Fractyl Health(US:GUTS) Globenewswire·2025-08-12 20:05Core Insights - Fractyl Health, Inc. is advancing its Revita and Rejuva platforms aimed at treating obesity and type 2 diabetes (T2D) through innovative approaches [2][3][18] - The company recently completed a $23 million underwritten public offering to extend its cash runway for upcoming clinical milestones [2][18] - Positive early data from the REVEAL-1 Cohort indicates that Revita can help maintain weight loss after discontinuation of GLP-1 drugs [7][20] Financial Performance - For Q2 2025, Fractyl reported a net loss of $27.9 million, compared to a net loss of $17.2 million in Q2 2024, largely due to increased operating expenses [16][27] - Research and development expenses were $21.2 million for the quarter, up from $16.8 million in the same period last year, reflecting ongoing clinical study advancements [16][27] - As of June 30, 2025, the company had approximately $22.3 million in cash and cash equivalents, which is expected to fund operations into 2026 [16][27] Clinical Developments - The REMAIN-1 pivotal study includes three cohorts: REVEAL-1, REMAIN-1 Midpoint, and REMAIN-1 Pivotal, with the latter expected to report 6-month data in H2 2026 [4][9][13] - The REVEAL-1 Cohort showed that 12 out of 13 participants maintained or reduced weight after a single Revita procedure following GLP-1 discontinuation [7][8] - The REMAIN-1 Midpoint Cohort is designed to assess Revita's efficacy in maintaining weight loss after GLP-1 discontinuation, with initial data expected in September 2025 [8][12] Strategic Initiatives - Fractyl has entered a non-binding Letter of Intent with Bariendo Inc. to explore collaboration for Revita as a post-GLP-1 weight maintenance intervention [18] - The company has been issued two new U.S. patents that enhance its duodenal mucosal resurfacing platform, strengthening its intellectual property portfolio [18] - The Rejuva platform is progressing towards clinical trials, with the first-in-human study expected to begin in 2026 [11][14]