89Bio (ETNB) 2025 Conference Transcript

Summary of 89Bio (ETNB) Conference Call Company Overview - Company: 89Bio - Focus: Development of FGF21 analogs for treating NASH (Non-Alcoholic Steatohepatitis) and related liver disorders Key Industry Insights - NASH as a Metabolic Disorder: NASH is primarily a metabolic dysregulation affecting the liver, leading to inflammation, fibrosis, and potentially cirrhosis [6][12] - FGF21 Mechanism: FGF21 is an endogenous metabolic hormone that regulates energy and lipid metabolism, with direct effects on the liver, distinguishing it from other treatments like GLP-1 [7][8] Clinical Development Highlights - Pivotal Study Results: The phase 2b study of pegosafirmin (FGF21 analog) involved 220 patients, showing significant improvements in liver histology markers, including fibrosis reduction and NASH resolution [8][9] - Comparison with Competitors: Recent data from competitors like efruxifirman supports the potential of FGF21 in severe patient populations (F4) with high unmet needs [10][12] - Cirrhosis Reversal: Over 45% of patients in a small dataset showed cirrhosis reversal without worsening NASH, indicating the potential of FGF21 analogs [12][13] Regulatory Pathway - Accelerated Approval Potential: 89Bio has received written confirmation from the FDA that demonstrating fibrosis reversal could lead to accelerated approval in the US and conditional approval in Europe [15][16] - Study Design: The ongoing phase 3 study will include a repeat biopsy after 24 months to assess liver healing, crucial for patients with dense fibrotic matrices [14][15] Study Enrollment and Design - F4 Study Enrollment: The F4 study aims to enroll approximately 750 compensated cirrhotic patients, with a focus on histology and outcomes [20][21] - Outcome Measures: The study will track decompensation events, mortality, and liver transplant rates, with a modified definition of decompensation to allow for earlier event detection [21][22] Manufacturing and Supply Chain - Manufacturing Locations: Currently, clinical products are manufactured in Europe, with commercial scaling in China. The company is exploring options to mitigate tariff impacts by transforming the API in Europe [33][35][36] Conclusion - Market Need: The FGF21 analogs represent a promising therapeutic avenue for patients with NASH and cirrhosis, with ongoing studies expected to provide critical data for regulatory approval and market entry [19][22]