false 0001785173 0001785173 2024-02-29 2024-02-29





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): February 29, 2024



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 February 29, 2024, 89bio, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 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 and year ended December 31, 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 February 29, 2024
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: February 29, 2024     By:   

/s/ Rohan Palekar

      Rohan Palekar
      Chief Executive Officer

Exhibit 99.1



89bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates

– Plan to initiate the Phase 3 ENLIGHTEN NASH program for non-cirrhotic (F2-F3) and cirrhotic (F4) patients in the first and second quarters of 2024, respectively –

– Long-term data from Phase 2b ENLIVEN trial demonstrated sustained benefits of pegozafermin at week 48 in patients with advanced NASH, which was consistent across patient sub-groups

– Data from Phase 2b ENLIVEN trial in patients with cirrhotic NASH were featured in an oral presentation during American Association for the Study of Liver Diseases The Liver Meeting® (AASLD) –

– Completed follow-on offering in the fourth quarter 2023 for $172.5 million in gross proceeds; cash, cash equivalents and marketable securities totaled $578.9 million as of December 31, 2023 –

SAN FRANCISCO, February 29, 2024 (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 fourth quarter and full year ended December 31, 2023, and provided corporate updates.

“In 2023, we advanced our late-stage clinical development programs and demonstrated the anti-fibrotic and metabolic benefits of pegozafermin, aligned our Phase 3 NASH program with regulatory agencies in the United States and Europe, initiated our Phase 3 trial for SHTG, and strengthened our financial position,” said Rohan Palekar, Chief Executive Officer of 89bio. “We are highly encouraged by the Phase 2b ENLIVEN data and the long-term efficacy and tolerability data, which demonstrated positive, sustained benefits over a 48-week period, which together, positions pegozafermin as a potential best-in-class FGF21. As we continue to pursue a new therapeutic option and standard of care for patients through the promise of pegozafermin, our team is focused on the execution of our planned Phase 3 trials in NASH and the ongoing Phase 3 trial in SHTG.”

Recent Highlights and Anticipated Milestones

Nonalcoholic Steatohepatitis (NASH), or Metabolic dysfunction-associated steatohepatitis (MASH)



Successful end-of-Phase 2 meetings (EOP2) with the U.S. Food & Drug Administration (FDA), and initial scientific advice received from the European Medicines Agency (EMA) supports the advancement of pegozafermin into Phase 3 in NASH.



The ENLIGHTEN program is expected to include two Phase 3 trials evaluating patients with NASH. ENLIGHTEN-Fibrosis is expected to enroll non-cirrhotic patients with fibrosis stage F2-F3 and ENLIGHTEN-Cirrhosis is expected to enroll NASH patients with compensated cirrhosis (F4).



ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis are expected to initiate in the first and second quarter of 2024, respectively.



Long-term data from the ENLIVEN Phase 2b trial demonstrated statistically significant improvements across key markers of fibrosis and liver health and at week 48 in NASH patients. Pegozafermin continued to demonstrate a favorable safety and tolerability profile consistent with previously reported data.



Data from the Phase 2b ENLIVEN trial of NASH patients with compensated cirrhosis (F4) were featured in an oral presentation during AASLD, showing clinically meaningful reductions in key non-invasive tests (NITs) of liver inflammation and fibrosis.



Severe Hypertriglyceridemia (SHTG)



Enrollment continues to progress well in ENTRUST, the Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with SHTG. Topline results from this trial are expected in 2025.

Corporate Updates



Completed follow-on offering in the fourth quarter of 2023 for $172.5 million in gross proceeds.

Fourth Quarter 2023 Financial Results

Cash Position. As of December 31, 2023, 89bio had cash, cash equivalents and marketable securities totaling $578.9 million, as compared to $188.2 million as of December 31, 2022.

Research and Development (R&D) Expenses. R&D expenses were $33.6 million and $122.2 million for the three months and year ended December 31, 2023, respectively, compared to $19.1 million and $80.8 million for the three months and year ended December 31, 2022, respectively. The increase in R&D expenses for the year was primarily driven by increases in contract manufacturing costs and personnel-related expenses.

General and Administrative (G&A) Expenses. G&A expenses were $7.6 million and $29.0 million for the three months and year ended December 31, 2023, respectively, compared to $6.3 million and $21.5 million for the three months and year ended December 31, 2022, respectively. The increase in G&A expenses for the year ended December 31, 2023, was primarily due to an increase in personnel-related expenses, employee headcount, including stock-based compensation expense, and increased consultant and professional service fees, partially offset by a decrease in insurance-related costs.

Net Loss. 89bio reported a net loss of $40.2 million and $142.2 million for the three months and year ended December 31, 2023, respectively, compared to a net loss of $24.6 million and $102.0 million for the three months and year ended December 31, 2022, respectively. The increase in net loss is primarily attributable to increased R&D expenses to advance the company’s programs, increased G&A expenses associated with additions in headcount, and expenses in support of the company’s expanded operations, offset by an increase in interest income.

The foregoing financial information is unaudited and subject to change, and actual results may vary from the foregoing.

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 candidate, pegozafermin, through clinical development for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. Pegozafermin has been granted Breakthrough Therapy Designation for the treatment of NASH with fibrosis from U.S. Food and Drug Administration (FDA). 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 initiation of the Phase 3 ENLIGHTEN-Fibrosis trial and Phase 3 ENLIGHTEN-Cirrhosis trial in NASH and the topline results from the ENTRUST Phase 3 trial in SHTG, and enrollment in clinical trials. 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 trials 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     Year Ended  
     December 31,     December 31,  
     2023     2022     2023     2022  

Operating expenses:


Research and development

   $ 33,592     $ 19,064     $ 122,230     $ 80,796  

General and administrative

     7,614       6,298       28,974       21,453  













Total operating expenses

     41,206       25,362       151,204       102,249  













Loss from operations

     (41,206     (25,362     (151,204     (102,249

Interest expense

     (866     (545     (4,794     (1,922

Interest income and other, net

     5,704       1,321       17,676       2,164  













Net loss before income tax

     (36,368     (24,586     (138,322     (102,007

Income tax expense

     (3,867     (16     (3,867     (19













Net loss

   $ (40,235   $ (24,602   $ (142,189   $ (102,026













Comprehensive loss

   $ (39,498   $ (24,512   $ (141,649   $ (102,312













Net loss per share, basic and diluted

   $ (0.50   $ (0.48   $ (2.00   $ (2.93













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

     80,696,621       50,809,279       71,172,870       34,806,349  













89bio, Inc.

Condensed Consolidated Balance Sheet Data


(In thousands)


     December 31,
     December 31,

Cash, cash equivalents and marketable securities

   $ 578,870      $ 188,160  

Total assets

     596,269        196,824  

Total current liabilities

     29,611        24,614  

Non-current liabilities

     30,352        20,378  

Total stockholders’ equity

     536,306        151,832  

Total liabilities and stockholders’ equity

   $ 596,269      $ 196,824  



Investor Contact:

Annie Chang

89bio, Inc.


PJ Kelleher

LifeSci Advisors, LLC



Media Contact:

Sheryl Seapy

Real Chemistry