89bio(ETNB) GlobeNewswire·2025-02-27 21:05Core Insights - 89bio, Inc. is advancing its Phase 3 trials for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG), with topline data expected in 2027 and 2026 respectively [1][2] - The company reported a cash position of 578.9 million in 2023, following a follow-on offering that raised 287.5 million [7][13] - Significant increases in research and development (R&D) expenses were noted, totaling 345 million for the year ended December 31, 2024, compared to 122.2 million in 2023, primarily due to contract manufacturing costs [8][10] Clinical Trials - The Phase 3 ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials for MASH were initiated in 2024, with topline histology data expected in 2027 and 2028 [6] - The ENTRUST trial for SHTG has completed enrollment with 369 patients, and topline data is now anticipated in the first quarter of 2026 [6][10] - The company aims for accelerated approval in the U.S. and conditional approval in Europe based on the outcomes of these trials [6] Financial Performance - R&D expenses for Q4 2024 were 111.3 million, a significant increase from 33.6 million in Q4 2023, driven by contract manufacturing and clinical development costs [8] - General and administrative (G&A) expenses rose to 39.6 million for the year ended December 31, 2024, compared to 367.1 million, up from $142.2 million in 2023, reflecting increased operational costs [10] Corporate Strategy - The company is focused on executing clinical trials and preparing for a potential Biologics License Application (BLA) filing, contingent on positive trial results [2][13] - Pegozafermin, the lead candidate, is positioned as a potentially best-in-class therapy for patients with advanced MASH and SHTG, with a favorable safety profile and convenient dosing [2][11]