89Bio (ETNB) UBS Global Healthcare Conference 2024 summary

Recent progress and milestones

• Lead program pegozafermin, an FGF21 analog, is in phase III for MASH (formerly NASH) and severe hypertriglyceridemia (SHTG), with three phase III studies ongoing.

• Two phase III MASH studies target pre-cirrhotic (F2/F3) and cirrhotic (F4) populations; SHTG phase III started in 2023 with results expected in 2025.

• Commercial-scale manufacturing has been achieved for clinical trials.

• Ended Q3 with $424 million in cash, providing runway into 2026 and access to an additional $150 million credit line.

Mechanism of action and differentiation

• FGF21 acts directly on the liver and periphery, addressing metabolic dysregulation and fibrosis in MASH.

• Pegozafermin shows direct effects on liver fat oxidation, fibrosis reduction, and improved lipid profiles.

• Compared to incretin therapies, FGF21 offers direct liver benefits and unique antifibrotic potential.

Competitive landscape and clinical data

• Pegozafermin demonstrated a 20% placebo-adjusted delta in MASH resolution after 24 weeks, outperforming recent ESSENCE data for semaglutide.

• Lower placebo response rates and higher odds ratios for efficacy compared to competitors.

• FGF21s, including pegozafermin, are positioned for advanced fibrosis and cirrhotic patients, where rapid antifibrotic action is needed.