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Jun 30, 2023
89Bio Q2 2023 Earnings Report
89Bio reported financial results for Q2 2023 and provided a corporate update.
Key Takeaways
89bio reported a net loss of $38.4 million for the second quarter ended June 30, 2023. The company's cash, cash equivalents, and short-term available-for-sale securities totaled $478.0 million as of June 30, 2023. The company initiated ENTRUST, the Phase 3 trial of pegozafermin in patients with SHTG.
Data from the Phase 2b ENLIVEN trial in NASH were published in NEJM and presented at the EASL Congress 2023.
New analyses presented at EASL showed pegozafermin resulted in significant benefit across several key sub populations of NASH patients.
The Company initiated ENTRUST, a Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with SHTG.
Positive data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with SHTG were published in Nature Medicine.
Forward Guidance
The Company intends to meet with the U.S. Food and Drug Administration in the second half of 2023 and to pursue European Union scientific advice in parallel. Subject to regulatory feedback, the Company’s proposed clinical development plans include a Phase 3 trial evaluating F2/F3 NASH patients with a histology endpoint for accelerated approval and a Phase 3 trial in parallel with an outcomes endpoint for full approval. The SHTG Phase 3 program is expected to also support the safety database requirements at the time of BLA submission.
Historical Earnings Impact
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