Capricor Therapeutics Inc Q3 2025 Earnings Call Transcript

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

Question: Edward Tenthoff - Piper Jaffray Inc - Analyst : Great. Excited for the upcoming HOPE-3 data. I just want to get a sense for what we should expect from that in terms of what will be actually released in the initial data reporting in the top-line data.

Question: Edward Tenthoff - Piper Jaffray Inc - Analyst : Just one quick follow-up, if I may. With the consideration of left ventricular ejection fraction as a key secondary, are there any statistical changes in this study because of elevating LVEF tanks?

Question: Leland Gershell, MD, Ph.D. - Oppenheimer & Co Inc - Analyst : I wanted to ask just a bit further on HOPE-3 and the SAP. We're in this unique circumstance of having a BLA that's for the cardiomyopathy, but the primary endpoint of the trial is the PUL 2.0. So wondering how the SAP designates treatment of the LVEF secondary endpoint in the situation in which you miss significance on the primary?

Question: Leland Gershell, MD, Ph.D. - Oppenheimer & Co Inc - Analyst : Also just a question with respect to the cardiac MRI review procedure. Could you just run us through that? Are all of these reviewed by an external review? Or is there an adjudication process? If you wouldn't mind just summarizing that.

Question: Joseph Pantginis, Ph.D. - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Linda, I just wanted to clarify something quickly before my question. So depending on the primary endpoint, you said you're going to continue to look for cardiomyopathy and then if statistically significant, expand to skeletal, if I heard you correctly. Would that be in the form of an sBLA?

Question: Joseph Pantginis, Ph.D. - H C Wainwright & Co LLC (Pre-Merger) - Analyst : I just wanted to make sure I understood. Because it looks like with regard to the analyses, you're going to be looking at the two manufacturing cohorts of A and B versus B alone. Does that include any alpha spend at all? Or how should we view those in general impacting the SAP or not?

Question: Joseph Pantginis, Ph.D. - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Maybe a question for AJ, and if you'd like to fill in, that would be great. I wanted to get a sense now with regard to your burn going forward. You have a couple of things coming down, a few things potentially going up. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 10, 2025 / 9:30PM, CAPR.OQ - Q3 2025 Capricor Therapeutics Inc Earnings Call You'll have HOPE-3 wrapping up in the clinical trial expenses around that. I wanted to see about discussing manufacturing expenses that might be increasing, personnel and then maybe a gradual increase in exosomes. Maybe some views on how the expenses might be going forward.

Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst : I just have a question on -- when you mentioned FDA intended to exercise regulatory flexibility. At what point would -- do you intend to ask them to exercise this flexibility? There's a possibility that you don't see statistical significance on PUL, but there is some apparent benefit on LVEF. Is this a situation in which you would want the FDA to try to look at the totality of the data going forward?

Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst : Then if there's anything you can share specifically what -- about what FDA did say when it comes to regulatory flexibility. We've obviously seen them be more stringent when it comes to statistics in recent decision-making. If there's anything you can give us to -- any more specific detail you can give us about what FDA has said about what it means to exercise regulatory flexibility?

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : A couple from us. Do you have a sense that from the FDA's position, how did they view Cohort B? Is it more importance than the aggregate PUL? And then secondly, maybe what is the bar to achieve a more rapid review time that you alluded to? And has that been a request that has been made? Or is that something that you would request alongside the submission of HOPE-3 data?

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : If I may ask one more to clarify. I think you answered this a couple of questions back. But could you clarify the LGE stratification, if that was balanced across both cohorts? Or is that a Cohort B specific stratification that was reached?

Question: Boobalan Pachaiyappan - Roth Capital Partners LLC - Analyst : So I just have a couple starting from the type 2 classification. I think this is the first time you're articulating that type 2 is likely. And obviously, this is going to garner a review period of six months. So I wonder if there were any recent developments between you and the FDA that made you believe or the Class 1 resubmission is impossible. I just wanted to know when this decision on type 2 was like set in stone.

Question: Boobalan Pachaiyappan - Roth Capital Partners LLC - Analyst : Secondly, can you discuss whether the potency assay adequately fulfills the FDA's guidance of potency test for cellular product expectations?

Question: Joseph Pantginis, Ph.D. - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Linda, I want to make sure I'm absolutely sure on this. So forgive me if there's any repetition here. And this goes to the SAP around HOPE-3 and I'm getting questions on this as well. So obviously, you need the primary to hit to be able to trigger LVEF, if I heard that correctly, number one.

Question: Joseph Pantginis, Ph.D. - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Is that the -- like I just want to make sure that's correct. You have to hit the primary in order to trigger the analysis of LVEF. And if you don't hit the primary, how would LVEF be analyzed? And what would you say would be the hurdle for success there?