earnings
confidence high
sentiment neutral
materiality 0.65
Larimar Q1 net loss $29.3M; FDA open to accelerated approval using skin FXN as surrogate endpoint
Larimar Therapeutics, Inc.
2025-Q1 EPS reported
-$0.46
- Net loss $29.3M ($0.46 per share) vs $14.7M ($0.27) YoY; R&D spend rose to $26.6M on manufacturing and Phase 3 prep.
- Cash, equivalents and marketable securities $157.5M as of March 31, 2025; runway into Q2 2026.
- FDA agreed to consider skin FXN concentration as reasonably likely surrogate endpoint for accelerated approval.
- BLA submission planned by year-end 2025; global Phase 3 study to begin mid-2025 with U.S. and international sites.
- Adolescent PK run-in dosing completed; 50 mg OLE and adolescent data expected in September 2025 program update.