AJ Bergmann: That’s correct. Yes, exactly. And look for our 10-Q to become available shortly, which will articulate this basically the same way I am saying it, but that should be put out there shortly.
Aydin Huseynov: Okay. I appreciate that. All right. Another question is on cohorts. So Cohort A completed enrollment 58 patients. It seems like you’re going to be starting Cohort B enrollment within weeks from now, I think you mentioned by the end of the year. So given the holidays, do you think it is still realistic to sort of enroll — actually enroll patients in Cohort B by the end of the year, between now and January 1st?
Linda Marbán: So Aydin, were you on my team call yesterday, because this is what I asked my clinical team and they said that enrollment is going to be pretty robust before the end of the year. There’s nothing else in clinical trial right now for these later stage boys and young men with DMD, nothing with recent failures in the space and some of the other companies pulling back. And so, there’s a line out the door to get into Cohort B, and we’ll be delighted to welcome them and treat them even with the holidays coming up.
Aydin Huseynov: This is great to hear. I mean, so given there’s nothing, no other trials, it is feasible that you will enroll. Okay, understood. So, given the DMD landscape is changing, obviously with different treatments, different approvals, so do you think the Cohort B will be somehow different from Cohort A, given that these are — this will be different patients? So, do you think any variability between two cohorts in the future?
Linda Marbán: That’s a really interesting and provocative question, again, one we’ve debated a lot internally. And I think the short answer is no. We have the same inclusion exclusion criteria, the same requirements in terms of their meds and all of that. The only potential differences with the approval of the new deflazacort were also open up to taking patients on that regimen, because many of them are switching due to a better safety profile. So, that’s really the only difference. We don’t think that’s going to mediate any difference in sort of the potential efficacy. We’ve talked at length to our KOLs, and sort of a steroid is a steroid is a steroid in terms of what it does to physiologically. So, we’re very hopeful that the enrollment criteria will be virtually the same and Cohort B will very rapidly allow us to transition from sort of clinical scale manufacturing to commercial scale manufacturing.
Aydin Huseynov: Appreciate that. This is very helpful. So another question I have is about expansion of potential label of CAP-1002. So, other DMD companies may have certain limitations to expand into other stages of DMD or other dystrophies or other types of DMD patients. So, you have a nice slide on your corporate presentation describing potential expansion into early stage DMD patients and do — and then into Becker muscular dystrophy or BMD. So, could you help us understand how the potential endpoints with early-stage patients may look like with CAP-1002? So, this likely won’t be pulled, because these patients are more active and more mobile. So just give us a little bit of an idea how these endpoints may look like.
Linda Marbán: Yes. So, it’s interesting. All of these patient reported outcome measures are — have their strengths and have their weaknesses. I think everybody really believed very strongly in the NSAA, but very recently with the Sarepta data, there’s been a little question around the veracity of that measure. There’s time to rise, which is an interesting one. We haven’t designed that trial yet. Frankly, we’re going to talk to FDA about label expansion potentially without more clinical work and then evaluate from there and use the advice of our key opinion leaders, who are used to working with these younger boys to help find the one that’s most effective in demonstrating the efficacy of CAP-1002 in these younger kids.
Aydin Huseynov: And the last question is regarding Becker dystrophy. So for Becker dystrophy, cardiomyopathy is obviously one of the major causes of death. And it would make sense sort of starting from the late stage patients. So could you share with us how or why Capricor is more advantageous — is in more advantageous position compared to other DMD — other dystrophy companies when it comes to Becker dystrophy?
Linda Marbán: In terms of Becker dystrophy, one of the major manifestations of Becker muscular dystrophy are the cardiac implications. And of course, as you know, one of our major advantages over almost any other therapeutic that’s in investigation or approved for DMD is that we have cardiac benefits. So we are highly enthusiastic, if you can sort of use that terminology when you’re talking about treating a dread disease, about the opportunity for CAT-1002 in Becker muscular dystrophy and its cardiac implications.
Aydin Huseynov: Thanks so much Linda and AJ. Congratulations again with the progress.
Linda Marbán: Thank you so much.
Operator: Thank you. [Operator Instructions] There are no further questions at this time. I will be turning the call back over to Capricor’s management for final remarks. Please go ahead.
Linda Marbán: Thank you so much. Thank you so much. And thank you AJ. Before we conclude today’s call, I want to extend my sincere appreciation to the clinicians, patients, and their families who are working with us to bring CAP-1002 closer to potential approval. I also just want to take a minute to thank our clinical operations team for doing an extraordinary job, for getting this trial fully enrolled. And hopefully, once we continue to follow these patients and get the data, we’ll be able to have an approved therapeutic for these later stage Duchenne patients. And I know that will be a day of celebration for the community as well as for us. We look forward to seeing you at upcoming meetings and hopefully, you’ll have a happy and healthy holiday season. Thank you so much.
Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you very much for participating and ask that you please disconnect your lines. Have a great day.
