Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q4 2022 Earnings Call Transcript

And of course, as soon as we have an idea of potential implications to the program, we’ll let everybody know. But I want to highlight that this is an incredibly positive step. We have a road map now to a biologics license application for this product. We know exactly what we need to do. We still need to iron out the edges in terms of number of patients, but this is a really good sign for us.

Joseph Pantginis: Got it. And then I guess my last one is more of a logistical question. With regard to the expected — you’re saying — the interim analysis in the fourth quarter. I guess is this more of a continuous plan or are we actually looking at real data that the Street can take away from?

Linda Marban: Yes. So as of right now, we have built it as a sample size re-estimation. Which is basically a blinded look at the data to determine whether or not we think it’s going to hit promising zone. And so, we don’t have a futility built in it yet nor do we have a stop for success. It’s just do we need to add more patients to potentially achieve success. Of course, we’re working with our statistical team right now to determine if there’s other ways that we might want to do an interim analysis to that. We have no further color at this time, but we will if we do.

Joseph Pantginis: Perfect. Thanks, Linda.

Linda Marban: Thanks, Joe. Be well.

Operator: Next question comes from Michael Okunewitch with Maxim Group. Please go ahead.

Michael Okunewitch: Hi, there. Thank you for taking my question and congratulations on the great progress over the quarter and over 2022 as a whole. So I guess to start off, I’d like to just ask, in terms of the agreement with Nippon Shinyaku in Japan. Do you have any thoughts on your development plans for the Japanese market? In particular, if there are any thoughts on using the ASRM pathway to reach Japanese patients with minimal additional clinical work?

Linda Marban: Yes. So exactly. Right now, the deal is freshly inked and we’re delighted to have them as our partner for Japan. We think they’re our ideal Japanese partner and this was in the makings for a while. We are the marketing authorization holder, so we will be responsible for the clinical work. We’re glad for that because we have a very seasoned regulatory team that will be able to take advantage of our learnings in the U.S., apply them to our opportunities with the PMDA and come up with a very efficacious plan to get CAP-1002 to market in Japan as well.

Michael Okunewitch: All right. Thank you for that. And I’d like to follow-up again on Nippon Shinyaku, since they’re already in the DMD space with the exon skipping drug, does their partnering in Japan give further confidence for the strategy to position CAP-1002 as a back bone therapy in DMD?

Linda Marban: Yes, absolutely. And we’ve been very strategic in selecting Nippon Shinyaku and NS Pharma as our partner. They’re ideal. They have a commercial product in Duchenne Muscular Dystrophy, they have a sales and distribution network. Their Med Affairs Group is focusing on solely primarily on DMD. And so, yes, it’s an extension of our strategy to make sure that CAP-1002 will be available to every DMD patient ultimately.

Michael Okunewitch: All right. Thank you for that. And then just one last one from me on the HOPE-3 trial. I’d like to see if you could just talk a little bit about what assumptions you currently have for (ph) and what this — and how the study is powered?