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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), a clinical-stage biopharmaceutical company, announced that CEO Rohan Palekar will present at the H.C. Wainwright 4th Annual NASH Investor Conference on October 5, 2020, at 11:30 AM ET. The event will be available via live and archived webcast on the company's website. 89bio is focused on developing innovative therapies for liver and cardio-metabolic diseases, with its lead product candidate, BIO89-100, targeting NASH and severe hypertriglyceridemia. The company is based in San Francisco and has operations in Israel.
89bio, Inc. (Nasdaq: ETNB) has announced the pricing of an upsized public offering of 3,300,000 shares at $28.00 each, aiming for gross proceeds of approximately $84.7 million. The offering consists of 3,025,000 shares from 89bio and 275,000 shares from a selling stockholder. Additionally, the underwriters have a 30-day option to purchase up to 495,000 additional shares. The offering is expected to close on September 21, 2020, pending customary conditions. BofA Securities, SVB Leerink, and RBC Capital Markets are leading the offering.
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced a public offering of 3,000,000 shares of common stock. This includes 2,700,000 shares from the company and 300,000 shares from stockholders. There is also an option for underwriters to purchase an additional 450,000 shares. The proceeds will support the BIO89-100 programs targeting nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The offering depends on market conditions and a registration statement that has yet to become effective.
89bio (Nasdaq: ETNB) announced positive topline results from its Phase 1b/2a trial of BIO89-100, an investigational FGF21 analog for nonalcoholic steatohepatitis (NASH). All dose groups achieved significant liver fat reductions, with up to 70% versus placebo. Notably, 88% of subjects had at least a 30% reduction in liver fat. The treatment demonstrated a strong safety profile, with low adverse event incidence. BIO89-100 is positioned as a promising therapy for NASH, with further trials planned in 2021.
89bio, Inc. (Nasdaq: ETNB) announced plans to share topline safety, tolerability, and efficacy data from its Phase 1b/2a study of BIO89-100 for NASH on September 14, 2020. The presentation will take place during a pre-market conference call at 8:30 AM PT, featuring a live webcast accessible through the company’s website. BIO89-100 is a glycoPEGylated analog of FGF21 aimed at treating NASH and severe hypertriglyceridemia. Investors can find further information on the event and future developments on the company’s investor relations page.
89bio, Inc. (Nasdaq: ETNB) announced the initiation of a Phase 2 trial for BIO89-100, targeting severe hypertriglyceridemia (SHTG), with enrollment of approximately 90 participants. This double-blind, placebo-controlled study seeks to evaluate the safety and efficacy of BIO89-100, a glycoPEGylated analog of FGF21. The primary endpoint focuses on reducing fasting triglycerides, while secondary endpoints include effects on other lipids and liver fat reduction. This study builds on promising early clinical data suggesting significant metabolic benefits, addressing a crucial need for alternative therapies.
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced CEO Rohan Palekar's participation in two upcoming conferences. He will speak at the BTIG Virtual Biotechnology Conference on August 10, 2020, at 11:30 AM ET, and at the Canaccord Genuity 40th Annual Growth Conference on August 12, 2020, at 10:00 AM ET. The company is developing therapies for liver and cardio-metabolic diseases, including its lead candidate, BIO89-100, targeted for NASH treatment. Webcasts will be available on their website after the events.
89bio, Inc. (Nasdaq: ETNB) has completed its upsized public offering of 3,047,040 shares of common stock, including the underwriters' additional purchase option. The offering price was $27.50 per share, generating approximately $83.8 million in gross proceeds, before expenses. This fundraise will support the development of innovative therapies for liver and cardio-metabolic diseases, particularly their lead candidate, BIO89-100, which is currently in clinical trials for NASH and NAFLD. The offering was led by BofA Securities, SVB Leerink, and RBC Capital Markets.
89bio, a clinical-stage biopharmaceutical company, announced an upsized public offering of 2,649,600 shares at $27.50 each, totaling approximately $72.9 million in gross proceeds. The underwriters also have a 30-day option to buy an additional 397,440 shares. The offering is expected to close on July 10, 2020. Major financial institutions, including BofA Securities and SVB Leerink, are managing the offering. The proceeds are aimed at advancing 89bio’s development of innovative therapies for liver and cardio-metabolic diseases, specifically targeting NASH and SHTG.
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), has announced a public offering of 2,200,000 shares of its common stock, with an option for underwriters to purchase an additional 330,000 shares. Proceeds will support the acceleration of its BIO89-100 programs for treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The offering is contingent on market conditions, and full details will be available in the prospectus.