89bio reports Q2 EPS (52c), consensus (41c)

As of June 30, 2023, 89bio had cash, cash equivalents and short-term available-for-sale securities totaling $478.0M. “Progress in our late-stage clinical development programs in both NASH and SHTG further position pegozafermin as a potentially leading FGF21 analog treatment option,” said CEO Rohan Palekar. “The importance of the Phase 2b ENLIVEN trial data in NASH was further validated with the recent New England Journal of Medicine publication. Specifically, the histology data and positive results seen across markers of total liver health in the overall trial population and in patients on background GLP-1 therapies continue to support the therapeutic utility of pegozafermin and highlight the potential opportunity for a combination approach in patients with comorbidities. As we continue to advance towards Phase 3 development, we look forward to discussions with regulatory agencies planned in the second half of 2023. In the second quarter of 2023, we initiated ENTRUST, the Phase 3 trial of pegozafermin in patients with SHTG, signifying entry of the first FGF21 analog into Phase 3 development. Results from our previous trials in SHTG, including the recently published Phase 2 ENTRIGUE data in Nature Medicine, highlight the therapeutic potential of pegozafermin to offer a highly differentiated treatment option that is supportive of adoption and compliance.”