89Bio (ETNB) Citi's Biopharma Back to School Conference summary

Market landscape and regulatory developments

• Two drugs have recently been approved for MASH, expanding diagnosis and treatment opportunities.

• Market growth is expected as more patients are diagnosed and treated, with metabolic drugs leading the first wave.

• Next-generation therapies are focusing on potent antifibrotic agents to address fibrosis progression.

• GLP-1s are widely used but do not directly address liver fibrosis, leaving significant unmet need.

• Clinical trial design accounts for GLP-1 use, with global studies reflecting varying utilization rates.

Clinical development and trial execution

• ENLIGHTEN studies for pegozafermin in F2/F3 fibrosis and F4 cirrhosis are progressing globally, with high site and patient engagement.

• Over 250 sites across 20+ countries are screening patients, highlighting strong global interest.

• Stratification for GLP-1 use ensures adequate power to detect differences in outcomes.

• Standard of care and comorbidity management are being standardized across geographies to minimize bias.

• Discontinuation rates are closely monitored, with early dropouts mostly related to tolerability.

Differentiation and commercial positioning

• Key differentiation factors include efficacy, safety, tolerability, and dosing convenience.

• Pegozafermin shows best relative risk reduction in fibrosis among FGF21s and a favorable safety/tolerability profile.

• Lower GI event rates and no significant bone safety signals are noted, especially important for F4 patients.

• Liquid formulation allows potential co-formulation with GLP-1s, offering lifecycle management opportunities.

• Persistence and tolerability are high priorities for chronic MASH treatment, influencing real-world adoption.