The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Joe Pantginis - H.C. Wainwright & Co. - Analyst
: Hey, Linda and A.J. Thanks for taking the question. Good afternoon. My first question, I'm going to start at the back end of your comments regarding
exosomes. So just wanted to get a sense of what potential news flow in pre-clinical data we might be getting over the next six to 12 months. And
secondly, I know you said there's ongoing discussions right now, so there might be some confidentiality, but can you disclose what kind of vaccines
you might be going after?
Question: Joe Pantginis - H.C. Wainwright & Co. - Analyst
: Got it. That's helpful. Thank you. And my main question has to do with the DMD program, obviously. And I guess there's a few working parts here.
But look, following your Type-B meeting, you had very, very important visibility about the path forward, to be able to file in Cohort A and Cohort
B. So I guess my question is, you know, maybe a little bit of a scenario analysis of your comment about still further potentially being able to accelerate
the program.
And I guess I would also focus my question around the upcoming interim analysis, with your disclosure to the public revolve around sort of continue
as planned or any potential data and any potential stopping rules you might be able to share with us? Thanks.
Question: Joe Pantginis - H.C. Wainwright & Co. - Analyst
: Appreciate the color. Thanks, Linda.
Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst
: Good afternoon, Linda, AJ. Congratulations with the big progress this quarter and congratulations with completing the enrollment in Cohort A. I
have couple of questions. The first, I want to start from milestone -- potential milestone payments from Nippon Shinyaku. So your total potential
sort of receivable from Nippon for next several years, if the drug gets approved, is $705 million.
So can you give us a sense how much from that total amount Nippon may pay by the end of the year, if the DSMB decision will be positive? Is it
$10 million, $20 million, $30 million? Can you give us overall, just a sense of it?
Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst
: Oh, yeah. This is super helpful. Appreciate that, AJ. Just to clarify, the $100 million, including approval milestones? So in -- imagine, that you've got
approval.
Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst
: Okay, got it.
Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst
: Okay. I appreciate that. All right, another question is on Cohorts -- so Cohort A completed enrollment, 58 patients. Seems like you're going to be
starting Cohort B enrollment within weeks from now, I think you mentioned by the end of the year. So given the holidays, do think it is still realistic
to sort of actual enroll patients in Cohort B by the end of the year, between now and January 1?
Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst
: Oh, yeah. This is great to hear. I mean, given there is not nothing -- no other trials if it's feasible that you will enroll. Okay. Understood.
So -- And -- so given the DMD landscape is changing, obviously with different treatments, different approvals, so do you think the Cohort B will be
somehow different from Cohort A, given that these will be different patients? So do you think any variability between two cohorts in the future?
Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst
: Appreciate that. This is very helpful. So another question I have is about expansion of potential label of CAP-1002. So other DMD companies may
have sort of limitations to expand into other stages of DMD or other dystrophies or other types of DMD patients.
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NOVEMBER 14, 2023 / 9:30PM, CAPR.OQ - Q3 2023 Capricor Therapeutics Inc Earnings Call
So you have a nice slide on your corporate presentation describing potential expansion into early-stage DMD patients and then into Becker muscular
dystrophy or BMD. So could you help us understand how the potential endpoints with early-stage patients may look like with CAP-1002? So this
likely won't be pool because these patients are more active and more mobile. So just give us a little bit of idea how these endpoints may look like.
Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst
: Understood. Understood. Thank you, Linda. And then the last question is from regarding Becker dystrophy. So for Becker dystrophy cardiomyopathy
is obviously one of the major cause of death. And it would make sense sort of starting from the late-stage patient. So could you share with us how
or why Capricor is more advantageous -- is in more advantageous position compared to other DMD -- other dystrophy companies when it comes
to the Becker dystrophy?
Question: Aydin Huseynov - Ladenburg Thalmann & Co. Inc. - Analyst
: Understood, understood. Thanks so much, Linda and AJ. Congratulations again with the progress.
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