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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______________to ____________

Commission File Number: 001-39122

89bio, Inc.

(Exact Name of Registrant as Specified in its Charter)


Delaware	36-4946844
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
655 Montgomery Street, Suite 1500 San Francisco, California	94111
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (415) 432-9270

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

     Title of each class

     Trading
Symbol(s)

     Name of each exchange on which registered

     Common stock, par value $0.001 per share

     ETNB

     Nasdaq Global Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of July 31, 2025, the registrant had 148,308,250 shares of common stock, $0.001 par value per share, outstanding.

Table of Contents


		Page
PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss	2
	Condensed Consolidated Statements of Stockholders’ Equity	3
	Condensed Consolidated Statements of Cash Flows	5
	Notes to Unaudited Condensed Consolidated Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26
PART II.	OTHER INFORMATION	27
Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	49
Item 3.	Default Upon Senior Securities	49
Item 4.	Mine Safety Disclosures	49
Item 5.	Other Information	49
Item 6.	Exhibits	50
Signatures		51

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

89bio, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share and per share amounts)


	June 30, 2025			December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	129,076		$	126,060
Marketable securities		432,088			313,895
Prepaid and other current assets		40,356			36,495
Total current assets		601,520			476,450
Property and equipment, net		77			23
Operating lease right-of-use assets		1,256			1,572
Other assets		632			640
Total assets	$	603,485		$	478,685
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	14,657		$	15,382
Accrued expenses		24,170			20,020
Operating lease liabilities, current		784			727
Total current liabilities		39,611			36,129
Operating lease liabilities, noncurrent		679			1,090
Warrant liability		—			516
Term loan, noncurrent, net		36,156			35,732
Other noncurrent liabilities		5,306			4,429
Total liabilities		81,752			77,896
Commitments and contingencies (Note 5)
Stockholders’ equity:
Common stock, $0.001 par value: 200,000,000 shares authorized; 148,304,875 and 119,849,436 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively		148			120
Additional paid-in capital		1,528,753			1,224,617
Accumulated other comprehensive income		122			563
Accumulated deficit		(1,007,290	)		(824,511	)
Total stockholders’ equity		521,733			400,789
Total liabilities and stockholders’ equity	$	603,485		$	478,685

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

89bio, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except share and per share amounts)


	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Operating expenses:
Research and development	$	103,902		$	44,865		$	168,296		$	92,293
General and administrative		11,922			8,571			23,437			18,420
Total operating expenses		115,824			53,436			191,733			110,713
Loss from operations		(115,824	)		(53,436	)		(191,733	)		(110,713	)
Interest expense		(1,137	)		(874	)		(2,404	)		(1,737	)
Interest income and other, net		6,210			6,473			12,248			13,029
Net loss before income tax		(110,751	)		(47,837	)		(181,889	)		(99,421	)
Income tax expense		(753	)		(134	)		(890	)		(231	)
Net loss	$	(111,504	)	$	(47,971	)	$	(182,779	)	$	(99,652	)
Other comprehensive income (loss):
Unrealized loss on marketable securities		(244	)		(169	)		(414	)		(883	)
Foreign currency translation adjustments		(19	)		5			(27	)		10
Total other comprehensive loss	$	(263	)	$	(164	)	$	(441	)	$	(873	)
Comprehensive loss	$	(111,767	)	$	(48,135	)	$	(183,220	)	$	(100,525	)
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		157,880,203			99,831,111			152,154,469			97,838,926

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

89bio, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(In thousands, except share amounts)


					Additional			Accumulated Other						Total
	Common Stock				Paid-in			Comprehensive			Accumulated			Stockholders’
	Shares		Amounts		Capital			Income			Deficit			Equity
Balance as of December 31, 2024		119,849,436	$	120	$	1,224,617		$	563		$	(824,511	)	$	400,789
Issuance of common stock and pre-funded warrants in public offering, net of issuance costs		25,957,142		26		269,877			—			—			269,903
Issuance of common stock upon exercise of stock options		4,000		—		33			—			—			33
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement		173,604		—		(1,030	)		—			—			(1,030	)
Stock-based compensation		—		—		7,216			—			—			7,216
Net loss		—		—		—			—			(71,275	)		(71,275	)
Other comprehensive loss		—		—		—			(178	)		—			(178	)
Balance as of March 31, 2025		145,984,182	$	146	$	1,500,713		$	385		$	(895,786	)	$	605,458
Issuance of common stock under at-the-market program, net of issuance costs		2,160,484		2		21,004			—			—			21,006
Issuance of common stock upon exercise of stock options		5,838		—		26			—			—			26
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement		115,539		—		(568	)		—			—			(568	)
Issuance of common stock under employee stock purchase plan		38,832		—		263			—			—			263
Stock-based compensation		—		—		7,315			—			—			7,315
Net loss		—		—		—			—			(111,504	)		(111,504	)
Other comprehensive loss		—		—		—			(263	)		—			(263	)
Balance as of June 30, 2025		148,304,875	$	148	$	1,528,753		$	122		$	(1,007,290	)	$	521,733

89bio, Inc.

Condensed Consolidated Statements of Stockholders’ Equity (continued)

(Unaudited)

(In thousands, except share amounts)


					Additional			Accumulated Other						Total
	Common Stock				Paid-in			Comprehensive			Accumulated			Stockholders’
	Shares		Amounts		Capital			Income (Loss)			Deficit			Equity
Balance as of December 31, 2023		93,269,377	$	93	$	993,455		$	190		$	(457,432	)	$	536,306
Issuance of common stock under at-the-market program, net of issuance costs		1,396,888		2		21,047			—			—			21,049
Issuance of common stock upon exercise of common stock warrants		337,713		—		1,798			—			—			1,798
Issuance of common stock upon exercise of stock options		1,626		—		7			—			—			7
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement		194,120		—		(1,229	)		—			—			(1,229	)
Stock-based compensation		—		—		4,998			—			—			4,998
Net loss		—		—		—			—			(51,681	)		(51,681	)
Other comprehensive loss		—		—		—			(709	)		—			(709	)
Balance as of March 31, 2024		95,199,724	$	95	$	1,020,076		$	(519	)	$	(509,113	)	$	510,539
Issuance of common stock upon exercise of common stock warrants		8,854,576		9		47,142			—			—			47,151
Issuance of common stock upon cashless exercise of pre-funded warrants		799,906		1		(1	)		—			—			—
Issuance of common stock upon exercise of stock options		26,355		—		54			—			—			54
Issuance of common stock upon vesting of restricted stock units, net of tax withholding for net share settlement		8,490		—		(39	)		—			—			(39	)
Issuance of common stock under employee stock purchase plan		26,125		—		178			—			—			178
Stock-based compensation		—		—		5,169			—			—			5,169
Net loss		—		—		—			—			(47,971	)		(47,971	)
Other comprehensive loss		—		—		—			(164	)		—			(164	)
Balance as of June 30, 2024		104,915,176	$	105	$	1,072,579		$	(683	)	$	(557,084	)	$	514,917

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

89bio, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)


	Six Months Ended June 30,
	2025			2024
Cash flows from operating activities:
Net loss	$	(182,779	)	$	(99,652	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		14,531			10,167
Net accretion of discounts on investments in marketable securities		(4,224	)		(5,406	)
Amortization of debt discount and accretion of deferred debt costs		773			330
Noncash operating lease expense		316			351
Depreciation		18			21
Change in fair value of warrant liability		(516	)		—
Other		—			113
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(4,202	)		(14,319	)
Accounts payable		(752	)		9,002
Accrued expenses		4,150			(1,410	)
Operating lease liabilities		(354	)		(91	)
Other noncurrent liabilities		877			10
Net cash used in operating activities		(172,162	)		(100,884	)
Cash flows from investing activities:
Proceeds from sales and maturities of marketable securities		212,131			178,090
Purchases of marketable securities		(326,514	)		(230,139	)
Purchases of property and equipment		(72	)		—
Net cash used in investing activities		(114,455	)		(52,049	)
Cash flows from financing activities:
Proceeds from issuance of common stock and pre-funded warrants in public offering, net of issuance costs		269,903			—
Payments of deferred offering costs		—			(116	)
Proceeds from issuance of common stock under at-the-market program, net of issuance costs		21,006			21,049
Proceeds from issuance of common stock upon exercise of common stock warrants		—			29,543
Proceeds from issuance of common stock upon exercise of stock options		59			61
Proceeds from issuance of common stock under employee stock purchase plan		263			178
Payments for taxes related to net share settlement upon vesting of restricted stock units		(1,598	)		(1,725	)
Net cash provided by financing activities		289,633			48,990
Net change in cash and cash equivalents		3,016			(103,943	)
Cash and cash equivalents at beginning of period		126,060			316,161
Cash and cash equivalents at end of period	$	129,076		$	212,218
Supplemental disclosures of cash information:
Cash paid for interest	$	1,641		$	1,368

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

89bio, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

1. Organization and Liquidity

Description of Business

89bio, Inc. (together with its consolidated subsidiaries, herein referred to as 89bio, the company, we, our or us) is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. Our lead product candidate, pegozafermin, is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin is currently being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), formerly nonalcoholic steatohepatitis (NASH), and for the treatment of severe hypertriglyceridemia (SHTG).

89bio was formed as a Delaware corporation in June 2019 to carry on the business of 89Bio Ltd., which was incorporated in Israel in January 2018.

Liquidity

We have incurred significant losses and negative cash flows from operations since inception and had an accumulated deficit of $1,007.3 million as of June 30, 2025. We have historically financed our operations primarily through the sale of equity securities, including warrants, and from borrowings under term loan facilities. To date, none of our product candidates have been approved for sale, and we have not generated any revenue from commercial products. We expect operating losses to continue and increase for the foreseeable future as we progress our clinical development activities for our product candidates.

We believe our existing cash, cash equivalents and marketable securities of $561.2 million as of June 30, 2025 will be sufficient to fund our planned operating expense requirements for a period of at least one year from the issuance date of these condensed consolidated financial statements.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying interim unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (U.S. GAAP), the instructions to Form 10-Q and Rule 10-01 of Regulation S-X and applicable rules and regulations of the Securities and Exchange Commission (SEC) regarding interim financial reporting.

Unaudited Interim Condensed Consolidated Financial Statements

The accompanying interim condensed consolidated financial statements are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2024 and reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results to be expected for the full year ending December 31, 2025 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2024 was derived from the audited financial statements as of that date and, due to its summary nature, does not include all the disclosures required by U.S. GAAP in audited financial statements. These condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on February 27, 2025.

Principles of Consolidation

The accompanying condensed consolidated financial statements include our accounts and those of our wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Our functional currency, and that of our subsidiary in Israel (our only significant subsidiary), is the U.S. Dollar.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying condensed consolidated financial statements include but are not limited to accruals for uncertain tax positions, accrued research and development expenses and the valuation of stock options. We evaluate our estimates and assumptions on an ongoing basis using historical experience and other factors and adjust those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates.

Fair Value Measurements

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. Assets and liabilities recorded at fair value are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels are directly related to the amount of subjectivity with the inputs to the valuation of these assets or liabilities as follows:

Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;

Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable inputs for similar assets or liabilities. These include quoted prices for identical or similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active; and

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

Financial instruments measured and recorded at fair value on a recurring basis consist of cash equivalents and marketable securities and common stock warrants issued in connection with a term loan facility that do not meet all of the criteria for equity classification.

Financial Instruments Not Carried at Fair Value

Our financial instruments, including cash, other current assets, accounts payable and accrued expenses are carried at cost which approximates their fair value because of the short-term nature of these financial instruments. We believe the fair value of our term loan is not materially different from its carrying value (amortized cost), as its interest rate adjusts periodically based on the U.S. Prime Rate, reflecting current market conditions for similar variable-rate debt.

Cash and Cash Equivalents

We consider all highly-liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents primarily consist of amounts invested in money market funds, commercial paper and U.S. government treasury securities and are carried at fair value.

Marketable Securities

We invest our excess cash in marketable securities with high credit ratings including money market funds, commercial paper, securities issued by the U.S. government and its agencies and corporate debt securities. We classify all marketable securities as available-for-sale, as the sale of such securities may be required prior to maturity. These marketable securities are carried at fair value, with unrealized gains and losses, net of tax, recognized as a component of accumulated other comprehensive income (loss) within stockholders’ equity until realized. The amortized cost of debt securities is adjusted for accretion of premiums and amortization of discounts to maturity. Such amortization and accretion, along with interest and dividends earned, are included in interest income and other, net. Realized gains and losses from the sale of marketable securities, if any, are determined on a specific identification basis and are also included in interest income and other, net. We classify our marketable securities as current assets, which reflects our intention to use the proceeds from sales of these securities to fund our operations, as necessary, even though the stated maturity date may be one year or more beyond the current balance sheet date.

We periodically assess our available-for-sale marketable securities for impairment. For marketable securities in an unrealized loss position, this assessment first takes into account our intent to sell, or whether it is more likely than not that we will be required to sell the security before recovery of its amortized cost basis. If either of these criteria are met, the marketable security’s amortized cost basis is written down to fair value through interest income and other, net. For marketable securities in an unrealized loss position that do not meet the aforementioned criteria, we assess whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, we consider the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the security, among other factors. If this assessment indicates that a credit loss may exist, the present value of cash flows expected to be collected from the security are compared to the amortized cost basis of the security. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses will be recorded in interest income and other, net, limited by the amount that the fair value is less than the amortized cost basis. Impairment not recorded through an allowance for credit losses is recognized in other comprehensive loss. Changes in the allowance for credit losses are recorded as provision for (or reversal of) credit loss expense. Losses are charged against the allowance when we believe the uncollectibility of a marketable security is confirmed or when either of the criteria regarding intent or requirement to sell is met. These changes are recorded in interest income and other, net. To date, we have not experienced any credit-related losses on our marketable securities.

Income Taxes

We account for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions. This evaluation is based on factors including, but not limited to, changes in facts or circumstances, changes in tax law, effectively settled issues under audit, and new audit activity. Interest and penalties related to unrecognized tax benefits are included within income tax expense.

For the three and six months ended June 30, 2025, we recorded income tax expense of $0.8 million and $0.9 million, respectively. For the three and six months ended June 30, 2024, we recorded income tax expense of $0.1 million and $0.2 million, respectively. Our income tax expense is primarily attributable to changes in our uncertain tax positions related to our Israeli subsidiary, mainly due to accrued interest and the impact of foreign currency exchange rate fluctuations

On July 4, 2025, President Trump signed the One Big Beautiful Bill Act. Included in this legislation are provisions that allow for the immediate expensing of domestic U.S. research and development expenses, a general requirement to reduce the deduction for research and development expense by any research credit taken, and other changes to the U.S. taxation of profits derived from foreign operations. We continue to evaluate the impact the new legislation will have on the consolidated financial statements.

Basic and Diluted Net Loss per Share

Basic and diluted net loss per share is calculated based upon the weighted-average number of shares of common stock outstanding during the period. Pre-funded warrants with a nominal exercise price are considered outstanding and are included in the calculation of basic net loss per share from their issuance date as they are economically equivalent to outstanding common stock. During periods of income, participating securities are allocated a proportional share of income determined by dividing total weighted-average participating securities by the sum of the total weighted-average common shares and participating securities. Shares of our common stock warrants participate in any dividends that may be declared by us and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, no loss is allocated to participating securities since they have no contractual obligation to share in our losses. Diluted loss per share is computed after considering the dilutive effect of stock options, restricted stock units (RSUs), performance stock units (PSUs) and common stock warrants, except where such non-participating securities would be anti-dilutive. As we incurred net losses for the periods presented, basic net loss per share is the same as diluted net loss per share since the effects of potentially dilutive securities are antidilutive.

Segment Information

Operating segments are defined as components of an enterprise that have the following characteristics: (i) they engage in business activities from which they may earn revenue and incur expense, (ii) their operating results are regularly reviewed by the chief operating decision maker (CODM) for resource allocation decisions and performance assessment, and (iii) their discrete financial information is available. Our CODM is our Chief Executive Officer (CEO), who manages and allocates resources to our operations on a consolidated basis. We manage our business as a single reportable segment and our operations are focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. Segment information is further described in Note 10.

Recently Adopted Accounting Standards

We did not adopt any new standards or updates issued by the Financial Accounting Standards Board (FASB) during the six months ended June 30, 2025 that had a material impact on our consolidated financial statements and related disclosures.

Accounting Pronouncements Not Yet Adopted

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09). ASU 2023-09 requires public business entities to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. In addition, ASU 2023-09 requires companies to disclose additional information about income taxes paid. ASU 2023-09 is effective for our annual periods beginning on January 1, 2025 and will be applied on a prospective basis with the option to apply the standard retrospectively. Early adoption is permitted. We expect to adopt ASU 2023-09 in our Annual Report on Form 10-K for the year ending December 31, 2025 and in annual periods thereafter. We are in the process of evaluating the requirements of this update, which is expected to result in expanded disclosures within our consolidated financial statements upon adoption.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (ASU 2024-03). ASU 2024-03 requires public business entities to provide expanded footnote disclosures disaggregating certain specified expense categories, such as purchases of inventory, employee compensation, depreciation, and amortization, included within relevant expense captions presented on the income statement. The objective of this guidance is to provide investors with more detailed information about an entity’s cost structure. ASU 2024-03 is effective for our annual periods beginning on January 1, 2027, and interim periods within annual reporting periods beginning January 1, 2028. Application is permitted on either a prospective or retrospective basis, and early adoption is permitted. We expect to adopt the annual disclosure requirements of ASU 2024-03 in our Annual Report on Form 10-K for the year

ending December 31, 2027, and the interim disclosure requirements beginning with our Quarterly Report on Form 10-Q for the quarter ending March 31, 2028. We are currently evaluating the requirements of this update, which is expected to result in significantly expanded disclosures regarding the composition of our expenses within our consolidated financial statements upon adoption.

3. Fair Value Measurements

Assets Measured at Fair Value on a Recurring Basis

The following table presents our financial assets measured at fair value on a recurring basis by level within the fair value hierarchy for the periods indicated (in thousands):


		June 30, 2025
	Valuation	Amortized		Unrealized		Unrealized			Fair
	Hierarchy	Cost		Gains		Losses			Value
Assets:
Money market funds	Level 1	$	5,535	$	—	$	—		$	5,535
Commercial paper	Level 2		101,664		—		(31	)		101,633
U.S. government bonds	Level 2		212,220		189		(28	)		212,381
Agency bonds	Level 2		56,716		19		(11	)		56,724
Corporate debt securities	Level 2		9,097		9		(3	)		9,103
U.S. Treasury securities	Level 2		111,158		2		(11	)		111,149
Total cash equivalents and marketable securities		$	496,390	$	219	$	(84	)	$	496,525
Classified as:
Cash equivalents									$	64,437
Marketable securities										432,088
Total cash equivalents and marketable securities									$	496,525


		December 31, 2024
	Valuation	Amortized		Unrealized		Unrealized			Fair
	Hierarchy	Cost		Gains		Losses			Value
Assets:
Money market funds	Level 1	$	22,645	$	—	$	—		$	22,645
Commercial paper	Level 2		51,982		14		(5	)		51,991
U.S. government bonds	Level 2		169,860		439		(29	)		170,270
Agency bonds	Level 2		63,753		111		(5	)		63,859
Corporate debt securities	Level 2		6,154		15		(3	)		6,166
U.S. Treasury securities	Level 2		44,499		10		—			44,509
Agency discount securities	Level 2		18,940		2		—			18,942
Total cash equivalents and marketable securities		$	377,833	$	591	$	(42	)	$	378,382
Classified as:
Cash equivalents									$	64,487
Marketable securities										313,895
Total cash equivalents and marketable securities									$	378,382

The cash equivalents presented in the above tables are a component of the total “Cash and cash equivalents” balance on the condensed consolidated balance sheets, which also includes cash held in deposit accounts carried at cost.

The valuation techniques used to measure the fair values of our Level 2 financial instruments, which generally have counterparties with high credit ratings, are based on quoted market prices when available. If quoted market prices are not available, the fair value for the security is estimated under the market or income approach using pricing models with market observable inputs.

The following table summarizes the estimated fair value of investments in marketable securities by effective contractual maturity dates as of June 30, 2025 (in thousands):


Within one year	$	476,549
After one year through two years		19,976
Total cash equivalents and marketable securities	$	496,525

As of June 30, 2025, marketable securities in an unrealized loss position include primarily fixed-rate debt securities of varying maturities, which are sensitive to changes in the yield curve and other market conditions. All of the fixed-rate debt securities in a loss position are investment-grade debt securities. We have the intent and ability to hold such securities until recovery of the unrealized losses. Based on our evaluation, the unrealized losses as of June 30, 2025 were insignificant and did not reflect increased credit risks within specific securities holdings. No allowance for credit losses was recorded as of June 30, 2025 and December 31, 2024.

Liabilities Measured at Fair Value on a Recurring Basis

Warrant Liability

Prior to June 30, 2025, our only financial liability measured at fair value on a recurring basis related to warrants to purchase up to 311,996 shares of our common stock issued in connection with the Term Loan Facility (see Note 6). The warrants were not considered to be indexed to our own stock under ASC 815-40, Derivatives and Hedging–Contracts in Entity’s Own Equity, and were therefore accounted for as a liability remeasured to fair value at each reporting date.

The exercisability of the warrants was contingent upon the availability and drawdown of three separate loan tranches, corresponding to warrants for 94,955 shares (Tranche 1 - second component), 81,390 shares (Tranche 2), 135,651 shares (Tranche 3). During the six months ended June 30, 2025, these contingencies were either resolved or the probability of exercise was determined to be remote. Specifically, the availability period for Tranche 1 expired undrawn. Furthermore, Tranche 2 had performance-based conditions that are not expected to be satisfied, while Tranche 3 is available only at the lenders’ discretion, making the combined probability of a drawdown remote.

The following table provides a reconciliation of our warrant liability measured at fair value on a recurring basis using unobservable inputs (Level 3) for the six months ended June 30, 2025 (in thousands):


	Warrant Liability
Balance outstanding as of December 31, 2024	$	516
Change in fair value		(516	)
Balance outstanding as of June 30, 2025	$	—

4. Balance Sheet Components

Prepaid and other current assets consist of the following as of the periods presented (in thousands):


	June 30, 2025		December 31, 2024
Prepaid research and development	$	37,802	$	32,550
Prepaid taxes		52		368
Prepaid other		2,502		3,577
Total prepaid and other current assets	$	40,356	$	36,495

Accrued expenses consist of the following as of the periods presented (in thousands):


	June 30, 2025		December 31, 2024
Accrued research and development expenses	$	17,363	$	11,426
Accrued employee and related expenses		5,016		6,872
Accrued professional and legal fees		1,749		1,680
Accrued other expenses		42		42
Total accrued expenses	$	24,170	$	20,020

5. Commitments and Contingencies

Asset Transfer and License Agreement with Teva Pharmaceutical Industries Ltd

In April 2018, we acquired certain patents and intellectual property from Teva Pharmaceutical Industries Ltd. (Teva) relating to Teva’s former glycoPEGylated FGF21 program, including the compound pegozafermin (the FGF21 Agreement).

Under the FGF21 Agreement, we are obligated to make future payments to Teva. A $2.5 million milestone payment was made in the fourth quarter of 2023 upon achievement of a specified clinical development milestone. Remaining potential payments under the FGF21 Agreement consist of up to $65.0 million upon achievement of specified commercial milestones. We are also obligated to pay Teva tiered royalties at percentages in the low-to-mid single-digits on worldwide net sales of any products containing pegozafermin.

As of June 30, 2025, the timing and likelihood of achieving any remaining milestones are uncertain. Milestone payment obligations will be recognized when payment becomes probable and reasonably estimable, which is generally upon achievement of the applicable milestone.

The FGF21 Agreement can be terminated (i) by us without cause upon 120 days’ written notice to Teva, (ii) by either party, if the other party materially breaches any of its obligations under the FGF21 Agreement and fails to cure such breach within 60 days after receiving notice thereof, or (iii) by either party, if a bankruptcy petition is filed against the other party and is not dismissed within 60 days. Teva can also terminate the agreement if we, or any of our affiliates or sublicensees, challenge the licensed patents and do not withdraw the challenge within 30 days of written notice from Teva.

BiBo Collaboration Agreement

Under the original terms of the Collaboration Agreement, our total commitment for the construction of the Commercial Facility was $135.0 million, exclusive of applicable value-added tax (VAT). In June 2025, we amended the Collaboration Agreement to address the cost of the Commercial Facility’s construction. Pursuant to the amendment, we agreed to fund an additional $40.0 million, exclusive of applicable VAT, which we paid in June 2025. Construction of the Commercial Facility remains on schedule to support a planned Biologics License Application (BLA) filing. Furthermore, the amendment provides that we have no obligation to pay for any additional costs related to the facility’s construction.

Our total contractual obligation for the Commercial Facility’s construction under the Collaboration Agreement, as amended, is $175.0 million, exclusive of applicable VAT. As of June 30, 2025, we have made aggregate payments of $161.5 million, consisting of $121.5 million in original milestone payments and the $40.0 million non-recurring payment related to the Commercial Facility’s construction cost. The final payment of $13.5 million is due upon the achievement of a substantive milestone, defined in the agreement as the completion of the facility. The payment will be recognized as an expense in the period in which the milestone is achieved. Accordingly, as the milestone had not been achieved as of June 30, 2025, no liability for this contingent payment is recorded in our condensed consolidated balance sheet.

Consistent with prior milestone payments, we recorded the $40.0 million payment, exclusive of applicable VAT, as “Research and development” expense in the condensed consolidated statement of operations for the three and six months ended June 30, 2025.

Israeli Tax Authority Matter

As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, our Israeli subsidiary is under audit by the Israeli Tax Authority (ITA) for tax years 2018 through 2021. In connection with this audit, we received a formal assessment order from the ITA (the Order) during the second quarter of 2025. This Order follows a preliminary assessment received in December 2023 from the ITA pertaining to our 2019 reorganization and related intercompany transactions. The formal assessment seeks to recharacterize an intercompany transfer of our subsidiary’s intellectual property rights as a taxable sale.

We disagree with the ITA’s positions outlined in the Order and continue to pursue various avenues to resolve this matter with the ITA. Subsequent to receipt of the Order, we filed an appeal within the timeframe mandated by Israeli tax law to defend our position through the appropriate administrative and judicial channels.

In accordance with ASC 740, Income Taxes, we reevaluated this uncertain tax position upon receipt of the Order. Based on our

analysis of the technical merits, we have recorded a liability for unrecognized tax benefit of $5.3 million as of June 30, 2025, related to this position. The ultimate resolution of this matter with the taxing authorities is subject to significant uncertainty. While we believe our recorded liability is adequate, it is reasonably possible that the total amount of the unrecognized tax benefit could increase. An unfavorable resolution could materially and adversely impact our financial condition and results of operations.

6. Term Loan Facility

As of June 30, 2025, our outstanding debt consisted of amounts drawn under a term loan facility (the Term Loan Facility) established pursuant to a Loan and Security Agreement, dated January 2023, as amended in September 2024 (as amended, the Loan Agreement) with certain lenders, K2 HealthVentures LLC serving as administrative agent, and Ankura Trust Company, LLC as collateral agent.

The Term Loan Facility provides for a maximum aggregate principal amount of $150.0 million, available in tranches:

•

Tranche 1: Provides for total borrowings of up to $70.0 million. An initial $35.0 million was funded upon closing of the related amendment in September 2024, the proceeds of which included the refinancing of the $25.0 million principal balance then outstanding under the original loan agreement. During the six months ended June 30, 2025, we did not make any additional borrowings under Tranche 1, and the remaining $35.0 million commitment expired undrawn on June 30, 2025.

•

Tranche 2: $30.0 million, the availability of which is contingent upon achievement of a specific clinical development milestone (positive Phase 3 SHTG Data) by December 31, 2025. In February 2025, we announced that we decided to unblind the ENTRUST Phase 3 study in SHTG after study completion at week 52 and not conduct the interim week 26 readout. As we now expect to report topline data from ENTRUST in the first quarter of 2026, the milestone is not expected to be achieved by the specified date.

•

Tranche 3: Up to $50.0 million, which may become available at our request, subject to the lenders’ sole discretion.

Our obligations under the Loan Agreement are secured by substantially all of our assets, excluding intellectual property. The Loan Agreement contains customary representations and warranties, restricts certain activities (including requiring prior lender consent for the sale or assignment of rights to our patents and other intellectual property), and includes customary events of default, including payment default, breach of covenants, change of control, and material adverse effects. In addition, commencing January 1, 2026, we are required to maintain minimum unrestricted cash, cash equivalents and marketable securities equal to 5.0 times the average change in such balances over the trailing three-month period. As of June 30, 2025, we were in compliance with all covenants of the Loan Agreement.

Borrowings under the Loan Agreement mature on October 1, 2028 and provide for interest-only payments until January 1, 2027. Thereafter, consecutive equal payments of principal and interest are due. The Term Loan Facility bears interest equal to the greater of (i) 8.95% and (ii) the sum of (a) the Prime Rate as reported in The Wall Street Journal plus (b) 1.75%. On the date the debt was refinanced and on June 30, 2025, the stated interest rate on the outstanding Term Loan Facility was 9.75% and 9.25%, respectively. An end of term fee of 5.95% of the aggregate principal amount of term loans advanced is also payable. We have the option to prepay the entire outstanding balance of borrowings, subject to a prepayment fee ranging from 1.0% to 3.0% depending on the timing of such prepayment.

In connection with the amendment of the original agreement, we issued warrants to purchase up to 406,951 shares of our common stock at an exercise price of $7.3719 per share that expire 10 years from the date of issuance. Of these, 94,955 shares were immediately exercisable and classified as equity. Warrants to purchase the remaining 311,996 shares of common stock become exercisable proportionally with future advances under the term loan tranches. These warrants are classified as a liability and remeasured to fair value at each reporting period (see Note 3).

The lenders also have the right to convert up to an aggregate of $7.5 million of the principal amount from the original term loan then outstanding and an additional aggregate of $5.0 million from the amended term loan then outstanding into shares of our common stock at conversion prices of $12.6943 and $9.5835 per share, respectively.

The expected repayments of principal amounts due on borrowings as of June 30, 2025 were as follows (in thousands):


2025 (remaining six months)	$	—
2026		—
2027		18,322
2028		16,678
Total principal outstanding		35,000
Plus accumulated accretion of end of term fees		1,651
Less unamortized debt discount		(495	)
Total net carrying value		36,156
Term loan, current		—
Term loan, noncurrent, net	$	36,156

7. Stockholders’ Equity

Common Stock Reserved for Issuance

Common stock reserved for future issuance, on an as-if-converted basis, were as follows:


	As of June 30, 2025		As of December 31, 2024
Stock options outstanding		11,698,226		7,707,342
RSUs and PSUs outstanding		2,508,289		1,818,994
Shares available for future grants under equity incentive plans		1,996,052		2,181,235
Shares available for future issuance under the employee stock purchase plan		3,246,812		2,087,150
Warrants to purchase common stock outstanding		397,123		517,078
Pre-funded warrants to purchase common stock outstanding		11,231,081		4,331,081
Conversion feature related to outstanding term loan		1,112,546		1,112,546
Total available for future issuance		32,190,129		19,755,426

Underwritten Public Offering

In January 2025, we completed an underwritten public offering consisting of 25,957,142 shares of common stock at an offering price of $8.75 per share, which includes 4,285,714 shares of common stock issued in February 2025 upon the underwriters’ exercise in full of their overallotment option. The offering included pre-funded warrants to purchase 6,900,000 shares of common stock at a public offering price of $8.749 per underlying share. We raised net proceeds of approximately $269.9 million, after deducting underwriting discounts and commissions of $17.3 million and other offering costs of $0.3 million.

At-the-Market Program

In March 2021, we entered into an at-the-market (ATM) sales agreement (as amended, the Sales Agreement) with Leerink Partners LLC and Cantor Fitzgerald & Co. as sales agents, establishing a program to sell up to $75.0 million of our common stock (the 2021 ATM Facility) from time to time, pursuant to an effective registration statement. In February 2023, we amended the Sales Agreement to establish a new ATM program (the 2023 ATM Facility), which provides for the offer and sale of up to $150.0 million of our common stock, also pursuant to an effective registration statement.

All sales activity in 2024 and 2025 occurred under the 2023 ATM Facility. During the three and six months ended June 30, 2025, we sold 2,160,484 shares of our common stock, receiving net proceeds of $21.0 million. During the six months ended June 30, 2024, we sold 1,396,888 shares of our common stock for net proceeds of $21.0 million. No sales were made during the three months ended June 30, 2024.

As of June 30, 2025, approximately $82.8 million remained available for future sales of our common stock under the 2023 ATM Facility.

Warrants

In January 2025, we issued pre-funded warrants in a public offering (described above). During the six months ended June 30, 2025, no warrants were exercised, and warrants to purchase 25,000 shares of common stock held by Silicon Valley Bank expired

unexercised.

During the six months ended June 30, 2024, the exercise of warrants to purchase 9,192,289 shares of common stock generated cash proceeds of $48.9 million, of which $19.4 million was received subsequent to June 30, 2024. Additionally, during the same period in 2024, we issued 799,906 shares of common stock upon the cashless exercise of pre-funded warrants.

As of June 30, 2025, outstanding warrants to purchase shares of our common stock were as follows:


	Shares of Common Stock Underlying Warrants	Exercise Price Per Share	Expiration Date
Warrant issued in connection with term loan (SVB)	33,923	$19.12	May 28, 2031
Warrants issued in connection with Term Loan Facility	51,204	$9.7649	January 27, 2033
Warrants issued in connection with amended Term Loan Facility	311,996	$7.3719	September 30, 2034
Pre-funded warrants issued in connection with public offerings	11,231,081	$0.001	Does not expire
Total outstanding	11,628,204

Exercise of pre-funded warrants is subject to a beneficial ownership limitation, initially capped at 9.99% of our outstanding common stock. Prior to issuance, a holder had the option to decrease this limitation to 4.99%. The holder may subsequently adjust this limitation, provided that it does not exceed 19.99%. The number of shares issuable upon exercise is subject to adjustment for stock dividends, stock splits, recapitalizations, reorganizations, or other similar events, as further specified in the warrant agreements. Under certain conditions, the pre-funded warrants may be exercised on a cashless basis.

8. Stock-Based Compensation

Equity Incentive Plans Activity

Stock Options

The following table summarizes stock option activity under our equity incentive plans for the six months ended June 30, 2025:


						Weighted
				Weighted		Average
				Average		Remaining		Aggregate
	Number of			Exercise		Contractual		Intrinsic
	Options			Price		Term		Value
						(In years)		(In thousands)
Balance outstanding as of December 31, 2024		7,707,342		$	12.19
Granted		4,249,085			9.53
Exercised		(9,838	)		5.99
Forfeited		(248,363	)		11.83
Balance outstanding as of June 30, 2025		11,698,226		$	11.24		8.0	$	11,680
Exercisable as of June 30, 2025		4,380,366		$	13.65		6.3	$	7,904

The fair value of stock option awards granted for the periods indicated was estimated at the date of grant using a Black-Scholes option-pricing model with the following assumptions:


	Six Months Ended June 30,
	2025	2024
Expected term (years)	5.5 - 6.1	5.5 - 6.1
Expected volatility	86.8 - 87.4%	87.3 - 90.4%
Risk-free interest rate	4.0 - 4.4%	3.8 - 4.6%
Expected dividend	—	—

As of June 30, 2025, total unrecognized stock-based compensation expense related to unvested stock options was $47.9 million, which is expected to be recognized over a weighted-average period of 2.9 years.

RSU and PSUs

The following table summarizes RSU and PSU activity for the six months ended June 30, 2025:


	RSUs					PSUs
	Number of Shares			Weighted-Average Grant Date Fair Value per Share		Number of Shares			Weighted-Average Grant Date Fair Value per Share
Balance outstanding as of December 31, 2024		1,503,994		$	9.65		315,000		$	7.67
Granted		1,210,375			9.60		—			—
Vested		(444,366	)		10.07		(2,500	)		9.98
Forfeited		(66,714	)		9.60		(7,500	)		9.98
Balance outstanding as of June 30, 2025		2,203,289		$	9.54		305,000		$	7.59

As of June 30, 2025, total unrecognized stock-based compensation expense related to RSUs and PSUs was $18.0 million, which is expected to be recognized over a weighted-average period of 1.8 years. During the three months ended June 30, 2025, we reassessed the performance condition for a certain grant of PSUs granted in 2024 and determined that vesting was no longer probable, reducing the related unrecognized stock-based compensation expense by $7.8 million.

Stock-Based Compensation

We recorded stock-based compensation expense for the periods indicated as follows (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
Research and development	$	3,184	$	2,342	$	6,586	$	4,657
General and administrative		4,131		2,827		7,945		5,510
Total stock-based compensation	$	7,315	$	5,169	$	14,531	$	10,167

9. Net Loss Per Share

The following table presents the weighted-average shares outstanding used to calculate basic and diluted net loss per share for the periods indicated:


	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
Common stock		146,649,122		98,495,085		142,028,913		96,230,372
Pre-funded warrants		11,231,081		1,336,026		10,125,556		1,608,554
Total		157,880,203		99,831,111		152,154,469		97,838,926

The following outstanding potentially dilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the periods indicated due to their anti-dilutive effect:


	As of June 30,
	2025		2024
Stock options outstanding		11,698,226		7,044,951
RSUs and PSUs outstanding		2,508,289		1,452,123
Warrants to purchase common stock		397,123		1,200,034
Conversion feature related to outstanding term loan		1,112,546		590,816
Total		15,716,184		10,287,924

10. Segment Information

We operate and manage our business as a single reportable segment focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. Our CEO serves as the CODM. The monitoring of budget versus actual results and cash on hand is used in assessing performance of the segment and in establishing resource allocation across the organization. To facilitate this, the CODM uses consolidated net loss as the measure to assess performance and reviews significant expense categories within consolidated net loss to monitor financial results against our budget. The measure of segment assets is reported on the consolidated balance sheets as total assets. Segment asset information, other than cash, cash equivalents, and marketable securities as reported on the consolidated balance sheet, is not used by the CODM to allocate resources or assess segment performance.

As of June 30, 2025, the table below presents the significant expense categories regularly reviewed by the CODM and included in the determination of consolidated net loss (in thousands):


	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Segment expenses and other segment items
Contract manufacturing	$	58,084		$	17,018		$	77,141		$	38,369
Clinical development		35,299			18,949			69,094			36,873
Research and development personnel-related		9,608			7,847			20,281			15,580
Other research and development(1)		911			1,051			1,780			1,471
General and administrative		11,922			8,571			23,437			18,420
Interest expense		1,137			874			2,404			1,737
Interest income and other, net (2)		(6,210	)		(6,473	)		(12,248	)		(13,029	)
Income tax expense		753			134			890			231
Net loss	$	(111,504	)	$	(47,971	)	$	(182,779	)	$	(99,652	)

(1) Includes pre-clinical development and other support expenses that are directly related to the development of pegozafermin.
(2) Interest income and other, net is primarily comprised of interest income derived from marketable securities and foreign currency transaction gains and losses.

Substantially all of our long-lived assets, which primarily consist of right-of-use assets related to operating leases, were located in the United States as of June 30, 2025 and December 31, 2024.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Forward Looking Statements

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q and our consolidated financial statements and related notes and other financial information included in our Annual Report on Form 10-K for the year ended December 31, 2024. Some of the information contained in this discussion and analysis includes forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those described in or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section titled “Risk Factors” included elsewhere in this Quarterly Report on Form 10-Q.

Overview

We are a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. Our lead product candidate, pegozafermin, is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin is currently being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), formerly nonalcoholic steatohepatitis (NASH), and for the treatment of severe hypertriglyceridemia (SHTG). MASH, a severe form of metabolic dysfunction-associated steatotic liver disease (formerly nonalcoholic fatty liver disease), is characterized by liver inflammation and fibrosis, potentially progressing to cirrhosis, liver failure, hepatocellular carcinoma and death.

Pegozafermin MASH Program

Pegozafermin is currently advancing through Phase 3 clinical development. This follows positive results from the Phase 1b/2a trial and the Phase 2b ENLIVEN trial, which demonstrated statistically significant histological improvements through 24 weeks and benefits across non-invasive tests (NITs) in both non-cirrhotic (F2-F3) and compensated cirrhotic (F4) MASH patients through 48 weeks.

The U.S. Food and Drug Administration (FDA) has granted pegozafermin Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted it Priority Medicines Designation (PRIME) for MASH.

We are enrolling patients in our Phase 3 ENLIGHTEN program of two global, randomized, double-blind, placebo-controlled trials, which were initiated in 2024, following successful end-of-Phase 2 interactions with the FDA and EMA in 2023:

•

ENLIGHTEN-Fibrosis: This trial is actively enrolling patients with MASH and fibrosis stage F2-F3. It evaluates weekly and every-two-week dosing regimens of pegozafermin versus placebo. The co-primary histology endpoints, assessed at week 52, are intended to support potential filings for accelerated approval in the United States and conditional approval in Europe. We currently anticipate reporting topline data from the histology cohort in the first half of 2027. Patients are expected to continue treatment for collection of outcome events for potential full approval in F2-F3 MASH.

•

ENLIGHTEN-Cirrhosis: This trial is actively enrolling patients with MASH and compensated cirrhosis (F4). It evaluates a weekly dosing regimen of pegozafermin versus placebo. The primary histology endpoint, assessed at 24 months, is intended to support potential filings for accelerated approval in the United States and conditional approval in Europe for F4 patients. We currently anticipate reporting topline data from the histology cohort in 2028. Patients are expected to continue treatment for collection of outcomes events, primarily decompensation events, which could support potential full approval for F4 and F2-F3 MASH.

Both Phase 3 trials are designed to enroll a proportion of patients on background glucagon-like peptide-1 (GLP-1) based therapies to evaluate the potential incremental benefit of pegozafermin. The trials will stratify patients based on their use of background GLP-1 based therapies. Patients in both trials can self-administer pegozafermin using the planned commercial liquid formulation via subcutaneous injection. We continue to execute on these trials with the goal of generating data to support regulatory submissions for pegozafermin as a potential treatment for patients with MASH.

Pegozafermin SHTG Program

We are also advancing pegozafermin for the treatment of SHTG, based on positive results from our Phase 2 ENTRIGUE trial and supportive feedback from the FDA indicating that two Phase 3 trials are required for registration using triglyceride reduction as the primary endpoint. Enrollment in the first of these Phase 3 trials, ENTRUST, was completed in December 2024 with 369 patients. This 52-week, randomized, double-blind, placebo-controlled global trial is evaluating weekly subcutaneous doses of pegozafermin (20

mg and 30 mg) against placebo. The primary endpoint—percent change from baseline in fasting triglycerides compared to placebo at Week 26—will be analyzed after study completion at Week 52. This timing of analysis aligns with our strategic prioritization of the MASH program, followed by the SHTG program. We expect to report topline data from the ENTRUST trial in the first quarter of 2026. Safety data from the ongoing ENTRUST trial is expected to support the safety database requirements for MASH and vice versa.

Manufacturing and Commercial Supply Preparedness

In April 2024, we entered into a collaboration agreement (the Collaboration Agreement) with BiBo Biopharma Engineering Co., Ltd. (BiBo), under which BiBo is constructing a production facility at its site in the Lin-gang Special Area of China (Shanghai) Pilot Free Trade Zone (the Commercial Facility). This manufacturing platform is specifically designed to enable the production of the bulk active ingredient required for pegozafermin’s commercial supply, and we expect it to provide capacity sufficient for our projected commercial needs. The scalability of our manufacturing process was demonstrated via the successful completion of a large-scale Good Manufacturing Practices (GMP) production run of pegozafermin during the fourth quarter of 2024 at an existing commercial-scale production line at BiBo’s facility in Shanghai. The Collaboration Agreement is a component of our broader global manufacturing strategy, intended to enhance resilience and flexibility by leveraging a diversified supply chain with alternative sources from contract development and manufacturing organizations (CDMOs). Our broader global manufacturing strategy is intended to mitigate reliance on any single partner and reduce macro/geopolitical risk exposure. As part of our ongoing risk management, we continue to monitor international trade policies and potential changes to import tariffs that could impact our manufacturing costs.

Components of Results of Operations

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for the development of our lead product candidate, pegozafermin. Our research and development expenses consist primarily of external costs related to preclinical and clinical development, including costs related to acquiring patents and intellectual property, expenses incurred under license agreements and agreements with contract research organizations and consultants, costs incurred pursuant to the Collaboration Agreement, costs related to acquiring and manufacturing clinical trial materials, including under agreements with contract manufacturing organizations and other vendors, costs related to the preparation of regulatory submissions and expenses related to laboratory supplies and services, as well as personnel costs. Personnel costs consist of salaries, employee benefits and stock-based compensation for individuals involved in research and development efforts.

We expense all research and development expenses in the periods in which they are incurred. We accrue for costs incurred as services are provided based on invoices and statements received from our external service providers and by monitoring the status of their activities. We adjust our accrued expenses as actual costs become known.

Payments associated with licensing agreements to acquire licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternate commercial use are expensed as incurred. Where contingent milestone payments are due to third parties under research and development arrangements or license agreements, the milestone payment obligations are expensed when payment becomes probable and reasonably estimable, which is generally upon achievement of the milestone.

We expect our research and development expenses to increase for the foreseeable future as we continue the development of pegozafermin and continue to invest in research and development and manufacturing activities. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of pegozafermin and any future product candidates is highly uncertain. To the extent that pegozafermin continues to advance into larger and later stage clinical trials, our expenses will increase substantially and may become more variable. The actual probability of success for pegozafermin or any future product candidate may be affected by a variety of factors, including the safety and efficacy of our product candidates, investment in our clinical programs, manufacturing capability and competition with other products. As a result, we are unable to determine the timing of initiation, duration and completion costs of our research and development efforts or when and to what extent we will generate revenue from the commercialization and sale of pegozafermin or any future product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel costs, expenses for outside professional services, including legal, human resources, audit and accounting services, consulting costs and allocated facilities costs. Personnel and related costs consist of salaries, employee benefits and stock-based compensation for personnel in executive, finance, commercial and other administrative functions. Facilities costs consist of rent and maintenance of facilities. We expect our general and administrative

expenses to increase for the foreseeable future as we increase the size of our administrative function to support the growth of our business and support our continued research and development activities.

Interest Expense

Interest expense consists of cash interest related to our term loan facility, noncash interest attributable to the accretion of end of term loan fees, amortization of deferred debt issuance costs related to our term loan facility and loss on extinguishment of debt.

Interest Income and Other, Net

Interest income and other, net is primarily comprised of interest income derived from marketable securities, including the accretion of discounts and amortization of premiums.

Income Taxes

We make estimates of the amounts to recognize for income taxes in each tax jurisdiction in which we operate. In addition, provisions are established for uncertain tax positions taken.

Results of Operations

Three Months Ended June 30, 2025 and 2024

The following table summarizes our results of operations for the periods presented (in thousands):


	Three Months Ended June 30,
	2025			2024			Change
Operating expenses:
Research and development	$	103,902		$	44,865		$	59,037
General and administrative		11,922			8,571			3,351
Total operating expenses		115,824			53,436			62,388
Loss from operations		(115,824	)		(53,436	)		(62,388	)
Interest expense		(1,137	)		(874	)		(263	)
Interest income and other, net		6,210			6,473			(263	)
Net loss before tax	$	(110,751	)	$	(47,837	)	$	(62,914	)

Research and Development Expenses

The following table summarizes the period-over-period changes in research and development expenses for the periods presented (in thousands):


	Three Months Ended June 30,
	2025		2024		Change
Contract manufacturing	$	58,084	$	17,018	$	41,066
Clinical development		35,299		18,949		16,350
Personnel-related expenses		9,608		7,847		1,761
Other expenses

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

89bio, Inc. 10-Q