Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q4 2018 Earnings Conference Call - Final Transcript

Mar 28, 2019 • 04:30 pm ET


Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q4 2018 Earnings Conference Call - Final Transcript


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Welcome to Capricor Therapeutics Fourth Quarter and Full Year 2018 Conference Call. My name is Morin and I'll 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 lines for questions. (Operator Instructions) Note that this conference is being recorded.

I will now turn the call over to Capricor's CFO, A.J. Bergmann. Sir.

AJ Bergmann

Thank you and good afternoon. 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 a 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 report. You're cautioned not to place undue reliance on these forward-looking statements and we disclaim any obligation to update such statements.

And with that, I will turn the call over now to Linda Marban, CEO.

Linda Marban

Good afternoon and thank you for joining us for our fourth quarter and full year update and conference call. Over the last few months, we have continued to make progress in the HOPE-2 clinical trial for Duchenne muscular dystrophy, which also included a pivotal meeting with the Food and Drug Administration under our RMAT designation. Additionally, we are continuing the development of our exosome platform technology. I'm delighted today to provide you with some colors on both programs.

As we announced earlier this year, we had a successful meeting with the FDA during which time we discussed the potential registration of CAP-1002 should hope to achieve its primary efficacy end point as well as other important issues such as trial size, clinical relevance of the performance of the upper limb as well as other measures of muscle function. We left that meeting not only with direction, but also feeling very encouraged. However, we were faced with a challenge right after the meeting when we learned that a patient in the HOPE-2 clinical trial sustained a serious adverse event otherwise known as an SAE during the infusion.

The event was an allergic reaction that occurred during infusion, which resulted in anaphylaxis. Luckily the patient was and continues to be fine. But the result of that incident was that we put ourselves on a voluntary dosing hold, while we investigated the SAE. It became apparent after investigation that these types of allergic reactions sometimes occur when a biologic is being