Earnings Labs

Capricor Therapeutics, Inc. (CAPR)

Q1 2016 Earnings Call· Fri, May 13, 2016

$34.07

-2.95%

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Transcript

Operator

Operator

Good afternoon and welcome to the Capricor Therapeutics First Quarter 2016 Financial Results and Business Highlights Conference Call. As a reminder, this presentation contains Forward-looking statements and information that are based on the belief of the management of Capricor Therapeutics Inc. as well as assumptions made by and information currently available to Capricor. All statements other than statements of historical facts 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 statements regarding the efficiency, safety, and intended utilization of Capricor’s product candidates, expectation of or dates for commencement of clinical trials, IND filings, plans regarding current and future collaborative activities and the ownership of commercial rights, expectations with respect to the expected use of proceeds from offerings and the anticipated effect of offering, 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 Capricor’s business are set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2015 as filed with the Securities and Exchange Commission on March 30, 2016 and in its Registration Statement on Form S-3 as filed with the Securities and Exchange commission on September 28, 2015. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual results may vary materially from those…

Leland Gershell

Management

Thank you, Linda. This afternoon's press release provides financial details for the first quarter ended March 31, 2016. The press release is available on the company’s website at capricor.com. In the first quarter of 2016, excluding the effect of stock-based compensation, we spent approximately $4.3 million in research and development activities and $0.9 million in general and administrative. As of March 31, 2016 we had approximately $14.3 million in cash, cash equivalents and marketable securities. This figure reflects the approximately $3.9 million in net proceeds from the operations completed in March. The participants in that financing considered primarily as member of Capicor's management team and boards of directors, legacy investors and Cedars-Sinai Medical Center. We currently expected our cash balance will fund our operations through at least the first quarter of 2017. And with that, I will turn it back over to Linda. Linda Marbán: Thank you, Leland. In closing, I would like to say that we are energized by the potential of clinical program to deliver new cells that may be transformational for Capricor less than 12 months from now. In the near term, we will announce the completion of enrolment in both the HOPE-Duchenne and ALLSTAR clinical trials those expected to occur next quarter. And by mid-year you should hear about our first clinical indication for the development of our CDC exosomes. Early next month we'll report to seeing some of you in San Francisco at the BIO International Convention I will now turn the call back over to the operator who will open the call up for questions. Operator?

Operator

Operator

Thank you. [Operator Instructions] And we'll go ahead and take our first question from Ted Tenthoff. Please go ahead. Your line is open.

Ted Tenthoff

Analyst

Great. Thanks and thanks for the update Linda. I apologize if there's any background noise. Just following up with respect to first, the cardiac program, kind of planning for success here, what would be next step if we get a positive data read that out at ALLSTART? Linda Marbán: Yes. So, thanks Ted. It's always great to hear your voice. So, positive data readout out of ALLSTAR, the first thing that happens obviously is that [Indiscernible] decided to whether it’s license in that therapy CAP 1002 and take it forward in this clinical development as well as commercial development program that’s something that we've been working with them and thinking about for a long time. If for some reason that doesn't happen and we certainly are not planning for that or thinking about it even. We would evaluate the opportunity if its positive data I'm sure we will have many suitors at the ball and we will take one that is locally the best opportunity for the company.

Ted Tenthoff

Analyst

Thanks and that's helpful. And if I may just the second one DMD, obviously this basis and tricky with respect to some of the recent regulatory interactions with the exosome shipping drugs, can you just really again kind of underscore how different you mechanism of action is? And why you think DMD is still an important area to invest? Linda Marbán: Yes. So, on that, Ted I want to think that we're most excited about in Capricor and that is the fact that on therapy CAP 1002 core [ph] the treatment of Duchenne muscular dystrophy associated cardiomyopathy is available to any and all of the boys and young men afflicted with Duchenne muscular dystrophy And as I said, I briefly highlighted this in the statements that I made is becoming more evidence that cardiomyopathy progresses at its own pace, which is independent of the skeletal musclemyopathy and such that we may see boys with really bad heart disease at age 8 and when they still ambulatory or boys that are still on wheel chairs at 22 with -- heart. So we'll be able to treat all of those boys and young men as their heart disease progresses. Additionally, we are mutation agnostic, so any type of Duchenne muscular dystrophy can be treated with our therapeutic and potentially have the same results that we have seen in CADUCEUS, which is the reduction in the amount of scar driving the boys back potentially from that decompensated heart failure which is the most common cause of death in these boys and young men.

Ted Tenthoff

Analyst

Great. Thank you very much. Linda Marbán: Thank you.

Operator

Operator

Thank you. [Operator Instructions] Our next question comes from Swayampakula Ramakanth. Please go ahead, your line is open.

Swayampakula Ramakanth

Analyst

Thank you. Hi, this is RK from HCW. So, couple of quick questions. Continuing with the DMD indication, so if the HOPE study, the data from study is favourable, do you need a pivotal study or can you use this data for an accelerated approval? Linda Marbán: So thank you, RK nice to meet you, bodes [ph] well of course to getting to know you better. We have been working with Food and Drug Administration since we filed two file in our IND for HOPE-Duchenne. We plan on keeping that conversation active, when the data comes in we'll of course go to the Food and Drug Administration and to tell them and map out the plan for what next steps are, what should be everything from, the application of NDA to next trial, we will have to how it will plays out. And still we're open to any in our possibility.

Swayampakula Ramakanth

Analyst

Okay. And then on the DYNAMIC study for the heart failure indication, do you plan to seek out the partner to develop for this indication or you want to do this independently, what's the current strategy for that? Linda Marbán: Thank you for that. Currently, DYNAMIC will be held under the umbrella of the exclusive license options held by Johnson, the city area of J&J. If they licensed it in, then they will have the rights to develop the therapeutic and for any and all indications and what we're thinking to be as a cardiology at this time and so we look forward to working with them on the development of that clinical program.

Swayampakula Ramakanth

Analyst

Great. Thank you very much.

Operator

Operator

Thank you. [Operator Instructions] We'll go and take our next question from Ted Tenthoff. Please go ahead. Your line is open.

Ted Tenthoff

Analyst

Great. Thanks for taking my follow-up question. Just with respect to exosomes, maybe you can give me a little color in terms what to expect? Is this something where you're going to primarily be targeting orphan diseases? Is this going to be a therapy that all we intended for larger broader diseases or the kind in their core area of cardiology, just give us a little bit of sense of what we're expecting for that? Linda Marbán: Thanks Ted. So exosomes are these nanometer-sized lipid-bilayer about the goals that are packed with nucleic acid primarily the RNAs and proteins. And what they do is, they go into cells and they literally change the behaviour of the cell and encouraging it to do everything from live which we'll be calling anti-fibrosis to other types of repair strategy. Our exosome seem to be very powerful healers in many of the indications that we're going after and thinking about. And so, what we're doing is looking at any opportunities in which those conversions of clinical relevance available patients, reimbursement, orphan diseases and indications that we can take to commercialization ourselves. One of the important things we're looking at in addition to the eye and skin diseases that we've been talking are treatments for oncology-based therapeutics, I can't go further than that, but I will hopefully [Indiscernible] you to stay tuned as we begin to talk about the programs that were going into developing, that are going to be related to oncology indication.

Ted Tenthoff

Analyst

Great. And just one last quick question if I may, is there is something where you’ll be seeking for great [ph] opportunities as well? Linda Marbán: Yes. I mean we are always looking and interested in meeting anybody who is potentially interested in talking with us and getting to know our programs, and if we can find the right balance of partner and opportunity we certainly will jump on that.

Ted Tenthoff

Analyst

Great. Thanks, Linda. Linda Marbán: Thanks Ted.

Operator

Operator

Thank you. [Operator Instructions] And it does appear that we have no further questions at this time. I will now hand it back over to our speakers for additional or closing remarks. Linda Marbán: Thank you very much for joining us today. We look forward to sharing news review as it comes out over the next several quarters. And we look forward to meeting you very soon at the BIO Convention in San Francisco. Thank you.

Operator

Operator

And that does conclude today's program. We'd like to thank you for your participation. Have a wonderful day. And you may disconnect at any time.