89bio, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for the treatment of liver and cardiometabolic diseases. The company's lead product candidate, pegozafermin, is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21) that is currently being evaluated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).
Company History and Growth
89bio was formed as a Delaware corporation in June 2019 to carry on the business of 89Bio Ltd., which was incorporated in Israel in January 2018. The company's origins trace back to 89Bio Ltd., which was incorporated in Israel in 2018. In 2019, 89Bio Ltd. underwent an internal reorganization transaction, resulting in the formation of 89bio, Inc. as the new parent company.
Since its inception, 89bio has made significant progress in advancing its lead product candidate, pegozafermin, through clinical development. In 2020 and 2022, the company reported positive topline results from its Phase 1b/2a trial of pegozafermin in MASH patients. In March 2023, 89bio reported positive topline 24-week data from its Phase 2b ENLIVEN trial of pegozafermin, including fibrosis benefits in both non-cirrhotic F2-F3 and compensated cirrhotic F4 MASH patients.
The FDA granted Breakthrough Therapy designation to pegozafermin in patients with MASH in September 2023, and in March 2024, the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to pegozafermin in patients with MASH based on clinical data from the ENLIVEN trial.
In December 2023, 89bio held successful end-of-Phase 2 meetings with the FDA and received scientific advice from the EMA, supporting the advancement of pegozafermin into a Phase 3 program and future Biologics License Application (BLA) filing. The company is currently conducting two Phase 3 trials, ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis, evaluating pegozafermin in patients with non-cirrhotic (F2-F3) and compensated cirrhotic (F4) MASH, respectively.
89bio has devoted substantially all of its resources to raising capital, acquiring its initial product candidate, identifying and developing pegozafermin, licensing certain related technology, conducting research and development activities including preclinical studies and clinical trials, and providing general and administrative support. In April 2018, the company entered into two Asset Transfer and License Agreements with Teva Pharmaceutical Industries Ltd., under which it acquired certain patents and intellectual property relating to Teva's glycoPEGylated FGF21 program, including pegozafermin, as well as Teva's development program of small molecule inhibitors of Fatty Acid Synthase. 89bio did not develop any product candidates under the Fatty Acid Synthase program and returned those rights to Teva in 2024.
The company has incurred net losses since its inception, reflecting the substantial investments required for the research and development of its product candidate, pegozafermin. To date, 89bio has financed its operations primarily through the sale of equity securities, including warrants, and from borrowings under term loan facilities. The company has not generated any revenue from product sales and does not expect to receive revenue from pegozafermin for a number of years, if ever.
Financials and Liquidity
As of December 31, 2024, 89bio had cash, cash equivalents, and marketable securities of $440.0 million. This was supplemented by $269.9 million in net proceeds from a follow-on equity offering completed in the first quarter of 2025. The company's strong cash position is expected to fund its planned operating expenses and capital expenditure requirements for at least one year following the filing of its 2024 Annual Report on Form 10-K.
In 2024, 89bio reported a net loss of $367.1 million, with research and development expenses of $345.0 million and general and administrative expenses of $39.6 million. The company did not generate any revenue during this period, as it remains in the clinical-stage of development. For the fourth quarter of 2024, 89bio reported a net loss of $118.4 million.
The increase in net loss from the previous year was primarily driven by $121.5 million in milestone payments made to the company's contract manufacturing partner, BiBo, under a collaboration agreement to secure manufacturing capacity for the potential commercial supply of pegozafermin. Research and development expenses increased to $345.0 million in 2024, up from $122.2 million in 2023, due to the advancement of the company's Phase 3 clinical trials for pegozafermin in MASH and SHTG.
89bio's financial performance has been consistent with the typical cash burn and lack of revenue experienced by clinical-stage biopharmaceutical companies. The company's strategy of focused investment in the development of its lead product candidate, pegozafermin, has resulted in significant research and development expenses, which have contributed to its net losses.
As of December 31, 2024, 89bio had a debt-to-equity ratio of 0.09, indicating a low level of debt relative to equity. The company has a term loan facility with a maximum aggregate principal of $150.0 million, of which $35.0 million was outstanding as of December 31, 2024. The company's current ratio and quick ratio were both 13.19, suggesting a strong short-term liquidity position.
Competitive Landscape and Risks
The biopharmaceutical industry is highly competitive, and 89bio faces competition from both large, established pharmaceutical companies and other specialized biotechnology firms. For the treatment of MASH, 89bio's pegozafermin competes with other therapies in development, such as resmetirom from Madrigal Pharmaceuticals, efruxifermin from Akero Therapeutics, and various GLP-1 receptor agonists.
In the SHTG market, pegozafermin would compete with currently approved therapies, including statins, fibrates, and omega-3 fatty acid products, as well as other novel agents in development, such as APOC3 inhibitors.
Key risks facing 89bio include the inherent uncertainties of clinical development, the potential for delays or failures in obtaining regulatory approvals, the ability to successfully manufacture and supply its product candidates, and the challenge of securing additional funding to support its ongoing operations and future growth.
Product Development and Clinical Trials
89bio's lead product candidate, pegozafermin, is being developed for the treatment of MASH, a severe form of metabolic dysfunction-associated steatotic liver disease characterized by inflammation and fibrosis in the liver that can progress to cirrhosis, liver failure, hepatocellular carcinoma, and death.
The company reported positive topline results from its Phase 2b ENLIVEN trial of pegozafermin in MASH patients. In the ENLIVEN trial, both the 44 mg every-two-week and the 30 mg weekly dose groups met, with high statistical significance, the two primary histology endpoints per the FDA guidance definitions on endpoints for accelerated approval in non-cirrhotic MASH patients. Specifically, the 44 mg every-two-week and the 30 mg weekly dose groups demonstrated at least one-stage fibrosis improvement without worsening of MASH in 27% and 26% of patients, respectively, which was 3.5 times the placebo rate of 7%. Additionally, these dose groups demonstrated MASH resolution without worsening of fibrosis in 26% and 23% of patients, respectively, which was between 12 to 14 times the placebo rate of 2%.
The ENLIVEN trial also included 14 biopsy-confirmed MASH patients with compensated cirrhosis (F4). In a descriptive analysis, five out of 11 pegozafermin-treated patients experienced at least one-stage improvement in liver fibrosis with no worsening of MASH by week 24, compared to zero out of one patient on placebo.
In addition to MASH, 89bio is advancing pegozafermin for the treatment of severe hypertriglyceridemia (SHTG), a condition identified by severely elevated levels of triglycerides (≥500 mg/dL) associated with an increased risk of MASH, cardiovascular events, and acute pancreatitis. The company reported positive topline results from its Phase 2 ENTRIGUE trial of pegozafermin in SHTG patients, which met its primary endpoint demonstrating statistically significant and clinically meaningful reductions in triglycerides from baseline.
Based on these positive results, 89bio has initiated its Phase 3 ENTRUST trial evaluating the efficacy and safety of pegozafermin in SHTG patients. The ENTRUST trial is expected to report topline data in the first quarter of 2026.
Outlook and Conclusion
89bio's focus on developing innovative therapies for the treatment of liver and cardiometabolic diseases, such as MASH and SHTG, positions the company as a promising clinical-stage biopharmaceutical player. The positive data from its Phase 2b ENLIVEN trial and the regulatory designations awarded to pegozafermin underscore the potential of the company's lead asset.
As 89bio advances its Phase 3 trials for pegozafermin, investors will closely follow the company's progress and its ability to navigate the complex clinical development and regulatory landscape. The company's strong cash position provides a solid foundation to support its ongoing operations and future growth initiatives.
While the biopharmaceutical industry is highly competitive, 89bio's differentiated approach and the potential of its lead product candidate, pegozafermin, make the company an intriguing investment opportunity for those with a risk appetite and a long-term outlook on the promising field of liver and cardiometabolic disease treatments.