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Capricor Therapeutics, Inc. (CAPR)

Q3 2015 Earnings Call· Fri, Nov 13, 2015

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Transcript

Operator

Operator

Good day everyone. This presentation contains forward-looking statements and information that are based on the beliefs of the management of Capricor Therapeutics Incorporated as well as the 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 dates for commencement of the 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, in our Registration Statement on Form S-3, as filed with the Securities and Exchange commission on September 28, 2015, and in our quarterly report on Form 10-Q for the quarter ended June 30, 2015, as filed with the Securities and Exchange Commission on August 14, 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 turn the program…

AJ Bergmann

Management

Thank you, Linda. This afternoon’s press release provided details for the third quarter of 2015. The press release is available on the Company’s website at capricor.com. For the third quarter of 2015, the Company reported a net loss of approximately 2.9 million or $0.18 per share compared to a net loss of approximately 1.5 million of $0.13 per share for the same period in the prior year. Research and development expenses increased to approximately 3.2 million in the quarter ended September 30, 2015 compared to approximately 2.2 million for the same period in the prior year. The increase was primarily due to increased clinical and operational expenses related to our ongoing clinical trials including ALLSTAR Phase II and DYNAMIC. General and administrative expenses increased to approximately 1 million in the quarter ended September 30, 2015 compared to approximately 800,000 for the same period in the prior year. The increase was primarily due to increases in compensation expenses related to increased headcount and non-cash stock based compensation cost. At quarter end, we had roughly 17.2 million in cash and marketable securities on hand. In addition there is approximately 11 million -- that is yet to be disbursed to us under the terms of our CIRM loan award which will be attributable to expenses incurred in the ongoing Phase II study. We believe this cash will be sufficient to take us to the fall of 2016. And with that I will turn the line back over to Linda. Linda Marbán: Thanks Ed. In summary, Capricor has had a very busy and productive third quarter. We presented positive data from the DYNAMIC clinical trial confirming the bioactivity of our CDCs. Over the coming year we look forward to completing enrollment in the HOPE-Duchenne trial and having data from that trial by the first quarter of 2017, announcing the first indication for our exosome program and having a pre-IND meeting with the FDA early next year, and also announcing our plan to the Natriuretic Peptides also early next year. We are hopeful that we would be able to deliver meaningful results on our various programs. And with that, I will now turn the call over the operator who will open up the call for questions. Thanks.

Operator

Operator

Thank you, doctor. [Operator Instructions]. And we will go ahead and take our first question from Mark with H.C. Wainwright. Please go ahead. Your line is open.

Mark Breidenbach

Analyst

Great, great. I just have a few questions mostly focusing on the DYNAMIC data. First of all, something we could talk a little bit more about dosing since we did use a range of doses in the 14 patients that we saw a readout from. I am wondering if you saw anything resembling dose effect in early data and maybe should we be thinking of going higher than 75 million cells or is the concept of a maximum tolerated dose normally applicable as long as you are operating above a certain therapeutic threshold? Linda Marbán: Yes, Mark thank you for your question. So in terms of dose responses, let me just say that it was a total trial of 14 patients, 12 reporting out in terms of data right now. So it’s early days in trying to determine a dose effect. However, we are keeping a careful eye on the highest dose. The data looks like -- if we continue to aggregate in the way that we did in this trial, we would see potential dose effect in the future. So we are confident that 75 million is a good dose to move forward and that’s the one that we are taking forward into HOPE-Duchenne somewhere between 50 million and 75 million depending upon the anatomy and the boys’ heart. In terms of the maximal dosing of 75 million cells, it certainly raises the question as to whether higher doses lead to better responses. We really believe strongly in the triple vessel infusion being able to get the cells to all areas of the injured heart. Some of the early work we did, and let me just take a minute to plug the enormous amount of mechanistic and preclinical work that went to get this company going and continues to fuel its research and development engine, funded largely by more academic colleges to do that work. We found that the maximum safe per vessel in a pig would be analogous to about 25 million cells in human. So we are not ready to push that envelope right now. We think that we are at the point at which we are able to safely deliver this number of cells and they seem to be working. So we might in the future look towards getting higher doses. But right now we feel pretty confident where we are.

Mark Breidenbach

Analyst

Got it, okay. Sounds reasonable. Another thing we saw in this early data work was quite a few endpoints included in the readout. Look curious on your thoughts on which of the functional endpoints in particular are the best surrogates for MACE, presumably MACE would be an important endpoint in a future registration or anti-trial. We have seen some heart failure trials ENP levels that predict cardiovascular morbidity and mortality. In this case would you say that [LDF] improvements might be a more relevant surrogate for this population of heart failure patients. Linda Marbán: Yes, another interesting topic to discuss sort of in great detail. What I can tell you is we're reviewing all the data. The reason that we collected so many endpoints was so that we could take a look at those, look back at the literature and correlate the potential surrogate endpoints with [data that could] be predictors of MACE downstream. Our team is in the process of doing that now and we'll start to think about what a larger DYNAMIC would look like in terms of how the endpoint would be delineated and what surrogates you would wrap in with MACE to get the full picture of how the patient has done.

Mark Breidenbach

Analyst

Okay, fair enough. More generally can you comment on how the DYNAMIC readout is maybe reshaping your thoughts about the developmental strategy for 10 and 2, I am curious if we are still going to see that randomized Phase Ib trial in advanced heart failure, or are we going to maybe see next trial encompass a broader full patient for the ischemic and non-ischemic with varying degrees of relief ejection traction and can you offer any thoughts on what we might see next in terms of trials? Linda Marbán: Yes. So this data is hot out the press. We literally just presented a few days ago. We are very excited. I can’t emphasize that enough what we’ve seen in this very small dataset. And so now we are sitting back reevaluating the clinical development plans. Some of the first steps will be meeting with the FDA and talking to our data with them and seeing sort of where they think this program can go. And then putting our heads together with our [KOLs] and the rest of the team and deciding what’s next and stay tuned for that. I am sure we’re going to be excited as excited to tell you as you will be able to excited to hear us.

Mark Breidenbach

Analyst

Okay, looking forward to that. I think on the last quarter call, we talked about 100 patient readout from ALLSTAR II, and it’s an interim readout. Is that coming in 2016 or is that way you were referring to us first quarter 2017? Linda Marbán: So we are spending a lot of time these days with our statisticians trying to work out the next step for ALLSTAR. I presented the details I think it was last quarter, or quarter before of the interim analysis plan. We’re getting close to the point at which we can do those evaluations. Our statisticians have been hard at work with data that we’ve already had in hand and we’re going to be presenting some of our thoughts regard where we’d like to see this go to our DSMB in January. And so stay tuned for or next earnings call to hear an update on the outcome of ALLSTAR. What we can tell you now is that we full anticipate having data readout in the early part of ’17 for ALLSTAR Phase II.

Mark Breidenbach

Analyst

I'll kind of finish with one question on Cenderitide earlier this week we saw an analysis come out from Novartis on their drug Entresto looking at 30 day readmission rates following discharge from hospitalization. And it looked, at first light quite impressive dropped readmission rate fairly sharply relative to patients on each inhibitors. Should we be thinking about Cenderitide as complementing or benefit in terms of reducing possible readmissions in the selling of post-acute decompensate of heart failure? Linda Marbán: So I actually haven’t seen this slate that announced by Novartis so I can’t really comment on the implications of and [indiscernible] their type but what I can say is that we’re very carefully reviewing Cenderitide that’s why we’re taking it slowly doing a couple of small clinical trials see where the therapeutic window of the drug and also where it will fit in the clinical development paradigm now that Entresto is on the market. And once we have that figured out then we can decide what to do with Cenderitide.

Mark Breidenbach

Analyst

And then we might see some efficacy data coming out either later this quarter of in early 2016? Linda Marbán: Yes, look for early 2016 for the Cenderitide I don’t know if we’d want to call it efficacy data but we can definitely continuing to caller in the picture or the story of Cenderitide.

Operator

Operator

Thank you. And we’ll go next to Jason Kolbert with Maxim Group. Please go ahead your line is open.

Unidentified Analyst

Analyst

This is actually Diane taking the call for Kolbert. First I just want to say congratulations on your exciting clinical programs. And can you just review with our team the data the [coalitions] from your early data that shows the effect between reduction in scar tissue, muscle mass and impacts on cardiac knees? Linda Marbán: So I assume you’re referring to the data that was presented in [caduceus] the proof of concept trial in patients with large heart attacks. So I think what we can say here is this is a much sicker patient population, so to look at scars is not probably going to give you as much information. Ultimately what we’re looking to do is look at these functional and quality of life and physiologic endpoints in patients that are very sick with heart failure to see if we can make that better to move towards a commercial product. And so we were able to do in DYNAMIC and in the earlier studies ALLSTAR and caduceus patients are still feeling well even though they’re very high risk for the development of heart failure. So scar size reduction is a great metric for determining if we can potentially take them back from that process, but functional endpoints are not usually as reliable because they’re still pretty healthy. So we don’t see a direct correlation in these two studies because we don’t have prior measurement at this point in the DYNAMIC patient population so we can say that we’re very excited that we have functional improvement in these very sick patients.

Unidentified Analyst

Analyst

And can you focus with me on the first half of 2016 events that you think are the most important for us to focus on? Linda Marbán: So we will be really ramping up in treating patients in HOPE-Duchenne muscular dystrophy trial of cardiomyopathy. We’ll be announcing the clinical development plan for Cenderitide, the natriuretic peptide that we’ve had in our wheelhouse for a while and the new [indiscernible] advanced heart failure decompensated heart failure. We also will be announcing an exosome clinical development program which is very exciting, it’s our new product I mentioned it for a few moments in the actual call in the update and what I did not mention and have said before is that this will be Capricor’s introduction to new product indication which will be something outside the heart and we are very much looking for to the opportunity to take this therapeutic of information in fibrosis.

Operator

Operator

And it does appear that we have no further questions at this time. I will now hand it back over to Dr. Marbán for any additional or closing remarks.