Earnings Labs

Capricor Therapeutics, Inc. (CAPR)

Q2 2017 Earnings Call· Fri, Aug 11, 2017

$34.07

-2.95%

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Transcript

Operator

Operator

Welcome to the Capricor’s Second Quarter 2017 Financial and Business Highlights Call. My name is Victoria and I’ll be your operator for today’s call. At this time, all participants are in a listen-only-mode and later, we will conduct a question-and-answer session. [Operator Instructions] Please note that this conference is being recorded. And I will now turn the call over Leland Gershell. Leland, you may begin.

Leland Gershell

Analyst

Thank you, operator and good afternoon. A short while ago Capricor issued a press release in which we announced our financial results for the second quarter of 2017 as well as provided an update on our business. This press release is available on our website at capricor.com. Joining me on today’s call are Dr. Linda Marbán, our President and Chief Executive Officer; and AJ Bergmann, our Vice President of Finance. During today’s call, we will be making certain forward-looking statements. These statements may include statements regarding among other things the efficacy, safety and intended utilization of our product candidates, our future research and development plans including our anticipated conduct and timing of preclinical and clinical studies, our plans to present or report additional data, our plans regarding regulatory filings and our possibly usage of existing cash and investment resources. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements and we disclaim any obligation to update such statements. With that, I’d now like to turn the call over to Linda Marbán. Dr. Linda Marbán: Thank you, Leland. Good afternoon and thank you for joining us today. On today’s call, I will devote the majority of my remarks to discussing our lead development candidate CAP-1002 for the treatment of Duchenne muscular dystrophy, which has been receiving a tremendous amount of attention from the patients, physician and advocacy community since we reported clinical data from our HOPE study…

Leland Gershell

Analyst

Thank you, Linda. Please refer to the today’s press release for a presentation of our second quarter 2017 financials. You may also refer to our quarterly report on Form 10-Quarter, we expect to become available in the next few days and can be accessed in the financial section of our website at capricor.com. During the second quarter excluding the effect of stock-based compensation, we incurred approximately $3 million in research and development expenses and approximately $950,000 in general and administrative expenses. At June 30, 2017, we held cash, cash equivalents and marketable securities totaling approximately $12.3 million, as compared to approximately $16.2 million at December 31, 2016. We expect our current resources to last us through the second quarter of 2018. And with that, I’ll now turn the call back over to Linda for her closing comments. Dr. Linda Marbán: Thank you, Leland. Well, with no summer slowdown here at Capricor, we make headway both with our cell and exosomes programs. With regard to upcoming items, we have submitted the six months data from both HOPE and ALLSTAR for presentation at medical conferences later this year and we will announce the details for each, once we have them. We are on track to submit our IND for our RESTORE-DMD trial of intravenous CAP-1002 by the end of this quarter with the goal of having commenced the trial by the end of the year. Finally on the topic of manufacturing, we expect assuming a well-established contract manufacture and begin the tech transfer process. So, that if and when we are able to commercialize our product, we will be prepared to scale up the manufacturing process to meet the anticipated demand. I will now turn the call over to the operator to open up the call for questions. Operator?

Operator

Operator

[Operator Instructions] Our first question comes from Joe Pantginis from Rodman and Renshaw. Please go ahead.

Joe Pantginis

Analyst

Couple of questions if you don’t mine. First on RESTORE, but first congratulations on all your positive interactions with the FDA, obviously for this continuing unmet need. So, my first question is, I guess, when you look at your overall goals today, before the FDA interaction, a lot of the focus has been on the potential for the impact on cardiomyopathy and that was certainly one of the endpoints in the HOPE study, as well as the PUL data as well. So, just curious with PUL being now the primary endpoint, are you going to be looking at cardiac impact as a secondary endpoint and if not, how come? Dr. Linda Marbán: So, one of the things that was beautiful about the whole study is that we were able to see improvement in skeletal muscle function which gives us a clinically relevant outcome that is actually one that can be used for approval. So, whereas the impact on the cardiovascular system was noted in HOPE, we had both improvements in scar and measure of cardiac function, none of those are endpoints that the FDA would consider for full approval. So, we were lucky to be able to have one that we can hang our hats on in terms of in terms of getting approval. And of course we will study heart and continue to look for improvement in cardiovascular structure function which we fully expect to see.

Joe Pantginis

Analyst

It’s actually really helpful. Thanks. And then with regard to PUL, obviously as you mentioned too, it is a clinically validated endpoint. Just wanted to talk about the -- I guess, how widespread knowledge of the exam is or the test is, and will physicians need any particular additional training for it? Dr. Linda Marbán: Yes, so that’s another really important and one that we really dug into deeply with the FDA. So, they were very interested in the same thing. So, the measures have been very well-validated. There are trainings at -- typically the physical therapies go through [ph] the test design in a reliable and repeatable fashion. And one of the things that’s nice about it as it’s become a validated measure is that it is highly repeatable and highly reliable in terms of its variation between measurement points.

Joe Pantginis

Analyst

Got it. And I guess a couple of just logistical standpoints and then I’ll jump back in the queue. So, first, you’ve had a lot of success to-date from non-dilutive funding from grants for all of your indications. I was just curious if you’re seeking any additional funding for the future of DMD? Dr. Linda Marbán: Yes. So, obviously that’s been something that we’ve used all the way aligned, we’re going to access it again. The CIRM has been a fabulous partner for us all along the way and supported HOPE. And as many of you may have seen, even one of the patients from HOPE has been featured on YouTube videos talking about its participation in the trial at CIRM. So, we’re going to talk to CIRM and stay in touch and hopefully I will be able to tap into that source again.

Joe Pantginis

Analyst

Great. And then the last housekeeping, if you don’t mind, I appreciate your patience. With regard to ALLSTAR, you mentioned obviously upcoming data at a medical conference. Is this going to be sort of publication of the data that you already have or are we going to be able to glean anything new from the study, ahead of the 12-month data? Dr. Linda Marbán: Yes. So, we’re actively working on publication and presentation. We expect to present the 6 and potentially 12 months data in very short order. You’ll see those announcements coming alive very soon. But yes, there will be new data and I think it will further help to clarify the story, which by the way, let me just say, one of the things that we see is that the cells bioactive, the patients that got the cells compared to this [indiscernible] in ALLSTAR had better volumes than other measures of cardiac structure and function. And so I think our goal of over time will be to understand how that interplays and then also use of its knowledge for moving forward our other clinical programs with the cells.

Operator

Operator

Our next question comes from Gregory [indiscernible] Please go ahead.

Unidentified Analyst

Analyst

So, I had two questions. One, a long list trial, first, given the sort of -- the lack of continued affects after the first three months to six months, is there any reason to anticipate that the 12-month data is going to show any continued efficacy? And related to that, I am sure you mentioned your plans to do repeat dosing in the potential trial that you’re going to file with the FDA later this year. Can you remind us about what results you saw within the mouse model with the repeat dosing and what your sort of thought process is in terms of repeat dosing can do and what you were hoping to see as a result of the repeat dosing? And then separately, if you wouldn’t mind just updating us, I thought you were doing something on exosomes in the eye and I am just -- an indication on the eye and I’m just wondering what happened with that; is that still moving forward or was there some result with that that made you o switch to this other HLHS on? Dr. Linda Marbán: Yes. So, hopefully I’ll get these all in order. So, in terms of the 12-month HOPE data, yes, we are very excited to get that data. I think it can be very interesting for us, either we’ll be able to continue to track improvements potentially, declines, stabilization, all of it will be very important in building RESTOR and understanding what we will be met and what the long-term opportunities provided by the cells. [Ph] In terms of skeletal muscle function, we do see a decline between three and six months. And so, it will be interesting to see if there is an attenuation of that in some way or another. So, stay tuned for…

Operator

Operator

[Operator Instructions] I am showing no further questions at this time. Dr. Linda Marbán: Thanks everyone for joining us. We look forward to keeping you informed as we make progress with our programs. Operator, you may now disconnect.

Operator

Operator

Thank you. Ladies and gentlemen, this concludes today’s call.