About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of
best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead
candidate, pegozafermin, through clinical development for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. Pegozafermin has been granted Breakthrough
Therapy designation for the treatment of NASH with fibrosis from U.S. Food and Drug Administration (FDA). The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn.
Forward-looking Statements
Certain statements in this
press release may constitute forward-looking statements within the meaning of the federal securities laws, including, but not limited to, statements regarding the therapeutic potential and utility, efficacy and clinical benefits of
pegozafermin, including the relationship between the results from the Phase 2 ENLIVEN trial and potential results of future clinical studies such as whether sustained improvement in key liver health markers observed could lead to greater
histological efficacy, the safety and tolerability profile of pegozafermin, trial designs, clinical development plans and timing for pegozafermin, including the ENTRUST Phase 3 trial in SHTG and the NASH Phase 3 trial, and anticipated work
with regulatory authorities. Words such as may, might, will, objective, intend, should, could, can, would, expect,
believe, design, estimate, predict, potential, anticipate, goal, opportunity, develop, plan or the negative of these terms, and
similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such
forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including,
without limitation, those set forth in 89bios filings with the Securities and Exchange Commission (SEC)), many of which are beyond 89bios control and subject to change. Actual results could be materially different. Risks and
uncertainties include: expectations regarding the initiation of the Phase 3 trial in NASH; expectations regarding the timing and outcome of the ENTRUST Phase 3 trial in SHTG; 89bios 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; receipt of BTD for pegozafermin in NASH may not result in a faster development process, review or approval compared to drugs considered for
approval under conventional FDA procedures and does not assure ultimate approval by the FDA; 89bios substantial dependence on the success of its lead product candidate; competition from competing products; the impact of general economic,
health, industrial or political conditions in the United States or internationally; the sufficiency of 89bios capital resources and its ability to raise additional capital; and other risks and uncertainties identified in 89bios Annual
Report on Form 10-K for the year ended December 31, 2022 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities
Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.