We believe REACT works in different subgroups, but the focus on stage 4 moving forward. And we have tortured this data, if you like, inside out and we’re very confident in our decision that we want to move forward with the stage 4 an advanced 3B population for proact 1. And part of it is based upon — part of it is based upon the data that you saw here today, part of it is based upon medical feedback, which Pablo mentioned around nephrologists recognizing that these patients are on a slippery slope to dialysis and we need an option for these patients. Part of it is for the lack of better word, some desperation from patients and not having other options within this group. And finally, having worked at CVS and sitting close to Aetna and understanding how payers think about this space and also understanding how other CMOs and other large health plans think about the space.
They clearly say that stage 4 kidney disease is their pain point. And so it’s for all those reasons, we’re refocusing our proact 1 study.
Pablo Legorreta: Actually, when they talk about the different stages, what you hear is that patients that are in stage 3 and 3b are patients that cost less than the premiums they collect but it completely changes when you get into stage 4, where actually the premiums that get paid do not cover the cost of stage 4 patients. So it creates opportunity for us. But I think the other key thing is that we feel confident that we’re going to actually enroll quicker but also hit events quicker because this stage 4 patients must — are having events much more quickly than other patients. But the data is quite interesting because we do see good responses from not only the stage 4 patients, but the other patients in the study also.
Operator: [Operator Instructions] The next question is coming from the line of Jason Gerberry from Bank of America.
Jason Gerberry: So if I heard you right, for proact 1 you enrolled 50 out of a target 600, I just wanted to confirm that. And it sounds like you think even with the new enrichment criteria that won’t slow enrollment, it actually will speed enrollment. And so then just a follow-up on the question about interim just to make sure, is it more a question of when, not if? We get an interim. I’m ultimately wondering you talked about multiple financeable catalyst before your cash runs out. What do you think are financeable catalysts if you don’t offer an interim before the cash runs out?
Dr. Bruce Culleton: Just for clarity, we’ve enrolled over 80 people in proact 1, not 50 — we think there’s about 50 that meter new inclusion criteria. Second is we believe we have multiple financing catalysts. Notably our study 007, which is, as stated earlier, diabetic patients who are biopsied, injected into the biopsy kidney and then three months later injected into the contralateral kidney with our commercial product. We think that mirrors more closely our Phase III program and we’re going to be happy to share with you an interim look at the data in mid-2024. We think that will offer a potential catalyst and final data for that we believe, in the first half of 2025. We’ll also bring to you final results of 002 in the first half of next year.
So we’ll have multiple opportunities to present publicly data from several different studies in the next couple of years. With regards to the interim analysis, I can give you some insight into how we’re thinking about it, the decisions haven’t been made, and we will share with you the decision in the future. But we received some feedback — I received some feedback and someone that’s led a global SGLT2 inhibitor trial, who essentially said you may want to think about an early IA in case the benefit is even bigger than what you expect. But I want to make it clear to everyone that when we do in IA, all we would get from our safety committee is a letter that says, continue to move forward or not. We’re not able to share with you any analysis at that interim analysis given the Phase III nature of the program.
And the endpoints that were chosen within this Phase III program are the eventual endpoints that will be adjudicated for FDA approval.
Jason Gerberry: And if I could just ask one follow-up here. You mentioned the 80 versus the 50. So does your — do you need to have 600 patients that meet the new inclusion criteria? Or is that adjusted to 570 patients that have to meet the criteria?
Dr. Bruce Culleton: Jason, we’re targeting 600 new incremental patients.
Jason Gerberry: Okay.
