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Dec 31, 2022
89Bio Q4 2022 Earnings Report
Reported financial results for the fourth quarter and full year ended December 31, 2022.
Key Takeaways
89bio reported a net loss of $24.6 million for the three months ended December 31, 2022. As of December 31, 2022, the company had cash, cash equivalents, and short-term investments totaling $188.2 million.
Topline results from ENLIVEN Phase 2b NASH trial on track for first quarter of 2023.
Feedback from FDA supports advancement of Phase 3 program for pegozafermin in SHTG; plan to initiate first of two SHTG Phase 3 trials in the second quarter of 2023.
Published results of Phase 1b/2a study of pegozafermin for the treatment of NASH in The Lancet Gastroenterology & Hepatology.
Entered into a loan and security agreement with K2 HealthVentures LLC, for an aggregate principal amount of up to $100 million, of which $25 million was drawn at closing.
89Bio
89Bio
Forward Guidance
The company is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
Positive Outlook
- ENLIVEN Phase 2b trial topline data on track for the first quarter of 2023
- Initiation of the first Phase 3 trial planned in the second quarter of 2023 based on feedback from the FDA
- The FDA agreed that the pre-clinical and clinical data package support the advancement of pegozafermin into Phase 3
- Presented new analysis of data from the ENTRIGUE Phase 2 trial highlighting the beneficial effects of pegozafermin in SHTG patients at the American College of Cardiology’s Annual Scientific Session
- 89bio has developed a new pre-filled syringe using its approved liquid formulation and intends to utilize this presentation in its planned SHTG Phase 3 trial in the second quarter of 2023.
Challenges Ahead
- expectations regarding the timing and outcome of the Phase 2b ENLIVEN trial in NASH
- expectations regarding the timing of topline data
- expectations regarding the initiation of the Phase 3 trial in SHTG
- 89bio’s ability to execute on its strategy
- positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies