Capricor Therapeutics, Inc.

Capricor reported no revenue for Q2 2026 or Q2 2025. Total operating expenses were $42.9 million, up from $27.7 million a year ago. Net loss was $40.7 million, or $0.70 per share, versus a net loss of $25.9 million, or $0.57 per share, in Q2 2025. For the first six months of 2026, net loss was $74.7 million versus $50.3 million in the same period of 2025. As of June 30, 2026, cash, cash equivalents and marketable securities totaled $237.9 million, and accumulated deficit was approximately $379.6 million. Management did not provide numeric revenue or earnings guidance; instead, it said it will submit a BLA amendment as soon as timing is finalized, and FDA indicated it would be willing to review it and extend the PDUFA date accordingly.

Linda Marbán framed the quarter around regulatory setback and strategic repositioning. She said the advisory committee vote was narrow in scope and focused on cardiomyopathy, while the HOPE-3 study was designed around skeletal muscle function, and she emphasized that the primary endpoint remained statistically significant. Her tone was disappointed but resolute, stressing continued collaboration with FDA, an updated submission, and a focus on getting Deramiocel to eligible DMD patients.

AJ Bergmann said Capricor ended the quarter with $237.9 million in cash, cash equivalents and marketable securities, and that spending was driven by regulatory, clinical, manufacturing, and commercial-readiness work. Operating expenses rose to $42.9 million from $27.7 million last year, and the quarterly net loss widened to $40.7 million, or $0.70 per share. He added that commercial expenditures are being paced as the regulatory timeline becomes clearer, with flexibility to deploy capital across the rest of the year.

There was no Q&A session; management declined to hold one because of the sensitivity of ongoing discussions with FDA. Instead, management used prepared remarks to answer the most obvious investor concern: whether the 3-9 AdCom vote ended the program. Capricor said it is instead pursuing a revised path based on the HOPE-3 upper-limb data and expects FDA to review an amendment that could extend the PDUFA date.