peutics Inc Earnings Call Transcript

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

Question: Edward Tenthoff - Piper Sandler Inc - Analyst : Great. Thank you so much for taking my question and I appreciate all of your hard work to keep fighting for these boys and get them a therapy that's going to help them with their heart function. I wanted to get a sense for the plan for next steps in terms of unblinding HOPE-3. Is the plan to get confirmation from the FDA on that first? Just maybe reiterating what the plan is. Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 11, 2025 / 8:30PM, CAPR.OQ - Q2 2025 Capricor Therapeutics Inc Earnings Call

Question: Edward Tenthoff - Piper Sandler Inc - Analyst : Great. And when do you expect to hear back from the FDA or get that query?

Question: Edward Tenthoff - Piper Sandler Inc - Analyst : Thanks so much, Linda. Good luck.

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Thanks, Linda, for the update and taking our questions. There's just a couple here. So just to be further from from Ed's inquiry. So if you go with the plan to not unblind HOPE-3 but continue with with the current BLA as it is, would there then be supplemental OLE data that could go into what the FDA has on file versus what had been submitted? I guess if you could share just what incremental, data ex-HOPE-3 that that could become available to them that would be different from what they had reviewed previously.

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Okay. And I guess, I have to ask, with Vinay Prasad now back at CBER, how does -- does that inform your thinking is -- are the people who you're interacting with the FDA, is there a different team now with Nicole Verdun out of the picture since the last few weeks? How should we think about who your counterparties are at FDA at this point?

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Okay. All right. Thanks very much for taking the questions.

Question: Joseph Pantginis - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Hi, Linda and AJ. Thanks for taking the questions. Good afternoon. So just to press the envelope a little bit, obviously, things could change incrementally or dramatically this week and about a month after that when you provide the details from the minutes to the Street. But with language in the press release and what you talked about today, you're talking about resubmitting in its current form, you're saying maybe not really having any incremental data from the OLE that you just discussed in the last question. So what would you expect that could be potentially different?

Question: Joseph Pantginis - H C Wainwright & Co LLC (Pre-Merger) - Analyst : All right, and so that's fair. And so maybe just another question starting at the -- or from the back end of your comments around StealthX. So it's great that it's getting into the clinic now. Any visibility with regard to what might be next with regard to an indication? Obviously, you mentioned influenza as a potential and how would you describe the early cost maturity levels of potential BD around StealthX?

Question: Joseph Pantginis - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Got it. Looking forward to more visibility out of the program and good luck with the meeting this week.

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : Hey, Linda and AJ. Thanks for taking our question. I was just curious, has there been any informal agency communication? I believe post-CRL, you had noted there was an opportunity for an informal teleconference, and just wondering what the takeaways were there and if that contributed to your decision to resubmit? Thank you.

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : Got it. Thanks. And then do you expect to get an answer on the primary endpoint change at the August meeting? I believe you said you were expecting an answer on that.

Question: Madison El-Saadi - B. Riley Securities Holdings Inc - Analyst : Got it. Well, good luck this week at the meeting.

Question: Aydin Huseynov - Ladenburg Thalmann & Co Inc - Analyst : Hi. Good afternoon, Linda. AJ. Thanks for taking questions and appreciate all the work you're doing. A couple from us. So first, I want to clarify and apologize if this has been addressed, but I want to clarify the the timeline of the upcoming events. So the fourth quarter, you're going to readout HOPE-3, resubmit the BLA. And how do we treat this BLA? Is it -- if it is the same BLA, what is the review process typical for this kind of reapplications? Is it two months acceptance and review months? Just curious your thoughts on the timeline.

Question: Aydin Huseynov - Ladenburg Thalmann & Co Inc - Analyst : Okay. I appreciate that. And regarding the left ventricular ejection fraction as the primary advocacy endpoint for HOPE-3. Could you walk us through your thought process as to why you chose this endpoint? I think the HOPE-2 had multiple cardiac endpoints I think 21 cardiac measures. And could you also remind us any prior successful or unsuccessful left ventricular ejection fraction primary input submissions so that we can model based on those precedents?

Question: Aydin Huseynov - Ladenburg Thalmann & Co Inc - Analyst : It is very helpful. I appreciate it, Linda. Just to summarize this maybe. Essentially, LVEF was a surrogate endpoint and it requires a little bit of innovative thinking on FDA side to make it like a primary endpoint going forward. Would that be fair summarization here?

Question: Aydin Huseynov - Ladenburg Thalmann & Co Inc - Analyst : Very helpful. Thank you so much. And one final question on Becker Muscular Dystrophy, my favorite one because part of our model modeling is based on that. So, but all these discussions, what takeaways it has for BMD? I mean, would you have to run another HOPE-3-style large trial in BMD to get a similar potential label as in DMD? And would left ventricular ejection fraction serve also a primary endpoint for BMD? Thank you.

Question: Aydin Huseynov - Ladenburg Thalmann & Co Inc - Analyst : Thank you. Thanks so much for your comments and good luck with your meetings with the FDA. Thank you.

Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst : Hi, Linda. Thanks for taking my question. So one question was when the FDA responded to your request for Type A meeting, gave you the date, did they give any substantive reply to your meeting request, particularly around positive or negative wording around the LVEF? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 11, 2025 / 8:30PM, CAPR.OQ - Q2 2025 Capricor Therapeutics Inc Earnings Call

Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst : Got it. And then the R&D expense for 2Q, what accounts for the increase? Does this build up of product inventory ahead of potential launch, or is this due to ongoing clinical studies we should expect to see continued growth on that line?

Question: Catherine Novack - Jonestrading Institutional Services LLC - Analyst : Okay. All right. Thanks. That's it for us.