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Dec 31, 2024
89Bio Q4 2024 Earnings Report
89bio reported its financial results for the fourth quarter and full year ended December 31, 2024, with a net loss of $118.4 million and a diluted EPS of -$1.02.
Key Takeaways
89bio, a clinical-stage biopharmaceutical company, reported a net loss of $118.4 million for the fourth quarter of 2024, an increase from the $40.2 million net loss in the same period last year. This was primarily driven by higher research and development expenses due to contract manufacturing and the advancement of Phase 3 programs, as well as increased general and administrative expenses.
Net loss for Q4 2024 was $118.4 million, significantly higher than $40.2 million in Q4 2023.
Diluted EPS for Q4 2024 was -$1.02, compared to -$0.50 in Q4 2023.
Research and development expenses increased to $111.3 million in Q4 2024 from $33.6 million in Q4 2023, primarily due to milestone payments and clinical trial costs.
Cash, cash equivalents, and marketable securities totaled $439.955 million as of December 31, 2024.
89Bio
89Bio
Forward Guidance
89bio anticipates continued progress in its clinical trials for MASH and SHTG, with topline histology data for ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis expected in 1H 2027 and 2028, respectively. Topline data for the ENTRUST trial in SHTG is now expected in 1Q 2026.
Positive Outlook
- ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials continue to advance with topline histology data expected in 1H 2027 and 2028.
- Data from histology cohorts of both trials are intended to support accelerated approval in the United States and conditional approval in Europe.
- The company remains on track for potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings, pending positive clinical data.
- Pegozafermin has the potential to significantly impact the lives of patients suffering from advanced MASH and SHTG due to its robust fibrosis benefit, tolerability, safety profile, and convenient dosing.
- Completed follow-on equity offerings in 4Q 2024 and 1Q 2025 for gross proceeds of $143.7 million and $287.5 million, respectively, strengthening financial position.
Challenges Ahead
- Topline data for the Phase 3 ENTRUST trial in SHTG is now expected in 1Q 2026, a delay from previous expectations.
- The unblinding of the ENTRUST trial will occur after study completion at Week 52, which may introduce potential bias if data were unblinded earlier.
- The company's ability to obtain accelerated approval and full approval is contingent on positive results from Phase 3 trials.
- Future results from clinical studies may not necessarily be predictive of the results of ongoing clinical studies.
- The company faces risks and uncertainties, including those related to general economic, health, industrial, or political conditions, and competition from other products.