FRACTYL HEALTH, INC.

Fractyl Health announced positive one-year results from its open-label REVEAL-1 Cohort for the Revita procedure. Patients maintained approximately 78% of their GLP-1-induced weight loss one year after discontinuing GLP-1 therapy and undergoing a single Revita procedure, significantly outperforming the ~15% weight regain seen in third-party studies after GLP-1 withdrawal alone. The study also showed sustained glycemic control and excellent tolerability, with 33% of patients continuing to lose weight.

Fractyl Health reported a net income of $9.2 million for the first quarter ended March 31, 2026, a substantial improvement from a net loss of $23.7 million in the prior year, primarily driven by a $30.1 million positive change in the fair value of warrant liabilities. The company received a Nasdaq notice for non-compliance with the minimum bid price rule and appointed Lara Smith Weber as its new CFO. Fractyl Health also made progress in its clinical programs, completing randomization for the Revita REMAIN-1 Pivotal Cohort and receiving CTA authorization for Rejuva RJVA-001 in the Netherlands, though it noted substantial doubt about its ability to continue as a going concern beyond early 2027 without additional funding.

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.

Fractyl Health, Inc. announced it has received Clinical Trial Application authorization in the Netherlands to initiate the Phase 1/2 first-in-human study of RJVA-001, the lead candidate from its Rejuva Smart GLP-1 gene therapy platform. This authorization makes Fractyl Health a dual clinical-stage company, with Revita in pivotal development and Rejuva entering clinical studies for Type 2 Diabetes. The company expects to dose the first patient and report preliminary data in the second half of 2026, with Rejuva's clinical development funded within its existing cash runway into early 2027.

Fractyl Health, Inc. announced it has received Clinical Trial Application authorization in the Netherlands to initiate a Phase 1/2 first-in-human study for RJVA-001, its lead candidate from the Rejuva® Smart GLP-1™ gene therapy platform. This authorization makes Fractyl Health a dual clinical-stage company, with RJVA-001 being the first adeno-associated virus (AAV)-based gene therapy candidate to enter clinical development for type 2 diabetes. The company expects to dose the first patient and report preliminary data in the second half of 2026, with funding for Rejuva's clinical development secured within its existing cash runway into early 2027.

Fractyl Health, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on June 10, 2026. Stockholders will vote on the election of three Class II directors and the ratification of Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026. The record date for voting is April 17, 2026.