GlobeNewswire·Aug 10, 2026, 4:05 PM ET

Fractyl Health Reports Second Quarter 2026 Financial Results and Business Updates

GUTS

One-year REMAIN-1 Midpoint Cohort data shows Revita patients maintained up to 84% of prior GLP-1-induced weight loss versus 46% with sham in patients receiving complete duodenal ablations.
One-year open-label REVEAL-1 Cohort data indicates patients maintained approximately 78% of their prior GLP-1-induced weight loss after a single Revita procedure.
REMAIN-1 Pivotal Cohort topline 6-month randomized data is on track for early Q4 2026, paving the way for a potential FDA De Novo submission in late Q4 2026.
Fractyl Health maintains a cash runway into early 2027, extending beyond anticipated pivotal data readouts and regulatory submissions.
R\&D expenses for the quarter ended June 30, 2026, were $13.8 million, a decrease from $21.2 million in the same period in 2025.
SG\&A expenses for the quarter ended June 30, 2026, were $5.3 million, an increase from $4.9 million in the same period in 2025.
Net loss for the quarter ended June 30, 2026, was $25.5 million compared to $27.9 million in the same period in 2025.
Adjusted EBITDA for the quarter ended June 30, 2026, was negative $16.3 million compared to negative $24.0 million in the same period in 2025.
Cash 位置 as of June 30, 2026, was approximately $47.1 million in cash 现金 equivalents.
Mike Zumdahl was appointed Senior Vice President, Market Access and Commercial Strategy in June 2026 to strengthen commercial readiness.
Rejuva platform lead candidate RJVA-001 received Clinical Trial Authorization in the Netherlands 2026 4 月 with ethics committee approval in Australia in July 2026.
Fractyl plans to report first-in-human dosing of RJVA-001 2026 2nd half, subject to site activation.
No device- or procedure-related serious adverse events occurred through one year in the REMAIN-1 Midpoint Cohort.
Fractyl will host a conference call on August 10, 2026, at 4:30 p.m. ET to discuss second quarter 2026 financial results.