Capricor Therapeutics Inc Hope 3 Top Line Data Call Transcript

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

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Good morning, Linda and team and, my congratulations on these very strong data from HOPE-3. Wanted to ask, and I know you had discussed this a bit during the prepared remarks, Linda, but with respect to the primary and secondary endpoints, percent slowing versus I think what was on clinicaltrials.gov of mean change. If you could just, walk us through maybe a bit further in your discussions with FDA and perhaps part of your SAP, how that will be handled versus, mean change and if there may be any differences or further discussion that's needed with respect to, the agency regarding those as registrational. Thanks.

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Thanks, just great, and one follow-up, as the results that were presented were across the entire HOPE-3 population, just wanted to ask with respect to cohorts, B versus A. Obviously B from San Diego, which is the facility that's been fully inspected and passed and all that versus A from LA. Just wanted to hear of any concerns or any possible items that may come up with respect to approvability of Deramiocel, given the data set across both A&B. Thanks. 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 03, 2025 / 1:00PM, CAPR.OQ - Capricor Therapeutics Inc Hope 3 Top Line Data Call

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Thanks very much and again my congratulations.

Question: Ed Tenthoff - Piper Sandler & Co. - Analyst : Great, thank you very much on this glorious day. Congratulations. I know how much hard work's going into this and really how meaningful this is going to be to boys who suffer from this terrible disease. I wanted to get a sense for, the response to the BLA. What really goes into that, to the reply, I'm sorry, to the, CRL is it. Just the submission of this new data set, are there any other components or any other anything else that needs to be included in that submission and you mentioned the potential to accelerate the review. Maybe tell us a little bit about that strategy.

Question: Ed Tenthoff - Piper Sandler & Co. - Analyst : Excellent.

Question: Ed Tenthoff - Piper Sandler & Co. - Analyst : Great, excellent. Well, congratulations and that's on these next steps.

Question: Joseph Pantginis - H.C. Wainwright & Co. - Analyst : Everybody, good morning and congratulations as well. This is really fantastic after the path you followed, building this case here. I know it's been difficult, but it's very rewarding now. So two questions to start. First, can you give a little perspective with regard to the LVEF percentage increase. Is and how this reflects clinically to the patients and then number 2, you just spent a bunch of time describing, the responses to the CRL components. What would you consider, if any, the worst or the most demanding case that might be still outstanding? Thanks a lot. 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 03, 2025 / 1:00PM, CAPR.OQ - Capricor Therapeutics Inc Hope 3 Top Line Data Call

Question: Joseph Pantginis - H.C. Wainwright & Co. - Analyst : That's fantastic. Thank you very much for that and looking forward to a potential positive FDA outcome. I think you have the data to show that, so congratulations again.

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : Good morning team. Congrats on the results. Much needed for the Shen patient community, and this is my am for Madison, on the significance of 85% non-ambulatory patients enrolled, I appreciate the context that was given earlier. Did you see any treatment effect differences between ambulatory and non-ambulatory? Sorry if I missed that forest slot that was, I think that's when the webcast froze, and also if you. Could comment on reasons for MRI data. Sample size is different in LVEF versus, what we see for P2. Maybe just comment on what, why is that. And then lastly, if you could touch on any cardiac outcomes in TAM data you, are seeing or will become available as you, get ready for this next print, towards the BLA resubmission and possibly looking at a mid-year producer date. Thanks for taking your questions.

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : Yeah, Linda, yes. Thank you. The ambulatory versus non-ambulatory, if you've done any forest, if that was included in your forest plot, sorry if I missed that. What was the treatment magnitude difference for ambulatory versus non-ambulatory?

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : Yes, and, your, and, your sample size forpo to, endpoint versus the LVEF, those ends are different. That was my clarifying question. Like, for LVEF, there were some assessments for MRI that may have been missed. Just can you clarify the explanation for that? 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 03, 2025 / 1:00PM, CAPR.OQ - Capricor Therapeutics Inc Hope 3 Top Line Data Call

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : I understood. Thank you and congrats again.

Question: Aydin Huseynov - Ladenburg Thalmann & Co Inc - Analyst : Good morning, Lynn, the team. My sincere congratulations. It's a great day for, Duchenne patients and parents. A couple of questions on my end. So I wanted to ask you about other cardiac endpoints that were described in HOPE-2, LBDS -- LVED volume, wall thickening, and others. I think there were about 20 cardiac measures in HOPE-2. And whether those measures were statistically significant in HOPE-3.

Question: Aydin Huseynov - Ladenburg Thalmann & Co Inc - Analyst : Yeah, thank you. Appreciate that. And just, follow-up question. So, given the effect, not only on, cardiac muscle myopathy, but also on skeletal muscle myopathy, so what do you think could be other applications of theroycil, on skeletal muscle myopathy in terms of other indications and what are your plans as it comes to other indications? 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 03, 2025 / 1:00PM, CAPR.OQ - Capricor Therapeutics Inc Hope 3 Top Line Data Call

Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst : Hi, morning, Linda and team. Congrats on the results. I think, some of our, the questions we're seeing are how this is going to be handled when FDA stats team looks at the raw data themselves and I just wanted to ask in one more, I know you've gotten this a bunch, but one more. Confirmatory question on the percent change versus the absolute change. It sounded like that was more of a tacit approval rather than specific feedback that you got. So, is there, does there seem like a possibility that they would run the absolute change as the primary endpoint in their analysis?

Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst : Oh, great. And then just going back to thoughts on, possible differences in statistical analysis, is there any difference Potentially, let's say in terms of handling of missing data where they could have a more rigorous approach that might change the statistical significance of the endpoint.

Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst : Got it. Well, thanks for taking the questions and congrats again on the data.

Question: Boobalan Pachaiyappan - Roth Capital Partners LLC - Analyst : Sorry. Hi, good morning. Can you hear me okay?

Question: Boobalan Pachaiyappan - Roth Capital Partners LLC - Analyst : All right, so congratulations on today's date. A couple of questions, mostly for the KOLs. So, let's just say like hypothetically, the Ramusil gets approved by tomorrow. So I wanted to speak to you or I wanted to get your thoughts on your comfort level in prescribing theammucil on top of patients who are getting, exon skipping therapy. Do you feel, there will be any pay or pushback or how are you thinking about it?

Question: Boobalan Pachaiyappan - Roth Capital Partners LLC - Analyst : Great. And then really quickly, with respect to the placebo response that we saw today, I was wondering if you could comment on whether this was what was expected and was it in line with what is known from the natural history studies. 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 03, 2025 / 1:00PM, CAPR.OQ - Capricor Therapeutics Inc Hope 3 Top Line Data Call

Question: Boobalan Pachaiyappan - Roth Capital Partners LLC - Analyst : Thanks, Linda. Maybe one final question to you. So after submitting the CRL response to the FDA, I was wondering how you're thinking about the pathway to approval in exCS regions, particularly in the UK and European Union. Do you think today's data will facilitate the process, or like how are you thinking about the timelines? Any thoughts? Thank you.

Question: Boobalan Pachaiyappan - Roth Capital Partners LLC - Analyst : Thank you very much and congratulations again.

Question: Yanan Zhu - Wells Fargo Securities LLC - Analyst : Oh, great. Thanks for taking our questions and I wanted to add my congrats on the splendid results here. Just wondering whether there is any correlation between the PUL endpoints and the LVEF endpoint. Especially between the absolute change of the PU endpoint and LVDS endpoint, given that there's some question this morning, but I understand. That the absolute, endpoint, changing P also hit P value, but if there's any correlation, I think that might, further reassure the results. . 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 03, 2025 / 1:00PM, CAPR.OQ - Capricor Therapeutics Inc Hope 3 Top Line Data Call

Question: Yanan Zhu - Wells Fargo Securities LLC - Analyst : Wonderful. Linda, I was also wondering about cohort B specifically, given that you mentioned that's the E em a, more of an EMA focus, and also you mentioned cohort B data actually looks even better than cohort A. So on the absolute change in PUL endpoint, could you comment on whether cohort B alone also reached that stake and whether that p-value is a little any different than the overall?

Question: Yanan Zhu - Wells Fargo Securities LLC - Analyst : Wonderful. Thanks for taking all the questions and congrats on the results.