Capricor Therapeutics (CAPR) Q1 2025 earnings summary

Executive summary

• Progress continues toward full approval of deramiocel for DMD cardiomyopathy, with strong clinical data, ongoing FDA engagement, and an upcoming advisory committee meeting; BLA was submitted in December 2024 and accepted for priority review with a PDUFA date of August 31, 2025.

• Commercial launch preparations are underway in the US with NS Pharma/Nippon Shinyaku, and manufacturing capacity is being expanded at the San Diego HQ to support future production.

• European and Japanese market entry strategies are being developed, with ongoing negotiations for distribution partnerships and exclusive agreements in place for the US and Japan.

• The exosome platform and StealthX vaccine program remain in development, with the vaccine entering phase one trials in Q3 2025, pending NIAID approval.

• Dr. Michael Binks was appointed Chief Medical Officer to support commercialization and physician education.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $144.8 million as of March 31, 2025, expected to fund operations into 2027.

• Q1 2025 revenues were zero, compared to $4.9 million in Q1 2024, due to full recognition of prior milestone payments by end of 2024.

• R&D expenses (excluding stock-based compensation) rose to $16.2 million in Q1 2025 from $10.1 million in Q1 2024; total R&D expenses reached $18.9 million, a 70% year-over-year increase.

• G&A expenses increased to $6.1 million in Q1 2025, up 49% year-over-year, mainly due to higher personnel and stock-based compensation.

• Net loss for Q1 2025 was $24.4 million ($0.53/share), up from $9.8 million ($0.31/share) in Q1 2024.

Outlook and guidance

• FDA review of deramiocel remains on track, with no substantive issues identified at mid-cycle review and active engagement ongoing; pre-licensing inspection of the San Diego facility is scheduled for the current quarter.

• Cash runway is projected to last into 2027, supporting ongoing clinical, regulatory, and pre-commercial activities.

• Four-year open-label extension data for deramiocel will be presented in June, showing promising long-term stabilization of cardiac and upper limb function.

• If FDA approval is not granted, plans are in place to submit HOPE-3 data for skeletal muscle indication.

• 2025 R&D spend expected at $40–50 million for deramiocel and $5–7.5 million for exosome programs.