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Capricor Therapeutics, Inc. (CAPR)

Q4 2014 Earnings Call· Fri, Mar 20, 2015

$34.07

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Transcript

Operator

Operator

Good afternoon and welcome to the Capricor Therapeutics 2014, Fourth Quarter Conference Call. At this all lines are in a listen-only and the floor will be open for questions and comments following the presentation. [Operator Instructions] As a reminder, this presentation contains forward-looking statements and information that are based on the beliefs of the management of Capricor Therapeutics, Incorporated, as well as assumptions made by and information currently available to Capricor. All statements other than statements of historical fact included in this presentation are forward-looking statements, including but not limited to statements identified by the words “anticipates,” “believes,” “estimates,” and “expects” and similar expressions. Such forward-looking statements also include any expectation of or date for commencement of clinical trials, IND filings, similar plans or projections and other matters that do not relate strictly to historical facts. These statements reflect Capricor’s current views with respect to future events, based on what we believe are reasonable assumptions; however, the statements are subject to a number of risks, uncertainties and assumptions. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact our business are set forth in our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on March 16, 2015, and in our Registration Statement on Form S-1 as filed with the Securities and Exchange commission on March 06, 2015. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those in the forward-looking statements. Further, Capricor’s management does not intend to update these forward-looking statements and information after the date of this presentation. It is now my pleasure to introduce your host Dr. Linda Marbán, CEO of Capricor Therapeutics, and AJ Bergmann Vice President of Finance. AJ you may begin.

AJ Bergmann

Analyst

Thank you and good afternoon everyone. I am AJ Bergmann the Vice President of Finance for Capricor Therapeutics. Thank you for joining today’s call. If you do not have a copy of the press release issued earlier this afternoon it’s available on the Capricor Web site at www.capricor.com. The call is expected to last approximately 30 minutes. For the benefit of those who maybe listening to the replay this call is held and recorded on March 18, 2015 since then Capricor may have made announcements related to the topics discussed, so please refer to the company’s most SEC filings and press releases. With that I’ll turn the call over to Linda. Linda Marbán: Good afternoon everyone, and thank you for joining. I look forward to updating you on the progress we've made over the last quarter. Slide 2, as mentioned a moment ago this presentation will include forward-looking statements. On Slide 3, I’m going to review today’s agenda. Over the next two slides I’m going to review some of our upcoming milestones, then I’ll provide a financial update, a clinical update including a glimpse into our new program in DMD cardiomyopathy. And finally we’ll look at our 2015 plan deliverable. On Slide 4, I’ll highlight Capricor’s heart failure program. Just to review we’re a clinical state company with a very diversified pipeline focusing on cardiovascular disease including orphan indication. Our first product is our regenerative medicine CDC, Cardiosphere-Derived Cell product. Second in our pipeline and in the clinic now is Cenderitide, the class of drug called Natriuretic Peptide, which we’re developing for heart failure. And finally in preclinical development we’ve a microRNA delivery platforms based on Exosomes. Exosomes are nanoparticles which are microRNA deliver vehicle that perpetualite cell function. This next Slide 5 reviews our recent milestones and accomplishments. On…

Operator

Operator

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question comes from the line of Ted Tenthoff with Piper Jaffray. Please proceed.

Ted Tenthoff

Analyst

Thank you very much for the thorough update Linda. It's really exciting the progress and also the expansion of the opportunity with the CDC. I guess kind of looking at delivery you started to talk about Exosome. Can you tell us a little bit more about sort of how these cells are -- what’s happening when the cells look like in the heart and what’s happening as they get there and how broadly are they able to get either through the heart picture or is it really just this type of injury, how do you think about delivery there? Linda Marbán: So the Exosomes are really exciting to have because they are first therapeutic that we really truly consider our platform therapeutic. We are by no means limiting the indications that we’ll go after to the heart itself and so one of the things we’re working on in the lab is understanding delivery of Exosome and not only for the heart, but other places as well and you look we’ll provide more color on that probably over the next year or so.

Ted Tenthoff

Analyst

And then in terms of the cells actually through the myocardium, how do they distribute over there? Linda Marbán: Yes so, of course we don’t really know in humans, but we’ve published extensively in animals and what happens is the process called extravagation and that’s why we’re sticking very closely to the intracoronary delivery method. There is a little bit of magic that happens when the cells probably lodge in the micro vessels somewhere and then they're taken up into the issue in a natural way, the way that any other molecule would get into the myocardium and we feel that this is the powerful way that the cell should work even in small number.

Operator

Operator

Thank you. Our next question comes from the line of Reni Benjamin with H.C. Wainwright. Please proceed.

Reni Benjamin

Analyst · H.C. Wainwright. Please proceed.

Just a couple of questions, I guess one on enrolment update on I guess both DYNAMIC and ALLSTAR. I think you mentioned Linda that ALLSTAR is expected to complete enrolment by the second half of 2016, maybe early 2017. Can you give us any additional color on the enrolment of ALLSTAR? Linda Marbán: Yes, so we tend to stay away a little bit from enrolment numbers, we just kind of get caught in that and there's slow periods and fast periods in all of these trials. We’re expecting data out in late 2016, early 2017 for ALLSTAR and that the top-line data that we’ll be passing onto [Janssen]. And then in terms of DYNAMIC, I think we've said that we’re going to complete enrolment in the first-half of 2015 and we are definitely on track to do that.

Reni Benjamin

Analyst · H.C. Wainwright. Please proceed.

And in terms of data presentation this year, could we be targeting something like ASA or do you have a sense as to how either preclinical or clinical data might come out here and at was constant? Linda Marbán: Yes, so we always target the major meetings. We like to have a presence at them, both with the preclinical and the clinical data and we're strategizing now how and when to release the data and where to go with that. And so, we’ll let you know at the time where we're presenting and what we're presenting.

Reni Benjamin

Analyst · H.C. Wainwright. Please proceed.

Just shifting gears real quick to DMD, can you give us any color on for that there was a pre Phase 1 or pre-IND meeting that you had with the FDA? And has there been any changes to the whole trial design and can you just review with us the whole trial design? Linda Marbán: Well I don’t -- we’re not talking about the trial design as yet. We’re very excited about it. We had a good meeting with the FDA and what I can tell you is the strategy that we went in with is pretty much the strategy we walked out with. And we’ll be announcing that trial soon. We don’t want to compromise our information that was given to us by the FDA which was given in confidence and so we’re -- suffice to say that we have enough data to prepare an IND which we’re actively doing at this time.

Reni Benjamin

Analyst · H.C. Wainwright. Please proceed.

And just one final question kind of piggybacking off of that regarding the Exosomes. As a platform technology, can you -- I know it's very early and hopefully we’ll see some preclinical data later this year, but could you expand about how this might be used as a platform more than just something specific to look very cardiovascular indication? Linda Marbán: Well so basically what we’re looking at are indications where some of presentations would be inflammation fibrosis in other words scar, apoptosis which is programmed cell death, so the types of injuries that you’d see for sure in the heart -- in the damaged heart but -- and you can think about many of those types of diseases in the [indiscernible] we're also targeting orphan indications. We feel like that there is a real opportunity here for us to take what we know and we have these cells that are making these Exosomes both of which are powerful therapeutic and we’ll likely be able to use them in different types of injuries and different types of healing processes.

Reni Benjamin

Analyst · H.C. Wainwright. Please proceed.

Is there a potential to generate -- I don’t know call them designer Exosomes where maybe you're working in collaboration with other biotechnology companies in order to use gene therapy or some other type of technologies that make it more custom designs or is that not really in the cards? Linda Marbán: One of the strengths of Capricor is our really strong connection to the academic labs of Eduardo and at [Peter Stine] and so a lot of these questions are under investigation in the lab right now. It's certainly something that everybody is looking at, is designer Exosomes and whether we can pack them full of things that we want to deliver and how to get them there. So it's something we’re actively working on and we’ll be able to provide more information on that as we learn more about them ourselves, they are very exciting to us.

Operator

Operator

Thank you. And we have no further questions in queue at this time. I would like to turn the floor back over to Dr. Marbán for closing remarks. Linda Marbán: Thank you very much for attending our call this afternoon. I look forward to updating you on our progress in the next quarter. And we look forward to continuing to deliver on our milestones. Thank you.

Operator

Operator

Thank you. This concludes today’s teleconference. You may disconnect your lines at this time. And thank you for your participation.