ETNB 89bio Inc.

26.48
+0.09  (+0%)
Previous Close 26.39
Open 26.51
52 Week Low 14.0001
52 Week High 47.2532
Market Cap $526,392,001
Shares 19,878,852
Float 10,082,550
Enterprise Value $308,034,155
Volume 76,179
Av. Daily Volume 173,852
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Upcoming Catalysts

Drug Stage Catalyst Date
BIO89-100
Severe hypertriglyceridemia
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
BIO89-100
Nonalcoholic steatohepatitis (NASH)
Phase 1/2
Phase 1/2
Phase 2b trial to be initiated 1H 2021.

Latest News

  1. 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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  2. 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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  3. – 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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  4. 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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  5. 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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