89Bio (ETNB) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Recent progress and clinical development

• Three phase III studies are ongoing: one in severe hypertriglyceridemia (SHTG) with top-line results expected next year, and two in MASH (pre-cirrhotic F2-F3 and cirrhotic F4 populations) with results expected in 2026 and 2028, respectively.

• Enrollment and site activation for all studies are progressing well, with strong enthusiasm from investigators and robust patient screening.

• FDA has agreed to histology as an endpoint for potential accelerated approval in the cirrhosis study.

Market landscape and therapeutic need

• Recent approval of the first MASH drug has increased awareness, screening, and diagnosis, but there remains a significant need for more effective therapies, especially for fibrosis.

• Pegozafermin has shown nearly double the fibrosis benefit compared to the first approved MASH drug, highlighting a substantial market opportunity for more potent antifibrotic agents.

Mechanism of action and differentiation

• FGF21 analogs, including pegozafermin, uniquely address both metabolic and antifibrotic pathways, unlike other classes such as GLP-1s, which primarily target metabolic effects.

• Pegozafermin demonstrates direct effects on liver fat, MASH resolution, transaminases, and fibrosis within 24 weeks.