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89bio, Inc. (ETNB)

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Previous Close24.77
Open24.69
Bid0.00 x 800
Ask0.00 x 800
Day's Range24.69 - 25.72
52 Week Range18.01 - 42.36
Volume105,298
Avg. Volume125,834
Market Cap505.043M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-72.33
Earnings DateMar 24, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est60.25
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  • 89bio Announces Plans for Phase 2b (ENLIVEN) Trial in NASH
    GlobeNewswire

    89bio Announces Plans for Phase 2b (ENLIVEN) Trial in NASH

    - Received written guidance from FDA related to trial design and agreement to use liquid formulation -- ENLIVEN trial to initiate as planned in 2Q21 - SAN FRANCISCO, April 05, 2021 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced it has received written guidance from the U.S. Food and Drug Administration (FDA) on the company’s design of its planned Phase 2b ENLIVEN trial evaluating BIO89-100 for the treatment of patients with fibrosis stage 2 or 3 non-alcoholic steatohepatitis (NASH), including agreement on the use of a liquid formulation. “We look forward to advancing our NASH program with the ENLIVEN trial following our promising Phase 1b/2a data,” said Rohan Palekar, Chief Executive Officer of 89bio. “With its differentiated profile, uniquely engineered structure, and convenient dosing schedule, we believe BIO89-100 has the potential to be a best-in-class FGF21 analog for the treatment of NASH. We believe the liquid formulation will provide a more convenient administration method which we know is critical for compliance for patients living with chronic conditions like NASH.” ENLIVEN will be a multicenter, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the safety and efficacy of BIO89-100 in biopsy-confirmed NASH patients with fibrosis stage 2 or 3. A total of approximately 200 patients will receive either one of two different weekly doses or an every two-week dose of BIO89-100 or placebo for 24 weeks followed by a blinded extension phase of an additional 24 weeks for a total treatment period of 48 weeks. The primary efficacy outcome measures at Week 24 will include the two key histology-based endpoints of NASH resolution without worsening of fibrosis and the improvement of fibrosis ≥ 1 stage without worsening of NASH. The ENLIVEN trial will utilize a liquid formulation of BIO89-100 instead of the frozen formulation used in the Phase 1b/2a trial. About 89bio 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate, BIO89-100, is a specifically engineered glycoPEGylated analog of FGF21. BIO89-100 is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Forward-looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, the therapeutic potential and clinical benefits of BIO89-100, the safety and tolerability of BIO89-100, clinical development plans and timing for BIO89-100, including the Phase 2b (ENLIVEN) trial, the expected trial design for the ENLIVEN trial, including patient enrollment, dosing schedules and trial endpoints. Words such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio's filings with the SEC), many of which are beyond 89bio's control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the timing and outcome of 89bio’s initiation of the Phase 2b trial in NASH; expectations regarding the timing of topline data; 89bio’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; the effect of the COVID-19 pandemic on 89bio’s clinical trials and business operations, and the impact of general economic, health, industrial or political conditions in the United States or internationally; and other risks and uncertainties identified in 89bio's Annual Report on Form 10-K for the year ended December 31, 2020 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Ryan Martins Chief Financial Officer investors@89bio.com Media Contact: Peter Duckler 773-343-3069 pduckler@w2ogroup.com

  • 89bio Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update
    GlobeNewswire

    89bio Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

    - Initiation of BIO89-100 Phase 2b NASH trial planned in 1H21 - - NASH histology cohort topline data expected by YE21 - - Phase 2 SHTG trial (ENTRIGUE) expected to report topline data in 2H21 - SAN FRANCISCO, March 24, 2021 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today reported its financial results for the quarter and full year ended December 31, 2020. “2020 was a transformative year for 89bio, and we are encouraged by the significant progress made in advancing BIO89-100 through the clinic. This was highlighted by our Phase 1b/2a data in NASH patients that underscored the potential for BIO89-100 as a best-in-class FGF21 analog and provided the impetus for advancing BIO89-100 into a Phase 2b trial for the treatment of NASH,” said Rohan Palekar, Chief Executive Officer of 89bio. “We are anticipating some important clinical milestones in 2021 that we expect will continue to validate BIO89-100’s potential in both NASH and SHTG.” Recent Highlights and Anticipated Milestones Presented updated clinical data from Phase 1b/2a study of BIO89-100 in NASH at AASLD’s The Liver Meeting® 2020 and at ENDO 2021. The data presented at AASLD confirmed BIO89-100’s compelling efficacy profile and favorable tolerability with weekly and every two-week dosing. New analyses demonstrated the significant correlation between relative reductions in MRI-PDFF and serum ALT in patients treated with BIO89-100. New analyses of BIO89-100’s Phase 1b/2a study data presented at ENDO 2021 demonstrated significant reductions in liver volume of up to 15% and liver fat volume of up to 65% at 13 weeks compared to baseline in treated patients as measured by MRI-PDFF.Initiate the Phase 2b trial in NASH patients in the first half of 2021. Report topline data from the paired-biopsy, open-label histology cohort in NASH patients by year-end 2021. This cohort is enrolling approximately 20 patients with biopsy-confirmed NASH and will provide an early opportunity to demonstrate BIO89-100’s benefits on histology endpoints.Report topline data from the Phase 2 ENTRIGUE study of BIO89-100 in SHTG patients in the second half of 2021. ENTRIGUE is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate safety, efficacy and tolerability in patients that will receive BIO89-100 administered weekly (9mg, 18mg or 27 mg), every two weeks (36mg) or placebo. The primary endpoint is the reduction in fasting triglycerides from baseline. Key secondary endpoints include other lipids and metabolic markers and change in liver fat measured by MRI-PDFF. ENTRIGUE was expanded recently with an additional cohort of patients on fibrates to assess the benefit of the 27 mg weekly dose of BIO89-100 when added to background fibrates. In this additional cohort, a total of 36 patients will be randomized to either BIO89-100 or placebo. The primary endpoint and key secondary endpoints are the same as in ENTRIGUE, including change in liver fat as measured by MRI-PDFF. Fourth Quarter and Full Year 2020 Financial Results Cash Position. As of December 31, 2020, 89bio had cash, cash equivalents, and short-term investments totaling $204.7 million compared to $93.4 million as of December 31, 2019. This included approximately $157.7 million in estimated net proceeds from underwritten public offerings of common stock in the third quarter of 2020. Research and Development (R&D) Expenses. R&D expenses were $8.8 million and $36.2 million for the three months and year ended December 31, 2020, respectively, compared to $7.2 million and $21.4 million for the three months and year ended December 31, 2019, respectively. The increase for the year ended December 31, 2020 was primarily driven by higher clinical development, contract manufacturing, and personnel expenses. General and Administrative (G&A) Expenses. G&A expenses were $3.8 million and $13.2 million for the three months and year ended December 31, 2020, respectively, compared to $2.4 million and $5.3 million for the three months and year ended December 31, 2019, respectively. The increase for the year ended December 31, 2020 was primarily due to higher personnel expenses and expenses relating to first full year of operations as a public company. About 89bio 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate, BIO89-100, is a specifically engineered glycoPEGylated analog of FGF21. BIO89-100 is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Forward-looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, the therapeutic potential and clinical benefits of BIO89-100, the safety and tolerability of BIO89-100, clinical development plans for BIO89-100, including the Phase 2b trial and open-label paired biopsy histology cohort for NASH and the Phase 2 trial for SHTG, and the anticipated timing for such plans. Words such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio's filings with the SEC), many of which are beyond 89bio's control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the timing and outcome of 89bio’s initiation of the Phase 2b trial in NASH; expectations regarding the timing of topline data; 89bio’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; the effect of the COVID-19 pandemic on 89bio’s clinical trials and business operations, and the impact of general economic, health, industrial or political conditions in the United States or internationally; and other risks and uncertainties identified in 89bio's Annual Report on Form 10-K for the year ended December 31, 2019 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. 89bio, Inc. Condensed Consolidated Statement of Operations Data (Unaudited) (In thousands, except share and per share amounts) Three months Three months Year Year Ended Ended Ended Ended December 31, December 31, December 31, December 31, 2020 2019 2020 2019 Operating expenses: Research and development $8,770 $7,192 $36,199 $21,346 General and administrative 3,777 2,419 13,156 5,294 Total operating expenses 12,547 9,611 49,355 26,640 Loss from operations 12,547 9,611 49,355 26,640 Other (income) expenses, net 116 9,540 203 30,562 Net loss before tax 12,663 19,151 49,558 57,202 Income tax expense (82) 132 (59) 218 Net loss $12,581 $19,283 $49,499 $57,420 Comprehensive loss $12,588 $19,283 $49,509 $57,420 Net loss per share, basic and diluted $0.63 $2.58 $3.08 $24.49 Weighted-average shares used to compute net loss per share, basic and diluted 19,895,952 7,486,577 16,087,785 2,344,191 89bio, Inc. Condensed Consolidated Balance Sheet Data (Unaudited) (In thousands) December 31, December 31, 2020 2019 Cash, cash equivalents, and short-term investments$204,654 $93,360 Total Assets 211,074 95,553 Total current liabilities 8,113 5,609 Total stockholders’ equity 202,961 89,944 Investor Contact: Ryan Martins Chief Financial Officer investors@89bio.com Media Contact: Peter Duckler 773-343-3069 pduckler@w2ogroup.com

  • 89bio Presents Additional Analysis of Phase 1b/2a NASH Study at the Annual ENDO 2021 Conference
    GlobeNewswire

    89bio Presents Additional Analysis of Phase 1b/2a NASH Study at the Annual ENDO 2021 Conference

    New analysis shows BIO89-100 meaningfully reduces liver fat volume and liver volume in patients with NASHSAN FRANCISCO, March 20, 2021 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced additional positive data from its Phase 1b/2a study of BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). The data will be presented in an on-demand poster presentation at ENDO 2021, the Endocrine Society’s annual meeting taking place virtually from March 20-23, 2021. “Excess liver fat is an important driver of disease progression for people living with NASH and can be associated with increased risk for cardiovascular events and even death,” said Hank Mansbach, chief medical officer of 89bio. “We are encouraged by new analyses from our Phase 1b/2a study that show BIO89-100 demonstrated clinically meaningful reductions in both liver fat volume and liver volume overall across all dosing groups. The data continues to highlight the promising clinical profile of BIO89-100 and supports further development of BIO89-100 in NASH and also severe hypertriglyceridemia.” New analyses of the Phase 1b/2a study data showed BIO89-100 treatment resulted in significant reductions in liver volume of up to 15% and liver fat volume of up to 65% in treated patients at 13 weeks compared to baseline, as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). These data extend the previously reported MRI-PDFF data in which BIO89-100 treatment resulted in up to 70% relative reduction in liver fat fraction relative to placebo treatment. Additionally, BIO89-100, as previously reported, demonstrated a favorable safety and tolerability profile, with rates of gastrointestinal side effects such as nausea, diarrhea and vomiting similar to placebo. The poster presentation details are as follows: Session: P02 - Integrated Physiology of Obesity and Metabolic DiseasePoster Presentation: #53Poster Title: BIO89-100 Demonstrated Robust Reductions in Liver Fat and Liver Fat Volume (LFV) by MRI-PDFF, Favorable Tolerability and Potential for Weekly (QW) or Every 2 Weeks (Q2W) Dosing in a Phase 1b/2a Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in NASHPresenting Author: Juan Pablo Frias, M.D. A copy of the poster presentation is also available for download via the 89bio website. About NASH NASH is the most advanced stage of nonalcoholic fatty liver disease (NAFLD). It is a complex metabolic disorder that causes fat buildup in the liver, as well as inflammation and eventually fibrosis, and it can worsen to cirrhosis and liver failure. NASH affects more than 16 million adults in the United States, and by 2030 its prevalence is predicted to increase by 63 percent. The exact cause of NASH is unknown, but it is commonly found in people with obesity and type 2 diabetes. While there are currently no approved treatments, the biopharmaceutical industry is actively involved in addressing this unmet medical need. About the Phase 1b/2a Study This clinical study was a multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose-ranging trial. It was designed to assess the safety, tolerability, and PK properties of BIO89-100 as well as change in liver fat measured by MRI-PDFF and key biomarker assessments in patients with biopsy-proven NASH with fibrosis or patients with phenotypical NASH (PNASH). PNASH was defined as patients with steatosis greater than 10% who have central obesity and Type 2 diabetes or central obesity and evidence of liver injury. Both populations that were enrolled had similar disease characteristics at baseline. A total of 81 patients were randomized to receive weekly or every two weeks subcutaneous dosing of BIO89-100 or placebo for up to 12 weeks. Results observed across all dose groups from the trial add to a growing body of evidence demonstrating the promise of BIO89-100 for the treatment of NASH. Results showed robust reductions in liver fat and key liver markers. A strong efficacy profile and favorable tolerability were observed with weekly and every two-week dosing. About BIO89-100 BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH. 89bio has optimally engineered BIO89-100 using a proprietary glycoPEGylation technology to balance efficacy and longer dosing interval. Recent Phase 1b/2a data show BIO89-100 demonstrated a favorable safety and tolerability profile and robust reductions in liver fat and key lipid markers when dosed weekly (QW) or once every two weeks (Q2W). BIO89-100 is also being developed for the treatment of severe hypertriglyceridemia (SHTG) and is currently in a Phase 2 trial. About 89bio 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate, BIO89-100, is a specifically engineered glycoPEGylated analog of FGF21. BIO89-100 is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Investor Contact:Ryan MartinsChief Financial Officerinvestors@89bio.com Media Contact:Peter Duckler773-343-3069pduckler@w2ogroup.com