UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
or
For the transition period from _____________ to _____________
Commission file number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of |
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(I.R.S. Employer |
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(Address of principal executive offices) |
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(Zip Code) |
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(Registrant’s telephone number, including area code)
N/A
(Former name, former address, and former fiscal year, if changed since last report.)
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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The |
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Warrants, to acquire one-half of one share of Common Stock for $11.50 per share |
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CLNNW |
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The Nasdaq Capital 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.
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, a 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 |
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
The number of shares outstanding of the Registrant’s common stock as of November 2, 2022 was
CLENE INC.
Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2022
i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements
CLENE INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
(Unaudited)
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September 30, |
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December 31, |
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2022 |
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2021 |
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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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Marketable securities |
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Accounts receivable |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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Restricted cash |
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Right-of-use assets |
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Property and equipment, net |
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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 liabilities |
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Operating lease obligations, current portion |
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Finance lease obligations, current portion |
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Total current liabilities |
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Operating lease obligations, net of current portion |
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Finance lease obligations, net of current portion |
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Notes payable |
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Convertible notes payable |
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Common stock warrant liability |
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Clene Nanomedicine contingent earn-out liability |
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Initial Stockholders contingent earn-out liability |
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TOTAL LIABILITIES |
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Commitments and contingencies ) |
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Stockholders’ equity (deficit): |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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Accumulated other comprehensive income |
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TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
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$ |
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$ |
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See accompanying notes to the condensed consolidated financial statements.
1
CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue: |
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Product revenue |
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$ |
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$ |
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$ |
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$ |
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Royalty revenue |
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Total revenue |
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Operating expenses: |
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Cost of revenue |
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Research and development |
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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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Other income (expense), net: |
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Interest expense |
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Gain on extinguishment of notes payable |
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Gain on termination of lease |
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Change in fair value of common stock warrant liability |
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Change in fair value of Clene Nanomedicine contingent earn-out liability |
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Change in fair value of Initial Stockholders contingent earn-out liability |
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Australia research and development credit |
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Other income (expense), net |
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Total other income (expense), net |
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Net income (loss) before income taxes |
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( |
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Income tax benefit |
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Net income (loss) |
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Other comprehensive loss: |
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Unrealized gain (loss) on available-for-sale securities |
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Foreign currency translation adjustments |
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Total other comprehensive loss |
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( |
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( |
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( |
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Comprehensive income (loss) |
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$ |
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$ |
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$ |
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$ |
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Net income (loss) per share (Note 16) |
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Basic |
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$ |
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$ |
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$ |
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$ |
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Diluted |
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$ |
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$ |
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$ |
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$ |
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Weighted average common shares outstanding (Note 16) |
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Basic |
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Diluted |
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See accompanying notes to the condensed consolidated financial statements.
2
CLENE INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share amounts)
(Unaudited)
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Common Stock |
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Additional |
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Accumulated |
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Accumulated |
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Total |
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Shares |
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Amount |
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Capital |
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Deficit |
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Income (Loss) |
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(Deficit) |
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Balances at December 31, 2021 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Reclassification of common stock warrant liability to equity |
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— |
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— |
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Exercise of stock options |
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Stock-based compensation expense |
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— |
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Unrealized loss on available-for-sale securities |
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— |
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( |
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Foreign currency translation adjustment |
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— |
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Net loss |
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— |
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( |
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Balances at 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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Exercise of stock options |
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Stock-based compensation expense |
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— |
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Issuance of common stock upon vesting of restricted stock awards |
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Unrealized loss on available-for-sale securities |
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— |
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( |
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Offering costs |
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— |
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( |
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( |
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Foreign currency translation adjustment |
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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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Balances at June 30, 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, net of issuance costs |
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Stock-based compensation expense |
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— |
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Issuance of common stock upon vesting of restricted stock awards |
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Unrealized gain on available-for-sale securities |
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— |
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Foreign currency translation adjustment |
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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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Balances at September 30, 2022 |
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$ |
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$ |
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