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., LLC - Analyst
: Hi. Good afternoon, Linda and AJ. Thanks for taking the questions. So I know there's a lot of working parts here. And I know my questions will
revolve around some things that you might not be able to detail because the FDA minutes are not out yet, but I'm still going to ask them.
With that said, I guess as San Diego comes online this quarter, if I heard you correctly, do you have a general range of the number of patients that
would be required from that facility to start with?
Question: Joe Pantginis - H.C. Wainwright & Co., LLC - Analyst
: That makes sense. And I guess for my next question, it's sort of in the same realm, but I'll ask it sort of scenario-based. So you do have the type --
you do have the minutes that you are awaiting right now. You also have the upcoming interim analysis in the fourth quarter for HOPE-3, which
you said is primarily based on futility. However, does one of the potential scenarios include the positive feedback from the minutes with regard to
the data you might see in the interim that could allow for the acceleration or resetting of the timelines positively for HOPE-3?
Question: Joe Pantginis - H.C. Wainwright & Co., LLC - Analyst
: Got it. And I guess my other questions are strictly logistical. In the conduct of HOPE-3, you're obviously encouraged by the enrollment rates that
you've been seeing, if I understand correctly. What are the prominent reasons for screening failure of patients? Or what does the patient -- and
also, what does the patient pipeline look like for potential enrollment?
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AUGUST 07, 2023 / 8:30PM, CAPR.OQ - Q2 2023 Capricor Therapeutics Inc Earnings Call
Question: Joe Pantginis - H.C. Wainwright & Co., LLC - Analyst
: Got it. And then lastly, going away from HOPE-3 and DMD, you did give us a little bit of a tease again about additional CAP-1002 opportunities.
And I was just curious here. Any potential for going back to any of the prior indications that you've worked on in the cardiovascular arena or any
teasing you might want to give us now with regard to newer indications? Or is this a wait and see?
Question: Joe Pantginis - H.C. Wainwright & Co., LLC - Analyst
: Got it. Thank you, Linda. Appreciate it.
Question: Alan Leong - BioWatch News - Analyst
: Linda, AJ, it's great to be back. And what wonderful commentary. Linda, your commentary extends way beyond the release and love to hear it. And
also, shout out to Joe, the last analyst, for the great questions. I had a couple of sets of questions. You're into really low-volume, high-margin
products. Although, Linda, you caught my ear about the breakdowns into scalability.
Is the pilot manufacturing model a possible template for Capricor's future path for vertical integration? In other words, are you considering this
your usual modus operandi going forward? If you could simply replicate pilot-size facilities, your product is soon to be in that sweet spot. But I
wonder if you could provide any commentary on that.
Question: Alan Leong - BioWatch News - Analyst
: Both. If I understand the manufacturing, you don't need a large footprint for either to accomplish what you need.
Question: Alan Leong - BioWatch News - Analyst
: It does. You also caught my ear about the ASO undisclosed pharma interest. But I want to go more general. Can I get more commentary on the
general pharma and suitor interest because I've been watching this? How much pursuit from suitors are combination trials? Because if I read --
some of the literature -- if I'm wrong, feel free to bat me on the head. There's an assertion -- serious assertion issues of the current gene and cell
therapies. And this is our -- CAP-1002 potentially becomes one plus one equals three and not two. That exerts a lot of interest from those who are
in that space. Can you further comment on that in general?
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AUGUST 07, 2023 / 8:30PM, CAPR.OQ - Q2 2023 Capricor Therapeutics Inc Earnings Call
Question: Alan Leong - BioWatch News - Analyst
: Yes.
Question: Alan Leong - BioWatch News - Analyst
: Last question, but this is for AJ. I guess for both of you, this will be a fun question, but it does get to some interesting things. You've got $10 million
more upfront cash in the last agreement. If you got a grant or another agreement that brings another $10 million, how would you like it used?
Question: Alan Leong - BioWatch News - Analyst
: Well, I look forward in the immediate future, Linda, to walk into your office. The future looks bright for both of us. And I'm (multiple speakers)
pleased with what I hear. Yeah.
Question: Alan Leong - BioWatch News - Analyst
: Thank you. Looking forward to it.
Question: Alan Leong - BioWatch News - Analyst
: Take care.
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