1. - 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…

    - 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 

    Media Contact: 

    Peter Duckler 

    773-343-3069 



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  2. - 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…

    - 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 

    Media Contact: 

    Peter Duckler 

    773-343-3069 



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  3. SAN 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…

    SAN 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 Disease

    Poster Presentation: #53

    Poster 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 NASH

    Presenting 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 Martins

    Chief Financial Officer

     

    Media Contact:

    Peter Duckler

    773-343-3069



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  4. SAN FRANCISCO, March 11, 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 present at the Oppenheimer 31st Annual Healthcare Conference, a virtual event, on Wednesday, March 17, 2021 at 1:10 p.m. ET.

    The presentation will be available through the Oppenheimer conference portal and an archived webcast will also be accessible in the investor section of 89bio's website.

    About 89bio

    89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment…

    SAN FRANCISCO, March 11, 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 present at the Oppenheimer 31st Annual Healthcare Conference, a virtual event, on Wednesday, March 17, 2021 at 1:10 p.m. ET.

    The presentation will be available through the Oppenheimer conference portal and an archived webcast will also be accessible in the investor section of 89bio's website.

    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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  5. SAN FRANCISCO, March 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 virtual H.C. Wainwright Global Life Sciences Conference to be held March 9-10, 2021.

    The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7 a.m. EST on Tuesday, March 9, 2021. An archived webcast will also be accessible in the investor section of 89bio's website.

    About 89bio
    89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of…

    SAN FRANCISCO, March 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 virtual H.C. Wainwright Global Life Sciences Conference to be held March 9-10, 2021.

    The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7 a.m. EST on Tuesday, March 9, 2021. An archived webcast will also be accessible in the investor section of 89bio's website.

    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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  6. SAN FRANCISCO, Feb. 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 announced that Company's Management will provide a corporate update and participate in one-on-one investor meetings at the Raymond James 42nd Annual Institutional Investors Conference on Wednesday, March 3, 2021 at 12:30 PM ET.

    The presentation will be available through the Raymond James conference portal and an archived webcast will also be accessible in the investor section of 89bio's website.

    About 89bio
    89bio is a clinical-stage biopharmaceutical company focused on the development and…

    SAN FRANCISCO, Feb. 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 announced that Company's Management will provide a corporate update and participate in one-on-one investor meetings at the Raymond James 42nd Annual Institutional Investors Conference on Wednesday, March 3, 2021 at 12:30 PM ET.

    The presentation will be available through the Raymond James conference portal and an archived webcast will also be accessible in the investor section of 89bio's website.

    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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  7. SAN FRANCISCO, Feb. 18, 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 provide a corporate update and participate in one-on-one investor meetings at the SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 5:00 PM ET.

    The presentation will be available through the SVB Leerink conference portal and an archived webcast will also be accessible in the investor section of 89bio's website.

    About 89bio
    89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization…

    SAN FRANCISCO, Feb. 18, 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 provide a corporate update and participate in one-on-one investor meetings at the SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 5:00 PM ET.

    The presentation will be available through the SVB Leerink conference portal and an archived webcast will also be accessible in the investor section of 89bio's website.

    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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  8. -Phase 2b NASH trial as part of a potential Phase 2b/3 program expected to initiate in 1H21-

    -Topline data from recently initiated NASH paired-biopsy, open-label histology cohort expected by YE21-

    -Topline data from BIO89-100's Phase 2 SHTG trial expected in 2H21-

    SAN FRANCISCO, Jan. 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 provided a corporate update, including its roadmap for advancing BIO89-100 in 2021.

    "We are extremely pleased by our 2020 progress across all aspects of the company including clinical, manufacturing and corporate advancements…

    -Phase 2b NASH trial as part of a potential Phase 2b/3 program expected to initiate in 1H21-

    -Topline data from recently initiated NASH paired-biopsy, open-label histology cohort expected by YE21-

    -Topline data from BIO89-100's Phase 2 SHTG trial expected in 2H21-

    SAN FRANCISCO, Jan. 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 provided a corporate update, including its roadmap for advancing BIO89-100 in 2021.

    "We are extremely pleased by our 2020 progress across all aspects of the company including clinical, manufacturing and corporate advancements," said Rohan Palekar, chief executive officer of 89bio. "We are steadily executing across our clinical development program for BIO89-100, a potentially best-in-class FGF21 analog engineered to achieve superior efficacy, optimal dosing convenience, as well as favorable safety and tolerability. In 2020, we presented encouraging topline Phase 1b/2a data, which has informed the advancement of our clinical strategy in NASH and we are looking forward to our major anticipated milestones in 2021 in both NASH and SHTG."

    Key 2021 Milestones

    • Report topline data from the paired-biopsy, open-label histology cohort as part of the Phase 1b/2a trial of BIO89-100 in NASH by year-end 2021
    • Initiate the Phase 2b NASH trial as part of a potential Phase 2b/3 program in the first half of 2021
    • Report topline data from the Phase 2 trial of BIO89-100 in SHTG in the second half of 2021

    Clinical Development Overview

    89bio is developing BIO89-100, a glycoPEGylated analog of FGF21 for the treatment of liver and cardio-metabolic diseases. BIO89-100 delivers a compelling risk-benefit profile by improving liver pathology and addressing the underlying metabolic issues while balancing these benefits with favorable tolerability and the dosing convenience necessary for adoption and compliance.

    NASH

    89bio plans to initiate a Phase 2b NASH trial as part of a potential Phase 2b/3 trial in the first half of 2021. Additionally, the Company recently initiated a paired-biopsy, open-label histology cohort as part of the Phase 1b/2a trial of BIO89-100 in NASH, with data anticipated by the end of 2021. This cohort will enroll approximately 20 patients with biopsy-confirmed NASH and will provide an early opportunity to demonstrate BIO89-100's benefits on histology endpoints. These patients will be treated for 20 weeks with 27 mg of BIO89-100 once weekly. The cohort will build on the recent data from 89bio's Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose-ranging trial. The 13-week trial enrolled a total of 81 patients and demonstrated relative reductions in liver fat of up to 70% versus placebo, as measured by magnetic resonance imaging—proton density fat fraction (MRI-PDFF). A majority of patients achieved a ≥ 30% (up to 88%) or a ≥ 50% (up to 71%) reduction in liver fat. ALT was significantly reduced (up to 44%) in these patients and key lipid markers like triglycerides, LDL, and non-HDL were also significantly improved. Results were consistent across the sub-populations of biopsy-confirmed NASH and phenotypic NASH (PNASH) patients enrolled in the trial and baseline characteristics were similar across these sub-populations as were the reductions in liver fat. The percentage of responders on MRI-PDFF and BIO89-100's effect on reducing ALT and triglycerides were also similar across these sub-populations. Overall, BIO89-100 had a favorable safety and tolerability profile with rates of gastrointestinal side effects such as nausea, diarrhea and vomiting similar to placebo.

    SHTG

    The ongoing Phase 2 trial investigating BIO89-100 for the treatment of severe hypertriglyceridemia (SHTG) will enroll approximately 90 patients. In this Phase 2 multi-center, randomized, double-blind, placebo-controlled study designed to evaluate safety, efficacy, and tolerability, BIO89-100 or placebo will be administered in one of four treatment groups either weekly or every two weeks. The primary endpoint is the reduction in fasting triglycerides from baseline. Key secondary endpoints include the effect of BIO89-100 on other lipids and metabolic markers and change in liver fat measured by MRI-PDFF. Topline data from the study are expected in the second half of 2021.

    Participation in the 10th Annual LifeSci Partners Corporate Access Event

    Rohan Palekar, chief executive officer of 89bio, will participate in 1x1 meetings with investors at the upcoming Annual LifeSci Partners Corporate Access Event, which will take place January 6-8 and 11-14, 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.

    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.

    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Peter Duckler

    773-343-3069



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  9. SAN FRANCISCO, Jan. 04, 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 Rohan Palekar, the company's Chief Executive Officer, will provide a corporate update at the virtual H.C. Wainwright BioConnect 2021 Conference to be held January 11-14, 2021.

    The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 6 a.m. EST on Monday, January 11, 2021. An archived webcast will also be accessible in the investor section of 89bio's website.

    About 89bio
    89bio is a clinical-stage biopharmaceutical company focused…

    SAN FRANCISCO, Jan. 04, 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 Rohan Palekar, the company's Chief Executive Officer, will provide a corporate update at the virtual H.C. Wainwright BioConnect 2021 Conference to be held January 11-14, 2021.

    The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 6 a.m. EST on Monday, January 11, 2021. An archived webcast will also be accessible in the investor section of 89bio's website.

    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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  10. SAN FRANCISCO, Nov. 24, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will participate in 1x1 meetings with investors at the Piper Sandler 32nd Annual Virtual Healthcare Conference on Wednesday, December 2, 2020. The conference will take place December 1-3, 2020. An archived webcast of the fireside chat is accessible in the investor section of 89bio's website.

    About 89bio
    89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies…

    SAN FRANCISCO, Nov. 24, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will participate in 1x1 meetings with investors at the Piper Sandler 32nd Annual Virtual Healthcare Conference on Wednesday, December 2, 2020. The conference will take place December 1-3, 2020. An archived webcast of the fireside chat is accessible in the investor section of 89bio's website.

    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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  11. Data demonstrated compelling efficacy profile and favorable tolerability with weekly and every two-week dosing –

    Consistent results and baseline characteristics across biopsy confirmed and phenotypic NASH patients

    Positive, highly significant correlation between relative changes in liver fat reduction and ALT

    SAN FRANCISCO, Nov. 13, 2020 (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 updated data from its positive Phase 1b/2a study of BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH…

    Data demonstrated compelling efficacy profile and favorable tolerability with weekly and every two-week dosing –

    Consistent results and baseline characteristics across biopsy confirmed and phenotypic NASH patients

    Positive, highly significant correlation between relative changes in liver fat reduction and ALT

    SAN FRANCISCO, Nov. 13, 2020 (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 updated data from its positive Phase 1b/2a study of BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). Previously disclosed topline data demonstrated reductions in liver fat with concurrent beneficial effects on lipids and other metabolic parameters, as well as favorable tolerability, with both weekly and every two-week dosing. New analyses from the trial will be presented today in a late-breaking poster (abstract #LP34) at The Liver Meeting Digital Experience™ 2020 of the American Association for the Study of Liver Diseases (AASLD).

    "I believe that these data highlight BIO89-100's robust potency in reducing liver fat as assessed by MRI-PDFF over a 12-week period. New analyses of the data demonstrate the strong and significant correlation between relative reductions in MRI-PDFF and serum ALT in patients treated with BIO89-100. Responses on these two measures have been shown to translate into histology improvement and potentially a clinically meaningful benefit in patients with NASH," said Rohit Loomba, MD, MHSc, Director of the UC San Diego NAFLD Research Center and Director of Hepatology at UC San Diego School of Medicine. "We saw a remarkable consistency of results across the sub-populations of biopsy-confirmed NASH and phenotypic NASH (PNASH) patients enrolled in the trial. Baseline characteristics were similar across these sub-populations and BIO89-100 treatment resulted in similar reductions in liver fat, ALT, and triglycerides."

    "We are moving forward with a comprehensive clinical development program designed to build upon the promising results from BIO89-100's Phase 1b/2a trial, which includes plans to initiate a Phase 2b study in the first half of 2021 and an open-label paired biopsy histology cohort in the near-term. Today's data are encouraging for these planned studies as we believe they demonstrate BIO89-100's compelling risk-benefit profile as a leading FGF21 analog in a class that could become a key part of the NASH treatment paradigm," said Rohan Palekar, Chief Executive Officer, 89bio.

    A copy of the poster presentation, entitled "BIO89-100 Demonstrated Robust Reductions in Liver MRI-PDFF, Favorable Tolerability and Potential for Every 2 Weeks Dosing in a Phase 1b/2a Placebo-Controlled, Double Blind, Multiple Ascending Dose Study in NASH," is available on the AASLD website and is also available for download via the 89bio website.

    The data presented show:

    • Similar reductions in liver fat, ALT and triglycerides between biopsy-confirmed NASH and PNASH patients treated with BIO89-100 and, importantly, their similar baseline characteristics underscored the consistency across these two sub-populations of patients enrolled in the trial.
    • Pharmacokinetics of BIO89-100 demonstrated dose proportional PK.
    • Positive and highly significant correlation (r=0.540, p<0.001) between relative reduction in liver fat by MRI-PDFF and ALT reduction at Week 13.
    • Treatment with BIO89-100 (N=81) resulted in significant reductions in liver fat on MRI-PDFF at Week 13 across all dose groups vs. placebo, with up to 70% and 60% relative reductions for the 27mg-QW and 36mg-Q2W dose groups vs. placebo, respectively (p<0.001).
    • Significant proportion of patients responded to therapy with up to 88% and 71% of patients achieving a ≥30% and a ≥50% reduction in liver fat vs. baseline, respectively.
    • Significant benefit in markers of liver injury and fibrosis, with up to 44% reduction in ALT and a 35 Units/Liter (U/L) decrease in patients with high ALT was observed.
    • Significant improvements were also observed in triglycerides. Reductions in TGs was more pronounced in patients who had higher levels of TGs at baseline.
    • Improvements were also noted across the spectrum of metabolic marker data vs. placebo for the 27mg QW dose group including HOMA-IR, glucose, HbA1c, weight (p<0.05) and adiponectin (p<0.001).
    • BIO89-100 was well-tolerated across all doses with no deaths or serious adverse events related to treatment and a low incidence of treatment-related adverse events (TRAEs) that occurred in ≥ 10% of patients.
    • Low frequency of gastrointestinal (GI) related adverse events was observed with a profile for BIO89-100 that was similar to placebo. Low rates of diarrhea (9.5% vs. 11.1% for placebo) and nausea (4.8% vs. 11.1% for placebo) and importantly, no vomiting were reported in BIO89-100 treated patients. No hypersensitivity AEs, few mild injection site reaction events, no tremor and no adverse effects on heart rate or blood pressure were observed.

    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.

    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, future clinical development plans for BIO89-100, including the Phase 2b study and open-label paired biopsy histology cohort 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 next trial in NASH; 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.

    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Peter Duckler

    773-343-3069



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  12. – Updated clinical data from BIO89-100's Phase 1b/2a NASH trial to be presented as a late-breaking poster at upcoming AASLD Liver Meeting –

    Planning to initiate the Phase 2b trial as part of the Phase 2b/3 program in NASH in 1H21

    Topline results from BIO89-100's Phase 2 SHTG trial expected in 2H21

    SAN FRANCISCO, Nov. 10, 2020 (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 September 30, 2020.

    "We have made significant advances across our development programs this quarter. We initiated our Phase 2 trial…

    – Updated clinical data from BIO89-100's Phase 1b/2a NASH trial to be presented as a late-breaking poster at upcoming AASLD Liver Meeting –

    Planning to initiate the Phase 2b trial as part of the Phase 2b/3 program in NASH in 1H21

    Topline results from BIO89-100's Phase 2 SHTG trial expected in 2H21

    SAN FRANCISCO, Nov. 10, 2020 (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 September 30, 2020.

    "We have made significant advances across our development programs this quarter. We initiated our Phase 2 trial in SHTG and in NASH we announced impressive results from our Phase 1b/2a trial that further support our view that BIO89-100 could be the best-in-class FGF21 analog within a class that could be the mainstay of treatment for NASH," said Rohan Palekar, chief executive officer of 89bio. "BIO89-100 delivers a compelling risk-benefit profile by improving liver pathology and addressing the underlying metabolic issues while balancing these benefits with favorable tolerability and the dosing convenience necessary for adoption and compliance. We are moving forward with a comprehensive clinical development program for BIO89-100, including initiating the Phase 2b trial in the first half of 2021 and initiating in parallel a new histology cohort in the near term as part of the Phase 1b/2a trial. The data from this new cohort will provide additional supporting information on the efficacy of BIO89-100 and is not expected to affect our planned timing for initiation of the Phase 2b/3 program."

    Recent Highlights

    • Reported positive Phase 1b/2a clinical data evaluating BIO89-100 in NASH. Results observed add to a growing body of evidence demonstrating the promise of BIO89-100 for the treatment of NASH. Results showed a strong efficacy and favorable tolerability profile with weekly and every two-week dosing. Specifically, the data demonstrated
      • Statistically significant reductions in liver fat of up to 70% versus placebo with 43% of patients at the highest dose achieving normal liver fat content of <5%.
      • Up to 88% and 71% of BIO89-100 patients achieved ≥30% and ≥50% liver fat reduction respectively.
      • Significant benefit in markers of liver injury and fibrosis, with up to 44% reduction in alanine aminotransferase (ALT) and up to 27% reduction in Pro-C3. A 35 U/L decrease in patients with high ALT was observed.
      • Significant improvements in key lipid markers—triglycerides, non-HDL, and LDL. Reductions in TGs was more pronounced in patients who had higher levels of TGs at baseline.
      • Improvements in the spectrum of metabolic marker data including HOMA-IR, glucose, HbA1c, weight and adiponectin.
      • Overall, BIO89-100 demonstrated a favorable safety and tolerability profile.
        • Well tolerated across tested dose range with few adverse events that occurred in ≥ 10% of subjects.
        • Very low frequency of gastrointestinal (GI) events was observed with a similar profile to placebo.
        • No hypersensitivity or tremor were observed and no adverse effects on heart rate or blood pressure were observed.
    • Initiated a Phase 2 trial of BIO89-100 in patients with SHTG.
    • Completed underwritten public offerings of common stock in the third quarter, resulting in an aggregate of approximately $157.7 million in estimated net proceeds.

    Expected Upcoming Milestones

    • Present updated clinical data from the Phase 1b/2a trial as a late-breaking poster at AASLD's The Liver Meeting® 2020 being held November 13-16 highlighting BIO89-100's compelling clinical profile and preclinical data covering BIO89-100's receptor activation profile.
    • Initiate a new open-label histology cohort as part of the Phase 1b/2a trial of BIO89-100 in NASH. This new cohort will enroll approximately 20 patients with biopsy-confirmed NASH that will be treated for 20 weeks with 27mg QW BIO89-100.
      • The new cohort will provide an early opportunity to demonstrate BIO89-100's benefits on histology endpoints.
      • This cohort is planned to start in the near term with results expected by the end of 2021.
    • Initiate a Phase 2b NASH trial as part of the Phase 2b/3 program in the first half of 2021.
    • Report topline data from the Phase 2 trial of BIO89-100 in SHTG in the second half of 2021.

    Third Quarter 2020 Financial Results

    Cash Position. As of September 30, 2020, 89bio had cash, cash equivalents and short-term investments of $219.2 million.

    Research and Development (R&D) Expenses. R&D expenses were $11.2 million for the three months ended September 30, 2020, compared to $6.7 million for the three months ended September 30, 2019. The increase in R&D expenses was primarily driven by increases in clinical development, contract manufacturing, pre-clinical development and personnel expenses.

    General and Administrative (G&A) Expenses. G&A expenses were $3.2 million for the three months ended September 30, 2020, compared to $1.5 million for the three months ended September 30, 2019. The increase in G&A expenses was primarily due to an increase in costs related to professional services and personnel expenses.

    Net Loss. 89bio reported a net loss of $14.6 million for the three months ended September 30, 2020, compared to a net loss of $18.7 million for the three months ended September 30, 2019. The decrease in net loss is primarily attributable to increased R&D expenses for our programs and increased G&A expenses associated with our becoming a public company offset by a non-recurring charge in 2019 for accounting of preferred stock liability.

    About the Phase 1b/2a Study

    89bio's Phase 1b/2a trial with BIO89-100 in patients with NASH 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 subjects with biopsy-proven NASH with fibrosis or subjects 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 subjects were randomized to receive weekly or every two weeks subcutaneous dosing of BIO89-100 or placebo for up to 12 weeks. Results showed robust reductions in liver fat and key liver and metabolic markers with a favorable tolerability profile. The positive results 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.

    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, 89bio's expectations and guidance regarding its business plans and objectives for BIO89-100, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of BIO89-100 and future clinical development plans; its plans to initiate an open-label histology cohort as part of the Phase 1b/2a trial of BIO89-100 in NASH; expectations regarding BIO89-100's development path with regulatory authorities and timeline; the expected timing of 89bio's Phase 2b trial; and expectations regarding 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 an open-label histology cohort and Phase 2b trial; 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 June 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 and Comprehensive Loss

    (Unaudited)

    (In thousands, except share and per share amounts)
             
      Three Months Ended Nine Months Ended
      September 30, September 30,
       2020  2019  2020  2019
             
    Operating expenses:        
    Research and development $11,208 $6,680 $27,429 $14,154
    General and administrative  3,225  1,518  9,379  2,875
    Total operating expenses  14,433  8,198  36,808  17,029
    Loss from operations  14,433  8,198  36,808  17,029
    Other expenses, net  146  10,470  87  21,022
    Net loss before tax  14,579  18,668  36,895  38,051
    Income tax expense  24  57  23  86
    Net loss $14,603 $18,725 $36,918 $38,137
    Comprehensive loss $14,606 $18,725 $36,921 $38,137
    Net loss per share, basic and diluted $0.86 $30.63 $2.49 $62.39
    Weighted-average shares used to compute

    net loss per share, basic and diluted
      16,884,244  611,226  14,809,131  611,226
             

     







    89bio, Inc.

    Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (In thousands)
     
         
     September 30, December 31,
      2020  2019 
         
    Cash, cash equivalents and short-term investments$219,153 $93,335 
    Total assets 223,428  95,553 
    Total current liabilities 9,424  5,609 
    Total stockholders' equity 214,004  89,944 
         



    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Peter Duckler

    773-343-3069

     

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  13. SAN FRANCISCO, Nov. 02, 2020 (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 clinical data from its Phase 1b/2a study evaluating BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH) will be presented in a late-breaking poster at The Liver Meeting Digital Experience™ 2020 of the American Association for the Study of Liver Diseases (AASLD) to be held November 13 - 16. 89bio will also be presenting a poster on preclinical data demonstrating that BIO89-100's receptor activation profile was similar to…

    SAN FRANCISCO, Nov. 02, 2020 (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 clinical data from its Phase 1b/2a study evaluating BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH) will be presented in a late-breaking poster at The Liver Meeting Digital Experience™ 2020 of the American Association for the Study of Liver Diseases (AASLD) to be held November 13 - 16. 89bio will also be presenting a poster on preclinical data demonstrating that BIO89-100's receptor activation profile was similar to that of native FGF21.

    The late-breaking poster details the promising clinical profile of BIO89-100 in NASH as measured by MRI-PDFF and other liver-related metabolic parameters, a favorable safety/tolerability profile, and potential best-in-class dosing. The presentation details are as follows:

    Abstract Number: LP34

    Poster Title: BIO89-100 Demonstrated Robust Reductions in Liver MRI-PDFF, Favorable Tolerability and Potential for Every 2 Weeks Dosing in a Phase 1b/2a Placebo-Controlled, Double Blind, Multiple Ascending Dose Study in NASH

    Presenting Author: Dr. Rohit Loomba, Director, NAFLD Research Center, Professor of Medicine, University of California at San Diego



    Abstract Number: 514

    Poster Title: BIO89-100, A Novel Glycopegylated Fibroblast Growth Factor 21 (FGF21), Activates FGF Receptors (FGFR) 1c, 2c, and 3c but not FGFR4 in L6 Cells Transfected With the Four Different Human FGFRS and Beta Klotho (KLB)

    Presenting Author: Dr. Moti Rosenstock, Preclinical Development, 89bio, Inc.

    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 subjects with biopsy-proven NASH with fibrosis or subjects 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 subjects 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. Strong efficacy 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 Martins

    Chief Financial Officer

    Media Contact:

    Peter Duckler

    773-343-3069



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  14. SAN FRANCISCO, Sept. 28, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will present at the H.C. Wainwright 4th Annual NASH Investor Conference on Monday, October 5, 2020 at 11:30 AM ET.

    The live and archived webcast of the presentation will be accessible from the company's website at https://ir.89bio.com/events-and-presentations. The replay of the webcast will be available on the company's website.

    About 89bio

    89bio is a clinical-stage biopharmaceutical company focused on the development…

    SAN FRANCISCO, Sept. 28, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will present at the H.C. Wainwright 4th Annual NASH Investor Conference on Monday, October 5, 2020 at 11:30 AM ET.

    The live and archived webcast of the presentation will be accessible from the company's website at https://ir.89bio.com/events-and-presentations. The replay of the webcast will be available on the company's website.

    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:

    Lori Rosen

    LDR Communications

    917-553-6808

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  15. - Longitude Venture Partners IV will build on the Firm's commitment to improve clinical outcomes, enhance patient quality of life, and drive efficiency in healthcare delivery -

    - In 2020 to date, Longitude portfolio companies announced 4 IPOs and 3 M&A transactions -

    MENLO PARK, Calif. and GREENWICH, Conn. and BOSTON, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Longitude Capital, a leading healthcare venture capital firm, today announced the closing of Longitude Venture Partners IV, L.P. ("LVP4"), with $585 million in capital commitments. LVP4, the largest fund that Longitude Capital has raised to date, will build on the proven strategy of its predecessor funds by investing in biotechnology, medical technology, and health solutions companies that…

    - Longitude Venture Partners IV will build on the Firm's commitment to improve clinical outcomes, enhance patient quality of life, and drive efficiency in healthcare delivery -

    - In 2020 to date, Longitude portfolio companies announced 4 IPOs and 3 M&A transactions -

    MENLO PARK, Calif. and GREENWICH, Conn. and BOSTON, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Longitude Capital, a leading healthcare venture capital firm, today announced the closing of Longitude Venture Partners IV, L.P. ("LVP4"), with $585 million in capital commitments. LVP4, the largest fund that Longitude Capital has raised to date, will build on the proven strategy of its predecessor funds by investing in biotechnology, medical technology, and health solutions companies that seek to transform the healthcare industry.

    "We are in the golden era of medical and biological innovation. The significant unmet clinical needs and the inefficiencies of our current healthcare system are driving meaningful scientific breakthroughs and creative solutions," said Patrick Enright, co-founder and Managing Director of Longitude Capital. Since inception in 2006, Longitude Capital has raised nearly $2 billion in cumulative capital commitments and managed over 30 company exits. "We are fortunate to have helped build many successful healthcare companies and look forward to working alongside the next wave of entrepreneurs and scientists to advance critical medicines, devices, and health solutions to the marketplace."

    Juliet Bakker, co-founder and Managing Director of Longitude Capital, added, "We are thankful for the continued support of, and partnerships with, our investors who value our differentiated venture growth investing approach, experienced team, and passion for forging new frontiers in healthcare."

    LVP4 will invest opportunistically across all stages of a company's development through a variety of approaches that include traditional venture capital investing and special situations such as spin-outs, equity-linked transactions, and private investments in public equities. Many of these investments stem from Longitude's proprietary research of targeted healthcare sectors, therapeutic areas, and technologies of interest.

    Longitude Capital's recent Initial Public Offerings (IPOs) and exits include 89bio (NASDAQ:ETNB), Aimmune (NASDAQ:AIMT, recently agreed to be acquired by Nestlé Health Science))), Axonics Modulation Technologies (NASDAQ:AXNX), Checkmate Pharmaceuticals (NASDAQ:CMPI), Inflazome (acquired by Roche), Inozyme Pharma (NASDAQ:INZY), KaNDy Therapeutics (acquired by Bayer), Molecular Templates (NASDAQ:MTEM), Poseida Therapeutics (NASDAQ:PSTX), and Vaxcyte (NASDAQ:PCVX).

    About Longitude Capital

    Longitude Capital is a leading healthcare venture capital firm, that invests in transformative biotechnology, medical technology, and health solutions companies seeking to improve clinical outcomes, enhance quality of life, and drive efficiency of healthcare delivery. Founded in 2006, Longitude Capital invests in both privately held and publicly traded companies through a variety of investment approaches. Longitude Capital has offices in Menlo Park, CA, Greenwich, CT, and Boston, MA. For more information, including a complete listing of investments, please visit www.longitudecapital.com.

    About Longitude Capital Recent IPOs and Exits

    • 89bio is a biopharmaceutical company developing and commercializing innovative therapies for the treatment of liver and cardio-metabolic diseases. 89bio was originally spun out of Teva Pharmaceuticals in 2018 by founding investors Longitude Capital and OrbiMed, and completed its IPO in November 2019. www.89bio.com.



    • Aimmune is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies. Aimmune's PALFORZIA® is the world's first approved treatment for peanut allergy. Longitude Capital was the founding institutional investor of Aimmune. In 2020, Aimmune agreed to be acquired by Nestlé Health Science for $34.50 per share in cash, representing a total equity value of $2.6 billion. www.aimmune.com.



    • Axonics Modulation Technologies is a medical technology company developing and commercializing novel implantable rechargeable sacral neuromodulation (SNM) devices for patients with urinary and bowel dysfunction. In 2018, Longitude Capital led a $40 million financing that preceded the company's IPO later that year. www.axonics.com.



    • Checkmate Pharmaceuticals is a clinical-stage biopharmaceutical company developing proprietary technology to harness the power of the immune system to combat cancer. In 2020, Longitude Capital and Novo Holdings led the company's $85 million Series C financing that preceded the company's IPO later in the year. www.checkmatepharma.com.



    • Inflazome is a biotechnology company developing small molecules that block harmful inflammation by targeting inflammasomes, protein complexes that generate signals in order to activate an immune response. In 2020, Inflazome announced its acquisition by Roche for an upfront payment of €380 million, and potential predetermined milestone payments. www.inflazome.com.



    • Inozyme Pharma is a rare disease pharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization. Longitude Capital led Inozyme's $49 million Series A financing in 2017, and was joined by New Enterprise Associates, Novo Holdings, and Sanofi Ventures. Inozyme completed its initial public offering in 2020. www.inozyme.com.



    • KaNDy Therapeutics was a UK-based clinical-stage company focused on optimizing the potential of its unique NK-1,3 receptor antagonist NT-814 to treat common, chronic debilitating conditions related to menopause. In 2020, KaNDy Therapeutics was acquired by Bayer Pharmaceuticals for an upfront payment of $425 million, and a potential $450 million in R&D, regulatory milestones and additional commercial milestones.



    • Molecular Templates is a clinical-stage company focused on the discovery and development of targeted biologic therapeutics. In 2017, Longitude Capital led Molecular Template's $40 million PIPE (private investment into public equity) financing. Molecular Templates now has strategic collaborations with Takeda Pharmaceuticals and Vertex Pharmaceuticals. www.mtem.com.



    • Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing its proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure various cancers. Longitude Capital led Poseida's $30 million Series B financing in 2018. Poseida completed its IPO in 2020. www.poseida.com.



    • Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. Longitude Capital invested in Vaxcyte's $22 million Series A financing and served on the Board of the company through its IPO in 2020. www.vaxcyte.com.

    About Longitude Capital Recent Investments

    • Eargo is a medical device company dedicated to improving the quality of life of people with hearing loss. Longitude Capital and Gilde Healthcare led Eargo's $81 million Series E financing in 2020. www.eargo.com.



    • Epirium Bio is a clinical-stage biopharmaceutical company that uses insights related to the biology of mitochondrial function and tissue regeneration to pursue novel and clinically significant therapeutic approaches for neuromuscular, neurodegenerative, and mitochondrial disorders. Longitude Capital and ARCH Venture Partners led Epirium's $85 million Series A financing in 2019. www.epirium.com.



    • Polares Medical is a clinical-stage medical technology company focused on the development of a unique trans-catheter mitral valve hemi-replacement system to treat patients suffering from mitral regurgitation (MR). Longitude Capital led Polares Medical's $40 million Series B financing in 2020. www.polaresmedical.com.



    • WelbeHealth is a services company dedicated to unlocking the full potential of vulnerable seniors through PACE (Program of All-Inclusive Care for the Elderly), a comprehensive medical and social care model. Longitude Capital and .406 Ventures led WelbeHealth's $30 million Series C in 2020. www.welbehealth.com.

    Source: Longitude Capital

    Contact Information
    
    Maggie Jamison
    Longitude Capital
    650-854-5700 
    

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  16. SAN FRANCISCO, Sept. 16, 2020 (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 pricing of an upsized underwritten public offering of 3,300,000 shares of its common stock at a public offering price of $28.00 per share. 3,025,000 shares are being offered by 89bio, and 275,000 shares are being offered by a selling stockholder. The gross proceeds of the offering to 89bio, before deducting the underwriting discount and other offering expenses payable by 89bio, are expected to be approximately $84.7 million.  In addition, 89bio has granted the underwriters…

    SAN FRANCISCO, Sept. 16, 2020 (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 pricing of an upsized underwritten public offering of 3,300,000 shares of its common stock at a public offering price of $28.00 per share. 3,025,000 shares are being offered by 89bio, and 275,000 shares are being offered by a selling stockholder. The gross proceeds of the offering to 89bio, before deducting the underwriting discount and other offering expenses payable by 89bio, are expected to be approximately $84.7 million.  In addition, 89bio has granted the underwriters a 30-day option to purchase up to an additional 495,000 shares of common stock, at the public offering price, less the underwriting discounts and commissions. 89bio will not receive any proceeds from the sale of shares of the company's common stock by the selling stockholder. The offering is expected to close on September 21, 2020, subject to the satisfaction of customary closing conditions.

    BofA Securities, SVB Leerink and RBC Capital Markets are acting as lead book-running managers for the offering. Raymond James is also acting as a book-running manager for the offering. BTIG, LLC is acting as co-manager for the offering.

    The registration statement relating to these securities became effective on September 16, 2020. The offering is being made solely by means of a prospectus. Copies of the prospectus related to the offering, when available, may be obtained from BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at ; RBC Capital Markets LLC, Attention: Equity Syndicate Department, 200 Vesey Street, 8th Floor, New York, New York 10281, or by telephone at (877) 822-4089, or by email at ; or Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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, 89bio's expectations regarding the consummation of the offering and the satisfaction of customary closing conditions with respect to the offering. 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: changes as a result of market conditions or for other reasons, the risk that the offering will not be consummated, 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 June 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.

    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808

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  17. SAN FRANCISCO, Sept. 14, 2020 (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 commenced an underwritten public offering of 3,000,000 shares of its common stock, which includes 2,700,000 shares of the common stock offered by the company and 300,000 shares of the common stock offered by certain of the company's stockholders. In addition, the company and a selling stockholder is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional 175,000 shares of common stock and 275,000 shares of…

    SAN FRANCISCO, Sept. 14, 2020 (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 commenced an underwritten public offering of 3,000,000 shares of its common stock, which includes 2,700,000 shares of the common stock offered by the company and 300,000 shares of the common stock offered by certain of the company's stockholders. In addition, the company and a selling stockholder is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional 175,000 shares of common stock and 275,000 shares of common stock, respectively, at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    89bio intends to use the net proceeds of the offering, along with its existing cash and cash equivalents, to accelerate and support its BIO89-100 programs in nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG), for the manufacture and scale up of BIO89-100, and for other general corporate purposes.

    BofA Securities, SVB Leerink and RBC Capital Markets are acting as lead book-running managers for the offering. Raymond James is also acting as a book-running manager for the offering.

    A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This offering is being made solely by means of a prospectus. Copies of the preliminary prospectus related to the offering, when available, may be obtained from BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at ; RBC Capital Markets LLC, Attention: Equity Syndicate Department, 200 Vesey Street, 8th Floor, New York, New York 10281, or by telephone at (877) 822-4089, or by email at ; or Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or by email at

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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, 89bio's expectations regarding the proposed offering and the anticipated use of the net proceeds of the offering. 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: changes as a result of market conditions or for other reasons, the risk that the offering will not be consummated, 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 June 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.

    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808

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  18. All dose groups achieved statistically significant reductions in liver fat, with relative reductions of up to 60% versus baseline and up to 70% versus placebo    

    Favorable safety and tolerability profile

    Strong efficacy profile with every two-week dosing

    Statistically significant improvements in markers of liver injury and key lipid parameters

    Conference call and webcast scheduled for 8:30 am ET (5:30 am PT) today

    SAN FRANCISCO, Sept. 14, 2020 (GLOBE NEWSWIRE) -- 89bio, Inc. (NASDAQ:ETNB) today announced positive topline results from its Phase 1b/2a trial with BIO89-100, an investigational FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). All dose groups demonstrated significant reductions in liver…

    All dose groups achieved statistically significant reductions in liver fat, with relative reductions of up to 60% versus baseline and up to 70% versus placebo    

    Favorable safety and tolerability profile

    Strong efficacy profile with every two-week dosing

    Statistically significant improvements in markers of liver injury and key lipid parameters

    Conference call and webcast scheduled for 8:30 am ET (5:30 am PT) today

    SAN FRANCISCO, Sept. 14, 2020 (GLOBE NEWSWIRE) -- 89bio, Inc. (NASDAQ:ETNB) today announced positive topline results from its Phase 1b/2a trial with BIO89-100, an investigational FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH). All dose groups demonstrated significant reductions in liver fat at week 13, with relative reductions up to 60% versus baseline and up to 70% versus placebo, as measured by magnetic resonance imaging – proton density fat factor (MRI-PDFF). A significant proportion of subjects responded to therapy with up to 88% and 71% of subjects achieving a ≥30% or a ≥50% reduction in liver fat versus baseline, respectively. Treatment with BIO89-100 also resulted in significant improvements in liver transaminases, with a 35 U/L decrease in ALT from baseline in subjects with elevated baseline levels, and reductions in ProC3, a marker of fibrosis. Importantly, BIO89-100 is the first FGF21 analog to show benefit in subjects with NASH with every two-week dosing.  BIO89-100 was well tolerated at all doses with low incidence of adverse events that occurred in ≥10% of subjects and very low frequency of gastrointestinal (GI) events relative to placebo.

    The MRI-PDFF results are summarized in the table below:

      BIO89-100

    (once-weekly)
    BIO89-100

    (once every two weeks)
    MeasurePlacebo

    (n= 19)
    3mg

    (n= 6)
    9mg

    (n= 12)
    18mg

    (n= 11)
    27mg

    (n= 10)
    18 mg

    (n= 14)
    36 mg

    (n= 9)
    Relative reduction/increase in liver fat vs. baseline+10%

    -37%**-50%**-36%**-60%**-43%**-50%**
    Relative reduction in liver fat vs. placebo -47%**-59%**-46%**-70%**-53%**-60%**
    Proportion of subjects with ≥30% relative reduction in liver fat0%

    60%*82%**60%**86%**69%**88%**
    Absolute change in liver fat vs. baseline+1.4 -7.5%*-10%**-7.5%**-13.5%**-9.0%**-9.7%**

    *p<0.01; **p<0.001 vs. placebo. n based on subjects randomized. Least square mean based on MRI analysis set (N=75) and responder analysis based on subjects with MRI at Week 13. Levels of liver fat in the BIO89-100 and placebo groups at baseline were 21.2% (on a pooled basis) and 21.8%, respectively. Baseline liver fat levels and changes in liver fat were similar in biopsy-confirmed NASH and phenotypical NASH subjects.



    "The robust reductions in liver fat and key liver markers add to a growing body of evidence demonstrating the promise of BIO89-100 for the treatment of NASH and cardio-metabolic diseases," said Rohit Loomba, MD, MHSc, Director of the UC San Diego NAFLD Research Center and Director of Hepatology at UC San Diego School of Medicine. "The magnitude of ≥30% relative reduction in liver fat has been shown in the literature to translate into higher odds of histologic response and potential to deliver clinically meaningful benefit to patients with NASH." 

    BIO89-100 had a favorable safety and tolerability profile with no deaths or serious adverse events related to treatment. The frequency of GI events compared favorably to placebo with diarrhea (BIO89-100 12.7% vs. placebo 22.2%) and nausea (BIO89-100 7.9% vs. placebo 16.7%) being the only GI events occurring in ≥5% of BIO89-100-treated subjects. The only treatment-related adverse event that occurred in ≥10% of all BIO89-100-treated subjects was mild, increased appetite (15.9%) consistent with other investigational FGF21 analogs. No adverse effects on heart rate or blood pressure were observed.   

    Treatment with BIO89-100 resulted in significant reductions in triglycerides (up to 28%; p <0.05), non-HDL (up to 16%; p<0.01) and LDL-C (up to 16%; p<0.05). Triglycerides were reduced to a greater extent in subjects with elevated triglycerides at baseline (TG≥200 mg/mL), and 53% of the BIO89-100 subjects in this group normalized triglyceride levels versus 0% in the placebo group. BIO89-100 also demonstrated significant increases in the insulin-sensitizing hormone adiponectin (up to 61%; p<0.001).  

    This study was a randomized, double-blind, placebo-controlled, multiple ascending dose-ranging trial in biopsy-proven NASH or phenotypical NASH (PNASH) subjects. A total of 81 subjects were randomized to receive weekly or every two-week dosing of BIO89-100 or placebo for up to 12 weeks. Key endpoints assessed were safety, tolerability, and PK of BIO89-100 as well as change in liver fat measured by MRI-PDFF and other metabolic markers.

    "The favorable safety and tolerability profile of BIO89-100 together with potential best-in-class dosing regimen could be important considerations for a NASH therapeutic given the chronic and generally asymptomatic nature of the disease," said Hank Mansbach, MD, Chief Medical Officer, 89bio. "These factors, combined with improvements in liver fat and metabolic markers, unequivocally support advancing the clinical development of BIO89-100 in NASH and reinforce our confidence in the severe hypertriglyceridemia program. We plan to initiate our next trial in NASH in the first half of 2021."

    "We are pleased with this data that highlight BIO89-100's promising clinical profile and its potential to be a leading FGF21 analog in a class with the potential to become a backbone treatment approach for NASH," said Rohan Palekar, Chief Executive Officer, 89bio. "I would like to sincerely thank all of our investigators, clinical sites, subjects, and employees who supported the trial, especially amid a pandemic that has severely impacted the global healthcare system in an unprecedented manner."   

    Conference Call/Webcast Details

    89bio will host a conference call and webcast with slides at 8:30am ET (5:30am PT) this morning, September 14. Details for the live conference call are as follows: Domestic – (833) 570-1145; International – (914) 987-7092; and Passcode - 5064866. To access the live webcast and slides, please visit "Events and Presentations" under the "Investors" section of 89bio's website at https://ir.89bio.com/events-and-presentations. Following the live audio webcast, a replay will be available on the company's website for 90 days.

    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 subjects 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 subjects were randomized to receive weekly or every two weeks subcutaneous dosing of BIO89-100 or placebo for up to 12 weeks. 



    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 or once every two weeks. 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 is BIO89-100, is a specifically engineered glycoPEGylated analog of FGF21. BIO89-100 is being developed for the treatment of NASH and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel. For more information, visit www.89bio.com.

    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, 89bio's expectations and guidance regarding its business plans and objectives for BIO89-100, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of BIO89-100 and future clinical development plans; 89bio's statements regarding the Phase 1b/2a Trial of BIO89-100; and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials, including the anticipated timing of the next trial in NASH. 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 next trial in NASH; 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; regulatory developments in the United States; 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 June 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.

    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808

     

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  19. SAN FRANCISCO, Sept. 13, 2020 (GLOBE NEWSWIRE) -- 89bio, Inc. (NASDAQ:ETNB) today announced that the company plans to share topline safety, tolerability and efficacy data from its Phase 1b/2a study of BIO89-100 in NASH in a pre-market press release and webcast to be held on Monday, September 14, 2020.

    Conference Call/Webcast Details
    The company will host a conference call and webcast with slides at 8:30am PT (5:30am PT) tomorrow morning, September 14. Details for the live conference call are as follows: Domestic – (833) 570-1145; International – (914) 987-7092; and Passcode - 5064866. To access the live webcast and slides, please visit "Events and Presentations" under the "Investors" section of 89bio's website at https://ir.89bio.com/events-and-presentations

    SAN FRANCISCO, Sept. 13, 2020 (GLOBE NEWSWIRE) -- 89bio, Inc. (NASDAQ:ETNB) today announced that the company plans to share topline safety, tolerability and efficacy data from its Phase 1b/2a study of BIO89-100 in NASH in a pre-market press release and webcast to be held on Monday, September 14, 2020.

    Conference Call/Webcast Details

    The company will host a conference call and webcast with slides at 8:30am PT (5:30am PT) tomorrow morning, September 14. Details for the live conference call are as follows: Domestic – (833) 570-1145; International – (914) 987-7092; and Passcode - 5064866. To access the live webcast and slides, please visit "Events and Presentations" under the "Investors" section of 89bio's website at https://ir.89bio.com/events-and-presentations. Following the live audio webcast, a replay will be available on the company's website for 90 days.

    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 NASH and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel. For more information, visit www.89bio.com.

    Investor Contact:

    Ryan Martins

    Chief Financial Officer



    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808

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  20. SAN FRANCISCO, Sept. 03, 2020 (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 a Phase 2 trial evaluating its product candidate BIO89-100 in patients with severe hypertriglyceridemia ("SHTG"). BIO89-100 is a glycoPEGylated analog of fibroblast growth factor 21 ("FGF21") in clinical development for the treatment of nonalcoholic steatohepatitis ("NASH") and SHTG.

    "This new program builds on our strategy to leverage the biology of FGF21 to bring meaningful benefit to patients across a range of serious diseases with high unmet needs," said…

    SAN FRANCISCO, Sept. 03, 2020 (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 a Phase 2 trial evaluating its product candidate BIO89-100 in patients with severe hypertriglyceridemia ("SHTG"). BIO89-100 is a glycoPEGylated analog of fibroblast growth factor 21 ("FGF21") in clinical development for the treatment of nonalcoholic steatohepatitis ("NASH") and SHTG.

    "This new program builds on our strategy to leverage the biology of FGF21 to bring meaningful benefit to patients across a range of serious diseases with high unmet needs," said Hank Mansbach, Chief Medical Officer of 89bio. "Existing therapies for SHTG do not address the range of metabolic issues faced by these patients, that result in the increased risk of cardiovascular events and NASH. Our early clinical data indicate that BIO89-100 could offer robust and durable reductions in triglycerides as well as deliver broad metabolic benefits. This suggests BIO89-100 has the potential to be a highly differentiated new therapy for this condition."

    The Phase 2 trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the safety, efficacy, and tolerability of BIO89-100 in patients with SHTG. The study will enroll approximately 90 patients who will be treated with BIO89-100 in one of four treatment groups or placebo administered in either weekly or every two weeks doses for a period of 8 weeks. The primary endpoint is the reduction in fasting triglycerides from baseline. Key secondary endpoints include the effect of BIO89-100 on other lipids and metabolic markers and change in liver fat measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Patients who meet screening criteria will undergo a lifestyle stabilization and triglyceride qualification period prior to randomization and will receive lifestyle counseling during the study.

    About Severe Hypertriglyceridemia

    SHTG is a condition identified by severely elevated levels of triglycerides (greater than or equal to 500 mg/dL). It is associated with an increased risk of NASH, cardiovascular events, and acute pancreatitis. It is estimated that up to 4 million patients in the United States have SHTG. Of these patients, it is estimated that 56% have hepatic fat, 42% have dyslipidemias and 27% have diabetes. This patient population is expected to increase due to the triple epidemic of obesity, metabolic syndrome, and Type 2 diabetes. While existing therapies may decrease triglyceride levels, they generally do not have broader metabolic benefits underscoring the urgent need for additional therapeutic options.

    About BIO89-100

    BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH and SHTG. 89bio has optimally engineered BIO89-100 using a proprietary glycoPEGylation technology to balance efficacy and longer dosing interval. In preclinical studies, BIO89-100 demonstrated significant improvements in hepatic steatosis, injury, and fibrosis. In 89bio's Phase 1a clinical trial of BIO89-100 in healthy volunteers, BIO89-100 demonstrated robust and durable improvements in key lipid markers, a favorable tolerability profile, and a long half-life that supports the potential for weekly or once every two weeks dosing.

    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. 89bio's lead product candidate is BIO89-100, a specifically engineered glycoPEGylated analog of FGF21. BIO89-100 is being developed for the treatment of NASH and SHTG with ongoing proof of concept studies in both indications. 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, 89bio's expectations regarding its new clinical program and clinical trials, the association of early data with potential clinical benefit, and the results and timing of anticipated 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, completion and outcome of 89bio's proof of concept Phase 2 clinical trial evaluating BIO89-100 in patients with SHTG; the unpredictable relationship between preclinical study results and clinical study results; 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 June 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.

    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    510-390-3407

    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808



     

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  21. - Topline results from BIO89-100's Phase 1b/2a NASH trial are expected in Late Q3 to Early Q4 -

    - BIO89-100's Phase 2 SHTG trial is expected to be initiated in Q3 -

    SAN FRANCISCO, Aug. 13, 2020 (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 June 30, 2020.

    "We are pleased with the progress we have made with our Phase 1b/2a trial for nonalcoholic steatohepatitis (NASH) and look forward to reporting topline results in late third quarter to early fourth quarter of this year," said Rohan Palekar, Chief Executive…

    - Topline results from BIO89-100's Phase 1b/2a NASH trial are expected in Late Q3 to Early Q4 -

    - BIO89-100's Phase 2 SHTG trial is expected to be initiated in Q3 -

    SAN FRANCISCO, Aug. 13, 2020 (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 June 30, 2020.

    "We are pleased with the progress we have made with our Phase 1b/2a trial for nonalcoholic steatohepatitis (NASH) and look forward to reporting topline results in late third quarter to early fourth quarter of this year," said Rohan Palekar, Chief Executive Officer of 89bio. "With our strengthened capital position, we look forward to continuing to advance BIO89-100 and remain on track to initiate the Phase 2 trial in severe hypertriglyceridemia (SHTG) patients during this quarter." 

    Recent Highlights and Upcoming Milestones

    Topline results from the Phase 1b/2a trial of BIO89-100 in NASH are expected in Late Q3 to Early Q4. In April 2020, 89bio closed enrollment in its Phase 1b/2a trial of BIO89-100 in NASH. Topline results are expected in late Q3 to early Q4.

    Phase 2 trial of BIO89-100 in SHTG on track for initiation in Q3. On May 8, 2020, the Division of Diabetes, Lipid Disorders, and Obesity at the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for BIO89-100 in patients with SHTG.      

    Completed underwritten offering of common stock. In July 2020, 89bio received approximately $78.3 million in net proceeds from an underwritten offering of common stock.

    Second Quarter 2020 Financial Results

    Cash Position. As of June 30, 2020, 89bio had cash, cash equivalents, and short-term investments of $73.9 million.

    Research and Development (R&D) Expenses. R&D expenses were $8.4 million for the three months ended June 30, 2020, compared to $3.2 million for the three months ended June 30, 2019. The increase in R&D expenses was primarily driven by increases in clinical development, contract manufacturing, pre-clinical development and personnel expenses.

    General and Administrative (G&A) Expenses. G&A expenses were $3.2 million for the three months ended June 30, 2020, compared to $0.8 million for the three months ended June 30, 2019. The increase in G&A expenses was primarily due to an increase in costs related to professional services and personnel expenses.

    Net Loss. 89bio reported a net loss of $11.8 million for the three months ended June 30, 2020, compared to a net loss of $15.0 million for the three months ended June 30, 2019. The decrease in net loss  is primarily attributable to increased R&D expenses for our programs and increased G&A expenses associated with our becoming a public company offset by a non-recurring charge in 2019 for accounting of preferred stock liability.

    About BIO89-100

    BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH and the treatment of severe hypertriglyceridemia (SHTG). 89bio has specifically engineered BIO89-100 using a proprietary glycoPEGylation technology designed to prolong the biological activity of native FGF21. In preclinical studies, BIO89-100 demonstrated consistent beneficial effects across a range of endpoints, including hepatic steatosis, injury, and fibrosis. In 89bio's Phase 1a clinical trial in healthy volunteers, BIO89-100 demonstrated a favorable tolerability profile and dose-proportional pharmacokinetics. BIO89-100 also demonstrated statistically significant improvements in key lipid parameters for two weeks after a single dose, which combined with results from the company's animal studies supports the potential for weekly or once every two weeks dosing. A proof of concept Phase 1a/2b clinical trial evaluating BIO89-100 in patients with NASH or NAFLD and a high risk of NASH is currently underway and a Phase 2 trial in patients with SHTG is expected to initiate shortly.  



    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 being developed for the treatment of NASH and for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH and a Phase 2 trial in patients with SHTG is expected to initiate shortly. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.

    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, 89bio's expectations regarding plans for its clinical programs and clinical studies. 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 U.S. Securities and Exchange Commission (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, completion and outcome of 89bio's Phase 1b/2a proof of concept clinical trial evaluating BIO89-100 in patients with NASH or patients with NAFLD and a high risk of NASH; expectations regarding the timing, completion and outcome of 89bio's proof of concept Phase 2 clinical trial evaluating BIO89-100 in patients with SHTG; the unpredictable relationship between preclinical study results and clinical study results; the effect of the COVID-19 pandemic on 89bio's clinical trials and business operations; liquidity and capital resources; and other risks and uncertainties identified in 89bio's Annual Report on Form 10-Q for the quarter ended March 31, 2020, filed May 13, 2020 with the SEC 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 Ended Six Months Ended
      June 30, June 30,
       2020   2019   2020   2019 
             
    Operating expenses:        
    Research and development $8,443  $3,165  $16,221  $7,474 
    General and administrative  3,230   834   6,154   1,357 
    Total operating expenses  11,673   3,999   22,375   8,831 
    Loss from operations  11,673   3,999   22,375   8,831 
    Other expenses (income), net  98   10,968   (59)  10,552 
    Net loss before tax  11,771   14,967   22,316   19,383 
    Income tax expense (benefit)     6   (1)  29 
    Net loss and comprehensive loss $11,771  $14,973  $22,315  $19,412 
    Net loss per share, basic and diluted $0.85  $24.50  $1.62  $31.76 
    Weighted-average shares used to compute net loss per share, basic and diluted  13,797,356   611,226   13,793,544   611,226 
             
             





     
    89bio, Inc. Condensed Consolidated Balance Sheet Data (Unaudited) (In thousands)
        
     June 30, December 31,
      2020   2019 
        
    Cash, cash equivalents and short-term investments$73,896  $93,335 
    Total Assets 76,562   95,553 
    Total current liabilities 6,791   5,609 
    Total stockholders' equity 69,771   89,944 
        
        



    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808





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  22. SAN FRANCISCO, Aug. 03, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2020 on Monday, August 10 , 2020 at 11:30 AM ET and the Canaccord Genuity 40th Annual Growth Conference on Wednesday, August 12, 2020 at 10:00 AM ET.

    The live and archived webcast of the presentation will be accessible from the company's website at https://ir.89bio.com/events-and-presentations. The replay of the webcast will be available on…

    SAN FRANCISCO, Aug. 03, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2020 on Monday, August 10 , 2020 at 11:30 AM ET and the Canaccord Genuity 40th Annual Growth Conference on Wednesday, August 12, 2020 at 10:00 AM ET.

    The live and archived webcast of the presentation will be accessible from the company's website at https://ir.89bio.com/events-and-presentations. The replay of the webcast will be available on the company's website.

    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 being developed for the treatment of NASH and for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.

    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808



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  23. SAN FRANCISCO, July 13, 2020 (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, announced the closing of its upsized underwritten public offering of 3,047,040 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase up to 397,440 additional shares of common stock, at a public offering price of $27.50 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by 89bio, were approximately $83.8 million. All of the shares were offered by 89bio.

    SAN FRANCISCO, July 13, 2020 (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, announced the closing of its upsized underwritten public offering of 3,047,040 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase up to 397,440 additional shares of common stock, at a public offering price of $27.50 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by 89bio, were approximately $83.8 million. All of the shares were offered by 89bio.

    BofA Securities, SVB Leerink and RBC Capital Markets acted as joint book-running managers for the offering. Oppenheimer & Co. acted as co-manager for the offering.

    The registration statements relating to these securities became effective on July 7, 2020. The offering was made solely by means of a prospectus. Copies of the prospectus related to the offering may be obtained from BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at ; or RBC Capital Markets LLC, Attention: Equity Syndicate Department, 200 Vesey Street, 8th Floor, New York, New York 10281, or by telephone at (877) 822-4089, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 being developed for the treatment of NASH and for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel.

    Investor Contact:

    Ryan Martins

    Chief Financial Officer

    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808



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  24. SAN FRANCISCO, July 07, 2020 (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 pricing of an upsized underwritten public offering of 2,649,600 shares of its common stock at a public offering price of $27.50 per share. The gross proceeds of the offering, before deducting the underwriting discount and other offering expenses payable by 89bio, are expected to be approximately $72.9 million. All of the shares are being offered by 89bio.  In addition, 89bio has granted the underwriters a 30-day option to purchase up to an additional 397,440 shares of common…

    SAN FRANCISCO, July 07, 2020 (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 pricing of an upsized underwritten public offering of 2,649,600 shares of its common stock at a public offering price of $27.50 per share. The gross proceeds of the offering, before deducting the underwriting discount and other offering expenses payable by 89bio, are expected to be approximately $72.9 million. All of the shares are being offered by 89bio.  In addition, 89bio has granted the underwriters a 30-day option to purchase up to an additional 397,440 shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on July 10, 2020, subject to the satisfaction of customary closing conditions.

    BofA Securities, SVB Leerink and RBC Capital Markets are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as co-manager for the offering.

    The registration statements relating to these securities became effective on July 7, 2020. The offering is being made solely by means of a prospectus. Copies of the prospectus related to the offering, when available, may be obtained from BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at ; or RBC Capital Markets LLC, Attention: Equity Syndicate Department, 200 Vesey Street, 8th Floor, New York, New York 10281, or by telephone at (877) 822-4089, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 being developed for the treatment of NASH and for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 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, 89bio's expectations regarding the consummation of the offering and the satisfaction of customary closing conditions with respect to the offering and the anticipated use of the net proceeds of the offering. 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: changes as a result of market conditions or for other reasons, the risk that the offering will not be consummated, 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 March 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

      

    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808

      



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  25. SAN FRANCISCO, July 06, 2020 (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 commenced an underwritten public offering of 2,200,000 shares of its common stock. In addition, the company is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional 330,000 shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed…

    SAN FRANCISCO, July 06, 2020 (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 commenced an underwritten public offering of 2,200,000 shares of its common stock. In addition, the company is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional 330,000 shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    89bio intends to use the net proceeds of the offering, along with its existing cash and cash equivalents, to accelerate and support its BIO89-100 programs in nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG), for the manufacture and scale up of BIO89-100, and for other general corporate purposes.

    BofA Securities, SVB Leerink and RBC Capital Markets are acting as joint book-running managers for the offering.

    A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This offering is being made solely by means of a prospectus. Copies of the preliminary prospectus related to the offering, when available, may be obtained from BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, or by email at ; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at ; or RBC Capital Markets LLC, Attention: Equity Syndicate Department, 200 Vesey Street, 8th Floor, New York, New York 10281, or by telephone at (877) 822-4089, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 being developed for the treatment of NASH and for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 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, 89bio's expectations regarding the proposed offering and the anticipated use of the net proceeds of the offering. 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: changes as a result of market conditions or for other reasons, the risk that the offering will not be consummated, 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 March 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

    Media Contact:

    Lori Rosen

    LDR Communications

    917-553-6808

     

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  26. SAN FRANCISCO, June 04, 2020 (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 appointment of Lota S. Zoth, CPA to its Board of Directors and as Chair of the Audit Committee. A veteran of the biopharmaceutical industry, Ms. Zoth brings more than 35 years of financial and strategic experience to her role.

    "We are very pleased to have someone of Lota's caliber join 89bio's Board of Directors," said Rohan Palekar, CEO of 89bio. "Lota brings decades of financial, operational and board experience to 89bio, which we expect will prove valuable as we advance the…

    SAN FRANCISCO, June 04, 2020 (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 appointment of Lota S. Zoth, CPA to its Board of Directors and as Chair of the Audit Committee. A veteran of the biopharmaceutical industry, Ms. Zoth brings more than 35 years of financial and strategic experience to her role.

    "We are very pleased to have someone of Lota's caliber join 89bio's Board of Directors," said Rohan Palekar, CEO of 89bio. "Lota brings decades of financial, operational and board experience to 89bio, which we expect will prove valuable as we advance the clinical development of BIO89-100 and execute against our goals as a public company."

    Ms. Zoth currently serves as the chair of the board of directors and the audit committee of Zymeworks, Inc. and as chair of the audit committees of Inovio Pharmaceuticals, Inc. and Lumos Pharma, Inc. She previously served on the board of directors of other biopharmaceutical companies including Spark Therapeutics, Inc., Hyperion Therapeutics, Inc. Orexigen Therapeutics, Inc., Aeras, Ikaria, Inc. and Circassia Pharmaceuticals, plc. Ms. Zoth served as chief financial officer of MedImmune, Inc. until her retirement in July 2007. Prior to MedImmune, she held senior financial positions at a number of publicly traded companies, including Sodexho Marriott Services, Inc., PSINet, Inc., Marriott International, Inc. and PepsiCo, Inc. Ms. Zoth is a certified public accountant and began her career as an auditor at Ernst & Young, LLP. She received a BBA in accounting, summa cum laude, from Texas Tech University.

    "I'm excited to join 89bio's Board of Directors during this pivotal period of growth and scientific advancement," said Ms. Zoth. "I look forward to collaborating with other members of the Board of Directors and company management to successfully execute on our vision of delivering differentiated medicines to patients with liver and cardio-metabolic diseases."

    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 being developed for the treatment of NASH. The company also intends to develop BIO89-100 for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.

    Investor Contact:
    Ryan Martins
    Chief Financial Officer

    Media Contact:
    Lori Rosen
    LDR Communications
    917-553-6808

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  27. - Topline results from BIO89-100's Phase 1b/2a NASH trial are expected in 2H20 -

    - Announces FDA Clearance of BIO89-100 IND Application for SHTG -

    SAN FRANCISCO, May 13, 2020 (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, 2020.

    "We are excited to have closed enrollment in our Phase 1b/2a trial for nonalcoholic steatohepatitis (NASH) and look forward to reporting topline results in the second half of 2020," said Rohan Palekar, Chief Executive Officer of 89bio. "The recent clearance by the FDA of our Investigational…

    - Topline results from BIO89-100's Phase 1b/2a NASH trial are expected in 2H20 -

    - Announces FDA Clearance of BIO89-100 IND Application for SHTG -

    SAN FRANCISCO, May 13, 2020 (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, 2020.

    "We are excited to have closed enrollment in our Phase 1b/2a trial for nonalcoholic steatohepatitis (NASH) and look forward to reporting topline results in the second half of 2020," said Rohan Palekar, Chief Executive Officer of 89bio. "The recent clearance by the FDA of our Investigational New Drug (IND) application for severe hypertriglyceridemia (SHTG) puts us in position to initiate our Phase 2 trial of BIO89-100 for the treatment of SHTG when conditions permit safe and effective execution of the trial."

    Recent Highlights and Upcoming Milestones

    Closed enrollment in the Phase 1b/2a trial of BIO89-100 in NASH. In April 2020, 89bio closed enrollment in its Phase 1b/2a trial of BIO89-100 in NASH with 98% of patients enrolled. 89bio is working closely with its contract research organization partners and clinical sites to mitigate, where possible, any potential impact of the COVID-19 pandemic on the trial. In this trial, 81 patients were randomized to receive weekly or every other week subcutaneous dosing of BIO89-100 or placebo for 12 weeks. Topline results are expected in the second half of 2020.

    FDA Clearance of BIO89-100's IND application for SHTG. On May 8, 2020, the Division of Diabetes, Lipid Disorders, and Obesity at the FDA cleared the IND Application for BIO89-100 in patients with SHTG. In April 2020, 89bio announced that it was delaying initiation of its Phase 2 trial of BIO89-100 for the treatment of SHTG due to the COVID-19 pandemic. 89bio is planning to complete all activities in order to be operationally prepared to enroll the trial once the external environment is conducive to executing the trial safely and effectively.

    New preclinical data confirms BIO89-100's mechanism of action via potent FGF receptor agonism. In April 2020, 89bio released new preclinical data demonstrating that BIO89-100 had similar activity to recombinant human FGF21 at very low nanomolar concentrations in cells co-expressing β-klotho and each of FGF receptors 1c, 2c or 3c. The data suggests that BIO89-100 could reproduce the beneficial metabolic benefits of the native hormone and confirming its potential to translate into clinical benefits for patients with NASH and SHTG. An EC50 could not be calculated for rhFGF21 or BIO89-100 at FGF receptor R4.  

    First Quarter 2020 Financial Results

    Cash Position. As of March 31, 2020, 89bio had cash and cash equivalents of $85.5 million.

    Research and Development (R&D) Expenses. R&D expenses were $7.8 million for the three months ended March 31, 2020, compared to $4.3 million for the three months ended March 31, 2019. The increase in R&D expenses was primarily driven by increases in clinical development, pre-clinical development and personnel expenses.

    General and Administrative (G&A) Expenses. G&A expenses were $2.9 million for the three months ended March 31, 2020, compared to $0.5 million for the three months ended March 31, 2019. The increase in G&A expenses was primarily due to an increase in costs related to professional services and personnel expenses.

    Net Loss. 89bio reported a net loss of $10.5 million for the three months ended March 31, 2020, compared to a net loss of $4.4 million for the three months ended March 31, 2019. The increase in net loss is primarily attributable to increased Research and Development expenses for our programs and increased General and Administrative expenses associated with our becoming a public company.

    About BIO89-100
    BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH and a trial is planned for evaluating its role in the treatment of severe hypertriglyceridemia (SHTG). 89bio has specifically engineered BIO89-100 using a proprietary glycoPEGylation technology designed to prolong the biological activity of native FGF21. In preclinical studies, BIO89-100 demonstrated consistent beneficial effects across a range of endpoints, including hepatic steatosis, injury, and fibrosis. In 89bio's Phase 1a clinical trial in healthy volunteers, BIO89-100 demonstrated a favorable tolerability profile and dose-proportional pharmacokinetics. BIO89-100 also demonstrated statistically significant improvements in key lipid parameters for two weeks after a single dose, which combined with results from the company's animal studies supports the potential for weekly or once every two weeks dosing. A proof of concept Phase 1a/2b clinical trial evaluating BIO89-100 in patients with NASH or NAFLD and a high risk of NASH is currently underway.

    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 being developed for the treatment of NASH. The company also intends to develop BIO89-100 for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.

    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, 89bio's expectations regarding plans for its clinical programs and clinical studies. 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 U.S. Securities and Exchange Commission (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, completion and outcome of 89bio's Phase 1b/2a proof of concept clinical trial evaluating BIO89-100 in patients with NASH or patients with NAFLD and a high risk of NASH; expectations regarding the timing, completion and outcome of 89bio's proof of concept Phase 2 clinical trial evaluating BIO89-100 in patients with SHTG; the unpredictable relationship between preclinical study results and clinical study results; the effect of the COVID-19 pandemic on 89bio's clinical trials and business operations; liquidity and capital resources; and other risks and uncertainties identified in 89bio's Annual Report on Form 10-K for the year ended December 31, 2019, filed March 18, 2020 with the SEC 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:
    Lori Rosen
    LDR Communications
    917-553-6808


     
    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,
          2020       2019  
             
    Operating expenses:        
    Research and development   $ 7,778     $ 4,309  
    General and administrative     2,924       523  
    Total operating expenses     10,702       4,832  
    Loss from operations     10,702       4,832  
    Other income, net     (157 )     (416 )
    Net loss before tax     10,545       4,416  
    Income tax (benefit) expense     (1 )     23  
    Net loss and comprehensive loss   $ 10,544     $ 4,439  
    Net loss per share, basic and diluted   $ 0.76     $ 7.26  
    Weighted-average shares used to compute net loss per share, basic and diluted     13,789,786       611,226  
             

     


     
    89bio, Inc. Condensed Consolidated Balance Sheet Data
    (Unaudited)
    (In thousands)
     
           
      March 31,   December 31,
       2020    2019
           
    Cash and cash equivalents $ 85,532   $ 93,335
    Total assets   87,689     95,553
    Total current liabilities   7,787     5,609
    Total stockholders' equity   79,902     89,944
           


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  28. SAN FRANCISCO, May 08, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will participate in a fireside chat at the BofA Securities 2020 Virtual Global Healthcare Conference on Thursday May 14, 2020 at 11:00 AM ET and the RBC Capital Markets 2020 Global Healthcare Virtual Conference on Wednesday, May 20, 2020 at 3:05 PM ET.

    The live and archived webcast of the presentation will be accessible from the company's website at https://ir.89bio.com/events-and-presentations. The replay of the webcast…

    SAN FRANCISCO, May 08, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will participate in a fireside chat at the BofA Securities 2020 Virtual Global Healthcare Conference on Thursday May 14, 2020 at 11:00 AM ET and the RBC Capital Markets 2020 Global Healthcare Virtual Conference on Wednesday, May 20, 2020 at 3:05 PM ET.

    The live and archived webcast of the presentation will be accessible from the company's website at https://ir.89bio.com/events-and-presentations. The replay of the webcast will be available on the company's website.

    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 being developed for the treatment of NASH. The company also intends to develop BIO89-100 for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.

    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, 89bio's expectations regarding plans for its clinical programs and clinical trials, the association of preclinical data with potential clinical benefit and timing of anticipated milestones. 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 U.S. Securities and Exchange Commission (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 enrollment, completion and outcome of 89bio's Phase 1b/2a proof of concept clinical trial evaluating BIO89-100 in patients with NASH or patients with NAFLD and a high risk of NASH; expectations regarding the timing, completion and outcome of 89bio's proof of concept Phase 2 clinical trial evaluating BIO89-100 in patients with SHTG; the unpredictable relationship between preclinical study results and clinical study results; the effect of the COVID-19 pandemic on 89bio's clinical trials and business operations; and other risks and uncertainties identified in 89bio's Annual Report on Form 10-K for the year ended December 31, 2019, filed March 18, 2020 with the SEC 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:
    Lori Rosen
    LDR Communications
    917-553-6808
     



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  29. SAN FRANCISCO, March 25, 2020 (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 appointment of Steven Altschuler, M.D., as chairman of its board of directors. Dr. Altschuler currently serves as managing director of Healthcare Ventures at Ziff Capital Partners. He brings 20 years of experience growing healthcare organizations in business and leadership capacities.

    "We are very pleased to welcome Steven as chairman of 89bio's board of directors," said Greg Grunberg, chair of the nominating and corporate governance committee of 89bio's board of directors…

    SAN FRANCISCO, March 25, 2020 (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 appointment of Steven Altschuler, M.D., as chairman of its board of directors. Dr. Altschuler currently serves as managing director of Healthcare Ventures at Ziff Capital Partners. He brings 20 years of experience growing healthcare organizations in business and leadership capacities.

    "We are very pleased to welcome Steven as chairman of 89bio's board of directors," said Greg Grunberg, chair of the nominating and corporate governance committee of 89bio's board of directors. "By any measure, Steven has distinguished himself throughout his career as an innovator and dynamic leader in the provider and biotechnology industries. We are incredibly fortunate to have him join the team and confident he is going to be a significant contributor to 89bio."

    In his role at Ziff Capital Partners, Dr. Altschuler co-leads the firm's efforts toward investing in, and facilitating the start-up and development of, companies with potentially transformative technologies that emphasize cellular and molecular approaches to human disease. He previously co-founded Spark Therapeutics to develop and commercialize the preclinical and clinical gene therapy programs advanced at the Children's Hospital of Philadelphia (CHOP) and other institutions. Dr. Altschuler served as Spark Therapeutics' board chair from its founding through its acquisition in 2019, which included leading the company through a successful transition to a public company and the launch of the first gene therapy for an inherited disease approved by the U.S. Food and Drug Administration and European Medicines Agency.

    "I joined the board of directors because of my enthusiasm for 89bio's potentially differentiated fibroblast growth factor 21 (FGF21), BIO89-100, and its commercial potential in non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG)," said Dr. Altschuler. "I look forward to working closely with the team and the rest of the board to advance our work in liver and cardio-metabolic diseases."

    Trained as a pediatric gastroenterologist, Dr. Altschuler formerly held CEO positions at CHOP, which is one of the nation's leading children's hospitals, and the University of Miami Health System. He is a member of the board of directors of WW (formerly Weight Watchers International), Orchard Therapeutics, AsclepiX Therapeutics, ImVaX and Platelet Biogenesis. He is also an independent trustee of the Brigham and Women's Physician Organization at Mass General Brigham. Dr. Altschuler holds a B.A. in mathematics and an M.D. from Case Western Reserve University.

    "Steven is an accomplished business leader who has led and served on the boards of numerous biotechnology companies," said Rohan Palekar, CEO of 89bio. "We look forward to drawing upon his strategic, operational and clinical expertise as we continue to grow the organization and work towards developing differentiated medicines for patients with liver and cardio-metabolic diseases."

    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 being developed for the treatment of NASH. The company also intends to develop BIO89-100 for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.

    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, 89bio's expectations regarding plans for its clinical programs and clinical studies. 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 U.S. Securities and Exchange Commission (SEC)), many of which are beyond 89bio's control and subject to change. Actual results could be materially different. 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:
    Lori Rosen
    LDR Communications
    917-553-6808

    Primary Logo

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  30. - BIO89-100 Phase 1b/2a NASH study on track for topline data in 2H20 -

    - Initiation of Phase 2 SHTG study planned in 1H20 -

    SAN FRANCISCO, March 18, 2020 (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, 2019.

    "The fourth quarter of 2019 capped an exciting year for 89bio where we reported positive topline data from our single ascending dose study of BIO89-100, scaled up our operations and manufacturing, and successfully completed an upsized initial public offering," said Rohan Palekar, Chief…

    - BIO89-100 Phase 1b/2a NASH study on track for topline data in 2H20 -

    - Initiation of Phase 2 SHTG study planned in 1H20 -

    SAN FRANCISCO, March 18, 2020 (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, 2019.

    "The fourth quarter of 2019 capped an exciting year for 89bio where we reported positive topline data from our single ascending dose study of BIO89-100, scaled up our operations and manufacturing, and successfully completed an upsized initial public offering," said Rohan Palekar, Chief Executive Officer of 89bio. "We expect 2020 to be another transformative year with topline data from our Phase 1b/2a nonalcoholic steatohepatitis (NASH) study expected in the second half of 2020 and planned initiation of our Phase 2 study in severe hypertriglyceridemia (SHTG) in the first half of 2020."

    Recent Highlights and Upcoming Milestones

    Phase 1b/2a Trial of BIO89-100 in NASH. In September 2019, 89bio announced that it had initiated dosing in its proof of concept Phase 1b/2a clinical trial evaluating BIO89-100 in patients with NASH or patients with nonalcoholic fatty liver disease (NAFLD) and a high risk of NASH. Enrollment in the study has been progressing well with topline data expected in the second half of 2020.

    Phase 2 Trial of BIO89-100 in SHTG. 89bio's Phase 2 clinical trial evaluating BIO89-100 in patients with SHTG, which has a planned primary endpoint of reduction from baseline in triglycerides, is currently on track for initiation in the first half of 2020 and topline data in the first half of 2021.

    Completed Successful Upsized Initial Public Offering. 89bio completed a successful, upsized IPO on November 13, 2019 that priced at $16.00 per share. The gross proceeds of the offering were approximately $97.6 million, which included the exercise in full by the underwriters of their option to purchase additional shares of common stock. The gross proceeds were calculated before deducting underwriting discounts and commissions and other offering expenses payable by 89bio.

    Fourth Quarter and Full Year 2019 Financial Results

    Cash Position. As of December 31, 2019, 89bio had cash and cash equivalents of $93.4 million, including the net proceeds from our IPO. 

    Research and Development (R&D) Expenses. R&D expenses were $7.2 million and $21.4 million for the three months and year ended December 31, 2019, respectively, compared to $3.7 million and $13.7 million for the three months and year ended December 31, 2018, respectively. The increase for the year ended December 31, 2019 was primarily driven by increases in clinical development, contract manufacturing, pre-clinical, and personnel expenses.

    General and Administrative (G&A) Expenses. G&A expenses were $2.4 million and $5.3 million for the three months and year ended December 31, 2019, respectively, compared to $0.7 million and $1.5 million for the three months and year ended December 31, 2018, respectively. The increase for the year ended December 31, 2019 was primarily due to costs incurred in preparation to be a public company and personnel related costs.

    About BIO89-100
    BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH and a trial is planned for evaluating its role in the treatment of severe hypertriglyceridemia (SHTG). 89bio has specifically engineered BIO89-100 using a proprietary glycoPEGylation technology designed to prolong the biological activity of native FGF21. In preclinical studies, BIO89-100 demonstrated consistent beneficial effects across a range of endpoints, including hepatic steatosis, injury, and fibrosis. In 89bio's Phase 1a clinical trial in healthy volunteers, BIO89-100 demonstrated a favorable tolerability profile and dose-proportional pharmacokinetics. BIO89-100 also demonstrated statistically significant improvements in key lipid parameters for two weeks after a single dose, which combined with results from the company's animal studies supports the potential for weekly or once every two weeks dosing. A proof of concept Phase 1a/2b clinical trial evaluating BIO89-100 in patients with NASH or NAFLD and a high risk of NASH is currently underway.

    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 being developed for the treatment of NASH. The company also intends to develop BIO89-100 for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.

    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, 89bio's expectations regarding plans for its clinical programs and clinical studies. 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 U.S. Securities and Exchange Commission (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 enrollment, completion and outcome of 89bio's proof of concept Phase 1b/2a clinical trial evaluating BIO89-100 in patients with NASH or patients with NAFLD and a high risk of NASH; expectations regarding the timing, completion and outcome of 89bio's proof of concept Phase 2 clinical trial evaluating BIO89-100 in patients with SHTG; the unpredictable relationship between preclinical study results and clinical study results; liquidity and capital resources; and other risks and uncertainties identified in 89bio's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed December 18, 2019 with the SEC 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 and Comprehensive Loss
    (Unaudited)
    (In thousands, except share and per share amounts)
                     
                    Period from
        Three months   Three months   Year   January 18,
         Ended   Ended   Ended   2018 (inception)
        December 31,   December 31,   December 31,   to December 31,
         2019    2018    2019    2018
                     
    Operating expenses:                
    Research and development   $ 7,192   $ 3,692   $ 21,346   $ 13,681
    General and administrative     2,419     716     5,294     1,481
    Total operating expenses     9,611     4,408     26,640     15,162
    Loss from operations     9,611     4,408     26,640     15,162
    Other (income) expenses, net     9,540     202     30,562     986
    Net loss before tax     19,151     4,610     57,202     16,148
    Income tax expense     132     28     218     28
    Net loss and comprehensive loss   $ 19,283   $ 4,638   $ 57,420   $ 16,176
    Net loss per share, basic and diluted   $ 2.58   $ 7.59   $ 24.49   $ 36.45
    Weighted-average shares used to compute net loss per share, basic and diluted     7,486,577     611,226     2,344,191     443,767
                     


     
    89bio, Inc.
    Condensed Consolidated Balance Sheet Data
    (Unaudited)
    (In thousands)
           
      December 31,   December 31,
     
       2019    2018  
           
    Cash and cash equivalents $ 93,360   $ 11,257  
    Total Assets   95,553     11,369  
    Total current liabilities   5,609     4,353  
    Convertible preferred stock/shares       23,073  
    Total stockholders' equity (deficit)   89,944     (16,057 )
           

    Investor Contact:
    Ryan Martins
    Chief Financial Officer

    Media Contact:
    Lori Rosen
    LDR Communications
    917-553-6808

    Primary Logo

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  31. Epirium Bio, Inc., a clinical-stage biopharmaceutical company focused on mitochondrial biogenesis and therapeutic approaches to neuromuscular diseases, today announced the appointment of Cristina Ghenoiu, Ph.D., as Senior Vice President (SVP) of Research and Development (R&D) Operations and New Product Planning. In this role, Dr. Ghenoiu will be responsible for R&D Operations, spearheading scientific collaborations on the mechanistic underpinnings of Epirium's mitochondrial biogenesis technology to reveal its full therapeutic potential. She will also lead Epirium's New Product Planning efforts as the company identifies new assets and therapeutic areas to expand its pipeline.

    "Dr. Ghenoiu has deep knowledge of the mitochondrial landscape having…

    Epirium Bio, Inc., a clinical-stage biopharmaceutical company focused on mitochondrial biogenesis and therapeutic approaches to neuromuscular diseases, today announced the appointment of Cristina Ghenoiu, Ph.D., as Senior Vice President (SVP) of Research and Development (R&D) Operations and New Product Planning. In this role, Dr. Ghenoiu will be responsible for R&D Operations, spearheading scientific collaborations on the mechanistic underpinnings of Epirium's mitochondrial biogenesis technology to reveal its full therapeutic potential. She will also lead Epirium's New Product Planning efforts as the company identifies new assets and therapeutic areas to expand its pipeline.

    "Dr. Ghenoiu has deep knowledge of the mitochondrial landscape having performed diligence on numerous assets in this space. This experience makes her uniquely qualified to add value to the management team at Epirium Bio. Cristina also has the right balance of scientific rigor along with the passion and commitment to make a difference for patients with mitochondrial disorders," said CEO, Russell Cox.

    Prior to joining Epirium, Dr. Ghenoiu served as a senior investment professional at Longitude Capital where she actively contributed to private and public investments, including company formation efforts. In addition to deal sourcing, evaluation and execution, she provided operational, corporate strategy and capital formation support to portfolio companies. Dr. Ghenoiu was a board observer at 89bio (NASDAQ:ETNB), Neurana Pharmaceuticals, SutroVax, and Rivas Pharmaceuticals, and the diligence lead on numerous other opportunities, including two of Longitude's investments developing mitochondrial-based therapeutics.

    "Cristina played an instrumental role in defining Epirium's value proposition and securing the company's successful $85MM Series A financing. This important new position represents a great opportunity for her, and we look forward to working closely with Cristina and the Epirium team to advance the company's programs for the benefit of patients with mitochondrial dysfunction," said Patrick Enright, Managing Director at Longitude Capital and board member at Epirium Bio.

    Before Longitude, she was a biotech equity research associate analyst at Cowen where she covered biotechnology companies across a multitude of therapeutic areas. Dr. Ghenoiu obtained her Ph.D. in Chromosome and Cell Biology from Weill Cornell Graduate School of Medical Sciences and undertook her postdoctoral training at The Rockefeller University. She also holds a Bachelor of Science degree in Biochemistry (magna cum laude) from Mount Holyoke College. Her scientific work is published in several prestigious journals, including first-author publications in Science and Molecular Cell.

    "I am thrilled to be joining the team at Epirium and look forward to putting my energy and expertise towards maximizing the full potential of the unique mitochondrial biology discovered by Epirium's founders," said Dr. Ghenoiu.

    About Epirium

    Epirium is a clinical stage biopharmaceutical company that has developed unique insights related to the biology of mitochondrial biogenesis and tissue function, potentially resulting in novel and clinically significant therapeutic approaches to currently intractable neuromuscular diseases. The Company has identified and established an IP-protected platform of small molecules that constitute a new class of therapeutics with the potential to stimulate mitochondrial biogenesis and tissue regeneration. Epirium intends to advance its first clinical candidate next year, initially in Becker Muscular Dystrophy, followed by drug development targeting other progressive neuromuscular disorders associated with mitochondrial depletion. To learn more, please visit www.epirium.com.

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  32. SAN FRANCISCO, Feb. 21, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will present at the SVB Leerink 9th Annual Global Healthcare Conference on Wednesday, February 26, 2020 at 11:30 AM ET in New York, NY.

    The live and archived webcast of the presentation will be accessible from the company's website at https://ir.89bio.com/events-and-presentations. The replay of the webcast will be available on the company's website.

    About 89bio
    89bio is a clinical-stage biopharmaceutical company focused on…

    SAN FRANCISCO, Feb. 21, 2020 (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 Rohan Palekar, the company's Chief Executive Officer, will present at the SVB Leerink 9th Annual Global Healthcare Conference on Wednesday, February 26, 2020 at 11:30 AM ET in New York, NY.

    The live and archived webcast of the presentation will be accessible from the company's website at https://ir.89bio.com/events-and-presentations. The replay of the webcast will be available on the company's website.

    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 being developed for the treatment of NASH. The company also intends to develop BIO89-100 for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.

    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, 89bio's expectations regarding plans for its clinical programs and clinical studies. 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 U.S. Securities and Exchange Commission (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 enrollment, completion and outcome of 89bio's proof of concept Phase 1b/2a clinical trial evaluating BIO89-100 in patients with NASH or patients with NAFLD and a high risk of NASH; expectations regarding the development of BIO89-100 for SHTG and the related Phase 2 study; the unpredictable relationship between preclinical study results and clinical study results; liquidity and capital resources; and other risks and uncertainties identified in 89bio's filings with the SEC. 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:
    Lori Rosen
    LDR Communications
    917-553-6808

    Primary Logo

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  33. - Upsized Initial Public Offering raises $97.6 million in gross proceeds -

    - BIO89-100 continues to advance in Phase 1b/2a NASH study -

    SAN FRANCISCO, Dec. 18, 2019 (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 September 30, 2019.

    "I am proud of what the 89bio team has accomplished with the successful completion of our IPO and the advancement of BIO89-100 in the Phase 1b/2a NASH study," said Rohan Palekar, Chief Executive Officer of 89bio. "With our strengthened capital position, we look forward to continuing…

    - Upsized Initial Public Offering raises $97.6 million in gross proceeds -

    - BIO89-100 continues to advance in Phase 1b/2a NASH study -

    SAN FRANCISCO, Dec. 18, 2019 (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 September 30, 2019.

    "I am proud of what the 89bio team has accomplished with the successful completion of our IPO and the advancement of BIO89-100 in the Phase 1b/2a NASH study," said Rohan Palekar, Chief Executive Officer of 89bio. "With our strengthened capital position, we look forward to continuing to advance BIO89-100 through clinical development in NASH and initiating development of BIO89-100 in our planned Phase 2 study in severe hypertriglyceridemia (SHTG) in 2020."

    Recent Highlights and Upcoming Milestones

    Initiated Phase 1b/2a Trial for BIO89-100. In the third quarter of 2019, 89bio announced that it had initiated dosing in its proof of concept Phase 1b/2a clinical trial evaluating BIO89-100 in patients with nonalcoholic steatohepatitis (NASH) or patients with nonalcoholic fatty liver disease (NAFLD) and a high risk of NASH. Topline data from this study is expected in the second half of 2020.

    Completed Upsized Initial Public Offering. 89bio completed a successful, upsized IPO on November 13, 2019 that priced at $16.00 per share. The gross proceeds of the offering were approximately $97.6 million which included the exercise in full by the underwriters of their option to purchase additional shares of common stock. The gross proceeds were calculated before deducting underwriting discounts and commissions and other offering expenses payable by 89bio.

    Presented BIO89-100 Data at The Liver Meeting 2019. 89bio presented two posters related to BIO89-100 at The Liver Meeting 2019 in November 2019. The poster presentations included one on the results from the Phase 1a clinical trial in healthy volunteers and a second poster on preclinical data demonstrating the positive effect of BIO89-100 in reducing preference for sweetened water in obese monkeys.

    Issued New Composition of Matter Patent. The United States Patent and Trademark Office issued US Patent 10,407,479, entitled "Mutant FGF-21 Peptide Pegylated Conjugates and Uses Thereof" to 89bio in September 2019. The patent covers the composition of BIO89-100 as well as methods for making and using BIO89-100 for a variety of therapeutic indications including NASH or metabolic syndrome. The patent expires in 2038 not including any potential patent term extension or regulatory exclusivity that would extend this date.

    Third Quarter 2019 Financial Results

    Cash Position. Cash, cash equivalents and marketable securities were $16.2 million as of September 30, 2019, compared to $11.3 million as of December 31, 2018.  Subsequent to September 30, 2019, 89bio raised gross proceeds of $97.6 million from its IPO before deducting underwriting discounts and commissions and other offering expenses.

    Research and Development (R&D) Expenses. R&D expenses were $6.7 million and $14.2 million for the three and nine months ended September 30, 2019, respectively, compared to $3.3 million and $10.0 million for the same periods in 2018, respectively. The increase in R&D expenses was mainly driven by increases in contract manufacturing, clinical development and personnel related expenses.

    General and Administrative (G&A) Expenses. G&A expenses were $1.5 million and $2.9 million for the three and nine months ended September 30, 2019, respectively, compared to $0.5 million and $0.8 million for the same periods in 2018, respectively. The increase in G&A expenses was primarily due to professional services and other costs associated with preparation to become a public company and personnel related expenses

    About BIO89-100
    BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH and a trial is planned for evaluating its role in the treatment of severe hypertriglyceridemia (SHTG). 89bio has specifically engineered BIO89-100 using a proprietary glycoPEGylation technology designed to prolong the biological activity of native FGF21. In preclinical studies, BIO89-100 demonstrated consistent beneficial effects across a range of endpoints, including hepatic steatosis, injury, and fibrosis. In 89bio's Phase 1a clinical trial in healthy volunteers, BIO89-100 demonstrated a favorable tolerability profile and dose-proportional pharmacokinetics. BIO89-100 also demonstrated statistically significant improvements in key lipid parameters for two weeks after a single dose, which combined with results from the company's animal studies supports the potential for weekly or once every two weeks dosing. A proof of concept Phase 1a/2b clinical trial evaluating BIO89-100 in patients with NASH or NAFLD and a high risk of NASH is currently underway.

    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 being developed for the treatment of NASH. The company also intends to develop BIO89-100 for the treatment of SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.

    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, 89bio's expectations regarding plans for its clinical programs and clinical studies. 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 U.S. Securities and Exchange Commission (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 enrollment, completion and outcome of 89bio's proof of concept Phase 1b/2a clinical trial evaluating BIO89-100 in patients with NASH or patients with NAFLD and a high risk of NASH; expectations regarding the development of BIO89-100 for SHTG and the related Phase 2 study; the unpredictable relationship between preclinical study results and clinical study results; liquidity and capital resources; and other risks and uncertainties identified in 89bio's filings with the SEC. 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)
                    Period from
        Three Months   Three Months   Nine Months   January 18,
         Ended   Ended   Ended   2018 (inception)
        September 30,   September 30,   September 30,   to September 30,
          2019       2018       2019       2018  
                     
    Operating expenses:                
    Research and development   $ 6,680     $ 3,289     $ 14,154     $ 9,989  
    General and administrative     1,518       497       2,875       765  
    Total operating expenses     8,198       3,786       17,029       10,754  
    Loss from operations     8,198       3,786       17,029       10,754  
    Other (income) expenses, net     10,470       379       21,022       784  
    Net loss before tax     18,668       4,165       38,051       11,538  
    Income tax expense     57             86        
    Net loss and comprehensive loss   $ 18,725     $ 4,165     $ 38,137     $ 11,538  
    Net loss per share, basic and diluted   $ (30.63 )   $ (6.81 )   $ (62.39 )   $ (29.79 )
    Weighted-average shares used to compute net loss per share, basic and diluted     611,226       611,226       611,226       387,334  
                     


     
    89bio, Inc.
    Condensed Consolidated Balance Sheet Data
    (Unaudited)
    (In thousands)
           
      September 30,   December 31,
        2019       2018  
           
    Cash and cash equivalents $ 16,226     $ 11,257  
    Total Assets   18,354       11,369  
    Total current liabilities   22,579       4,353  
    Convertible preferred stock/shares   49,746       23,073  
    Total stockholders' deficit   (53,971 )     (16,057 )
           

    Investor Contact:
    Ryan Martins
    Chief Financial Officer

    Media Contact:
    Lori Rosen
    LDR Communications
    917-553-6808

    Primary Logo

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