false 0001785173 0001785173 2022-05-11 2022-05-11





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): May 11, 2022



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 May 11, 2022, 89bio, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2022. 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 March 31, 2022, 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 May 11, 2022
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: May 11, 2022     By:  

/s/ Rohan Palekar

      Rohan Palekar
      Chief Executive Officer

Exhibit 99.1



89bio Reports First Quarter 2022 Financial Results and Provides Corporate Update

- ENTRIGUE Phase 2 trial of pegozafermin in severe hypertriglyceridemia (SHTG) patients remains on track with topline data expected in the second quarter of 2022 -

- ENLIVEN Phase 2b NASH trial enrollment completion expected in the third quarter of 2022 followed by topline data in the first half of 2023 -

SAN FRANCISCO, May 11, 2022 (GLOBE NEWSWIRE) - 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today reported its financial results for the quarter ended March 31, 2022.

“Our team continued to execute very well in the first quarter and we are now well positioned to deliver on multiple upcoming milestones,” said Rohan Palekar, Chief Executive Officer of 89bio. “We plan to report topline data from the ENTRIGUE trial in SHTG this quarter. We are excited about the opportunity in this indication given pegozafermin’s unique profile to potentially reduce triglyceride levels and treat other metabolic co-morbidities associated with SHTG. On our NASH program, we now expect to complete enrollment in the ENLIVEN trial in the third quarter of 2022, and have implemented changes to the ENLIVEN protocol to maximize the probability of success in this trial.”

Recent Highlights and Anticipated Milestones


Topline data for the Phase 2 ENTRIGUE trial of pegozafermin in SHTG patients expected in the second quarter of 2022.



ENTRIGUE is a proof-of-concept study designed to assess the impact of pegozafermin on triglycerides as well as other metabolic markers. A total of 85 SHTG patients were enrolled in the trial. Positive results would support moving into a Phase 3 program in 2023 following regulatory discussions.

Hosted key opinion leader webinar on SHTG that reinforced pegozafermin’s unique proposition in this patient population.



The webinar featured presentations from KOLs Harold Bays, MD, President, Louisville Metabolic and Atherosclerosis Research Center, Inc., and Deepak L. Bhatt, MD, MPH, Brigham and Women’s Health and Harvard Medical School.



The discussion highlighted the importance of treating the highly prevalent co-morbidities associated with SHTG and the potential differentiated profile that pegozafermin offers.



An archived replay of the webinar is available on the company website and can be accessed from the investors section of the 89bio website.




Expect to complete enrollment in the third quarter of 2022 with ~200 patients in the ENLIVEN Phase 2b trial; topline data expected in the first half of 2023.



ENLIVEN is a Phase 2b trial designed to evaluate the safety and efficacy of weekly or every two-week pegozafermin for the treatment of patients with fibrosis stage F2 - F3 NASH and NAS ≥ 4

Implemented modifications to the ENLIVEN protocol to optimize the trial including:



Redistribution of patients across treatment arms with a focus on the higher dosing groups. The planned approximate randomization is 4 : 4 : 2.5 : 1 (placebo : 30mg QW : 44mg Q2W : 15mg QW)



Inclusion of additional composite histology endpoints to potentially help stabilize the placebo response and better identify the drug benefit



Adoption of a three-panel consensus read for biopsies, the industry best-in-class approach, to improve the accuracy of biopsy analysis

First Quarter 2022 Financial Results

Cash Position. As of March 31, 2022, 89bio had cash, cash equivalents, and short-term investments of $126.1 million. Based upon current projections, 89bio believes it has sufficient cash to fund operations into the second half of 2023.

Research and Development (R&D) Expenses. R&D expenses were $19.8 million for the three months ended March 31, 2022, compared to $10.1 million for the three months ended March 31, 2021. The increase in R&D expenses was primarily driven by increases in clinical development costs, contract manufacturing and personnel expenses.

General and Administrative (G&A) Expenses. G&A expenses were $5.3 million for the three months ended March 31, 2022, compared to $4.6 million for the three months ended March 31, 2021. The increase in G&A expenses was primarily due to an increase in costs related to personnel expenses, offset by a reduction in expenses for professional services.

Net Loss. 89bio reported a net loss of $25.6 million for the three months ended March 31, 2022, compared to a net loss of $14.8 million for the three months ended March 31, 2021. 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 candidate, pegozafermin, through clinical development for the treatment of non-alcoholic 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. The company is headquartered in San Francisco with operations in Herzliya, Israel. 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, the therapeutic potential and clinical benefits of pegozafermin, clinical development plans and timing for pegozafermin, including the Phase 2b ENLIVEN trial and Phase 2 ENTRIGUE trial, the expected trial design for the ENLIVEN trial, including patient enrollment, dosing schedules and trial endpoints, the timing for topline data for the ENLIVEN trial and the Phase 2 ENTRIGUE trial, 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 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 the Phase 2b ENLIVEN trial in NASH and Phase 2 ENTRIGUE trial in SHTG; expectations regarding the timing of topline data; 89bio’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; 89bio’s substantial dependence on the success of it lead product candidate; competition from competing products; 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; the sufficiency of 89bio’s capital resources and its ability to raise additional capital; and other risks and uncertainties identified in 89bio’s Quarterly Report on Form 10-Q for the quarter ended March 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
March 31,
     Three months
March 31,

Operating expenses:


Research and development

   $ 19,849      $ 10,131  

General and administrative

     5,259        4,608  







Total operating expenses

     25,108        14,739  







Loss from operations

     25,108        14,739  

Other expenses, net

     (456      (43







Net loss before tax

     25,564        14,782  

Income tax expense

     1        —    







Net loss

   $ 25,565      $ 14,782  







Comprehensive loss

   $ 25,757      $ 14,775  







Net loss per share, basic and diluted

   $ 1.26      $ 0.74  







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

     20,339,416        20,010,412  







89bio, Inc.

Condensed Consolidated Balance Sheet Data


(In thousands)


     March 31,
     December 31,

Cash, cash equivalents and short-term investments

   $ 126,111      $ 150,745  

Total assets

     135,765        162,422  

Total current liabilities

     18,400        19,537  

Non current liabilities

     14,624        16,928  

Total stockholders’ equity (deficit)

     102,741        125,957  

Total Liabilities and stockholders’ equity

   $ 135,765      $ 162,422  



Investor Contact:

Ryan Martins

Chief Financial Officer