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Overview
89Bio, Inc. (symbol: ETNB) is a United States-based clinical-stage biopharmaceutical company committed to advancing innovative therapies for patients with liver and cardiometabolic diseases. Employing cutting-edge glycoPEGylation technology, the company is focused on enhancing the biological activity and prolonging the half-life of its therapeutic candidates through advanced drug engineering. With a robust pipeline centered on conditions such as metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG), 89Bio is addressing significant unmet clinical needs with precision and scientific rigor.
Core Business and Product Pipeline
The company’s primary focus is on the development and eventual commercialization of pegozafermin, a specifically engineered fibroblast growth factor 21 (FGF21) analog. This molecule, enhanced by unique glycoPEGylated technology, has been designed to exert potent anti-fibrotic and metabolic effects. It aims to treat advanced liver conditions by reducing fibrosis and ameliorating metabolic dysregulation, a dual approach that positions 89Bio uniquely in the biotech landscape. Beyond its lead candidate, the company continues to explore additional therapeutic avenues within the liver and cardiometabolic realms, ensuring a diversified approach to clinical development.
Clinical Development and Research
89Bio has structured its clinical research around rigorous Phase 3 trials, notably the ENLIGHTEN program, which encompasses pivotal studies in both non-cirrhotic MASH (with fibrosis stages F2-F3) and MASH with compensated cirrhosis (F4). These randomized, double-blind, placebo-controlled trials are designed to evaluate key endpoints such as histological improvements in liver fibrosis and resolution of steatohepatitis. By integrating noninvasive diagnostic tools alongside traditional biopsy assessments, the company aims to streamline patient evaluation and enhance the sensitivity of therapeutic response measurement. Moreover, the advanced design of these trials reflects 89Bio's commitment to scientific excellence and clear regulatory communication, as evidenced by recent supportive designations from global regulatory bodies.
89bio, Inc. (Nasdaq: ETNB) has announced the pricing of its public offering of 16,923,077 shares of common stock at $16.25 per share, which will raise approximately $275 million in gross proceeds. The offering includes a 30-day option for underwriters to purchase an additional 2,538,461 shares. The offering is expected to close around March 28, 2023, subject to customary conditions. BofA Securities, SVB Securities, and Evercore ISI are acting as lead book-running managers. 89bio focuses on innovative therapies for liver and cardio-metabolic diseases, with its lead candidate targeting non-alcoholic steatohepatitis (NASH).
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced a public offering of $200 million in common stock or pre-funded warrants. The offering includes a 30-day option for underwriters to purchase an additional $30 million. Proceeds will support clinical activities for pegozafermin, focusing on liver and cardio-metabolic diseases. The offering is subject to market conditions. BofA Securities, SVB Securities, and Evercore ISI are the book-running managers. The company emphasizes that this press release is not an offer to sell securities, as per SEC regulations.
89bio, Inc. (ETNB) announced positive results from its Phase 2b ENLIVEN trial of pegozafermin in patients with nonalcoholic steatohepatitis (NASH). The trial demonstrated statistically significant improvements in fibrosis and NASH resolution, with the 44mg Q2W and 30mg QW doses achieving placebo-adjusted effect sizes of 20% and 19% for fibrosis improvement, and 24% and 21% for NASH resolution, respectively. The study's results support progression to Phase 3 trials, highlighting pegozafermin’s potential as a differentiated treatment for NASH. The company’s rigorous methodology adds credibility to the findings.
89bio, a clinical-stage biopharmaceutical company, reported significant advancements in its late-stage development program for pegozafermin. Key updates include topline results from the ENLIVEN Phase 2b trial for NASH, anticipated in Q1 2023, and FDA feedback supporting a Phase 3 program for severe hypertriglyceridemia (SHTG), with trials set to begin in Q2 2023. Financially, the company held $188.2 million in cash as of December 31, 2022, a rise from $150.7 million in 2021. However, net losses increased to $102 million for the year, driven by higher R&D and G&A expenses.
89bio, a clinical-stage biopharmaceutical company, presented additional findings from the Phase 2 ENTRIGUE trial at ACC.23/WCC, demonstrating that pegozafermin significantly reduced triglycerides and atherogenic lipids in patients with severe hypertriglyceridemia (SHTG).
The study involved 85 participants, showing a 62% reduction in triglycerides for patients not on background therapy and 68% for those on lipid-modifying therapy, compared to placebo. The overall success of pegozafermin supports advancing to a Phase 3 trial. This treatment is expected to offer new therapeutic options for SHTG, which affects millions in the U.S., presenting a compelling profile for cardiovascular risk reduction.
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