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Mar 31, 2023
89Bio Q1 2023 Earnings Report
89bio reported first quarter 2023 financial results and provided a corporate update.
Key Takeaways
89bio reported positive topline results from the ENLIVEN Phase 2b trial of pegozafermin in NASH, demonstrating high statistical significance on both primary histology endpoints. The company completed an underwritten public offering with $316.2 million in gross proceeds and had a cash balance of $480.9 million as of March 31, 2023.
Positive topline results from ENLIVEN Phase 2b trial of pegozafermin in NASH demonstrated high statistical significance on both primary histology endpoints supporting advancement to Phase 3.
Discussions with regulatory agencies are planned for the second half of 2023.
SHTG Phase 3 trial is expected to be initiated in the second quarter of 2023.
Completed underwritten public offering with $316.2 million in gross proceeds; cash balance of $480.9 million as of March 31, 2023.
89Bio
89Bio
Forward Guidance
89bio is focused on advancing pegozafermin through clinical development for NASH and SHTG. The company plans to meet with the FDA and pursue EU scientific advice. Clinical development plans include Phase 3 trials for F2/F3 and F4 patients.
Positive Outlook
- Pegozafermin shows therapeutic potential and clinical benefits.
- Pegozafermin has a favorable safety and tolerability profile.
- Phase 3 trial in SHTG is expected to be initiated.
- Phase 3 trial is planned based on results from the Phase 2b ENLIVEN trial.
- The company expects to meet with regulatory authorities.
Challenges Ahead
- Positive results from clinical studies may not be predictive of future results.
- 89bio is substantially dependent on the success of its lead product candidate.
- Competition from competing products.
- Impact of general economic, health, industrial, or political conditions.
- Sufficiency of 89bio’s capital resources and ability to raise additional capital.