Capricor Therapeutics (CAPR) Q3 2024 earnings summary

Executive summary

• Initiated rolling BLA submission for deramiocel (CAP-1002) for DMD cardiomyopathy, with full submission expected by year-end 2024 and potential FDA decision in H2 2025; strong clinical data and FDA collaboration support a de-risked regulatory path.

• Commercial preparations are robust, leveraging a partnership with Nippon Shinyaku for US, Japan, and Europe, with manufacturing scale-up underway to meet anticipated demand.

• Positive long-term data from HOPE-2 and HOPE-3 trials support regulatory filings in the US, Europe, and Japan.

• Expanded StealthX exosome platform, including a COVID-19 vaccine candidate selected for Project NextGen, with a Phase 1 trial planned for 2025.

• Recent $86 million public offering and $15 million private placement with Nippon Shinyaku boost cash position, providing runway into 2027.

Financial highlights

• Q3 2024 revenue was $2.3 million, down from $6.2 million in Q3 2023; nine-month revenue was $11.1 million, down from $13.1 million year-over-year, primarily from ratable recognition of a $40 million upfront payment.

• Q3 2024 net loss was $12.6 million ($0.38/share), compared to $6.4 million ($0.25/share) in Q3 2023; nine-month net loss was $33.4 million versus $21.5 million year-over-year.

• Operating expenses for Q3 2024 were $15.3 million, up from $13.1 million in Q3 2023, driven by increased R&D and G&A expenses.

• Cash, cash equivalents, and marketable securities totaled $85 million as of September 30, 2024; pro forma $166 million after public offering.

• Total assets increased to $93 million as of September 30, 2024, from $58.7 million at year-end 2023.

Outlook and guidance

• Cash runway expected to support operations into 2027, with BLA submission for deramiocel on track for year-end 2024 and potential FDA approval in H2 2025.

• Commercial launch preparations are advanced, with rapid adoption expected and initial patient transfers from open-label extension groups.

• Indication expansion into Becker muscular dystrophy and further exosome platform development planned for 2025.

• Plans to deliver StealthX vaccine candidate to NIAID in Q1 2025, with preliminary data expected in Q2 2025.

• Expects to spend $30–35 million in 2024 on DMD programs and $3–5 million on exosome platform development.