Summary of 89Bio (ETNB) Conference Call Company Overview - **Company**: 89Bio - **Focus**: Development of pegosafirman, an FGF21 analog, targeting NASH (Non-Alcoholic Steatohepatitis) and SHTG (Severe Hypertriglyceridemia) [2][3] Key Points and Arguments Ongoing Studies - 89Bio has three ongoing Phase III studies: one for SHTG and two for NASH, including pre-cirrhotic and cirrhotic patients [3][4] - The SHTG program has completed enrollment, with results expected early next year [3] SHTG Program - SHTG is identified as a significant unmet medical need, with many patients also suffering from fatty liver disease and diabetes [6][7] - Pegoasafirman aims to reduce triglycerides and improve liver fat, glycemic control, and lipid profiles, showing a potential advantage over existing treatments [8][9] - Phase II data indicated a triglyceride reduction of 57-63% and improvements in liver fat and transaminases [9] NASH Program - The company has received written agreement from the FDA for an accelerated approval pathway if improvement in fibrosis is demonstrated at the two-year histology endpoint [21][22] - The FDA's stance is based on the scientific argument that reversing fibrosis could predict better patient outcomes [22][23] - The company is working on refining definitions of clinical outcomes to make studies more tractable [26][27] Pricing Strategy - The pricing strategy will depend on the data generated; better outcomes could command higher prices [17][18] - There is speculation that pricing could be similar to existing treatments for NASH, potentially around $50,000 [16] Regulatory Developments - The FDA has shown a willingness to explore new surrogate endpoints for NASH, which could impact the broader field but not the ongoing studies of 89Bio [38][39] - The company is capturing FibroScan data in its studies, which could strengthen its market position [46][47] Market Interest - There is ongoing strategic interest in the NASH space, particularly for FGF21, with recognition of its potential in advanced fibrosis and cirrhosis [57][58] Additional Important Insights - The company is optimistic about the enrollment and progress of its studies, with over 250 sites activated for the Phase III studies [51][52] - The potential impact of competing drugs like semaglutide on enrollment and outcomes is being monitored [49][55] - The company is confident in the safety profile of pegosafirman, particularly regarding bone mineral density [35][37] This summary encapsulates the critical insights from the conference call, highlighting the company's strategic direction, ongoing studies, regulatory interactions, and market positioning.

Market Overview - The MASH (Metabolic Associated Steatotic Hepatitis) space is experiencing significant growth due to recent regulatory approvals of two drugs for treatment, addressing a substantial unmet medical need [2] - The approval of Rezdiffra last year and the recent approval of sema are expected to enhance market expansion and increase diagnosis rates among MASH patients [2] Patient Impact - There are millions of MASH patients, but a large majority remain undiagnosed and untreated, indicating a critical opportunity for market growth and patient care improvement [2]

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.

Group 1 - 89bio, Inc. is advancing Pegozafermin, a long-acting FGF21 analog, through Phase 3 trials [1] - Pegozafermin targets large Total Addressable Markets (TAMs) with unmet needs in Metabolic Associated Steatotic Liver Disease (MASH) with and without cirrhosis, and severe hypertriglyceridemia (SHTG) [1] - The company is pursuing a dual-path approval strategy for Pegozafermin [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________to ____________ Commission File Number: 001-39122 89bio, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 36-4946844 (State ...

89bio develops new medicines for metabolic and liver diseases. Its lead asset, pegozafermin, is a drug candidate designed to treat serious conditions like metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH) and severe hypertriglyceridemia (SHTG). 89bio (ETNB -4.85%), a clinical-stage biotech focused on metabolic and liver diseases, released its second quarter 2025 results on August 7, 2025. The company posted GAAP earnings per share of $(0.71), missing the consensus estimate of $ ...

Exhibit 99.1 Severe Hypertriglyceridemia (SHTG) • The Phase 3 ENLIGHTEN-Fibrosis trial in non-cirrhotic (F2-F3) MASH and Phase 3 ENLIGHTEN-Cirrhosis trial in compensated cirrhotic (F4) MASH continue to enroll patients, with topline data from the histology cohorts of these trials expected in the first half of 2027 and in 2028, respectively. • The Company anticipates data from the histology cohorts of the Phase 3 ENLIGHTEN trials to support accelerated approval in both non-cirrhotic (F2-F3) and compensated ci ...

Financial Data and Key Metrics Changes - The company is experiencing significant excitement in the NASH space, particularly with the approval of Resdiffera, which has validated the potential for effective treatments in this large market [3][4] - The company anticipates that the market for NASH will expand significantly due to increased awareness and screening, particularly as new mechanisms come into play [5][6] Business Line Data and Key Metrics Changes - The company is focused on both pre-cirrhotic and cirrhotic patient populations, with ongoing studies that are expected to yield significant data in the coming years [8][33] - Pegazifirman is positioned to differentiate itself from competitors based on efficacy, safety, tolerability, and dosing convenience [10][12] Market Data and Key Metrics Changes - The FGF21 class is expected to dominate the advanced fibrosis market, with the company projecting to capture over 50% of this market due to its better safety and tolerability profile [68][71] - The company believes that there is a large market opportunity in advanced fibrosis patients, which includes millions of patients who are at risk of progressing to cirrhosis [69][70] Company Strategy and Development Direction - The company is developing pegazifirman with a focus on advanced fibrosis patients, aiming to prevent progression to cirrhosis while also considering the potential for combination therapies with GLP-1s [67][71] - The company is exploring co-formulation opportunities with GLP-1s, which could enhance its market position and provide additional benefits to patients [72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of pegazifirman to deliver significant benefits in the treatment of cirrhosis and advanced fibrosis, citing strong data from ongoing studies [36][64] - The company is optimistic about the regulatory environment, having received positive feedback from the FDA regarding its study designs and endpoints [63][66] Other Important Information - The company is actively managing enrollment in its clinical trials, with no significant impact from the approval of ResDiffera reported to date [41][42] - Management highlighted the importance of patient tolerability in clinical trials, as it directly affects patient compliance and study outcomes [39][40] Q&A Session Summary Question: How does pegazifirman differentiate from others in the FGF21 class? - The company highlighted differences in efficacy, safety, tolerability, and dosing convenience as key differentiators for pegazifirman compared to other FGF21 drugs [10][12] Question: What gives the company confidence regarding bone mineral density loss? - Management stated that data through week 48 showed no clinically meaningful changes in bone mineral density or biomarkers, providing confidence in the drug's safety profile [24][25] Question: How has enrollment been impacted by the availability of ResDiffera? - Management reported no significant impact on enrollment due to ResDiffera, with many patients still opting to participate in clinical studies [41][42] Question: What is the company's strategy for the phase three program? - The company is focused on powering its studies based on historical placebo responses and aims for a robust design to ensure statistically significant outcomes [48][50] Question: How does the company view the commercial opportunity for pegazifirman? - Management believes pegazifirman will have a dominant position in the advanced fibrosis market, particularly among compensated cirrhotic patients [67][68]

Company Overview - 89bio, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardiometabolic diseases [3] - The company is headquartered in San Francisco and aims to provide best-in-class treatment options for patients lacking optimal therapies [3] Key Developments - The company will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025, at 11:20 AM EDT [1] - Management will also engage in one-on-one investor meetings during the conference [1] Product Focus - 89bio is advancing its lead candidate, pegozafermin, through Phase 3 clinical development for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG) [3] - Pegozafermin is a fibroblast growth factor 21 (FGF21) analog utilizing glycoPEGylated technology to enhance biological activity and extend half-life [3]

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]