89Bio (ETNB) Conference Transcript

Summary of 89Bio (ETNB) Conference Call - September 03, 2025 Company Overview - Company: 89Bio (ETNB) - Industry: Biopharmaceuticals, specifically focusing on NASH (Non-Alcoholic Steatohepatitis) treatment Key Points and Arguments NASH Market Dynamics - The NASH space is experiencing significant growth due to the approval of two drugs: Resdiffera and SEMA, addressing a substantial unmet need in the market [4][5] - There are millions of undiagnosed NASH patients, presenting a large opportunity for market expansion as awareness and diagnosis improve [5][6] - The next generation of products, particularly potent anti-fibrotic agents like pegosofirmin, is expected to further enhance treatment options and market growth [7][8] Current Treatment Landscape - GLP-1 drugs are being utilized but do not directly target liver fibrosis, leading to continued disease progression in many patients [10][11] - Despite the presence of GLP-1s, there remains a significant market for liver-directed therapies, as many patients still have advanced fibrosis [12][13] Clinical Trials and Study Updates - The ENLIGHTEN studies for pegosofirmin are progressing well, with high enthusiasm from clinical sites and a large number of patients being screened [15][16] - The studies are global, involving over 250 sites across 20+ countries, indicating a robust initiative to address the unmet need in cirrhosis [17][18] Differentiation and Competitive Advantage - Physicians recognize the difference between current metabolic drugs and more potent anti-fibrotic agents, with excitement around the potential of FGF21s and pegosofirmin in treating advanced fibrosis [19][20] - Pegosofirmin shows promising data in combination with GLP-1s, indicating potential synergistic effects on liver fibrosis and metabolic markers [21][22][24] Safety and Tolerability - Safety and tolerability are critical factors for long-term patient compliance, especially in chronic conditions like NASH [40][53] - Pegosofirmin has demonstrated lower rates of gastrointestinal events compared to competitors, which is crucial for maintaining patient adherence [42][53] Future Directions and Potential Indications - Beyond NASH, there is potential for pegosofirmin in other fibrotic conditions, including liver cirrhosis from various etiologies, renal fibrosis, and cardiac fibrosis [71][72] - The company is considering partnerships to explore these additional indications while preserving capital for NASH and SHTG (Severe Hypertriglyceridemia) studies [73][75] Commercial Strategy - The potential for co-formulation with GLP-1s is seen as a significant opportunity for differentiation in the market, providing convenience for patients [45][47] - Pricing strategies for combination therapies will depend on the strength of clinical data and market dynamics [50][76] Additional Important Insights - The company is focused on executing its Phase III studies effectively, with a keen eye on the evolving landscape of NASH treatments and patient needs [17][18] - There is a recognition of the importance of long-term weight management and glycemic control in impacting fibrosis outcomes, emphasizing the chronic nature of NASH [29][30] This summary encapsulates the key discussions and insights from the conference call, highlighting the strategic positioning of 89Bio in the evolving NASH treatment landscape.