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.

Financial Data and Key Metrics Changes - The company reported a significant improvement in clinical results, particularly in the cirrhotic population, demonstrating a one-stage improvement in fibrosis, which is a first in the field [10][11] - The effect size in the pre-cirrhotic population showed a 75% one-stage improvement of fibrosis with a 50% effect size over placebo, indicating strong performance compared to competitors [11] Business Line Data and Key Metrics Changes - The company highlighted the differentiation of its drug affruxifirmin from competitors, emphasizing its unique modifications that enhance binding and efficacy [6][7] - Clinical data showed a 25% difference in fibrosis improvement between active and placebo groups at week 96, indicating the importance of longer dosing [12][13] Market Data and Key Metrics Changes - The company is positioned to address a large market for NASH treatments, particularly in the F2, F3, and F4 patient populations, with a focus on reversing fibrosis [52] - The competitive landscape includes other FGF21 agents, but the company believes its unique data and efficacy will differentiate it in the market [56][58] Company Strategy and Development Direction - The company is actively preparing for Phase 3 trials, leveraging learnings from Phase 2b studies to refine patient inclusion criteria [19][40] - There is a strategic focus on cirrhosis treatment, with plans to explore other causes of cirrhosis beyond NASH, indicating a broader therapeutic approach [68] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term potential of their drug, particularly in the cirrhotic population, despite acknowledging that not all patients may respond immediately [15][16] - The company is aware of the competitive landscape and is preparing to demonstrate the value of its drug to payers, emphasizing the need for differentiation in a crowded market [60][62] Other Important Information - The company has a strong cash position with $1.128 billion, which is expected to support operations into 2028 [72] - Management noted the importance of combination therapies and the potential for their drug to be used alongside other treatments for NASH [64] Q&A Session Summary Question: How does affruxifirmin differentiate from other agents? - The CEO explained that affruxifirmin has unique modifications that enhance its binding and efficacy compared to other FGF21 agents [6][7] Question: What are the implications of the clinical data presented? - Management highlighted the significance of the one-stage improvement in fibrosis and the importance of longer dosing for better outcomes [10][12] Question: How does the company view the competitive landscape? - The company believes that while there are multiple agents entering the market, its unique data and efficacy will provide a competitive edge [56][58] Question: What is the company's strategy for Phase 3 trials? - The company is refining inclusion criteria based on Phase 2b learnings and is focused on enrolling the right patient populations for success [19][40] Question: How does the company plan to address payer concerns? - Management emphasized the need to demonstrate the drug's value and differentiate it from existing treatments to gain favorable payer access [60][62]