UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED
or
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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)
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(State or Other Jurisdiction of |
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(I.R.S. Employer |
Incorporation or Organization) |
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Identification Number) |
(Address of Principal Executive Offices)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act: |
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Name of exchange on which registered |
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The |
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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, 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 |
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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
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
As of November 10, 2022, there were
Achieve Life Sciences, Inc.
Index to Form 10-Q
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Item 1 |
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Consolidated Balance Sheets as of September 30, 2022 (unaudited) and December 31, 2021 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 4. |
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Item 1A. |
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Item 6. |
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Items 2, 3 and 4 are not applicable and therefore have been omitted. |
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2
PART I. FINANCIAL INFORMATION
Item 1. |
Consolidated Financial Statements |
Achieve Life Sciences, Inc.
Consolidated Balance Sheets
(Unaudited)
(In thousands, except per share and share amounts)
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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 [note 6] |
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$ |
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Grant receivable [note 3] |
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Prepaid expenses and other assets |
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Total current assets |
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Right-of-use assets [note 9] |
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Other assets and restricted cash [note 6] |
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License agreement [note 4 and 5] |
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Goodwill [note 5] |
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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 other |
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Accrued clinical liabilities |
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Accrued compensation |
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Current portion of long-term obligations [note 9] |
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Total current liabilities |
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Convertible debt [note 7] |
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Long-term obligations [note 9] |
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— |
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Total liabilities |
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Commitments and contingencies [note 9] |
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Stockholders' equity: |
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Series A convertible preferred stock, $ issued and outstanding at September 30, 2022 and zero issued and outstanding at December 31, 2021 |
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Series B convertible preferred stock, $ issued and outstanding at September 30, 2022 and zero issued and outstanding at December 31, 2021 |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Accumulated other comprehensive income |
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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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Going concern [note 1] |
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See accompanying notes.
3
Achieve Life Sciences, Inc.
Consolidated Statements of Loss and Comprehensive Loss
(Unaudited)
(In thousands, except per share and share amounts)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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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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EXPENSES |
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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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OTHER INCOME (EXPENSE) |
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Interest income |
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Interest expense [note 7] |
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( |
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— |
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( |
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— |
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Other income (expense) |
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( |
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( |
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( |
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Total other (expense) |
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( |
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( |
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Net loss and comprehensive loss |
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$ |
( |
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$ |
( |
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( |
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Basic and diluted net loss per common share [note 8[d]] |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Weighted average shares used in computation of basic and diluted net loss per common share [note 8[d]] |
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See accompanying notes.
4
Achieve Life Sciences, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
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Nine Months Ended |
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September 30, |
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2022 |
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2021 |
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Operating Activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization [note 4] |
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Stock-based compensation [note 8[c], note 8[e], note 8[f] and note 8[g]] |
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Shares issued as settlement with trade vendor |
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Accrued interest on SVB convertible debt [note 7] |
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— |
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Changes in operating assets and liabilities: |
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Grant receivable [note 3] |
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( |
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Prepaid expenses and other assets |
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( |
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( |
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Accounts payable |
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( |
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Accrued liabilities other |
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( |
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Accrued clinical liabilities |
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Accrued compensation |
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( |
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( |
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Lease obligation [note 9] |
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( |
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( |
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Net cash used in operating activities |
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( |
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( |
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Financing Activities: |
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Proceeds from exercise of warrants |
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Proceeds from ATM, net of issuance costs [note 8[b]] |
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— |
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Financing costs relating to convertible debt with SVB [note 7] |
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( |
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— |
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Proceeds from the May 2021 public offering, net of issuance costs |
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— |
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Proceeds from employee stock purchase plan [note 8[g]] |
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— |
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Taxes paid related to net share settlement of equity awards |
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( |
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— |
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Net cash provided by financing activities |
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Effect of exchange rate changes on cash |
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( |
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( |
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Net decrease in cash, cash equivalents and restricted cash |
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( |
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( |
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Cash, cash equivalents and restricted cash at beginning of the period |
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Cash, cash equivalents and restricted cash at end of the period |
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$ |
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$ |
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See accompanying notes.
5
Achieve Life Sciences, Inc.
Consolidated Statements of Stockholders’ Equity
(Unaudited)
(In thousands, except share amounts)
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Accumulated |
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Additional |
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Other |
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Total, |
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Common Stock |
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Preferred 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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Amount |
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Shares |
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Amount |
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Capital |
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Income (Loss) |
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Deficit |
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Equity |
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Balance, 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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$ |
( |
) |
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$ |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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Shares issued on exercise of warrants |
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— |
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— |
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— |
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— |
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— |
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Shares issued from purchase agreement with Virtu |
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— |
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— |
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— |
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— |
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— |
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Shares issued as settlement with trade vendor |
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— |
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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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— |
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( |
) |
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( |
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Balance, 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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$ |
( |
) |
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$ |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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Shares issued from purchase agreement with Virtu |
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— |
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— |
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— |
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— |
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— |
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Restricted stock unit settlements |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Restricted stock unit settlements withheld and retired to treasury |
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( |
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— |
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— |
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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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— |
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( |
) |
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( |
) |
Balance, 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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$ |
( |
) |
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$ |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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Shares issued under employee share purchase plan |
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— |
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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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— |
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( |
) |
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( |
) |
Balance, September 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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$ |
( |
) |
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$ |
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6
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Accumulated |
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Additional |
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Other |
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Total, |
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Common Stock |
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Preferred 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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Amount |
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Shares |
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Amount |
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Capital |
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Income (Loss) |
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Deficit |
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Equity |
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Balance, December 31, 2020 |
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$ |
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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 expense |
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— |
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— |
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— |
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— |
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— |
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— |
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Shares issued on exercise of warrants |
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— |
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— |
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— |
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— |
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— |
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Shares issued as settlement with trade vendor |
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— |
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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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— |
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|
( |
) |
|
|
( |
) |
Balance, March 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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|
$ |
( |
) |
|
$ |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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Shares issued on exercise of warrants |
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— |
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— |
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— |
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— |
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— |
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Shares issued - May 2021 public offering |
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— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Shares issued as settlement with trade vendor |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, June 30, 2021 |
|
|
|
|
|
$ |
|
|
|
|
— |
|
|
$ |
— |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |