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Mar 31, 2022
89Bio Q1 2022 Earnings Report
89Bio reported financial results for Q1 2022 and provided a corporate update.
Key Takeaways
89bio reported a net loss of $25.6 million for the first quarter of 2022. The company's cash, cash equivalents, and short-term investments totaled $126.1 million as of March 31, 2022, which is expected to fund operations into the second half of 2023.
ENTRIGUE Phase 2 trial of pegozafermin in severe hypertriglyceridemia (SHTG) patients remains on track with topline data expected in the second quarter of 2022.
ENLIVEN Phase 2b NASH trial enrollment completion expected in the third quarter of 2022 followed by topline data in the first half of 2023.
R&D expenses were $19.8 million for the three months ended March 31, 2022, compared to $10.1 million for the three months ended March 31, 2021.
As of March 31, 2022, 89bio had cash, cash equivalents, and short-term investments of $126.1 million.
89Bio
89Bio
Forward Guidance
89bio anticipates several milestones, including topline data from the ENTRIGUE trial in SHTG and completion of enrollment in the ENLIVEN trial in NASH.
Positive Outlook
- Topline data for the Phase 2 ENTRIGUE trial of pegozafermin in SHTG patients expected in the second quarter of 2022.
- Positive results from ENTRIGUE would support moving into a Phase 3 program in 2023 following regulatory discussions.
- Expect to complete enrollment in the third quarter of 2022 with ~200 patients in the ENLIVEN Phase 2b trial.
- Topline data from ENLIVEN trial expected in the first half of 2023.
- Sufficient cash to fund operations into the second half of 2023.
Challenges Ahead
- The timing and outcome of the Phase 2b ENLIVEN trial in NASH and Phase 2 ENTRIGUE trial in SHTG are uncertain.
- Positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies.
- 89bio’s substantial dependence on the success of its lead product candidate poses a risk.
- Competition from competing products could adversely affect 89bio’s prospects.
- The effect of the COVID-19 pandemic on 89bio’s clinical trials and business operations remains a concern.