UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
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) |
(
(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 |
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
Number of shares of common stock outstanding as of February 12, 2024 was
TABLE OF CONTENTS
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Page No. |
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Item 1. |
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1 |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
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Item 3. |
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28 |
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Item 4 |
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28 |
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Item 1. |
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29 |
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Item 1A. |
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29 |
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Item 2. |
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Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities. |
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Item 3. |
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30 |
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Item 4. |
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30 |
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Item 5. |
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30 |
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Item 6. |
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31 |
i
PART 1. - FINANCIAL INFORMATION
Item 1. Financial Statements.
Kintara Therapeutics, Inc.
Condensed Consolidated Interim Financial Statements
(Unaudited)
For the six months ended December 31, 2023
(expressed in US dollars unless otherwise noted)
1
Kintara Therapeutics, Inc.
Condensed Consolidated Interim Balance Sheets
(In thousands, except par value amounts)
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December 31, |
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June 30, |
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Note |
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$ |
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$ |
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(unaudited) |
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Assets |
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Current assets |
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Cash and cash equivalents |
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Subscriptions receivable |
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7 |
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— |
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Prepaid expenses, taxes and other receivables |
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Clinical trial deposit |
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3 |
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Total current assets |
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Property and equipment, net |
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5 |
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Total assets |
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Liabilities |
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Current liabilities |
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Accounts payable and accrued liabilities |
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Related party payables |
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6 |
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Total current liabilities |
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Milestone payment liability |
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9 |
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Total liabilities |
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Stockholders' equity |
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Preferred stock |
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Authorized |
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Issued and outstanding |
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7 |
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7 |
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Common stock |
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Authorized |
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Issued and outstanding |
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7 |
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Additional paid-in capital |
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7 |
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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 |
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Total liabilities and stockholders’ equity |
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Nature of operations, corporate history, going concern and management plans (note 1) |
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Subsequent events (note 10) |
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The accompanying notes are an integral part of these condensed consolidated interim financial statements.
2
Kintara Therapeutics, Inc.
Condensed Consolidated Interim Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
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Three months ended |
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Six months ended |
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Note |
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2023 |
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2022 |
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2023 |
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2022 |
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Expenses |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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General and administrative |
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( |
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( |
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( |
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Other income (loss) |
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Foreign exchange |
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Interest, net |
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( |
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Net loss for the period |
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( |
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Computation of basic loss per share |
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Net loss for the period |
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( |
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( |
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Series A Preferred cash dividend |
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7 |
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( |
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( |
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( |
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( |
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Series C Preferred stock dividend |
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7 |
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— |
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— |
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( |
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Net loss for the period attributable to common stockholders |
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$ |
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( |
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$ |
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$ |
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$ |
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Basic and fully diluted loss per share |
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$ |
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( |
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$ |
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$ |
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$ |
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Basic and fully diluted weighted average number of shares |
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The accompanying notes are an integral part of these condensed consolidated interim financial statements.
3
Kintara Therapeutics, Inc.
Condensed Consolidated Interim Statements of Stockholders’ Equity (Deficiency)
(Unaudited)
For the six months ended December 31, 2023
(In thousands)
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Number |
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Common |
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Additional |
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Accumulated |
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Preferred |
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Accumulated |
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Total stockholders' |
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Balance - June 30, 2023 |
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( |
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Issuance of shares on vesting of restricted stock units |
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— |
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— |
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— |
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— |
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— |
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— |
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Conversion of Series C Preferred stock to common stock |
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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 option 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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Restricted stock unit 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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Series A Preferred cash dividend |
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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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Series C Preferred stock dividend |
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— |
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— |
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— |
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( |
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— |
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Loss for the period |
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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, 2023 |
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( |
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Issuance of shares pursuant to equity line - net of issue costs |
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— |
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— |
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— |
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— |
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Issuance of shares pursuant to ATM - net of issue costs |
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— |
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— |
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— |
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Conversion of Series C Preferred stock to common stock |
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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 option 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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Restricted stock unit 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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Series A Preferred cash dividend |
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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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Loss for the period |
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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 - December 31, 2023 |
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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.
4
Kintara Therapeutics, Inc.
Condensed Consolidated Interim Statements of Stockholders’ Equity
(Unaudited)
For the six months ended December 31, 2022
(In thousands)
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Number |
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Common |
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Additional |
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Accumulated |
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Preferred |
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Accumulated |
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Total stockholders' |
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Balance - June 30, 2022 |
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( |
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Issuance of shares - net of issue costs |
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— |
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— |
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— |
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Stock option 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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Series A Preferred cash dividend |
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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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Series C Preferred stock dividend |
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— |
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— |
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( |
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— |
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Loss for the period |
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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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Conversion of Series C Preferred stock to common stock |
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— |
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— |
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( |
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— |
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— |
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Additional shares issued on reverse stock split |
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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 option 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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Series A Preferred cash dividend |
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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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Loss for the period |
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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 - December 31, 2022 |
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( |
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The accompanying notes are an integral part of these condensed consolidated interim financial statements.
5
Kintara Therapeutics, Inc.
Condensed Consolidated Interim Statements of Cash Flows
(Unaudited)
(In thousands)
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Six months ended |
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2023 |
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2022 |
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Note |
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$ |
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$ |
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Cash flows from operating activities |
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Loss for the period |
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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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Amortization of clinical trial deposit |
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3 |
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— |
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Depreciation of property and equipment |
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5 |
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Change in fair value of milestone liability |
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( |
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Stock option expense |
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7 |
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Restricted stock unit expense |
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7 |
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— |
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Changes in operating assets and liabilities |
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Prepaid expenses, taxes and other receivables |
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( |
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Clinical trial deposit |
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( |
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Accounts payable and accrued liabilities |
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( |
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( |
) |
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Related party payables |
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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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Cash flows from investing activities |
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Purchase of equipment |
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5 |
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( |
) |
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( |
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Net cash used in investing activities |
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( |
) |
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( |
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Cash flows from financing activities |
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Net proceeds from the issuance of shares - equity line |
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7 |
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Net proceeds from the issuance of shares - ATM |
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7 |
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— |
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Series A Preferred cash dividend |
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6 |
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( |
) |
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( |
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Net cash provided by financing activities |
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Decrease in cash and cash equivalents |
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( |
) |
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( |
) |
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Cash and cash equivalents – beginning of period |
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Cash and cash equivalents – end of period |
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Supplementary information (note 8) |
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The accompanying notes are an integral part of these condensed consolidated interim financial statements.
6
Kintara Therapeutics, Inc.
Notes to Condensed Consolidated Interim Financial Statements
(Unaudited)
December 31, 2023
(expressed in US dollars and in thousands, except par value and per share amounts, unless otherwise noted)
1 Nature of operations, corporate history, and going concern and management plans
Nature of operations
Kintara Therapeutics, Inc. (the “Company”) is a clinical-stage drug development company with a focus on the development of novel cancer therapies for patients with unmet medical needs. The Company is developing one late-stage therapeutic - REM-001 for cutaneous metastatic breast cancer (“CMBC”). In order to accelerate the Company’s development timelines, it leverages existing preclinical and clinical data from a wide range of sources. The Company may seek marketing partnerships in order to potentially offset clinical costs and to generate future royalty revenue from approved indications of its current and future product candidates.
Corporate history
The Company is a Nevada corporation formed on June 24, 2009, under the name Berry Only, Inc. On January 25, 2013, the Company entered into and closed an exchange agreement (the “Exchange Agreement”), with Del Mar Pharmaceuticals (BC) Ltd. (“Del Mar (BC)”), 0959454 B.C. Ltd. (“Callco”), and 0959456 B.C. Ltd. (“Exchangeco”) and the security holders of Del Mar (BC). Upon completion of the Exchange Agreement, Del Mar (BC) became a wholly-owned subsidiary of the Company (the “Reverse Acquisition”).
On August 19, 2020, the Company completed its merger with Adgero Biopharmaceuticals Holdings, Inc., a Delaware corporation (“Adgero”) in which Adgero continued its existence under Delaware law and became a direct, wholly-owned subsidiary of the Company. Following the completion of the merger, the Company changed its name from DelMar Pharmaceuticals, Inc. to Kintara Therapeutics, Inc. and began trading on The Nasdaq Capital Market LLC (“Nasdaq”) under the symbol “KTRA”.
Kintara Therapeutics, Inc. is the parent company of Del Mar (BC), a British Columbia, Canada corporation and Adgero which are clinical-stage companies with a focus on the development of drugs for the treatment of cancer. The Company is also the parent company to Callco and Exchangeco which are British Columbia, Canada corporations. Callco and Exchangeco were formed to facilitate the Reverse Acquisition. In connection with the Adgero merger, the Company also became the parent company of Adgero Biopharmaceuticals, Inc. (“Adgero Bio”), formerly a wholly-owned subsidiary of Adgero.
References to the Company refer to the Company and its wholly-owned subsidiaries.
Going concern and management plans
These condensed consolidated interim financial statements have been prepared on a going concern basis which assumes that the Company will continue its operations for the foreseeable future and contemplates the realization of assets and the settlement of liabilities in the normal course of business.
For the six months ended December 31, 2023, the Company reported a loss of $
Consequently, management is pursuing various financing alternatives to fund the Company’s operations so it can continue as a going concern. Management plans to continue to pursue opportunities to secure the necessary financing through the issue of new equity, including its ATM facility, debt, and/or entering into strategic partnership arrangements. However, the Company’s ability to raise additional capital could be affected by various risks and uncertainties including, but not limited to, global unrest. The Company
7
may not be able to raise sufficient additional capital and may need to tailor its drug candidate development programs based on the amount of funding the Company is able to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.
These condensed consolidated interim financial statements do not give effect to any adjustments to the amounts and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern. Such adjustments could be material.
2 Significant accounting policies
Reverse stock split
On November 10, 2022, the Company filed a Certificate of Change to the Company’s Articles of Incorporation, as amended, in order to effectuate a 1:
Basis of presentation
The condensed consolidated interim financial statements of the Company have been prepared in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAP”) and are presented in United States dollars. The functional currency of the Company and each of its subsidiaries is the United States dollar.
The accompanying condensed consolidated interim financial statements include the accounts of the Company and its wholly-owned subsidiaries, Adgero, Adgero Bio, Del Mar (BC), Callco, and Exchangeco. All intercompany balances and transactions have been eliminated in consolidation.
The principal accounting policies applied in the preparation of these condensed consolidated interim financial statements are set out below and have been consistently applied to all periods presented.
Unaudited interim financial data
The accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial information. Accordingly, they do not include all of the information and the notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated interim financial statements should be read in conjunction with the June 30, 2023, audited consolidated financial statements of the Company included in the Company’s Form 10-K filed with the SEC on September 18, 2023. In the opinion of management, the unaudited condensed consolidated interim financial statements reflect all adjustments, consisting of normal and recurring adjustments, necessary for a fair presentation. The results for six months ended December 31, 2023, are not necessarily indicative of the results to be expected for the fiscal year ending June 30, 2024, or for any other future annual or interim period.
Use of estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions about future events that affect the reported amounts of assets, liabilities, expenses, contingent assets, and contingent liabilities as at the end of, or during, the reporting period. Actual results could significantly differ from those estimates. Significant areas requiring management to make estimates include the valuation of equity instruments issued for services, milestone payment liability, and clinical trial accruals. Further details of the nature of these assumptions and conditions may be found in the relevant notes to these condensed consolidated interim financial statements.
Loss per share
Income or loss per share is calculated based on the weighted average number of common shares outstanding. For the six-month periods ended December 31, 2023, and 2022, diluted loss per share does not differ from basic loss per share since the effect of the Company’s warrants, stock options, restricted stock units, and convertible preferred shares is anti-dilutive. As of December 31, 2023, potential common shares of
8
Series C preferred stock warrants,
Government assistance
Government grants, including grants from similar bodies, are recognized when there is reasonable assurance that the Company has met the requirements of the approved grant program and there is reasonable assurance that the grant will be received. Grants that compensate the Company for expenses incurred are recognized in income or loss in reduction thereof in the same period in which the expenses are recognized. The Company uses a net presentation basis whereby the grant offsets the research and development expenses as it is being recovered under the grant program.
Recently issued accounting standards
Management does not believe that any recently issued, but not yet effective, accounting standards, if currently adopted, would have a material effect on the Company’s condensed consolidated interim financial statements.
3 Clinical trial deposit
In October 2020, the Company announced that it had entered into a final agreement with a contract research organization (“CRO”) for the management of the Company’s registrational study of VAL-083 for glioblastoma. Under the agreement, the Company supplied the drug for the study and the CRO managed all operational aspects of the study including site activation and patient enrollment. The Company was required to make certain payments under the agreement related to patient enrollment milestones. For the three and six months ended December 31, 2023, the Company has recognized a recovery of $
On October 31, 2023, the Company announced that preliminary topline results from this registrational study for VAL-083 did not perform better than the current standards of care in glioblastoma. As a result, the Company announced that it has terminated the development of VAL-083. In the six months ended December 31, 2023, the remaining deposit of $
In the six months ended December 31, 2023, the Company paid $
4 Clinical trials grant
Effective July 1, 2023, the Company was awarded a $
The grant is subject to various performance conditions and funding risk where the financial conditions of the NIH may change from time to time. The Company recognizes the grant only to the extent there is reasonable assurance the grant will be funded to the Company.
5 Property and equipment, net
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$ |
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Balance, June 30, 2023 |
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Additions |
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Depreciation |
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( |
) |
Balance, December 31, 2023 |
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9
At December 31, 2023, the total capitalized cost of property and equipment was $
6 Related party transactions
Valent Technologies, LLC Agreements
On November 20, 2023, Dr. Brown was terminated from his position as the Company’s Chief Scientific Officer as a result of cost-cutting measures adopted by the Company; he remains a consultant to the Company. Dr. Brown is a principal of Valent Technologies, LLC (“Valent”) and as a result Valent is a related party to the Company.
On September 12, 2010, the Company entered into a Patent Assignment Agreement (the “Valent Assignment Agreement”) with Valent pursuant to which Valent transferred to the Company all its right, title and interest in, and to, the patents for VAL-083 owned by Valent. The Company now owns all rights and title to VAL-083 and is responsible for further development and commercialization. In accordance with the terms of the Valent Assignment Agreement, Valent is entitled to receive a future royalty on all revenues derived from the development and commercialization of VAL-083. In the event that the Company terminates the agreement, the Company may be entitled to receive royalties from Valent’s subsequent development of VAL-083 depending on the development milestones the Company has achieved prior to the termination of the Valent Assignment Agreement.
On September 30, 2014, the Company entered into an exchange agreement (the “Valent Exchange Agreement”) with Valent and Del Mar (BC). Pursuant to the Valent Exchange Agreement, Valent exchanged its loan payable in the outstanding amount of $
Related party payables
As of December 31, 2023, there is an aggregate amount of $
7 Stockholders’ equity
Preferred stock
Series C Preferred Stock
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Series C Preferred Stock |
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Number |
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$ |
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Balance – June 30, 2023 |
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Conversion of Series C Preferred stock to common stock |
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( |
) |
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( |
) |
Balance – December 31, 2023 |
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In August 2020, the Company issued
The Series C Preferred Stock dividends do not require declaration by the board of directors and are accrued annually as of the date the dividend is earned in an amount equal to the fair value of the Company’s common stock on the dates the respective dividends are paid. The fair value of the Series C Preferred Stock dividend paid on August 19, 2023, was determined by multiplying the
10
dividends paid of
The Series C Preferred Stock shall with respect to distributions of assets and rights upon the occurrence of a liquidation, rank (i) senior to the Company’s common stock and (ii) senior to any other class or series of capital stock of the Company hereafter created which does not expressly rank pari passu with, or senior to, the Series C Preferred Stock. The Series C Preferred Stock is pari passu in liquidation to the Company’s Series A Preferred Stock. The liquidation value of the Series C Preferred Stock at December 31, 2023, is the stated value of $
The Company’s Series C Preferred Stock outstanding, conversion shares, and aggregate dividends as of December 31, 2023, are as follows:
Series |
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Number |
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Conversion |
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Number of |
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Dividend Shares (in thousands) |
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Series 1 |
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Series 2 |
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Series 3 |
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Series C Dividends |
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Dividend Shares |
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10% - August 19, 2021 (actual) |
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15% - August 19, 2022 (actual) |
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20% - August 19, 2023 (actual) |
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25% - August 19, 2024 (estimated) |
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Series A Preferred Stock
Effective September 30, 2014, the Company filed a Certificate of Designation of Series A Preferred Stock (the “Series A Certificate of Designation”) with the Secretary of State of Nevada. Pursuant to the Series A Certificate of Designation, the Company designated
The Series A Preferred Stock shall with respect to distributions of assets and rights upon the occurrence of a liquidation, rank (i) senior to the Company’s common stock, and (ii) senior to any other class or series of capital stock of the Company hereafter created which does not expressly rank pari passu with, or senior to, the Series A Preferred Stock. The Series A Preferred Stock is pari passu in liquidation to the Company’s Series C Preferred Stock. The liquidation value of the Series A Preferred stock at December 31, 2023, is its stated value of $
There was
Common stock
Common stock issuances during the six months ended December 31, 2023
On September 19, 2023, the Company entered into a Sales Agreement, (the “Sales Agreement”) with A.G.P./Alliance Global Partners (the “Agent”) pursuant to which the Company may offer and sell, from time to time, through the Agent, as sales agent and/or principal, shares of common stock having an aggregate offering price of up to $
11
proceeds, after deducting share issuance costs of $
During the six months ended December 31, 2023, the Company sold
During the six months ended December 31, 2023, the Company issued
Common stock issuances during the six months ended December 31, 2022
On August 2, 2022, the Company entered into a stock purchase agreement, dated as of August 2, 2022, (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to a maximum of $
Pursuant to the Purchase Agreement, the Company has the right, in its sole discretion, to present Lincoln Park with a purchase notice directing Lincoln Park to purchase up to
If the Company directs Lincoln Park to purchase the maximum number of shares of common stock that the Company may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park to purchase additional shares of common stock in an “accelerated purchase” (each, an “Accelerated Purchase”) and an “additional accelerated purchase” (each, an “Additional Accelerated Purchase”) (including multiple Additional Accelerated Purchases on the same trading day) as provided in the Purchase Agreement. The purchase price per share for each Accelerated Purchase and Additional Accelerated Purchase will be based on market prices of the common stock on the applicable purchase date for such Accelerated Purchases and such Additional Accelerated Purchases.
During the six months ended December 31, 2023, the Company received stockholder approval to issue
During the six months ended December 31, 2022, the Company sold
2017 Omnibus Incentive Plan
As subsequently approved by the Company’s stockholders at an annual meeting of stockholders, on April 11, 2018, the Company’s board of directors approved the adoption of the Company’s 2017 Omnibus Equity Incentive Plan (the “2017 Plan”), as amended. The board of directors also approved a form of Performance Stock Unit Award Agreement to be used in connection with grants of performance stock units (“PSUs”) as well as a Restricted Stock Unit ("RSU") award under the 2017 Plan. As approved by the Company’s stockholders on June 21, 2022, the number of common shares available under the 2017 Plan as of December 31, 2023, is
The following table sets forth the aggregate information on all equity compensation plans as of December 31, 2023:
12
Plan (in thousands, except per share amounts) |
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Number of shares of common stock to be issued upon exercise of outstanding stock options and rights |
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Weighted-average exercise price of stock options and rights |
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Number of shares of common stock remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))(2) |
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Equity compensation plans approved by security holders - 2017 Plan(1) |
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Equity compensation plans not approved by security holders - Del Mar (BC) 2013 Amended and Restated Stock Option Plan |
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— |
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Totals |
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(1) The Del Mar (BC) 2013 Amended and Restated Stock Option Plan refers to the Company’s previous equity compensation plan.
(2) The balance of
The maximum number of shares of Company common stock with respect to which any one participant may be granted awards during any calendar year is
Stock options
During the six months ended December 31, 2023, a total of
The following table sets forth changes in stock options outstanding under all plans:
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Number of |
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Weighted |
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Balance – June 30, 2023 |
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Granted |
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Expired |
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( |
) |
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Forfeited |
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( |
) |
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Balance – December 31, 2023 |
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The following table summarizes stock options outstanding and exercisable under all plans at December 31, 2023:
Exercise price |
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Number |
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Weighted |
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Number |
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— |
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13
Stock options granted during the six months ended December 31, 2023, have been valued using a Black-Scholes pricing model with the following assumptions:
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December 31, 2023 |
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Dividend rate |
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— |
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% |
Estimated volatility |
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% |
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Risk-free interest rate |
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% |
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Expected term – years |
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The estimated volatility of the Company’s common stock at the date of issuance of the stock options is based on the historical volatility of the Company. The risk-free interest rate is based on rates published by the government for bonds with a maturity similar to the expected remaining term of the stock options at the valuation date. The expected term of the stock options has been estimated using the plain vanilla method.
The Company has recognized the following amounts as stock option expense for the periods noted (in thousands):
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Three months ended |
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Six months ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Research and development |
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