Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q3 2023 Results Conference Call November 14, 2023 4:30 PM ET

Company Participants

AJ Bergmann - CFO

Linda Marbán - CEO

Conference Call Participants

Joe Pantginis - H.C. Wainwright

Aydin Huseynov - Ladenburg

Operator

Good afternoon, ladies and gentlemen and welcome to the Capricor’s Third Quarter 2023 Financial Results and Corporate Update Call. This conference call is being recorded.

I would now like to turn the conference call over to our host, Mr. AJ Bergmann, Capricor’s Chief Financial Officer. Please go ahead.

AJ Bergmann

Thank you. Good afternoon, everyone.

Before we start, I would like to state that we will be making certain forward-looking statements during today’s call and 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, manufacturing capabilities, potential milestone payments 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 will turn the call over to Linda Marbán, CEO.

Linda Marbán

Thanks, AJ. Good afternoon. And thank you for joining us today.

I’m extremely pleased with the progress we are making towards the development of our lead asset CAP-1002, for the treatment of Duchenne Muscular Dystrophy.

As I begin the call today, I am delighted to inform you that we have reached our targeted enrollment goal for our HOPE-3 Phase 3 pivotal study, which is designed to enroll approximately 58 patients across the United States. Additionally, we are planning on announcing the outcome of our interim analysis from the study prior to the end of this year. The purpose of this important milestone will be to determine if the trial is futile or should continue as planned. The analysis is based on the six-month results. Reminder, our primary endpoint is based on one year. This blinded data will be presented to our DSMB, which will evaluate safety and efficacy and give us their decision as to whether the trial should continue as planned. Should the trial be determined not to be futile, this will trigger our first milestone payment under our U.S. agreement with Nippon Shinyaku. There are also other potential milestone payments leading up to an approval of a BLA that will continue to support our balance sheet, should we achieve them.