HURA 10-Q
TuHURA Biosciences, Inc./NV (HURA)
ROC
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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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 |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 11, 2026, the registrant had
Table of Contents
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PART I. |
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1 |
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Item 1. |
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1 |
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2 |
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3 |
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4 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
5 |
Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
14 |
Item 3. |
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25 |
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Item 4. |
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25 |
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PART II. |
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26 |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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i
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward-looking statements. The words “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
These forward-looking statements include, among other things, statements about:
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q and our 2025 Annual Report filed with the Securities and Exchange Commission (“SEC“) on March 31, 2026, particularly in the “Risk Factors” section, that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or into which we may enter.
You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed or incorporated by reference as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
ii
PART I—FINANCIAL INFORMATION
Item 1. Condensed Financial Statements.
TuHURA Biosciences, Inc.
Condensed Consolidated Balance Sheets
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June 30, |
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December 31, |
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2026 |
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2025 |
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(Unaudited) |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Stock subscription receivable |
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- |
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Other current assets |
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Total Current Assets |
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Property and equipment, net |
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Operating right-of-use assets |
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Other noncurrent assets |
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Goodwill |
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In-process research and development |
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Revolving credit facility debt issuance costs, net |
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- |
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Total Assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current Liabilities: |
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Accounts payable and accrued expenses |
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$ |
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$ |
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Revolving credit facility - interest and annual fee |
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- |
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Revolving credit facility - commitment fee to be settled in shares |
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- |
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Lease liabilities, current |
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Total Current Liabilities |
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Long-term Liabilities: |
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Revolving credit facility borrowings, related party |
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Lease liability, long term |
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Deferred tax liability |
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Total Liabilities |
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Stockholders’ Equity: |
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Preferred Stock Series A (assumed in Kintara merger); $ |
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Common stock, $ |
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Additional paid in capital |
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Accumulated deficit |
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( |
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( |
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Total Stockholders’ Equity |
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Total Liabilities and Stockholders’ Equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
TuHURA Biosciences, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Research and development expenses |
$ |
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$ |
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$ |
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$ |
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Acquisition-related costs |
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- |
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- |
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General and administrative expenses |
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Operating Loss |
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( |
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( |
) |
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( |
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( |
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Other (Expense) Income: |
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Grant income |
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- |
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- |
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Interest expense |
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( |
) |
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- |
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( |
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- |
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Interest income |
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Total Other (Expense) Income |
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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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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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Net Loss attributable to common stockholders |
$ |
( |
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$ |
( |
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$ |
( |
) |
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$ |
( |
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Net Loss per share, basic and diluted |
$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Weighted-average shares outstanding, basic and diluted |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
TuHURA Biosciences, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
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Additional |
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Accumulated |
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Total |
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Preferred Stock |
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Common Stock |
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Paid in |
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Due from |
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Equity |
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Stockholders’ |
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Shares |
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Dollars |
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Shares |
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Dollars |
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Capital |
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Stockholders |
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(Deficit) |
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Equity |
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Balances at January 1, 2025 |
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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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Contributed capital for warrants |
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- |
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- |
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( |
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- |
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Stock options exercised, cashless |
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( |
) |
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- |
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- |
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- |
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Stock compensation expense |
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- |
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- |
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- |
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- |
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- |
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- |
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Series A Preferred Stock cash |
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( |
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( |
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Net loss |
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- |
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- |
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- |
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- |
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- |
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- |
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( |
) |
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( |
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Balances at March 31, 2025 |
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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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Issuance of common shares for warrants |
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- |
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- |
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- |
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Issuance of common shares, net of |
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- |
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- |
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- |
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- |
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Issuance of common shares for Kineta |
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- |
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- |
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- |
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- |
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Stock options exercised, cashless |
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( |
) |
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- |
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- |
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- |
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Stock compensation expense |
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- |
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- |
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- |
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- |
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- |
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- |
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Series A Preferred Stock cash |
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- |
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- |
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- |
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- |
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- |
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- |
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( |
) |
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( |
) |
Net loss |
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- |
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- |
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- |
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- |
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- |
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- |
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( |
) |
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( |
) |
Balances at June 30, 2025 |
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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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Additional |
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Accumulated |
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Total |
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Preferred Stock |
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Common Stock |
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Paid in |
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Due from |
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Equity |
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Stockholders’ |
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Shares |
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Dollars |
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Shares |
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Dollars |
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Capital |
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Stockholders |
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(Deficit) |
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Equity |
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Balances at January 1, 2026 |
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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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Issuance of common shares in RDO, |
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- |
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- |
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- |
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- |
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Stock compensation expense |
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- |
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- |
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- |
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- |
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- |
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- |
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Series A Preferred Stock cash |
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- |
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- |
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- |
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- |
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- |
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- |
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( |
) |
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( |
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Net loss |
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- |
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- |
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- |
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- |
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- |
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- |
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( |
) |
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( |
) |
Balances at March 31, 2026 |
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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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Issuance of common shares in ATM, |
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- |
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- |
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- |
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- |
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Stock compensation expense |
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- |
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- |
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- |
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- |
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- |
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- |
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Warrant modification associated with |
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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 A Preferred Stock cash |
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- |
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- |
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- |
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- |
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- |
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- |
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( |
) |
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( |
) |
Net loss |
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- |
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- |
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- |
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- |
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- |
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- |
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( |
) |
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( |
) |
Balances at June 30, 2026 |
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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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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
TuHURA Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Six months ended |
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June 30, |
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June 30, |
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2026 |
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2025 |
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Cash flows from Operating activities: |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
Adjustments to reconcile net loss to cash |
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used in operating activities: |
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Stock compensation expense |
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Depreciation and amortization |
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Amortization of deferred loan costs |
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- |
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Changes in operating assets and liabilities: |
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Other current assets |
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( |
) |
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Other noncurrent assets |
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( |
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Accrued interest |
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- |
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Accounts payable and accrued expenses |
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( |
) |
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Net cash flows from operating activities |
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( |
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( |
) |
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Cash flows from investing activities: |
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Cash paid for business acquisition, net of cash received from Kineta |
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- |
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( |
) |
Purchase of property and equipment |
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( |
) |
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( |
) |
Net cash flows from investing activities |
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( |
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( |
) |
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Cash flows from financing activities: |
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Cash dividend payment of preferred stock Series A |
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( |
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( |
) |
Proceeds from warrants exercised |
|
|
- |
|
|
|
|
|
Proceeds from revolving credit facility |
|
|
|
|
|
- |
|
|
Payment of revolving credit facility debt issuance costs |
|
|
( |
) |
|
|
- |
|
Proceeds from issuance of common stock |
|
|
|
|
|
|
||
Payments made on Kineta severance promissory notes |
|
|
( |
) |
|
|
- |
|
Payment of transaction costs related to Kintara merger |
|
|
- |
|
|
|
( |
) |
Principal payments of finance lease |
|
|
( |
) |
|
|
- |
|
Payment of placement agent fees and offering costs |
|
|
( |
) |
|
|
( |
) |
Payment of net liabilities assumed in reverse recapitalization with Kintara |
|
|
- |
|
|
|
( |
) |
Net cash flows from financing activities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Net change in cash and cash equivalents |
|
|
( |
) |
|
|
( |
) |
Cash and cash equivalents at the beginning of the period |
|
|
|
|
|
|
||
Cash and cash equivalents at the end of the period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
|
|
$ |
- |
|
|
Supplemental non-cash activity |
|
|
|
|
|
|
||
Due from stockholders not yet received for common stock |
|
$ |
- |
|
|
$ |
|
|
Consideration in common shares for Kineta acquisition |
|
|
- |
|
|
|
|
|
Fair value of placement agent warrants issued in connection with common stock issuance |
|
|
- |
|
|
|
|
|
Fair value of investor warrants issued in connection with common stock issuance |
|
|
- |
|
|
|
|
|
Warrant amendment agreements modified in connection with revolving credit facility |
|
|
|
|
|
- |
|
|
Revolving credit facility commitment fee not yet paid |
|
|
|
|
|
- |
|
|
Revolving credit facility issuance costs not yet paid |
|
|
|
|
|
- |
|
|
Offering costs not yet paid |
|
|
|
|
|
|
||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
TuHURA Biosciences, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
Note 1—Description of business and basis of presentation
TuHURA Biosciences, Inc., a Nevada corporation (“we,” “our,” “TuHURA,” or the “Company”), is a clinical stage immuno-oncology company with three distinct technologies focused on the development of novel therapeutics designed to overcome primary and acquired resistance to cancer immunotherapies.
Our proprietary Immune FxTM technology platform, or IFx, is an innate immune agonist technology designed to “trick” the body’s immune system to attack tumor cells by making tumor cells look like bacteria. Our lead product candidate, IFx-2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. In June 2025, we initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for patients with advanced or metastatic Merkel cell carcinoma who are checkpoint inhibitor naïve utilizing the FDA’s accelerated approval pathway. We anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 in the second half of 2027.
In addition to our IFx technology platform, in June 2025 we acquired the rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody formerly known as KVA12123, through our acquisition of Kineta, Inc. (“Kineta”) via merger on June 30, 2025 (the “Kineta Merger”). VISTA (otherwise referred to as V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells that is believed to be a strong driver of immunosuppression in the tumor microenvironment and is believed to be a primary mechanism by which leukemic blasts escape immune recognition contributing to low response rates and high rates of recurrence in acute myeloid leukemia, or AML. Following our acquisition of Kineta, we are currently planning on investigating TBS-2025 in a Phase 1b/2 trial in patients with r/r mutNPM1 AML.
In addition to IFx and TBS-2025, we are leveraging our Delta Opioid Receptor (DOR) technology to develop first-in-class bi-functional, bi-specific antibody-drug conjugates (“ADCs”) targeting the DOR on Myeloid Derived Suppressor Cells (“MDSCs”) to modulate their immunosuppressive influence on the bone marrow and tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
Note 2—Summary of significant accounting policies
Basis for Consolidation – The condensed consolidated 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 unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Adgero Biopharmaceuticals Holdings Inc., Adgero Biopharmaceuticals, Inc., Kineta, LLC, and TuHURA Biosciences, Inc., a Delaware corporation (“Legacy TuHURA”). All intercompany balances and transactions have been eliminated in consolidation.
The Company’s significant accounting policies are described herein and in Note 2, “Summary of significant accounting policies,” in the 2025 Annual Report. There have been no changes to the significant accounting policies during the six months ended June 30, 2026.
Reclassification – The Company reclassified the break-out of $
Accounting Estimates – The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect various amounts reported in condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates.
Research and Development Expenses – Research and development consists of expenses incurred in connection with the discovery and development of product candidates. The Company expenses research and development costs as incurred.
5
Concentration of Credit Risk – The Company maintains cash balances in domestic financial institutions. These balances are insured by the Federal Deposit Insurance Corporation up to $
Stock Compensation Expense – The Company accounts for stock-based awards to employees and nonemployees using the fair value-based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation. Fair value of each common stock option is estimated on the date of grant using the Black-Scholes valuation model. The Black-Scholes model uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatility is based on historical volatility of a peer group’s common stock and other factors estimated over the expected term of the options. The expected term of the options granted is derived using the “simplified method” which computes expected term as the average of the sum of the average vesting term plus the contract term. The risk-free rate is based on the U.S. Treasury yield.
Business Combinations and Asset Acquisitions – We account for acquired businesses using the acquisition method of accounting, which requires that the assets acquired, and liabilities assumed be recorded at the date of acquisition at their respective fair values if the acquisition meets the definition of a business combination. If the acquisition does not meet the definition of a business combination, then it is accounted for as an asset acquisition and the purchase consideration is allocated to the acquired assets.
Indefinite-Lived Intangible Assets – Indefinite-lived intangible assets consist of In-Process Research and Development (“IPR&D”). The fair values of IPR&D project assets acquired in business combinations are capitalized. We utilized the Cost Method to determine the estimated fair value of the IPR&D assets acquired in our recent business combination with Kineta. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate.
Intangible assets with indefinite lives, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. However, an entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that an indefinite-lived intangible asset’s fair value is less than its carrying amount. Otherwise, no further impairment testing is required. The indefinite-lived intangible asset impairment test consists of a one-step analysis that compares the fair value of the intangible asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. The Company considers many factors in evaluating whether the value of our intangible assets with indefinite lives may not be recoverable, including, but not limited to, the cost of equity and debt capital, general economic conditions, outlook and market performance of the Company’s industry and recent and forecasted financial performance.
We will evaluate indefinite-lived intangible assets for impairment at least annually and whenever facts and circumstances indicate that their carrying amounts may not be recoverable. The Company did not identify any impairment triggering events during the six months ended June 30, 2026.
Goodwill – Goodwill represents the amount of consideration paid in excess of the fair value of net assets acquired as a result of the Company’s business acquisitions accounted for using the acquisition method of accounting. Goodwill is not amortized and is subject to impairment testing at a reporting unit level on an annual basis or when a triggering event occurs that may indicate the carrying value of the goodwill is impaired. An entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that the fair value of the reporting units is less than its carrying amount.
We will evaluate goodwill for impairment at least annually and whenever facts and circumstances indicate that their carrying amounts may not be recoverable. The Company did not identify any impairment triggering events during the six months ended June 30, 2026.
Deferred loan costs on revolving credit facility – Deferred loan costs incurred in connection with obtaining our $50 million revolving credit facility (the “Parkview Credit Facility”) with Parkview Holdings One LLC (“Parkview”) are capitalized and
6
amortized to the maturity date and are presented as an asset. Amortization of debt issuance costs is included in interest expense in the consolidated statements of operations.
Segment Data – The Company operates in one reportable segment, which includes all activities related to advancing therapies for cancer treatment. The determination of a single reportable segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker, which is its chief executive officer, who reviews and evaluates consolidated net loss for purposes of assessing performance, making operating decisions, allocating resources and planning and forecasting for future periods. The measure of segment assets is reported on the balance sheet as total assets. There is no segment revenue for the three and six months ended June 30, 2026, and 2025. The accounting policies of the cancer treatment segment are the same as those described in the summary of significant accounting policies. All tangible assets are held in the United States.
Net loss per share – Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the Company has reported net losses for each period presented.
Note 3—Liquidity and management’s plans
The Company has been engaged in research and development activities related to Immune Fx, TBS-2025, and ADCs, which will require additional investment until revenue-generating activities can begin.
The Company has historically incurred negative cash flows from operations, and these operating cash deficits have been funded through a combination of debt and equity financings.
For the six months ended June 30, 2026, the Company incurred $
The Company expects to raise cash through the sale of capital stock and warrants, debt issuances and draw-downs, obtaining grants, or commercial partnerships. However, there can be no assurance that any fundraising will be achieved or on commercially reasonable terms, if at all.
Note 4—Net loss per share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows:
|
Three months ended June 30 |
|
|
Six months ended June 30 |
|
||||||||||||
|
2026 |
|
|
|
2025 |
|
|
2026 |
|
|
|
2025 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss attributable to common stockholders |
$ |
( |
) |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average common shares outstanding - basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to common shareholders - basic and diluted |
$ |
( |
) |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
$ |
( |
) |
Common stock warrants in the amount of
The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. For the three months ended
7
|
As of June 30 |
|
|
||||||
|
2026 |
|
|
|
2025 |
|
|
||
Stock options issued and outstanding |
|
|
|
|
|
|
|
||
Unvested restricted stock units |
|
|
|
|
|
|
|
||
Warrants |
|
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
|
||
Note 5—Other current assets
Other current assets consist of the following as of June 30, 2026, and December 31, 2025:
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Prepaid insurance |
|
$ |
|
|
$ |
|
||
Clinical trial deposit |
|
|
|
|
|
|
||
Other current assets |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
Note 6—Property and equipment, net
Property and equipment, net consists of the following as of June 30, 2026, and December 31, 2025:
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Furniture and fixtures |
|
$ |
|
|
$ |
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Machinery and office equipment |
|
|
|
|
|
|
||
Software |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Less accumulated depreciation and amortization |
|
|
( |
) |
|
|
( |
) |
|
|
$ |
|
|
$ |
|
||
Depreciation and amortization of property and equipment totaled approximately $
Note 7—Accounts payable and accrued expenses
Accounts payable and accrued expenses consist of the following as of June 30, 2026, and December 31, 2025:
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Trade accounts payable |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
Note 8—Revolving Credit Facility
Parkview Credit Facility
On April 21, 2026, the Company entered into a Loan Agreement (the “Loan Agreement”) with Parkview, an affiliate of K&V Investment LLC (“K&V Investment One”) (a holder of more than
8
to repay principal equal to
Each borrowing shall be an amount not to exceed the greater of (i) $
In connection with the Loan Agreement, the Company and Parkview entered into: (i) a Fee Letter pursuant to which the Company agreed to pay a one-time commitment fee of $
The Loan Agreement contains certain embedded features that were identified and evaluated as not material to the condensed consolidated financial statements. In particular, due to inherent uncertainties involved in bringing a product through regulatory approval, the Royalty Agreement has nominal value and therefore none of the debt proceeds have been allocated to this feature.
A summary of the revolving credit facility activity is as follows:
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Drawdowns |
|
$ |
|
|
$ |
|
||
Contractual interest |
|
|
|
|
|
|
||
1.5% accrued annual cash facility fee |
|
|
|
|
|
|
||
Less: Payments |
|
|
|
|
|
|
||
Less: Current portion of contractual interest and annual facility fee |
|
|
( |
) |
|
|
|
|
Revolving credit facility |
|
$ |
|
|
$ |
|
||
A summary of the debt issuance costs activity is as follows:
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Transaction costs |
|
$ |
|
|
$ |
|
||
Warrant amendment agreements modification at incremental fair value |
|
|
|
|
|
|
||
One-time commitment fee letter to be paid in shares |
|
|
|
|
|
|
||
Less: Amortization of debt issuance costs |
|
|
( |
) |
|
|
|
|
Revolving credit facility debt issuance costs, net |
|
$ |
|
|
$ |
|
||
The following table details interest expense related to the revolving credit facility.
|
|
Three months ended June 30 |
|
|
Six months ended June 30 |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Amortization of debt issuance costs |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Annual cash facility fee |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contractual interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total interest expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
9
Future principal, contractual interest, and facility fee payments on the Parkview Credit Facility are due as follows:
|
|
Amounts |
|
|||||||||
|
|
Principal |
|
|
Contractual |
|
|
Facility Fee |
|
|||
Year ending December 31, 2026 (6 months) |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Year ending December 31, 2027 |
|
|
|
|
|
|
|
|
|
|||
Year ending December 31, 2028 |
|
|
|
|
|
|
|
|
|
|||
Year ending December 31, 2029 |
|
|
|
|
|
|
|
|
|
|||
Year ending December 31, 2030 |
|
|
|
|
|
|
|
|
|
|||
Year ending December 31, 2031 |
|
|
|
|
|
|
|
|
|
|||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
Note 9—Income taxes
Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to be reversed. Valuation allowances are provided if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, including its net operating losses. Based on its history of operating losses, the Company believes that it is more likely than not that the benefit of its deferred tax assets will not be realized. Accordingly, the Company has provided a full valuation allowance for deferred tax assets as of June 30, 2026, and December 31, 2025.
Note 10—Stockholders’ equity
As of June 30, 2026, the Company had two classes of stock authorized in its Articles of Incorporation, as amended (the “Articles”).
Common Stock
The Company is authorized to issue up to
Preferred Stock
The Company is authorized to issue up to
The historical Kintara Series A Preferred Stock was assumed in connection with our October 2024 reverse merger transaction with Kintara Therapeutics, Inc. (the “Kintara Merger”), and
ATM Program
On November 3, 2025, the Company and Wainwright entered into an At-The-Market Offering Agreement (the “Offering Agreement”) with respect to an at-the-market offering program (the “ATM Program”) under which the Company may sell shares of its common stock having an aggregate offering price of up to $
10
Warrants
The following table summarizes the Company’s outstanding common stock warrants as of June 30, 2026.
|
|
Outstanding |
|
|
Weighted |
|
|
Expiration dates |
|||
Legacy TuHURA common stock warrants |
|
|
|
|
$ |
|
|
to |
|||
Historical Kintara common stock warrants |
|
|
|
|
$ |
|
|
to |
|||
2024 common stock warrants issued to financial advisor |
|
|
|
|
$ |
|
|
||||
2025 PIPE investors common stock warrants |
|
|
|
|
$ |
|
|
||||
2025 PIPE placement agent common stock warrants |
|
|
|
|
$ |
|
|
||||
Bridge loan warrants |
|
|
|
|
$ |
|
|
to |
|||
2025 RDO Series A investors common stock warrants |
|
|
|
|
$ |
|
|
||||
2025 RDO Series B investors common stock warrants |
|
|
|
|
$ |
|
|
||||
2025 RDO placement agent common stock warrants |
|
|
|
|
$ |
|
|
||||
Total warrants outstanding at June 30, 2026 |
|
|
|
|
|
$ |
|
|
|
||
|
|
|
|
|
|
|
|
|
|||
Warrant Amendment Agreements
On April 21, 2026, the Company entered into two Warrant Amendment Agreements to extend to April 21, 2031, the exercise period during which
Note 11—Stock option plans
Stock options
The Company uses the Black-Scholes option pricing model to estimate the fair value of stock-based awards on the date of grant. The assumptions employed in the calculation of the fair value of share-based compensation expense were calculated as follows for the six months ended June 30, 2026 and 2025:
|
|
|
2026 |
|
|
2025 |
|
||
Common stock fair value (weighted-average) |
|
|
$ |
|
|
$ |
|
||
Risk free interest rate |
|
|
|
|
|
||||
Expected dividend yield |
|
|
|
|
|
||||
Expected term |
|
|
|
|
|
||||
Expected stock volatility |
|
|
|
|
|
||||
Below is a summary of stock option activity for the six months ended June 30, 2026:
11
|
|
|
|
Weighted |
|
|
Weighted |
||
|
Number |
|
|
Average |
|
|
Average |
||
|
of options |
|
|
Exercise Price |
|
|
Contractual Life |
||
Outstanding at December 31, 2025 |
|
|
|
$ |
|
|
|||
|
|
|
|
|
|
|
|
||
Forfeited and cancelled |
|
( |
) |
|
$ |
|
|
|
|
Exercised |
|
|
|
$ |
|
|
|
||
Granted |
|
|
|
$ |
|
|
|
||
Outstanding at June 30, 2026 |
|
|
|
$ |
|
|
|||
Exercisable at June 30, 2026 |
|
|
|
$ |
|
|
|||
Options outstanding had an intrinsic value of approximately $
Stock compensation expense
Total stock-based compensation expense for the six months ended June 30, 2026 and 2025 was allocated as follows:
|
|
|
2026 |
|
|
2025 |
|
||
General and administrative |
|
|
$ |
|
|
$ |
|
||
Research and development |
|
|
|
|
|
|
|
||
Total stock-based compensation expense |
|
|
$ |
|
|
$ |
|
||
Note 12—Commitments and contingencies
Lease Commitments – The Company leases facilities under non-cancelable operating leases for the laboratory and offices in Tampa, Florida, and finance leases for laboratory equipment. The current operating lease expires in March 2028 and finance lease expires in June 2028. Operating leases are included in Operating right of use assets, Lease liabilities, current and Lease liability, long term. Finance leases are included in Property and equipment, net, Lease liabilities, current and Lease liability, long term.
Future minimum lease payments under these leases are as follows:
|
Finance |
|
|
Operating |
|
||
Year ending December 31, 2026 (6 months) |
$ |
|
|
$ |
|
||
Year ending December 31, 2027 |
|
|
|
|
|
||
Year ending December 31, 2028 |
|
|
|
|
|
||
Interest portion of right of use liability |
|
( |
) |
|
|
( |
) |
Lease liabilities |
$ |
|
|
$ |
|
||
Operating leases – Total lease expense was approximately $
Cash paid for amounts included in the measurement of lease liabilities was approximately $
For the current lease, the weighted-average lease term is
Finance leases – Cash paid for amounts included in the measurement of finance lease liabilities was $
For the current finance lease, the weighted-average lease term is
12
Employment Agreements – The Company maintains employment agreements with its Chief Executive Officer and Chief Financial Officer, each entered into in May 2023 by Legacy TuHURA, as amended and as subsequently assumed by the Company in connection with the closing of the Kintara Merger.
Future minimum payments under these employment agreements are as follows:
Year ending December 31, 2026 (6 months) |
|
|
$ |
|
|
Year ending December 31, 2027 |
|
|
|
|
|
|
|
|
$ |
|
Note 13—Related Party Transactions
Tendler Biotech Consulting
On March 18, 2026, we entered into a Consulting Agreement with Tendler Biotech Consulting LLC (“Tendler Biotech”), an entity owned by one of the Company's directors, Dr. Craig Tendler. Under this agreement, Dr. Tendler provides, through Tendler Biotech, specified consulting services on an as-requested basis relating to the Company’s development strategy and operations in connection with the Company’s product pipeline. Under this agreement, Tendler Biotech is entitled to receive an hourly fee of $
Loan Agreement
On April 21, 2026, we entered into the Loan Agreement with Parkview. Pursuant to the Loan Agreement, Parkview agreed to extend a $
Note 14—Subsequent events
Subsequent events – The Company has evaluated subsequent events through August 14, 2026 in connection with the preparation of these unaudited condensed consolidated financial statements, which is the date the financial statements were available to be issued.
Parkview Credit Facility
The Company has, subsequent to June 30, 2026, borrowed under the Parkview Credit Facility in the amount of $
ATM Program
The Company has, subsequent to June 30, 2026, issued
13
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and audited consolidated financial statements in the Annual Report on Form 10-K filed with the SEC on March 31, 2026 (the “2025 Annual Report”). Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth under the heading “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, as well as those set forth under the heading “Risk Factors” in Part I, Item 1A in the 2025 Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. See also “Special Note Regarding Forward-Looking Statements”.
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025. References to periods prior to the closing of the Kintara Merger refer to Legacy TuHURA, and to TuHURA Biosciences, Inc. (formerly Kintara Therapeutics, Inc. (“Kintara”)) for all other periods, as the context requires.
Overview
We are a clinical stage immuno-oncology company developing novel technologies designed to overcome primary and acquired resistance to cancer immunotherapies. Our proprietary Immune FxTM technology platform, or IFx, is an innate immune agonist technology designed to “trick” the body’s immune system to attack tumor cells by making tumor cells look like bacteria. Our lead product candidate, IFx-2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. In June 2025, we initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for patients with advanced or metastatic Merkel cell carcinoma who are checkpoint inhibitor naïve utilizing the FDA’s accelerated approval pathway. In addition to our IFx technology platform, in June 2025 we acquired the rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody formerly known as KVA12123, through our acquisition of Kineta, Inc. (“Kineta”) on June 30, 2025 (the “Kineta Merger”). VISTA (otherwise referred to as V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells that is believed to be a strong driver of immunosuppression in the tumor microenvironment and is believed to be a primary mechanism by which leukemic blasts escape immune recognition contributing to low response rates and high rates of recurrence in acute myeloid leukemia, or AML. Following our acquisition of Kineta, we are currently planning on investigating TBS-2025 in a Phase 1b/2 trial in combination with a menin inhibitor vs menin inhibitor alone in mutNPM1 AML.
To date, we have devoted substantially all of our resources to organizing and staffing, business planning, raising capital, identifying and developing product candidates, enhancing our intellectual property portfolio, undertaking research, conducting preclinical studies and clinical trials, and securing manufacturing for our development programs. We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations primarily through debt financings, the issuance of capital stock, warrants and convertible notes.
We are not profitable and have incurred significant operating losses in each period since our inception, including net losses of $9.2 million and $16.8 million for the three and six months ended June 30, 2026, and $30.1 million for the year ended December 31, 2025. As of June 30, 2026, we had an accumulated deficit of $157.9 million. Our operating losses may fluctuate significantly from quarter-to-quarter and year-to-year as a result of several factors, including the timing of our preclinical studies and clinical trials and the expenditures related to other research and development activities. We expect to continue to incur operating losses. We anticipate these losses will increase substantially as we advance our product candidates through preclinical and clinical development, develop additional product candidates and seek regulatory approvals for our product candidates. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more product candidates. In addition, if we obtain marketing approval for any product candidate, we expect to incur pre-commercialization expenses and significant commercialization expenses related to marketing, sales, manufacturing and distribution. We may also incur expenses in connection with the in-licensing of additional product candidates.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity offerings, debt financings, collaborations and licensing arrangements or other capital sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates that we would otherwise prefer to develop and market ourselves.
14
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
As of June 30, 2026, we had cash and cash equivalents of $1.0 million. See “ — Liquidity and Capital Resources” below.
Recent Developments
Parkview Credit Facility
On April 21, 2026, the Company entered into a Loan Agreement (the “Loan Agreement”) with Parkview Holdings One LLC (“Parkview”), an affiliate of K&V Investment LLC (“K&V Investment One”) (a holder of more than 5% of the Company’s fully diluted capital stock and an entity owned by Mr. Vijay Patel), pursuant to which Parkview agreed to extend a $50 million revolving credit facility to the Company maturing on April 21, 2031. Borrowings under the facility bear interest at 12% per annum (plus an additional 6% during any event of default), payable monthly in arrears, and are secured by substantially all assets of the Company and its subsidiaries. The Company is obligated to repay principal equal to 75% of net profits from pharmaceutical product sales from the prior quarter if it achieves net profits for two consecutive fiscal quarters. As of the date of this Quarterly Report on Form 10-Q, the Company has borrowed approximately $5.8 million under the Loan Agreement since the inception of the Parkview Credit Facility.
In connection with the Loan Agreement, the Company and Parkview entered into: (i) a Fee Letter pursuant to which the Company agreed to pay a one-time commitment fee of $5 million, which the Company elected to pay by issuing 1,878,287 shares of common stock to Parkview (subject to stockholder approval), and an annual facility fee of 1.5% of the total commitment beginning on the first anniversary; (ii) a Royalty Agreement granting Parkview an annual royalty in the low to mid-single digits on Net Sales (as defined therein) of products based on the Company’s IFx-2.0 intellectual property, up to $450 million in Net Sales per year, continuing through the last-to-expire IFx-2.0 patent; and (iii) two Warrant Amendment Agreements extending to April 21, 2031 the exercise period for 4,364,873 warrants to purchase common stock held by K&V Investment One (3,049,432 warrants at $3.69 per share and 1,315,441 warrants at $5.70 per share).
ATM Program
On November 3, 2025, the Company and H.C. Wainwright & Co., LLC (“Wainwright”) entered into an At-The-Market Offering Agreement (the “Offering Agreement”) with respect to an at-the-market offering program (the “ATM Program”) under which the Company may sell shares of its common stock having an aggregate offering price of up to $50,000,000 through Wainwright as its sales agent. On April 8, 2026, the Company filed a prospectus supplement to the Company’s shelf registration statement on Form S-3 filed with the SEC on November 3, 2025 (File No. 333-291239) relating to the shares of common stock available for sale under the Offering Agreement. The Company began making sales under the Offering Agreement in 2026, selling an aggregate of 301,545 shares of common stock at a weighted average price of $2.61 per share for gross proceeds of approximately $0.8 million since the program’s inception.
Components of Our Results of Operations
Revenue
We did not generate any revenue and do not expect to generate any revenue from the sale of products in the near future.
Research and Development Expenses
To date, our research and development expenses have related primarily to the development of IFx-2.0, IFx-3.0 (which we are no longer advancing), TBS-2025, manufacturing, clinical studies, and other early pre-clinical activities related to our portfolio. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
15
Research and development expenses include:
Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial portion of our clinical trial activities, utilizing external entities such as CROs, independent clinical investigators and other third-party service providers to assist us with the execution of our clinical trials.
We plan to substantially increase our research and development expenses for the foreseeable future as we continue the development of our product candidates and seek to discover and develop new product candidates.
Due to the inherently unpredictable nature of preclinical and clinical development, we cannot determine with certainty the timing of the initiation, duration or costs of future clinical trials and preclinical studies of product candidates. Clinical and preclinical development timelines, the probability of success and the amount of development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates and development programs to pursue and how much funding to direct to each product candidate or program on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments and our ongoing assessments as to each product candidate’s commercial potential. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
Our future clinical development costs may vary significantly based on factors such as:
16
Acquisition-related costs
Acquisition-related costs, consisting of expenses incurred in connection with a business combination, including legal, advisory, accounting, and valuation fees, are expensed as incurred.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for personnel in our executive, finance, and other administrative functions. Other significant costs include facility related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services and insurance costs. We anticipate that our general and administrative expenses will increase in the future to support our continued research and development activities, and, if any product candidates receive marketing approval, commercialization activities. We also anticipate increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums and investor relations costs associated with operating as a public company.
Other Income (Expense)
Other income (expense) consists of interest income on our cash and cash equivalents, interest expense on the issued notes payable to the former Kineta employees, and grant income from our NIH-funded research grant assumed in our October 2024 reverse merger transaction with Kintara Therapeutics, Inc. (“Kintara”, and such merger, the “Kintara Merger”).
Results of Operations
Comparisons for the Three Months Ended June 30, 2026, and June 30, 2025
|
|
Three months ended |
|
|
|
|
||||||
|
|
June 30, |
|
|
Change |
|
||||||
|
|
2026 |
|
|
2025 |
|
|
|
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
6,620,323 |
|
|
$ |
4,926,936 |
|
|
$ |
1,693,387 |
|
Acquisition-related costs |
|
|
- |
|
|
|
3,086,982 |
|
|
|
(3,086,982 |
) |
General and administrative |
|
|
2,142,961 |
|
|
|
1,862,038 |
|
|
|
280,923 |
|
Total operating expenses |
|
|
8,763,284 |
|
|
|
9,875,956 |
|
|
|
(1,112,672 |
) |
Loss from operations |
|
|
(8,763,284 |
) |
|
|
(9,875,956 |
) |
|
|
1,112,672 |
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|||
Grant income |
|
|
- |
|
|
|
322,655 |
|
|
|
(322,655 |
) |
Interest expense |
|
|
(467,634 |
) |
|
|
- |
|
|
|
(467,634 |
) |
Interest income |
|
|
7,620 |
|
|
|
29,466 |
|
|
|
(21,846 |
) |
Total other income (expense) |
|
|
(460,014 |
) |
|
|
352,121 |
|
|
|
(812,135 |
) |
Net loss |
|
$ |
(9,223,298 |
) |
|
$ |
(9,523,835 |
) |
|
$ |
300,537 |
|
Series A Preferred cash dividend |
|
|
(2,089 |
) |
|
|
(2,089 |
) |
|
|
- |
|
Net loss attributable to common shareholders |
|
$ |
(9,225,387 |
) |
|
$ |
(9,525,924 |
) |
|
$ |
300,537 |
|
17
Research and Development Expenses. The following table summarizes our research and development expenses by program for the periods presented.
|
|
Three months ended |
|
|
|
|
||||||
|
|
June 30, |
|
|
Change |
|
||||||
|
|
2026 |
|
|
2025 |
|
|
|
|
|||
Direct program costs: |
|
|
|
|
|
|
|
|
|
|||
IFx-2.0 |
|
$ |
2,504,053 |
|
|
$ |
1,999,543 |
|
|
$ |
504,510 |
|
TBS-2025 |
|
|
746,885 |
|
|
|
- |
|
|
|
746,885 |
|
Preclinical research costs |
|
|
259,336 |
|
|
|
593,490 |
|
|
|
(334,154 |
) |
Indirect program costs: |
|
|
|
|
|
|
|
|
|
|||
Personnel and facilities related costs |
|
|
3,110,049 |
|
|
|
2,333,903 |
|
|
|
776,146 |
|
Total research and development expenses |
|
$ |
6,620,323 |
|
|
$ |
4,926,936 |
|
|
$ |
1,693,387 |
|
Research and development expenses were $6.6 million and $4.9 million for the three months ended June 30, 2026, and 2025, respectively. The increase of $1.7 million is related to the following.
Acquisition-related costs. Acquisition-related costs were $3.1 million for the three months ended June 30, 2025 and represent costs incurred in relation to the Kineta Merger.
General and Administrative Expenses. General and administrative expenses were $2.1 million and $1.9 million for the three months ended June 30, 2026, and 2025, respectively. The increase of $0.3 million was primarily due to increases in non-cash stock compensation expense and costs associated with being a public company.
Grant Income. Grant income was $0.3 million for the three months ended June 30, 2025. In October 2024, we assumed the Kintara Health and Human Services grant on REM-001 and received reimbursements for related expenses associated with the grant.
Interest Expense. Interest expense was $0.5 million for the three months ended June 30, 2026 related primarily to the Parkview credit facility.
Interest Income. Interest income was less than $0.1 million for the three months ended June 30, 2026 and 2025, respectively, related primarily to interest income earned on deposits at various banks.
Preferred Stock Series A cash dividend. The holder of our Series A Preferred Stock received cash dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
18
Comparisons for the Six Months Ended June 30, 2026, and June 30, 2025
|
|
Six months ended |
|
|
|
|
||||||
|
|
June 30, |
|
|
Change |
|
||||||
|
|
2026 |
|
|
2025 |
|
|
|
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
11,852,864 |
|
|
$ |
9,508,608 |
|
|
$ |
2,344,256 |
|
Acquisition-related costs |
|
|
- |
|
|
|
3,506,025 |
|
|
|
(3,506,025 |
) |
General and administrative |
|
|
4,440,319 |
|
|
|
3,878,346 |
|
|
|
561,973 |
|
Total operating expenses |
|
|
16,293,183 |
|
|
|
16,892,979 |
|
|
|
(599,796 |
) |
Loss from operations |
|
|
(16,293,183 |
) |
|
|
(16,892,979 |
) |
|
|
599,796 |
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|||
Grant income |
|
|
- |
|
|
|
575,209 |
|
|
|
(575,209 |
) |
Interest expense |
|
|
(495,608 |
) |
|
|
- |
|
|
|
(495,608 |
) |
Interest income |
|
|
28,895 |
|
|
|
129,564 |
|
|
|
(100,669 |
) |
Total other income (expense) |
|
|
(466,713 |
) |
|
|
704,773 |
|
|
|
(1,171,486 |
) |
Net loss |
|
$ |
(16,759,896 |
) |
|
$ |
(16,188,206 |
) |
|
$ |
(571,690 |
) |
Series A Preferred cash dividend |
|
|
(4,178 |
) |
|
|
(4,178 |
) |
|
|
- |
|
Net loss attributable to common shareholders |
|
$ |
(16,764,074 |
) |
|
$ |
(16,192,384 |
) |
|
$ |
(571,690 |
) |
Research and Development Expenses. The following table summarizes our research and development expenses by program for the periods presented.
|
|
Six months ended |
|
|
|
|
||||||
|
|
June 30, |
|
|
Change |
|
||||||
|
|
2026 |
|
|
2025 |
|
|
|
|
|||
Direct program costs: |
|
|
|
|
|
|
|
|
|
|||
IFx-2.0 |
|
$ |
3,834,763 |
|
|
$ |
4,080,386 |
|
|
$ |
(245,623 |
) |
TBS-2025 |
|
|
1,265,193 |
|
|
|
- |
|
|
|
1,265,193 |
|
Preclinical research costs |
|
|
536,311 |
|
|
|
1,019,046 |
|
|
|
(482,735 |
) |
Indirect program costs: |
|
|
|
|
|
|
|
|
|
|||
Personnel and facilities related costs |
|
|
6,216,597 |
|
|
|
4,409,176 |
|
|
|
1,807,421 |
|
Total research and development expenses |
|
$ |
11,852,864 |
|
|
$ |
9,508,608 |
|
|
$ |
2,344,256 |
|
Research and development expenses were $11.9 million and $9.5 million for the six months ended June 30, 2026, and 2025, respectively. The increase of $2.3 million is related to the following.
Acquisition-related costs. Acquisition-related costs were $3.5 million for the six months ended June 30, 2025 and represent costs incurred in relation to the Kineta Merger.
General and Administrative Expenses. General and administrative expenses were $4.4 million and $3.9 million for the six months ended June 30, 2026, and 2025, respectively. The increase of $0.6 million was primarily due to increases in non-cash stock compensation expense and costs associated with being a public company.
Grant Income. Grant income was $0.6 million for the six months ended June 30, 2025. In October 2024, we assumed the Kintara Health and Human Services grant on REM-001 and received reimbursements for related expenses associated with the grant.
19
Interest Expense. Interest expense was $0.5 million for the six months ended June 30, 2026 related primarily to the Parkview Credit Facility.
Interest Income. Interest income was less than $0.1 million and $0.1 million for the six months ended June 30, 2026 and 2025, respectively, related primarily to interest income earned on deposits at various banks.
Preferred Stock Series A cash dividend. The holder of our Series A Preferred Stock received cash dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
Liquidity and Capital Resources
We have incurred net losses and negative cash flows from operations since our inception and we anticipate that we will continue to incur net losses for the foreseeable future. We incurred net losses of $30.1 million and $22.6 million for the years ended December 31, 2025, and 2024, respectively, and incurred net losses of $16.7 million and $16.2 million for the six months ended June 30, 2026 and 2025, respectively. Additionally, we used $27.6 million and $14.7 million of cash from our operating activities for the years ended December 31, 2025 and 2024, respectively, and used $13.0 million and $11.0 million from our operating activities for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $157.9 million.
As of June 30, 2026, we had cash and cash equivalents of $1.0 million. We invest our cash and cash equivalents in liquid money market accounts.
We have received approximately $0.8 million in gross proceeds to date under the ATM Program. We have received approximately $5.8 million in gross proceeds to date under the Parkview Credit Facility.
Sources of Liquidity
To date, we have financed our operations principally through private placements of our common and preferred stock (which, in the case of Legacy TuHURA, have all since been converted into shares of Legacy TuHURA common stock and exchanged for shares of Kintara common stock in connection with the completion of the Kintara Merger) and issuance of convertible notes that were converted into Legacy TuHURA common stock prior to the Kintara Merger). Since inception, Legacy TuHURA raised approximately $41.6 million in net proceeds through the sale of its preferred stock and approximately $36.0 million in aggregate principal amount through the issuance of convertible notes. Since the Kintara Merger, TuHURA has raised approximately $34.8 million in aggregate principal amount through the issuance of common stock, bridge financings, and the Parkview Credit Facility.
Parkview Credit Facility
On April 21, 2026, the Company entered into the Loan Agreement with Parkview, pursuant to which Parkview agreed to extend a $50 million revolving credit facility to the Company maturing on April 21, 2031. Borrowings under the facility bear interest at 12% per annum (plus an additional 6% during any event of default), payable monthly in arrears, and are secured by substantially all assets of the Company and its subsidiaries. The Company is obligated to repay principal equal to 75% of net profits from pharmaceutical product sales from the prior quarter if it achieves net profits for two consecutive fiscal quarters. As of this Quarterly Report on Form 10-Q, the Company has borrowed approximately $5.8 million from Parkview under the Loan Agreement.
ATM Program
On November 3, 2025, the Company and Wainwright entered into the Offering Agreement with respect to an at-the-market offering program under which the Company may sell shares of its common stock having an aggregate offering price of up to $50,000,000 through Wainwright as its sales agent. As of the date of this Quarterly Report on Form 10-Q, we have sold approximately 301,545 shares of common stock through the program.
December 2025 Registered Direct Offering
On December 9, 2025, we entered into a securities purchase agreement (the “RD Purchase Agreement”) with certain investors. The RD Purchase Agreement relates to the sale and issuance in a registered direct offering (such sale and issuance, the “Registered Direct Offering”), by the Company of an aggregate of: (i) 9,462,423 shares of the Company’s common stock, (ii) Series A common stock purchase warrants to purchase up to 9,462,423 shares of common stock (the “Series A Warrants”), and (iii) Series B common stock purchase warrants to purchase up to 9,462,423 shares of common stock (the “Series B Warrants”, and together with the Series A Warrants, the “Common Warrants”). The offering price for each share of common stock and accompanying Series A Warrant
20
and Series B Warrant was $1.65. Each Common Warrant has an exercise price of $1.95 per share and is exercisable beginning six months after the date of issuance. The Registered Direct Offering resulted in gross proceeds to the Company of approximately $15.6 million, before deducting the placement agents’ fees and other offering expenses payable by the Company.
June 2025 Offering
On June 2, 2025, the Company and certain accredited investors (the “Purchasers”) entered into a securities purchase agreement pursuant to which we agreed to issue and sell to the Purchasers, in a private placement, an aggregate of 4,759,309 shares of the Company’s common stock, together with warrants to purchase an equal number of shares of common stock at an exercise price of $3.3125 (the “Offering Warrants”), for an aggregate offering amount of $12.6 million (the “Private Placement”). The combined effective offering price for each share and accompanying Offering Warrant in the offering was $2.65.
Warrant Exercise Notes
On February 12, 2025, four holders (the “Makers”) of common stock purchase warrants (the “Warrants”) of the Company made and issued to the Company secured promissory notes (the “Warrant Exercise Notes”) in the aggregate principal amount of $3.0 million as payment of the exercise price of an aggregate of 1,034,836 Warrants held by the Makers. The Makers were comprised of KP Biotech Group, LLC, CA Patel F&F Investments, LLC, Dr. Kiran C. Patel and Donald Wojnowski. Upon the exercise of the Warrants, the Company issued to the Makers an aggregate of 1,034,836 shares of common stock, all of which are “restricted securities” within the meaning of the federal securities laws. The amounts due under the Warrant Exercise Notes were collected in full in the second quarter of 2025.
Cash Flows
The following table sets forth a summary of the net cash flow activity for the six months ended June 30, 2026 and 2025, respectively:
|
|
Six Months Ended |
|
|||||
|
|
June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash provided by (used in): |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(13,046,552 |
) |
|
$ |
(10,986,584 |
) |
Investing activities |
|
|
(185,824 |
) |
|
|
(1,307,511 |
) |
Financing activities |
|
|
10,608,404 |
|
|
|
8,149,741 |
|
Net increase (decrease) in cash |
|
$ |
(2,623,972 |
) |
|
$ |
(4,144,354 |
) |
Operating Activities
For the six months ended June 30, 2026, net cash used in operating activities was $13.0 million, which primarily consisted of a net loss of $16.8 million and a change in net operating assets and liabilities of $1.6 million, and non-cash charges of $5.3 million. The net non-cash charges were primarily related to depreciation and amortization expense of $0.1 million, stock-based compensation of $4.9 million, amortization of debt issuance costs of $0.3 million associated with the revolving credit facility. The $1.6 million change in net operating assets and liabilities was due to a decrease in accounts payable and accrued expenses of approximately $1.7 million due to timing of invoices and vendor payments, an increase in accrued interest of $0.2 million, and a decrease in current and non-current assets of $0.1 million.
For the six months ended June 30, 2025, net cash used in operating activities was $11.0 million, which primarily consisted of a net loss of $16.2 million, a change in net operating assets and liabilities of $2.3 million, and non-cash charges of $2.9 million. The net non-cash charges were primarily related to depreciation and amortization expense of less than $0.1 million, and stock-based compensation of $2.8 million. The $2.3 million net change in operating assets and liabilities is primarily due to increases in accounts payable and accrued expenses of approximately $2.3 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately less than $0.1 million.
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Investing Activities
For the six months ended June 30, 2026, net cash used in investing activities was $0.2 million, which consisted of purchases of property and equipment.
For the six months ended June 30, 2025, net cash used in investing activities was $1.3 million, which consisted of purchases of property and equipment and deposits and payments in connection with the Kineta acquisition.
Financing Activities
For the six months ended June 30, 2026, net cash provided by financing activities was $10.6 million, which consisted of $3.6 million proceeds from the credit revolver, $7.8 million in gross proceeds from the issuance of common stock of which $0.5 million was attributable to the Private Placement, $7.0 million was attributable to the Registered Direct Offering, and $0.3 million was attributable to the ATM Program, offset by $0.4 million in payments for the placement agent fees and offering costs related to the various financings, and $0.2 million in payments for the credit facility debt issuance costs.
For the six months ended June 30, 2025, net cash provided by financing activities was $8.1 million, which consisted of $3.6 million proceeds from warrant exercises, $5.9 million in gross proceeds from the issuance of common stock attributable to the Private Placement, offset by $0.3 million in payments for deferred offering costs attributable to the Private Placement and $1.1 million in merger transaction costs and net liabilities attributable to Kintara.
Funding Requirements
We expect to incur costs associated with operating as a public company. In addition, we anticipate that we will need substantial additional funding in connection with our development programs and continuing operations. We believe that our existing cash and cash equivalents, together with the ATM Program and $50.0 million revolving credit facility with Parkview, will be sufficient to meet our anticipated cash requirements into the end of 2028.
Our forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. Management based projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and we may deplete our available capital resources sooner than management expects. Our future capital requirements will depend on many factors, including:
Until such time, if ever, as we can generate substantial product revenues to support our capital requirements, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, collaborations and licensing arrangements or other capital sources. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders of our common stock. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through collaborations, or other similar
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arrangements with third parties, we may need to relinquish valuable rights to our product candidates, future revenue streams or research programs or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds through equity or debt financings as and when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in Note 2 of our condensed consolidated financial statements for the six months ended June 30, 2026, contained in Part I, Item 1 in this Quarterly Report on Form 10-Q, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.
Stock-Based Compensation Expense
Stock-based compensation expense represents the cost of the grant date fair value of equity awards recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. We estimate the fair value of equity awards using the Black-Scholes option pricing model and recognize forfeitures as they occur. Estimating the fair value of equity awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of variables, including the risk-free interest rate, the expected stock price volatility, the expected term of stock options, the expected dividend yield and the fair value of the underlying common stock on the date of grant. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require significant analysis and judgment to develop. See Note 2 of our financial statements for information concerning certain of the specific assumptions we use in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted.
Kineta Acquisition and Valuation of Intangible Assets
On June 30, 2025 we completed the Kineta Merger contemplated by the TuHURA-Kineta Merger Agreement, pursuant to which the Company acquired Kineta in a cash and stock transaction through a series of merger transactions, with Kineta surviving the mergers as a wholly-owned subsidiary of ours.
Upon completion of the Kineta Merger, pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each share of Kineta common stock issued and outstanding immediately prior to the merger (a “Kineta Share”), was converted into the right to receive 0.185298 shares of our common stock for an aggregate of approximately 2.9 million shares of our common stock. Also pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Kineta Share received its pro rata portion of approximately 1.1 million shares of our common stock in December 2025, in accordance with the terms of the TuHURA-Kineta Merger Agreement. In addition, each Kineta Share is entitled to the right to its pro rata share of cash consideration received by Kineta pursuant to disposed asset payments related to legacy Kineta assets. Such payments, if any, will be made at a later date and in accordance with the terms of the TuHURA-Kineta Merger Agreement. In each case, in lieu of the issuance of any fractional shares of our common stock, we will pay an amount equal to the product of (A) such fractional share and (B) $5.7528.
The estimated fair value of the aggregate share component of the Kineta Merger was calculated using the closing stock price on the date of the Kineta Merger.
We recognized in-process research and development (“IPR&D”) in connection with the acquisition. We estimated the fair value of the IPR&D assets using the cost approach, which is based on the amount that a market participant would incur to recreate the assets, adjusted for obsolescence, inefficiencies, and the current stage of completion of the underlying development efforts.
Goodwill and other intangible assets comprised of IPR&D on our balance sheet as of June 30, 2026 and December 31, 2025 were in connection with the Kineta Merger.
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In a business combination, the fair value of acquired IPR&D is capitalized and accounted for as indefinite-lived intangible assets, and not amortized until the underlying project receives regulatory approval, at which point the intangible assets will be accounted for as definite-lived intangible assets or discontinued. If discontinued, the intangible assets will be written off. R&D costs incurred after the acquisition are expensed as incurred.
We test indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If we conclude it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed.
Recently Issued and Adopted Accounting Pronouncements
There are no recently issued and adopted accounting pronouncements that have a material effect on the Company’s financial statements.
Off-Balance Sheet Arrangements
During the periods presented, we do not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate risks and inflation risks. Periodically, we maintain deposits in accredited financial institutions in excess of federally insured limits. We deposit our cash in financial institutions that we believe have high credit quality and have not experienced any losses on such accounts and do not believe we are exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Interest Rate Risk
Our cash consists of cash in readily-available checking accounts. We may also invest in short- term money market fund investments. Such interest-earning instruments carry a degree of interest rate risk; however, historical fluctuations in interest income have not been significant.
Inflation Risk
Inflation generally affects us by increasing our cost of labor and research and development contract costs. We do not believe inflation has had a material effect on our results of operations during the periods presented.
Item 4. Controls and Procedures.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Evaluation of Disclosure Controls and Procedures
Our management has evaluated, with the participation of the Chief Executive Officer (our principal executive officer) and the Chief Financial Officer (our principal financial officer), the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our Chief Executive Officer and the Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2026.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during our most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may be involved in various disputes and litigation matters that arise in the ordinary course of business. As of the date of this Quarterly Report on Form 10-Q, we are not party to any material legal matters or claims.
Item 1A. Risk Factors.
There have been no material changes to the risk factors identified in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 31, 2026 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 which was filed with the SEC on April 14, 2026.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
(a) None.
(b) None.
(c) Director and Officer Trading Arrangements
None of our directors or officers, as defined in Rule 16a-1(f) under the Exchange Act,
On June 4, 2026, James A. Bianco, the Company’s President and Chief Executive Officer and a member of the Company’s board of directors, adopted a written trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act. The plan provides for the potential sale of up to an aggregate of 1,500,000 option shares and other shares of the Company’s common stock subject to the terms and conditions of the plan. The plan terminates on the earliest of one year from the date the broker begins executing sales under the plan, the execution of all trades contemplated by the plan, or the occurrence of certain other events specified in the plan.
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Item 6. Exhibits.
Exhibit Number |
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Description |
3.1 |
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3.2 |
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4.1 |
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10.1 |
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10.2 |
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10.3 |
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10.4 |
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10.5 |
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31.1* |
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31.2* |
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32.1**
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32.2**
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101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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* Filed herewith.
** This certification is being furnished solely to accompany this Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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TUHURA BIOSCIENCES, INC. |
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Dated: August 14, 2026 |
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By: |
/s/ James A. Bianco, M.D. |
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James A. Bianco |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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Dated: August 14, 2026 |
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By: |
/s/ Dan Dearborn |
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Dan Dearborn |
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Chief Financial Officer |
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(Principal Financial Officer) |
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