ETNB 89bio Inc.

25.53
+0.64  (+3%)
Previous Close 24.89
Open 25.9
52 Week Low 14.0001
52 Week High 47.2532
Market Cap $430,278,842
Shares 16,853,852
Float 7,057,550
Enterprise Value $345,596,376
Volume 835,146
Av. Daily Volume 126,593
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Drug Pipeline

Drug Stage Notes
BIO89-100
Nonalcoholic steatohepatitis (NASH)
Phase 1/2
Phase 1/2
Phase 1b/2 data released September 14, 2020. All dose groups demonstrated significant reductions in liver fat at week 13.
BIO89-100
Severe hypertriglyceridemia
Phase 2
Phase 2
Phase 2 trial initiation announced September 3, 2020.

Latest News

  1. 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

    Primary Logo

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  2. 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

    Primary Logo

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  3. 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

     

    Primary Logo

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  4. 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

    Primary Logo

    View Full Article Hide Full Article
  5. 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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