SEC Filing – 89bio, Inc.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

View:

Download DOC

Download PDF

Download XLS

Download XBRL

etnb-10q_20220930.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended September 30, 2022

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

For the transition period from _______________to ____________

Commission File Number: 001-39122

89bio, Inc.

(Exact Name of Registrant as Specified in its Charter)

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

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

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

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common stock, par value $0.001 per share

ETNB

Nasdaq Global Market

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

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

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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

As of November 7, 2022, the registrant had 46,536,970 shares of common stock, $0.001 par value per share, outstanding.

Table of Contents

		Page
PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss	2
	Condensed Consolidated Statements of Stockholders’ Equity	3
	Condensed Consolidated Statements of Cash Flows	5
	Notes to Unaudited Condensed Consolidated Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	24
Item 4.	Controls and Procedures	24
PART II.	OTHER INFORMATION	25
Item 1.	Legal Proceedings	25
Item 1A.	Risk Factors	25
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	42
Item 3.	Default Upon Senior Securities	42
Item 4.	Mine Safety Disclosures	42
Item 5.	Other Information	42
Item 6.	Exhibits	43
Signatures		44

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

89bio, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

	September 30,			December 31,
	2022			2021
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	72,401		$	52,432
Restricted cash		—			25
Short-term available-for-sale securities		120,940			98,288
Prepaid and other current assets		6,513			11,237
Total current assets		199,854			161,982
Operating lease right-of-use asset		403			—
Property and equipment, net		105			150
Other assets		218			290
Total assets	$	200,580		$	162,422
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	14,151		$	6,843
Accrued expenses		13,437			10,194
Operating lease liability, current		168			—
Term loan, current		6,667			2,500
Total current liabilities		34,423			19,537
Operating lease liability, non-current		229			—
Term loan, non-current, net		12,958			16,898
Other non-current liability		395			30
Total liabilities		48,005			36,465
Commitments and contingencies (Note 5)
Stockholders’ equity:
Common stock		44			20
Additional paid-in capital		443,612			339,218
Accumulated other comprehensive loss		(440	)		(64	)
Accumulated deficit		(290,641	)		(213,217	)
Total stockholders’ equity		152,575			125,957
Total liabilities and stockholders’ equity	$	200,580		$	162,422

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

89bio, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except share and per share amounts)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2022			2021			2022			2021
Operating expenses:
Research and development	$	22,197		$	23,590		$	61,732		$	49,351
General and administrative		4,844			4,622			15,155			14,151
Total operating expenses		27,041			28,212			76,887			63,502
Loss from operations		(27,041	)		(28,212	)		(76,887	)		(63,502	)
Other income (expenses), net		238			(117	)		(534	)		(332	)
Net loss before tax		(26,803	)		(28,329	)		(77,421	)		(63,834	)
Income tax expense		(2	)		—			(3	)		—
Net loss	$	(26,805	)	$	(28,329	)	$	(77,424	)	$	(63,834	)
Other comprehensive (loss) income:
Unrealized (loss) gain on available-for-sale securities		(136	)		(4	)		(408	)		5
Foreign currency translation adjustments		14			6			32			11
Total other comprehensive (loss) income	$	(122	)	$	2		$	(376	)	$	16
Comprehensive loss	$	(26,927	)	$	(28,327	)	$	(77,800	)	$	(63,818	)
Net loss per share, basic and diluted	$	(0.57	)	$	(1.41	)	$	(2.63	)	$	(3.18	)
Weighted-average shares used to compute net loss per share, basic and diluted		47,253,527			20,092,094			29,413,421			20,043,301

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

89bio, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

For the Three and Nine Months Ended September 30, 2022

(Unaudited)

(In thousands, except share amounts)

								Accumulated
					Additional			Other						Total
	Common Stock				Paid-in			Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Capital			Loss			Deficit			Equity
Balance as of December 31, 2021		20,317,204	$	20	$	339,218		$	(64	)	$	(213,217	)	$	125,957
Issuance of common stock upon exercise of stock options		12,065		—		29			—			—			29
Issuance of common stock upon vesting of restricted stock units, net		22,115		—		—			—			—			—
Stock-based compensation		—		—		2,512			—			—			2,512
Net loss		—		—		—			—			(25,565	)		(25,565	)
Other comprehensive loss		—		—		—			(192	)		—			(192	)
Balance as of March 31, 2022		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
Issuance of common stock and warrants in public offering, net of issuance costs		18,675,466		20		88,219			—			—			88,239
Issuance of common stock in at-the-market public offering, net of issuance costs		1,242,132		1		8,369			—			—			8,370
Issuance of common stock upon cashless exercise of warrants		3,143,682		3		(3	)		—			—			—
Issuance of common stock upon exercise of warrants		10,000		—		53			—			—			53
Issuance of common stock upon exercise of stock options		114,203		—		208			—			—			208
Issuance of common stock upon vesting of restricted stock units, net of withholding taxes		71,779		—		(53	)		—			—			(53	)
Stock-based compensation		—		—		2,500			—			—			2,500
Net loss		—		—		—			—			(26,805	)		(26,805	)
Other comprehensive loss		—		—		—			(122	)		—			(122	)
Balance as of September 30, 2022		43,624,625	$	44	$	443,612		$	(440	)	$	(290,641	)	$	152,575

89bio, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

For the Three and Nine Months Ended September 30, 2021

(Unaudited)

(In thousands, except share amounts)

							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
Issuance of common stock upon exercise of stock options		23,488		—		78		—			—			78
Stock-based compensation		—		—		2,314		—			—			2,314
Net loss		—		—		—		—			(28,329	)		(28,329	)
Other comprehensive income		—		—		—		2			—			2
Balance as of September 30, 2021		20,104,153	$	20	$	333,673	$	6		$	(186,929	)	$	146,770

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

89bio, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

	Nine Months Ended
	September 30,
	2022			2021
Cash flows from operating activities:
Net loss	$	(77,424	)	$	(63,834	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		7,598			6,524
Accretion of final payment fee on term loan		365			—
Amortization of debt issuance costs		227			392
Amortization of premium on available-for-sale securities		(183	)		704
Non-cash operating lease expense		135			—
Depreciation		50			58
Changes in operating assets and liabilities:
Prepaid and other current assets		4,756			(4,119	)
Other assets		72			4
Accounts payable		7,308