false 0001785173 0001785173 2023-08-09 2023-08-09





Washington, D.C. 20549







Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 9, 2023



89bio, Inc.

(Exact name of registrant as specified in its charter)




Delaware   001-39122   36-4946844

(State or other jurisdiction

of incorporation)



File Number)


(IRS Employer

Identification No.)

142 Sansome Street, Second Floor

San Francisco, CA 94104

(Address of principal executive offices, including zip code)

(415) 432-9270

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class




Name of each exchange

on which registered

Common Stock, par value $0.001 per share   ETNB   The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.




Item 2.02

Results of Operations and Financial Condition.

On August 9, 2023, 89bio, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

This Item 2.02 and the Press Release attached hereto as Exhibit 99.1, insofar as they disclose information regarding the Company’s results of operations and financial condition for the quarter ended June 30, 2023, are being furnished to the Securities and Exchange Commission.


Item 9.01

Financial Statements and Exhibits.

(d) Exhibits. The following exhibit is being furnished herewith:





99.1    Press Release, dated August 9, 2023
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


    89bio, Inc.
Date: August 9, 2023     By:  

/s/ Rohan Palekar

      Rohan Palekar
      Chief Executive Officer

Exhibit 99.1


89bio Reports Second Quarter 2023 Financial Results and Provides Corporate Update

– Published data from ENLIVEN Phase 2b trial of pegozafermin in NASH in The New England Journal of Medicine; presented the data in a late-breaker session at the EASL International Liver Congress –

– Discussions with regulatory agencies regarding Phase 3 NASH program are planned for the second half of 2023 –

– Initiated ENTRUST Phase 3 trial of pegozafermin in patients with severe hypertriglyceridemia (SHTG) –

– Published positive results from Phase 2 ENTRIGUE trial of pegozafermin in SHTG in Nature Medicine –

SAN FRANCISCO, August 9, 2023 (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 cardiometabolic diseases, today reported its financial results for the second quarter ended June 30, 2023.

“Progress in our late-stage clinical development programs in both NASH and SHTG further position pegozafermin as a potentially leading FGF21 analog treatment option,” said Rohan Palekar, Chief Executive Officer of 89bio. “The importance of the Phase 2b ENLIVEN trial data in NASH was further validated with the recent New England Journal of Medicine (NEJM) publication. Specifically, the histology data and positive results seen across markers of total liver health in the overall trial population and in patients on background GLP-1 therapies continue to support the therapeutic utility of pegozafermin and highlight the potential opportunity for a combination approach in patients with comorbidities. As we continue to advance towards Phase 3 development, we look forward to discussions with regulatory agencies planned in the second half of 2023.”

Mr. Palekar continued, “In the second quarter of 2023, we initiated ENTRUST, the Phase 3 trial of pegozafermin in patients with SHTG, signifying entry of the first FGF21 analog into Phase 3 development. Results from our previous trials in SHTG, including the recently published Phase 2 ENTRIGUE data in Nature Medicine, highlight the therapeutic potential of pegozafermin to offer a highly differentiated treatment option that is supportive of adoption and compliance.”

Recent Highlights and Anticipated Milestones

Nonalcoholic Steatohepatitis (NASH)



Data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with NASH were published online in NEJM. The data were simultaneously presented in a late-breaking oral session at the EASL Congress 2023 in Vienna, Austria and were also selected for inclusion in the Best of EASL Congress summary.



New analyses presented at EASL showed pegozafermin resulted in significant benefit across several key sub populations of NASH patients, including type 2 diabetes status, fibrosis stage (F2 or F3), and ALT levels. Adding pegozafermin to patients taking GLP-1 therapies improved key NASH measures, including liver markers of fibrosis, improvements in liver fat, ALT levels as well as metabolic (HbA1c) markers.




A subgroup of patients on background GLP-1 therapy saw improvements in key markers in the pooled pegozafermin group versus placebo for ELF score (-0.4 vs. +0.3 points), VCTE (-2.1 vs. -0.4 kPa), ALT (-22.3 vs. -12.4 U/L), MRI-PDFF (-54% vs. -28%), and hemoglobin A1c (HbA1c; -0.4 vs. -0.1). While GLP-1 therapies are promising for early-stage disease, there remains an unmet need for liver targeted therapies that demonstrate a fibrosis benefit like pegozafermin for medium-high risk (F2/F3) non-cirrhotic patients and compensated cirrhotic patients.



Across all patients, treatment with pegozafermin demonstrated statistically significant improvements on hepatic inflammation and fibrosis, which is consistent with previously reported markers. Further, there were no clinically relevant changes observed on vital signs, bone biomarkers or dual x-ray absorptiometry (DEXA) scans.



The Company intends to meet with the U.S. Food and Drug Administration in the second half of 2023 and to pursue European Union scientific advice in parallel. Subject to regulatory feedback, the Company’s proposed clinical development plans include a Phase 3 trial evaluating F2/F3 NASH patients with a histology endpoint for accelerated approval and a Phase 3 trial in parallel with an outcomes endpoint for full approval. The SHTG Phase 3 program is expected to also support the safety database requirements at the time of BLA submission.

Severe Hypertriglyceridemia (SHTG)



The Company initiated ENTRUST, a Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with SHTG.



ENTRUST is a randomized, double-blind, placebo-controlled global trial that is planned to enroll up to 360 SHTG patients randomized in a 3:3:2 ratio of pegozafermin (30 mg, 20 mg or placebo) given once weekly by subcutaneous injection for 52 weeks. The primary endpoint is the percent change from baseline in fasting triglycerides at Week 26 compared to placebo. Secondary endpoints include the assessment of liver fat measured by MRI-PDFF, non-HDL-C, HDL-C, apo-B, VLDL-C, HbA1c for those with baseline ≥ 6.5%, and total cholesterol at Week 26 compared to placebo.



Previously reported positive data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with SHTG were published online in Nature Medicine.

Second Quarter 2023 Financial Results

Cash Position. As of June 30, 2023, 89bio had cash, cash equivalents and short-term available-for-sale securities totaling $478.0 million.

Research and Development (R&D) Expenses. R&D expenses were $34.9 million for the three months ended June 30, 2023, compared to $19.7 million for the three months ended June 30, 2022. The increase in R&D expenses was primarily driven by increases in contract manufacturing costs, personnel expenses, and clinical development costs.

General and Administrative (G&A) Expenses. G&A expenses were $7.2 million for the three months ended June 30, 2023, compared to $5.1 million for the three months ended June 30, 2022. The increase in G&A expenses was primarily due to an increase in costs related to professional services and stock-based compensation, offset in part by a decrease in insurance-related costs.



Net Loss. 89bio reported a net loss of $38.4 million for the three months ended June 30, 2023, compared to a net loss of $25.1 million for the three months ended June 30, 2022. The increase in net loss is primarily attributable to increased R&D expenses for our programs and increased G&A expenses associated with operating as a public company.

About 89bio

89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead therapeutic candidate, pegozafermin, through clinical development for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn.

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, statements regarding the therapeutic potential and utility, efficacy and clinical benefits of pegozafermin, the safety and tolerability profile of pegozafermin, trial designs, clinical development plans and timing for pegozafermin, including the SHTG Phase 3 program, the ENTRUST Phase 3 trial in SHTG and the NASH Phase 3 trial, the timing for meeting with regulatory authorities, the use of the SHTG Phase 3 program to support safety database requirements and expectations regarding the time period over which 89bio’s capital resources will be sufficient to fund its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “anticipate,” “goal,” “opportunity,” “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 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 initiation of the Phase 3 trial in NASH; expectations regarding the timing and outcome of the ENTRUST Phase 3 trial in SHTG; 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; 89bio’s substantial dependence on the success of it lead product candidate; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of 89bio’s capital resources and its ability to raise additional capital; and other risks and uncertainties identified in 89bio’s Annual Report on Form 10-K for the year ended December 31, 2022 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


(In thousands, except share and per share amounts)


     Three Months Ended
June 30,
    Six Months Ended
June 30,
     2023     2022     2023     2022  

Operating expenses:


Research and development

   $  34,915     $ 19,686     $ 57,221     $ 39,535  

General and administrative

     7,214       5,052       13,432       10,311  













Total operating expenses

     42,129       24,738       70,653       49,846  













Loss from operations

     (42,129     (24,738     (70,653     (49,846

Interest expense

     (894     (434     (2,969     (842

Interest income and other, net

     4,630       118       6,393       70  













Net loss before income tax

     (38,393     (25,054     (67,229     (50,618

Income tax expense

     —         —         —         (1













Net loss

   $ (38,393   $ (25,054   $ (67,229   $ (50,619













Comprehensive loss

   $ (38,747   $ (25,116   $ (67,473   $ (50,873













Net loss per share, basic and diluted

   $ (0.52   $ (1.23   $ (1.06   $ (2.49













Weighted-average shares used to compute net loss per share, basic and diluted

     74,126,569       20,351,560       63,706,856       20,345,521  













89bio, Inc.

Condensed Consolidated Balance Sheet Data


(In thousands)


     June 30,
     December 31,

Cash and cash equivalents and short-term investments

   $ 477,995      $ 188,160  

Total assets

     492,511        196,824  

Total current liabilities

     25,944        24,614  

Non current liabilities

     24,581        20,378  

Total stockholders’ equity

     441,986        151,832  

Total liabilities and stockholders’ equity

   $ 492,511      $ 196,824  



Investor Contact:

Ryan Martins

Chief Financial Officer


PJ Kelleher

LifeSci Advisors, LLC




Media Contact:

Sheryl Seapy

Real Chemistry