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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 the appointment of E. Morrey Atkinson, Ph.D., to its Board of Directors. Dr. Atkinson, with over 20 years of expertise in biopharmaceutical development and manufacturing, previously held senior roles at Vertex and Bristol Myers Squibb. CEO Rohan Palekar emphasized Atkinson’s valuable experience in optimizing manufacturing and commercializing therapies. This comes after promising data from the Phase 1b/2a study of 89bio's lead candidate, pegozafermin, targeting liver diseases like NASH and SHTG.
89bio, a clinical-stage biopharmaceutical company (Nasdaq: ETNB), announced its participation in the SVB Leerink 11th Annual Global Healthcare Conference on February 16, 2022, at 12:00 PM ET. The management team will engage in a fireside chat and one-on-one investor meetings. A presentation will be available via the conference portal and archived on its website.
89bio, focused on therapies for liver and cardio-metabolic diseases, announced positive results from a Phase 1b/2a study of pegozafermin for treating NASH. In an expansion cohort of 20 patients, 63% achieved a 2-point improvement in NAS without worsening fibrosis, with 32% showing NASH resolution. The treatment also showed significant changes in liver health and cardio-metabolic markers, with pegozafermin being generally well tolerated. The ongoing Phase 2b ENLIVEN trial is expected to provide further insights, with results anticipated in the first half of 2023.
89bio, Inc. (Nasdaq: ETNB) recently presented findings from the Phase 1b/2a study of BIO89-100 at The Liver Meeting 2021, revealing a significant average reduction of 11.8% in spleen volume among NASH patients. This post-hoc analysis establishes a correlation between liver fat reduction and decreased spleen volume, suggesting improved portal blood flow as a mechanism. The oral presentation was recognized by the AASLD as a key presentation at the event. With promising preliminary data, 89bio aims to further explore BIO89-100's therapeutic potential for NASH.
89bio, Inc. (Nasdaq: ETNB) reported its Q3 2021 financial results, highlighting significant advancements in its clinical program for BIO89-100, targeted at liver and cardio-metabolic diseases. The company plans to release data from its NASH study in January 2022 and from its SHTG study in the first half of 2022. As of September 30, 2021, 89bio had $157.4 million in cash but reported a net loss of $28.3 million for Q3 2021, an increase from the previous year, mainly due to rising R&D and G&A expenses.
89bio, Inc. (Nasdaq: ETNB) has appointed Kathy LaPorte to its Board of Directors, effective immediately. LaPorte brings over 30 years of biotech industry experience, enhancing operational capabilities and driving growth. CEO Rohan Palekar praised her expertise as invaluable for advancing the ongoing clinical development of BIO89-100, a potential treatment for NASH. LaPorte's background includes leadership roles in various biotech boards and a strong record in venture investing.
This strategic appointment aims to bolster 89bio's efforts in developing innovative therapies for liver and cardio-metabolic diseases.
89bio, Inc. (ETNB) announced new findings from a sub-analysis of its Phase 1b/2a study on BIO89-100 for non-alcoholic steatohepatitis (NASH), revealing a correlation between increased liver fat and spleen volume. The results will be presented at the AASLD The Liver Meeting 2021, taking place virtually from November 12-15, 2021. Additionally, the population pharmacokinetics and pharmacodynamics of BIO89-100 will be showcased. This treatment is engineered to enhance the biological activity of FGF21, aimed at addressing the root causes of NASH and severe hypertriglyceridemia.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, announced a corporate update and one-on-one investor meetings at the Cantor Global Healthcare Conference on September 28, 2021, at 2:40 p.m. ET. The event will be virtual, and the presentation can be accessed via the investor section of 89bio's website. The company focuses on innovative therapies for liver and cardio-metabolic diseases, with its lead candidate BIO89-100 targeting nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
89bio, Inc. (Nasdaq: ETNB) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation will be available on-demand starting September 13 at 7:00 a.m. ET via the H.C. Wainwright conference portal. An archived webcast will be accessible on 89bio’s website. 89bio focuses on innovative therapies for liver and cardio-metabolic diseases, with its lead product candidate, BIO89-100, targeting nonalcoholic steatohepatitis and severe hypertriglyceridemia.
89bio, Inc. (Nasdaq: ETNB) announced the initiation of the Phase 2b ENLIVEN trial for its leading drug candidate BIO89-100, targeting patients with NASH. The trial will assess safety and efficacy over 48 weeks with various dosing strategies. The company completed enrollment in the histology cohort and expects topline data by year-end 2021. Financially, 89bio reported a net loss of $20.7 million for Q2 2021, driven by increased R&D expenses totaling $15.6 million. As of June 30, 2021, the company held $171 million in cash and equivalents, positioning it strongly for ongoing clinical developments.
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