Earnings Labs

Capricor Therapeutics, Inc. (CAPR)

Q1 2015 Earnings Call· Wed, May 13, 2015

$34.07

-2.95%

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Transcript

Operator

Operator

Good afternoon and welcome to the Capricor Therapeutics 2015 First Quarter Conference Call. At this time all lines are in a listen-only and the floor will be open for questions and comments following the presentation. [Operator Instructions]. 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 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, and in our Registration Statement on Form S-1 as filed with the Securities and Exchange commission on March 06, 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…

Operator

Operator

Ladies and gentlemen please remain on the line, we’re experiencing minor technical difficulties. One moment please. Gentlemen we are now reconnected with AJ Bergmann. Sir, please go ahead.

AJ Bergmann

Analyst

Thank you and I apologize for the disconnection. I would go from the beginning and my remarks will be brief. As Linda mentioned a few minutes ago, we are very pleased to have completed two financing in the first quarter of this year securing 17 million in additional capital. This financing include participation from Broadfin Capital, Sabby Capital, CureDuchenne Ventures and Cedars-Sinai Medical Center among others. Certainly after these financings were completed, they were uplifted to begin trading our common stock on the NASDAQ Capital Market. For the first quarter of 2015, the company reported a net loss of approximately 3.5 million or $0.23 per share compared to a net loss of approximately 1.2 million or $0.10 per share for the same period in the prior year. Research and development expenses increased to approximately 3.8 million in the quarter ended March 31, 2015, compared to approximately 1.4 million for the same period in the prior year. The increase was primarily due to the initiation of clinical trials, including the DYNAMIC trial, the Cenderitide trial as well as the ongoing ALLSTAR Phase II clinical trial. General and administrative expenses increased to approximately 1.4 million in the quarter ended March 31, 2015, compared to approximately $900,000 million for the same period in the prior year. The increase was primarily due to increases in compensation expenses related to increased headcount and noncash stock-based compensation cost. At quarter end, we had over 22 million in cash and marketable securities available. In addition, there is approximately 11 million that has 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 ALLSTAR trial. We believe this cash will be sufficient to take up to the fall 2015. And with that, I will turn it back over to Linda. Linda Marbán: Thank you, AJ. I'd like to finish up this call by just calling your attention to some of our upcoming 2015 milestones. First we expect to initiate the HOPE-DUCHENNE trial project for regulatory approval, we expect to put our initial DYNAMIC clinical trial results, our initial Cenderitide results the as well we plan to now follow a clinical development program for the Natriuretic Peptide and we plan to now first indicate into our platform technology. Lastly, Capricor was presenting a two upcoming conferences this quarter let me just say to all the adjusters well the HealthCare Conference in the New York on June 1 my presentation start at 11:00 a.m. and we will be stay at the Healthcare Conference again in New York City on June 23rd our presentation started again at 12:00 p.m. Thank you very much for your time and attention this afternoon let me just say I didn't participate it but I am disconnecting and nonetheless I will now open up the line and look forward to your questions.

Operator

Operator

Thank you. Ladies and gentlemen, at this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question is coming from the line of Reni Benjamin with H.C. Wainwright. Your line is now open. You may proceed with your question.

Reni Benjamin

Analyst

Hi, good afternoon guys and thanks for taking the questions and congratulations on all the progress. Just a couple of quick questions, maybe starting off with the Exosomes platform, can you talk a little bit about maybe the preclinical data that you’ve generated and I guess we're kind of glad what models you use to give us a sense of what indications you may actually go into given that your R&D you know has now been advanced by about a year? Linda Marbán: Yeah. Well thanks for the question Reni I am very, very excited about the Exosomes. The preclinical models that we have made our initial observations in are of course the cardiac model that we've presented at public rates. The other work we haven’t yet talked about presented in a public forum so suffice to say that those announcements will be coming and we are looking very much forward to taking this platform technology outside the cardiovascular space.

Reni Benjamin

Analyst

Got it and just moving on to the dynamic study the initial 14 patients enrolled extremely quickly you mentioned that this is the first arm can you talk about the next arm and when we might see the data from that arm? Linda Marbán: So the next arm actually is under review right now we were very pleased with how quickly that trail enrolled 14 patients in 13 weeks, thus far the triple vessel infusion looks to be safe we haven’t had any reported safety events which is also very exciting allows us to be the harden cells the post just going after the one inarticulate - which is what necessary post MI study excess function. Because this is such an important therapeutic avenue for Capricor after the patients with the events are - we are taking our time and carefully reviewing the data and thinking about what the next best clinical trial is. So again stay tuned.

Reni Benjamin

Analyst

Okay. Regarding the interim analysis for the ALLSTAR study can you talk a little bit about sort of what are the outcomes that can happen here for example is there a utility analysis built in you mentioned the potential to combine the two cohorts and potentially speed up enrollment but can you could there also be an outcome whereby you are increasing the size of each of the cohort? Maybe just some color on that interim. And I guess one other question is can J&J with that data opt in based on your option agreement? Linda Marbán: So thank you for that question. In terms of the interim analysis yes it’s a very fluid tool that we are excited about being able to take advantage of and are very probably had the biostatisticians specially the ones with J&J help us build this plan, what it allows us to do is look at the data as it’s come in and in subset of patients approximately two thirds of the patients and then what we can do is decide whether we can pull the group until one the two cohorts becoming one trail we also are going to be doing a utility analysis just to make sure that it’s not working across the board and also there will be a futility analysis on in each of the two cohorts so the recent and or the chronic. So it allow us to finish the trail with the most likelihood of hitting our endpoint which is the 15% scar reduction at one year post therapy.

Reni Benjamin

Analyst

And regarding J&J’s ability to… Linda Marbán: I think it was the second part of it in terms of J&J’s decision to opt J&J is looking for the data they are looking for proof of concept which is exactly how this trial was designed they reviewed all of our data when they did their due diligence and decided along with us that also was a good trail and wish to prove the - reduction in scar size using the allergenic cell which is something that was very important to J&J we have an off the shelf product when we have data hits that point which is the reduction in scar to the level that we had described they will make the decision as to whether or not to opt in.

Reni Benjamin

Analyst

Got it, okay. And just one final question from me on the IND for the DMD study can you just give us a sense as to the trial design of that study? Linda Marbán: As much as I would really like to do because I am very excited about this trail we are waiting for comments from the FDA we don’t want to either A; jinx this or B; - some things that we know what we are doing we’ll let them adjudicate that and then as soon as we have color on that trial we’ll be announcing it.

Reni Benjamin

Analyst

Terrific, thank you and good luck going forward.

Operator

Operator

Thank you. [Operator Instructions] At this time there are no question to take over the phone. I would like to turn the floor back to management for any closing remarks or internet based questions that they may have received. Linda Marbán: Thank you very much for your time. We look forward to providing an update on the next quarter when we will have the second quarter earnings call to update you on.

Operator

Operator

Thank you. Ladies and gentlemen this does conclude today’s teleconference. You may disconnect your lines at this time. Thank you very much for your participation and have a wonderful day.