Capricor Therapeutics Inc Q2 2021 Earnings Call Transcript

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

Question: Emanuela Branchetti - H.C. Wainwright & Co., LLC. - Analyst : Good afternoon, guys, and thank you for taking my questions. It's very exciting to hear that CAP-1002 is moving forward. So, congrats on that. And maybe you can share more details from the trial endpoints. So is the PUL 2.0 on primary endpoint, and what about the target to measure, are you including those in the trial design as well?

Question: Emanuela Branchetti - H.C. Wainwright & Co., LLC. - Analyst : Thank you for that. And you mentioned that the patients enrolled in the HOPE-2 are going to be eligible for moving forward to HOPE-3. Are all the

Question: Emanuela Branchetti - H.C. Wainwright & Co., LLC. - Analyst : Got it. Thank you for that. And just last question about data, can you share your estimates on the cost of the study? 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 12, 2021 / 8:30PM, CAPR.OQ - Q2 2021 Capricor Therapeutics Inc Earnings Call

Question: Emanuela Branchetti - H.C. Wainwright & Co., LLC. - Analyst : The cost of the study of the HOPE-3, yes.

Question: Emanuela Branchetti - H.C. Wainwright & Co., LLC. - Analyst : Got it. Got it. Thank you. And switching to the booster vaccine, I think that's very smart strategy, but could you share your thoughts around a little bit around the clinical development since this is a booster some sequence to other vaccines? Are there are particular requirements that you have to meet for the IND approval and for moving forward? I just wanted to have your thoughts on that.

Question: Emanuela Branchetti - H.C. Wainwright & Co., LLC. - Analyst : Got it. Thank you very much and congrats on the progress.

Question: Alan Leong - BioWatch News, LLC - Analyst : Linda and AJ, congratulations on the San Diego expansion and for grabbing Dr. Elliott out of Johns Hopkins along with her team. To me, and I think, to everyone, this is a major signpost. So congratulations.

Question: Alan Leong - BioWatch News, LLC - Analyst : Yeah, yeah, a couple. Yeah -- has actually been waiting for that shoe to drop, and really happy. Good. I am going to ask something about the pivotal trial. You mentioned that interim -- look, are they safety-only, or go-no-go signal are there any other extremely, like, where you get a full peak at the ongoing endpoints? 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 12, 2021 / 8:30PM, CAPR.OQ - Q2 2021 Capricor Therapeutics Inc Earnings Call

Question: Alan Leong - BioWatch News, LLC - Analyst : I see. So, the FDA is pretty much wanting to look at the 12 months or 18 month primary endpoint, an early peak would move their hand for any early approval?

Question: Alan Leong - BioWatch News, LLC - Analyst : Wonderful. I want to get your thoughts on the INSPIRE trial. It looks at treating severe COVID respiratory deterioration. Are you thinking about generalizing to respiratory deterioration overall, requiring a CPAP? Several years ago, there were several failed trials for respiratory recovery. And frankly, those type of companies have given the right arm for your results. I can see you forgot the military when you talk about that using for general respiratory deterioration for trauma or is it now just confined to severe -- are you thinking just confined and focus confined to severe COVID for now?

Question: Alan Leong - BioWatch News, LLC - Analyst : Thanks. And just one more question, if I may. And I recognize this is an old question, but I am getting lots of inquiries. Can you comment on the projected ease, in relative terms, either manufacturing costs and scalability of exosomes, there is a little bit of fear that this is actually more complicated and/or is complicated as usual cell therapy manufacturing?

Question: Alan Leong - BioWatch News, LLC - Analyst : Congratulations, Linda, and AJ, for making the strategic term and being able to carry it out. So, I am looking forward to your next year.

Question: Brian Corday - BullBear Partners, LLC - Analyst : Hi Linda and AJ, great job. Thanks for the update. I had a question for you regarding the program for Dr. McDonald, where you said you are going to have 65 to 75 patients. Are you planning -- how many are you planning to enroll per month? Do you have several on the waiting list, because I know you told me that there is -- in the past, you have told me there is people that really want to join this study. And will you be giving updates on enrollment throughout the next three months to six months?

Question: Brian Corday - BullBear Partners, LLC - Analyst : Alright. And the San Diego addition where you are bringing in 10 scientists, are they going to be full time for Capricor? Are they subbing out? And did you build the facility? Did you buy the facility? Are you leasing it? And the last part of that is the total cost, you think it's going to be? 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 12, 2021 / 8:30PM, CAPR.OQ - Q2 2021 Capricor Therapeutics Inc Earnings Call

Question: Brian Corday - BullBear Partners, LLC - Analyst : Good. Last question and I would like to come out there. Question on the exosome platform, when you said you were conducting talks with a large pharmaceutical company, what would be your ideal scenario to develop out of that? Full costs or partnership with royalties, what are you envisioning?

Question: Brian Corday - BullBear Partners, LLC - Analyst : So, are you going to look at partnering for regions, or selling off worldwide? How do you envision that?

Question: Brian Corday - BullBear Partners, LLC - Analyst : Alright. And the last question I had for you is, any update on the peer reviewed journal?

Question: Brian Corday - BullBear Partners, LLC - Analyst : Alright. Well, I appreciate it. Keep up the good work. 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 12, 2021 / 8:30PM, CAPR.OQ - Q2 2021 Capricor Therapeutics Inc Earnings Call