are looking into that. But we are confident that we will see something over the period of time to see some differentiation.
Unidentified Analyst: Great. That’s very helpful.
Gilmore O’Neill: I think it’s also worth reemphasizing, of course, that the biochemical and physiologic differences that we’re already describing are certainly generating significant excitement with prescribing and treating physicians and actually also within the patient community as based on alluded to in the feedback and the follow-up that we’ve had since presenting very exciting data around the correction of anemia in addition to robust and durable cyclic hemoglobin expression at the EHA meetings and our webinar in June.
Operator: Our next question comes from Luca Issi with RBC.
Luca Issi: Great on the progress. Maybe one more manufacturing since you’re moving your manufacturing process to a new facility. Is it fair to assume that the FDA will ask you to run a clinical bridging study similar to what we’ve seen from REGENX? Or do you think that just analytical comparability study will be sufficient. So get any color there much appreciated. And then maybe on R&D, pretty material decline in the R&D spend this quarter versus prior quarters. So I wonder if you could provide any additional color on what drove that and how should we think about modeling that line going forward? And then finally, one last one on BD. Any update on partnering LCA10
Gilmore O’Neill: Yes. Thanks very much, Luca. With regard to manufacturing, I think a couple of key points. One is that we are manufacturing within the Asia space. We’re already running our clinical supply in a separate Asia space. With regard to the details and specifics of what will be required. This is a — would be part of our alignment and meetings with the FDA, as we have outlined. With regard to R&D spend, I will start and then ask Eric if he wants to actually add any additional color to the spend. The key thing about the R&D spend, obviously, was that following the rollout of our new strategy where we sharpened our focus on in vivo and really focused on accelerating our 301 asset. We did actually sharpen and narrow our pipeline. And so that had an impact on spend with the divestiture of our NK assets to Shoreline as well as the cessation of our AAV inherited Redland dystrophy programs. Eric, I don’t know if you want to add anything more to that?
Erick Lucera: No, I think you covered that pretty well. I would just add from a philosophical basis that I think we’re all aligned that we want to be focused on high conviction, R&D spend, high conviction assets. We’re not really into “depipelines”” and lots of shots on goal. We really want to focus our resources on a few assets that we have high conviction on and I think that’s the philosophy that the team here shares across the board.
Gilmore O’Neill: And I think that’s an important piece of guidance and is actually a key reason that Linda has joined us. It’s not just about continuing that to advance the work that we have in progress are in vivo. But Linda is very aligned philosophically with myself and the leadership team when it comes to our approach to selecting targets and maximizing the probity of technical and commercial success by clearly selecting targets where we can with our technology differentiate from the standard of care in a meaningful manner. With regard to the update on LCA10, I will give you a more specific update when — if we have a take or a deal. I will tell you there has been some interest. And obviously, we are — we believe that we saw something a signal in the patient data set that we analyzed and hope that another firm or sponsor with a specialty interest in that disorder would actually take it forward.
Luca Issi: Thanks so much.
Operator: Our next question comes from Liisa Bayko with Evercore ISI.
