89Bio (ETNB) Leerink’s Global Healthcare Conference 2025 summary

Company overview and financial position

• Focused on late-stage clinical development for MASH and cardiometabolic diseases, with pegozafermin as the lead FGF21 analog in two indications.

• Two global phase 3 studies in MASH are enrolling; phase 3 in severe hypertriglyceridemia (SHTG) has completed enrollment, with results expected in Q1 next year.

• Ended December with $440 million in cash and raised an additional $287 million in January, providing runway through key upcoming catalysts.

Clinical data and competitive positioning

• Recent positive data for FGF21 class in cirrhotic MASH validates the mechanism and supports optimism for pegozafermin.

• Pegozafermin’s dosing and duration in phase 3 are comparable to successful studies in the class, with a two-year study design.

• Clinical and preclinical data suggest pegozafermin’s potency is at least equivalent to efruxifermin, with a recent meta-analysis highlighting its fibrosis benefit.

• Pegozafermin’s molecular profile and PK properties support comparable or higher active protein delivery versus competitors.

Regulatory and trial design updates

• ENLIGHTEN-Cirrhosis phase 3 study includes histology and outcomes cohorts, with plans to file for accelerated/conditional approval if positive data are achieved.

• Regulatory agencies (FDA, EMA) have confirmed that a 1-point fibrosis improvement is sufficient for accelerated approval.

• Unique trial design redefines decompensation events to make outcome studies feasible, with flexibility to adjust based on emerging data.