GUTS · Fractyl Health, Inc. Common Stock

This disclosure represents a pivotal inflection point for Fractyl Health: RJVA-001’s authorization marks the company’s transition to a dual clinical-stage entity, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human trials for type 2 diabetes. As the first AAV-based gene therapy cleared for clinical testing in T2D, RJVA-001 introduces a fundamentally differentiated therapeutic modality — one-time, pancreas-targeted, physiologic GLP-1 expression — designed to circumvent systemic exposure and associated side effects of chronic GLP-1RA therapy. The trial’s design reflects careful patient selection (HbA1c 7.0–10.0%, BMI 27–40 kg/m², on stable GLP-1RAs plus up to three oral agents) and rigorous safety monitoring over 12 months, with long-term follow-up planned for up to five years. Critically, Fractyl explicitly states that Rejuva’s clinical development is fully funded within its existing cash runway into early 2027 — extending beyond the anticipated REMAIN-1 Pivotal Cohort readout — and confirms no revision to capital plans. This de-risks near-term execution and signals confidence in resource allocation across both platforms. For investors, the event validates Fractyl’s platform strategy, expands its addressable market into a high-unmet-need T2D population refractory to current GLP-1 therapies, and establishes a clear near-term catalyst: first-in-human dosing and preliminary data in H2 2026.