89Bio Q4 2024 Earnings Report
Key Takeaways
89bio reported a net loss of $118.4 million for the three months ended December 31, 2024. The company's cash, cash equivalents, and marketable securities totaled $440.0 million as of December 31, 2024. The Phase 3 ENTRUST trial in severe hypertriglyceridemia (SHTG) will be unblinded after study completion at Week 52 vs. Week 26 following discussions with the U.S. Food and Drug Administration (FDA); topline data are now expected in 1Q 2026.
Initiated Phase 3 ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials in MASH.
Completed enrollment in the Phase 3 ENTRUST trial for SHTG.
Completed follow-on equity offerings in 4Q 2024 and 1Q 2025, grossing $143.7 million and $287.5 million, respectively.
Cash, cash equivalents, and marketable securities totaled $440.0 million as of December 31, 2024.
89Bio
89Bio
Forward Guidance
89bio is focused on advancing its clinical trials and completing scale-up and regulatory activities for a potential BLA filing, pending positive Phase 3 trial results.
Positive Outlook
- Potential for accelerated approval in the United States and conditional approval in Europe for MASH.
- Ongoing Phase 3 trials for pegozafermin in MASH and SHTG.
- Regulatory feedback obtained from the FDA and EMA.
- Pegozafermin has potential as a best-in-class therapy for liver and cardiometabolic diseases.
- Data analyses from the Phase 2b ENLIVEN trial highlighting potential anti-fibrotic effects
Challenges Ahead
- Topline data from ENTRUST trial now expected in 1Q 2026.
- Reliance on positive results from Phase 3 trials for BLA filing.
- Increased R&D expenses due to contract manufacturing and clinical trial costs.
- Uncertainties regarding the timing and outcome of clinical trials.
- Dependence on the success of lead product candidate, pegozafermin.