# EDGAR Filing Document

**Accession Number:** 0001785173
**File Stem:** 0001193125-25-175445
**Filing Date:** 2025-8
**Character Count:** 16591
**Document Hash:** e8155cf5e9612d6a827d0c5f8036ed22
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-175445.hdr.sgml**: 20250807

**ACCESSION NUMBER**: 0001193125-25-175445

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250807

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250807

**DATE AS OF CHANGE**: 20250807

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** 89bio, Inc.
- **CENTRAL INDEX KEY:** 0001785173
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 831114349
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39122
- **FILM NUMBER:** 251194299

**BUSINESS ADDRESS:**
- **STREET 1:** 655 MONTGOMERY STREET
- **STREET 2:** SUITE 1500
- **CITY:** SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94111
- **BUSINESS PHONE:** (415) 432-9270

**MAIL ADDRESS:**
- **STREET 1:** 655 MONTGOMERY STREET
- **STREET 2:** SUITE 1500
- **CITY:** SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94111

?xml version='1.0' encoding='ASCII'? 8-K

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

### FORM 8-K

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): August 7, 2025

## 89bio, Inc.

#### (Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-39122** | **36-4946844** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

#### 655 Montgomery Street, Suite 1500

#### San Francisco, CA 94111

#### (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** | **Trading<br>Symbol(s)** | **Name of each exchange**<br> **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. ☐

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| | |
|:---|:---|
| **Item 2.02** | **Results of Operations and Financial Condition.**  |

---

On August 7, 2025, 89bio, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended June 30, 2025. 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, 2025, are being furnished to the Securities and Exchange Commission.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  |

---

(d) *Exhibits*. The following exhibits are being furnished herewith:

#### EXHIBIT INDEX

---

| | |
|:---|:---|
| **Exhibit<br>No.** | **Description** |
| 99.1 | [Press Release, dated August 7, 2025](d915354dex991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

------

#### SIGNATURES
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.** | **89bio, Inc.** |
| Date: August 7, 2025 | By: | /s/ Rohan Palekar |
|  |  | Rohan Palekar |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**![LOGO](g915354dsp1.jpg)

**89bio Reports Second Quarter 2025 Financial Results and Corporate Updates** 

*– ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 topline histology data expected in 1H 2027 and* 

*in 2028, respectively; each trial designed to support accelerated approval to treat patients with* 

*metabolic dysfunction-associated steatohepatitis (MASH) –* 

*– ENTRUST Phase 3 topline data in severe hypertriglyceridemia (SHTG) expected in 1Q 2026 –* 

*– Cash, cash equivalents, and marketable securities totaled $561.2 million as of June 30, 2025 –* 

SAN FRANCISCO, Calif., August 7, 2025 (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, 2025, and provided corporate updates.

"As we enter the second half of 2025, we remain diligently focused on execution across our three global Phase 3 trials for pegozafermin in MASH and SHTG. In SHTG, we continue to expect topline data from our Phase 3 *ENTRUST* trial in the first quarter of 2026," said Rohan Palekar, Chief Executive Officer of 89bio. "In MASH, we expect topline histology data from *ENLIGHTEN-Fibrosis* in the first half of 2027, and *ENLIGHTEN-Cirrhosis* in 2028, underpinning our accelerated-approval filings for patients with F2-F3 and F4 MASH, respectively. As our clinical development program in MASH continues to progress, we believe pegozafermin is poised to potentially deliver best-in-class relative risk ratio on histology endpoints, a favorable safety and tolerability profile, and a convenient dosing approach to the large and underserved MASH patient population."

**Recent Highlights and Anticipated Milestones** 

***Metabolic Dysfunction-Associated Steatohepatitis (MASH)***

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Phase 3 *ENLIGHTEN-Fibrosis* trial in non-cirrhotic (F2-F3) MASH and Phase 3 *ENLIGHTEN-Cirrhosis* trial in compensated cirrhotic (F4) MASH continue to enroll patients, with topline data from the histology cohorts of these trials expected in the first half of
2027 and in 2028, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Company anticipates data from the histology cohorts of the Phase 3 *ENLIGHTEN* trials to support
accelerated approval in both non-cirrhotic (F2-F3) and compensated cirrhotic (F4) MASH, based on alignment with the U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA). Both trials will continue for outcomes, to potentially support full approval.

***Severe Hypertriglyceridemia (SHTG)***

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *ENTRUST* is a randomized, double-blind, placebo-controlled global study evaluating the efficacy, safety,
and tolerability of pegozafermin in SHTG patients randomized to pegozafermin (30 mg, 20 mg) or placebo in a 3:3:2 ratio given once weekly (QW) for 52 weeks. The primary endpoint of the trial is the percent change from baseline in fasting
triglycerides at Week 26 compared to placebo.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Topline data from the Phase 3 *ENTRUST* trial in SHTG are expected in the first quarter of 2026.

------

![LOGO](g915354dsp1.jpg)

**Second Quarter 2025 Financial Results** 

**Cash Position.** As of June 30, 2025, 89bio had cash, cash equivalents, and marketable securities of approximately $561.2 million.

**Research and Development (R&D) Expenses.** R&D expenses were $103.9 million for the three months ended June 30, 2025, compared to $44.9 million for the three months ended June 30, 2024. The increase in R&D expenses was driven by the Phase 3 *ENLIGHTEN* trials in MASH and a non-recurring payment of $42.4 million related to the cost of construction of the commercial-scale production facility for pegozafermin. Construction of this facility remains on schedule to support the Biologics License Application (BLA) filing for pegozafermin. The Company's remaining obligation for the facility is limited to a final milestone payment of $13.5 million to be paid in 2026 upon completion of the construction of the facility.

**General and Administrative (G&A) Expenses.** G&A expenses were $11.9 million for the three months ended June 30, 2025, compared to $8.6 million for the three months ended June 30, 2024. The increase in G&A expenses was primarily attributable to an increase in personnel-related expenses including stock-based compensation, driven by higher headcount.

**Net Loss.** 89bio reported a net loss of $111.5 million for the three months ended June 30, 2025, compared to a net loss of $48.0 million for the three months ended June 30, 2024. The increased net loss was primarily driven by higher R&D expenses associated with contract manufacturing, the advancement of the Company's Phase 3 MASH programs, and personnel-related expenses, including stock-based compensation, driven by higher headcount.

**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 in Phase 3 trials for its lead candidate, pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, 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. For more information, visit <u>www.89bio.com</u> or follow the Company on <u>LinkedIn</u>.

**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 topline histology data from the ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials in patients with non-cirrhotic (F2-F3) and compensated cirrhotic (F4) MASH, topline results from the ENTRUST Phase 3 trial in SHTG and the possibility of obtaining accelerated approval in the United States and conditional approval in Europe in non-cirrhotic MASH (F2-F3) patients and compensated cirrhosis (F4) MASH patients and the possibility of outcomes data supporting full

------

![LOGO](g915354dsp1.jpg)

approval. 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 timing and outcome of the ENLIGHTEN-Fibrosis Phase 3 trial and Phase 3 ENLIGHTEN-Cirrhosis trial in MASH and 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, including recently announced tariffs and potential additional tariffs; FDA and comparable foreign regulatory authorities changes in leadership or policies or issuing additional regulations or revising existing regulations; 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, 2024 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 Contacts:**

Annie Chang

89bio, Inc.

<u>investors@89bio.com</u> 

Eva Bilange

89bio, Inc.

<u>eva.bilange@89bio.com</u> 

**Media Contact**:

Sheryl Seapy

Real Chemistry

<u>sseapy@realchemistry.com</u> 

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![LOGO](g915354dsp1.jpg)

**89bio, Inc.** 

**Condensed Consolidated Statement of Operations and Comprehensive Loss** 

**(Unaudited)** 

***(In thousands, except share and per share amounts)***

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended**<br>**June 30,** | **Three Months Ended**<br>**June 30,** | **Six Months Ended**<br>**June 30,** | **Six Months Ended**<br>**June 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
|  Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Research and development | $103902 | $44865 | $168296 | $92293 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; General and administrative | 11922 | 8571 | 23437 | 18420 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Total operating expenses | 115824 | 53436 | 191733 | 110713 |
|  Loss from operations | (115824) | (53436) | (191733) | (110713) |
|  Interest expense | (1137) | (874) | (2404) | (1737) |
|  Interest income and other, net | 6210 | 6473 | 12248 | 13029 |
|  Net loss before income tax | (110751) | (47837) | (181889) | (99421) |
|  Income tax expense | (753) | (134) | (890) | (231) |
|  Net loss | $(111504) | $(47971) | $(182779) | $(99652) |
|  Comprehensive loss | $(111767) | $(48135) | $(183220) | $(100525) |
|  Net loss per share, basic and diluted | $(0.71) | $(0.48) | $(1.20) | $(1.02) |
|  Weighted-average shares used to compute net loss per share, basic and diluted | 157880203 | 99831111 | 152154469 | 97838926 |

---

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![LOGO](g915354dsp1.jpg)

**89bio, Inc.** 

**Condensed Consolidated Balance Sheet Data** 

**(Unaudited)** 

***(In thousands)***

---

| | | |
|:---|:---|:---|
|  | **June 30,**<br>**2025** | **December 31,**<br>**2024** |
|  Cash, cash equivalents and marketable securities | $&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;561164 | $439955 |
|  Total assets | 603485 | 478685 |
|  Total current liabilities | 39611 | 36129 |
|  Non current liabilities | 42141 | 41767 |
|  Total stockholders' equity | 521733 | 400789 |
|  Total liabilities and stockholders' equity | $603485 | $478685 |

---