Capricor is actively scaling up its commercial readiness and manufacturing capabilities to support the potential launch of Deramiocel. The company is expanding its in-house GMP manufacturing capacity from its current level of approximately 200–250 patients per year to a planned capacity of 2,000–2,500 patients per year, with full validation targeted for 2027. Additionally, the company is expanding its commercial leadership team, including the appointment of Michael Maurer as Chief Commercial Officer in May 2026, to oversee global commercial operations, market access, and distribution strategy.

Expected impact: Ensures sufficient product supply and commercial infrastructure to rapidly launch and distribute Deramiocel to eligible DMD patients upon potential FDA approval.

Capricor is advancing its proprietary StealthX exosome platform, which uses engineered exosomes for vaccine development and targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics. The platform's lead candidate is currently being evaluated in an NIAID-sponsored Phase 1 clinical trial under Project NextGen. Capricor aims to leverage positive clinical data to secure strategic partnerships for platform advancement and pipeline expansion into infectious diseases, oncology, and other rare diseases.

Expected impact: Unlocks significant long-term pipeline optionality and non-dilutive funding opportunities through strategic collaborations and platform licensing.