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, 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
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes
As of November 12, 2025, the registrant had
Table of Contents
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Page |
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PART I. |
1 |
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Item 1. |
1 |
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1 |
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2 |
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3 |
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5 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
18 |
Item 3. |
31 |
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Item 4. |
31 |
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PART II. |
32 |
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Item 1. |
32 |
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Item 1A. |
32 |
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Item 2. |
32 |
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Item 3. |
32 |
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Item 4. |
32 |
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Item 5. |
32 |
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Item 6. |
33 |
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35 |
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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
ii
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 2024 Annual Report filed with the Securities and Exchange Commission (“SEC“), or the SEC, on March 31, 2025, 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.
iii
PART I—FINANCIAL INFORMATION
Item 1. Condensed Financial Statements.
TuHURA Biosciences, Inc.
Condensed Consolidated Balance Sheets
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September 30, |
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December 31, |
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2025 |
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2024 |
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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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Deposits, planned business acquisition (note 1) |
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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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- |
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Goodwill |
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- |
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In-process research and development |
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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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Note Payable to former Kineta employees |
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- |
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Holdback liability, payable 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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Lease liability, long term |
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- |
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Other long-term liabilities |
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- |
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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 September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Research and development expenses |
$ |
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$ |
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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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( |
) |
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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Other expense |
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( |
) |
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- |
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( |
) |
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- |
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Change in fair value of Kineta merger holdback shares |
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( |
) |
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- |
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( |
) |
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- |
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Change in fair value of derivative liability |
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- |
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- |
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( |
) |
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Total Other (Expense) Income |
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( |
) |
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( |
) |
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( |
) |
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Net Loss |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
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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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Deemed dividend on warrant modifications |
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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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$ |
( |
) |
|
$ |
( |
) |
Net Loss per share, basic and diluted |
$ |
( |
) |
|
$ |
( |
) |
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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 (Deficit)
(Unaudited)
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Total |
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Additional |
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Accumulated |
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Stockholders' |
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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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Equity |
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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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(Deficit) |
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Balances at January 1, 2024 |
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$ |
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$ |
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$ |
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$ |
- |
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$ |
( |
) |
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$ |
( |
) |
|||||
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Retroactive application of reverse |
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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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||
Preferred stock (Series A ratio of |
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Recast balances, beginning of period |
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$ |
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$ |
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$ |
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$ |
- |
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|
$ |
( |
) |
|
$ |
( |
) |
|||||
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Stock options exercised, cashless |
|
- |
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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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||
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balances at March 31, 2024 |
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||
Stock compensation expense |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
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|
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|
- |
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|
- |
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||
Fair value of warrants associated with convertible notes payable |
|
- |
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- |
|
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- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
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||
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balances at June 30, 2024 |
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||
Issuance of common shares, net of offering costs |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
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|
||||
Issuance of common shares for equity issuance placement agent fees |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
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|
||||
Issuance of common shares for convertible note placement agent fees |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
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|
|
|
|
- |
|
|
|
- |
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||||
Issuance of common shares for warrants exercised |
|
- |
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|
- |
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- |
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- |
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||||
Stock options exercised, cash and cashless |
|
- |
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|
- |
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|
|
|
|
|
- |
|
|
|
- |
|
|
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|
||||
Stock compensation expense |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
Fair value of warrants associated with convertible notes payable |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
Deemed dividend on warrant modification |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balances at September 30, 2024 |
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||
3
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Total |
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||||||||
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Additional |
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Accumulated |
|
|
Stockholders' |
|
|||||||||||
|
Preferred Stock |
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|
Common Stock |
|
|
Paid in |
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|
Due from |
|
|
Equity |
|
|
Equity |
|
||||||||||||||
|
Shares |
|
|
Dollars |
|
|
Shares |
|
|
Dollars |
|
|
Capital |
|
|
Stockholders |
|
|
(Deficit) |
|
|
(Deficit) |
|
||||||||
Balances at January 1, 2025 |
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
|
||||||
|
|
|
|
|
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|
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|
|
|
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|
||||||||
Issuance of common shares for |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
- |
|
|
|
|
||||
Stock options exercised, cashless |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
||
Stock compensation expense |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
Series A Preferred Stock cash |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balances at March 31, 2025 |
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||||
Contributed capital for |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|||
Issuance of common shares, net of issuance costs |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||||
Issuance of common shares for Kineta merger |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||||
Stock options exercised, cashless |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
||
Stock compensation expense |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
Series A Preferred Stock cash |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balances at June 30, 2025 |
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
|
||||||
Issuance of common shares for settlement of Kineta obligations |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||||
Issuance of common shares, net of issuance costs |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||||
Vesting of RSU shares |
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
||
Stock compensation expense |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
Series A Preferred Stock cash dividend |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
Balances at September 30, 2025 |
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
|
||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
TuHURA Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
|
|
Nine months ended |
|
|||||
|
|
September 30, |
|
|
September 30, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Cash flows from Operating activities: |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to cash |
|
|
|
|
|
|
||
used in operating activities: |
|
|
|
|
|
|
||
Stock compensation expense |
|
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
|
||
Amortization of debt discount |
|
|
- |
|
|
|
|
|
Loss on share settlement of Kineta employee compensation assumed from merger |
|
|
|
|
|
- |
|
|
Change in fair value of derivative liability |
|
|
- |
|
|
|
|
|
Change in fair value of Kineta merger holdback shares |
|
|
|
|
|
- |
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Other current assets |
|
|
|
|
|
|
||
Other noncurrent assets |
|
|
( |
) |
|
|
( |
) |
Accounts payable and accrued expenses |
|
|
( |
) |
|
|
|
|
Net cash flows from operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from investing activities: |
|
|
|
|
|
|
||
Cash paid for business acquisition, net of cash received from Kineta |
|
|
( |
) |
|
|
( |
) |
Purchase of property and equipment |
|
|
( |
) |
|
|
( |
) |
Net cash flows from investing activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from financing activities: |
|
|
|
|
|
|
||
Cash dividend payment of preferred stock Series A |
|
|
( |
) |
|
|
- |
|
Proceeds from warrants exercised |
|
|
|
|
|
|
||
Proceeds from convertible notes payable |
|
|
- |
|
|
|
|
|
Payment of debt issuance costs |
|
|
- |
|
|
|
( |
) |
Proceeds from issuance of common stock |
|
|
|
|
|
|
||
Proceeds from stock options exercised |
|
|
- |
|
|
|
|
|
Payment of debt assumed from Kineta merger |
|
|
( |
) |
|
|
- |
|
Payment of note payables to former Kineta employees |
|
|
( |
) |
|
|
- |
|
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 |
|
|
|
|
|
|
||
Kineta employee compensation assumed from merger exchanged for note payables |
|
$ |
|
|
$ |
- |
|
|
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 |
|
|
|
|
|
- |
|
|
Property and equipment recognized in exchange for finance lease obligations |
|
|
|
|
|
- |
|
|
Deferred offering costs not yet paid |
|
|
|
|
|
|
||
Right-of-use asset recognized in exchange for operating lease obligations |
|
|
- |
|
|
|
|
|
Debt issuance costs not yet paid |
|
|
- |
|
|
|
|
|
Fair value of warrants associated with convertible notes payable |
|
|
- |
|
|
|
|
|
Derivative liability associated with make-whole premium |
|
|
- |
|
|
|
|
|
Deemed dividend on warrant modifications |
|
|
- |
|
|
|
|
|
Issuance of common stock for placement agent fees |
|
|
- |
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
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, IFx2.0, 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 KVA1213, through our acquisition of Kineta on June 30, 2025. 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 relapse 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 randomized Phase 2 trial in combination with a menin inhibitor vs menin inhibitor alone in mutated NPM1 (mutNPM1) AML.
In addition to our IFx and TBS-2025 technologies, we are leveraging our Delta Opioid Receptor technology to develop tumor microenvironment modulators in the form of first-in-class bi-specific antibody-peptide conjugates (“APCs”) and antibody-drug conjugates (“ADCs”) targeting Myeloid Derived Suppressor Cells (“MDSCs”). Our APCs and ADCs are being developed to inhibit the immune-suppressing effects of MDSCs on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
In the opinion of Management, the accompanying unaudited condensed consolidated financial statements are prepared in accordance with the instructions for Form 10-Q, and include all adjustments which we considered necessary for a fair presentation of the results for the periods presented. Certain information and footnote disclosures normally included in the consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted. It is suggested that these condensed consolidated financial statements be read in conjunction with the 2024 Annual Report. The results for the three and nine months ended September 30, 2025 are not necessary indicative of the results to be expected for future periods or the full year.
June 2025 Private Placement
On June 2, 2025, the Company and certain accredited investors (the “Purchasers”) entered into a securities purchase agreement (the “Securities Purchase Agreement”) pursuant to which the Company agreed to issue to the Purchasers, in a private placement (the “Offering”), an aggregate of
Pursuant to the Securities Purchase Agreement, each Purchaser was obligated to purchase such Purchaser’s respective investment in the Offering in four equal tranches, as follows:
• $
• $
6
• $
• $
In addition to the approximately $
On September 5, 2025, each of Deferral Investors and the Company entered into an agreement (the “Final Purchase Agreements”) pursuant to which they agreed to immediately purchase an aggregate of $
Merger with Kineta, Inc.
On June 30, 2025, the Company completed the previously announced acquisition contemplated by the Agreement and Plan of Merger, dated December 11, 2024, and as amended by that certain First Amendment to Agreement and Plan of Merger, dated May 5, 2025 (as amended, the “TuHURA-Kineta Merger Agreement”), by and among the Company, Hura Merger Sub I, Inc., a Delaware corporation and a direct wholly-owned subsidiary of the Company (“Merger Sub I”), Hura Merger Sub II, LLC, a Delaware limited liability company and direct wholly-owned subsidiary of the Company (“Merger Sub II”), Kineta, and Craig Philips, solely in his capacity the representative, agent and attorney-in-fact of the stockholders of Kineta. Pursuant to the terms of the TuHURA-Kineta Merger Agreement, among other things, Merger Sub I (a) merged with and into Kineta (the “First Merger”), with Kineta being the surviving corporation of the First Merger, also known as the “Surviving Entity” and (b) immediately following the First Merger, the Surviving Entity merged with and into Merger Sub II (the “Second Merger”, and together with the First Merger, the “Kineta Merger”), with Merger Sub II being the surviving company of the Second Merger and subsequently changing its name to Kineta, LLC.
Upon completion of the Kineta Merger, pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each share of Kineta common stock, par value $
Special Meeting of the Stockholders
In connection with the closing of the Kineta Merger, the Company held its special meeting of the stockholders in lieu of an annual meeting on June 23, 2025 (the “Special Meeting”) to submit, among other proposals, the proposal to increase the Company’s authorized shares of common stock from
Note 2—Summary of significant accounting policies
7
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 condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Adgero Biopharmaceuticals Holdings Inc., Adgero Biopharmaceuticals, Inc., Kineta, LLC (following its merger with and into Merger Sub II), 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 2024 Annual Report. There have been no changes to the significant accounting policies during the nine months ended September 30, 2025
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.
Grant Income – The Company assumed in the reverse merger with Kintara Therapeutics, Inc. (the “Kintara Merger”) a $
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.
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.
8
Goodwill and Intangible Assets – We recognized goodwill and other intangible assets comprised of in-process research and development. (“IPR&D”) during the nine months ended September 30, 2025, in connection with our acquisition of Kineta (Note 4), which closed on June 30, 2025. The fair value of acquired IPR&D was capitalized and accounted for as an indefinite-lived intangible asset and is not subject to amortization. Subsequent to the acquisition, the Company will assess goodwill and the IPR&D assets (collectively, the “Intangible Assets”) for impairment at least annually or whenever changes in circumstances indicate the carrying amount may not be recoverable. Acquired IPR&D is subject to impairment testing until completion or abandonment of the associated R&D efforts. If abandoned, the carrying value of the IPR&D asset is written off. Once the associated R&D efforts are completed, the carrying value of the acquired IPR&D is reclassified as a finite-lived asset and amortized over its useful life. Incremental R&D costs incurred subsequent to the acquisition are expensed as incurred.
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 (CODM), which is its , 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
Fair Value of Financial Instruments - ASC 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances.
ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes between the following:
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. See Note 4 for more information related to the Company’s Level 3 fair value measurement.
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, which have been funded through a combination of debt and equity financings.
9
For the nine months ended September 30, 2025, the Company incurred $
The Company expects to raise cash through the sale of preferred shares, common shares, debt issuances, 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. As such, there is substantial doubt about the Company’s ability to continue as a going concern for the next 12 months from the date that these unaudited interim consolidated financial statements were available to be issued.
Note 4—Acquisition
Goodwill will not be deductible for tax purposes. We expect the determination of fair value for assets acquired and liabilities assumed to be finalized by the end of 2025.
The preliminary allocation of the consideration for the net assets acquired for the acquisition of Kineta were as follows.
|
|
June 30, |
|
|
|
|
2025 |
|
|
Purchase Consideration |
|
|
|
|
Exclusivity cash deposit |
|
$ |
|
|
Equity issued to Kineta shareholders |
|
|
|
|
Holdback liability to be issued in equity |
|
|
|
|
Cash previously advanced for clinical trial funding and working capital |
|
|
|
|
Fair value of consideration |
|
$ |
|
|
Assets Acquired: |
|
|
|
|
Cash |
|
$ |
|
|
Acquired in-process research and development |
|
|
|
|
Total assets acquired |
|
|
|
|
Liabilities Assumed: |
|
|
|
|
Accrued expenses, assumed debt, and severance liabilities |
|
$ |
( |
) |
Total liabilities assumed |
|
|
( |
) |
Net assets acquired |
|
|
|
|
Goodwill |
|
$ |
|
|
|
|
|
|
|
The fair value of equity was determined based on the closing price of the Company’s common stock immediately prior to acquisition, and included
The delayed consideration to be settled in Company shares of common stock continues to be recorded at its fair value through the settlement date with changes recorded to earnings. Additionally, the estimated fair value of the delayed consideration that will be settled in equity uses both observable and unobservable inputs, specifically considering the price of the Company's common stock, as well as the probability of the payout at the end of the holding period, and is considered a Level 3 measurement as defined in ASC 820 and will be fulfilled within 12 months of the balance sheet date. Changes in fair value are recognized in the consolidated statements of
10
operations. Using the closing price of $
Included in consideration transferred is the settlement of the pre-existing Clinical Trial Funding Agreement and working capital loans owed by Kineta to the Company, which were effectively settled and became intercompany arrangements as of the closing of the transaction. The settlement of pre-existing relationships between the Company and Kineta did not result in any material gain or loss.
The preliminary fair value of the acquired IPR&D intangible assets was determined based on the market capitalization of Kineta, as previously traded on the NASDAQ capital market.
The fair value of the assumed accounts payable, accrued expenses and notes payable were deemed to be equivalent to their carrying value due to the short-term nature of their obligations.
The results of operations of Kineta are included in the accompanying condensed consolidated statement of operations from the June 30, 2025 acquisition date.
The Company incurred approximately $
The following unaudited pro forma financial information reflects the consolidated results of operations of TuHURA as if the acquisition of Kineta had taken place on January 1, 2024 and January 1, 2025. The pro forma information includes acquisition-related expenses.
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||||
|
2025 |
|
|
|
2024 |
|
|
2025 |
|
|
|
2024 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administration expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating Loss |
|
( |
) |
|
|
|
( |
) |
|
|
( |
) |
|
|
|
( |
) |
Other (Expense) Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gain on sale of assets |
|
- |
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
Grant income |
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
||
Gain (loss) on liabilities settlement |
|
( |
) |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
Changes in fair value measurements |
|
( |
) |
|
|
|
|
|
|
( |
) |
|
|
|
( |
) |
|
Interest income (expense), net |
|
( |
) |
|
|
|
( |
) |
|
|
|
|
|
|
( |
) |
|
Total Other (Expense) Income |
|
( |
) |
|
|
|
( |
) |
|
|
|
|
|
|
( |
) |
|
Net Loss |
$ |
( |
) |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Note 5—Net loss per share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows:
|
Three months ended September 30 |
|
|
Nine months ended September 30 |
|
||||||||||
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
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 |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
11
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.
|
As of September 30 |
|
|
|||||
|
2025 |
|
|
2024 |
|
|
||
Preferred Series A (as converted) |
|
|
|
|
|
|
||
Preferred Series A-1 (as converted) |
|
|
|
|
|
|
||
Preferred Series B (as converted) |
|
|
|
|
|
|
||
Convertible Notes (as converted) |
|
|
|
|
|
|
||
Stock options issued and outstanding |
|
|
|
|
|
|
||
Unvested restricted stock units |
|
|
|
|
|
|
||
Warrants |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Note 6—Other current assets
Other current assets consist of the following as of September 30, 2025, and December 31, 2024:
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Employee Retention Tax Credit |
|
$ |
|
|
$ |
|
||
NIH Grant Receivable |
|
|
|
|
|
|
||
Clinical trial deposit |
|
|
|
|
|
|
||
Other current assets |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
Note 7—Property and equipment, net
Property and equipment, net consists of the following as of September 30, 2025, and December 31, 2024:
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
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 8—Accounts payable, debt, and accrued expenses
12
Accounts payable and accrued expenses consist of the following as of September 30, 2025, and 2024:
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
Trade accounts payable |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
|
||
|
|
$ |
|
|
$ |
|
||
In exchange for separation payments assumed from the Kineta Merger for
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 reverse. 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 September 30, 2025, and December 31, 2024.
Note 10—Stockholders’ equity
As of September 30, 2025, 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 were assumed in connection with the Kintara Merger and
Securities Purchase Agreement
On June 2, 2025, the Company entered into the Securities Purchase Agreement with the Purchasers (Note 1), pursuant to which the Company issued and sold an aggregate of
In addition to the funds received in the four initial tranches of the Offering, the remaining $
13
also entered into placement agent agreements with Paulson Investment Company, LLC (“Paulson”) as the as the primary placement agent for the offering, and Brookline Capital Markets (“Brookline”) as the secondary placement agent for the Offering. In connection with the placement agent agreements, the Company agreed to pay Paulson a reimbursement of $
On August 12, 2025, the Company filed a registration statement on Form S-1 (the “Resale Registration Statement”), including the prospectus therein, relating to the resale of the common stock and shares of common stock issuable upon the exercise of Warrants from time to time purchased by the selling stockholders named therein pursuant to the Securities Purchase Agreement. The Resale Registration Statement became effective on September 26, 2025.
Shares issued to Former Kineta Employees
Subsequent to the completion of the Kineta Merger, the Company entered into consulting agreements with
Warrants
The following table summarizes the Company’s outstanding common stock warrants as of September 30, 2025
|
|
Outstanding |
|
|
Weighted |
|
|
Expiration dates |
|||
Legacy TuHURA common stock warrants |
|
|
|
|
$ |
|
|
to |
|||
Historical Kintara common stock warrants |
|
|
|
|
$ |
|
|
to |
|||
TuHURA Warrants from 2025 Securities Purchase Agreement |
|
|
|
|
$ |
|
|
||||
TuHURA Warrants issued to placement agent |
|
|
|
|
|
$ |
|
|
|||
2024 common stock warrants issued to financial advisor |
|
|
|
|
$ |
|
|
||||
There were
In connection with the Securities Purchase Agreement entered into on June 2, 2025, relating to the issuance of an aggregate of
14
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 nine months ended September 30, 2025 and 2024:
|
|
|
September 30, 2025 |
|
|
September 30, 2024 |
|
||
Common stock fair value |
|
|
$ |
|
|
$ |
|
||
Risk free interest rate |
|
|
|
|
|
||||
Expected dividend yield |
|
|
|
|
|
||||
Expected term |
|
|
|
|
|
||||
Expected stock volatility |
|
|
|
|
|
||||
Below is a summary of stock option activity for the nine months ended September 30, 2025:
|
|
|
|
Weighted |
|
|
Weighted |
||
|
Number |
|
|
Average |
|
|
Average |
||
|
of options |
|
|
Exercise Price |
|
|
Contractual Life |
||
Outstanding at December 31, 2024 |
|
|
|
$ |
|
|
|||
|
|
|
|
|
|
|
|
||
Forfeited and cancelled |
|
( |
) |
|
$ |
|
|
|
|
Exercised |
|
( |
) |
|
$ |
|
|
|
|
Granted |
|
|
|
$ |
|
|
|
||
Outstanding at September 30, 2025 |
|
|
|
$ |
|
|
|||
Exercisable at September 30, 2025 |
|
|
|
$ |
|
|
|||
Options outstanding had an intrinsic value of $
Stock compensation expense
Total stock-based compensation expense for the nine months ended September 30, 2025 and 2024 was allocated as follows:
|
|
|
2025 |
|
|
2024 |
|
||
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 2026 and finance lease expires in June 2028. Operating leases are included in operating lease right of use assets, lease liabilities current and lease liabilities non-current. Finance leases are included in property and equipment, other current liabilities and other non-current liabilities.
Future minimum lease payments under these leases are as follows:
15
|
Finance |
|
|
Operating |
|
||
Year ending December 31, 2025 (3 months) |
$ |
|
|
$ |
|
||
Year ending December 31, 2026 |
|
|
|
|
|
||
Year ending December 31, 2027 |
|
|
|
|
- |
|
|
Year ending December 31, 2028 |
|
|
|
|
- |
|
|
Interest portion of right of use liability |
|
( |
) |
|
|
( |
) |
Operating lease liabilities |
$ |
|
|
$ |
|
||
Operating leases -Total lease expense for the operating lease was approximately $
Cash paid for amounts included in the measurement of operating lease liabilities was approximately $
For the current operating 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
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, 2025 (3 months) |
|
|
$ |
|
|
Year ending December 31, 2026 |
|
|
|
|
|
|
|
|
$ |
|
Note 13—Subsequent events
Subsequent events – The Company has evaluated subsequent events through November 14, 2025 in connection with the preparation of these unaudited condensed consolidated financial statements, which is the date they were available to be issued.
Registration Statement on Form S-3 and ATM Offering
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 under which the Company may sell shares of its common stock having an aggregate offering price of up to $
Bridge loan transaction
On October, 27, 2025, the Company entered into a Secured Promissory Note and Loan Agreement (the “Loan Agreement”) with an accredited investor and shareholder of the Company (the “Lender”). Pursuant to the terms of the Loan Agreement, the Lender agreed to make loans to the Company in an aggregate principal amount of up to $
16
period beginning on the date of the Loan Agreement. The Lender advanced the first loan to the Company in the amount of $
17
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, 2025 (the “2024 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 I, 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 2024 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 nine months ended September 30, 2025 compared to the three and nine months ended September 30, 2024. 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
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, IFx2.0, 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 KVA1213, through our acquisition of Kineta, Inc. (“Kineta”) on June 30, 2025. 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 relapse 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 randomized Phase 2 trial in combination with a menin inhibitor vs menin inhibitor alone in mutated NPM1 (mutNPM1) AML.
In addition to our IFx and TBS-2025 technologies, we are leveraging our Delta Opioid Receptor technology to develop tumor microenvironment modulators in the form of first-in-class bi-specific antibody-peptide conjugates (“APCs”) and antibody-drug conjugates (“ADCs”) targeting Myeloid Derived Suppressor Cells (“MDSCs”). Our APCs and ADCs are being developed to inhibit the immune-suppressing effects of MDSCs on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
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 the private placement of capital stock and convertible notes.
We are not profitable and has incurred significant operating losses in each period since its inception, our net losses were $22.6 million for the year ended December 31, 2024 and $29.3 million for the year ended December 31, 2023 (which includes the expensing of the entire $16.2 million purchase price for the assets of TuHURA Biopharma, Inc. (“TuHURA Biopharma”), of which $15.0 million was paid in the form of Legacy TuHURA common stock), and $23.3 million and $15.7 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $134.4 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 it advances our product candidates through preclinical and clinical development, develops additional product candidates and seeks 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
18
obtains 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. Furthermore, we expect to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations, compliance and other expenses that we did not previously incur as a private company.
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 it 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 itself.
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 September 30, 2025, we had cash and cash equivalents of $2.7 million. See “ — Liquidity and Capital Resources” below.
Recent Developments
June 2025 Private Placement
On June 2, 2025, we entered into with certain accredited investors (the “Purchasers”) a securities purchase agreement (the “Securities Purchase Agreement”) pursuant to which we agreed to issue to the Purchasers, in a private placement (the “Offering”), an aggregate of 4,759,309 shares of common stock together with warrants to purchase an equal number of shares of common stock at an exercise price of $3.3125 (the “Warrants”), for an aggregate offering amount of approximately $12.6 million. The combined effective offering price for each share and accompanying Warrant in the Offering was $2.65. The Warrants have an exercise price per share equal to $3.3125 and will expire on the fifth (5th) anniversary of December 3, 2025. The exercise price of the Warrants is subject to proportional adjustment for stock splits, reverse stock splits, and similar transactions.
Pursuant to the Securities Purchase Agreement, each Purchaser was obligated to purchase such Purchaser’s respective investment in the Offering in four equal tranches, as follows:
• $2.23 million was purchased on June 2, 2025 (the “Initial Closing”);
• $2.23 million was purchased on June 9, 2025, following our notification to the Purchasers that the Food and Drug Administration (FDA) has notified us that we are no longer subject to the partial clinical hold set forth in the FDA’s Partial Clinical Hold letter to us dated January 24, 2024, with respect to our planned Phase 3 trial of IFx-2.0;
• $2.23 million was purchased on June 24, 2025, following our notification to the Purchasers that the
Phase 3 trial for IFx-Hu2.0 (the “Phase 3 Trial”) had been initiated; and
• $2.23 million was purchased on June 30, 2025, following our notification to the Purchasers that all material conditions for the closing of our merger transaction with Kineta have been satisfied (other than conditions that cannot be satisfied until on or immediately before the closing of the Kineta Merger) and that we were prepared to close the Kineta Merger.
In addition to the approximately $8.9 million that was purchased in four equal tranches pursuant to the foregoing milestones, the remaining $3.7 million in the Offering (the “Final Tranche Offering Amount”) was required to be purchased and funded by December 31, 2025 by certain Purchasers who agreed to invest an aggregate of $4.0 million or more in the Offering and who elected to defer the purchase of a portion of such Purchaser’s common stock and Warrants until such time (the “Derral Investors”).
On September 5, 2025, each of Deferral Investors and the Company entered into an agreement (the “Final Purchase Agreements”) pursuant to which they agreed to immediately purchase an aggregate of $3.2 million of the Final Tranche Offering Amount in exchange for the Company’s agreement, set forth in a Warrant Amendment Agreement between the Company and each Deferral Investor (the “Warrant Amendment Agreements”), to extend the expiration dates of certain warrants to purchase an
19
aggregate of 1.5 million shares of Company common stock that were issued by the Company’s predecessor in a 2024 private placement of convertible notes (the “2024 Warrants”). As of September 30, 2025, an aggregate of $0.5 million remains outstanding in the Final Tranche Offering Amount to be purchased on or before December 31, 2025. Under the Warrant Amendment Agreements, the expiration dates of the 2024 Warrants was extended to December 31, 2030.
In connection with the Offering and the sale of shares of common stock and Warrants to purchase common stock sold to the Purchasers pursuant to the Securities Purchase Agreement, the Company filed a registration statement on Form S-1 (the “Resale Registration Statement”), including the prospectus therein, relating to the resale of the common stock and shares of common stock underlying the Warrants from time to time purchased by the selling stockholders named therein pursuant to the Securities Purchase Agreement. The Resale Registration Statement was declared effective by the Securities and Exchange Commission on September 26, 2025.
Closing of Kineta Merger
On June 30, 2025, we completed the previously announced acquisition contemplated by the Agreement and Plan of Merger, dated December 11, 2024, and as amended by that certain First Amendment to Agreement and Plan of Merger, dated May 5, 2025 (as amended, the “TuHURA-Kineta Merger Agreement”), by and among us, Hura Merger Sub I, Inc., a Delaware corporation and a direct wholly-owned subsidiary of ours (“Merger Sub I”), Hura Merger Sub II, LLC, a Delaware limited liability company and direct wholly-owned subsidiary of ours (“Merger Sub II”), Kineta, and Craig Philips, solely in his capacity as the representative, agent and attorney-in- fact of the stockholders of Kineta. Pursuant to the terms of the TuHURA-Kineta Merger Agreement, among other things, Merger Sub I (a) merged with and into Kineta (the “First Merger”), with Kineta being the surviving corporation of the First Merger, also known as the “Surviving Entity” and (b) immediately following the First Merger, the Surviving Entity merged with and into Merger Sub II (the “Second Merger”, and together with the First Merger, the “Kineta Merger”), with Merger Sub II being the surviving company of the Second Merger and subsequently changing its name to Kineta, LLC.
Upon completion of the Kineta Merger, pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each share of Kineta common stock, par value $0.001 per share (each, a “Share”), issued and outstanding immediately prior to the First Merger, was converted into the right to receive 0.185298 shares of our common stock for an aggregate of approximately 2,868,169 shares of our common stock. Also pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Share is also entitled to (i) its pro rata portion of approximately 1,129,885 shares of our common stock to be issued after six months following the closing of the Kineta Merger, subject to adjustment for losses incurred or accrued during the six month period from the closing of the Kineta Merger, and (ii) 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.
Bridge Loan Transaction
On October 27, 2025, the Company entered into a Secured Promissory Note and Loan Agreement (the “Loan Agreement”) with an accredited investor and shareholder of the Company (the “Lender”). Pursuant to the terms of the Loan Agreement, the Lender agreed to make loans to the Company in an aggregate principal amount of up to $3,000,000 (the “Loans”) during a 30-day availability period beginning on the date of the Loan Agreement. The Lender advanced the first loan to the Company in the amount of $1,500,000 simultaneously with the execution of the Loan Agreement (the “Initial Advance”), and upon advance notice by the Company in accordance with the terms therein, may loan up to an additional $1,500,000. The Loans will be used by the Company for working capital purposes. The interest rate on the loan agreement is 3.0% and has a maturity date of December 31, 2025. In addition, on the date of the Initial Advance, the Company issued to the Lender an aggregate of 65,217 shares of common stock (the “Lender Warrant”). The Lender Warrant is immediately exercisable and will expire on the date that is two years from the date of issuance.
Registration Statement on Form S-3 and ATM Offering
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 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. The shares of common stock to be offered and sold under the Offering Agreement will be sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-219239), which was filed with the SEC on November 3, 2025 (the “Shelf Registration Statement”). A prospectus supplement related to the at the market offering program was filed as part of the Shelf Registration Statement. As of the date of this Quarterly Report on Form 10-Q, the Shelf Registration Statement has not been declared effective by
20
the SEC. No shares of common stock may be sold pursuant to the Offering Agreement until the Shelf Registration Statement has been declared effective by the SEC.
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, 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.
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:
21
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 other expense on share settlement of Kineta merger separation payments, interest income on our cash and cash equivalents, interest expense on borrowings under our convertible notes and issued notes payable to the former Kineta employees, grant income from our NIH-funded research grant assumed in the Kintara Merger in October 2024, and non-cash changes in the fair value of our derivative liability associated with the make-whole premium on our convertible notes and our Kineta Merger holdback shares.
Warrant Modification
Warrant modification represents an extension of the exercise period of common stock purchase warrants issued in connection with Legacy TuHURA Series A Preferred Stock (the “Series A Warrants”) for an additional six months, with a new expiry date of February 12, 2025. The warrant modification has been recorded as a direct increase in accumulated deficit.
Results of Operations
Comparisons for the Three Months Ended September 30, 2025, and September 30, 2024
22
|
|
Three months ended |
|
|
|
|
||||||
|
|
September 30, |
|
|
Change |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
|
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
4,968,596 |
|
|
$ |
2,946,768 |
|
|
$ |
2,021,828 |
|
General and administrative |
|
|
1,761,007 |
|
|
|
783,459 |
|
|
|
977,548 |
|
Total operating expenses |
|
|
6,729,603 |
|
|
|
3,730,227 |
|
|
|
2,999,376 |
|
Loss from operations |
|
|
(6,729,603 |
) |
|
|
(3,730,227 |
) |
|
|
(2,999,376 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|||
Grant income |
|
|
138,299 |
|
|
|
- |
|
|
|
138,299 |
|
Interest expense |
|
|
(16,532 |
) |
|
|
(2,002,886 |
) |
|
|
1,986,354 |
|
Interest income |
|
|
6,060 |
|
|
|
132,767 |
|
|
|
(126,707 |
) |
Other expense |
|
|
(185,019 |
) |
|
|
- |
|
|
|
(185,019 |
) |
Change in fair value of Kineta merger holdback liability |
|
|
(315,660 |
) |
|
|
- |
|
|
|
(315,660 |
) |
Change in fair value of derivative liability |
|
|
- |
|
|
|
21,229 |
|
|
|
(21,229 |
) |
Total other income (expense) |
|
|
(372,852 |
) |
|
|
(1,848,890 |
) |
|
|
1,476,038 |
|
Net loss |
|
$ |
(7,102,455 |
) |
|
$ |
(5,579,117 |
) |
|
$ |
(1,523,338 |
) |
Series A Preferred cash dividend |
|
|
(2,089 |
) |
|
|
- |
|
|
|
(2,089 |
) |
Warrant modification |
|
|
- |
|
|
|
(965,177 |
) |
|
|
965,177 |
|
Net loss attributable to common shareholders |
|
$ |
(7,104,544 |
) |
|
$ |
(6,544,294 |
) |
|
$ |
(560,250 |
) |
Research and Development Expenses. The following table summarizes our research and development expenses by program for the periods presented.
|
|
Three months ended |
|
|
|
|
||||||
|
|
September 30, |
|
|
Change |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
|
|
|||
Direct program costs: |
|
|
|
|
|
|
|
|
|
|||
IFx-2.0 |
|
$ |
1,567,077 |
|
|
$ |
1,421,233 |
|
|
$ |
145,844 |
|
TBS-2025 |
|
|
317,340 |
|
|
|
- |
|
|
|
317,340 |
|
Preclinical research costs |
|
|
580,904 |
|
|
|
377,537 |
|
|
|
203,367 |
|
Indirect program costs: |
|
|
|
|
|
|
|
|
|
|||
Personnel and facilities related costs |
|
|
2,503,275 |
|
|
|
1,147,999 |
|
|
|
1,355,276 |
|
Total research and development expenses |
|
$ |
4,968,596 |
|
|
$ |
2,946,769 |
|
|
$ |
2,021,827 |
|
Research and development expenses were $5.0 million and $2.9 million for the three months ended September 30, 2025, and 2024, respectively. The increase of $2.1 million related to the following.
General and Administrative Expenses. General and administrative expenses were $1.8 million and $0.8 million for the three months ended September 30, 2025, and 2024, respectively. The increase of $1.0 million was primarily due to increases in non-cash stock compensation expense, merger transaction costs related to the Kineta acquisition, and costs associated with being a public company.
Grant Income. Grant income was $0.1 million for the three months ended September 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.
23
Interest Expense. Interest expense was $2.0 million for the three months ended September 30, 2024. From December 2023 to September 2024, as part of our private placement financing under which we offered and sold convertible promissory note (the “TuHURA Notes”), we issued convertible notes totaling $31.3 million. The TuHURA Notes included interest at 20% per annum, accretion to maturity date, and amortization of debt discount. Upon the completion of the Kintara Merger, all principal and accrued and unpaid interest and make-whole amounts under the TuHURA Notes automatically converted into shares of our common stock at a conversion price $3.80 per share of our common stock. There was no cash paid for interest in the TuHURA Notes. Interest expense was less than $0.1 million for the three months ended September 30, 2025 due to interest on the issued notes payable to former Kineta employees.
Interest Income. Interest income was less than $0.1 million and $0.1 million for the three months ended September 30, 2025 and 2024, respectively, related primarily to interest income earned on deposits at various banks.
Other Expense. Other expense was $0.2 million for the three months ended September 30, 2025, related to share settlement in exchange for a portion of the separation payments to the former Kineta employees assumed from the merger.
Change in Fair Value of Derivative Liability. For the three months ended September 30, 2024, there was a loss of $0.3 million associated with the bifurcated embedded derivative liability related to the make-whole premium on the TuHURA Notes.
Change in Fair Value of Kineta Merger Holdback Liability. For the three months ended September 30, 2025, there was a loss of $0.3 million associated with the holdback shares from the Kineta merger and due to the increase in share price in comparison to the merger date.
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.
Warrant Modification. For the three months ended September 30, 2024, there was a $1.0 million deemed dividend due to extending the exercise period on certain of the Series A Warrants for an additional six months.
Comparisons for the Nine Months Ended September 30, 2025, and September 30, 2024
|
|
Nine months ended |
|
|
|
|
||||||
|
|
September 30, |
|
|
Change |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
|
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
14,477,204 |
|
|
$ |
9,358,845 |
|
|
$ |
5,118,359 |
|
General and administrative |
|
|
9,145,378 |
|
|
|
2,595,860 |
|
|
|
6,549,518 |
|
Total operating expenses |
|
|
23,622,582 |
|
|
|
11,954,705 |
|
|
|
11,667,877 |
|
Loss from operations |
|
|
(23,622,582 |
) |
|
|
(11,954,705 |
) |
|
|
(11,667,877 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|||
Grant income |
|
|
713,508 |
|
|
|
- |
|
|
|
713,508 |
|
Interest expense |
|
|
(16,532 |
) |
|
|
(3,615,466 |
) |
|
|
3,598,934 |
|
Interest income |
|
|
135,624 |
|
|
|
197,449 |
|
|
|
(61,825 |
) |
Other expense |
|
|
(185,019 |
) |
|
|
- |
|
|
|
(185,019 |
) |
Change in fair value of Kineta merger holdback shares |
|
|
(315,660 |
) |
|
|
- |
|
|
|
(315,660 |
) |
Change in fair value of derivative liability |
|
|
- |
|
|
|
(313,772 |
) |
|
|
313,772 |
|
Total other income (expense) |
|
|
331,921 |
|
|
|
(3,731,789 |
) |
|
|
4,063,710 |
|
Net loss |
|
$ |
(23,290,661 |
) |
|
$ |
(15,686,494 |
) |
|
$ |
(7,604,167 |
) |
Series A Preferred cash dividend |
|
|
(6,267 |
) |
|
|
- |
|
|
|
(6,267 |
) |
Warrant modification |
|
|
- |
|
|
|
(965,177 |
) |
|
|
965,177 |
|
Net loss attributable to common shareholders |
|
$ |
(23,296,928 |
) |
|
$ |
(16,651,671 |
) |
|
$ |
(6,645,257 |
) |
Research and Development Expenses. The following table summarizes our research and development expenses by program for the periods presented.
24
|
|
Nine months ended |
|
|
|
|
||||||
|
|
September 30, |
|
|
Change |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
|
|
|||
Direct program costs: |
|
|
|
|
|
|
|
|
|
|||
IFx-2.0 |
|
$ |
5,647,463 |
|
|
$ |
5,192,858 |
|
|
$ |
454,605 |
|
TBS-2025 |
|
|
317,340 |
|
|
|
- |
|
|
|
317,340 |
|
Preclinical research costs |
|
|
1,599,950 |
|
|
|
817,373 |
|
|
|
782,577 |
|
Indirect program costs: |
|
|
|
|
|
|
|
|
|
|||
Personnel and facilities related costs |
|
|
6,912,451 |
|
|
|
3,348,615 |
|
|
|
3,563,836 |
|
Total research and development expenses |
|
$ |
14,477,204 |
|
|
$ |
9,358,846 |
|
|
$ |
5,118,358 |
|
Research and development expenses were $14.5 million and $9.4 million for the nine months ended September 30, 2025, and 2024, respectively. The increase of $5.1 million related to the following.
General and Administrative Expenses. General and administrative expenses were $9.1 million and $2.6 million for the nine months ended September 30, 2025, and 2024, respectively. The increase of $6.5 million was primarily due to increases in non-cash stock compensation expense, merger transaction costs related to the Kineta acquisition, and costs associated with being a public company.
Grant Income. Grant income was $0.7 million for the nine months ended September 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 $3.6 million for the nine months ended September 30, 2024. From December 2023 to September 2024, as part of our private placement financing under which we offered and sold convertible promissory note (the “TuHURA Notes”), we issued convertible notes totaling $31.3 million. The TuHURA Notes included interest at 20% per annum, accretion to maturity date, and amortization of debt discount. Upon the completion of the Kintara Merger, all principal and accrued and unpaid interest and make-whole amounts under the TuHURA Notes automatically converted into shares of our common stock at a conversion price $3.80 per share of our common stock. There was no cash paid for interest in the TuHURA Notes. Interest expense was less than $0.1 million for the nine months ended September 30, 2025 due to interest on the issued notes payable to former Kineta employees.
Interest Income. Interest income was $0.1 million and $0.2 million for the nine months ended September 30, 2025 and 2024, respectively, related primarily to interest income earned on deposits at various banks.
Change in fair value of Kineta merger holdback liability. For the nine months ended September 30, 2025, there was a loss of $0.3 million associated with the holdback shares from the Kineta merger and due to the increase in share price in comparison to the merger date.
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.
Warrant modification. For the nine months ended September 30, 2024, there was a $1.0 million deemed dividend due to extending the exercise period on certain of the Series A Warrants for an additional six months.
25
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 $22.6 million and $29.3 million for the years ended December 31, 2024, and 2023, respectively, and incurred net losses of $23.3 and $15.7 million for the nine months ended September 30, 2025 and 2024, respectively. Additionally, we used $14.7 million and $12.0 million of cash from our operating activities for the years ended December 31, 2024, and 2023, respectively, and used $22.1 million and $12.1 million from our operating activities for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $134.4 million.
As of September 30, 2025, we had cash and cash equivalents of $2.7 million. In October 2025, we received $1.5 million in a bridge loan financing with the Lender. We invest our cash and cash equivalents in liquid money market accounts.
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 the Kintara Merger). Since inception, Legacy TuHURA has 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 $13.6 million in aggregate principal amount through the issuance of common stock and bridge financings.
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 $3,011,373 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 Warrant Shares, 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.
Securities Purchase Agreement
On June 2, 2025, the Company and the Purchasers entered into the Securities Purchase Agreement pursuant to which the Company 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 “Warrants”), for an aggregate offering amount of $12,612,169. The combined effective offering price for each share and accompanying Warrant in the Offering was $2.65.
Cash Flows
The following table sets forth a summary of the net cash flow activity for the nine months ended September 30, 2025 and 2024, respectively:
|
|
Nine Months Ended |
|
|||||
|
|
September 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Net cash provided by (used in): |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(22,073,128 |
) |
|
$ |
(12,128,521 |
) |
Investing activities |
|
|
(1,307,511 |
) |
|
|
(5,228,869 |
) |
Financing activities |
|
|
13,420,877 |
|
|
|
33,288,380 |
|
Net increase (decrease) in cash |
|
$ |
(9,959,762 |
) |
|
$ |
15,930,990 |
|
Operating Activities
26
For the nine months ended September 30, 2025, net cash used in operating activities was $22.1 million, which primarily consisted of a net loss of $23.3 million, a change in net operating assets and liabilities of $3.6 million, and non-cash charges of $4.8 million. The net non-cash charges were primarily related to depreciation and amortization expense of less than $0.1 million, a change in fair value of the Kineta Merger holdback shares of $0.3 million, loss on share settlement of Kineta assumed liabilities of $0.2 million, and stock-based compensation of $4.3 million. The $3.6 million net change in operating assets and liabilities is primarily due to decrease in accounts payable and accrued expenses of approximately $3.9 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately $0.3 million.
For the nine months ended September 30, 2024, net cash used in operating activities was $12.1 million, which primarily consisted of a net loss of $15.7 million and a change in net operating assets and liabilities of $1.2 million, and non-cash charges of $2.4 million. The net non-cash charges were primarily related, depreciation and amortization expense of $0.1 million, stock-based compensation of $0.9 million, amortization of debt discount and change in fair value of the derivative liability of $1.4 million associated with the TuHURA Note Financing. The $1.2 million change in net operating assets and liabilities was due to an increase in accounts payable and accrued expenses of approximately $1.3 million due to timing of invoices and vendor payments, and a decrease in current and non-current assets of $0.1 million.
Investing Activities
For the nine months ended September 30, 2025 and 2024, net cash used in investing activities was $1.3 million and $5.2 million, which consisted of purchases of property and equipment and deposits and payments in connection with the Kineta acquisition.
Financing Activities
For the nine months ended September 30, 2025, net cash provided by financing activities was $13.4 million, which consisted of $3.6 million proceeds from warrants exercises, $12.1 million in gross proceeds from the issuance of common stock attributable to the Offering, offset by $0.7 million in payments for deferred offering costs attributable to the Offering, $0.4 million of debt assumed from the Kineta Merger, $0.1 million principal payment of note payables to former Kineta employees, and $1.1 million in merger transaction costs and net liabilities attributable to Kintara.
For the nine months ended September 30, 2024, net cash provided by financing activities was $33.3 million, which consisted of $27.5 net proceeds from convertible notes issued as part of the TuHURA Note Financing, $4.7 million net proceeds from the common stock private offering, $2.0 million proceeds from stock options and warrants exercises, and $0.9 million in deferred offering costs paid in connection with the Kintara Merger.
Funding Requirements
We expect to incur additional 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 payment of the Warrant Exercise Notes, bridge loan transaction, and the financing from the Securities Purchase Agreement with the accredited investors, will be sufficient to meet our anticipated cash requirements through the end of 2025.
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:
27
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 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 three months ended September 30, 2025, contained in Item 1 in this Quarterly Report, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.
Accrued Research and Development Expenses
As part of the process of preparing our financial statements, we are required to estimate our accrued expenses as of each balance sheet date. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. We make estimates of our accrued expenses as of each balance sheet date based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and adjusts, if necessary. The significant estimates in our accrued research and development expenses include the costs incurred for services performed by our vendors in connection with research and development activities for which we have not yet been invoiced.
We base our expenses related to research and development activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with vendors that conduct research and development on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract-to-contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the research and development expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid expense accordingly. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.
Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting
28
our that are too high or too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts actually incurred.
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 recognizes 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.
Common Stock Valuations
We are required to estimate the fair value of the common stock underlying our equity awards when performing fair value calculations. The fair value of the common stock underlying our equity awards was determined on each grant taking into account input from management and taking into account the pricing offered in our equity raises. All options to purchase shares of our common stock are intended to be granted with an exercise price per share no less than the fair value per share of our common stock underlying those options on the date of grant, based on the information known to us on the date of grant. In the absence of a public trading market for our common stock, on each grant date we develop an estimate of the fair value of our common stock in order to determine an exercise price for the option grants. Our determination of the fair value of our common stock was made by considering the prices of preferred stock sold to investors in arm’s length transactions and the rights, preferences and privileges of our preferred stock relative to those of our common stock.
In determining the fair value of shares of our underlying stock option grants prior to our reverse merger with Kintara, for the three months ended September 30, 2024, we used the market approach by reference to the closest round of equity financing, preceding the date of valuation and analysis of the trading values of publicly traded companies deemed comparable to us.
Following our reverse merger with Kintara, the fair value of our common stock will be determined based on the quoted market price of our common stock. In connection with our reverse merger with Kintara, all outstanding shares of our preferred stock were converted into shares of our common stock.
Kineta Acquisition and Valuation of Intangible Assets
On June 30, 2025 we completed the business combination 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 issued and outstanding immediately prior to the First Merger, was converted into the right to receive 0.185298 shares of our common stock for an aggregate of approximately 2,868,169 shares of our common stock. Also pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Share is also entitled to (i) its pro rata portion of approximately 1,129,885 shares of our common stock to be issued after six months following the closing of the Kineta Merger, subject to adjustment for losses incurred or accrued during the six month period from the closing of the Kineta Merger, and (ii) 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 Kineta Merger.
We recognized in-process research and development (“IPR&D”) in connection with the acquisition. The preliminary fair value of the acquired IPR&D intangible assets was determined based on the market capitalization of Kineta, as previously traded on the Nasdaq capital market.
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Goodwill and other intangible assets comprised of IPR&D on our balance sheet as of September 30, 2025 were in connection with the Kineta Merger.
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 will engage a third-party valuation firm to assist us with the valuation of the IPR&D. The valuation of our acquired IPR&D has significant measurement uncertainty given the lack of historical data on which to base assumptions. Assumptions are difficult to make accurately and were mainly derived from life science studies, industry data, and peer company information that our management believes represent appropriate comparable data.
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
A description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our 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 has high credit quality and have not experienced any losses on such accounts and does not believe it is 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 Annual Report. 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 September 30, 2025.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act. Our management, under the supervision and with the participation of our principal executive officer and principal financial officer, conducted an assessment of the effectiveness of our internal control over financial reporting as of September 30, 2025 based on the criteria set forth in “Internal Control – Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, our management concluded that, as of September 30, 2025, our internal control over financial reporting was effective.
Attestation Report of the Registered Public Accounting Firm
For so long as we qualify as a non-accelerated filer, our independent registered public accounting firm is not required to issue an attestation report on our internal control over financial reporting.
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, we are not party to any material legal matters or claims.
Item 1A. Risk Factors.
Except as set forth below, 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, 2024 filed with the SEC on March 31, 2025and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 which was filed with the SEC on April 14, 2025 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 which was filed with the SEC on August 14, 2025. Factors that are not currently known to us, factors that we currently consider immaterial or factors that are not specific to us, such as general economic conditions, may also materially adversely affect our business or financial condition.
Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
The ability of the FDA and other government agencies to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, a government agency’s ability to hire and retain key personnel and accept the payment of user fees, government shutdowns and other events that may otherwise affect the government agency’s ability to perform routine functions. Average review times at the FDA and other government agencies have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs or modifications to approved drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times, including the most recent shutdown that began on October 1, 2025, and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities. If the current government shutdown continues or a new government shutdown occurs, or if future global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions.
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,
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Item 6. Exhibits.
Exhibit Number |
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Description |
2.1 † |
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2.2 |
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2.3 †
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3.1 |
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3.2 |
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4.1 |
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4.2 |
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4.3 |
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4.4 |
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4.5 |
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4.6 |
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4.7 |
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4.8 |
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4.9 |
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4.10 |
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4.11 |
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4.12 |
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4.13 |
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4.14 |
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4.15 |
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4.16 |
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Form of Warrant (incorporated by reference to Exhibit 4.1 to TuHURA Biosciences, Inc.’s Current |
4.17 |
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10.1 |
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10.2 |
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10.3 |
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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.
# In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release Nos. 33-8238 and 34-47986, Final Rule: Management's Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purpose of Section 18 of the Exchange Act. Such certifications will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.
†Annexes, schedules and certain exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. TuHURA Biosciences, Inc. hereby undertakes to furnish copies of any of the omitted schedules upon request by the Securities and Exchange Commission.
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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: November 14, 2025 |
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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: November 14, 2025 |
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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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