Capricor Therapeutics Inc To Host DMD Program Update Call Transcript

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

Question: Joe Pantginis - H.C. Wainwright & Co., LLC - Analyst : Hi, Good morning, everybody. Thanks for taking the questions. Linda, I got two questions. One is a perspective question and one is a little more specific one diving into the total picture for CAP-1002 opportunity in DMD. So with regard to the perspective, obviously, I hope it resonates today. The level of the scientific achievement that you've achieved here with regard to the comparability analysis and the perspective that I'm looking for is these comparability analyses or potency assays specifically have really represented a major hurdle and has led to even significant delays for other companies. So hopefully you can add some perspective to that about what you've accomplished.

Question: Joe Pantginis - H.C. Wainwright & Co., LLC - Analyst : I appreciate that. Thank you. And I guess the more specific question about the profile is you obviously have the agreed-upon path with regard to your primary endpoint performance of upper [limb 2.0], et cetera, as the key metric. But when you look at the profile. Again, we've discussed this in the past, but to what extent currently has your cardiovascular data impacted your discussions with the FDA? And obviously, that should be a represent a big component of the data coming out from HOPE-3. So where do you think cardiovascular could fit in the overall picture? without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. APRIL 29, 2024 / 12:30PM, CAPR.OQ - Capricor Therapeutics Inc To Host DMD Program Update Call

Question: Joe Pantginis - H.C. Wainwright & Co., LLC - Analyst : So appreciate it, Linda, looking forward to the update from Europe coming clinical meeting with the FDA.

Question: Ted Tenthoff - Piper Sandler - Analyst : Great. Thank you very much, and thank you for the thorough update today. Clearly, a lot of work and some really constructive discussions with the agency. Ken, on what should we be expecting from the upcoming longer-term [LOE] data? And how important is that durability? And when it really comes to the discussions, not just with the agency, but also ultimately with some physicians and their boys. Thanks.

Question: Ted Tenthoff - Piper Sandler - Analyst : Yeah, makes a lot of sense, especially on the cardiovascular, but as you mentioned, too, just on the functional on and movement endpoints had. Thank you very much. And looking forward to that upfront and that's that next data set.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Hey guys, thanks so much for the call and kudos to the team for handling a lot of being important or relocating well ahead of schedule. And I know it's a very cumbersome process. So if you're open and was granted a rolling BLA what items would you be able to hopefully submit between that time through the data expected later this year? And would you receive any feedback lifetime or would the expectation be that feedback would occur at the end of the BLA cycle. I know you have a number of designations, which means you have frequent meetings and conversations.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Okay, thanks. And I know that the team has grown substantially over the last. We are heading into this pivotal moment. But based on your more conservative approach initially ahead of this meeting and the work being done across both sites simultaneously. How does this FDA feedback allow you to shorten the timeframe, but more importantly, give more time to prepare in advance and focus on this potential commercialization? Thanks again.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst :

Question: Aydan Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Good morning, Linda team. Thank you for walking us through the on the history, and congratulations with the progress of the FDA. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. APRIL 29, 2024 / 12:30PM, CAPR.OQ - Capricor Therapeutics Inc To Host DMD Program Update Call A couple of questions. So regarding a potency assay circle product approval, or any sequencing, an anti-fibrotic assay that was specifically requested by FDA. So given the anti fibrotic mechanism of action, what do you think about applications of CAP-1002 in fibrotic indications such as a late-stage systemic sclerosis, IPF, et cetera?

Question: Aydan Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Thank you, Linda, this is helpful. One question regarding commercial planning. So your partner and as pharma responsible for commercialization and but and they already have their own exon skippers. So could you describe any complementary synergistic on commercial activity as it relates to CAP-1002 and the exon skipping that they already have?

Question: Aydan Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : So do you think the same patients can get both exon Skipper and CAP-1002 and thinking of the future arm. And do you think the FDA will put any restrictions in terms of days of using CAP-1002 with other medicines?

Question: Aydan Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Perfect. Thank you. And the last question I have on Becker muscular dystrophy. So I don't see the path forward for Baker. I know you talked a little bit during presentation smaller patient population, but longer use. So will there be any preclinical data related to Baker or any of the discussions to initiate a clinical trial on Becker? Just can you give us a little bit more detail, if you can?

Question: Aydan Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst : Very helpful. Linda, thank you so much. I congratulate and thank all of the departments. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. APRIL 29, 2024 / 12:30PM, CAPR.OQ - Capricor Therapeutics Inc To Host DMD Program Update Call