Capricor Therapeutics Inc Provides Regulatory Update Transcript

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

Question: Edward A. Tenthoff - Piper Sandler & Co. - Analyst : Sorry to hear this news, Linda. I know the CBER director has been vocal in his opposition, but we really think this is a therapy that needs to get approved for the patients. When it comes to the BLA, the response to the CRL, as you laid out, when do you think you might be able to respond to the CRL? And with the HOPE-3 data, would this still be for DMD cardiomyopathy? Or would it potentially be for the more expanded DMD label broadly?

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Also sharing my disappointment to hear the news. I wanted to just clarify with respect to sort of dividing between the observations that have been made and the statistical analyses that have been applied. If you could just sort of provide us some more color there and also how those may impact upon your statistical analysis plan for HOPE-3 with the understanding that the HOPE-3 primary endpoint is the skeletal muscle function analysis? Thank you.

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Thanks. And then could you remind us or have you shared the specific powering of HOPE-3 for the full primary endpoint based on prior data?

Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst : Sorry to hear about this. I know how much you genuinely care about this patient group. I had a few questions. First, was there anything that they said about the data itself being clinically or not clinically meaningful? Or is the sense here that it was just more on the magnitude, the way the study was statistically analyzed based what you just said for HOPE-2 and the number of patients?

Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst : Okay thanks. And then just for the HOPE-3 study, we understand you're probably somewhere in the cleaning up and analyzing the data step. Can you just give us a sense of your confidence in this trial being successful? I don't know if you have seen any data from the trial yet or anything of that nature.

Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst : Okay, thanks. And then last one for me on the why a BLA -- a new BLA might not be required. Essentially, do you get the sense of certain modules in the application that are already going to be sufficient? They don't need to kind of look over from scratch? I guess I'm trying to understand why a new application might not be required. Or is it just the case that you think they're going to just look at essentially what's going to be new to the package, primarily HOPE-3 data? Thanks again, everyone.

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : I wanted to ask, you mentioned that the powering on HOPE-3 on (inaudible) was at 80%. Just wondering what that powering would look like if the ejection fraction was moved to the primary endpoint? And then if you could, could you clarify, are you expecting like a Class II resubmission? Or REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JULY 11, 2025 / 12:30PM, CAPR.OQ - Capricor Therapeutics Inc Provides Regulatory Update will this be a major amendment since it's not going to be an independent BLA? And then lastly, could you mention if the FDA viewed the [pull] data point in HOPE-2 as statistically significant?

Question: Catherine Novack - Jones Research - Analyst : Just another question on sort of the timeline. You have just under two months left on the review. Would that new review period be those two months plus whatever kind of PDUFA extension, assuming you can submit the data under the existing BLA? And why would the FDA stop the review so early prior to looking at any of your CMC responses?

Question: Catherine Novack - Jones Research - Analyst : Okay, thanks for clarifying that. And then I just want to ask about the partnership with NS Pharma. Obviously, are they aware of the CRL? Have they said anything about their commitment to commercialization in the US?