UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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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.
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).
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.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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
As of November 6, 2023, the registrant had
Table of Contents
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Page |
PART I. |
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Item 1. |
1 |
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1 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
2 |
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3 |
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5 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
15 |
Item 3. |
22 |
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Item 4. |
23 |
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PART II. |
24 |
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Item 1. |
24 |
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Item 1A. |
24 |
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Item 2. |
42 |
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Item 3. |
42 |
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Item 4. |
42 |
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Item 5. |
42 |
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Item 6. |
43 |
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44 |
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i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
89bio, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
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September 30, |
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December 31, |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term available-for-sale securities |
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Prepaid and other current assets |
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Total current assets |
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Operating lease right-of-use asset |
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Property and equipment, net |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Operating lease liability, current |
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Total current liabilities |
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Operating lease liability, non-current |
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Term loan, non-current, net |
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Total liabilities |
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Stockholders’ equity: |
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Common stock |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
) |
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( |
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Accumulated deficit |
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( |
) |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
89bio, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended |
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Nine Months Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Interest expense |
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( |
) |
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( |
) |
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( |
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( |
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Interest income and other, net |
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Net loss before income tax |
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( |
) |
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( |
) |
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( |
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( |
) |
Income tax expense |
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— |
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( |
) |
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— |
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( |
) |
Net loss |
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$ |
( |
) |
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$ |
( |
) |
$ |
( |
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$ |
( |
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Other comprehensive income (loss): |
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Unrealized gain (loss) on available-for-sale securities |
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( |
) |
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( |
) |
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( |
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Foreign currency translation adjustments |
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Total other comprehensive income (loss) |
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$ |
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$ |
( |
) |
$ |
( |
) |
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$ |
( |
) |
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Comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
$ |
( |
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$ |
( |
) |
Net loss per share, basic and diluted |
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$ |
( |
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$ |
( |
) |
$ |
( |
) |
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$ |
( |
) |
Weighted-average shares used to compute net loss per share, |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
89bio, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
For the Three and Nine Months Ended September 30, 2023
(Unaudited)
(In thousands, except share amounts)
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Additional |
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Accumulated Other |
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Total |
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Common Stock |
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Paid-in |
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Comprehensive |
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Accumulated |
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Stockholders’ |
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Shares |
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Amounts |
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Capital |
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(Loss) Income |
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Deficit |
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Equity |
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Balance as of December 31, 2022 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Issuance of common stock in public offering, net of issuance costs |
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— |
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— |
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Issuance of common stock in at-the-market public offerings, |
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— |
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— |
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Issuance of common stock upon exercise of warrants |
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— |
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— |
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Issuance of common stock upon exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock upon vesting of restricted stock units, |
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— |
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( |
) |
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— |
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— |
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( |
) |
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Issuance of common stock warrants in connection with term loan |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Other comprehensive income |
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— |
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— |
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— |
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— |
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Balance as of March 31, 2023 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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Issuance of common stock in at-the-market public offerings, |
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— |
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— |
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Issuance of common stock upon exercise of warrants |
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— |
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— |
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Issuance of common stock upon exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock upon vesting of restricted stock units, |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock upon ESPP purchases |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
|
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— |
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( |
) |
Balance as of June 30, 2023 |
|
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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Issuance of common stock upon exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock upon vesting of restricted stock units, |
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— |
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( |
) |
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— |
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— |
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( |
) |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Other comprehensive income |
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— |
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— |
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— |
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— |
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||
Balance as of September 30, 2023 |
|
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
|
$ |
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3
89bio, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
For the Three and Nine Months Ended September 30, 2022
(Unaudited)
(In thousands, except share amounts)
|
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Additional |
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Accumulated Other |
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Total |
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Common Stock |
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Paid-in |
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Comprehensive |
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Accumulated |
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Stockholders’ |
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Shares |
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Amounts |
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Capital |
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Loss |
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Deficit |
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Equity |
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Balance as of December 31, 2021 |
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
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$ |
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Issuance of common stock upon exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock upon vesting of restricted stock units, net |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Balance as of March 31, 2022 |
|
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
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Issuance of common stock upon ESPP purchases |
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— |
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— |
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— |
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Withholding taxes related to restricted stock units |
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— |
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— |
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( |
) |
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— |
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— |
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( |
) |
Stock-based compensation |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
|
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— |
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( |
) |
Balance as of June 30, 2022 |
|
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|
$ |
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|
$ |
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|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of common stock and warrants in public offering, |
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— |
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— |
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Issuance of common stock in at-the-market public offering, |
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— |
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— |
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Issuance of common stock upon cashless exercise of warrants |
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( |
) |
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— |
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— |
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— |
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||
Issuance of common stock upon exercise of warrants |
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— |
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— |
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— |
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Issuance of common stock upon exercise of stock options |
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— |
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— |
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— |
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Issuance of common stock upon vesting of restricted stock units, |
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— |
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( |
) |
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— |
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— |
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( |
) |
|
Stock-based compensation |
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— |
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— |
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— |
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— |
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||
Net loss |
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— |
|
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— |
|
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— |
|
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— |
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|
( |
) |
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( |
) |
Other comprehensive loss |
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— |
|
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— |
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— |
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|
|
( |
) |
|
|
— |
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|
( |
) |
Balance as of September 30, 2022 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
89bio, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
|
|
Nine Months Ended |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Cash flows from operating activities: |
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|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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||
Stock-based compensation |
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||
Net accretion on available-for-sale securities |
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( |
) |
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( |
) |
Accretion of final payment fee on term loan |
|
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|
||
Amortization of debt issuance costs |
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||
Loss on extinguishment of term loan facility |
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— |
|
|
Noncash operating lease expense |
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|
||
Depreciation |
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||
Changes in operating assets and liabilities: |
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|
||
Prepaid and other current assets |
|
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( |
) |
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Other assets |
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— |
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|
Accounts payable |
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|
( |
) |
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|
|
Accrued expenses |
|
|
|
|
|
|
||
Operating lease liability |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
||||