89Bio Q3 2022 Earnings Report
Key Takeaways
89bio reported a net loss of $26.8 million for the third quarter ended September 30, 2022. The company's cash, cash equivalents, and short-term investments totaled $193.3 million as of September 30, 2022. Enrollment was completed in the ENLIVEN Phase 2b NASH trial, with topline data expected in Q1 2023.
Completed enrollment in ENLIVEN Phase 2b NASH trial with topline data expected in the first quarter of 2023.
Presented additional post-hoc exploratory analyses from the Phase 1b/2a NASH study of pegozafermin at AASLD The Liver Meeting® 2022.
Reported additional positive data from ENTRIGUE Phase 2 trial of pegozafermin in severe hypertriglyceridemia patients at European Society of Cardiology Congress 2022.
Initiation of Phase 3 trial of pegozafermin in SHTG patients expected in the first half of 2023.
89Bio
89Bio
Forward Guidance
89bio anticipates several milestones, including topline data from the ENLIVEN Phase 2b trial in Q1 2023 and initiation of a Phase 3 trial in SHTG in the first half of 2023.
Positive Outlook
- Pegozafermin has therapeutic potential and clinical benefits.
- Pegozafermin has a positive clinical benefit, safety and tolerability profile.
- Phase 2b ENLIVEN trial is underway.
- Topline data for the ENLIVEN trial is expected.
- Phase 3 trial in SHTG is expected to be initiated.
Challenges Ahead
- The timing and outcome of the Phase 2b ENLIVEN trial in NASH are uncertain.
- The timing of topline data is uncertain.
- The initiation of the Phase 3 trial in SHTG is uncertain.
- 89bio's ability to execute on its strategy is not guaranteed.
- Positive results from a clinical study may not be predictive of future results.