Dr. Bruce Culleton: So I’ll address your second question first, Yigal, if I could. So first, we believe based upon the data that we see, that REACT works across multiple different patient groups. And so we do believe that even including those patients up to an eGFR 44, we might see a possible benefit. So we did want to include them for the reasons that were outlined. And then second, from an FDA perspective, we do not see our change or modification to the study, the 006 study as being a significant modification and we plan to submit a notification letter to the FDA. We — based upon our regulatory feedback internally, we do not believe that this will require an in-person or a specific meeting to discuss this modification. So we think it’s a lower risk and can be managed with the letter.
Operator: Our next question is from the line of Justin Zelin with BTIG.
Justin Zelin: Congrats on the data here. I just wanted to hear your latest thoughts on the durability of effect of the treatment. And how does that fall into your thinking about potential redosing after two years? And I have some follow-ups.
Dr. Bruce Culleton: Thanks, Justin, for your question. We — the data that we have — that we showed you today there’s a suggestion, but keep in mind that Phase II data, and we don’t have a control group out to 24, 18 or 24 months. There’s a suggestion that some benefit may tail off towards the end. We can’t be confident about the durability of REACT based upon this data. We do think we’ll see with a parallel control group in our Phase III program, we’ll get more insights from that program on the durability of REACT. And it’s quite likely that we may need to redose at some point, 18 to 24 months after first injection. But more to come on that, Justin, in the future.
Justin Zelin: Great. And if I could ask, it looks like you had 27 patients here for preservation of eGFR. Of those 27, do you have the data as far as whether they fit into that new enrollment criteria of 20 to 35 stage 4 CKD.
Dr. Bruce Culleton: Yes, Justin, I think 56% of those are in stage 4. And I don’t have the data off hand on how many of those are in that 3b category of 30 to 35, but it’s already a majority of patients already included in that group. We can follow up with you on that question.
Pablo Legorreta: But it’s 23 of the 73 that actually are stage 4 with ACR greater than 300 that are actually pretty stable. I mean some of those, you see maybe a slight decline. But relative to the similar group in the standard of care, which declined by 6 points, it’s actually quite impressive.
Operator: Next question comes from the line of Kelly Shi with Jefferies.
Unidentified Analyst: This is Clare on for Kelly. So for the [indiscernible] Phase III trial enrollment as you mentioned the CKD premium landscape is evolving. So would you expect more patients having received treatments such as GLP-1 before coming to REACT cell therapy. What kind of GLP-1 drop impact would have on REACT activity for kidney preservation.
Dr. Bruce Culleton: Thanks for the question, Clare. So I understand you’re asking about our Phase III program and the changing CKD landscape, including GLP-1s, we will — so several points on that. So the first, just from a study perspective, we will be — we think it’s extremely important for us to ensure that standard of care as defined by clinical practice guidelines is instituted across both arms of those studies and we’re working to make sure that, that will happen. The second, with regards to the GLP-1 effect within the chronic kidney disease space. We do understand based upon published data that the FLOW study, which I think some of you may be familiar with, the percent of patients with stage 4 kidney disease included in the FLOW study was a small amount compared to the rest of the CKD subjects in that study.
It’s — I know this — the FLOW study was stopped early for efficacy. And it’s hard for me to comment on what that actually means at this point. We do know that GLP-1s do have a favorable cardiovascular event profile. But we’ll have to wait until that data is actually published for me to have a more educated answer to your question.
Operator: Our next question comes from the line of Jonathan Miller with Evercore.
Jonathan Miller: Okay, let’s start with maybe some housekeeping. How many patients that are already enrolled aren’t meeting the new criteria? I just want to get a sense for how many folks in total that are going to be in that — in the final analysis to the FDA, but maybe not on the primary endpoint? And then secondly, I would love to probe a little bit deeper into the assertion that it’s the stage 4 patients that are getting the most benefit. I noticed that none of the presented analysis directly compare the benefit patients are getting to the severity at baseline, you’re pulling out that subgroup. So I guess I’m looking at the entire deferred cohort and it seems like they also see stabilization — similar stabilization of that stage 4 cohort. So I’d love to dive a little bit deeper into what’s underlying the assertion that stage 4 is getting the most benefit.
Dr. Bruce Culleton: Thanks for your questions, Jonathan. So I’m sure you can appreciate that our 006 or proact 1 study is an ongoing Phase III program. And we are not analyzing that data on a day-to-day basis because of the nature of it being a Phase III program. We’re also blinded, as you could — as you know to the treatment groups. What I can say is that based upon the information we can have access to that we’ve enrolled over 80 subjects. And we believe that approximately 50 of those subjects will meet our new inclusion criteria. And then, Jonathan, on your other question, you rightly do point out that we see a very impressive stabilization preservation of eGFR in patients who were crossed over and received react for out to 18 months, in that group after their first react injection.
