Net Loss. 89bio reported a net loss of $118.4 million and $367.1 million for the three
months and year ended December 31, 2024, respectively, compared to a net loss of $40.2 million and $142.2 million for the three months and year ended December 31, 2023, respectively. The increased net loss in both the current
quarter and the current year was primarily driven by higher research and development expenses associated with contract manufacturing and the advancement of the Company’s Phase 3 programs, along with increased general and administrative expenses
due to expanded operations and headcount growth. These increases were partially offset by higher interest income for the full year ending December 31, 2024.
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
in Phase 3 trials for its lead candidate, pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, 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. 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, the safety and tolerability profile of pegozafermin, trial designs, clinical development plans and timing for pegozafermin, including the topline histology data from the ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials in
patients with non-cirrhotic (F2-F3) and compensated cirrhotic (F4) MASH, topline results from the ENTRUST Phase 3 trial in SHTG, the possibility of obtaining accelerated
approval in the United States and conditional approval in Europe in non-cirrhotic MASH (F2-F3) patients and compensated cirrhosis (F4) MASH patients and the possibility
of outcomes data supporting full approval, and plans for scale-up and regulatory activities ahead of a potential BLA filing. 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 89bio’s filings with the Securities and Exchange Commission
(SEC)), many of which are beyond 89bio’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the timing and outcome of the ENLIGHTEN-Fibrosis Phase 3 trial and
Phase 3 ENLIGHTEN-Cirrhosis trial in MASH and ENTRUST Phase 3 trial in SHTG; 89bio’s 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; 89bio’s substantial dependence on the success of it lead product candidate; competition from competing products; the
