on
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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Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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 ☐ |
Accelerated filer ☐ |
Smaller reporting company |
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
As of November 8, 2024, the registrant had
TABLE OF CONTENTS
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Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3 – Qualitative and Quantitative Disclosures about Market Risk |
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1
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Report contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian securities law, which we collectively refer to as “forward-looking statements”. Such forward-looking statements reflect our current beliefs and are based on information currently available to us. In some cases, forward-looking statements can be identified by terminology such as “may,” “would,” “could,, “will,” “should,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “hope,” “foresee” or the negative of these terms or other similar expressions concerning matters that are not historical facts.
Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements, including, among others:
2
More detailed information about risk factors and their underlying assumptions is included in our Annual Report on Form 10-K for the year ended December 31, 2023, under Item 1A – Risk Factors. Except as required under applicable securities legislation, we undertake no obligation to publicly update or revise forward-looking statements, whether as a result of new information, future events or otherwise.
3
PART I—FINANCIAL INFORMATION
ITEM 1 – FINANCIAL STATEMENTS
Condensed Consolidated Interim Financial Statements
(Unaudited)
APTOSE BIOSCIENCES INC.
For the three months and nine months ended September 30, 2024 and 2023
4
APTOSE BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Financial Position
(Expressed in thousands of US dollars)
(unaudited)
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September 30, |
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December 31, |
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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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Prepaid expenses |
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Other current assets |
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Total current assets |
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Non-current assets: |
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Property and equipment |
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Right-of-use assets, operating leases |
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Total non-current assets |
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Total assets |
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$ |
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$ |
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Liabilities and Shareholders’ Equity |
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Current liabilities: |
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Accounts payable to related parties |
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— |
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$ |
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Accounts payable |
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Accrued liabilities |
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Current portion of lease liability, operating leases |
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Total current liabilities |
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Non-current liabilities: |
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Lease liability, operating leases |
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Loan payable to related parties |
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— |
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Total non-current liabilities |
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Total liabilities |
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Shareholders’ equity: |
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Share capital: |
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Common shares, |
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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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Deficit |
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( |
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( |
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Total shareholders’ equity |
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( |
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( |
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Total liabilities and shareholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated interim financial statements (unaudited).
Going concern, see Note 2.
Commitments, see Note 8.
Related party transactions, see Note 9.
Subsequent events, see Note 10 and 12.
5
APTOSE BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Loss and Comprehensive Loss
(Expressed in thousands of US dollars, except for per common share data)
(unaudited)
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Three months ended |
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Nine months ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Expenses: |
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Research and development |
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General and administrative |
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Operating expenses |
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Other income/(expense): |
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Interest income |
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Foreign exchange income/(loss) |
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( |
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( |
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Total other income |
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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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Other comprehensive loss: |
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Unrealized (loss) gain on available-for-sale securities |
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Total comprehensive loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Basic and diluted loss per common share |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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Weighted average number of common shares outstanding used in the calculation of |
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The accompanying notes are an integral part of these condensed consolidated interim financial statements (unaudited).
6
APTOSE BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Changes in Shareholders’ Equity
(Expressed in thousands of US dollars, except for per common share data)
(unaudited)
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Common Shares |
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Additional |
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Accumulated other |
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Shares |
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Amount |
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paid-in |
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comprehensive |
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Deficit |
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Total |
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Balance, December 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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Shares and warrants issued under the Registered Direct Offering |
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$ |
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Common shares and warrants issued under the Hanmi Subscription Agreement |
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— |
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— |
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Common shares and warrants issued in S-1 financing |
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— |
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— |
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Common shares issued under the 2023 Committed Equity Facility |
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( |
) |
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— |
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— |
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Common shares issued under the 2022 ATM |
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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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Common shares issued under the ESPP plan |
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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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( |
) |
Balance, September 30, 2024 |
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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, 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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Common shares issued under the Hanmi Subscription Agreement |
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— |
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— |
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— |
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Common shares issued in exchange for RSUs |
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( |
) |
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— |
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— |
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— |
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Common shares issued under the 2023 Committed Equity Facility |
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— |
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— |
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— |
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Common shares issued under the 2022 ATM Facility |
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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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Common shares issued under the ESPP plan |
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— |
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— |
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— |
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Other comprehensive gain |
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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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( |
) |
Balance, September 30, 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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The accompanying notes are an integral part of these condensed consolidated interim financial statements (unaudited).
7
APTOSE BIOSCIENCES INC.
Condensed Consolidated Interim Statements of Cash Flows
(Expressed in thousands of US dollars)
(unaudited)
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Three months ended |
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Nine months ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Cash flows used in operating activities: |
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Net loss for the period |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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$ |
( |
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Items not involving cash: |
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Stock-based compensation |
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( |
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Depreciation and amortization |
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Loss on disposal of property and equipment |
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Amortization of right-of-use assets |
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Interest on lease liabilities |
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Unrealized (gain)/loss on short-term investment |
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( |
) |
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( |
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Accrued interest on investments |
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( |
) |
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( |
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Changes in non-cash operating assets and liabilities: |
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Prepaid expenses |
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Other current assets |
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( |
) |
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( |
) |
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( |
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( |
) |
Operating lease liabilities |
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( |
) |
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( |
) |
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( |
) |
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( |
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Accounts payable to related parties |
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( |
) |
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Accounts payable |
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( |
) |
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( |
) |
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( |
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( |
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Accrued liabilities |
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( |
) |
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Cash used in operating activities |
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( |
) |
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( |
) |
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( |
) |
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( |
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Cash flows from financing activities: |
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Proceeds from loan payable to related parties |
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Issuances of common shares and warrants under the Registered Direct Offering |
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Issuance of common shares and warrants under the S-1 Filing |
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Shares issuances to Hanmi under subscription agreement |
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Issuance of common shares under 2023 CMPO |
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Share subscription advance under the 2023 CMPO |
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Issuance of common shares under 2022 ATM Facility |
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Cost of offering |
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( |
) |
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( |
) |
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( |
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Issuance of common shares under the ESPP plan |
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Cash from financing activities |
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Cash flows from/(used in) investing activities: |
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Disposal/(purchase) of property and equipment, net |
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( |
) |
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Maturity /(acquisition) of investments, net |
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Cash from/(used in) investing activities |
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Effect of exchange rate fluctuations on cash and cash equivalents |
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Increase/(decrease) in cash and cash equivalents |
|
$ |
( |
) |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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Cash and cash equivalents, beginning of period |
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$ |
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$ |
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$ |
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$ |
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Cash and cash equivalents, end of period |
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$ |
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$ |
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$ |
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$ |
|
The accompanying notes are an integral part of these condensed consolidated interim financial statements (unaudited).
8
APTOSE BIOSCIENCES INC.
Notes to Condensed Consolidated Interim Financial Statements (unaudited)
Three months and nine months ended September 30, 2024 and 2023
(Tabular amounts in thousands of United States dollars, except as otherwise noted)
Aptose Biosciences Inc. (“Aptose,” “the Company,” “we,” “us,” or “our”) is a science-driven, clinical-stage biotechnology company committed to the development and commercialization of precision medicines addressing unmet clinical needs in oncology, with an initial focus on hematology. The Company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. The Company’s executive offices are located in San Diego, California, and our head office address has been changed to 66 Wellington Street West, Suite 5300, TD Bank Tower Box 48, Toronto, Ontario, Canada.
We are advancing targeted agents to treat life-threatening hematologic cancers that, in most cases, are not elective for patients and require immediate treatment. We have two clinical-stage investigational products for hematological malignancies: tuspetinib, an oral, potent myeloid kinase inhibitor, and luxeptinib, an oral, dual lymphoid and myeloid kinase inhibitor.
Since our inception, we have financed our operations and technology acquisitions primarily from equity financing, proceeds from the exercise of warrants and stock options, and interest income on funds held for future investment. Our uses of cash for operating activities have primarily consisted of salaries and wages for our employees, facility and facility-related costs for our offices and laboratories, fees paid in connection with preclinical and clinical studies, licensing fees, drug manufacturing costs, laboratory supplies and materials, and professional fees.
Management recognizes that in order for us to meet our capital requirements, and continue to operate, additional financing will be necessary. We plan to raise additional funds to fund our business operations but there is no assurance that such additional funds will be available for us to finance our operations on acceptable terms, if at all. The Company's current cash and cash equivalents are projected to support operations through January 2025. We have based these estimates on assumptions and plans, which may change and which could impact the magnitude and/or timing of operating expenses and our cash runway, See Note 2(a).
Our ability to raise additional funds has been affected by adverse market conditions, the status of our product pipeline, possible delays in enrollment in our trial, and various other factors and we may be unable to raise capital when needed, or on terms favorable to us. The raising of additional capital, and/or the trade sale of some of the Company’s operations to make bulk payments to repay accounts payable, if successful, would potentially alleviate any significant doubt on the Company’s ability to continue as a going concern. In the event that debt and/or capital financing is unable to be secured or contemplated trade sale fail to materialize, the Company may need to resolve to other means of protecting its assets in the best interests of its shareholders, including foreclosure or forced liquidation and/or seeking creditors’ protection.
We do not expect to generate positive cash flow from operations for the foreseeable future due to the early stage of our clinical trials. It is expected that negative cash flow will continue until such time, if ever, that we receive regulatory approval to commercialize any of our products under development and/or royalty or milestone revenue from any such products exceeds expenses.
The Company's financial statements are prepared using generally accepted accounting principles in the United States of America applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, the use of the going concern assumption on which these unaudited condensed interim consolidated financial statements are prepared may not be appropriate based on the factors described in Note 2(a). Management recognizes that in order to meet the capital requirements, and continue to operate, additional financing will be necessary. The Company plans to raise additional funds to fund our business operations through equity financing under other financing activities, as further described in Note 10 and Note 12. Management continues considering other options for raising capital including debt, equity, collaborations, and reorganization to reduce operational expenses. However, given the decrease in the share price, difficulty for micro-cap market capitalization companies to raise significant capital and the matters in Note 10, Share capital, that may impact the Company's ability to raise significant financing in the capital markets, the Company may be unable to access financing when needed. As such, there can be no assurance that the Company will be able to obtain additional liquidity when needed or under acceptable terms, if at all. These conditions raise substantial doubt about the Company’s ability to continue as a going concern, see Note 2(a). The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
9
On May 23, 2023, during the Aptose Annual and Special Meeting of Shareholders, our shareholders voted to approve special resolutions providing for an amendment to our articles of incorporation to effect a reverse share split of our outstanding Common Shares, at a ratio in the range of 1-for-10 to 1-for-20. Our Board of Directors then approved a ratio of 1-for-15 on May 23, 2023. On May 24, 2023, we filed articles of amendment under the Canada Business Corporations Act to give effect to the reverse stock split (consolidation) of our Common Shares on the basis of one post-consolidation Common Share for each 15 pre-consolidation Common Shares (the “Reverse Stock Split”). The Common Shares commenced trading on a post-Reverse Stock Split basis at market open on Tuesday, June 6, 2023. All references in this report to historical Common Share prices, numbers of Common Shares, and earnings per share calculations have been presented to reflect the effect of the Reverse Stock Split.
These unaudited condensed consolidated interim financial statements have been prepared in conformity with generally accepted accounting principles in the United States, or GAAP and the rules and regulations of the Securities and Exchange Commission, or SEC, related to quarterly reports filed on Form 10-Q, assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and discharge of liabilities in the normal course of operations as they come due. In assessing whether the going concern assumption is appropriate, management takes into account all available information about the future, which is at least, but is not limited to, twelve months from the end of the reporting year. The Company is in substantial doubt to continue as a going concern; As of September 30, 2024, the Company had negative shareholder's equity of $
The Company faces increasingly challenging financial and business conditions, including an inability to raise sufficient equity and equity-linked financing to fully fund execution of its business plans and to satisfy its $
Management recognizes that in order to meet the capital requirements, and continue to operate, additional financing will be necessary. The Company is evaluating strategies to obtain the required additional funding for future operations. These strategies may include, but are not limited to, obtaining equity financing, debt financing, committed equity facilities or other financing instruments and restructuring of operations to decrease expenses. However, given the impact of the volatile financial markets on micro-cap market capitalization companies such as the Company and the matter in Note 10, Share capital and 12, Subsequent events, the Company may be unable to access further equity when needed. As the Company is primarily pursuing one compound that is licensed from a related party with significant licensing payments who will have influence on the Company, other investors may not be willing to invest in the Company. As such, there can be no assurance that the Company will be able to obtain additional liquidity when needed or under acceptable terms, if at all. The Company's current cash and cash equivalents are projected to support operations through January 2025. We have based these estimates on assumptions and plans, which may change and which could impact the magnitude and/or timing of operating expenses and our cash runway. The unaudited condensed consolidated interim financial statements do not reflect any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern. Such adjustments could be material.
These condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All intercompany transactions, balances, revenue, and expenses are eliminated on consolidation.
During the nine months ended September 30, 2024, there have been no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on March 26, 2024.
The preparation of the unaudited condensed consolidated interim financial statements requires management to make judgments, estimates and assumptions that affect the application of accounting policies and reported amounts of assets and liabilities at the date of
10
the unaudited condensed consolidated interim financial statements and reported amounts of revenue and expenses during the reporting period. Actual outcomes could differ from those estimates. The unaudited condensed consolidated interim financial statements include estimates, which, by their nature, are uncertain.
The impacts of such estimates are pervasive throughout the unaudited condensed consolidated interim financial statements and may require accounting adjustments based on future occurrences.
The estimates and underlying assumptions are reviewed on a regular basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised and in any future periods affected.
We have adopted no new accounting pronouncements during the three months and nine months ended September 30, 2024. There were various accounting standards and interpretations issued recently, none of which are expected to have a material impact on our financial position, operations or cash flows.
The functional and presentation currency of the Company is the US dollar.
The Company is subject to credit risk from the Company’s cash and cash equivalents and investments. The carrying amount of the financial assets represents the maximum credit exposure. The Company manages credit risk associated with its cash and cash equivalents and investments by maintaining minimum standards of R1‑low or A‑low investments and the Company invests only in highly rated corporations and treasury bills, which are capable of prompt liquidation.
Cash and cash equivalents as of September 30, 2024, consist of restricted cash of $
On August 27, 2024, the Company received $
Prepaid expenses as of September 30, 2024 and December 31, 2023 are shown below. Other prepaid expenses primarily consist of subscriptions, software, conference deposits and deposits for general and administrative items.
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Prepaid research and development expenses |
|
$ |
|
|
$ |
|
||
Prepaid insurance |
|
|
|
|
|
|
||
Other prepaid operating expenses |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
11
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Right-of-use assets, beginning of period |
|
$ |
|
|
$ |
|
||
Additions to right-of-use assets |
|
|
|
|
|
|
||
Right-of-use assets, end of period |
|
|
|
|
|
|
||
Accumulated amortization |
|
|
( |
) |
|
|
( |
) |
Right-of use assets, NBV |
|
$ |
|
|
$ |
|
12
The fair value hierarchy establishes three levels to classify the inputs to valuation techniques used to measure fair value.
Level 1 ‑ inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 ‑ inputs are quoted prices in markets that are not active, quoted prices for similar assets or liabilities in active markets, inputs other than quoted prices that are observable for the asset or liability, or inputs that are derived principally from or corroborated by observable market data or other means; and
Level 3 ‑ inputs are unobservable (supported by little or no market activity).
The fair value hierarchy gives the highest priority to Level 1 inputs and the lowest priority to Level 3 inputs.
The following table presents the fair value of Company's assets that are measured at fair value on a recurring basis for the periods presented:
|
|
September 30, |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
||||
High interest savings account |
|
$ |
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
||||
High interest savings accounts |
|
$ |
|
|
|
|
|
|
|
|
|
|
||||
United States Treasury Bills |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
|
|
|
$ |
|
|
|
|
Accrued liabilities as of September 30, 2024 and December 31, 2023 consisted of the following:
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Accrued personnel related costs |
|
$ |
|
|
$ |
|
||
Accrued research and development expenses |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
Aptose leases office space in San Diego, California. The lease for the San Diego office space is scheduled to expire in May 31, 2026. We leased office space in Toronto, Ontario, Canada, which lease expired on June 30, 2024. The Company has not included any extension periods in calculating its right-to-use assets and lease liabilities. The Company also enters into leases for small office equipment.
Minimum payments, undiscounted, under our operating leases are as follows:
Years ending December 31, |
|
|
|
|
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
Total |
|
$ |
|
13
The following table presents the weighted average remaining term of the leases and the weighted average discount rate:
|
|
September 30, |
|
|
December 31, |
|
||
Weighted-average remaining term – operating leases (years) |
|
|
|
|
|
|
||
Weighted-average discount rate – operating leases |
|
|
% |
|
|
% |
||
|
|
|
|
|
|
|
||
Lease liability, current portion |
|
$ |
|
|
$ |
|
||
Lease liability, long-term portion |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
Operating lease costs and operating cash flows from our operating leases are as follows:
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
2024 |
|
|
2023 |
|
||||
Operating lease cost |
|
$ |
|
|
$ |
|
$ |
|
|
$ |
|
||||
Operating cash flows from operating leases |
|
$ |
|
|
$ |
|
$ |
|
|
$ |
|
Hanmi Pharmaceutical Co. Ltd.
On November 4, 2021, Aptose entered a licensing agreement (the "Hanmi Licensing Agreement") with the South Korean company Hanmi Pharmaceutical Co. Ltd. ("Hanmi") for the clinical and commercial development of tuspetinib. Under the terms of the Hanmi Licensing Agreement, Hanmi granted Aptose exclusive worldwide rights to tuspetinib for all indications. Hanmi received an upfront payment of $
In 2022, the Company and Hanmi also entered into a separate supply agreement for additional production of new drug substance ("API") and drug product to support further tuspetinib clinical development, for which the Company pays Hanmi per batch of production. Expenses related to this supply agreement have been recognized by the Company, amounting to
The Company paid supply costs to Hanmi of $
On August 27, 2024, the Company entered into a loan agreement (the "Hanmi Loan Agreement") with the South Korean Company Hanmi Pharmaceutical Co. Ltd ("Hanmi") for $
On September 2, 2024, and in connection with the Hanmi Loan Agreement, Aptose and Hanmi executed a letter of understanding ("LOU"), which outlines the steps associated with the negotiation of the Future Collaboration Agreement (the "Future Collaboration
14
Agreement"). This agreement will establish a co-development collaboration for the advancement of tuspetinib. Under the terms of the Future Collaboration Agreement, upon execution, the loan principal and any accrued and unpaid interest under the "Hanmi Loan Agreement" will automatically convert to Hanmi's prepayment of future milestone obligations under the Future Collaboration Agreement. Upon conversion, the Hanmi Loan Agreement, consisting of the $
See Note 10, Share capital, for share capital transactions with Hanmi.
On April 2, 2024, the Company received a letter (the “Notification Letter”) from Nasdaq stating that the Company was not in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Rule”) because the stockholders’ equity of the Company as of December 31, 2023, as reported in the Company’s Annual Report on Form 10-K, was below the minimum requirement of $
On June 28, 2024 , the Company received a letter from Nasdaq stating that Nasdaq had granted the Company an extension until September 30, 2024 to regain compliance with the Rule. On August 1, 2024 the Company filed a preliminary S-1 prospectus to raise financing as part of its Compliance Plan, in addition to funds raised in the 10a.(i), June 2024 Registered Direct Offering.
On July 16, 2024, the Company received a deficiency letter (the “Deficiency Letter”) from the Staff of The Nasdaq Stock notifying the Company that, for the prior thirty consecutive business days, the closing bid price for the Company’s Common Shares have been below the minimum $
As of September 30, 2024, the Company had not gained compliance with the requirement. The Company's stockholder's equity as of September 30, 2024 was negative $
On October 1, 2024, the Company received a staff determination letter from the Listing Department stating that the Company did not meet the terms of the extension because it did not complete its proposed financing initiatives to regain compliance. On October 8, 2024, the Company requested an appeal and hearing; such hearing is scheduled for November 21, 2024. The hearing request has automatically stayed Nasdaq’s delisting of the Company’s Common Shares pending the Panel’s decision. At or prior to the hearing, the Company plans to present to Nasdaq information demonstrating that it has regained compliance with the continued listing standards under the Nasdaq Listing Rules, or alternatively a plan to regain compliance and a request for an extension of time to effectuate the plan. Notwithstanding the foregoing, there can be no assurance that the Company will regain compliance with the continued listing standards under the Nasdaq Listing Rules, or that the Panel will grant the Company an extension of time to regain compliance, in the event the Company requests such an extension.
On October 30, 2024, the Company filed Amendment 1 to this S-1, see note 12, Subsequent Events.
The Company has authorized share capital of an unlimited number of Common Shares.
(i) June 2024 Registered Direct Offering
15
On June 3, 2024, the Company closed a registered direct offering priced at-the-market under Nasdaq rules of
On September 5, 2024, the Company held a Special Meeting of Shareholders pursuant to which, shareholders voted to authorize, for purposes of complying with Nasdaq Listing Rule 5635(d), the issuance of Common Shares underlying certain warrants in an amount equal to or in excess of
(ii) January 2024 Public Offering and Private Placement
On January 31, 2024, the Company announced the closing of a $
On February 29, 2024, the Company received a deficiency letter (the “February Deficiency Letter”) from the Nasdaq Listing Qualifications Department of Nasdaq notifying the Company that the Company’s Private Placement violated Nasdaq Listing Rule 5635(d) because the Company did not obtain shareholder approval prior to such issuance. Nasdaq stated that the Private Placement involved the issuance of greater than
In response to a Deficiency Letter from Nasdaq received on February 29, 2024 regarding the private placement with Hanmi and the resulting claimed violation of Nasdaq Listing Rule 5635(d), the Company submitted a plan to regain compliance on April 15, 2024. On April 25, 2024, the Company received a letter from the Listing Qualifications Department (the “Staff”) of Nasdaq notifying the Company of the Staff’s determination that the Company had regained compliance with Nasdaq Listing Rule 5635(d) and the Staff has determined that the matter is now closed. Pursuant to the Company's plan to regain compliance, on April 26, 2024, the Company announced that it had amended the warrant agreement with Hanmi to prohibit the exercise of the Hanmi warrants in excess of the Nasdaq 19.99% limitation (the "Nasdaq 19.99% Cap"), unless shareholder approval is first obtained to exceed the Nasdaq 19.99% Cap.
(iii) Hanmi 2023 Investment
On August 10, 2023, the Company entered into a binding term sheet with Hanmi whereby Hanmi agreed at their sole discretion to invest, up to a maximum of $
16
agreed to sell
(iv) 2023 Committed Equity Facility
On May 25, 2023, the Company and Keystone Capital Partners, LLC ("Keystone") entered into a committed equity facility, (the "2023 Committed Equity Facility"), which provides that subject to the terms and conditions set forth therein, we may sell to Keystone up to the lesser of (i) $
Upon entering into the 2023 Committed Equity Facility, the Company agreed to issue to Keystone an aggregate of
In the year ended December 31, 2023, the Company's issuance of Common Shares to Keystone comprised
(v) 2022 At-The-Market Facility ("ATM")
On December 9, 2022, the Company entered into an equity distribution agreement pursuant to which the Company may, from time to time, sell Common Shares having an aggregate offering value of up to $
17
Loss per share is calculated using the weighted average number of Common Shares outstanding and is presented in the table below: