Capricor Therapeutics, Inc. Q4 FY2025 earnings call

Good afternoon, everyone. Linda, CEO, welcomes investors and others. Capricorn is focused on advancing Garam ISL for Duchenne muscular dystrophy approval. US FDA accepted BLA for review with PDUFA target date of August 22, 2026. HOPE III trial top-line results released, showing positive efficacy. Additional data presented at Muscular Dystrophy Association Conference. Manufacturing facility in San Diego completed FDA pre-license inspection, with expansion underway. Scientific front: strengthening foundation for Jeremiah Cell, including published peer-reviewed paper. Exosome platform phase 1 COVID vaccine study underway. Hiring plan based on launch preparation. Financial position: cash $318 million as of Dec 31, 2025, net loss increased, but capital sufficient to 2027.

Based on current operating plan, cash, cash equivalents, and marketable securities sufficient to fund operating expenses and capital expenditures into Q4 2027. Excludes potential milestone payments and strategic capital uses. Common stock approved for uplisting to NASDAQ global select market.

Q: Congrats on progress, anticipating adcom, commercial prep for Jeremiah cell approval.

A: No adcom plans yet, will be prepared. Commercial readiness involves building own program for market access, payers, etc.

Q: Refresh on HOPE III cohorts, timing of peer-reviewed publication.

A: FDA considers HOPE III as 1 trial, cohort B statistically significant. Peer-reviewed publication ongoing.

Q: Labeling discussions, conditional approval.

A: No conditional approval needed. Labeling likely for DMD skeletal muscle and cardiomyopathy aspects.

Q: Class 2 resubmission, manufacturing capacity.

A: Manufacturing facility passed pre-licensing, CMC-related questions expected. Expansion to 2500 patients per year, need to show product comparability.

Q: MDA feedback, European rights, StealthX platform.

A: MDA feedback positive, physicians convinced. European rights under evaluation. StealthX platform results from NIAID trial expected, but data slow.