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Mar 31, 2024
89Bio Q1 2024 Earnings Report
89bio's financial results for Q1 2024 were reported, along with a corporate update.
Key Takeaways
89bio reported a net loss of $51.7 million for the first quarter of 2024. The company initiated the Phase 3 ENLIGHTEN-Fibrosis trial and expects to initiate the ENLIGHTEN-Cirrhosis trial this quarter. They also received PRIME status from the EMA for pegozafermin in MASH treatment.
Initiated Phase 3 ENLIGHTEN-Fibrosis trial in non-cirrhotic MASH patients.
Expect to initiate ENLIGHTEN-Cirrhosis trial this quarter in MASH patients with compensated cirrhosis.
Granted PRIME status from EMA for pegozafermin in treating MASH with fibrosis and compensated cirrhosis.
Data from the 48-Week Extension Phase of the ENLIVEN Phase 2b Trial to be presented at EASL.
89Bio
89Bio
Forward Guidance
89bio anticipates topline data from the ENTRUST Phase 3 trial in SHTG in 2025 and is focused on executing Phase 3 trials for MASH.
Positive Outlook
- On track to begin the ENLIGHTEN-Cirrhosis trial for compensated cirrhotic MASH patients in the second quarter.
- Pegozafermin has the potential to be the leading therapy in treating advanced MASH patients with fibrosis.
- Focused on the execution of Phase 3 trials for MASH and the synergistic Phase 3 trial in severe hypertriglyceridemia (SHTG).
- Agreement for commercial supply is designed to strategically enhance readiness for potential commercialization.
- Enrollment continues to progress well in ENTRUST, the Phase 3 trial evaluating the efficacy, safety, and tolerability of pegozafermin in patients with SHTG.
Challenges Ahead
- Trial outcomes are subject to various risks and uncertainties.
- Positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies.
- Substantial dependence on the success of lead product candidate.
- Competition from competing products.
- Impact of general economic, health, industrial or political conditions.