Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q2 2023 Earnings Call Transcript

So that leads into the answer to your second question. The pipeline of potential patients is very rich. There’s a lot energy around this open label extension data. At the PPMD meeting, we were by far one of the busiest booths, second only to [Sarepta] (ph) with the gene therapy. And so, we are looking to build with Sarepta with all of the gene therapies that could come along as anchor therapy for CAP-1002. And so the families see it that way as well. So we do not see, any potential turn down or downturn — downturn in patient opportunities moving forward.

Joe Pantginis: Got it. And then lastly, going away from HOPE-3 and DMD, you did give us a little bit of a tease again about additional CAP-1002 opportunities. And I was just curious here, any potential for going back to any of the prior indications that you’ve worked on in the cardiovascular arena or any teasing you might want to give us now with regard to newer indications or is this a wait and see?

Linda Marban: Yes. So, I think the best way to answer that is, we are very pleased with the progress of CAP-1002 and DMD. I think it’s very clear that there seems to be a disease modifying and a very strong treatment effect that persists after years. Our patients have done really well on a repeated exposure. We have open label extension patients that are in their third year and coming into their fourth year of treatment. And so, it’s very safe. The infusions are easy. So we are opening the door internally to look at a potential opportunities for CAP-1002. We’re exploring those now and we’ll provide updates as we have them to where we will likely deploy CAP-1002 next. But what I can tell you if you’re sort of looking into your crystal ball, we’ve seen really nice data and an inflammatory cardiomyopathy skeletal muscle disease, neuromuscular disease, we know that CAP-1002’s primary mode of action is immunomodulatory and pro regenerative.

So we’re going to continue to explore indications set so the disease pathogenesis would be highlighted by those two processes.

Joe Pantginis: Got it. Thank you, Linda. Appreciate it.

Linda Marban: Thanks, Joe. Take care. I’ll see you soon.

Operator: [Operator Instructions] Your next question comes from the line of [Alan Long] from BioVoice News. Please go ahead.

Unidentified Participant: A.J., it’s great to be back and what wonderful commentary. Linda, your commentary extends way beyond the release and love to hear it. And also shot out to Joe, the last analyst, for a great question. I have a couple of sets of questions. You’re into really low volume, high-margin products. Although Linda, you taught my year about the breakdown into scalability. Is the pilot manufacturing model a possible template for Capricor’s future path for vertical integration? In other words, are you considering this your usual modus operandi going forward? You could simply replicate pilot-sized facilities, your products seem to be in that sweet spot. I wonder if you could provide any commentary on that?

Linda Marban: Are you talking, Alan — by the way, it’s great to hear your voice. And I hope you’re continuing to do well. But are you talking primarily about exosomes or CAP-1002 in terms of pilot manufacturing expansion?

Unidentified Participant: Both. If I understand the manufacturing, you don’t need a large footprint for either to accomplish what you need.

Linda Marban: Right. So they’re similar, but different, obviously. So with CAP-1002, we really have put several manufacturing scale out and scale opportunities in place so that we can reduce the footprint necessary and create more sales. That’s been pretty effective, and that’s largely been the focus of the transfer to the San Diego GMP facility. We’re working really closely with FDA and their CMC group in order to make sure that the product is the same as we produce in the pilot facility, which is why we’re working right now to get those out there and into the clinic. So yes, we expect that we could expand this. And I won’t exactly be, as I think you’re envisioning, which is we take 10 little pilot facilities and turn it into a 100 little pilot facilities.