Capricor Therapeutics (CAPR) investor relations material

Executive summary

• Deramiocel’s BLA remained under FDA review with a November 22, 2026 PDUFA date; the August amendment added 24-month HOPE-3 extension data and proposed an indication for upper-limb impairment in DMD patients older than 9.

• The FDA advisory committee voted 3–9 against evidence for the cardiomyopathy indication; the vote did not address HOPE-3’s primary upper-limb endpoint or overall benefit-risk.

• Quarter-end cash, cash equivalents, restricted cash and marketable securities totaled $198.5M, expected to fund operations for at least 12 months.

Financial highlights

• Q3 2026 revenue was $0; operating expenses were $44.7M versus $26.3M in Q3 2025, including R&D expense of $29.6M and G&A of $15.1M.

• Q3 net loss was $42.7M, or $0.73/share, versus $24.6M, or $0.54/share; 9M net loss was $117.3M, or $2.03/share, versus $74.9M, or $1.64/share.

• 9M operating expenses were $124.4M versus $79.0M; operating cash use was $96.4M versus $46.2M. No revenue was recognized in 9M 2026 or 9M 2025.

Outlook and guidance

• Existing liquidity was expected to fund operations for at least 12 months; spending and commercialization costs depend on FDA review, additional funding and the NS distribution arbitration outcome.

• The San Diego facility’s first floor was ready for initial launch supply; cleanroom expansion and second-floor validation were targeted for H1 2027, with planned full capacity of 2,000–2,500 patients or up to 10,000 doses annually.

• European and Japanese regulatory engagement began; next steps for younger DMD patients and Becker muscular dystrophy depend on the U.S. regulatory outcome.

• Final Phase 1 StealthX vaccine results, including cellular immune-response data, were anticipated in H1 2027, subject to NIAID study finalization.