89Bio (ETNB) investor relations material

Program updates and clinical progress

• Three phase III studies are ongoing: one in severe hypertriglyceridemia (SHTG) with results expected early next year, and two in MASH (pre-cirrhotic and cirrhotic), both actively enrolling patients.

• Pegozafermin, an FGF21 analog, is positioned to address significant unmet needs in SHTG and MASH, especially in cirrhotic populations.

• SHTG program aims to replicate strong phase II results, targeting triglyceride reduction and improvements in liver fat, glycemic control, and lipids.

• Differentiation from APOC3s is highlighted by pegozafermin's positive impact on glycemic control, unlike competitors.

• Commercial positioning may target specific patient subgroups, such as those with fatty liver disease or diabetes.

Regulatory and study design insights

• FDA and EMA have agreed that improvement in fibrosis at two years could support accelerated approval for pegozafermin in compensated cirrhotic MASH.

• Study endpoints and definitions for decompensation events in cirrhosis were refined in collaboration with regulators to allow for earlier, clinically meaningful outcomes.

• Histology analysis in cirrhotic MASH uses a well-compensated patient subset, with conservative powering assumptions based on historical placebo responses.

• Consensus read methodology for histology is consistent across phase II and III, with an expanded panel of pathologists for global studies.

• Bone mineral density is being closely monitored in cirrhotic patients, with confidence grounded in biology and prior data.

Market landscape and strategic outlook

• SHTG market awareness is expected to rise with new therapies; pricing could approach MASH levels if broader metabolic benefits are demonstrated.

• Strategic interest in FGF21 and MASH remains high, with recent transactions underscoring the value of this target in advanced fibrosis and cirrhosis.

• Enrollment in global phase III MASH studies is progressing well, with strong site activation and enthusiasm from investigators.

• The evolving regulatory landscape for non-invasive endpoints in MASH is seen as a positive step, though not expected to impact current studies.

• Flexibility in patient medication use (e.g., GLP-1s, Rezdiffra) is being incorporated into study protocols to reflect real-world practice.