Quarterly ResultMay 12, 2026, 04:08 PM
Fractyl Health Q1 Net Income $9.2M; Revita Pivotal Data Q4 2026
AI Summary
Fractyl Health reported a net income of $9.2 million for the first quarter of 2026, a significant improvement from a $23.7 million net loss in Q1 2025, primarily driven by a $30.1 million non-cash accounting change in warrant liabilities. The company reiterated its cash runway into early 2027, extending beyond the anticipated pivotal data readout. Key clinical milestones for Revita, including topline 6-month randomized data from the REMAIN-1 Pivotal Cohort, remain on track for early Q4 2026, with a potential FDA De Novo marketing application submission in late Q4 2026. Additionally, the first-in-human dosing of RJVA-001 for T2D is anticipated in the second half of 2026.
Key Highlights
- Q1 2026 Net Income: $9.2 million, compared to a net loss of $23.7 million in Q1 2025.
- Q1 2026 Research and Development Expenses: $15.6 million, down from $19.4 million in Q1 2025.
- Q1 2026 Selling, General and Administrative Expenses: $5.2 million, consistent with $5.3 million in Q1 2025.
- Q1 2026 Adjusted EBITDA: Negative $18.0 million, an improvement from negative $23.0 million in Q1 2025.
- Cash and cash equivalents as of March 31, 2026: $63.2 million.
- Cash runway guidance reiterated: Into early 2027, beyond anticipated pivotal data readout.
- Revita REMAIN-1 Pivotal Cohort 6-month randomized data: Expected early Q4 2026.
- RJVA-001 first-in-human dosing for T2D: Anticipated in the second half of 2026.