89Bio (ETNB) 7th Annual Evercore ISI HealthCONx Healthcare Conference summary

Company overview and clinical programs

• Focuses on liver and cardiometabolic diseases with lead candidate pegozafermin, an FGF21 analog in late-stage development.

• Two phase III trials for MASH: one in pre-cirrhotic (F2/F3) and one in cirrhotic populations, both initiated this year.

• Phase III trial in severe hypertriglyceridemia (SHTG) with readout expected in 2025.

• Drug is a biologic, administered weekly or biweekly via liquid prefilled syringe, emphasizing patient convenience.

• Pro forma cash position is approximately $565 million following recent financing.

Market landscape and competitive positioning

• MASH market is validated by strong Rezdiffra launch, with broad physician adoption and payer coverage without biopsy requirements.

• FGF21 class, including pegozafermin, is positioned for advanced fibrosis (F3/F4) and cirrhotic patients, offering potent anti-fibrotic effects.

• FGF21s expected to complement GLP-1s, targeting patients who progress despite metabolic therapy.

• Multiple FGF21s (Akero, Boston Pharma, Novo) are emerging, with the market large enough for several blockbusters.

• Differentiation includes dosing frequency, tolerability, formulation (liquid vs. lyophilized), and development in multiple indications.

Clinical data interpretation and development strategy

• Phase III endpoints: a 10% placebo-adjusted delta is clinically meaningful; 12-15% would drive broad utilization.

• High placebo response in cirrhosis trials is rare; longer studies expected to show greater treatment effect.

• Flexibility to adjust phase III design based on emerging data, with focus on efficacy and tolerability markers.

• SHTG strategy aims for supplemental BLA if MASH is approved first, leveraging a large safety database.

• Excludes cryptogenic cirrhosis from phase III to avoid confounding, but may study separately in the future.