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 ~~August 5, 2022,~~May 2, 2023, the registrant had ~~39,073,995~~72,868,455 shares of common stock, $0.001 par value per share, outstanding.

	June 30,			December 31,
	2022			2021			March 31, 2023			December 31, 2022
	(Unaudited)						(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	60,618		$	52,432		$	350,930		$	55,255
Restricted cash		25			25
Short-term available-for-sale securities		78,707			98,288			129,953			132,905
Prepaid and other current assets		7,218			11,237			12,747			7,920
Total current assets		146,568			161,982			493,630			196,080
Operating lease right-of-use asset		109			—			322			363
Property and equipment, net		121			150			78			92
Other assets		797			290			289			289
Total assets	$	147,595		$	162,422		$	494,319		$	196,824
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	4,907		$	6,843		$	16,727		$	12,502
Accrued expenses		14,388			10,194			7,117			11,944
Operating lease liability, current		104			—			171			168
Term loan, current		7,500			2,500
Total current liabilities		26,899			19,537			24,015			24,614
Operating lease liability, non-current								142			186
Term loan, non-current, net		12,050			16,898			24,332			20,192
Liability related to public offering		28,186			—
Other non-current liability		275			30
Total liabilities		67,410			36,465			48,489			44,992
Commitments and contingencies (Note 5)
Stockholders’ equity:
Common stock		20			20			73			51
Additional paid-in capital		344,319			339,218			790,076			467,374
Accumulated other comprehensive loss		(318	)		(64	)		(240	)		(350	)
Accumulated deficit		(263,836	)		(213,217	)		(344,079	)		(315,243	)
Total stockholders’ equity		80,185			125,957			445,830			151,832
Total liabilities and stockholders’ equity	$	147,595		$	162,422		$	494,319		$	196,824

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

	Three Months Ended						Six Months Ended
	June 30,						June 30,						Three Months Ended March 31,
	2022			2021			2022			2021			2023			2022
Operating expenses:
Research and development	$	19,686		$	15,630		$	39,535		$	25,761		$	22,306		$	19,849
General and administrative		5,052			4,921			10,311			9,529			6,218			5,259
Total operating expenses		24,738			20,551			49,846			35,290			28,524			25,108
Loss from operations		(24,738	)		(20,551	)		(49,846	)		(35,290	)		(28,524	)		(25,108	)
Other expenses, net		(316	)		(172	)		(772	)		(215	)
Net loss before tax		(25,054	)		(20,723	)		(50,618	)		(35,505	)
Interest expense														(2,075	)		(408	)
Interest income and other, net														1,763			(48	)
Net loss before income tax														(28,836	)		(25,564	)
Income tax expense		—			—			(1	)		—			—			(1	)
Net loss	$	(25,054	)	$	(20,723	)	$	(50,619	)	$	(35,505	)	$	(28,836	)	$	(25,565	)
Other comprehensive (loss) income:
Unrealized (loss) gain on available-for-sale securities		(77	)		13			(272	)		9
Other comprehensive income (loss):
Unrealized gain (loss) on available-for-sale securities														114			(195	)
Foreign currency translation adjustments		15			(6	)		18			5			(4	)		3
Total other comprehensive (loss) income	$	(62	)	$	7		$	(254	)	$	14
Total other comprehensive income (loss)													$	110		$	(192	)
Comprehensive loss	$	(25,116	)	$	(20,716	)	$	(50,873	)	$	(35,491	)	$	(28,726	)	$	(25,757	)
Net loss per share, basic and diluted	$	(1.23	)	$	(1.03	)	$	(2.49	)	$	(1.77	)	$	(0.54	)	$	(1.26	)
Weighted-average shares used to compute net loss per share, basic and diluted		20,351,560			20,060,061			20,345,521			20,017,677			53,171,370			20,339,416

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

For the Three ~~and Six~~ Months Ended ~~June 30,~~March 31, 2023 and 2022 ~~and 2021~~


																								Accumulated
																					Additional			Other						Total
																	Common Stock				Paid-in			Comprehensive			Accumulated			Stockholders’
																	Shares		Amounts		Capital			(Loss) Income			Deficit			Equity
Balance as of December 31, 2022																		50,560,590	$	51	$	467,374		$	(350	)	$	(315,243	)	$	151,832
Issuance of common stock in public offering, net of issuance costs																		19,461,538		19		296,798			—			—			296,817
Issuance of common stock in at-the-market public offerings, net of issuance costs																		968,000		1		13,421			—			—			13,422
Issuance of common stock upon exercise of warrants																		1,682,500		2		8,958			—			—			8,960
Issuance of common stock upon exercise of stock options																		61,408		—		185			—			—			185
Issuance of common stock upon vesting of restricted stock units, net of withholding taxes																		133,669		—		(693	)		—			—			(693	)
Issuance of common stock warrants in connection with term loan																		—		—		482			—			—			482
Stock-based compensation																		—		—		3,551			—			—			3,551
Net loss																		—		—		—			—			(28,836	)		(28,836	)
Other comprehensive income																		—		—		—			110			—			110
Balance as of March 31, 2023																		72,867,705	$	73	$	790,076		$	(240	)	$	(344,079	)	$	445,830

								Accumulated																Accumulated
					Additional			Other						Total							Additional			Other						Total
	Common Stock				Paid-in			Comprehensive			Accumulated			Stockholders’			Common Stock				Paid-in			Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Capital			Loss			Deficit			Equity			Shares		Amounts		Capital			Loss			Deficit			Equity
Balance as of December 31, 2021		20,317,204	$	20	$	339,218		$	(64	)	$	(213,217	)	$	125,957			20,317,204	$	20	$	339,218		$	(64	)	$	(213,217	)	$	125,957
Issuance of common stock upon exercise of stock options		12,065		—		29			—			—			29			12,065		—		29			—			—			29
Issuance of common stock upon vesting of restricted stock units, net		22,115		—		—			—			—			—			22,115		—		—			—			—			—
Stock-based compensation		—		—		2,512			—			—			2,512			—		—		2,512			—			—			2,512
Net loss		—		—		—			—			(25,565	)		(25,565	)		—		—		—			—			(25,565	)		(25,565	)
Other comprehensive loss		—		—		—			(192	)		—			(192	)		—		—		—			(192	)		—			(192	)
Balance as of March 31, 2022		20,351,384		20		341,759			(256	)		(238,782	)		102,741			20,351,384	$	20	$	341,759		$	(256	)	$	(238,782	)	$	102,741
Issuance of common stock upon ESPP purchases		15,979		—		43			—			—			43
Withholding taxes related to restricted stock units		—		—		(69	)		—			—			(69	)
Stock-based compensation		—		—		2,586			—			—			2,586
Net loss		—		—		—			—			(25,054	)		(25,054	)
Other comprehensive loss		—		—		—			(62	)		—			(62	)
Balance as of June 30, 2022		20,367,363	$	20	$	344,319		$	(318	)	$	(263,836	)	$	80,185

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Comprehensive

Accumulated

Stockholders’

Shares

Amount

Capital

(Loss) Income

Deficit

Equity

Balance as of December 31, 2020

19,931,660

$
20

$
326,046

$
(10
)

$
(123,095
)

$
202,961

Issuance of common stock upon exercise of stock options

103,170

—

216

—

—

216

Stock-based compensation

—

—

1,793

—

—

1,793

Net loss

—

—

—

—

(14,782
)

(14,782
)
Other comprehensive income

—

—

—

7

—

7

Balance as of March 31, 2021

20,034,830

20

328,055

(3
)

(137,877
)

190,195

Issuance of common stock upon exercise of stock options

40,628

—

152

—

—

152

Issuance of common stock upon ESPP purchases

5,207

—

83

—

—

83

Issuance of common stock warrant in connection with term loan facility

—

—

574

—

—

574

Stock-based compensation

—

—

2,417

—

—

2,417

Net loss

—

—

—

—

(20,723
)

(20,723
)
Other comprehensive income

—

—

—

7

—

7

Balance as of June 30, 2021

20,080,665

$
20

$
331,281

$
4

$
(158,600
)

$
172,705

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

Six Months Ended

June 30,

2022

2021

Cash flows from operating activities:

Net loss

$
(50,619
)

$
(35,505
)
Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation

5,098

4,210

Accretion of final payment fee on term loan

245

—

Amortization of debt issuance costs

152

194

Amortization of premium on available-for-sale securities

128

472

Non-cash operating lease expense

91

—

Depreciation

34

35

Changes in operating assets and liabilities:

Prepaid and other current assets

4,037

(4,032
)
Other assets

(507
)

77

Accounts payable

(1,936
)

(159
)
Accrued expenses

4,194

(383
)
Operating lease liability

(96
)

—

Net cash used in operating activities

(39,179
)

(35,091
)
Cash flows from investing activities:

Proceeds from maturities of available-for-sale securities

59,912

63,952

Purchases of available-for-sale securities

(40,731
)

(93,218
)
Purchases of property and equipment

(5
)

(20
)
Net cash provided by (used in) investing activities

19,176

(29,286
)
Cash flows from financing activities:

Proceeds from public offering, prior to closing

28,186

—

Proceeds from issuance of common stock upon ESPP purchases

43

83

Proceeds from issuance of common stock upon stock option exercises

29

368

Payment of withholding taxes related to restricted stock units

(69
)

—

Proceeds from term loan facility, net of issuance costs

—

1,457

Net cash provided by financing activities

28,189

1,908

Net change in cash and cash equivalents, and restricted cash

8,186

(62,469
)
Cash and cash equivalents, and restricted cash at beginning of period

52,457

98,208

Cash and cash equivalents, and restricted cash at end of period

$
60,643

$
35,739

Components of cash and cash equivalents, and restricted cash:

Cash and cash equivalents

$
60,618

$
35,714

Restricted cash

25

25

Total cash and cash equivalents, and restricted cash

$
60,643

$
35,739

Supplemental disclosures of cash information:

Cash paid for interest

$
404

$
—

Cash paid for operating leases

$
127

$
—

Supplemental disclosures of non-cash information:

Offering costs included in other assets and accrued expenses

$
580

$
—

Purchases of property and equipment included in accounts payable and accrued expenses

$
—

$
3

Issuance of common stock warrant in connection with term loan facility

$
—

$
574

Debt issuance costs included in accounts payable

$
—

$
6

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

2. Summary of Significant Accounting Policies

Unaudited Condensed Consolidated Financial Statements

The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and applicable rules and regulations of the SEC regarding interim financial reporting.

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, ~~2021~~2022 and, in the opinion of management, reflect all adjustments, which include only normal recurring

adjustments, necessary to present fairly the Company’s consolidated financial position, results of operations and comprehensive loss, and cash flows. The results of operations for the three ~~and six~~ months ended ~~June 30, 2022~~March 31, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, ~~2022~~2023 or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, ~~2021~~2022 was derived from the audited financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Annual Report on Form 10-K for the year ended December 31, ~~2021,~~2022, which was filed with the SEC on March ~~24, 2022.~~15, 2023.

Reclassification

Certain prior period amounts in the Company’s condensed consolidated statements of operations and comprehensive loss have been reclassified to conform to the current period presentation. Specifically, interest expense is disclosed separately on the Company’s condensed consolidated statements of operations and comprehensive loss, which had no impact on reported net loss, comprehensive loss, or loss per share.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

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 accrued research and development expenses and the fair value of stock ~~options and certain accrued expenses.~~options. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates.

Fair Value Measurements

Financial assets and liabilities are recorded at fair value on a recurring basis in the condensed consolidated balance sheets. The carrying values of Company’s financial assets and liabilities, including cash and cash equivalents, restricted cash, prepaid and other current assets, accounts payable and accrued expenses approximate to their fair value due to the short-term nature of these instruments. The fair value of the Company’s term loan approximates its carrying value, or amortized cost, due to the prevailing market rates of interest it bears. 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.

~~Risks and Uncertainties~~

The ongoing COVID-19 pandemic has disrupted and may continue to disrupt the Company’s business and delay its preclinical and clinical programs and timelines. The Company does not yet know the full extent of potential delays to clinical trials, which could prevent or delay the Company from obtaining approval for pegozafermin. The extent to which the COVID-19 pandemic may impact the Company’s future operating results and financial condition is uncertain.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market funds and commercial paper that are stated at fair value.

Investments

~~Investments~~

Investments have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its available-for-sale investments in debt securities at the time of purchase. Generally, investments with original maturities beyond three months at the date

of purchase are classified as short-term because it is management’s intent to use the investments to fund current operations or to make them available for current operations.

~~Unrealized~~ Realized gains and losses, if any, on available-for-sale securities are ~~excluded from earnings~~included in interest income and ~~are reported as a component~~other, net. The cost of ~~comprehensive loss.~~ investments sold is based on the specific-identification method. The Company has not experienced any material realized gains or losses in the periods presented.

The Company periodically evaluates whether declines in fair values of its available-for-sale securities below ~~their book value~~amortized cost are ~~other-than-temporary.~~due to credit-related factors or other factors. This evaluation consists of several qualitative and quantitative factors regarding the creditworthiness of the issuers of the security, the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs. Additionally, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale securities before recovery of its amortized cost basis. ~~Realized gains~~If a credit loss exists, an allowance for credit losses is recorded in interest income and ~~losses and declines in fair value judged to be~~ other, ~~than temporary, if~~net. To date, the Company has not recorded any impairment charges on its available-for-sale securities related to expected credit losses. Any remaining losses related to other factors are included in other expenses, net. The cost of investments sold is based on the specific-identification method. The Company has 0t experienced material realized gains or losses or other-than-temporary losses in the periods presented. Interest on available-for-sale securities is included in other expenses, netexcluded from earnings and ~~is not material for the periods presented.~~

~~Leases~~

~~Prior to January 1, 2022, the Company accounted for leases under Accounting Standards Codification (“ASC”) 840,~~ ~~Leases~~ ~~(“ASC 840”). Effective January 1, 2022, the Company adopted and accounts for leases under ASC 842,~~ ~~Leases~~ (“ASC 842”) as discussed below in the section titled “Recently Adopted Accounting Standards”. Therefore, as of December 31, 2021 and for the three and six months ended June 30 2021, the Company’s consolidated financial statements continue to be presented in accordance with ASC 840, the accounting standard originally in effect for such periods. As of June 30, 2022 and for the three and six months ended June 30, 2022, the Company’s consolidated financial statements are ~~presented in accordance with ASC 842. The Company’s existing leases are for office and laboratory space.~~

~~The Company accounts for a contract~~reported as a ~~lease when it has the right to control the asset for a period~~component of ~~time while obtaining substantially all of the asset’s economic benefits. The Company determines if~~comprehensive loss as an arrangement is a lease or contains an embedded lease at inception. For arrangements that meet the definition of a lease, the Company determines the initial classification and measurement of its right-of-use (“ROU”) asset and lease liability at the lease commencement date and thereafter if modified. Operating lease ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make the contractual lease payments over the lease term. The lease term includes any renewal options that the Company is reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable, otherwise, the Company uses its estimated collateralized incremental borrowing rate for the lease term. The Company has elected not to record leases with an original term of twelve months or less on its consolidated balance sheets and recognizes those lease payments in operating expenses in the consolidated statements of operations and comprehensiveunrealized loss. ~~The Company’s short-term lease is not material.~~

Comprehensive Loss

~~In addition, the leases may require the Company to pay additional costs, such as utilities, maintenance and other operating costs, which are generally referred to as~~ ~~non-lease~~ ~~components and vary based on future outcomes. The Company has elected to not separate lease and~~ ~~non-lease~~ ~~components. Only the fixed costs for lease components and their associated~~ ~~non-lease~~ ~~components are accounted for as a single lease component and recognized as part of a~~ ~~ROU~~ asset and lease liability. Any variable expenses are recognized in operating expenses as incurred. The rent expense for an operating lease liability is recognized on a straight-line basis over the lease term and is included in operating expenses in the consolidated statements of operations and comprehensive loss.

~~Comprehensive Loss~~

The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains or losses on available-for-sale securities and foreign currency translation adjustments.

Recently Adopted Accounting Standards

On January 1, 2022, the Company adopted ASC 842 using the modified retrospective transition method and elected the practical expedients to not reassess whether any expired or existing contracts are or contain leases, carry forward its historical lease classification and not reassess initial direct costs for existing leases. Upon adoption of ASC 842, the Company recorded an operating ROU asset of $0.2 million and an operating lease liability of $0.2 million. T~~here was 0 adjustment to the opening balance of accumulated deficit as a result of adoption.~~ Results for the three and six months ended June 30, 2022 are presented under ASC 842. Prior period amounts preceding January 1, 2022 continue to be reported in accordance with the Company’s historical accounting under the previous lease guidance, ASC 840.

~~Recent Accounting Pronouncements~~

In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which replaces the existing incurred loss impairment model with an expected credit loss model and requires a financial asset measured at amortized cost to be presented at the net amount expected to be collected. ~~As an emerging growth company, ASU 2016-13 is effective for the~~The Company ~~for the year ending December 31, 2023 and interim periods within that fiscal year~~adopted ~~and must be adopted~~this new guidance on January 1, 2023, using a modified retrospective approach ~~with certain exceptions. The Company is evaluating~~and adoption did not have a material impact on the ~~impact of this standard on its~~Company's consolidated financial statements and related disclosures.

In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity's Own Equity (Subtopic 815-40)—Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which simplifies the accounting for convertible instruments, amends the guidance on derivative scope exceptions for contracts in an entity's own equity, and modifies the guidance on diluted earnings per share calculations as a result of these changes. The Company early adopted ASU 2020-06 as of January 1, 2023, using a modified retrospective approach and adoption did not have a material impact on the Company’s consolidated financial statements and related disclosures.

3. Fair Value Measurements

The ~~following table presents the~~ Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of March 31, 2023 were as follows (in thousands):

~~June 30, 2022~~ ~~(in thousands):~~


	Valuation	Amortized		Unrealized		Unrealized			Fair
	Hierarchy	Cost		Gains		Losses			Value
Money market funds	Level 1	$	25,143	$	—	$	—		$	25,143
Commercial paper	Level 2		80,534		10		(119	)		80,425
U.S. government bonds	Level 2		18,407		13		(60	)		18,360
Agency bonds	Level 2		23,251		8		(55	)		23,204
Corporate debt securities	Level 2		11,440		2		(32	)		11,410
U.S. treasury bills	Level 2		7,851		4		(13	)		7,842
Agency discount securities	Level 2		2,795		—		—			2,795
Non-U.S. debt securities	Level 2		1,496		—		(5	)		1,491
Total cash equivalents and available- for-sale securities		$	170,917	$	37	$	(284	)	$	170,670
Classified as:
Cash equivalents									$	40,717
Short-term available-for-sale securities										129,953
Total cash equivalents and available- for-sale securities									$	170,670

June 30, 2022

Valuation

Amortized

Unrealized

Unrealized

Hierarchy

Cost

Gains

Losses

Fair Value

Money market funds

Level 1

$
14,347

$
—

$
—

$
14,347

Commercial paper

Level 2

45,710

—

(15
)

45,695

U.S. government bonds

Level 2

25,565

—

(226
)

25,339

Agency bonds

Level 2

3,999

—

(35
)

3,964

Corporate debt securities

Level 2

3,630

—

(37
)

3,593

Non-U.S. debt securities

Level 2

3,479

—

(10
)

3,469

U.S. treasury bills

Level 2

1,986

—

(11
)

1,975

Municipal bonds

Level 2

1,587

—

(1
)

1,586

Total cash equivalents and available-for-sale securities

$
100,303

$
—

$
(335
)

$
99,968

Classified as:

Cash equivalents

$
21,261

Short-term available-for-sale securities

78,707

Total cash equivalents and available-for-sale securities

$
99,968

~~As of June 30, 2022, all of the~~The Company’s ~~available-for-sale securities~~financial assets measured at fair value by contractual maturity ~~are within one year.~~as of March 31, 2023 were as follows (in thousands):


Within one year	$	154,706
After one year through two years		15,964
Total cash equivalents and available-for-sale securities	$	170,670

The ~~following table presents the~~ Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy as of December 31, ~~2021~~2022 were as follows (in thousands):

December 31, 2021

Valuation

Amortized

Unrealized

Unrealized

Hierarchy

Cost

Gains

Losses

Fair Value

Money market funds

Level 1

$
21,477

$
—

$
—

$
21,477

Commercial paper

Level 2

59,647

—

(10
)

59,637

U.S. government bonds

Level 2

21,662

—

(42
)

21,620

Corporate debt securities

Level 2

8,776

1

(1
)

8,776

Agency bonds

Level 2

7,747

1

(7
)

7,741

Municipal bonds

Level 2

4,251

—

(4
)

4,247

Non-U.S. debt securities

Level 2

2,506

—

(1
)

2,505

Total cash equivalents and available-for-sale securities

$
126,066

$
2

$
(65
)

$
126,003

Classified as:

Cash equivalents

$
27,715

Short-term available-for-sale securities

98,288

Total cash equivalents and available-for-sale securities

$
126,003


	Valuation	Amortized		Unrealized		Unrealized			Fair
	Hierarchy	Cost		Gains		Losses			Value
Money market funds	Level 1	$	18,224	$	—	$	—		$	18,224
Commercial paper	Level 2		104,279		1		(84	)		104,196
U.S. government bonds	Level 2		18,225		1		(109	)		18,117
Agency bonds	Level 2		13,986		—		(78	)		13,908
Corporate debt securities	Level 2		10,488		—		(62	)		10,426
U.S. treasury bills	Level 2		7,414		1		(21	)		7,394
Agency discount securities	Level 2		5,216		9		—			5,225
Non-U.S. debt securities	Level 2		3,975		—		(20	)		3,955
Total cash equivalents and available- for-sale securities		$	181,807	$	12	$	(374	)	$	181,445
Classified as:
Cash equivalents										48,540
Short-term available-for-sale securities										132,905
Total cash equivalents and available- for-sale securities									$	181,445

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

~~On January 1, 2022, the Company adopted ASC 842 (see Note 2) and the following disclosures as of June 30, 2022 and for the three and six months ended June 30, 2022 are presented under ASC 842.~~

For the three and six months ended June 30, 2022, the Company incurred $47,000 and $0.1 million in rent expense, respectively. Variable lease payments and short-term lease costs were immaterial for the three and six months ended June 30, 2022. As of June 30, 2022, the remaining lease term was 0.5 years and the Company’s incremental borrowing rate used to determine the operating lease liability was 4.25%.

~~As of June 30, 2022, the undiscounted future minimum lease payments due under the Company’s non-cancellable operating lease are as follows (in thousands):~~

~~In accordance with ASC 840, rent expense for the three and six months ended June 30, 2021 was $72,000 and $0.1 million respectively. The~~ ~~total future minimum annual payments for operating leases in effect as of December 31, 2021, were as follows (in thousands):~~

In April 2018, the Company concurrently entered into two Asset Transfer and License Agreements (the “Teva Agreements”) with Teva Pharmaceutical Industries Ltd (“Teva”) under which it acquired certain patents and intellectual property relating to two programs: (1) Teva’s glycoPEGylated FGF21 program, including the compound TEV-47948 (pegozafermin), a glycoPEGylated long-acting FGF21 and (2) Teva’s development program of small molecule inhibitors of fatty acid synthase. Pursuant to the Teva Agreements, the Company paid Teva an initial nonrefundable upfront payment of $6.0 million and the Company could be obligated to pay Teva up to ~~$67.5~~$67.5 million under each program, for a total of ~~$135.0~~$135.0 million, upon the achievement of certain clinical development and commercial milestones. In addition, the Company is obligated to pay Teva tiered royalties at percentages in the low-to-mid single-digits on worldwide net sales on all products containing the Teva compounds.

The Teva Agreements can be terminated (i) by the Company 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 Teva Agreements 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. In addition, Teva can also terminate the agreement related to the Company’s glycoPEGylated FGF21 program in the event the Company, or any of its affiliates or sublicensees, challenges any of the Teva patents licensed to the Company, and the challenge is not withdrawn within 30 days of written notice from Teva.

During the three ~~and six~~ months ended ~~June 30,~~March 31, 2023 and 2022, ~~and 2021, none~~none of the development and commercial milestones were met and accordingly, there were 0no milestone payments related to the Teva Agreements.

6. Term Loan

2021 Loan ~~and Security~~ Agreement

In April 2020, the Company entered into a Loan and Security Agreement, (the “Loan Agreement”) with the lenders referred to therein, ~~(the “Lenders”),~~ and Silicon Valley Bank (“SVB”), as collateral agent. The Loan Agreement as amended in May 2021 (the “2021 Loan Agreement”) provided for (i) a secured term A loan facility (the “Term A Loan Facility”) of up to ~~$10.0~~$20.0 million and (ii) a secured term B loan facility (the “Term B Loan Facility”) of up to ~~$5.0~~$5.0 million. The Term A Loan Facility of $20.0 million was fully drawn as of December 2022 and the Term Loan B Loan Facility expired unused.

In January 2023, the Company executed a loan and security agreement with new lenders (the “2023 Loan Agreement”) and from the proceeds repaid $21.4 million in outstanding principal, final payment fee, prepayment fee and interest due under the 2021 Loan Agreement. Repayment of the 2021 Loan Agreement was accounted for as an extinguishment as the 2023 Loan Agreement was with new lenders. The Company recorded a loss on extinguishment of $1.2 million, which was recognized as a component of interest expense on the Company’s condensed consolidated statements of operations and comprehensive loss.

2023 Loan Agreement

In January 2023, the Company executed the 2023 Loan Agreement with the lenders referred to therein, K2 HealthVentures LLC (“K2HV”) as administrative agent and Ankura Trust Company, LLC as collateral agent. The 2023 Loan Agreement provides for up to $100.0 million in aggregate principal in term loans, consisting of a first term loan of $25.0 million that ~~became available~~was funded at closing, two subsequent term loans totaling $25.0 million that may be funded upon the ~~satisfaction~~achievement of certain time-based, clinical and regulatory milestones, ~~each~~and a fourth term loan of ~~which was available~~up to $50.0 million that may be ~~drawn through May 31, 2021.~~ funded upon discretionary approval by the lenders.

The term ~~loan is~~loans are secured by ~~certain assets of the Borrowers (as defined in the Loan Agreement), including~~ substantially all of the assets of the Company, excluding the Company’s intellectual property. The ~~term loan~~2023 Loan Agreement contains customary representations and warranties, ~~affirmative~~restricts certain activities and includes customary events of default, including payment default, breach of covenants, change of control, and ~~also certain restrictive covenants.~~

material adverse effects. In ~~April 2020, in connection with the execution of the Loan Agreement,~~addition, starting January 1, 2024, the Company ~~issued SVB a warrant~~is required to ~~purchase 25,000 shares of~~maintain minimum unrestricted cash and cash equivalents equal to 5.0 times the ~~Company’s common stock with a warrant exercise price of $22.06 per share~~average change in cash and cash equivalents measured over the trailing three-month period.

The term loans mature on January 1, 2027, provided that ~~is immediately exercisable~~the maturity date may be extended to July 1, 2027, if the second and ~~expires onJune 30, 2025, as amended. The fair value of the warrant at the issuance date was determined by using the Black-Scholes option-pricing model~~third term loans are funded and the ~~fair value allocated to the warrant of $0.6 million met the requirements for equity classification within additional paid-in capital. Additionally, the~~ Company ~~incurred $0.2 million in closing costs, which together with the value of the warrants, were recorded as debt issuance costs.~~

~~In May 2021, the parties further amended the Loan Agreement (as amended, the “2021 Loan Agreement”).~~ achieves certain other financing milestones. The 2021 Loan Agreement increased the Term A Loan Facility to up to $20.0 million, which was fully drawn as of December 2021. The Term B Loan Facility of up to $5.0 million remains available to be drawn upon on achievement of certain additional milestones, on or before September 30, 2022. The 20212023 Loan Agreement provides for interest-only payments ~~until October~~to February 1, ~~2022, followed by consecutive monthly~~2025 that could be extended to February 1, 2026, provided that the maturity date is extended. Consecutive equal payments of principal and interest ~~starting on October 1, 2022 and continuing through September 1, 2024,~~are due once the ~~maturity date of the term loan. The interest only~~interest-only period ~~may be extended to April 1, 2023, if on or before September 20, 2022, the Company receives net cash proceeds of at least $75.0 million from the sale of its equity securities.~~has elapsed. The term ~~loan bears~~loans bear interest atequal to the greater of (i) ~~4.25%~~8.45% and (ii) the sum of (a) the Prime Rate as reported in The Wall Street Journal plus (b) ~~1.00%~~2.25%. The interest rate on the term loan was ~~4.25%~~9.75% at inception and ~~5.75%~~10.25% as of ~~June 30, 2022.~~March 31, 2023. In addition, a final payment fee of 5.0% of the principal amount of the loan is due when the term loan becomes due or upon prepayment of the term loan. If the Company elects to prepay the loan, there is also a prepayment fee of between 1.0% and 3.0%5.95% of the principal amount of the term ~~loan~~loans is due upon the earlier of prepayment or maturity of the term loans. The Company has the option to prepay the entire outstanding balance of the term loans subject to a prepayment fee ranging from 3.0% to 1.0% depending on the timing of such prepayment. A commitment fee equal to 0.6% of the principal amount of the fourth term loan is also payable should such loan be funded.

At any time prior to full repayment of the term loans, the lenders may elect to convert up to an aggregate of $7.5 million of the principal amount of the term loans then outstanding into shares of the Company's common stock at a conversion price of $12.6943 per share. The embedded conversion option qualifies for a scope exception from derivative accounting because it is both indexed to the Company’s own stock and meets the conditions for equity classification.

Total debt issuance costs related to the first term loan were $0.8 million, including the fair value of the warrant related to the first term loan (discussed below) were recorded as a debt discount since the first term loan was funded at inception. The debt discount, together with the final payment fee, are recognized as interest expense using the effective interest method over the term of the loan.

The expected repayments of principal amount due on the term loans as of March 31, 2023 are as follows (in thousands):


Remainder of 2023	$	—
2024		—
2025		10,805
2026		13,012
2027		1,183
Total principal repayments		25,000
Final payment fee		87
Total principal repayments and final payment fee		25,087
Unamortized debt discount		(755	)
Total term loan, non-current, net	$	24,332

Warrants

In ~~May 2021,~~January 2023, in connection with the ~~execution of the 2021~~2023 Loan Agreement, the Company issued ~~SVB~~the lenders a warrant to purchase ~~33,923~~up to an aggregate of 204,815 shares of the Company’s common stock ~~with a warrant~~at an exercise price of ~~$19.12~~$9.7649 per share (the “warrant shares”) that expires in January 2033. The warrant shares become exercisable upon the funding of each term loan. In connection with the first term loan that was funded at closing, 51,204 of the warrant shares became exercisable. The warrant shares cannot be settled for cash and include a cashless exercise feature allowing the holder to receive shares net of shares withheld in lieu of the exercise price. The warrant shares also provide for automatic cashless exercise under certain specific conditions and settlement is ~~immediately exercisable and expires on May 28, 2031.~~ permitted in unregistered shares. The 51,204 warrant shares meet the requirements for equity classification.

The Company determined the fair value of the 51,204warrant ~~at the issuance date by~~shares issued using the Black-Scholes option-pricing model with the following assumptions: risk-free interest rate of ~~1.6%~~3.9%, 0no dividends, expected volatility of ~~98.6%~~93.8% and expected term of 10.0 years. ~~Upon issuance,~~

The remaining 153,611 warrant shares are contingently exercisable upon the ~~fair value~~funding of each subsequent term loan and have the ~~warrant of $0.6 million was recorded as a debt issuance cost~~same exercise price and ~~met~~contractual term (the “contingent warrants”). The contingent warrants did not meet the ~~requirements for~~derivative scope exception or equity classification ~~within additional paid-in capital in the consolidated balance sheets. In addition, closing costs incurred~~criteria and were not material. In connection with Term B Loan Facility, if funded, the Company will issue additional warrant to purchase 11,305 shares of the Company’s common stock with the exercise price at the Company’s stock price at the time of issuance.

~~The 2021 Loan Agreement was~~ accounted for as a ~~modification to a credit facility.~~derivative liability. The ~~debt issuance costs incurred in May 2021, including~~initial fair value and the fair value as of March 31, 2023 of the ~~warrant, together~~contingent warrants was insignificant. The contingent warrants derivative liability will be remeasured each reporting period until settled or extinguished with ~~the remaining unamortized debt issuance costs related to the Loan Agreement of $0.4 million were~~subsequent changes in fair value recorded ~~as deferred assets and recognized on a straight-line basis~~ as interest expense over the availability of the draw period. Since all amounts under the Term A Loan Facility were drawn as of December 31, 2021, all debt issuance costs were reclassified as debt discount. The carrying value of the debt discount, together with the final payment fee, are recognized using the effective interest method. Interest expense is recorded within other expenses, net in the condensed consolidated statements of operations and comprehensive loss.

The ~~expected repayments~~initial fair value of ~~principal amount due~~the contingent warrants derivative liability was determined using a probability weighted Black-Scholes option pricing model based on the ~~term loan, excluding the final payment fee (which is presented as an other non-current liability on the condensed consolidated balance sheets) as of June 30, 2022 are as follows (in thousands):~~same input assumptions above.

Remainder of 2022

$
2,500

2023

10,000

2024

7,500

Total principal repayments

20,000

Less: unamortized debt discount

(450
)
Total term loan, net

19,550

Less: term loan, current

(7,500
)
Term loan, non-current, net

$
12,050

7. Stockholders’ Equity

As of March 31, 2023, the Company’s shares of common stock available for future issuance were as follows:


Shares available for future grant under the equity incentive plans			2,144,800
Shares available for future issuance under the employee stock purchase plan			1,234,824
Shares available for future issuance upon the exercise of warrants and pre-funded warrants			12,488,597
Total available for future issuance			15,868,221

Public Offerings

At-the-Market Offerings

In March 2021, the Company entered into a sales agreement (the “Sales Agreement”) with SVB Securities LLC and Cantor Fitzgerald & Co. (the “Sales Agents”) pursuant to which it may offer and sell up to $75.0 million of the Company’s common stock,

from time to time, in “at-the-market” offerings (the “ATM Facility”). The Sales Agents are entitled to compensation at a commission equal to 3.0% of the aggregate gross sales price per share sold under the Sales Agreement.

During the three months ending March 31, 2023, the Company received aggregate proceeds of $13.4 million, net of commissions from sales of 968,000 shares of its common stock pursuant to the ATM Facility.

On February 15, 2023, the Company entered into Amendment No. 1 to the Sales Agreement with the Sales Agents, pursuant to which the Company may offer and sell up to $150.0 million of its common stock, from time to time, through the ATM Facility.

July 2022 Public Offering

In July 2022, the Company completed an underwritten public offering of its common stock, warrants to purchase shares of its common stock and pre-funded warrants to purchase shares of its common stock. The Company sold 18,675,466 shares of its common stock with accompanying warrants to purchase up to 9,337,733 shares of its common stock at a combined public offering price of $3.55 per share. The Company also sold 7,944,252 pre-funded warrants to purchase shares of its common stock with accompanying warrants to purchase up to 3,972,126 shares of its common stock at a combined public offering price of $3.549 per pre-funded warrant, which represents the per share public offering price for the common stock less $0.001 per share, the exercise price for each pre-funded warrant. The Company raised aggregate proceeds of $88.2 million, net of underwriting discounts and commissions of $5.7 million and other offering costs of $0.6 million.

The exercise of the outstanding warrants is subject to a beneficial ownership limitation of 9.99%, or at the election of the holder prior to the issuance of the warrant, 4.99%. The exercise of the outstanding pre-funded warrants is subject to a beneficial ownership limitation of 9.99%, or at the election of the holder prior to the issuance of the pre-funded warrant, 4.99%, which a holder may increase or decrease from time to time but shall not exceed 19.99%. The exercise price and number of shares of common stock issuable upon the exercise of the warrants and pre-funded warrants are subject to adjustment in the event of any stock dividends, stock splits, reverse stock split, recapitalization, or reorganization or similar transaction, as described in the agreements. Under certain circumstances, the warrants and pre-funded warrants may be exercisable on a “cashless” basis. The warrants and pre-funded warrants were classified as a component of stockholders’ equity and additional paid-in capital because such warrants and pre-funded warrants (i) are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, (ii) are immediately exercisable, (iii) do not embody an obligation for the Company to repurchase its shares, (iv) permit the holders to receive a fixed number of common shares upon exercise, (v) are indexed to the Company’s common stock and (vi) meet the equity classification criteria. In addition, the warrants and pre-funded warrants do not provide any guarantee of value or return.

March 2023 Public Offering

In March 2023, the Company completed an underwritten public offering of its common stock. The Company sold 19,461,538 shares of its common stock at a public offering price of $16.25 per share. The Company raised aggregate proceeds of $296.8 million, net of underwriting discounts and commissions of $19.0 million and other offering costs of $0.5 million.

Common Stock Warrants

As of March 31, 2023, the Company’s outstanding warrants to purchase shares of its common stock were as follows:


	Shares of Common Stock Underlying Warrants		Exercise Price Per Share		Expiration Date
Warrant issued with term loan to SVB		25,000	$	22.06	June 30, 2025
Warrant issued with term loan to SVB		33,923		19.12	May 28, 2031
Warrants issued with term loan to K2HV		204,815		9.76	January 27, 2033
Warrants issued in public offering		11,424,859		5.325	July 1, 2024
Pre-funded warrants issued in public offering		800,000		0.001	Do not Expire
Total outstanding		12,488,597

8. Stock-Based Compensation

Equity Incentive ~~Plan~~Plans

In September 2019, the Company’s board of directors adopted the 2019 Equity Incentive Plan (the “2019 Plan”), which also became effective in September 2019. The Company initially reserved 2,844,193 shares of common stock for issuance under the 2019 Plan. In addition, the number of shares of common stock reserved for issuance under the 2019 Plan will automatically increase on the first day of January for a period of up to ten years in an amount equal to 4%4% of the total number of shares of the Company’s capital stock outstanding on the immediately preceding December 31, or a lesser number of shares determined by the Company’s board of directors. As

In February 2023, the Company’s board of ~~June 30, 2022, there were 953,596~~directors adopted the 2023 Inducement Plan (the “2023 Plan”), which also became effective in February 2023. The Company initially reserved 1,500,000 shares of common stock ~~available~~ for issuance ~~as future equity grants~~ under the ~~2019~~2023 Plan. Under the 2023 Plan, new employees are eligible to receive equity awards as a material inducement to the commencement of employment with the Company. As of March 31, 2023, no awards had been granted under the 2023 Plan.

Employee Stock Purchase Plan

In October 2019, the Company’s board of directors adopted the 2019 Employee Stock Purchase Plan (“ESPP”), which became effective in November 2019. The Company initially reserved 225,188 shares of common stock for purchase under the ESPP. The number of shares of common stock reserved for issuance under the ESPP will automatically increase on the first day of January for a period of up to ten years in an amount equal to 1%1% of the total number of shares of the Company’s common stock outstanding on the immediately preceding December 31, or a lesser number of shares determined by the Company’s board of directors. Purchases are accomplished through the participation of discrete offering periods and each offering is expected to be six months in duration. For each offering period, ESPP participants will purchase shares of common stock at a price per share equal to ~~85%~~85% of the lesser of the fair market value of the Company’s common stock on (1) the first trading day of the applicable offering period or (2) the last trading day of the applicable offering period.

Stock Options~~As of June 30, 2022, there were 731,603 shares of common stock available for issuance under the ESPP.~~

The following table summarizes stock option activity for the ~~six~~three months ended ~~June 30, 2022:~~March 31, 2023:

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, 2021

2,406,668

$
16.46

8.1

$
9,970

Granted

956,816

4.19

Exercised

(12,065
)

2.43

Cancelled

(199,145
)

14.49

Balance outstanding as of June 30, 2022

3,152,274

$
12.92

8.1

$
790

Exercisable as of June 30, 2022

1,365,395

$
13.14

7.0

$
642


						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, 2022		3,161,917		$	12.80		7.9	$	16,612
Granted		1,366,200			14.61
Exercised		(61,408	)		3.01
Cancelled and forfeited		(3,250	)		17.85
Balance outstanding as of March 31, 2023		4,463,459		$	13.49		8.2	$	21,278
Exercisable as of March 31, 2023		1,686,003		$	14.32		7.0	$	10,573

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,						Three Months Ended March 31,
	2022			2021			2023	2022
Expected term (years)	5.5-6.1			5.5-6.1			5.5-6.1	6.0-6.1
Expected volatility	89.9-91.0		%	94.0-97.6		%	91.6-93.2%	90.6-91.0%
Risk-free interest rate	1.6-2.8		%	0.7-1.0		%	3.4-3.8%	1.6-1.9%
Expected dividend		—			—		—	—

Restricted Stock Units (“RSUs”)

~~Pursuant to the Company’s 2019 Plan, RSUs are granted to executives and certain employees.~~

~~In February 2021 and 2022, the~~The Company has granted certain employees service-based RSUs that generally vest annually over a two or three-year period. The restrictions lapse over time for these service-based RSUs. In the event of termination of the holder’s continuous service to the Company, any unvested portion of the service-based RSUs ~~are~~is cancelled. For the three months ended ~~June 30,~~March 31, 2023 and 2022, ~~and 2021,~~ the Company recognized ~~$0.2~~$0.7 million and ~~$0.1~~$0.2 million, respectively, in expense related to the service-based RSUs. ~~For the six months ended June 30, 2022 and 2021, the Company recognized $0.4 million and $0.2 million, respectively, in expense related to the service-based RSUs.~~

In February 2021, the Company granted performance-based RSUs that vest as to one-third on each one-year anniversary date, subject to achievement of a development milestone and continued service to the Company. In each of February 2022 and 2023, a portion of the performance-based RSUs vested upon achievement of the development milestone and satisfaction of the continued service condition. ~~Also, in~~

In February and September 2022, the Company granted performance-based RSUs that vest during the applicable performance period, subject to the achievement of certain corporate or department targets and continued service to the Company. ~~Expense~~In September 2022 and March 2023, a portion of the performance-based RSUs that were granted in February 2022 vested upon achievement of specific targets and satisfaction of the continued service condition.

As of March 31, 2023, it was ~~recognized~~probable that the remaining performance conditions would be met for the Company’s performance-based RSUs and expense was recognized using the accelerated attribution ~~method because it is probable that the performance conditions will be met.~~method. For the three months ended ~~June 30,~~March 31, 2023 and 2022, ~~and 2021,~~ the Company recognized ~~$0.4~~expense of $0.3 million ~~and $0.2 million, respectively,~~ in ~~expense~~each period related to ~~the~~ performance-based RSUs. ~~For the six months ended June 30, 2022 and 2021, the Company recognized $0.7 million and $0.3 million, respectively, in expense related to the performance-based RSUs.~~

The following table summarizes RSU activity for the ~~six~~three months ended ~~June 30, 2022:~~March 31, 2023:

Weighted Average

Number of

Grant Date

RSUs

Fair Value

Balance outstanding as of December 31, 2021

106,394

$
23.10

Granted

596,891

4.44

Vested / released

(22,115
)

23.10

Cancelled / forfeited

(80,522
)

5.64

Balance outstanding as of June 30, 2022

600,648

$
6.51


	Number of RSUs			Weighted Average Fair Value at Date of Grant per Unit
Balance outstanding as of December 31, 2022		1,095,738		$	5.77
Granted		339,075			14.70
Vested / released		(133,669	)		7.31
Cancelled / forfeited		(82,767	)		7.31
Balance outstanding as of March 31, 2023		1,218,377		$	7.98

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


	Three Months Ended March 31,
	2023		2022
Research and development	$	1,486	$	884
General and administrative		2,065		1,628
Total stock-based compensation	$	3,551	$	2,512

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

You should read the followingdiscussionand analysisof our financialconditionand resultsof operationstogetherwith our unaudited condensed consolidatedfinancialstatementsand relatednotes and other financialinformation includedelsewherein this Quarterly Report on Form 10-Q and our consolidatedfinancialstatementsand relatednotes and other financialinformation included in our Annual Report on Form 10-K for the year ended December 31, ~~2021.~~2022. 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.

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, ~~(previously BIO89-100),~~ a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (“FGF21”), is currently being developed for the treatment of nonalcoholic steatohepatitis (“NASH”) and severe hypertriglyceridemia (“SHTG”) ~~and nonalcoholic steatohepatitis (“NASH”)~~.

SHTG is a condition identified by severely elevated levels of triglycerides (≥500 mg/dL), which is associated with an increased risk of NASH, cardiovascular events and acute pancreatitis. In June 2022, we reported positive topline results from our Phase 2 trial (ENTRIGUE) in SHTG patients. Treatment with pegozafermin resulted in clinically meaningful and statistically significant reductions in triglycerides from baseline across all doses (with a 63% reduction in the highest dosing group; p<0.001), statistically significant improvements in key markers of cardiovascular risk (non-HDL-C and apo B), reductions in liver fat, and improvements in glycemic control markers. Results were consistent in patients not on background therapy or on background therapy (consistent results on statins or statin combos, prescription fish oils, and fibrates) and across various subgroups, including those with the greatest disease burden, such as patients with Type 2 diabetes and those with baseline triglyceride levels ≥750 mg/dL. Pegozafermin was generally well tolerated with a favorable safety profile across doses consistent with prior studies. The most commonly reported treatment-related adverse events were nausea, diarrhea, and injection site reactions, all which were classified as mild or moderate. No tremors or transaminase elevation adverse events were observed. There were no drug-related serious adverse events and two Grade 2 treatment-related discontinuations. We plan to initiate our Phase 3 SHTG trial in the first half of 2023 pending our end of Phase 2 meeting with the FDA.

NASH is a severe form of nonalcoholic fatty liver disease, characterized by inflammation and fibrosis in the liver that can progress to cirrhosis, liver failure, hepatocellular carcinoma ~~(“HCC”)~~ and death. There are currently no approved products for the treatment of NASH. In ~~January~~2020 and 2022, we ~~announced~~presented positive topline results from ~~an expansion~~cohorts 1 through 6 and cohort ~~(cohort 7) of the~~7 respectively, in our Phase 1b/2a trial of pegozafermin in NASH ~~after announcing positive topline data from cohorts 1 through 6~~patients which has informed the advancement of our clinical strategy in ~~September 2020.~~NASH. We ~~also~~ initiated a Phase 2b trial (ENLIVEN) evaluating pegozafermin in fibrosis stage 2 or 3 NASH patients in June 2021. Patients ~~will receive~~received weekly doses (15 mg and 30 mg) or aan every two-week dose (44 mg) of pegozafermin or placebo for 24 weeks followed by a blinded extension phase of an additional 24 weeks for a total treatment period of 48 ~~weeks. Dose selection for ENLIVEN was informed by concentration response relationships~~weeks, with some of the placebo patients re-randomized to receive pegozafermin in the ~~NASH Phase 1b/2a study. Maximal effect for relevant response metrics was observed at concentrations achieved with 27 – 30 mg once weekly dose. We are making good progress~~extension phase. In August 2022, we reported the completion of enrollment in ENLIVEN ~~and project to close enrollment in the third quarter of 2022 and expect to report~~with 219 patients. We reported topline data from ~~this trial~~ENLIVEN in March 2023. The 44 mg every-two-week and the ~~first quarter~~30 mg weekly dose groups both met with high statistical significance, both of ~~2023. Based~~the primary histology endpoints per the U.S. Food and Drug Administration (“FDA”) guidance on ~~learnings from our recent cohort, developments~~endpoints for accelerated approval in non-cirrhotic NASH patients. The 44 mg every two-week and the ~~field,~~30 mg weekly dose groups both demonstrated at least one-stage fibrosis improvement without worsening of NASH (27% and ~~feedback from our steering committee, we have implemented steps~~26%, respectively) at 3.5 times the placebo rate (7%) and NASH resolution without worsening of fibrosis (26% and 23%, respectively), between 12 to ~~optimize~~14 times the placebo rate (2%). These dose groups also demonstrated statistically significant and clinically meaningful improvements in liver fat, non-invasive markers of liver fibrosis and inflammation as well as meaningful improvements in other metabolic and lipid markers. Pegozafermin was generally well tolerated with a favorable safety profile consistent with prior studies.

The ENLIVEN ~~trial. In 2021, we completed a pharmacokinetic~~ study ~~of pegozafermin in~~also included 14 biopsy-confirmed NASH patients with compensated cirrhosis ~~(fibrosis stage F4) demonstrating that pegozafermin 30 mg has similar single-dose pharmacokinetics~~(F4 patients) who were not part of the primary analysis but continued in the study. 12 of these 14 patients underwent a follow-up biopsy at week 24. In a descriptive analysis of these data, five out of 11 pegozafermin-treated patients experienced at least one-stage improvement in liver fibrosis with no worsening of NASH by week 24 compared with zero out of 1 patient on placebo. An additional two pegozafermin-treated patients experienced at least one-stage improvement in liver fibrosis with no worsening of ballooning or inflammation.

The Company intends to meet with the FDA in the second half of 2023 and ~~pharmacodynamics~~to pursue EU scientific advice in parallel. Subject to regulatory approval, the Company’s proposed clinical development plans include a Phase 3 trial evaluating F2/F3 patients with a histology endpoint for accelerated approval and a Phase 3 trial evaluating F4 ~~as it does~~patients in ~~non-cirrhotic NASH.~~ parallel with an outcomes endpoint for full approval. The planned SHTG Phase 3 trials are expected to satisfy database requirements.

We are ~~currently evaluating~~also developing pegozafermin for the ~~potential opportunity for~~treatment of SHTG. In June 2022, we announced positive topline results from the ENTRIGUE Phase 2 trial of pegozafermin in ~~these fibrosis stage F4~~SHTG patients. SHTG is a condition identified by severely elevated levels of triglycerides (≥500 mg/dL), which is associated with an increased risk of NASH, cardiovascular events and acute pancreatitis. The trial met its primary endpoint demonstrating statistically significant and clinically meaningful reductions in triglycerides from baseline and key secondary endpoints. We have received feedback from the FDA supporting the advancement of pegozafermin into Phase 3 and are planning to initiate the first of two recommended Phase 3 trials in the second quarter of 2023.

We commenced operations in 2018 and have devoted substantially all of our resources to raising capital, acquiring our initial product candidate, identifying and developing pegozafermin, licensing certain related technology, conducting research and development activities (including preclinical studies and clinical trials) and providing general and administrative support for these operations.

As of ~~June 30, 2022,~~March 31, 2023, our cash and cash equivalents and short-term available-for-sale securities totaled ~~$139.3~~$480.9 million. Based on our current operating plan, we believe that our cash and cash equivalents and short-term available-for-sale securities ~~together with the proceeds received from our offering~~as of ~~common stock, warrants and pre-funded warrants consummated in July 2022, and proceeds available from our~~ ~~at-the-market facility,~~March 31, 2023 will be sufficient to meet our anticipated cash requirements for a period of at least one year from the date this Quarterly Report on Form 10-Q is filed with the Securities and Exchange Commission (“SEC”).

We have incurred net losses since our inception. Our net losses for the three months ended ~~June 30,~~March 31, 2023 and 2022 ~~and 2021~~ were ~~$25.1~~$28.8 million and ~~$20.7 million, respectively. Our net losses for the six months ended June 30, 2022 and 2021 were $50.6 million and $35.5~~$25.6 million, respectively. As of ~~June 30, 2022,~~March 31, 2023, we had an accumulated deficit of ~~$263.8~~$344.1 million. We expect to continue to incur significant expenses and increasing operating losses as we advance pegozafermin and any future product candidates through clinical trials, seek regulatory approval for pegozafermin and any future product candidates, expand our clinical, regulatory, quality, manufacturing and commercialization capabilities, protect our intellectual property, prepare for and, if approved, proceed to commercialization of pegozafermin and any future product candidates, expand our general and administrative support functions, including hiring additional personnel, and incur additional costs associated with operating as a public company. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.

The ongoing COVID-19 pandemic has disrupted and may continue to disrupt our business and delay our development timeline. The extent to which the COVID-19 pandemic may impact our future operating results and financial condition is uncertain. We do not yet know the full extent of potential delays that may affect our clinical trials, which could prevent or delay us from obtaining approval for pegozafermin. Given the surges in cases of COVID-19 experienced previously and uncertainty regarding other variants, we cannot predict how our ongoing trials may be impacted. For more information regarding risks related to the ongoing COVID-19 pandemic, please see the risk factor entitled “The ongoing COVID-19 pandemic has resulted and may in the future result in significant disruptions to our clinical trials or other business operations, which could have a material adverse effect on our business,” in Part II. Item 1A of this Quarterly Report on Form 10-Q. To the extent the ongoing COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks set forth under “Risk Factors” in this Quarterly Report on Form 10-Q.

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 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 by monitoring the status of specific activities and invoices received from our external service providers. 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 the milestone results are probable and estimable, which is generally upon achievement of milestones.

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 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.

Generaland administrativeexpensesconsistprimarilyof personnelcosts,expensesfor outside professionalservices,includinglegal,human resource,auditand accountingservices,consultingcostsand allocatedfacilitiescosts.Personneland relatedcostsconsistof salaries,benefitsand stock-basedcompensation for personnelin executive,financeand otheradministrativefunctions.Facilitiescostsconsistof rentand maintenanceof facilities.We expectour generaland administrativeexpensesto increasefor the foreseeable futureas weincreasethe sizeof our administrativefunctionto supportthe growth of our businessand support our continued research and development activities.

~~Other expenses~~,~~net~~Interest expense primarily consistsof interest expense, ~~amortization~~accretion of ~~deferred debt issuance costs~~final payment fees and amortization of ~~premium on available-for-sale securities offset by~~ ~~interest income on available-for-sale securities.~~

~~The followingtablesummarizesour resultsof operationsfor the periodspresented(in thousands):~~

~~The followingtablesummarizesthe period-over-periodchanges in researchand developmentexpenses for the periods~~ ~~presented~~ ~~(in thousands):~~

~~Researchand developmentexpensesincreased by $4.1 million,or 26%, to $19.7 million~~ ~~for~~ ~~the three monthsended June 30, 2022 from$15.6 million for the three months ended June 30, 2021. The changewas primarilydue to an increase of $5.5 million in~~

clinical development costs related to our ongoing clinical trials and an increase of $0.8 million in personnel-related costs, including stock-based compensation due to higher headcount, offset in part by a decrease of $1.9 million in contract manufacturing costs, mainly as a result of the completion of manufacturing batches to cater to the current supply requirement for our ongoing clinical trials and a decrease of $0.3 million in other expenses primarily due to lower overhead costs.

~~Generaland administrativeexpensesincreasedby $0.1 million,or 3%, to $5.1 millionfor the three monthsended June 30, 2022 from$4.9 millionfor the three months ended June 30, 2021.~~ ~~The changewas primarily due to an increasein personnel-relatedcosts,includingstock-based compensation.~~

~~Other expenses,net increasedby $0.1 million~~ ~~to $0.3 million for the three months ended~~ ~~June 30, 2022from$0.2 million~~ ~~for the three months ended~~ ~~June 30, 2021, primarily due to higher~~ ~~interest expense, including the accretion of the final payment fee and amortization of~~deferred debt issuance costs related to our term loan facility.

Interest income and other, net primarily consists of interest income including accretion of discount on available-for-sale securities, offset by amortization of premium on available-for-sale securities.

The followingtablesummarizesour resultsof operationsfor the periods presented (in thousands):

The followingtablesummarizesthe period-over-periodchanges in researchand developmentexpenses for the periods presented (in thousands):

Researchand developmentexpensesincreased by ~~$13.8~~$2.5 million,or ~~53%~~12%, to ~~$39.5 million~~ ~~for~~ ~~the six monthsended June 30, 2022 from$25.8~~$22.3 million for the ~~six~~three months ended ~~June 30, 2021.~~March 31, 2023 from $19.8 million for the three months ended March 31, 2022. The changewas ~~primarily~~due to an increase of ~~$13.0~~$3.6 million in ~~clinical development~~contract manufacturing costs related to ~~our ongoing clinical trials,~~manufacturing and scale-up activities, and an increase of ~~$2.1~~$1.1 million in personnel-related costs ~~including stock-based compensation~~mainly due to higher ~~headcount,~~payroll costs and stock-based compensation, offset in part by a decrease of ~~$1.0~~$2.2 million in ~~contract manufacturing~~clinical development costs, mainly as a result of approaching the ~~completion~~end of ~~manufacturing batches to cater to the current supply requirement for~~one of our ~~ongoing clinical trials and a decrease of $0.2 million in other expenses primarily due to lower overhead costs.~~on-going trials.

General and administrativeexpensesincreasedby ~~$0.8~~$1.0 million,or 8%18%, to ~~$10.3~~$6.2 millionfor the ~~six~~three monthsended ~~June 30, 2022~~March 31, 2023 from~~$9.5~~ $5.3 millionfor the ~~six~~three months ended ~~June 30, 2021.~~ March 31, 2022. The changewas primarily due to an increase ~~of $1.2 million~~in ~~personnel-related~~costs~~includingstock-based compensation,drivenby higher headcount, offset in part by a decrease of $0.3 million in consulting~~ related to professional services and ~~a decrease of $0.1~~stock-based compensation.

~~Other expenses,net increasedby $0.6 million~~ to ~~$0.8~~$2.1 million for the ~~six~~three months ended ~~June 30, 2022from$0.2~~March 31, 2023 compared to $0.4 million for the ~~six~~three months ended ~~June 30, 2021,~~March 31, 2022, primarily due to ~~higher~~ ~~interest expense, including the accretion~~a $1.2 million loss on extinguishment upon repayment of ~~the final payment fee and amortization of debt issuance costs, related to~~ our previous term loan ~~facility.~~and due to higher interest rates during the three months ended March 31, 2023 as compared to the three months ended March 31, 2022.

Interest income and other, net increased to $1.8 million for the three months ended March 31, 2023 compared to a $48,000 net expense for the three months ended March 31, 2022, which was due to higher interest income from our cash equivalents and short-term available-for-sale securities as a result of higher investment balances and favorable interest rates during the three months ended March 31, 2023 as compared to the three months ended March 31, 2022.

To date, we have incurred significant net losses and negative cash flows from operations. Asof ~~June 30, 2022,~~March 31, 2023, wehad availablecash and cash equivalents and short-term available-for-sale securities of ~~$139.3~~$480.9 millionand an accumulateddeficitof ~~$263.8 million~~.$344.1 million.

In March 2021, we entered into a sales agreement (the “Sales Agreement”) with SVB ~~Leerink~~Securities LLC and Cantor Fitzgerald & Co. (the “Sales Agents”) pursuant to which we may offer and sell up to $75.0 million ~~of shares~~ of our common stock, from time to time, in “at-the-market” offerings (the “ATM Facility”). The Sales Agents are entitled to compensation at a commission equal to 3.0% of the aggregate gross sales price per share sold under the Sales Agreement. ~~In October and November 2021,~~During the three months ending March 31, 2023, pursuant to our ATM Facility, we received aggregate proceeds of ~~$3.3~~$13.4 million, net of commissions ~~and offering expenses~~ from sales of ~~186,546~~968,000 shares of our common ~~stock at a weighted-average price of $17.97 per share~~stock. In February 2023, we entered into Amendment No. 1 to the Sales Agreement with the Sales Agents, pursuant to ~~the ATM Facility.~~ ~~For the six months ended June 30, 2022, there were no sales pursuant~~which we may offer and sell up to $150.0 million of our common stock, from time to time, through the ATM Facility.

In May 2021, we amended our secured term loan facility (“2021 Loan Agreement”) to increase the aggregate committed principal amount up to $25.0 million. As of December 2021, we had drawn $20.0 million under the term loan facility and $5.0 million remains available to be drawn on or before September 30, 2022, upon achievement of certain milestones.

In July 2022, ~~pursuant to a shelf registration~~ ~~statement on Form S-3 (No. 333-254684),~~ we completed an underwritten public offering of our common stock, warrants to purchase shares of our common stock and pre-funded warrants to purchase shares of our common ~~stock. We sold 18,675,466 shares~~stock and raised aggregate proceeds of ~~our common stock with accompanying~~ $88.2 million, net of underwriting discounts and commissions of $5.7 million and other offering costs of $0.6 million. As of March 31, 2023, warrants to purchase ~~up to 9,337,733~~11,424,859 shares of our common stock at ~~a combined public offering~~an exercise price of ~~$3.55~~$5.325 per ~~share. We also sold 7,944,252~~share remain outstanding. Our pre-funded warrants to purchase shares of our common stock ~~with accompanying warrants to purchase up to 3,972,126~~are exercisable for a nominal amount. In March 2023, we completed an underwritten public offering of our common stock and sold 19,461,538 shares of our common stock at a ~~combined~~ public offering price of ~~$3.549 per pre-funded warrant. The warrants have an exercise price of $5.325~~$16.25 per share. ~~The offering was completed on July 1, 2022 and we~~We raised ~~net~~aggregate proceeds of ~~approximately $88.2~~$296.8 million, ~~after deducting~~net of underwriting discounts and commissions of ~~approximately $5.7~~$19.0 million and other offering costs of ~~approximately $0.6~~$0.5 million. ~~We received $28.2~~

In January 2023, we entered into a loan and security agreement (the “2023 Loan Agreement”) with the lenders named therein (the “Lenders”). The 2023 Loan Agreement provides up to $100.0 million principal in ~~proceeds prior~~term loans, consisting of a first term loan of $25.0 million that was funded at closing, two subsequent term loans totaling $25.0 million that may be funded upon the achievement of certain time-based, clinical and regulatory milestones, and a fourth term loan of up to $50.0 million that may be funded upon discretionary approval by the ~~closing~~Lenders. The proceeds of the ~~offering.~~first term loan were primarily used to repay our obligations under our prior term loan facility.

Our primaryuse of cash is to fund operatingexpenses,which consistprimarilyof researchand developmentexpendituresrelatedto our lead productcandidate,pegozafermin. We plan to increaseour research and developmentexpensesfor the foreseeablefutureas wecontinuethe clinicaldevelopmentof our currentand futureproductcandidates.At thistime,due to the inherently unpredictable nature of~~unpredictablenature~~of clinical development,wecannot reasonablyestimatethe costswewill incurand the timelinesthatwill be requiredto completedevelopment,obtainmarketingapproval,and commercializeour currentproductcandidateor any futureproductcandidates.For the samereasons,weare also unable to predictwhen,if ever, wewill generate revenuefromproductsalesor our currentor any futurelicenseagreementswhich wemay enterinto or whether, or when,if ever, wemay achieveprofitability.Clinicaland preclinicaldevelopmenttimelines,the probabilityof success,and developmentcostscan differmateriallyfromexpectations.In addition,wecannot forecastthe timingand amountsof milestone,royaltyand otherrevenuefromlicensingactivities,which futureproduct candidatesmay be subjectto futurecollaborations,whensuch arrangementswill be secured,if at all,and to what degreesuch arrangementswould affectour developmentplans and capital requirements.

Based on our researchand developmentplans, weexpectthatour existingcash and cash equivalents and short-term available-for-sale securities as of ~~June 30, 2022,~~ ~~together with the proceeds received from our July 2022 offering and the proceeds from our ATM Facility,~~March 31, 2023 will be sufficientto fund our ~~operations~~anticipated cash requirements for a period of at least one year from the date this Quarterly Report on Form 10-Q is filed with the ~~SEC~~.SEC. However, our operatingplans and otherdemandson our cash resourcesmay change as a resultof many factors,and wemay seek additionalfunds sooner than planned. There can be no assurancethatwewill be successfulin acquiringadditionalfunding at levelssufficientto fund our operationsor on termsfavorableto us.

Our futurefunding requirementswill depend on many factors,includingthe following:

We expect to continue to generate substantial operating losses for the foreseeable future as we expand our research and development activities. We will continue to fund our operations primarily through utilization of our current financial resources and through additional raises of capital to advance our current product candidate through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. However, there is no assurance that such funding will be available to us or that it will be obtained on terms favorable to us or will provide us with sufficient funds to meet our objectives. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies.

To the extent that we raise additional capital through partnerships or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams or research programs or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our then-existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our clinical trials or preclinical studies, research and development programs or commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

The followingtablesummarizesour cash flows for the periods presented (in thousands):

During the ~~six~~three monthsended ~~June 30, 2022,~~March 31, 2023, net cash used in operatingactivitieswas ~~$39.2~~$30.1 million, which consistedof a net loss of ~~$50.6~~$28.8 million and a net change of $5.2 million in our net operating assets and liabilities, offset in part by non-cash charges of $4.0 million. The non-cash charges are primarily comprised of $3.6 million in stock-based compensation, $1.2 million in loss recognized on extinguishment of our prior term loan, $0.1 million in amortization of debt issuance costs and $0.1 million in accretion of final payment fee related to our new term loan facility, offset in part by $1.0 million of net accretion on available-for-sale securities. The change in our operating assets and liabilities was primarily due to a $4.6 million increase in prepaid and other current assets ~~$5.7~~due to higher contract manufacturing costs related to manufacturing and scale-up related spend and a net decrease of $0.6 million in accounts payable and accrued expenses due to the timing of payments.

During the three months ended March 31, 2022, net cash used in operating activities was $24.3 million, which consisted of a net loss of $25.6 million, and a net change of ~~$5.7~~$1.6 millionin our net operatingassetsand liabilities,. offset in part by non-cash charges of $2.8 million. The non-cashchargesare primarilycomprised of ~~$5.1~~$2.5 millionin stock-based compensation ~~$0.2~~and $0.1 million in accretion of the final payment fee related to our term loan facility, ~~$0.2 million in amortization of debt issuance costs and~~ $0.1 ~~million in amortization of premium on available-for-sale securities.The change in our operatingassetsand liabilitieswas primarilydue to~~ a ~~$4.0 million decrease in prepaid and other current assets and a $2.3 million increase in~~ ~~accounts payable and accrued expenses due to the timing of payments, partially offset by a $0.5 million increase in other assets, primarily due to offering costs related to our public offering.~~

During the six months ended June 30, 2021, net cash used in operating activities was $35.1 million, which consisted of a net loss of $35.5 million and a net change of $4.5 million in our net operating assets and liabilities, partially offset by non-cash charges of $4.9

~~million. The non-cash charges are primarily comprised of $4.2 million in stock-based compensation, $0.5~~ million in amortization of premium on available-for-sale securities and ~~$0.2~~$0.1 million in amortization of debt issuance costs. The change in our operating assets and liabilities was primarily due to a ~~$4.0 million increase in prepaid and other current assets and a $0.5~~$3.6 million decrease in accounts payable and accrued expenses due to the timing of our payables, offset in part by a $2.0 million decrease in prepaid and other current assets due to the timing of payments.

During the ~~six~~three monthsended ~~June 30,~~March 31, 2023, net cash provided by investing activities was $4.1 million, which primarily consisted of $37.9 million in proceeds from sales and maturities of available-for-sale securities, offset in part by $33.8 million in purchases of available-for-sale securities.

During the three months ended March 31, 2022, net cash provided by investing activities was ~~$19.2~~$26.8 million, which ~~primarily~~ consisted of ~~$59.9~~$36.2 million in proceeds from maturities of available-for-sale securities, offset in part by ~~$40.7~~$9.4 million in purchases of available-for-sale securities.

During the ~~six~~three months ended ~~June 30, 2021,~~March 31, 2023, net cash ~~used in investing~~provided by financing activities was ~~$29.3~~$321.7 million, which primarily consisted ~~primarily~~ of ~~$93.2~~net proceeds of $296.8 million ~~in purchases~~from the sale of ~~available-for-sale securities,~~our common stock from our public offering, net proceeds of $24.4 million from our new term loan facility, net proceeds of $13.4 million pursuant to the sale of our common stock under our ATM Facility and $9.0 million from the exercise of warrants. This was offset in part by ~~$64.0~~the repayment of $21.4 million ~~in proceeds from sales~~on our prior term loan, including the final payment and ~~maturities of available-for-sale securities.~~prepayment fees.

During the ~~six~~three months ended ~~June 30,~~March 31, 2022, net cash provided by financing activities ~~was $28.2 million, which primarily related to proceeds received in the current period related to our public offering that closed in July 2022.~~

~~During the six months ended June 30, 2021, net cash provided by financing activities was $1.9 million, which~~ consisted of proceeds ~~of $1.5 million from our term loan facility and proceeds of $0.4 million~~ from the issuance of common stock upon exercise of stock ~~options and ESPP purchases.~~options.

Our ~~2021~~2023 Loan Agreement provides for ~~a total~~term loans up to $100.0 million. As of March 31, 2023, we had drawn the first term loan ~~facility~~ of $25.0 million. ~~As of December 2021,~~The term loans mature on January 1, 2027, provided that the maturity date may be extended to July 1, 2027, if the second and third term loans are funded and we ~~had drawn $20.0 million under the term loan facility and~~ ~~are required to make~~achieve certain other financing milestones. The 2023 Loan Agreement provides for interest-only payments ~~until October~~to February 1, ~~2022 followed by consecutive monthly~~2025 that could be extended to February 1, 2026, provided that the maturity date is extended. Consecutive equal payments of principal and interest ~~starting on October 1, 2022 and continuing through September 1, 2024,~~rates are due once the ~~maturity date of the term loan. The~~ interest-only period ~~may be extended~~has elapsed. The term loans bear interest equal to ~~April 1, 2023, if on or before September 20, 2022, we receive net cash proceeds of at least $75.0 million from the sale of our equity securities. Our term loan bears interest at~~ the greater of (i) ~~4.25%~~8.45% and (ii) the sum of (a) the Prime Rate as reported in The Wall Street Journal plus (b) ~~1.00%~~2.25%. The interest rate on the term loan was ~~4.25% at inception and 5.75%~~10.25% as of ~~June 30, 2022.~~March 31, 2023. In addition, a final payment fee of 5.0% of the principal amount of the loan is due when the term loan becomes due or upon prepayment of the term loan. If we elect to prepay the loan, there is also a prepayment fee of between 1.0% and 3.0%5.95% of the principal amount of the term ~~loan~~loans is due upon the earlier of prepayment or maturity of the term loans. We have the option to prepay not less than all of the outstanding term loans subject to a prepayment fee ranging from 3.0% to 1.0% depending on the timing of such prepayment. A 0.6% commitment fee is also payable should the fourth term loan be funded.

See Note 5 to our condensed consolidated financial statements for additional disclosures. There have been no other material changes from the contractual obligations disclosed in our Annual Report on Form 10-K for the year ended December 31, ~~2021~~2022..

There have been no significant changes in our critical accounting estimates as compared to the critical accounting estimates disclosed in our Annual Report on Form 10-K for the year ended December 31, ~~2021~~2022..

See Note 2 to our condensed consolidated financial statements for more information.

We are an emerginggrowth company,as definedin the JOBSAct. Under the JOBSAct, emerging growth companiescan delay adoptingnewor revisedaccountingstandardsissuedsubsequentto the enactmentof the JOBSAct untilsuch timeas those standardsapply to private companies.~~companies.~~

We have electedto use thisextendedtransitionperiodto enableus to complywith newor revised accountingstandardsthathave differenteffectivedatesfor publicand privatecompaniesuntilthe earlierof the date we(i)are no longeran emerginggrowth company or (ii)affirmativelyand irrevocablyopt out of the extendedtransitionperiodprovidedin the JOBSAct. Asa result,our consolidatedfinancialstatementsand our interim condensed consolidated financialstatementsmay not be comparableto companiesthatcomplywith new or revised accounting pronouncements.

We are a smaller reporting company, as defined by Rule 12b-2 under the Securities and Exchange Act of 1934 and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.

As of ~~June 30, 2022,~~March 31, 2023, our management, with the participation and supervision of our principal executive officer and our principal financial officer, evaluated our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on this evaluation, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were effective as of ~~June 30, 2022~~March 31, 2023 to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the quarter ended ~~June 30, 2022~~March 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

We are currently not a party to any material legal proceedings. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors, and there can be no assurances that favorable outcomes will be obtained.

An investment in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below before deciding whether to make an investment decision with respect to shares of our common stock. You should also refer to the other information contained in this Quarterly Report on Form 10-Q, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited condensed consolidated financial statements and related notes. Our business, financial condition, results of operations and prospects could be materially and adversely affected by any of these risks or uncertainties. In any such case, the trading price of our common stock could decline, and you could lose all or part of your investment. We caution you that the risks, uncertainties and other factors referred to below and elsewhere in this Quarterly Report on Form 10-Q may not contain all of the risks, uncertainties and other factors that may affect our future results and operations. Moreover, new risks will emerge from time to time. It is not possible for our management to predict all ~~risks~~.risks.

Investing in our common stock involves significant risks. You should carefully consider the risks described below before making a decision to invest in our common stock. If we are unable to successfully address these risks and challenges, our business, financial condition, results of operations, or prospects could be materially adversely affected. In such case, the trading price of our common stock would likely decline, and you may lose all or part of your investment. Below is a summary of some of the risks we face.

We are a clinical-stage biopharmaceuticalcompany with a limitedoperatinghistoryandnoproducts approvedfor commercialsale. We have incurred net lossessince our inception,weexpectto incur significantand increasingoperatinglossesandwemay never be profitable.Ourstock is a highly speculative investment.~~investment.~~

We are a clinical-stage biopharmaceutical company with a limited operating history that may make it difficult to evaluate the success of our business to date and to assess our future viability. We commenced operations in 2018, and to date, our operations have been focused on organizing and staffing our company, raising capital, acquiring our initial product candidate, pegozafermin and licensing certain related technology, conducting research and development activities, including preclinical studies and clinical trials, and providing general and administrative support for these operations. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect and/or an acceptable safety profile, gain regulatory approval and become commercially viable. We have no products approved for commercial sale, we have not generated any revenue from product sales to date and we continue to incur significant research and development and other expenses related to our ongoing operations. We have limited experience as a company conducting clinical trials and no experience as a company commercializing any products.

Pegozafermin is in development and, to date, we have not generated any revenue from the licensing or commercialization of pegozafermin. We will not be able to generate product revenue unless and until pegozafermin or any future product candidate, alone or with future partners, successfully completes clinical trials, receives regulatory approval and is successfully commercialized. As pegozafermin is in development, we do not expect to receive revenue from it for a number of years, if ever. Although we may seek to obtain revenue from collaboration or licensing agreements with third parties, we currently have no such agreements that could provide us with material, ongoing future revenue and we may never enter into any such agreements.

We are not profitable and have incurred net losses since our inception. Consequently, predictions about our future success or viability may not be as accurate as they would be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products. We have spent, and expect to continue to spend, significant resources to fund research and development of, and seek regulatory approvals for, pegozafermin and any future product candidates. We expect to incur substantial and increasing operating losses over the next several years as our research and development, clinical ~~trial~~trials and manufacturing

activities increase. In addition, because of the numerous risks and uncertainties associated with pharmaceutical product development, including that our product candidates may not advance or may take longer than expected to advance through development or may not achieve the endpoints of applicable clinical trials, we are unable to predict the timing or amount of increased expenses, or if or when we will achieve or maintain profitability. The size of our future

net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. The net losses we incur may fluctuate significantly from quarter-to-quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. Even if we eventually generate product revenue, we may never be profitable and, if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

~~We will require substantial additional capital to finance our operations, which may not be available to us~~Our business depends on ~~acceptable terms, or at all. As a result, we may not complete~~ the ~~development and commercialization~~success of pegozafermin, ~~or develop new~~our only product ~~candidates.~~

Ascandidate under clinical development, which has not completed a ~~clinical-stage biopharmaceutical company, our operations have consumed significant amounts of cash since our inception. We expect our research and development expenses~~pivotal trial. If we are unable to increase in connection with our ongoing activities, particularly as we conduct clinical trials of and seek regulatory approvals for pegozafermin. We believe that our existing cash and cash equivalents and short-term available-for-sale securities, including the net proceeds from our July 2022 offering, will fund our projected operating requirements for a period of at least one year from the date this Quarterly Report on Form 10-Q is filed with the SEC.

~~We will require additional capital to discover, develop,~~ obtain regulatory approval for and successfully commercialize pegozafermin and any future product candidates. Our ability to complete new clinical trials for pegozafermin may be subject to our ability to raise additional capital. We do not have any committed external source of funds other than the unused portion of the line of credit available to us pursuant to our Loan and Security Agreement (as amended, the “2021 Loan Agreement”) with Silicon Valley Bank (“SVB”) and as a result of any sales that we may make pursuant to the sales agreement for our “at-the-market” offerings (the “ATM Facility”). We expect to finance future cash needs through public or private equity or debt offerings or product collaborations. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. The current market environment for small biotechnology companies, like 89bio, and broader macroeconomic factors may preclude us from successfully raising additional capital.

If we do not raise additional capital, we may not be able to expand our operations or otherwise capitalize on our business opportunities, our business and financial condition will be negatively impacted and we may need to: significantly delay, scale back or discontinue research and discovery efforts and the development or commercialization of any product candidates or cease operations altogether; seek strategic alliances for research and development programs when we otherwise would not, or at an earlier stage than we would otherwise desire or on terms less favorable than might otherwise be available; or relinquish, or license on unfavorable terms, our rights to technologies or any product candidates that we otherwise would seek to develop or commercialize ourselves.

In addition, if pegozafermin receives approval and is commercialized, we will be required to make milestone and royalty payments to Teva Pharmaceutical Industries Ltd (“Teva”), from whom we acquired certain patents and intellectual property rights relating to pegozafermin, and from whom we licensed patents and know-how related to glycoPEGylation technology that is used in the manufacture of pegozafermin. For additional information regarding this license agreement, please see Note 5 of our accompanying unaudited condensed consolidated financial statements.

The ongoing COVID-19 pandemic has resulted and may in the future result in significant disruptions to our clinical trials or other business operations, which could have a material adverse effect on our business.

Our business and its operations, including but not limited to our research and development activities, could be adversely affected by health epidemics in regions where we have business operations, and such health epidemics could cause significant disruption in the operations of third parties upon whom we rely. In response to COVID-19, we have implemented hybrid work policy. The effects of which may negatively impact our growth, including our ability to recruit and onboard new employees, and productivity.

The COVID-19 pandemic has impacted execution and enrollment of our trials. Given the surges in cases of COVID-19 experienced previously and uncertainty regarding other variants, we cannot predict how our ongoing or future trials may be impacted.

In addition, COVID-19 has impacted and may continue to impact personnel at third-party manufacturing facilities in the United States, Europe and other countries, or the availability or cost of materials we use or require to conduct our business, including product development, which would disrupt our supply chain. In particular, BTPH, our sole source supplier for pegozafermin, has missed certain project deadlines for our manufacturing scale-up due to quarantine orders and has forecasted other delays due to COVID-19-related impacts on their suppliers. Furthermore, we have experienced and may continue to experience delays due to widespread supply chain issues relating to the COVID-19 pandemic, as well as historically the designation of certain supplies for vaccine production, which may limit our ability to obtain sufficient materials for our drug products. However, we have not experienced and do not expect to experience any delays to the overall timeline for the delivery of clinical supplies.

If COVID-19 continues to spread in the United States and elsewhere, we may experience additional disruptions that could severely impact our business, preclinical studies and clinical trials, including: delays in receiving authorization from local regulatory authorities to initiate our planned clinical trials; delays or difficulties in enrolling patients in our clinical trials; delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials; changes in local regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted and result in unexpected costs, or discontinuing our clinical trials altogether; a diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; interruption of key clinical trial activities or interruption of clinical trial subject visits and study procedures, the occurrence of which could affect the completeness and integrity of clinical trial data and, as a result, determine the outcomes of the trial; the risk that participants enrolled in our clinical trials will acquire COVID-19 while the clinical trial is ongoing, which could impact the results of

the clinical trial, including by increasing the number of observed adverse events; the refusal of the FDA to accept data from clinical trials in affected geographies; and interruption or delays to our clinical activities.

The COVID-19 pandemic continues to evolve. The ultimate impact of the COVID-19 pandemic or a similar public health emergency is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, healthcare systems, or the global economy as a whole. However, any one or a combination of these events could have an adverse effect on the operation of and results from our clinical trials and on our other business operations, including preventing or delaying approval for pegozafermin.

~~Ourbusiness depends onthe success of pegozafermin,our only product candidateunder clinicaldevelopment, whichhas not completeda pivotaltrial.If weare unable to obtain regulatoryapproval for andsuccessfullycommercialize pegozafermin~~or other future product candidates, or weexperiencesignificantdelaysin doing so, our business will be materially harmed.~~harmed.~~

The primary focus of our product development is pegozafermin for the treatment of patients with NASH and the treatment of patients with SHTG. Currently, pegozafermin is our only product candidate under clinical development. This may make an investment in our company riskier than similar companies that have multiple product candidates in active development and that therefore may be able to better sustain a failure of a lead candidate. Successful continued development and ultimate regulatory approval of pegozafermin for the treatment of NASH or SHTG is critical to the future success of our business. We have invested, and will continue to invest, a significant portion of our time and financial resources in the clinical development of pegozafermin. If we cannot successfully develop, obtain regulatory approval for and commercialize pegozafermin, we may not be able to continue our operations. The future regulatory and commercial success of pegozafermin is subject to a number of risks, including that if approved for NASH or SHTG, pegozafermin will likely compete with products that may reach approval for the treatment of NASH prior to pegozafermin, products that are currently approved for the treatment of SHTG and the off-label use of currently marketed products for NASH and SHTG.

Clinicaldrug developmentinvolvesa lengthy andexpensiveprocesswith uncertain timelinesanduncertain outcomes,andthe resultsof prior preclinicalor clinicaltrialsare not necessarilypredictiveof our future results.

Pegozafermin and any future product candidates will be subject to rigorous and extensive clinical trials and extensive regulatory approval processes implemented by the FDA and comparable foreign regulatory authorities before obtaining marketing approval from these regulatory authorities. The drug development and approval process is lengthy and expensive, and approval is never certain. Investigational new drugs, such as pegozafermin, may not prove to be safe and effective in clinical trials. We have no direct experience as a company in conducting pivotal trials required to obtain regulatory ~~approval.~~approval and we expect that the Phase 3 trials we plan to conduct will be more expansive and complex than the trials we’ve conducted to date. We may be unable to conduct clinical trials at preferred sites, enlist clinical investigators, enroll sufficient numbers of participants, procure sufficient supply or begin or successfully complete clinical trials in a timely fashion, if at all. In addition, the design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. We may be unable to design and execute a clinical trial to support regulatory approval. Even if a current clinical trial is successful, it may be insufficient to demonstrate that pegozafermin is safe or effective for registration purposes.

There is a high failure rate for drugs and biologic products proceeding through clinical trials. Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials of pegozafermin or any future product candidate may not be predictive of the results of later-stage clinical studies or trials and the results of studies or trials in one set of patients or line of treatment may not be predictive of those obtained in another. In fact, many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical studies and earlier stage clinical trials. In addition, data obtained from preclinical and clinical activities is subject to varying interpretations, which may delay, limit or prevent regulatory approval. It is impossible to predict when or if pegozafermin or any future product candidate will prove effective or safe in humans or will receive regulatory approval. Owing in part to the complexity of biological pathways, pegozafermin or any future product candidate may not demonstrate in patients the biochemical and pharmacological properties we anticipate based on laboratory studies or earlier stage clinical trials, and they may interact with human biological systems or other drugs in unforeseen, ineffective or harmful ways. The number of patients exposed to product candidates and the average exposure time in the clinical development programs may be inadequate to detect rare adverse events or findings that may only be detected once a product candidate is administered to more patients and for greater periods of time. To date, our Phase 1a, Phase 1b/2a and Phase 2 clinical trials have involved small patient populations and, because of the small sample size in such trials, the results of these clinical trials may be subject to substantial variability, including the inherent variability associated with biopsies in NASH patients, and may not be indicative of either future interim results or final results in future trials of patients with liver or cardio-metabolic diseases. If we are unable to successfully demonstrate the safety and efficacy of pegozafermin or other future product candidates and receive the necessary regulatory approvals, our business will be materially harmed.

We will require substantial additional capital to finance our operations, which may not be available to us on acceptable terms, or at all. As a result, we may not complete the development and commercialization of pegozafermin or develop new product candidates.

As a clinical-stage biopharmaceutical company, our operations have consumed significant amounts of cash since our inception. We expect our research and development expenses to increase in connection with our ongoing activities, particularly as we conduct clinical trials of and seek regulatory approvals for pegozafermin. We believe that our existing cash and cash equivalents and short-term available-for-sale securities will fund our projected operating requirements for a period of at least one year from the date this Quarterly Report on Form 10-Q is filed with the SEC.

We will require additional capital to discover, develop, obtain regulatory approval for and commercialize pegozafermin and any future product candidates. Our ability to complete new and ongoing clinical trials for pegozafermin may be subject to our ability to raise additional capital. We do not have any committed external source of funds other than as a result of any sales that we may make pursuant to the Sales Agreement for our ATM Facility (defined below) and proceeds from our 2023 Loan Agreement, which are subject to the achievement of certain milestones and/or consent of the lenders. We may also receive additional funds from the exercise of outstanding warrants. We expect to finance future cash needs through public or private equity or debt offerings or product collaborations. Additional capital may not be available in sufficient amounts or on reasonable terms, if at all. The current market environment for small biotechnology companies, like 89bio, and broader macroeconomic factors may preclude us from successfully raising additional capital.

Our business and its operations, including but not limited to our research and development activities, have been adversely affected by health epidemics in regions where we have business operations, and such health epidemics have caused and could continue to cause significant disruption in the operations of third parties upon whom we rely. In response to COVID-19, we have implemented hybrid work policy. The effects of which may negatively impact our growth, including our ability to recruit and onboard new employees, and productivity.

If we experiencedelaysin clinicaltesting,our commercialprospectswill be adverselyaffected,our costsmay increaseandour business may be harmed.

We cannot guarantee that we will be able to initiate and complete clinical trials and successfully accomplish all required regulatory activities or other activities necessary to gain approval and commercialize pegozafermin or any future product candidates. We currently have two active investigational new drug (“IND”) applications with the FDA in the United States for pegozafermin. In the future, we may file an additional IND with another division for any future indications or future product candidates. If any such

future IND is not approved by the FDA, our clinical development timeline may be negatively impacted and any future clinical programs may be delayed or terminated. As a result, we may be unable to obtain regulatory approvals or successfully commercialize our products. We do not know whether any other clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Our product development costs will increase if we experience delays in clinical testing. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize pegozafermin and any future product candidates or allow our competitors to bring products to market before we do, which would impair our ability to successfully

commercialize pegozafermin or any future product candidates and may harm our business, results of operations and prospects. Our or our future collaborators’ inability to timely complete clinical development could result in additional costs to us as well as impair our ability to generate product revenue, continue development, commercialize pegozafermin and any future product candidates, reach sales milestone payments and receive royalties on product sales. In addition, if we make changes to a product candidate including, for example, a new formulation, we may need to conduct additional nonclinical studies or clinical trials to bridge or demonstrate the comparability of our modified product candidate to earlier versions, which could delay our clinical development plan or marketing approval for our current product candidate and any future product candidates.

If weencounter difficultiesin enrollingpatientsin our clinicaltrials,our clinicaldevelopmentactivitiescould be delayedor otherwise adversely affected.~~adverselyaffected.~~

The timely completion of clinical trials largely depends on patient enrollment. We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our future clinical trials, and even once enrolled, we may be unable to retain a sufficient number of patients to complete any of our trials. Furthermore, there are inherent difficulties in diagnosing NASH, which can currently only be definitively diagnosed through a liver biopsy, and identifying SHTG patients. Specifically, identifying patients most likely to meet NASH enrollment criteria on biopsy is an on-going challenge, with existing clinical indicators lacking both sensitivity and specificity. As a result, NASH trials often suffer from high levels of screen failure following central review of the baseline liver biopsy, which can lead to lower enrollment. As a result of such difficulties and the significant competition for recruiting NASH and SHTG patients in clinical trials, we or our future collaborators may be unable to enroll the patients we need to complete clinical trials on a timely basis, or at all. In addition, our competitors, some of whom have significantly greater resources than we do, are conducting clinical trials for the same indications and seek to enroll patients in their studies that may otherwise be eligible for our clinical studies or trials. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which could further reduce the number of patients who are available for our clinical trials in these sites. Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. Even if we are able to enroll a sufficient number of patients in our clinical studies or trials, delays in patient enrollment may result in increased costs or may affect the timing or outcome of our clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of pegozafermin and any future product candidates. We plan to leverage the safety database from the SHTG Phase 3 program across both the SHTG and NASH indications. If we are not able enroll enough patients in our trials sufficient to support the safety database, our ability to advance the development of pegozafermin may be adversely affected.

We have relied on, and expect to continue to rely on, third-party manufacturers and vendors to produce and release pegozafermin or any future product candidates. Any failure by a third-party to produce and release acceptable product candidates for us pursuant to our specifications and regulatory standards may delay or impair our ability to initiate or complete our clinical trials, obtain and maintain regulatory approvals or commercialize approved products.

We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates, and we lack the resources and the capabilities to do so. As a result, we currently rely, and expect to rely for the foreseeable future, on third-party manufacturers to supply us with pegozafermin and any future product candidates. We currently have a sole source relationship with BTPH pursuant to which they supply us with pegozafermin. If there should be any disruption in our supply arrangement with BTPH, including any adverse events affecting BTPH, it could have a negative effect on the clinical development of pegozafermin and other operations while we work to identify and qualify an alternate supply source. In addition, we will require large quantities of pegozafermin for large clinical trials and to commercialize pegozafermin. Our current manufacturer may not be able to ~~scale production to~~produce the larger ~~quantities.~~quantities required for Phase 3 studies. We have identified a manufacturing partner for commercial-scale manufacturing, however, we cannot guarantee that such partner will be able to scale up and produce the quantities we would require to commercialize pegozafermin.

We do not have a long-term supply agreement with any third-party ~~manufacturer.~~manufacturer and there is no guarantee that our third-party manufacturers will be able to fulfill our supply needs. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufacture product candidates or products ourselves. For example, if we do not maintain our key manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities in a timely manner or at all, which could delay or impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete profit margins, if any. If we do find replacement manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us, and there could be a substantial delay before new facilities could be qualified and registered with the FDA and other comparable foreign regulatory authorities.

We have begun producing certain of the reagents required for the glycoPEGylation at BTPH using the know-how transferred to us from Teva under our Reagent Supply and Technology Transfer Agreement. We have not completed the manufacturing process for all these reagents and cannot guarantee that we will be able to produce them successfully, or scale up our production for the quantities needed for commercialization.

Teva ~~continues to supply~~supplied us with certain reagents ~~and will continue to do so~~ until December 31, 2022. We ~~expect~~transferred the manufacturing of such reagents ~~will be transferred~~ to a new ~~supplier~~suppliers prior to the end of 2022. ~~Any complications arising under our~~

~~agreement with Teva or any difficulties securing a new supplier could considerably delay the manufacture of pegozafermin.~~ Any significant delay in the acquisition or decrease in the availability of these raw materials from ~~Teva or any new supplier~~suppliers could considerably delay the manufacture of pegozafermin, which could adversely impact the timing of any planned trials or the regulatory approvals of pegozafermin.

We rely on third-party vendors for our assay development and testing. If such third-party vendors are unable to successfully produce or test such assays, it may substantially increase our cost or could adversely impact the timing of any planned trials or the regulatory approvals of pegozafermin.

The FDA and other comparable foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and other comparable foreign regulatory authorities also inspect these facilities to confirm compliance with cGMP. We have little to no control regarding the occurrence of third-party manufacturer incidents. Any failure to comply with cGMP requirements or other FDA or comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop pegozafermin or any future product candidates and market our products following approval. Our sole source supplier, BTPH, has not yet manufactured a commercial product, and as a result, has not been subject to inspection by the FDA and other comparable foreign regulatory authorities.

Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop our product candidates and commercialize any products that receive regulatory approval on a timely basis. Supply chain issues, including those resulting from the COVID-19 pandemic and the ongoing war in Ukraine, may affect our third-party vendors and cause delays. Furthermore, since we have engaged a manufacturer located in China, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the United States or Chinese governments, political unrest or unstable economic conditions in China. If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. For example, in the event that we need to switch our third-party manufacturer of pegozafermin from BTPH, which is our sole manufacturing source for pegozafermin, we anticipate that the complexity of the glycoPEGylation manufacturing process may materially impact the amount of time it may take to secure a replacement manufacturer. The delays associated with the verification of a new manufacturer, if we are able to identify an alternative source, could negatively affect our ability to develop product candidates in a timely manner or within budget.

Pegozaferminandany future product candidatesmay cause undesirableside effectsor have other propertiesthat could delay or preventtheirregulatoryapproval or limitthe commercialprofileof anapproved label.

Undesirable side effects caused by pegozafermin or any future product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities. Additional clinical studies may be required to evaluate the safety profile of pegozafermin or any future product candidates. As with other drugs, we have seen evidence of adverse effects in animal and human studies and it is possible that other adverse effects will become apparent in ongoing or future animal or human safety studies. It may be difficult to discern whether certain events or symptoms observed during our clinical trials or by patients using our approved products are related to pegozafermin or any future product candidates or approved products or some other factor. As a result, we and our development programs may be negatively affected even if such events or symptoms are ultimately determined to be unlikely related to pegozafermin or any future product candidates or approved products. Further, we expect that pegozafermin will require multiple administrations via subcutaneous injection in the course of a clinical trial. This chronic administration increases the risk that rare adverse events or chance findings are discovered in the commercial setting, where pegozafermin would be administered to more patients or for greater periods of time, that were not uncovered by our clinical drug development programs.

We are developingpegozaferminfor the treatmentof NASH, an indication for which there are no approved products, and the treatment of SHTG. The requirements for approval of pegozafermin by the FDA and comparable foreign regulatory authorities may be difficult to predict and may change over time, which makes it difficultto predictthe timingandcostsof the clinical development.~~development.~~

We are developing pegozafermin for the treatment of NASH, an indication for which there are no approved products. Although there are guidelines issued by the FDA for the development of drugs for the treatment of NASH, the development of a novel product candidates such as pegozafermin may be more expensive and take longer than for other, better known or extensively studied product candidates. As other companies are in later stages of clinical trials for their potential NASH therapies, we expect that the path for regulatory approval for NASH therapies may continue to evolve in the near term as these other companies refine their regulatory approval strategies and interact with regulatory authorities. Such evolution may impact our future clinical trial designs, including trial size and endpoints, in ways that we cannot predict today. In particular, regulatory authority expectations about liver biopsy data may evolve especially as more information is published about the inherent variability in liver biopsy data. Certain of our competitors have experienced regulatory setbacks for NASH therapies following communications from the FDA. We currently do not know the impact, if any, that these setbacks could have on the path for regulatory approval for NASH therapies generally or for pegozafermin. Furthermore, the histology endpoints from our Phase 2b ENLIVEN trial may not be accepted as primary endpoints for a pivotal Phase 3 trial or for FDA approval.

We are also developing pegozafermin for the treatment of SHTG. Clinical trials for the treatment of SHTG may be relatively costly and time consuming. We currently expect that our SHTG program would be subject to smaller clinical trials and that we may expect a relatively quicker overall development timeline for this indication. These expectations are based on a published FDA surrogate endpoint table for drug approval that includes SHTG, as well as the development path followed by other companies that

~~developed an SHTG therapy. However,~~time-consuming. In addition, the requirements for approval by the FDA and comparable foreign regulatory authorities may change over time. If the FDA disagrees with our trial and program design for our planned Phase 3 program for SHTG or requires additional evidence to support a successful submission for approval, we may be required to make changes to our program design that could impact timelines and cost.

Our anticipated development costs would likely increase if development of pegozafermin or any future product candidate is delayed because we are required by the FDA to perform studies or trials in addition to, or different from, those that we currently anticipate, or make changes to ongoing or future clinical trial designs. In addition, if we are unable to leverage our safety database for both SHTG and NASH indications, we may be required to perform additional trials, which would result in increased costs and may affect the timing or outcome of our clinical trials.

Lack of efficacy, adverse events or undesirable side effects may emerge in clinical trials conducted by third parties developing FGF product candidates, which could adversely affect our stock price, our ability to attract additional capital and our development program.

Lack of efficacy, adverse events or undesirable side effects may emerge in clinical trials conducted by third parties developing FGF product candidates like ours. For example, Novo Nordisk, ~~and~~ Akero Therapeutics, Inc. and Boston Pharmaceuticals are also developing FGF21 product candidates for the treatment of NASH. We have no control over their clinical trials or development program, and lack of efficacy, adverse events or undesirable side effects experienced by subjects in their clinical trials could adversely affect our stock price, our ability to attract additional capital and our clinical development plans for pegozafermin or even the viability or prospects of pegozafermin as a product candidate, including by creating a negative perception of FGF therapeutics by healthcare providers or patients.

Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose preliminary or topline data from our clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our clinical trials. In addition, we may report interim analyses of only certain endpoints rather than all endpoints. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.

Themanufactureof biologicproducts is complexandweare subjectto many manufacturingrisks,any of whichcould substantiallyincreaseour costsandlimitsupply of our products.

Todate, pegozafermin has been manufacturedby a singlethird-partymanufacturer,BTPH,solelyfor preclinicalstudiesand clinicaltrials.The processof manufacturing pegozafermin, and in particular,the glycoPEGylationprocess, is complex,highly regulated and subjectto severalrisks and requiressignificantexpertiseand capitalinvestment,including for the developmentof advanced manufacturing techniquesand processcontrols.Manufacturersof biologicproductsoftenencounterdifficultiesin production, including difficultieswith productioncostsand yields,qualitycontrol,includingstabilityof the product, qualityassurancetesting,operatorerrorand shortagesof qualifiedpersonnel,as well as compliancewith strictly enforcedfederal,stateand foreignregulations.We cannot assureyou thatany stabilityor otherissuesrelatingto the manufactureof pegozafermin will not occur in the future. We have limitedprocessdevelopmentcapabilitiesand have accessonly to externalmanufacturing capabilities.We do not have and wedo not currentlyplan to acquireor develop the facilitiesor capabilitiesto manufacturebulk drug substanceor filleddrug productfor use in human clinicaltrialsor commercialization.

We face substantialcompetition,whichmay resultin others discovering,developingor commercializing competingproducts beforeor more successfullythan us.

The biopharmaceuticalindustryis intenselycompetitiveand subjectto rapidinnovationand significant technologicaladvancements.Our competitors includemultinationalpharmaceuticalcompanies,specializedbiotechnologycompanies,universitiesand other researchinstitutions.Anumberof biotechnologyand pharmaceuticalcompaniesare pursuingthe developmentor marketingof pharmaceuticalsthattargetthe samediseasesthatweare targeting. Certain of these companies have recently published positive data regarding their clinical trials, which may further increase the competition we face. Smalleror earlier-stage companiesmay also prove to be significantcompetitors,particularlythrough collaborativearrangementswith large,establishedcompanies.Given the high incidenceof NASHand SHTG, it is likelythatthe numberofcompaniesseekingto develop productsand therapiesfor the treatmentof liverand cardio-metabolicdiseases, such as NASHand SHTG, will increase.

Thereare numerouscurrentlyapproved therapiesfor treatingdiseasesotherthan NASHand some of thesecurrentlyapproved therapiesmay exerteffectsthatcould be similarto pegozafermin in NASH. Many of theseapproved drugs are well-establishedtherapiesor productsand are widely acceptedby physicians,patientsand third-partypayors. Some of thesedrugs are branded and subjectto patentprotection,and othersare availableon a genericbasis.This may make it difficultfor us to differentiateour productsfromcurrentlyapproved therapies,which may adverselyimpactour businessstrategy. We expect thatif pegozafermin or any futureproductcandidatesare approved, they will be pricedat a significantpremium over competitive generic products, including

branded genericproducts.Insurersand otherthird-partypayors may also encouragethe use of genericproductsor specificbranded products prior to utilization of pegozafermin.In addition,many companiesare developingnewtherapeutics,and wecannot predictwhat the standardof care will be as pegozafermin or any futureproductcandidatesprogressthrough clinicaldevelopment.In addition,to the extentpegozafermin or any futureproductcandidatesare approved for liver or cardio-metabolicindications,such as SHTG, the commercialsuccessof our productswill also depend on our abilityto demonstratebenefitsover the then-prevailingstandardof care,includingdiet,exerciseand lifestylemodifications.

Further,if pegozafermin or any futureproductcandidatesare approved for the treatmentof SHTG,wewill competewith currentlyapproved therapiesand therapiesfurtheralong in development.Our competitorsboth in the United Statesand abroad includelarge,well-establishedpharmaceuticaland genericcompanieswith significantlygreatername recognition.Our competitorsmay be able to chargelower pricesthan wecan, which may adverselyaffectour marketacceptance.Many of thesecompetitorshave greaterresourcesthan wedo, includingfinancial,productdevelopment,marketing,personneland other resources.~~resources.~~

If our competitorsmarketproductsthatare moreeffective,saferor cheaperthan our productsor that reachthe marketsooner than our products,wemay not achievecommercialsuccess.Many of our competitorshave substantiallygreaterfinancial,technical,human and otherresourcesthan wedo and may be betterequipped to develop, manufactureand markettechnologicallysuperiorproducts.Asa result,our competitorsmay obtainregulatoryapprovalof theirproductsmorerapidlythan wedo or may obtainpatentprotectionor otherintellectualpropertyrightsthatlimitour abilityto develop or commercializeour productcandidateor any futureproductcandidates.Our competitorsmay also develop and succeedin obtainingapprovalfor drugs thatare moreeffective,moreconvenient,morewidely used and less costlyor have a bettersafetyprofilethan our productsand thesecompetitorsmay also be moresuccessfulthan weare in manufacturingand marketing their products.~~theirproducts.~~

Unstable market and economic conditions, inflation, increases in interest rates, natural disasters, public health crises such as the COVID-19 pandemic, political crises, geopolitical events, such as the crisis in Ukraine, or other macroeconomic conditions, may have serious adverse consequences on our business and financial condition.

~~Global~~The global economy, including credit and financial markets, have experienced extreme volatility and disruptions at various points over the last few ~~decades. If another such disruption~~decades, including, among other things, diminished liquidity and credit availability, declines in ~~credit~~consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates, and uncertainty about economic stability. For example, the COVID-19 pandemic resulted in widespread unemployment, economic slowdown and extreme volatility in the capital markets. The Federal Reserve has raised interest rates multiple times in response to concerns about inflation and it may raise them again. Higher interest rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and ~~deterioration~~affect consumer spending. Similarly, the ongoing military conflict between Russia and Ukraine and the rising tensions between China and Taiwan have created extreme volatility in the global capital markets and may have further global economic consequences, including disruptions of ~~confidence in economic conditions occurs,~~the global supply chain. Any such volatility and disruptions may adversely affect our business or the third parties on whom we rely. If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity financing more difficult to complete, more costly, and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and share price and could require us to delay or abandon development or commercialization plans. In addition, there is a risk that one or more of our service providers, manufacturers or other partners would not survive or be able to meet their commitments to us under such circumstances, which could directly affect our ability to attain our operating goals on schedule and on budget.

We have experienced and may in the future experience disruptions as a result of such macroeconomic conditions, including delays or difficulties in initiating or expanding clinical trials and manufacturing sufficient quantities of materials. Any one or a combination of these events could have a material and adverse effect on our results of operations and financial condition.

The ~~2021~~2023 Loan Agreement contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay any outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation.

Pursuant to the ~~2021~~2023 Loan Agreement, we have pledged substantially all of our assets, other than our intellectual property rights, and have agreed that we may not sell or assign rights to our patents and other intellectual property without the prior consent of ~~SVB.~~our lenders. Additionally, the ~~2021~~2023 Loan Agreement contains certain affirmative and negative covenants that could prevent us from taking certain actions without the consent of our lenders. These covenants may limit our flexibility in operating our business and our ability to take actions that might be advantageous to us and our stockholders. The ~~2021~~2023 Loan Agreement also includes customary events of default, including, among other things, an event of default upon a change of control. Upon the occurrence and continuation of an event of default, all amounts due under the ~~2021~~2023 Loan Agreement become automatically (in the case of a bankruptcy ~~event)~~event of default) or may become (in the case of all other events of default and at the option of ~~SVB)~~the administrative agent), immediately due and payable. If an event of default under the ~~2021~~2023 Loan Agreement should occur and be continuing, we could be required to immediately repay any outstanding indebtedness. If we are unable to repay such debt, the lenders would be able to foreclose on the secured collateral, including our cash accounts, and take other remedies permitted under the ~~2021~~2023 Loan Agreement. Even if we are able to repay ~~any indebtedness on~~such accelerated debt amount under the 2023 Loan Agreement upon an event of default, the repayment of these sums may significantly reduce our working capital and impair our ability to operate as planned.

We may encounter difficulties in managing our growth, which could adversely affect our operations.

We are in the early stages of building the full team that we anticipate we will need to complete the development pegozafermin and other future product candidates. As we advance our preclinical and clinical development programs for product candidates, seek

regulatory approval in the United States and elsewhere and increase the number of ongoing product development programs, we anticipate that we will need to increase our product development, scientific and administrative headcount. We will also need to establish commercial capabilities in order to commercialize any product candidates that may be approved. Such an evolution may impact our strategic focus and our deployment and allocation of resources. Our ability to manage our operations and growth effectively depends upon the continual improvement of our procedures, reporting systems and operational, financial and management controls. We may not be able to implement administrative and operational improvements in an efficient or timely manner and may discover deficiencies in existing systems and controls. In addition, in order to continue to meet our obligations as a public company and to support our anticipated long-term growth, we will need to increase our general and administrative capabilities. Our management, personnel and systems may experience difficulty in adjusting to our growth and strategic focus.

We must attractandretainhighly skilledemployeesin order to succeed. If weare not able to retainour current senior managementteamandour scientificadvisorsor continue to attractandretainqualified scientific,technicalandbusiness personnel, our business will suffer.

We may not be able to attractor retainqualifiedpersonneland consultantsdue to the intense competitionfor such individuals in the biotechnologyand pharmaceuticalindustries.If weare not able to attractand retainnecessarypersonneland consultantsto accomplishour businessobjectives,it may significantlyimpedethe achievementof our developmentand commercialobjectivesand our abilityto implementour businessstrategy. In addition, we are highly dependenton the development,regulatory, manufacturing, commercializationand financialexpertiseof the membersof our executiveteam,as well as otherkey employeesand consultants.If welose one or moreof our executiveofficersor otherkey employeesor consultants,our abilityto implementour businessstrategy successfullycould be seriously harmed.~~harmed.~~

We are developinga new~~drug product~~ presentations for the liquid formulation~~for~~ of pegozaferminandwemay be unsuccessful.Anychanges in methodsof product candidatemanufacturingor formulationmay resultin the need to performnewclinical trials or obtain new drug product,whichwouldrequireadditionalcostsandcause delay.

~~Our current drug product comes in a liquid formulation, which is being used in all current and planned studies.~~ We are ~~also~~ developing a ~~newdrug productformulationof pegozafermin~~pre-filled syringe and ~~a pre-filled syringe. We also~~ plan to begin development of a pen-type~~autoinjector.~~ autoinjector to deliver the liquid formulation of pegozafermin. Any formulation and presentation intended for commercialization is subject to regulatory approval. ~~There~~While the FDA has approved our new drug product formulation, there is no assurancethatwewill be successful in developing~~a newdrug productformulation,~~ and receiving approval of a pre-filled syringeor an autoinjectoron a timelybasisor at all, any ofwhich could impede our developmentand commercializationstrategyfor pegozafermin. In addition, there is no assurance comparable foreign regulatory authorities will approve our new drug product formulation. The FDAor othercomparableforeign regulatoryauthoritiescould requirenonclinicalstudiesor clinicaltrialsto supportintroductionof any new formulation, pre-filled syringeand autoinjector, which could delay completionof clinicaltrials,requirethe conduct of bridging clinicaltrialsor the repetitionof one or moreclinicaltrials,increaseour clinicaltrialcosts,delay approvalof pegozafermin and jeopardizeour abilityto commenceproductsalesand generaterevenuefrompegozafermin, if approved.

We rely on third parties for certain aspects of our product candidate development process and we may not be able to obtain and maintain the third-party relationships that are necessary to develop, commercialize and manufacture some or all of our product candidates.

We expect to depend on collaborators, partners, licensees, clinical investigators, contract research organizations, manufacturers and other third parties to support our discovery efforts, to formulate product candidates, to conduct clinical trials for some or all of our product candidates, to manufacture clinical and commercial scale quantities of our drug substance and drug product and to market, sell and distribute any products we successfully develop. Anyof thesethirdpartiesmay terminatetheir engagementswith us at any time.If weneed to enterinto alternativearrangements,it would delay our product developmentactivitiesand such alternativearrangementsmay not be availableon termsacceptableto us. We also expectto relyon otherthirdpartiesto storeand distributedrug suppliesfor our clinicaltrials. Anyperformancefailureon the partof our distributorscould delay clinicaldevelopment,marketingapproval and/orcommercializationof pegozafermin or any futureproductcandidates,producingadditionallossesand deprivingus of potential revenue.~~revenue.~~

Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.

Our operations, and those of our contract research organizations, CMO, suppliers, and other contractors and consultants, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, acts of war, medical pandemics or epidemics, such as the novel coronavirus, and other natural or man-made disasters or business interruptions. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

If we fail to develop and commercialize additional product candidates, we may be unable to grow our business.

Although the developmentand commercializationof pegozafermin is currentlyour primaryfocus, as part of our longer-termgrowth strategy,we plan to evaluatethe developmentand commercializationof other therapiesrelatedto NASHand otherliverand cardio-metabolicdiseases.The successof thisstrategydepends primarilyupon our abilityto identifyand validatenew therapeuticcandidates,and to identify,develop and commercializenew drugs and biologics.Our researcheffortsmay initiallyshow promisein discoveringpotential new drugs and biologicsyet failto yieldproductcandidatesfor clinicaldevelopmentfor a numberof reasons.

We may use our limitedfinancialandhumanresourcesto pursue a particularresearchprogram or product candidatethat is ultimatelyunsuccessfulor lesssuccessfulthan other programsor product candidatesthat we may have forgone or delayed.

Because we have limitedpersonneland financialresources,we may foregoor delay the developmentof certainprogramsor productcandidatesthatlaterprove to have greatercommercialpotentialthan the programsor productcandidatesthatwe do pursue. Our resourceallocationdecisionsmay cause us to failto capitalizeon viablecommercialproductsor profitablemarketopportunities.Our spending on currentand futureresearchand developmentprogramsfor productcandidatesmay not yieldany commerciallyviableproducts.Similarly,our decisionsto delay or terminatedrug developmentprogramsmay also be incorrectand could cause us to miss valuable opportunities.~~opportunities.~~

We may seek to establish commercial collaborations for our product candidates, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

Our drug development programs and the potential commercialization of our product candidates will require substantial additional cash to fund expenses. We may decide to collaborate with other pharmaceutical and biotechnology companies for the development and potential commercialization of our product candidates. Collaborations are complex and time-consuming to negotiate and document. We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities or increase our expenditures and undertake development or commercialization activities at our own expense.

We may not be successful in our efforts to identify, in-license or acquire, discover, develop or commercialize additional product candidates.

We may seek to identify, in-license or acquire, discover, develop and commercialize additional product candidates. We cannot assure you that our effort to in-license or acquire additional product candidates will be successful. Even if we are successful in in-licensing or acquiring additional product candidates, their requisite development activities may require substantial resources, and we cannot assure you that these development activities will result in regulatory approvals.

Ourinternationaloperationsmay expose us to business, regulatory,political,operational,financial,pricing andreimbursementrisksassociatedwith doing business outsideof the United States.

Our use of our internationalfacilitiessubjectsus to U.S.and foreigngovernmentaltrade,importand export,and customsregulationsand ~~laws.~~laws including various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls and the U.S. Export Administration Regulations. Compliancewith theseregulationsand laws is costlyand exposes us to penaltiesfor non-compliance.Doing businessinternationallypotentiallyinvolvesa numberof risks, any of which could harmour ongoing internationalclinicaloperationsand supply chain, as well as any futureinternationalexpansionand operationsand, consequently,our business,financialcondition, prospectsand resultsof operations.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercialize any resulting products. Product liability claims may be brought against us by subjects enrolled in our clinical trials, patients, or others using our products. Our clinical trial liability insurance coverage may not adequately cover all liabilities that we may incur.

Ouremployees,contractors,vendors, principalinvestigators,consultantsandfuture partnersmay engage in misconductor other improperactivities,including noncompliancewith regulatorystandards andrequirements andinsidertrading.

We are exposed to the risk of fraud or other misconduct by our employees, contractors, vendors, principal investigators, consultants or future partners. Misconduct by these parties could include failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with federal and state healthcare fraud and abuse laws and regulations, to report financial information or data timely, completely or accurately, or to disclose unauthorized activities to us. Most states also have statutes or regulations similar to these federal laws, which may apply to items such as pharmaceutical products and services reimbursed by private insurers. We and/or our future partners may be subject to administrative, civil and criminal sanctions for violations of any of these laws.

We depend on our information technology systems and those of our third-party collaborators, service providers, contractors or consultants. Our internal computer systems, or those of our third-party collaborators, service providers, contractors or consultants, may fail or suffer security breaches, disruptions, or incidents, which could result in a material disruption of our development programs or loss of data or compromise the privacy, security, integrity or confidentiality of sensitive information related to our business and have a material adverse effect on our reputation, business, financial condition or results of operations.

In the ordinarycourseof our business,wecollect,storeand transmitlargeamountsof confidential information,includingintellectualproperty,proprietarybusinessinformationand personalinformation.Our internaltechnologysystemsand infrastructure,and those of our currentor futurethird-partycollaborators, serviceproviders,contractorsand consultantsare vulnerableto damagefromcomputerviruses,unauthorized accessor use resultingfrommalware,naturaldisasters,terrorism,war and telecommunicationand electrical failures,denial-of-serviceattacks,cyber-attacksor cyber-intrusionsover the Internet,hacking, phishingand other socialengineeringattacks,personsinsideour organizations~~(including~~ (including employeesor contractors),loss or theft,or personswith accessto systemsinsideour organization. From time to time, we are subject to periodic phishing attempts. In the third quarter of 2021, we discovered a business email compromise caused by phishing. The phishing attack did not result in the misappropriation of any ~~funds. Even though~~funds and we ~~are implementing remedial measures promptly following this incident and~~ do not believe that it had a material adverse effect on our ~~business,~~business. We implemented remedial measures promptly following this incident, however, we cannot guarantee that our implemented remedial measures will prevent additional related, as well as unrelated, incidents. If a material systemfailure,accidentor securitybreach were to occur and cause interruptionsin our operationsor the operationsof third-partycollaborators,serviceproviders, contractorsand consultants,it could resultin a materialdisruptionof our developmentprogramsand significant reputational,financial,legal,regulatory,businessor operational harm.~~harm.~~

Tothe extentthatany realor perceivedsecuritybreachaffectsour systems~~(or~~ (or those of our third-partycollaborators,serviceproviders,contractorsor consultants),or resultsin the loss of or accidental,unlawfulor unauthorizedaccessto, use of, releaseof, or otherprocessingof personallyidentifiable informationor damageto our data or applicationsor otherdata or applicationsrelatingto our technologyor productcandidates,or inappropriatedisclosureof confidentialor proprietaryinformation,wecould incur liabilitiesand the furtherdevelopmentof our productcandidatescould be delayed.Anyfailureor perceivedfailureby us or any third-partycollaborators,serviceproviders,contractorsor consultantsto complywith our privacy,confidentiality,data securityor similarobligations,or any data security incidentsor othersecuritybreachesthatresultin the accidental,unlawfulor unauthorizedaccessto, use of, releaseof, processingof, or transferof sensitiveinformation,includingpersonallyidentifiableinformation,may resultin negativepublicity,harmto our reputation,governmentalinvestigations,enforcementactions,regulatory fines,litigationor publicstatementsagainstus, could cause thirdpartiesto lose trustin us or could resultin claimsby thirdparties,includingthose thatassertthatwehave breachedour privacy,confidentiality,data securityor similarobligations,any of which could have a materialadverseeffecton our reputation,business, financialconditionor resultsof operations.

Pegozaferminhas not receivedregulatoryapproval. If weare unable to obtain regulatoryapprovalsto market pegozaferminor any future product candidates,our business will be adversely affected.~~affected.~~

We do not expect pegozafermin or any future product candidate to be commercially available for several years, if at all. Pegozafermin is and any future product candidate will be subject to strict regulation by regulatory authorities in the United States and in other countries. We cannot market any product candidate until we have completed all necessary preclinical studies and clinical trials and have obtained the necessary regulatory approvals. We do not know whether regulatory agencies will grant approval for pegozafermin or any future product candidate. Even if we complete preclinical studies and clinical trials successfully, we may not be able to obtain regulatory approvals or we may not receive approvals to make claims about our products that we believe to be necessary to effectively market our products. Data obtained from preclinical studies and clinical trials is subject to varying interpretations that could delay, limit or prevent regulatory approval, and failure to comply with regulatory requirements or inadequate manufacturing processes are examples of other problems that could prevent approval.

The regulatory authorities in the United States and the EU have not approved any products for the treatment of NASH, and while there are guidelines issued by the FDA for the development of drugs for the treatment of NASH, ~~and an FDA surrogate endpoint table for drug approval that includes SHTG,~~ it is unclear whether the requirements for approval will change in the ~~future.~~future or whether the FDA will rely on regulatory precedent for future regulatory approvals. Any such changes may require us to conduct new trials that could delay our timeframe and increase the costs of our programs related to

pegozafermin or any future product candidate for the treatment of NASH or SHTG. ~~While the FDA has approved reduction~~In addition, we cannot be certain which efficacy endpoints or presentation thereof clinical or regulatory agencies may require in ~~triglycerides levels as~~ a ~~surrogate endpoint~~Phase 3 clinical trial of NASH or for ~~the full~~ approval of ~~drugs for the treatment of SHTG, it is unclear whether this endpoint will apply to any product candidates that we develop. If such endpoint is not deemed to apply to~~ our product candidates, it would delay our development timeline and increase the costs of our programs for the treatment of SHTG. We have not had any discussions with the FDA regarding a surrogate endpoint or accelerated approval regulations. However,candidates.

Even if we currently expect that our SHTG program would be subject to smaller clinical trials and that we may expect a relatively quicker overall development timeline for this indication. These expectations are based on a published FDA surrogate endpoint table for drug approval that includes SHTG, as well as the development path followed by other companies that developed an SHTG therapy.

~~Evenif we~~are able to obtain regulatoryapprovalsfor pegozaferminor any future product candidate,if they exhibitharmfulside effectsafterapproval, our regulatoryapprovalscould be revoked or otherwisenegatively impacted,andwecould be subjectto costlyanddamaging product liability claims.~~claims.~~

Even if we receive regulatory approval for pegozafermin or any future product candidates, we will have tested them in only a small number of patients during our clinical trials. If our applications for marketing are approved and more patients begin to use our product, new risks and side effects associated with our products may be discovered. As a result, regulatory authorities may revoke their approvals. We have not had any discussions with the FDA regarding a surrogate endpoint or accelerated approval regulations. However, based on ~~recent~~ guidelines issued by the FDA for the development of drugs for the treatment of NASH, if pegozafermin is approved by the FDA based on a surrogate endpoint pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act and the accelerated approval regulations (21 C.F.R. part 314, subpart H; 21 C.F.R. part 601, subpart E), consistent with FDA guidance, we will be required to conduct additional clinical trials establishing clinical benefit on the ultimate outcome of NASH. If pegozafermin is approved by the FDA for the treatment of SHTG based on an endpoint of the reduction of triglycerides, the FDA may still require a cardiovascular outcomes study as part of a post-marketing authorization commitment. Such a study would be time consuming and costly and we cannot guarantee that we will see positive results, which could result in the revocation of the approval. Additionally, we may be required to conduct additional clinical trials, make changes in labeling of our product, reformulate our product or make changes and obtain new approvals for our and our suppliers’ manufacturing facilities for pegozafermin and any future product candidates. We might have to withdraw or recall our products from the marketplace. We may also experience a significant drop in the potential sales of our product if and when regulatory approvals for such product are revoked. As a result, we may experience harm to our reputation in the marketplace or become subject to lawsuits, including class actions. Any of these results could decrease or prevent any sales of our approved product or substantially increase the costs and expenses of commercializing and marketing our product.

Theregulatoryapproval processesof the FDAandcomparableforeignregulatoryauthoritiesare lengthy, time-consumingandinherentlyunpredictable.Ourinabilityto obtain regulatoryapproval for pegozaferminor any future product candidateswouldsubstantiallyharm our business.

Currently, we do not have any product candidates that have received regulatory approval. The time required to obtain approval from the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of preclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s development and may vary among jurisdictions. It is possible that none of pegozafermin or any future product candidates will ever obtain regulatory approval. Pegozafermin or any future product candidate could fail to receive regulatory approval from the FDA or comparable foreign regulatory authorities for many reasons, including those referenced in Part I, Item 1. “Business—Government Regulation and Product Approval” in our Annual Report on Form ~~10-K for the year ended December 31, 2021.~~10-K. If we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of the product candidate.

We plan to conduct clinical trials for pegozafermin at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.

We have conducted and expect in the future to conduct one or more of our clinical trials outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles. The trial population must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will depend on its determination that the trials also complied with all applicable U.S. laws and regulations. If the FDA does not accept the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and would delay or permanently halt our development of the applicable product candidates. Even if the FDA accepted such data, it could require us to modify our planned clinical trials to receive clearance to initiate such trials in the United States or to continue such trials once initiated.

Further, conducting international clinical trials presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs that could restrict or limit our ability to conduct our clinical trials, the administrative burdens of conducting clinical trials under multiple sets of foreign regulations, foreign exchange fluctuations, diminished protection of intellectual property in some countries, as well as political and economic risks relevant to foreign countries.

Even if pegozafermin or any future product candidate receives regulatory approval, it may still face future development and regulatory difficulties.

Even if we obtained regulatory approval for a product candidate, it would be subject to ongoing requirements by the FDA and comparable foreign regulatory authorities governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-market information. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP, regulations and standards. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory agency may: issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such product; mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners; require that we conduct post-marketing studies; require us to enter into a consent decree, which can include imposition of various fines, reimbursements for

inspection costs, required due dates for specific actions and penalties for noncompliance; seek an injunction or impose civil or criminal penalties or monetary fines; suspend marketing of, withdraw regulatory approval of or recall such product; suspend any ongoing clinical studies; refuse to approve pending applications or supplements to applications filed by us; suspend or impose restrictions on operations, including costly new manufacturing requirements; or seize or detain products, refuse to permit the import or export of products or require us to initiate a product recall. The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate product revenue.

Current and future legislation may increase the difficulty and cost for us, and any collaborators, to obtain marketing approval of and commercialize our drug candidates and affect the prices we, or they, may obtain.

Heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare therapies, which could result in reduced demand for our product candidates or additional pricing pressures. Most recently, on August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (“IRA”), which, among other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms. We cannot be sure whether additional legislation or rulemaking related to the IRA will be issued or enacted, or what impact, if any, such changes will have on the profitability of any of our drug candidates, if approved for commercial use, in the future.

Healthcare insurance coverage and reimbursement may be limited or unavailable for our product candidate, if approved, which could make it difficult for us to sell our product candidate or other therapies profitably.

The success of pegozafermin, if approved, depends on the availability of coverage and adequate reimbursement from third-party payors including governmental healthcare programs, such as Medicare and Medicaid, commercial payors, and health maintenance organizations. We cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our product candidates or assure that coverage and reimbursement will be available for any product that we may develop.

Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.

In some countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a drug. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations. To obtain coverage and reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our drug candidate to other available procedures. If reimbursement of our drugs is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.

Oursuccessdepends uponour abilityto obtain andmaintainintellectualpropertyprotectionfor our products and technologies.~~technologies.~~

Our success will depend in significant part on our current or future licensors’, licensees’ or collaborators’ ability to establish and maintain adequate protection of our owned and licensed intellectual property covering the product candidates we plan to develop, and the ability to develop these product candidates and commercialize the products resulting therefrom, without infringing the intellectual property rights of others. In addition to taking other steps to protect our intellectual property, we hold issued patents, we have applied for patents, and we intend to continue to apply for patents with claims covering our technologies, processes and product candidates when and where we deem it appropriate to do so. We have filed numerous patent applications both in the United States and in certain foreign jurisdictions to obtain patent rights to inventions we have discovered, with claims directed to compositions of matter, methods of use and other technologies relating to our programs. There can be no assurance that any of these patent applications will issue as patents or, for those applications that do mature into patents, that the claims of the patents will exclude others from making, using or selling our product candidates or products that compete with or are similar to our product candidates. In countries where we have not sought and do not seek patent protection, third parties may be able to manufacture and sell our product candidates without our permission, and we may not be able to stop them from doing so.

With respect to patent rights, we do not know whether any of the pending patent applications for any of our product candidates will result in the issuance of patents that effectively protect our technologies, processes and product candidates, or if any of our issued patents or our current or future licensors’, licensees’ or collaborators’ issued patents will effectively prevent others from commercializing competitive technologies, processes and products. We cannot be certain that we or our current or future licensors, licensees or collaborators were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or our current or future licensors, licensees or collaborators were the first to file for patent protection of such inventions.

Any changes we make to our pegozafermin or any future product candidates to cause them to have what we view as more advantageous properties may not be covered by our existing patents and patent applications, and we may be required to file new applications and/or seek other forms of protection for any such altered product candidates. The patent landscape surrounding the technology underlying our product candidates is crowded, and there can be no assurance that we would be able to secure patent protection that would adequately cover an alternative to pegozafermin or any future product candidates.

We and our current or future licensors, licensees or collaborators may not be able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we or our current or future licensors, licensees or collaborators will fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection for them. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain or enforce the patents, covering technology that we license from or license to third parties and may be reliant on our current or future licensors, licensees or collaborators to perform these activities, which means that these patent applications may not be prosecuted, and these patents enforced, in a manner consistent with the best interests of our business. If our current or future licensors, licensees or collaborators fail to establish, maintain, protect or enforce such patents and other intellectual property rights, such rights may be reduced or eliminated. If our current or future licensors, licensees or collaborators are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised.

Similar to the patent rights of other biotechnology companies, the scope, validity and enforceability of our owned and licensed patent rights generally are highly uncertain and involve complex legal and factual questions. The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. In recent years, these areas have been the subject of much litigation in the industry. As a result, the issuance, scope, validity, enforceability and commercial value of our and our current or future licensors’, licensees’ or collaborators’ patent rights are highly uncertain. Our and our current or future licensors’, licensees’ or collaborators’ pending and future patent applications may not result in patents being issued that protect our technology or product candidates, or products resulting therefrom, in whole or in part, or that effectively prevent others from commercializing competitive technologies and products. The patent examination process may require us or our current or future licensors, licensees or collaborators to narrow the scope of the claims of pending and future patent applications, which would limit the scope of patent protection that is obtained, if any. Our and our current or future licensors’, licensees’ or collaborators’ patent applications cannot be enforced against third parties practicing the technology that is currently claimed in such applications unless and until a patent issues from such applications, and then only to the extent the claims that issue are broad enough to cover the technology being practiced by those third parties.

Furthermore, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after the resulting products are commercialized. As a result, our owned and in-licensed patents may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. We expect to seek extensions of patent terms for our issued patents, where available. The applicable authorities, including the FDA in the United States, and any comparable foreign regulatory authorities, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. In addition, we may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to the expiration of relevant patents or otherwise failing to satisfy applicable requirements.

We may not be able to protect our intellectual property rights throughout the world.

The legal protection afforded to inventors and owners of intellectual property in countries outside of the United States may not be as protective or effective as that in the United States and we may, therefore, be unable to acquire and enforce intellectual property rights outside the United States to the same extent as in the United States. Whether filed in the United States or abroad, our patent applications may be challenged or may fail to result in issued patents. Filing, prosecuting, enforcing and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States are less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and certain state laws in the United States.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with pegozafermin or any future product candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

We rely on a license from Teva and a sublicense from ratiopharm to patents and know-how related to glycoPEGylation technology that are used in the development, manufacture and commercialization of pegozafermin. Any termination or loss of significant rights, including the right to glycoPEGylation technology, or breach, under these agreements or any future license agreement related to our product candidates, would materially and adversely affect our ability to continue the development and commercialization of the related product candidates.

In April 2018, we entered into an Asset Transfer and License Agreement (the “FGF21 Agreement”) with Teva under which we acquired certain patents, intellectual property and other assets relating to Teva’s glycoPEGylated FGF21 program, including pegozafermin. Under this agreement, we were granted a perpetual, non-exclusive (but exclusive as to pegozafermin), non-transferable, worldwide license to patents and know-how related to glycoPEGylation technology used in the development, manufacture and commercialization of pegozafermin and products containing pegozafermin. The FGF21 Agreement also contains numerous covenants with which we must comply, including the utilization of commercially reasonable efforts to develop and ultimately commercialize pegozafermin, as well as certain reporting covenants and the obligation to make royalty payments, if and when pegozafermin is approved for commercialization. Our failure to satisfy any of these covenants could result in the termination of the FGF21 Agreement. In addition, we entered into a Sublicense Agreement with ratiopharm (the “ratiopharm Sublicense”), under which we were granted a perpetual, exclusive, worldwide sublicense to patents and know-how related to glycoPEGylation technology used in the development, manufacture and commercialization of pegozafermin and products containing pegozafermin. Termination of the FGF21 Agreement or the ratiopharm Sublicense will impact our rights under the intellectual property licensed to us by Teva and ratiopharm, respectively, including our license to glycoPEGylation technology, but will not affect our rights under the assets assigned to us.

Beyond this agreement, our commercial success will also depend upon our ability, and the ability of our licensors, to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. A third party may hold intellectual property rights, including patent rights, that are important or necessary to the development of our product candidates. As a result, we may enter into additional license agreements in the future. If we fail to comply with the obligations under these agreements, including payment and diligence obligations, our licensors may have the right to terminate these agreements, in which event we may not be able to develop, manufacture, market or sell any product that is covered by these agreements or to engage in any other activities necessary to our business that require the freedom to operate afforded by the agreements, or we may face other penalties under the agreements.

We may be unable to obtain intellectualpropertyrightsor technologynecessaryto developandcommercialize pegozaferminandany future product candidates.

The patent landscape around our programs is complex, and we are aware of several third-party patents and patent applications containing subject matter that might be relevant to pegozafermin. Depending on what claims ultimately issue from these patent applications, and how courts construe the issued patent claims, as well as depending on the ultimate formulation and method of use of pegozafermin or any future product candidates, we may need to obtain a license to practice the technology claimed in such patents. There can be no assurance that such licenses will be available on commercially reasonable terms, or at all.

We may becomeinvolvedin lawsuitsor other proceedingsto protector enforceour intellectualproperty, whichcould be expensive,time-consumingandunsuccessfulandhave a materialadverseeffectonthe success of our business.

Third parties may infringe our patents or misappropriate or otherwise violate our intellectual property rights. In the future, we may initiate legal proceedings to enforce or defend our intellectual property rights, to protect our trade secrets or to determine the validity or scope of intellectual property rights we own or control. Also, third parties may initiate legal proceedings against us to challenge the validity or scope of intellectual property rights we own, control or to which we have rights. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, narrowed, held unenforceable or interpreted in such a manner that would not preclude third parties from entering the market with competing products.

Third-party pre-issuance submission of prior art to the USPTO, or opposition, derivation, revocation, reexamination, inter partes review or interference proceedings, or other pre-issuance or post-grant proceedings or other patent office proceedings or litigation in the United States or other jurisdictions provoked by third parties or brought by us, may be necessary to determine the inventorship,

priority, patentability or validity of inventions with respect to our patents or patent applications. An unfavorable outcome could leave our technology or product candidates without patent protection, allow third parties to commercialize our technology or product candidates and compete directly with us, without payment to us, or could require us to obtain license rights from the prevailing party in order to be able to manufacture or commercialize our product candidates without infringing third-party patent rights. Our business could be harmed if the prevailing party in such a case does not offer us a license on commercially reasonable terms, or at all. Even if we obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates. Even if we successfully defend such litigation or proceeding, we may incur substantial costs and our defense may distract our management and other employees.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, many foreign jurisdictions have rules of discovery that are different than those in the United States and that may make defending or enforcing our patents extremely difficult. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common stock.

Third parties may initiate legal proceedings against us alleging that we infringe their intellectual property rights or we may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, including in oppositions, interferences, revocations, reexaminations, inter partes review or derivation proceedings before the USPTO or its counterparts in other jurisdictions. These proceedings can be expensive and time-consuming and many of our adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we can. We could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent of a third party. A finding of infringement could prevent us from commercializing our pegozafermin or any future product candidates or force us to cease some of our business operations, which could materially harm our business.

Although we have reviewed certain third-party patents and patent filings that we believe may be relevant to our therapeutic candidates or products, we have not conducted a freedom-to-operate search or analysis for any of our therapeutic candidates or products, and we may not be aware of patents or pending or future patent applications that, if issued, would block us from commercializing our product candidates. Thus, we cannot guarantee that our product candidates, or our commercialization thereof, do not and will not infringe any third party’s intellectual property.

Thepriceof our common stock may be volatile,andyou may lose all or part of your investment.

The market price of our common stock could fluctuate significantly, and you may not be able to resell your shares at or above the price you paid for your shares. Those fluctuations could be based on various factors in addition to those otherwise described in this ~~prospectus,~~Quarterly Report on Form 10-Q, including those described in these “Risk Factors.” Any of these factors may result in large and sudden changes in the volume and trading price of our common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted securities class action litigation against that company.

Sales of our common stock, or the perception that such sales may occur, or issuance of shares of our common stock upon exercise of warrants could depress the price of our common stock.

Sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could depress the market price of our common stock. Certain holders of shares of our common stock have rights, subject to certain conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. In addition, we have filed a registration statement registering under the Securities Act the shares of our common stock reserved for issuance under our 2019 Equity Incentive Plan, including shares issuable upon exercise of

outstanding options. These shares can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates. Further, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt or equity securities.

In addition, we must settle exercises of our outstanding warrants in shares of our common stock. The issuance of shares of our common stock upon exercise of the warrants will dilute the ownership interests of our stockholders, which could depress the trading price of our common stock. In addition, the market’s expectation that exercises may occur could depress the trading price of our common stock even in the absence of actual exercises. Moreover, the expectation of exercises could encourage the short selling of our common stock, which could place further downward pressure on the trading price of our common stock.

Raising additionalcapitalmay cause dilutionto existing stockholders,restrictour operationsor requireus to relinquishrightsto our technologies.

Existing stockholders could suffer dilution or be negatively affected by fixed payment obligations we may incur if we raise additional funds through the issuance of additional equity securities, including under the ATM Facility (defined below), or ~~debt or pursuant to the 2021 Loan Agreement.~~debt. Furthermore, these securities may have rights senior to those of our common stock and could contain covenants or protective rights that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.

Hedging activity by investors in the warrants could depress the trading price of our common stock.

We expect that many investors in our warrants will seek to employ an arbitrage strategy. Under this strategy, investors typically short sell a certain number of shares of our common stock and adjust their short position over time while they continue to hold the warrants. Investors may also implement this type of strategy by entering into swaps on our common stock in lieu of, or in addition to, short selling shares of our common stock. This market activity, or the market’s perception that it will occur, could depress the trading price of our common stock.

Ourdirectors,executiveofficersandcurrent holders of 5% or more of our capitalstock have substantialcontrolover our company,whichcould limityour abilityto influencethe outcomeof matterssubjectto stockholderapproval, including a change of control.

As of ~~June 30, 2022,~~March 31, 2023, our executive officers, directors and other holders of 5% or more of our common stock beneficially owned a majority of our outstanding common stock. As a result, our executive officers, directors and other holders of 5% or more of our common stock, if they act, will be able to influence or control matters requiring approval by our stockholders, including the election of directors and the approval of mergers, acquisitions or other extraordinary transactions. In addition, our current directors, executive officers and other holders of 5% or more of our common stock, acting together, would have the ability to control the management and affairs of our company. They may also have interests that differ from yours and may vote in a way with which you disagree and that may be adverse to your interests. This concentration of ownership may have the effect of delaying, preventing or deterring a change of control of our company, could deprive our stockholders of an opportunity to receive a premium for their shares of our common stock as part of a sale of our company.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

We ~~previously identified~~designed our disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

~~materialweaknesses~~These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our ~~internal~~control~~over financialreporting, which have been remediated. If we identify additional material weaknesses in the future~~ system, misstatements due to error or ~~otherwise fail to maintain~~an~~effectivesystemof internalcontrols, we~~fraud may occur and not be ~~able~~detected. ~~to produce timely and accurate financialstatements, and we or our independent registered public accounting firm may conclude that our internal control over financial reporting is not effective,whichcould adverselyaffect~~ ~~our~~ ~~investors’confidence and our stock price.~~

As an emerging growth company under the JOBS Act, our management is required to report upon the effectiveness of our internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act. Our independent registered public accounting firm is not required to formally attest to the effectiveness of our internal control over financial reporting until the date we are no longer an emerging growth company and reach accelerated filer status. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our consolidated financial statements or identify other areas for further attention or improvement. As previously disclosed, in connection with our financial statement close process for 2018, we identified material weaknesses in the design and operating effectiveness of our internal control over financial reporting. While we have remediated such material weaknesses, we cannot assure you that we have identified all material weaknesses or that there will not be additional material weaknesses or deficiencies that we will identify in the future.

Our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could prevent a third party from acquiring us (even if an acquisition would benefit our stockholders), may limit the ability of our stockholders to replace our management and limit the price that investors might be willing to pay for shares of our common stock.

Our amended and restated certificate of incorporationand our amended and restated bylaws could have the effectof makingit moredifficultfor a thirdpartyto acquire,or of discouraginga thirdpartyfromattemptingto acquire,controlof us. These provisionscould delay or preventa change in controlof the ~~company~~Company and could limitthe pricethatinvestors mightbe willingto pay in the futurefor sharesof our commonstock. In addition, asa Delaware corporation,weare subjectto the anti-takeoverprovisionsof Section203 of the Delaware GeneralCorporationLaw,which prohibitsa Delaware corporationfromengaging in a business combinationspecifiedin the statutewith an interestedstockholder~~(as~~ (as definedin the statute)for a periodof three yearsafterthe date of the transactionin which the person firstbecomesan interestedstockholder,unlessthe businesscombinationis approved in advance by a majorityof the independentdirectorsor by the holdersof at leasttwo-thirdsof the outstandingdisinterestedshares.The applicationof Section203 of the Delaware General CorporationLawcould also have the effectof delayingor preventinga change of control of us.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain actions or proceedings under Delaware statutory or common law. Our amended and restated certificate of incorporation provides further that the federal district courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. These choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees. If a court were to find the choice of forum provision contained in our amended and restated certificate of incorporation to be inapplicable or unenforceable, we may incur additional costs associated with resolving such action in other jurisdictions.

Our ability to use our net operating loss carryforwards and other tax attributes may be limited.

As of December 31, 2022, we had U.S. federal and state net operating loss (“NOL”) carryforwards of $160.9 million and $169.8 million, respectively, which may be available to offset future taxable income. As of December 31, 2022, we also had gross federal tax credits of $4.3 million, which may be used to offset future tax liabilities. These NOLs and tax credit carryforwards will begin to expire in 2040. Use of our NOL carryforwards and tax credit carryforwards depends on many factors, including having current or future taxable income, which cannot be assured. In addition, the Company is currently under examination by the Israeli tax authorities for 2018 and 2019, which could impact our NOL carryforwards.

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 thereunto duly authorized.


Delaware	36-4946844
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
142 Sansome Street, Second Floor San Francisco, California 94104	94104
(Address of principal executive offices)	(Zip Code)


		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	4
	Notes to Unaudited Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	14
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	2221
Item 4.	Controls and Procedures	2221
PART II.	OTHER INFORMATION	2322
Item 1.	Legal Proceedings	2322
Item 1A.	Risk Factors	2322
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	40
Item 3.	Default Upon Senior Securities	40
Item 4.	Mine Safety Disclosures	40
Item 5.	Other Information	40
Item 6.	Exhibits	41
Signatures		42


	March 31, 2023		December 31, 2022
Prepaid research and development	$	10,537	$	5,727
Prepaid taxes		620		646
Prepaid other		1,590		1,547
Total prepaid and other current assets	$	12,747	$	7,920


	March 31, 2023		December 31, 2022
Accrued research and development expenses	$	4,048	$	6,499
Accrued employee and related expenses		1,800		4,165
Accrued professional and legal fees		1,016		1,052
Accrued other expenses		253		228
Total accrued expenses	$	7,117	$	11,944

	June 30,		December 31,
	2022		2021
Accrued research and development expenses	$	10,827	$	6,195
Accrued employee and related expenses		2,208		3,168
Accrued professional and legal fees		1,178		495
Accrued other expenses		175		336
Total accrued expenses	$	14,388	$	10,194


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


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

		June 30, 2022
	Valuation	Amortized		Unrealized		Unrealized
	Hierarchy	Cost		Gains		Losses			Fair Value
Money market funds	Level 1	$	14,347	$	—	$	—		$	14,347
Commercial paper	Level 2		45,710		—		(15	)		45,695
U.S. government bonds	Level 2		25,565		—		(226	)		25,339
Agency bonds	Level 2		3,999		—		(35	)		3,964
Corporate debt securities	Level 2		3,630		—		(37	)		3,593
Non-U.S. debt securities	Level 2		3,479		—		(10	)		3,469
U.S. treasury bills	Level 2		1,986		—		(11	)		1,975
Municipal bonds	Level 2		1,587		—		(1	)		1,586
Total cash equivalents and available-for-sale securities		$	100,303	$	—	$	(335	)	$	99,968
Classified as:
Cash equivalents									$	21,261
Short-term available-for-sale securities										78,707
Total cash equivalents and available-for-sale securities									$	99,968

		December 31, 2021
	Valuation	Amortized		Unrealized		Unrealized
	Hierarchy	Cost		Gains		Losses			Fair Value
Money market funds	Level 1	$	21,477	$	—	$	—		$	21,477
Commercial paper	Level 2		59,647		—		(10	)		59,637
U.S. government bonds	Level 2		21,662		—		(42	)		21,620
Corporate debt securities	Level 2		8,776		1		(1	)		8,776
Agency bonds	Level 2		7,747		1		(7	)		7,741
Municipal bonds	Level 2		4,251		—		(4	)		4,247
Non-U.S. debt securities	Level 2		2,506		—		(1	)		2,505
Total cash equivalents and available-for-sale securities		$	126,066	$	2	$	(65	)	$	126,003
Classified as:
Cash equivalents									$	27,715
Short-term available-for-sale securities										98,288
Total cash equivalents and available-for-sale securities									$	126,003


Within one year	$	175,243
After one year through two years		6,202
Total cash equivalents and available-for-sale securities	$	181,445

	December 31, 2021
Within one year	$	120,726
After one year through two years		5,277
Total cash equivalents and available-for-sale securities	$	126,003

Remainder of 2022	$	98
2023		7
Total undiscounted future minimum lease payments	$	105
Less: imputed interest	$	(1	)
Present value of operating lease liability, current	$	104

				Weighted Average
	Number of			Grant Date
	RSUs			Fair Value
Balance outstanding as of December 31, 2021		106,394		$	23.10
Granted		596,891			4.44
Vested / released		(22,115	)		23.10
Cancelled / forfeited		(80,522	)		5.64
Balance outstanding as of June 30, 2022		600,648		$	6.51


	Three Months Ended March 31,
	2023			2022
Net cash (used in) provided by
Operating activities	$	(30,085	)	$	(24,344	)
Investing activities		4,106			26,772
Financing activities		321,654			29
Net change in cash and cash equivalents, and restricted cash	$	295,675		$	2,457


Exhibit Number		Description

2.1		Contribution and Exchange Agreement, dated as of September 17, 2019, by and among 89Bio Ltd., the Company and its shareholders (filed with the SEC as Exhibit 2.1 to the Company’s Form S-1 filed on October 11, 2019).

3.1		Second Amended and Restated Certificate of Incorporation (filed with the SEC as Exhibit 3.1 to the Company’s Form 8-K filed on November 15, 2019).

3.2		Second Amended and Restated Bylaws (filed with the SEC as Exhibit 3.2 to the Company’s Form 8-K filed on November 15, 2019).

4.1		Specimen common stock certificate of the registrant (filed with the SEC as Exhibit 4.1 to the Company’s Form S-1/A filed on October 28, 2019).

~~4.2~~		Investors’ Rights Agreement, dated as of September 17, 2019, by and among the Company and certain of its shareholders (filed with the SEC as Exhibit 4.2 to the Company’s Form S-1 filed on October 11, 2019).
4.2
~~4.3~~		Form of Warrant to Purchase Common Stock for Silicon Valley Bank (filed with SEC as Exhibit 4.1 to the Company’s Form 8-K filed on April 13, 2020).

~~4.4~~ 4.3		Form of Warrant (filed with the SEC as Exhibit 4.1 to the Company’s Form 8-K filed on July 1, 2022).

~~4.5~~ 4.4		Form of Pre-Funded Warrant (filed with the SEC as Exhibit 4.2 to the Company’s Form 8-K filed on July 1, 2022).

4.5		Form of Warrant to Purchase Common Stock for K2 HealthVentures LLC (filed with the SEC as Exhibit 4.1 to the Company’s Form 8-K/A filed on February 2, 2023).

10.1		Loan and Security Agreement, dated as of January 4, 2023, among 89bio, Inc., 89bio Management, Inc., 89Bio Ltd., K2 HealthVentures LLC and Ankura Trust Company, LLC (filed with the SEC as Exhibit 10.1 to the Company’s Form 8-K filed on January 6, 2023).

10.2		Amendment No. 1 to Sales Agreement, dated February 15, 2023, by and among the Company, SVB Securities LLC and Cantor Fitzgerald & Co. (filed with the SEC as Exhibit 1.2 to the Company’s Current Report on Form 8-K filed on February 16, 2023).

10.3+		2023 Inducement Plan (filed with the SEC as Exhibit 99.3 to the Company’s Registration Statement on Form S-8 filed on March 15, 2023).

10.4†*		Master Contract Services Agreement by and between 89bio, Inc. and BiBo Biopharma Engineering Co., Ltd., dated as of February 10, 2023, as amended.

31.1*		Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934.

31.2*		Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934.

32#		Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350.

101.INS*		Inline XBRL Instance Document

101.SCH*		Inline XBRL Taxonomy Extension Schema Document

101.CAL*		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF*		Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB*		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE*		Inline XBRL Taxonomy Extension Presentation Linkbase Document

104		The cover page for the Company’s Quarterly Report on Form 10-Q has been formatted in Inline XBRL and contained in Exhibit 101


	89bio, Inc.

Date: ~~August 11, 2022~~May 5, 2023	By:	/s/ Rohan Palekar
		Rohan Palekar
		Chief Executive Officer (principal executive officer)

Date: ~~August 11, 2022~~May 5, 2023	By:	/s/ Ryan Martins
		Ryan Martins Chief Financial Officer
		(principal financial and accounting officer)

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company