Earnings Labs

Capricor Therapeutics, Inc. (CAPR)

Q4 2015 Earnings Call· Thu, Mar 17, 2016

$34.07

-2.95%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-3.35%

1 Week

+0.74%

1 Month

+24.16%

vs S&P

+21.59%

Transcript

Operator

Operator

Good afternoon and welcome to the Capricor Therapeutics Fourth Quarter and Full Year 2015 Financial Results and Business Highlights Conference Call and Webcast. Please note this presentation will include a slide presentation, which can be viewed through the webcast link or is also available on the company’s website in the Events and Presentations section. As a reminder, this presentation contains forward-looking statements and information that are based on the beliefs 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 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 statements regarding the efficacy, 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, 2014 as filed with the Securities and Exchange Commission on March 16, 2015 in its Registration Statement on Form S-3…

Leland Gershell

Management

Thank you, Linda. This afternoon’s press release provided details for the fourth quarter and full year ending December 31, 2015. The press release is available on the company’s website at capricor.com. As of December 31, 2015, we had approximately $13.6 million in cash, cash equivalents and marketable securities. In the fourth quarter of 2015, excluding the effect of stock-based compensation, we spent approximately $3.2 million in research and development activities and $0.8 million in general and administrative, with the approximate $3.9 million in net proceeds from the offering we announced this past Tuesday and the approximate $3.4 million in grant award from CIRM as confirmed yesterday. We currently expect our cash balance to fund our operations to release the first quarter of 2017. And with that, I will turn it back over to Linda. Linda Marbán: Thank you, Leland. In closing, we see enormous potential value in our pipeline program and we look forward to updating you as we continue to make progress. The last potential milestones that I would like to reiterate are one, the announcement of the first potential indications for clinical development in our exosome therapeutics program; two, the data from [indiscernible] type Phase 2 towards midyear 2016; three, the enrollments of completion of enrollment in our HOPE-Duchenne and ALLSTAR trials of CAP-1002, which we expect to occur in the third quarter of this year and our report of the top line data from the HOPE trial in the first quarter of 2017. We also expect to have the 6-month ALLSTAR data available in the first quarter of next year. I will now turn the call over to the operator who will open the call up for questions. Operator?

Operator

Operator

[Operator Instructions] Our first question comes from Mark Breidenbach with H.C. Wainwright. Please go ahead.

Mark Breidenbach

Analyst

Hey, guys. Congrats on all the exciting recent developments and thanks for taking the questions. I think I have to start with the ALLSTAR Phase 2 resizing. Obviously, this is a really terrific bit of news for the company. And it sounds like the delta between the two study arms may actually be a bit larger than you had originally anticipated when the protocol was first designed. Can you clarify for me a little bit how the physical assessment was made for the resizing? Was this actually based on a blinded interim analysis of the ALLSTAR Phase 2 data or is this more of an extrapolation from some of the other trials involving CAP-1002 like the ALLSTAR Phase 1 and DYNAMIC trial results? Linda Marbán: Yes, Mark, thank you very much for that question. Your latter assumption was the correct one. The statistical stimulations are done using the CADUCEUS data, the ALLSTAR Phase 1 data and some of the other datasets that we have.

Mark Breidenbach

Analyst

Okay, that’s what I thought. I just wanted to make sure. And I was also curious if we are going to see any longer term follow-up data from the Phase 1 DYNAMIC trial, we saw some really nice data presented last year, but I am wondering if we did see additional follow-up and more to the point, I am wondering if we might see any sort of MACE analysis from this trial or if that’s something that’s off the table for 2016? Linda Marbán: Yes. Mark thanks for reminding me about that. We are now collecting the final bit of data from the 12 month portion of DYNAMIC. We expect to report that out at some point once we finished the data analysis, look forward to one of the major cardiology meeting sometime later this year.

Mark Breidenbach

Analyst

Okay, great, great. And maybe too early to talk about what sort of endpoint readouts might be included in that or is it pretty much going to be the same types of metrics we saw at the ACA scientific sessions or AHA scientific sessions, I should say? Linda Marbán: Yes. So, what you saw in the 6 months data at the AHA and what we had previously reported will be the metrics by which we are now analyzing the 12 months data as well. So, you are likely to see much the same reports and readouts. We, of course, will look at all the data that comes in and I am pleased to gather the story of DYNAMIC as we get in.

Mark Breidenbach

Analyst

Okay, great. Let me also follow-up with a few exosome questions if I may. So, obviously, exosomes have some similar properties to cell therapies, but since they are not really alive they can be viewed as entirely different animals. With the cell therapies we can measure parameters like secretion profiles and things like that to accept batch to batch consistency during manufacturing process and kind of guess how potent they might be? How that work with an exosome based drug? Linda Marbán: Yes, that’s one of the most exciting parts of the exosome that we can quantify that even more tightly. So, we started talking about our licensing in the exosome technology a while ago and then we have sort of been saying its coming and its coming. The reason for that is that we have a pretty deep bench working on process and product development of the exosome turning it from a very exciting scientific study to a product that can be used to treat a variety of inflammatory and fibrotic disorders and part of that work has been really delving into what’s inside those exosomes and what they do physiologically. So, we think we are going to have a pretty good handle on it. We are certainly going to run what we think by the FDA before we come out with it and hope that they concur, but then we should be able to fine tune that and get this product into patients very soon.

Mark Breidenbach

Analyst

Okay. And I am just curious is the activity of the exosomes that you are seeing, is it driven more by nucleic acid or by protein or a small molecule metabolite. I am thinking can you kill the activity of an exosome or what’s your thinking thus far? Linda Marbán: So, a lot of the mechanistic work is done by the academic lab at Cedars-Sinai directed by Eduardo Marbán. And they publish regularly on sort of what’s in the exosomes and what they do and so stay tuned to those papers as they come out. What I can tell you is that there is a significant portion of novel things that have been discovered inside those exosomes that seemed to mediate a very significant biologic effect and repair.

Mark Breidenbach

Analyst

Okay, got it. And then in the rapid model data that you showed, is it a topically delivered drug or is it actually injected into the cornea or into the eye? Linda Marbán: So, we are not going to go into too many details on that right now. What I can say is that we have worked in a dose-dependent way and we have a really good delivery method that we feel will be good at mediating the biologic effect.

Mark Breidenbach

Analyst

Okay, great. I will wait for future updates to as more detailed questions, but thanks very much for taking the questions today and congrats again. Linda Marbán: It’s a pleasure, Mark. Have a nice day.

Operator

Operator

Thank you. We will go next to Ted Tenthoff with Piper Jaffray. Please go ahead.

Ted Tenthoff

Analyst

Great. Thank you for taking the question and for this update. My question is with DMD, can you give us a sense I know it’s so early and congratulations on giving that study of enrolling, can you tell us how enrollments going and when we may guess some data from that trial? Linda Marbán: Yes. So, Ted, hi how are you? Good to talk to you always even in this venue. Yes, the trial is starting to enroll like gangbusters. The word is getting out. We are enrolling at Cincinnati Children’s under the direction of our principal investigator, John Jefferies and at Cedars-Sinai Medical Center. We have a third very, very credible site coming on soon. And what I can tell you is that all of inside screening is robust.

Ted Tenthoff

Analyst

Great. So, well I look forward to an update. I think that’s a really important study. Linda Marbán: And sorry, just to answer your second question, we anticipate enrolling this trial, fully enrolling by the third quarter of this year with the 6-month preliminary data, your top line data end of the first quarter of 2017.

Ted Tenthoff

Analyst

Great. I look forward to that. Thanks, Linda. Linda Marbán: Me too.

Operator

Operator

Thank you. [Operator Instructions] We will go next to [indiscernible] with Chardan. Please go ahead.

Unidentified Analyst

Analyst

Yes, thank you. I have two questions for Dr. Marbán. The first with respect to ALLSTAR having reduced the enrollment size, can you tell us what your hypothesized treatment effect is that you are expecting in terms of the reduction in infarct size? Linda Marbán: We are looking for a 15% reduction in infarct size at one year.

Unidentified Analyst

Analyst

Okay, great. And then also with respect to ALLSTAR are there other secondary efficacy measurements you will be taking physiological measurements like the LVEF systolic diastolic volume, those sorts of things? Linda Marbán: Yes. So we have a rather large plethora of secondary efficacy endpoints that we have built in based on cardiac function, cardiac structure and then of course the standard quality of life and other measures of those kinds of things. So yes it’s a well designed trial with a lot of potential guidance for our future clinical trial design.

Unidentified Analyst

Analyst

Okay, very good. Thanks. That’s all I have. Linda Marbán: Thank you very much.

Operator

Operator

Thank you. [Operator Instructions] It appears we have no further questions at this time. I will turn it back to our speakers for any final or additional remarks. Linda Marbán: Well, thank you for joining us on the call today. We hope to see many of you in New York City next week at the ARM Cell & Gene Therapy Investor Day which will be held on Tuesday, March 22. Again, thank you. Operator, you may now disconnect and happy Saint Patrick’s Day everybody.

Operator

Operator

Thank you. This does conclude today’s conference. We do appreciate your participation and you may disconnect at any time. Have a great day.