Earnings Labs

Capricor Therapeutics, Inc. (CAPR)

Q2 2016 Earnings Call· Mon, Aug 15, 2016

$34.07

-2.95%

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Transcript

Operator

Operator

Good afternoon and welcome to the Capricor Therapeutics’ Second 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 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 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 and in its quarterly report on Form 10-Q for the quarter ended March 31, 2016. Should one or more of these risks or…

Leland Gershell

Management

Thank you, Linda. This afternoon's press release provides financial details for the second quarter ended June 30, 2016. The press release is available on the company website at capricor.com. In the second quarter of 2016, excluding the effect of stock-based compensation, we spent approximately $4.1 million in research and development activities and $1.0 million in general and administrative. As of June 30, 2016, we had approximately $11.4 million in cash, cash equivalents and marketable securities. We currently expect our cash balance to 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, very much Leland. We are looking forward to announcing the completion of enrollment in both HOPE-Duchenne and ALLSTAR later this quarter and to their readouts in early 2017. Also, we will be featuring a more complete dataset of the 12 month DYNAMIC results at the Transcatheter Cardiovascular Therapeutics Conference, better known as TCT this fall. I will now turn the call over to the operator who will open up the line for questions. Thank you. Operator?

Operator

Operator

[Operator Instructions] We will go ahead and take our first question from Joe Pantginis with Roth Capital Partners. Please go ahead. Your line is open.

Joseph Pantginis

Analyst

Hi, Linda. Hi, guys, thanks for taking the question. Linda, I first wanted to ask you about ALLSTAR and the upcoming decision process from Janssen. What is your plan with regard to releasing the news to the investment community? Will you disclose the results from ALLSTAR or will it all be depending on what Janssen decides to do? Linda Marbán: Yes, so, that only has a little bit to do with Janssen, Joe. First of all, thank you, always good to hear your voice and look forward to capping up in person soon. The decision will be made primarily in conjunction with DSMB, the Diagnosis Safety and Monitoring Board of the company, which will decide whether or not we can release top-line data or not. A lot of it will have to do with making sure the patients see treatment through all the way through to their one year endpoint. So, we want to be sensitive to the needs of the patients that are in the trial and the company will follow along those all I am sure everybody out there and not least including myself is excited to see the ALLSTAR data.

Joseph Pantginis

Analyst

Got it. That’s helpful. And if I could just switch over to HOPE MD obviously this has some very large potential, especially since its independent and could be complementary to the Exon Skipping technology. So I guess, I would ask it this way, first from a high level standpoint, what are you looking to see with regard to efficacy in HOPE MD? And then, I guess more granular, what are you looking at with regard to the findings that you saw in the MDX model with regard to exercise benefits beyond the cardiac benefits and how that might be able to translate to HOPE MD patients? Linda Marbán: That is again, yes, in regard to your first question, what we are really looking for is the stabilization or improvement in the amount of scar in heart in the boys and young men that are getting the therapy. So, I think, many of you have heard me present, and we’ve talked a lot about the fact that the scar increases in a linear fashion once it gets rolling leading ultimately to decrement in function and decompensated heart failure. What we are looking to do is stabilize that process and look for the scar to actually stop increasing as it were – or in fact improve. So we’ll be excited to see those results. In terms of the cell to muscle opportunity, we are paying careful attention to some of those functional matters that we’ve built into HOPE MD. We are looking at the performance of the upper limb as well as some other indicators of function improvements such as the six minute walk has been a variety of others. The reason for this is, as you may recall, the mice ran rather and longer, in fact 50% improvement in treadmill running time compared to their littermates who did not get self and this improvement was greater than what would be expected based on that improvement in cardiac performance. So that has led to an entire body of investigation in the academic lab, which I believe that which was shown at the American Heart Association last November, that in the animals that were treated with the cells in their heart had improvement in the contractile function of a leg muscle. So we are continuing to watch this very carefully and are very excited at the potential systemic implications of the cells in DMD.

Joseph Pantginis

Analyst

That’s great. Thank you very much. Linda Marbán: Thanks, Joe. Take care.

Operator

Operator

[Operator Instructions] Our next question comes from Swayampakula Ramakanth. Please go ahead. Your line is open.

Swayampakula Ramakanth

Analyst

Thank you. Good afternoon, Linda. This is RK from HCW. How are you doing? Linda Marbán: Good, RK, how are you?

Swayampakula Ramakanth

Analyst

Good, good. So, just for us to understand a little bit about this new indication that you are going for CAP 2003, how large is the ocular GVHD market? And what needs to be done if/or what additional growth – from the trial that you are saying you won’t file till the first half of 2017? Linda Marbán: Sorry, I didn’t hear the second part of your question, you faded out. In terms of how large is the market, we are just getting to a score, but we are very excited at the potential opportunity as we mentioned about 40% of those patients that get bone marrow transplants develop the ocular implications and of those, a subset develops the severe version of it that would definitely be right and ready for a different type of therapeutic such as CAP 2003. So we are exploring the size of the market right now and are very excited to be able to provide the therapies for these very, very debilitated patients. What was the second part of your question? I didn’t hear as to whether to some point.

Swayampakula Ramakanth

Analyst

Okay, so, how – what work needs to be done for you to file the IND, because you say you can’t – now you are planning to file in the first half of 2017. So, what needs to be done, between now and then? Linda Marbán: Yes, so one of the reasons we’ve planned the pre-IND meeting when we did it to give a time to button up some of the things that we needed to do. I can tell you that we are doing late-stage pre-clinical development, final study analyses that needs to be part of our application process as well as the late-stage CMC development that to make sure that we are in line with what the FDA would like us to do. So, once all those things are buttoned up, we will be ready to file our IND.

Swayampakula Ramakanth

Analyst

Okay, thank you. And then on the Duchenne - HOPE-Duchenne, so how should we think about what the strategy would be for the company once, let’s say, you have quality data in the first quarter of 2017? How would you take this forward into registration? Linda Marbán: Yes, so, of course the first thing we will do is, we’ll go and meet with the regulatory agency and we’ll show them the data and we’ll move forward based on their recommendations. We will be very excited to do that and look forward to share that information with the street as that becomes available.

Swayampakula Ramakanth

Analyst

And would you be doing this yourself or you will need some partnership to help out for the development in the Duchenne indication? Linda Marbán: So, one of the beauties of the DMD program is that we can take it all the way it comes through to commercialization ourselves and we are building that plan as we speak it has been really for the past year. So our goal with this particular therapy is to take all the way through ourselves. If an appropriate partner came along, or somebody wanting to join the closable party with us we would definitely listen to any opportunity, but our goal right now is to move it ourselves.

Swayampakula Ramakanth

Analyst

Okay, and the last question is just, so, I am guessing that Janssen has been following you through the DYNAMIC study and have been watching all the data. Is it not beneficial for them to jump ahead and work with you even before the ALLSTAR data comes out or do they – is there something that they are really looking for in the ALLSTAR data? Linda Marbán: Yes, so, I think, first thing they have been watching ourselves all the way and they have been working with us and have seen the DYNAMIC data and are very excited on the edge of their seats. In terms of moving faster, there is really no need to. The plan was built around delivering the six months, so Janssen will be having sixty days after that to make the decision. Neither partner is in a hurry to get that timeline along. So, we are happy to wait and they are looking forward to the data as well.

Swayampakula Ramakanth

Analyst

Okay, thank you very much. Linda Marbán: Thank you. Have a great day.

Operator

Operator

Thank you. And our next question comes from Tim McInerney with Riverbank Capital. Please go ahead. Your line is open.

Timothy McInerney

Analyst · Riverbank Capital. Please go ahead. Your line is open.

Linda, good afternoon. How are you? Linda Marbán: Hey, Tim, still on time. How are you?

Timothy McInerney

Analyst · Riverbank Capital. Please go ahead. Your line is open.

I am doing fine, thank you. If you could give a little bit more clarity on the data release around ALLSTAR, you make reference that the DSMB and delivery of data to Janssen, DSMB is a data safety – as we all know, either the trial will be deemed complete or not, what if any data would you deliver to Janssen, you are implying that you would in the first half of next year, and I would think that you would want to release that publicly as the material event for the company. So, just trying to understand a little bit better about the mechanics of data release as was referenced in the first question. I know – I think the DSMB is just part of the equation. Maybe you can just paint a different picture there. So we can understand a little better possibly, I appreciate it. Thank you. Linda Marbán: Yes, yes, Tim, certainly. So, here is the thing. ALLSTAR’s primary efficacy endpoint is one year measurement of scar size post therapy. So technically, we will be able to have data from our endpoint until a year after the last patient is treated. So, last patient plus one year. When Janssen came in and did their analysis, they looked at the CADUCEUS data and realized that there was already trends towards the reduction in scar size at six months that was none again reflected at one year. So the agreement that we made with Janssen is that they can have an early look at the data. They could see that six months data and could make their decision based on that, because we’ve got that, by that we would see relevant biologic improvement with the treatment in cells. What’s happened since then is that, the six months data maybe material for the company only if we are allowed to release it. So we may not be able to release it, because of the fact that the endpoint is for one year. So we may have to hold on to it.

Timothy McInerney

Analyst · Riverbank Capital. Please go ahead. Your line is open.

Okay, thank you. I’ll catch up with you in the not too distant future, directly as well. I Appreciate it. Thanks. Linda Marbán: Great, thanks.

Operator

Operator

Thank you. [Operator Instructions] Linda Marbán: Okay, so if we have no further questions, I’d like to thank you for joining us on the call today. Operator, you may now disconnect.

Operator

Operator

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