Capricor Therapeutics Inc Q2 2024 Earnings Call Transcript

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

Question: Joseph Pantginis - H.C. Wainwright & Co., LLC - Analyst : Good afternoon, Linda and AJ, and thanks for taking the questions. Two questions, if you don't mind. So Linda, in your prepared comments, you're talking about you just met with the FDA and it sounds like the key aspects were deciding on the two alternate path for filing. I guess I wanted to get the latest update. And of course, I know this is before you get the minutes is to what extent did the cardiovascular play into this latest meeting? And what do you consider the key outstanding questions or issues still?

Question: Joseph Pantginis - H.C. Wainwright & Co., LLC - Analyst : That's very helpful. Thanks. And if I could just switch swiftly to the exosome program. Obviously it's a platform that has a broad-reaching capability. So you mentioned your BD efforts. I guess how would you describe sort of the proportion of, say, inbound versus outbound from reaching with regard to BD?

Question: Joseph Pantginis - H.C. Wainwright & Co., LLC - Analyst : Thank you very much for the color, Linda.

Question: Leland Gershell - Oppenheimer - Analyst : Yes, hi. Thanks for taking the questions. Just hoping to get some clarity on the timelines here. You mentioned the pre-BLA meeting and quorum plans that will be coming up from around the data and thereafter, I want to understand you know, have you begun any aspects of the rolling submission? If not, when do you expect to begin that and how long after that top line data from the HOPE-3 study we expect to complete the rolling BLA submission?

Question: Leland Gershell - Oppenheimer - Analyst : Okay, thank you. And then a question on the on the ex-US potential partnership. Wondering if there's any, based on where you may be in your discussions, if you can make any comment as to on the the view of having one or more partnerships in place by year end, just sort of want to understand kind of what the evolution of those discussions will lead to perform from here.

Question: Leland Gershell - Oppenheimer - Analyst : Thank you.

Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Hi. Good afternoon, everyone, and congrats with the progress. A positive FDA meeting. Discussion and finding another name for CAP-1002 with Deramiocel. So a couple of questions regarding the FDA meeting. So you mentioned that you had some discussions about expansion of the indication. And I was just curious to see if there is any preliminary feedback or reaction of FDA to potential Becker dystrophy expansion and any thoughts that they have, any hypothetical DMD trial design?

Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : And I still think that this is helpful for full potential DMD label for very myself. How we should think about the label, do you think it would be pretty broad label that would include Pinon on DMD patients are similar to the ones you recruited and hoped to and hopefully trial? Or do you think the FDA may sort of specify patients with cardiomyopathy only? And how to how do you think the FDA will approach?

Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Alright. Great, makes sense. Regarding the -- sort of advanced discussions regarding partnerships in Europe, so would you like to pursue a partnership deal before the top line readout in the fourth quarter 2024 or after the readout? So this is purely economic question, is that cash now or more cash later?

Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Got it. And the last question I have is regarding the potential milestones from Nippon Shinyaku. So we know there's $90 million of waiting up until BLA approval, but are you -- should we expect anything before the FDA approval, should we expect anything based on the top line readout at the end of this year? 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 07, 2024 / 8:30PM, CAPR.OQ - Q2 2024 Capricor Therapeutics Inc Earnings Call

Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Got it. Understood. All right. Thank you so much for taking my questions and congrats with the progress.

Question: Rick Miller - Cantor Fitzgerald - Analyst : Hello. This is Rick Miller on for Christian. Thanks for taking our questions. We've got two for you here. What are you hearing from physicians and caregivers about the potential for non-ambulant DMD patients now receiving gene therapy on an accelerated basis? How confident is the space in this, especially as it relates to these cardiac issues that you were talking about?

Question: Rick Miller - Cantor Fitzgerald - Analyst : Okay. Maybe just one more question then from us. Switching to Becker, can you help us kind of frame the cardiomyopathy opportunity that you're thinking about here. I think sometimes the field thinks sort of naively about Becker as being a less severe form of DMD. So how does the kind of cardiac burden and Becker break down as it relates to DMD? Is it sort of more proportional or more severe? Thoughts there?

Question: Rick Miller - Cantor Fitzgerald - Analyst : Okay. Thank you so much.