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Mar 31, 2021
89Bio Q1 2021 Earnings Report
Reported financial results for the first quarter of 2021 and provided a corporate update.
Key Takeaways
89bio reported its Q1 2021 financial results, highlighting the FDA's written guidance on the Phase 2b ENLIVEN trial design for NASH and a cash position of $189.6 million as of March 31, 2021.
Received FDA guidance on Phase 2b ENLIVEN trial design for NASH, planned to initiate in Q2 2021.
Topline data from the paired-biopsy, open-label histology cohort in NASH patients expected by year-end 2021.
Topline data from the Phase 2 ENTRIGUE trial in severe hypertriglyceridemia patients expected in 2H21.
Cash, cash equivalents, and short-term investments totaled $189.6 million as of March 31, 2021.
89Bio
89Bio
Forward Guidance
89bio anticipates several milestones, including initiating the ENLIVEN Phase 2b trial in NASH, reporting topline data from the paired-biopsy cohort in NASH patients, and reporting topline data from the ENTRIGUE Phase 2 trial in severe hypertriglyceridemia patients.
Positive Outlook
- Initiate Phase 2b ENLIVEN trial in NASH in Q2 2021.
- Report topline data from paired-biopsy, open-label histology cohort in NASH patients by year-end 2021.
- Report topline data from Phase 2 ENTRIGUE trial in severe hypertriglyceridemia patients in 2H21.
- BIO89-100 has potential in both NASH and severe hypertriglyceridemia (SHTG).
- Well-funded to reach multiple clinical and regulatory milestones.
Challenges Ahead
- COVID-19 surge in Europe has resulted in enrollment challenges in certain geographies for the ENTRIGUE trial.
- The timing and outcome of 89bio’s initiation of the Phase 2b ENLIVEN trial in NASH and Phase 2 ENTRIGUE trial in SHTG are uncertain.
- Expectations regarding the timing of topline data are uncertain.
- Positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies.
- The effect of the COVID-19 pandemic on 89bio’s clinical trials and business operations is uncertain.