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Dec 31, 2020
89Bio Q4 2020 Earnings Report
89bio reported financial results for Q4 and full year 2020 and provided a corporate update.
Key Takeaways
89bio reported cash, cash equivalents, and short-term investments totaling $204.7 million as of December 31, 2020. R&D expenses were $8.8 million for the three months ended December 31, 2020, and G&A expenses were $3.8 million for the same period. The company anticipates important clinical milestones in 2021 to validate BIO89-100's potential in NASH and SHTG.
Presented updated clinical data from Phase 1b/2a study of BIO89-100 in NASH at AASLD’s The Liver Meeting® 2020 and at ENDO 2021.
Initiate the Phase 2b trial in NASH patients in the first half of 2021.
Report topline data from the paired-biopsy, open-label histology cohort in NASH patients by year-end 2021.
Report topline data from the Phase 2 ENTRIGUE study of BIO89-100 in SHTG patients in the second half of 2021.
89Bio
89Bio
Forward Guidance
89bio anticipates several clinical milestones in 2021, including the initiation of a Phase 2b NASH trial and topline data reports from NASH histology cohort and Phase 2 SHTG trial.
Positive Outlook
- Initiation of BIO89-100 Phase 2b NASH trial planned in 1H21
- NASH histology cohort topline data expected by YE21
- Phase 2 SHTG trial (ENTRIGUE) expected to report topline data in 2H21
- BIO89-100's compelling efficacy profile and favorable tolerability with weekly and every two-week dosing confirmed
- Significant reductions in liver volume and liver fat volume at 13 weeks compared to baseline in treated patients
Challenges Ahead
- Reliance on forward-looking statements based on current estimates and assumptions
- Various risks and uncertainties could cause actual results to be materially different
- Uncertainties regarding the timing and outcome of the Phase 2b trial in NASH
- Potential effect of the COVID-19 pandemic on clinical trials and business operations
- Impact of general economic, health, industrial or political conditions