Capricor Therapeutics Inc to Host Webinar Highlighting Positive Phase 3 HOPE-3 Topline Result Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Yeah, I, well, thank you all for the presentation. I think we're just going to hop in. I've seen a bunch of questions come in. We had a handful that were submitted before. I think what we'll probably start with is some of just the regulatory kind of process questions, and then we can dive into some of the HOPE 3 data. And I'll probably, when we get to those, go back to the specific slides, that were relevant. But, we did have a handful of questions kind of come in around timing and things like that. So, I think just first question here would be, how soon do you anticipate having a formal submission for this HOPE 3 data to the FDA for filing and review?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Great. Thank you. And then the other piece of this that I think is always a little bit, tough is we're learning more as we continue to have more approvals and what this process looks like as a community, but it's always a little bit challenging. And so, given that there was the previous BLA and the CRL, do you maintain your kind of priority review status as you go through this process? Has that, does any of that change, at this time?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : And then you also said that you have some of those responses to the CRL. Is there, any other kind of pending responses that need to be addressed aside from this new phase 3 data?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Thank you. And then that was all obviously very FDA specific. The other, we did have a question, we have a lot of international, families as well and who are on. And so I think, question of, will you be making submissions to like, globally, kind of what's the plan for outside the US?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : And then if we could go back to slide 6. So as questions were coming in, I was trying to mark them and match them up to maybe the content that would be most relevant. So, just to start, again, we did have a question, I think essentially asking, how does this differ from maybe other approved therapies. I think sometimes families sees, they see anti-inflammatory and they go, okay, well, I'm already on a steroid. LSEG STREETEVENTS | www.lseg.com | Contact Us consent of LSEG. 'LSEG' and the LSEG logo are registered trademarks of LSEG and its affiliated companies. DECEMBER 17, 2025 / 6:00PM, CAPR.OQ - Capricor Therapeutics Inc to Host Webinar Highlighting Positive Phase 3 HOPE-3 Topline Result So, can you just maybe talk through a little bit of the mechanism? And then, just a reminder, you said that you, someone from the company has made a mechanism of action video that the families can view as well.

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Thank you. And it'll be helpful, I think, too, yeah, families have additional, they can go kind of watch that video, which should also be helpful. On slide 9, when you were talking about, I guess this is twofold. So, one just general question around kind of like, what's the, for the procedure, kind of how long does a typical infusion take? And then there was also just a question with this of, I think, Mike, you noted that there was use of antihistamines to kind of help deal with some of the AEs that were seen. Was this, was that implemented into the protocol? It's kind of prophylactic? Is that something that you anticipate, or is this more just kind of by, decision of the treating physician?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Thank you. And then I think on the, we had a question related to, both, so both the pool and and some kind of ambulatory. So maybe on the next, maybe that was slide 10 where you started to talk about some of the prognostic factors and looking at some of the late ambulatory patients. So, there's a question of basically, is this something that could also benefit, ambulatory boys, not just the non-ambulatory. And so, Knowing that you enrolled some late ambulatory patients, do you, two parts, I guess. One, do you have any functional data from kind of lower limb, functional outcomes? And the other piece of that would be, do you, anticipate this being something that could be used in younger ambulatory patients?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Great. Well, thank you. And I, yeah, we also had a question come in, basically, I think around the newborn screening thing with news of the Duchen being added to the resp yesterday about, how early of intervention can we think about for, something like deramiocel cell. I think that's always the thought of, earlier intervention potentially being beneficial. And of course, conducting studies to identify safety and efficacy is also important. On the next slide, I think there was just a question, and I think you did show this data in the forest plot of just, so this is showing some of the mean change, and I think there was just a question about kind of what was the actual, change in kind of, points between the two groups. But I also thought it might be helpful just to talk through, for those who aren't familiar with the poll, what, how is the performance of upper limb kind of scored?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : That's really helpful explanation. Thank you. And then we had a series of kind of cardiac related questions come in. So maybe we move to slide 12. And the first just being, kind of 4, or maybe we can go to maybe slide 13. . There we go, but for the patients enrolled in the study, knowing that there's kind of, variants and kind of cardiac meds that patients get started on, were patients in both the placebo and the treated group on similar stable cardiac kind of regimens throughout the study?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : And then we had a question come in about, similar idea to some of what we're talking about to the skeletal muscle function, which is, should we be thinking about this from an earlier intervention standpoint, and would there be benefit from starting something like this therapy before we see cardiac involvement. And so, John, I don't know if you wanted to speak a little bit to just the care aspect of how we generally think about maybe initiating cardiac meds in Duchenne and then how that might relate to something like deramiocel.

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Thanks, John. And then I think on slide 15, where you kind of talked a little bit about that la gadolinium enhancement piece, there was another question that came in, just around kind of, I think, a similar thought of differences in terms of LVEF of, was a patient starting at a certain LVF better responder? And I think maybe it's helpful to just talk again about kind of this la gadolinium enhancement and how this, what the response was in these patients. LSEG STREETEVENTS | www.lseg.com | Contact Us consent of LSEG. 'LSEG' and the LSEG logo are registered trademarks of LSEG and its affiliated companies. DECEMBER 17, 2025 / 6:00PM, CAPR.OQ - Capricor Therapeutics Inc to Host Webinar Highlighting Positive Phase 3 HOPE-3 Topline Result

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Thank you, John. And then, I mean, a sim, another question on the same lines, and I think probably a little bit thinking of some of approved therapies where we do have maybe recommendations around minimum ejection fractions. So, there was a question of, would there be a minimum minimum ejection fraction needed to receive deramiocel? And this also might be too premature. But.

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : And then I know Craig already touched on, I think on slide 17, and Linda, you did as well, that, the, this should work, in combination with other approved therapies. I think a question was, were there any patients that were on approved therapies enrolled in the study, and if so, kind of what those therapies were.

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : And then we had another question just asking about kind of, timeline of this would be a therapy, like, how frequently would this be administered and would it be continually administered throughout the lifetime of a patient if approved?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Thank you. And then kind of a final question was around we also see a lot of cardiac involvement in our Becker population. And so, I think there's curiosity to is there would this potentially be a suitable approach for that population? And are there any plans to expand and look at that?

Question: Eric Camino - Parent Project Muscular Dystrophy - Analyst : Right well, we're, we've kind of come to time. So I did want to just say that, first of all, thank you all for joining us, walking through the data, taking questions from the community. And then as, you move forward in your engagement with the FDA, as you have the, announcements to share, we'll make sure to, share that with the community as well, so everyone can be as up to date as possible. Again, if you have additional questions, please feel free to send them along to us and we'll make sure we get in contact with the team at Capricorp. And again, we, this was recorded, so this will be, online, so feel free to share with friends and family who might find this relevant. But, again, I'd like to thank everyone for taking time to speak with the community today.