Capricor Therapeutics, Inc. (CAPR) Q2 2026 Earnings Call

Investor webinar replay

Replay transcript excerpt

Good afternoon, ladies and gentlemen, and welcome to the Capricor Therapeutics second quarter 2026 conference call. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, August 13, 2026. And I would now like to turn the conference over to CFO, AJ Bergmann, for the forward-looking statement. Thank you. Please go ahead. Thank you very much. Before we begin, I'd like to remind you that any statements made during today's call that are not historical are considered to be forward-looking statements. Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the risk factors section of our company's most recent annual report on Form 10-K. and our most recent quarterly reports on Form 10-Q, as well as other reports filed with the SEC. Any forward-looking statements may represent our views as of today, August 13th, 2026 only. Replay of the call will be available on our website following its completion. With that, I will turn the call over to Linda Marbán, CEO. Good afternoon, everyone, and thank you for joining Capricor's second quarter 2026 earning calls. Our BLA for Daromyosal remains under review with the FDA with a current PDUFA target action date of August 22nd. Because that review is ongoing, there is a limit to what I can say about our interactions with the agency, but wanted to provide an update across three main topics. Our regulatory status and pathway for Daromyosal, our commercial and manufacturing readiness, and our dispute with NS Pharma. I will then briefly address our pipeline programs before turning it back to aging. On July 29, 2026, the FDA convened the Cellular Tissue and Gen...