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89bio, Inc. (Nasdaq: ETNB) is a clinical-stage biopharmaceutical company headquartered in San Francisco, California. Since its founding in 2018, 89bio has been committed to developing and commercializing innovative therapies for the treatment of liver and cardio-metabolic diseases, addressing critical unmet medical needs.
The company’s lead product candidate is pegozafermin (formerly BIO89-100), a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin has shown promise in treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). This candidate targets metabolic dysfunction-associated steatohepatitis (MASH), which can lead to severe liver complications, including cirrhosis and liver failure.
89bio is actively advancing pegozafermin through various phases of clinical trials. Recently, the company announced a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), allowing them to proceed to Phase 3 trials. Two Phase 3 trials, ENLIGHTEN-Cirrhosis and ENLIGHTEN-Fibrosis, are set to enroll patients in 2024. The ENLIGHTEN program aims to evaluate the efficacy and safety of pegozafermin in patients with different stages of liver fibrosis.
Pegozafermin has demonstrated strong anti-fibrotic and anti-inflammatory properties in the liver, as well as improved lipid metabolism, insulin resistance, and glycemic control. It has received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) status from the European Medicines Agency (EMA), emphasizing its therapeutic potential and the urgency for such treatments.
Financially, 89bio reported substantial cash reserves, ensuring robust support for ongoing clinical activities. As of December 31, 2023, the company had $578.9 million in cash and equivalents. This strong financial position enables continued development and potential scaling up for commercial production.
89bio maintains strategic partnerships to bolster its clinical and commercialization efforts. These collaborations are crucial as the company aims to bring pegozafermin to market, providing solutions for patients with liver and cardio-metabolic diseases who lack effective treatment options.
For more detailed updates, recent financial results, and upcoming milestones, visit their official website or follow their LinkedIn profile.
89bio, Inc. (Nasdaq: ETNB) announced significant advancements in its clinical development program during Q3 2020. Positive results from the Phase 1b/2a trial of BIO89-100 for NASH highlighted a 70% liver fat reduction and excellent tolerability. The company is set to present data at the AASLD Liver Meeting and initiate a Phase 2b trial in NASH in H1 2021. Financially, 89bio reported a net loss of $14.6 million, improving from $18.7 million year-over-year, with cash reserves at $219.2 million, supporting ongoing research initiatives.
89bio, Inc. (Nasdaq: ETNB) announced the presentation of promising clinical data for its drug BIO89-100 targeted at treating nonalcoholic steatohepatitis (NASH) during The Liver Meeting Digital Experience™ 2020 from November 13-16. Results from a Phase 1b/2a study revealed significant reductions in liver fat via MRI-PDFF, with favorable safety and tolerability profiles, suggesting potential best-in-class dosing. The study demonstrated robust efficacy with both weekly and biweekly dosing, highlighting the drug's potential as a treatment in a field lacking approved options.
89bio, a clinical-stage biopharmaceutical company focused on liver and cardio-metabolic diseases, 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 presentation will be available via live and archived webcast on the company’s website. 89bio's lead product, BIO89-100, targets nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The company is headquartered in San Francisco with operations in Herzliya, Israel.
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.
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