Core Insights - Fractyl Health, Inc. is advancing its pivotal studies on obesity and Type 2 Diabetes (T2D) treatments, with significant data expected in the coming quarters [1][2][3] Company Updates - The company reported compelling weight maintenance data from its Revita® and Rejuva® platforms at ObesityWeek® 2024 [1][3] - Enrollment for the REMAIN-1 pivotal study is progressing rapidly, with mid-point data analysis anticipated in Q2 2025 [1][5] - The REVEAL-1 open-label cohort data is expected to begin reporting in Q4 2024 [1][5] - Fractyl is finalizing in vivo studies for its RJVA-001 candidate aimed at T2D, with plans to initiate a first-in-human study in the first half of 2025 if the Clinical Trial Application (CTA) is approved [2][6] Financial Performance - For Q3 2024, Fractyl reported a net loss of 15.7 million in Q3 2023, primarily due to higher operating expenses [10][20] - Research and development expenses rose to 9.4 million in the same period of 2023, reflecting progress in clinical studies [8][20] - The company had approximately $84.7 million in cash and cash equivalents as of September 30, 2024, sufficient to fund operations through key milestones into Q4 2025 [11][19] Upcoming Milestones - The REMAIN-1 study is a randomized, double-blind pivotal study evaluating Revita's efficacy in maintaining weight loss after GLP-1 therapy discontinuation, with topline results expected in mid-2025 [5][14] - The REVITALIZE-1 study is ongoing, targeting patients with T2D, with topline results anticipated in mid-2025 [5][14] - The company plans to disclose additional data from its German Real-World Registry Study in Q1 2025 [5][6]
Fractyl Health Reports Third Quarter 2024 Financial Results and Provides Business Updates