89Bio Q2 2021 Earnings Report
Key Takeaways
89bio reported a net loss of $20.7 million for the quarter ended June 30, 2021. The company had cash, cash equivalents, and short-term investments of $171.0 million as of June 30, 2021. The company initiated Phase 2b ENLIVEN trial in NASH patients and completed enrollment in NASH histology cohort.
Initiated Phase 2b ENLIVEN trial in NASH patients.
Completed target enrollment of 20 patients in open-label histology cohort in biopsy-confirmed fibrosis stage F2 – F3 NASH patients.
Planning to initiate a pharmacokinetic study in NASH patients with compensated cirrhosis in 3Q21.
Topline data from the Phase 2 ENTRIGUE trial in severe hypertriglyceridemia patients expected in the first half of 2022.
89Bio
89Bio
Forward Guidance
89bio is focused on advancing BIO89-100 for NASH and severe hypertriglyceridemia, with multiple clinical trials underway and data readouts expected in the near future.
Positive Outlook
- Initiated ENLIVEN Phase 2b trial of BIO89-100 for the treatment of NASH.
- Completed target enrollment in open-label histology cohort in biopsy-confirmed NASH patients.
- Initiate Pharmacokinetic (PK) study in NASH patients with compensated cirrhosis (fibrosis stage F4) in 3Q21.
- Report topline data from the Phase 2 ENTRIGUE trial of BIO89-100 in severe hypertriglyceridemia patients in the first half of 2022.
- Strengthened leadership team with key hires across different functions.
Challenges Ahead
- Expectations regarding the timing and outcome of 89bio’s initiation of the Phase 2b ENLIVEN trial in NASH and Phase 2 ENTRIGUE trial in SHTG.
- Expectations regarding the timing of topline data.
- 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.
- The effect of the COVID-19 pandemic on 89bio’s clinical trials and business operations, and the impact of general economic, health, industrial or political conditions in the United States or internationally.