89bio, Inc. has recently released its 10-Q report, revealing its continued focus on the development and commercialization of therapies for liver and cardio-metabolic diseases. The company's lead product candidate is pegozafermin, a glycoPEGylated analog of fibroblast growth factor 21, aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia. The company was founded in 2018 and is headquartered in San Francisco, California.
In the 10-Q report, 89bio detailed its progress in the development of pegozafermin, particularly in its Phase 3 clinical trials for MASH and severe hypertriglyceridemia. The U.S. Food and Drug Administration (FDA) has granted pegozafermin Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted it Priority Medicines Designation (PRIME) for MASH. The company is actively enrolling patients for its Phase 3 ENLIGHTEN program, which consists of two global, randomized, double-blind, placebo-controlled trials, with the expectation of reporting topline data from the histology cohort in the first half of 2027.
Moreover, 89bio is also advancing pegozafermin for the treatment of severe hypertriglyceridemia, with the completion of enrollment in the first Phase 3 trial, ENTRUST, in December 2024. The company expects to report topline data from the ENTRUST trial in the first quarter of 2026.
In terms of financial performance, the 10-Q report revealed that 89bio's total operating expenses for the three months ended March 31, 2025, amounted to $75.9 million, compared to $57.3 million for the same period in 2024. The increase in research and development expenses was primarily driven by additional spending across Phase 3 clinical programs and personnel-related expenses, while general and administrative expenses increased due to higher headcount.
As of March 31, 2025, 89bio had cash, cash equivalents, and marketable securities of $638.8 million and an accumulated deficit of $895.8 million. The company has utilized various sources of liquidity, including At-the-Market (ATM) offerings and underwritten public offerings to support its ongoing operations and clinical development efforts. Following these announcements, the company's shares moved 7.4%, and are now trading at a price of $8.73. For the full picture, make sure to review 89bio's 10-Q report.
