Capricor Therapeutics Inc Q1 2025 Earnings Call Transcript

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

Question: Edward A. Tenthoff - Piper Sandler & Co. - Analyst : Great thank you very much can you hear me, okay?

Question: Edward A. Tenthoff - Piper Sandler & Co. - Analyst : Very well thanks. So, I just want to pick up on some of the comments that you have. Have you guys had your, site inspection yet in San Diego? And if not, can you tell us when that's scheduled for? And then, just with respect to preparation for the [AdCom], walk us through maybe what you consider to be key features and anything along the lines in terms of particular prep. Thank you.

Question: Edward A. Tenthoff - Piper Sandler & Co. - Analyst : Great thank you so much.

Question: Leland Gershell - Oppenheimer & Co. Inc. - Analyst : Good afternoon and thanks for taking our questions. Just two from us, Linda, first, just want to ask with respect to Nippon Shinyaku, you had signed kind of that that, letter of intent or what have you back in the fall, and I know you'd updated us that you've extended that negotiation period. Just wondering if we could also maybe read into that. That you may be considering an alternative mechanism for launching in Europe perhaps on your own, which could be more lucrative to Capricor in terms of economic preservation, as you've seen rare disease therapy is often to be even better over in Europe than in the states. And the second question is with respect to and that's in the states. If you could just share to the extent, you can kind of how they're set up here in terms of their footprint, for marketing Deramiocel presenting approval. Thanks.

Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst : Hi, good afternoon, everyone. Thanks for taking the questions, and I look forward to meeting and working with Dr. Binks on your team. So, you made a comment that when you talk to several key leaders, they truly point out that these effects can't be by chance, and that's something that we often hear as well when we speak to thought leaders. I wanted to ask what are the biggest key drivers that these physicians say is that proof, and I know the FDA certainly is no stranger to the natural history work having funded it themselves, but maybe can you talk about what they're viewing as truly the strongest signals when they look at that data set.

Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst : Thank you for that and yeah, that was literally going to be my next question. Last summer is when you presented the three year data and well I know we don't have a date yet for this ad con I'm wondering if you will have any four year data to share at that point with the agency or if you've been disclosing early data as you've had these ongoing review meetings.

Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst : Okay thanks and then the last question that I had is obviously there's been a lot of changes at the administration so can you just talk from a high level if the people that you've been speaking with over the course of the year and beyond when you first presented these data to the FDA has there been a lot of changes within that or for the most part are most of the people that you're speaking and working with the same people that have been part of the process. Thanks again.

Question: Catherine Novack - Jones Research - Analyst : Hi. Good afternoon. Thanks for taking my questions. I'm just wondering strategically, suppose that the FDA issued a CRL for efficacy in August. What's the plan? Would you then read out HOPE-3 and submit for DMD skeletal muscle function, where do you see going from there?

Question: Catherine Novack - Jones Research - Analyst : Got it. So, you would intend to submit for both if you were filing with HOPE-3 data. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 13, 2025 / 8:30PM, CAPR.OQ - Q1 2025 Capricor Therapeutics Inc Earnings Call

Question: Catherine Novack - Jones Research - Analyst : Great. And then, if you can share any specific feedback [FDA] has given you about LVF as a surrogate endpoint, what have they said about this endpoint, the ability to predict cardiac outcomes? How much of that are you supporting with your OLE data? Thanks.

Question: Catherine Novack - Jones Research - Analyst : Got it, thanks for clarifying that for me that was very helpful.

Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Hi, good afternoon, Linda. Congrats for the quarter. Thank you for taking questions. I got a couple. So given the sort of general pressure on all gene and cell therapy companies recently and especially in those sort of treatments that were approved conditionally for almost a decade, never got confirmatory studies, do you think a full approval or my cell would put it into some kind of, Specific position when it can actually be utilized more than [exosome skipper] or AV gene therapies.

Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Appreciate that. And for the whole data, could you, remind us again when do you plan to disclose that, I mean, irrespective of what's going to happen in August, and if you get approved in based on HOPE-2, how do you think the label is going to change hypothetically once you disclose HOPE-3 data and add for a label expansion?

Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Thank you, Linda. Very helpful. The final last question is regarding PRV voucher that you may be eligible to receive in August or September. So, would you plan to sell it right away and get whatever the last price is, I think $155 million, or would you like to keep it for possibly using for some indications on your own, such as [Duchenne muscular dystrophy]?

Question: Manasa - Roth Capital - Analyst : Hi, my name is Manasa, and I'm dialing in for Boobalan. So, congrats on your progress team, and we have a few questions. First, in your pay, market research studies, have the participants indicated the type of profile that you know would make their own best in indication?

Question: Manasa - Roth Capital - Analyst : Yeah, like, have the participants indicated the type of, the profile that would like what that preference would be, yeah, that's what I'm trying to ask.

Question: Manasa - Roth Capital - Analyst : Okay, and the next question is like, can you provide some color on the progress achieved with the Japanese regulators? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 13, 2025 / 8:30PM, CAPR.OQ - Q1 2025 Capricor Therapeutics Inc Earnings Call

Question: Manasa - Roth Capital - Analyst : Okay, thank you. And the last question is, can you kind of, speak about the [AdCom] like can you speak to the [AdCom] committee composition and expertise and do you regard the [AdCom] as a positive indicator?

Question: Manasa - Roth Capital - Analyst : Okay. Thank you so much and congratulations again on.