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89Bio Q1 2025 Earnings Report
89bio reported its financial results for the first quarter ended March 31, 2025, showing increased R&D and G&A expenses, leading to a higher net loss compared to the previous year, while also providing updates on its clinical trials and a strong cash position.
Key Takeaways
89bio reported a net loss of $71.3 million for the first quarter of 2025, an increase from $51.7 million in the same period last year, primarily due to higher research and development expenses related to advancing its Phase 3 programs and increased general and administrative expenses. The company maintained a strong cash position with $638.8 million in cash, cash equivalents, and marketable securities as of March 31, 2025.
Net loss for Q1 2025 was $71.3 million, up from $51.7 million in Q1 2024.
Research and development expenses increased to $64.4 million in Q1 2025 from $47.4 million in Q1 2024, driven by clinical development of Phase 3 ENLIGHTEN trials.
General and administrative expenses rose to $11.5 million in Q1 2025 from $9.8 million in Q1 2024, mainly due to personnel-related expenses.
Cash, cash equivalents, and marketable securities totaled $638.8 million as of March 31, 2025, bolstered by a $287.5 million follow-on equity offering.
89Bio
89Bio
Forward Guidance
89bio anticipates key data readouts from its Phase 3 trials for MASH and SHTG, aiming for accelerated approval for pegozafermin, and has implemented a flexible global manufacturing strategy.
Positive Outlook
- Topline histology data from ENLIGHTEN-Fibrosis (F2-F3 MASH) expected in 1H 2027.
- Topline histology data from ENLIGHTEN-Cirrhosis (compensated F4 MASH) expected in 2028.
- Both ENLIGHTEN trials are designed to support accelerated approval for MASH.
- Topline data from the Phase 3 ENTRUST trial in SHTG expected in 1Q 2026.
- Flexible, global manufacturing strategy implemented to support development and commercial readiness.
Challenges Ahead
- Future clinical study results may not necessarily be predictive of past positive results.
- Substantial dependence on the success of the lead product candidate, pegozafermin.
- Competition from other products in the market could impact performance.
- General economic, health, industrial, or political conditions could affect operations.
- Changes in regulatory policies or leadership could impact approvals and existing regulations.