89bio, Inc. has recently released its 10-Q report, detailing its financial performance and operational updates. The clinical-stage biopharmaceutical company, founded in 2018 and headquartered in San Francisco, California, focuses on developing and commercializing therapies for liver and cardio-metabolic diseases. Its lead product candidate is pegozafermin, a glycoPEGylated analog of fibroblast growth factor 21, intended for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia.
In the 10-Q, the company's management's discussion and analysis of financial condition and results of operations highlighted several key points. The report emphasized the progress of pegozafermin through Phase 3 clinical development, with positive results from Phase 1b/2a and Phase 2b trials. 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 for MASH.
The report also detailed the ongoing Phase 3 ENLIGHTEN program, consisting of two global, randomized, double-blind, placebo-controlled trials for MASH patients. Additionally, the company is advancing pegozafermin for the treatment of severe hypertriglyceridemia, with enrollment completed in the Phase 3 ENTRUST trial, expecting to report topline data in the first quarter of 2026.
Furthermore, the 10-Q provided insights into the company's manufacturing and commercial supply preparedness, including a collaboration agreement with BiBo Biopharma Engineering Co., Ltd. for the construction of a production facility in China. The report also outlined the company's financial performance, indicating a net loss before tax of $71.1 million for the three months ended March 31, 2025, and a total operating expenses of $75.9 million for the same period.
The report highlighted the increase in research and development expenses by $17.0 million, primarily attributed to higher investment in the Phase 3 clinical programs. General and administrative expenses also increased by $1.7 million, driven by higher headcount. Additionally, interest expense increased by $0.4 million, while interest income and other, net decreased by $0.5 million for the same period.
As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of $638.8 million and an accumulated deficit of $895.8 million. The sources of liquidity were detailed, including the At-the-Market (ATM) offerings and underwritten public offerings, which have contributed to the company's financial resources. The market has reacted to these announcements by moving the company's shares 7.4% to a price of $8.73. Check out the company's full 10-Q submission here.
