earnings
confidence high
sentiment neutral
materiality 0.65
Fractyl Health Q1 net loss $23.7M, cash $42.1M; REMAIN-1 pivotal enrollment complete
FRACTYL HEALTH, INC.
2025-Q1 EPS reported
-$0.49
- Net loss $23.7M vs $3.3M YoY, driven by non-cash fair value change and $3.2M operating expense increase.
- Cash $42.1M expected to fund operations into Q4 2025; R&D expenses rose to $19.4M from $14.4M.
- REMAIN-1 Pivotal Cohort (315 patients) enrollment completed ahead of schedule; 6-month primary endpoint data H2 2026.
- REVEAL-1 3-month open-label data update expected June 2025; REMAIN-1 Midpoint Cohort data Q3 2025.
- Rejuva gene therapy advancing; first CTA module submission for RJVA-001 expected June 2025.