89Bio (ETNB) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Company overview and lead program

• Focuses on liver and cardiometabolic health with lead candidate pegozafermin, an FGF21 analog showing strong clinical data in MASH and severe hypertriglyceridemia.

• Proprietary GlycoPEGylation technology extends half-life, enabling weekly or biweekly dosing without compromising efficacy.

• Well-capitalized with over $550 million, supporting ongoing late-stage clinical programs.

Clinical development and trial results

• Two phase 3 studies in MASH: pre-cirrhotic (F2/F3) with results expected end of 2026, and cirrhotic (F4) with results in 2028.

• Phase 2b NASH study showed statistically significant improvements in fibrosis and MASH resolution, with best-in-class liver fat reduction (50%-55%).

• Consistent benefits observed across non-invasive markers and on top of GLP-1 therapy.

• Encouraging fibrosis reversal in compensated cirrhosis (F4) patients, with 45% showing improvement.

• Safety profile favorable, with low rates of adverse events and no significant bone or vital sign changes.

Regulatory and market positioning

• Received breakthrough and PRIME designations in the US and Europe.

• First to gain regulatory buy-in for accelerated approval in F4 population.

• FGF21 analogs expected to capture dominant market share in advanced fibrosis and cirrhosis, with up to 60% in F4 patients.

• Market for diagnosed MASH expected to grow significantly, potentially reaching 1.8 million patients in 10 years.