89Bio (ETNB) H.C. Wainwright 8th Annual NASH Virtual Conference summary

Key developments and forward-looking statements

• Three phase III studies are ongoing: two in MASH (initiated this year) and one in severe hypertriglyceridemia, with the first phase III data expected in 2025.

• Manufacturing scale-up and BLA submission preparations are underway, with commercialization strategies being considered for potential independent launch.

• ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis phase III trials target F2/F3 and compensated cirrhotic patients, respectively, with accelerated and full approval pathways based on histology and outcomes.

• The ENTRUST phase III study in severe hypertriglyceridemia is expected to read out next year, with high confidence in replicating strong phase II results.

Mechanism of action and differentiation

• Pegozafermin, an FGF21 analog, acts on both metabolic and liver pathways, directly impacting fibrosis and inflammation.

• GlycoPEGylation technology extends dosing intervals to weekly or biweekly, offering convenience and improved tolerability compared to competitors.

• Liquid pre-filled syringe formulation may enable future combination products with incretin therapies.

• Studied in two distinct indications, providing commercial leverage and broader patient reach.

Clinical data and efficacy

• Phase IIb ENLIVEN study showed a 20% placebo-adjusted delta in fibrosis reversal at 24 weeks, outperforming some competitors and matching other FGF21 agents.

• Odds ratio for fibrosis improvement was 3.5, higher than other late-stage studies.

• Consistent efficacy was observed in patients on GLP-1 therapy and in compensated cirrhotics, with additional metabolic benefits.

• Maintenance of response was seen at 48 weeks across non-invasive markers.