Earnings Labs

Capricor Therapeutics, Inc. (CAPR)

Q1 2018 Earnings Call· Thu, May 10, 2018

$34.07

-2.95%

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Transcript

Operator

Operator

Welcome to Capricor Therapeutics’ First Quarter 2018 Conference Call. My name is Brian and I will be your operator for today’s call. At this time, all participants are in a listen only mode. At the end of this call, we will open up the line for questions. [Operator Instructions] Note that this conference is being recorded. I will now like to turn the conference call over to Capricor’s CFO, AJ Bergmann.

AJ Bergmann

Analyst

Thank you, and good afternoon everyone. Before we start, I would like to state that we will be making certain forward-looking statements during today’s presentation. 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, potential regulatory developments involving our product candidates and our possible uses 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 SEC, 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 would like to turn the call over to Linda Marbán, CEO. Linda Marbán: Good afternoon and thank you for joining us for our 2018 first quarter earnings update. The first quarter has been a busy and productive one for Capricor. The first and most important thing I will talk about today is the initiation of HOPE-2 our clinical trial investigating the use of CAP-1002 in boys and young men with Duchenne muscular dystrophy otherwise known as DMD. The first patients have now been treated and we are hoping that the trial will enroll briskly. HOPE-2 is a very important trial because it may be the first potentially pivotal trial for an immunomodulatory treatment for DMD and also one specifically targeting the later stages of the disease…

AJ Bergmann

Analyst

Thank you, Linda. This afternoon’s press release provided a summary of our first quarter 2018 financials on a GAAP basis. You may also refer to our quarterly report on Form 10-Q, which we expect to become available in the next few days and will be accessible on the SEC website, as well as in the financial section of our company website. As of March 31, 2018, the company’s cash, cash equivalents and marketable securities totaled approximately $13.2 million, compared to approximately $14.1 million on December 31, 2017. Based on our current plans and projections, Capricor expects that its cash, cash equivalents and marketable securities will fund its research and development programs and other operations into the first quarter of 2019. In the first quarter of 2018, our net cash used in operating activities was approximately $3.4 million. Excluding stock-based compensation, our research and development expense was approximately $2.6 million in Q1 2018, compared to approximately $3.1 million in Q1 2017. Again, excluding stock-based compensation our general and administrative expense was approximately 1.1 million in Q1 2018 compared to approximately 900,000 in Q1 2017. With that I will now turn the call back over to Linda and we will then open the lineup for questions. Linda Marbán: Thank you, AJ. Just like to conclude with reminding everyone that we will be at BIO in Boston which will be held in early June. We look forward to seeing you there. With that thank you for joining us today. And now open the line for question.

Operator

Operator

[Operator Instructions] And our first question comes from the line of Joseph Pantginis with H.C. Wainwright. Your line is now open.

Joseph Pantginis

Analyst

Linda now that you are officially a pivotal stage company, can you talk more to the pending conduct of the study, first, how patients are to be screened and anticipated top one or two reasons for screen failure. Thanks. Linda Marbán: Thank you, Joe, it's good to talk to you. So, the inclusion criteria was very carefully designed primarily using our steering committee and Craig McDonald, our national PI with a tremendous amount of experience in this patient population. We don’t have any data on screen fails, we’re expecting that the trial will enroll well.

Joseph Pantginis

Analyst

And just the second part of that question is, and I think it's somewhat rhetorical since it is IV but what special training, if any, did you need to provide to the clinical sites with regard to the infusions to ensure standardization? Linda Marbán: The beauty of switching to this standardizing method is that it requires very little specialized knowledge, most of the infusions are done in hospitals with infusion centers where the team has tremendous experience from using standard commercially available catheters and needles and so there really is nothing very special about it.

Operator

Operator

[Operator Instructions]. Our next question comes from the line of Jason McCarthy from Maxim Group. Your line is now open.

Unidentified Analyst

Analyst

Hi guys this is [indiscernible] calling on behalf of Jason McCarthy. Thanks for taking my call. My question is in additional to PUL, are there other secondaries that could further support potential registration. [indiscernible] had multiple measures and [indiscernible] it got approved. Linda Marbán: Thank you and good to hear from you. Of course, we built a significant and relevant number of secondary endpoints into the design of HOPE-2 which will allow us to measure among other things called muscle performance, the cardiac muscle performance as well as [respiratory] performance and all of those will be very carefully prespecified in our statistical analysis plan and looked at in totality with the data when its opened and the blind is revealed.

Operator

Operator

[Operator Instructions]. And I’m showing no further questions. I would now like to turn the call back to Linda Marbán CEO for any closing remarks. Linda Marbán: Thank you very much for your time today and we look forward to providing with updates on the second quarterly conference call. Have a good day.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today’s conference call. This does conclude the program. And you may all disconnect. Everyone have a great day.