ETNB 89bio Inc.

18.26
+1.34  (+8%)
Previous Close 16.92
Open 16.77
52 Week Low 14.7
52 Week High 42.36
Market Cap $366,300,494
Shares 20,060,268
Float 9,684,253
Enterprise Value $124,518,796
Volume 149,513
Av. Daily Volume 119,298
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Upcoming Catalysts

Drug Stage Catalyst Date
BIO89-100 - ENLIVEN
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
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BIO89-100 (ENTRIGUE)
Severe hypertriglyceridemia
Phase 2
Phase 2
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Latest News

  1. SAN FRANCISCO, Aug. 03, 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 that Company's Management will participate in the following upcoming investor conferences in August:

    • BTIG Virtual Biotechnology Conference 2021
      Format: Fireside chat and one-on-one investor meetings
      Date: Monday, August 9, 2021
      Presentation Time: 3:30 p.m. EDT
    • Canaccord Genuity 41st Annual Growth Conference
      Format: One-on-one investor meetings
      Date: Wednesday, August 11, 2021

    BTIG-hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please…

    SAN FRANCISCO, Aug. 03, 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 that Company's Management will participate in the following upcoming investor conferences in August:

    • BTIG Virtual Biotechnology Conference 2021

      Format: Fireside chat and one-on-one investor meetings

      Date: Monday, August 9, 2021

      Presentation Time: 3:30 p.m. EDT
    • Canaccord Genuity 41st Annual Growth Conference

      Format: One-on-one investor meetings

      Date: Wednesday, August 11, 2021

    BTIG-hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please contact your BTIG representative.

    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 Martins

    Chief Financial Officer

    Media Contact:

    Peter Duckler

    773-343-3069



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  2. SAN FRANCISCO, Aug. 02, 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 that it has completed target enrollment of 20 patients in the paired-biopsy, open-label histology cohort in biopsy-confirmed fibrosis stage F2 – F3 NASH patients.

    "This is an important clinical milestone and step forward in advancing BIO89-100 as a new treatment option for patients suffering from NASH," said Hank Mansbach, Chief Medical Officer of 89bio. "We believe assessing histology endpoints could reinforce the robust efficacy improvements we previously observed in our proof-of-concept…

    SAN FRANCISCO, Aug. 02, 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 that it has completed target enrollment of 20 patients in the paired-biopsy, open-label histology cohort in biopsy-confirmed fibrosis stage F2 – F3 NASH patients.

    "This is an important clinical milestone and step forward in advancing BIO89-100 as a new treatment option for patients suffering from NASH," said Hank Mansbach, Chief Medical Officer of 89bio. "We believe assessing histology endpoints could reinforce the robust efficacy improvements we previously observed in our proof-of-concept study and will provide further validation of the FGF21 class. In addition, this cohort is intended to support both the clinical utility of BIO89-100 and our overall clinical development strategy in NASH. We look forward to sharing topline data by year-end 2021."

    The paired-biopsy, open-label histology cohort is an expansion of the Phase 1b/2a trial of BIO89-100 in NASH. In this cohort, biopsy-confirmed NASH patients are treated for 20 weeks with 27 mg of BIO89-100 once weekly. The key efficacy endpoints include a 2-point or greater improvement in the NAFLD Activity Score (NAS), NASH resolution without worsening of fibrosis, and the improvement of fibrosis ≥ 1 stage without worsening of NASH.

    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 potential efficacy of BIO89-100, clinical development plans for BIO89-100, and the anticipated timing for topline data. 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 of topline data; 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 its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 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 

    Media Contact: 

    Peter Duckler

    773-343-3069



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  3. SAN FRANCISCO, June 16, 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 that Company's Management will participate in the following upcoming investor conferences in June:

    • SVB Leerink CybeRx Series: Liver Disease Day
      Format: One-on-one investor meetings
      Date: Thursday, June 17, 2021
    • Raymond James Human Health Innovation Conference
      Panel Discussion: "State" of the Union: Current Thinking in NASH
      Date: Wednesday, June 23, 2021 at 12:00 PM ET
    • Piper Sandler EASL Takeaway Day
      Format: One-on-one investor meetings
      Date: Monday, June 28, 2021

    About 89bio
    89bio is a…

    SAN FRANCISCO, June 16, 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 that Company's Management will participate in the following upcoming investor conferences in June:

    • SVB Leerink CybeRx Series: Liver Disease Day

      Format: One-on-one investor meetings

      Date: Thursday, June 17, 2021
    • Raymond James Human Health Innovation Conference

      Panel Discussion: "State" of the Union: Current Thinking in NASH

      Date: Wednesday, June 23, 2021 at 12:00 PM ET
    • Piper Sandler EASL Takeaway Day

      Format: One-on-one investor meetings

      Date: Monday, June 28, 2021

    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 Martins

    Chief Financial Officer

    inves

    Media Contact:

    Peter Duckler

    773-343-3069



    Primary Logo

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  4. SAN FRANCISCO, June 10, 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 the initiation of ENLIVEN, a Phase 2b trial evaluating BIO89-100 for the treatment of patients with fibrosis stage 2 or 3 non-alcoholic steatohepatitis (NASH). 89bio is also pleased to announce that a distinguished group of clinicians and scientists will provide their deep expertise and valuable insight as part of the steering committee for ENLIVEN.

    "We are pleased to initiate the ENLIVEN trial, an important milestone in our clinical development program for NASH," said Hank Mansbach…

    SAN FRANCISCO, June 10, 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 the initiation of ENLIVEN, a Phase 2b trial evaluating BIO89-100 for the treatment of patients with fibrosis stage 2 or 3 non-alcoholic steatohepatitis (NASH). 89bio is also pleased to announce that a distinguished group of clinicians and scientists will provide their deep expertise and valuable insight as part of the steering committee for ENLIVEN.

    "We are pleased to initiate the ENLIVEN trial, an important milestone in our clinical development program for NASH," said Hank Mansbach, Chief Medical Officer of 89bio. "ENLIVEN is a well-powered trial that builds on positive data from the Phase 1b/2a trial, which demonstrated that BIO89-100 has the potential to combine strong efficacy, a favorable safety and tolerability profile, and potentially best-in-class dosing convenience. We are encouraged by the robust responses that were observed across various efficacy measures and believe these improvements will translate into histology benefits in ENLIVEN."

    ENLIVEN is a multicenter, randomized, double-blind, placebo-controlled Phase 2b study in biopsy-confirmed NASH patients with fibrosis stage 2 or 3. A total of 216 patients will receive either one of two weekly doses (15mg or 30mg) or an every two-week dose (44mg) of BIO89-100 in a liquid formulation or placebo for 24 weeks. All patients will continue treatment in a blinded extension phase for 24 weeks for a total treatment period of 48 weeks, with some of the placebo patients re-randomized to receive BIO89-100 in the extension phase. The primary endpoints at Week 24 are NASH resolution without worsening of fibrosis and the improvement of fibrosis ≥ 1 stage without worsening of NASH.

    Concurrent with the initiation of ENLIVEN, 89bio has established a steering committee for the trial comprising a distinguished group of clinicians, researchers, and experts in NASH. Members of the steering committee include:

    • Manal Abdalmalek, M.D., Professor of Medicine and Director of NAFLD Clinical Research Program at Duke University
    • Naim Alkhouri, M.D., VP of Academic Affairs and Director of Fatty Liver Program at Arizona Liver Health
    • Deepak L. Bhatt, M.D., MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital, and Professor of Medicine at Harvard Medical School
    • Juan Frias, M.D., Medical Director and Principal Investigator at National Research Institute, Los Angeles
    • Kris V. Kowdley, M.D., Director of Liver Institute Northwest and Clinical Professor at Elson S. Floyd College of Medicine and Washington State University
    • Rohit Loomba, M.D., MHSc, Director of NAFLD Research Center, Professor of Medicine in the Division of Gastroenterology, and Adjunct Professor in the Division of Epidemiology at the University of California San Diego

    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 ENLIVEN Phase 2b trial, 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 ENLIVEN 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 its Quarterly Report on Form 10-Q for the quarter ended March 30, 2021 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 

    Media Contact: 

    Peter Duckler

    773-343-3069



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  5. SAN FRANCISCO, May 12, 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 ended March 31, 2021.

    "We are pleased to have received written guidance from the U.S. Food and Drug Administration (FDA) on our planned Phase 2b ENLIVEN trial design in non-alcoholic steatohepatitis (NASH)," said Rohan Palekar, Chief Executive Officer of 89bio. "We have a well-defined work plan ahead of us and are well-funded to reach multiple clinical and regulatory milestones, which we expect will continue to validate BIO89-100's potential…

    SAN FRANCISCO, May 12, 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 ended March 31, 2021.

    "We are pleased to have received written guidance from the U.S. Food and Drug Administration (FDA) on our planned Phase 2b ENLIVEN trial design in non-alcoholic steatohepatitis (NASH)," said Rohan Palekar, Chief Executive Officer of 89bio. "We have a well-defined work plan ahead of us and are well-funded to reach multiple clinical and regulatory milestones, which we expect will continue to validate BIO89-100's potential in both NASH and severe hypertriglyceridemia (SHTG)."  

    Recent Highlights and Anticipated Milestones

    • Received written guidance from the FDA on the Phase 2b ENLIVEN trial design, planned to initiate in 2Q21: ENLIVEN is a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial designed to evaluate the safety and efficacy of BIO89-100 for the treatment of patients with fibrosis stage 2 or 3 NASH and will utilize a liquid formulation. A total of approximately 200 patients will receive either one of two different weekly doses or a 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.



    • Report topline data from the paired-biopsy, open-label histology cohort in NASH patients by year-end 2021: This cohort is enrolling patients with biopsy-confirmed NASH and is expected to provide an early opportunity to demonstrate the benefits of BIO89-100 on histology endpoints.



    • Report topline data from the Phase 2 ENTRIGUE trial of BIO89-100 in severe hypertriglyceridemia patients in 2H21: ENTRIGUE is a multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate safety and efficacy in patients who will receive BIO89-100 administered weekly (9mg, 18mg or 27 mg), every two weeks (36mg) or placebo. ENTRIGUE was expanded recently with an additional cohort of patients on background fibrates. While the recent COVID-19 surge in Europe has resulted in enrollment challenges in certain geographies, we are working closely with our CRO and remain optimistic that enrollment will pick up in the trial.

    First Quarter 2021 Financial Results

    Cash Position. As of March 31, 2021, 89bio had cash, cash equivalents, and short-term investments of $189.6 million.

    Research and Development (R&D) Expenses. R&D expenses were $10.1 million for the three months ended March 31, 2021, compared to $7.8 million for the three months ended March 31, 2020. The increase in R&D expenses was primarily driven by increases in contract manufacturing and personnel expenses.

    General and Administrative (G&A) Expenses. G&A expenses were $4.6 million for the three months ended March 31, 2021, compared to $2.9 million for the three months ended March 31, 2020. The increase in G&A expenses was primarily due to an increase in costs related to personnel expenses, insurance-related expenses, and expenses for professional services.

    Net Loss. 89bio reported a net loss of $14.8 million for the three months ended March 31, 2021, compared to a net loss of $10.5 million for the three months ended March 31, 2020. The increase in net loss is primarily attributable to increased R&D expenses for our programs and increased G&A expenses associated with operating 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 and timing for BIO89-100, including the Phase 2b ENLIVEN trial and Phase 3 ENTRIGUE trial, the expected trial design for the ENLIVEN trial and the ENTRIGUE trial, including patient enrollment, dosing schedules and trial endpoints, and the timing for topline data. 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 ENLIVEN trial in NASH and Phase 2 ENTRIGUE trial in SHTG; 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.

    89bio, Inc.

    Condensed Consolidated Statement of Operations Data

    (Unaudited)

    (In thousands, except share and per share amounts)


           
           
     Three months   Three months 
      Ended   Ended 
     March 31,    March 31,  
     2021   2020 
           
    Operating expenses:      
    Research and development$10,131  $7,778 
    General and administrative4,608   2,924 
    Total operating expenses14,739   10,702 
    Loss from operations14,739   10,702 
    Other (expenses) income, net(43)  157 
    Net loss before tax14,782   10,545 
    Income tax expense (benefit)   (1)
    Net loss$14,782  $10,544 
    Comprehensive loss$14,775  $10,544 
    Net loss per share, basic and diluted$0.74  $0.76 
    Weighted-average shares used to compute

    net loss per share, basic and diluted
    20,010,412   13,789,786 



    89bio, Inc.

    Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (In thousands)
        
     March 31, December 31,
     2021 2020
        
    Cash, cash equivalents and short-term investments$189,650 $204,654
    Total assets198,654 211,074
    Total current liabilities8,459 8,113
    Total stockholders' equity (deficit)190,195 202,961

    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Peter Duckler

    773-343-3069



    Primary Logo

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