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ROC
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2026
OR
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☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 001-37823
TUHURA BIOSCIENCES, INC.
(Exact Name of Registrant as Specified in its Charter)
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Nevada |
99-0360497 |
( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
10500 University Center Dr., Suite 110 Tampa, FL |
33612 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (813) 875-6600
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
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HURA |
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The Nasdaq Capital Market LLC |
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. Yes ☒ No ☐
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). Yes ☒ No ☐
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.
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Large accelerated filer |
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☐ |
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Accelerated filer |
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☐ |
Non-accelerated filer |
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☒ |
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Smaller reporting company |
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☒ |
Emerging growth company |
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☐ |
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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 ☒ No ☐
As of May 12, 2026, the registrant had 63,682,528 shares of common stock, $0.001 par value per share, outstanding.
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:
•our ability to raise funds for general corporate purposes and operations, including our research activities and clinical studies;
•our ability to draw down sufficient funds from the credit facility that we entered into April 2026;
•the therapeutic potential of IFx-2.0, TBS-2025 and future product candidates;
•the anticipated development, regulatory pathway and timing of our IFx-2.0 Phase 3 trial and our planned TBS-2025 Phase 2 trial, as well as our other technologies and product candidates;
•the regulatory approval processes of the U.S. Food and Drug Administration and other comparable foreign regulatory authorities, which are lengthy, time-consuming and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, such product candidates, and our ability to generate revenue will be materially impaired;
•our ability to recruit qualified management and technical personnel;
•the cost, timing, scope and results of our clinical studies;
•existing regulations and regulatory developments in the United States and other jurisdictions;
•our ability to attract and retain key scientific, medical, commercial and management personnel;
•our ability to obtain and maintain required regulatory approvals for our products;
•our expectations regarding our cash resources;
•our ability to obtain or maintain patents or other appropriate protection for the intellectual property utilized in our current and planned products;
•our ability to develop and commercialize products without infringing the intellectual property rights of third parties; and
•other risks and uncertainties, including those listed under “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Annual Report”).
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q and our 2025 Annual Report filed with the Securities and Exchange Commission (“SEC“) on March 31, 2026, particularly in the “Risk Factors” section, that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or into which we may enter.
You should read this Quarterly Report on Form 10-Q and the documents that we reference herein and have filed or incorporated by reference as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
PART I—FINANCIAL INFORMATION
Item 1. Condensed Financial Statements.
TuHURA Biosciences, Inc.
Condensed Consolidated Balance Sheets
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March 31, |
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December 31, |
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2026 |
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2025 |
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(Unaudited) |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
6,298,127 |
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$ |
3,619,949 |
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Stock subscription receivable |
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- |
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500,000 |
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Other current assets |
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684,156 |
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|
|
501,187 |
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Total Current Assets |
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6,982,283 |
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4,621,136 |
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Property and equipment, net |
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326,012 |
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|
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300,639 |
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Operating right-of-use assets |
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349,633 |
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384,530 |
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Other noncurrent assets |
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33,769 |
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33,769 |
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Goodwill |
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10,738,082 |
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10,738,082 |
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In-process research and development |
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11,275,000 |
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11,275,000 |
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Total Assets |
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$ |
29,704,779 |
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$ |
27,353,156 |
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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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$ |
5,860,053 |
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$ |
5,522,887 |
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Kineta severance promissory notes |
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- |
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197,354 |
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Lease liabilities, current |
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206,851 |
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199,041 |
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Total Current Liabilities |
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6,066,904 |
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5,919,282 |
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Long-term Liabilities: |
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Lease liability, long term |
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250,075 |
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303,627 |
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Deferred tax liability |
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197,919 |
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197,919 |
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Total Liabilities |
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6,514,898 |
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6,420,828 |
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Stockholders' Equity: |
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Preferred Stock Series A (assumed in Kintara merger); $1.00 par value, 278,530 shares outstanding as of March 31, 2026 and December 31, 2025 |
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278,530 |
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278,530 |
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Common stock, $0.001 par value, 200,000,000 shares authorized; 63,578,528 and 59,336,104 shares issued and outstanding as of March 31, 2026 and December 31, 2025. |
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63,578 |
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59,336 |
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Additional paid in capital |
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171,571,362 |
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161,779,364 |
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Accumulated deficit |
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(148,723,589 |
) |
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(141,184,902 |
) |
Total Stockholders’ Equity |
|
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23,189,881 |
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|
20,932,328 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
29,704,779 |
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|
$ |
27,353,156 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
TuHURA Biosciences, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
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Three Months Ended March 31, |
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2026 |
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2025 |
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Research and development expenses |
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$ |
5,232,541 |
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$ |
4,581,672 |
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Acquisition-related costs |
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- |
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419,042 |
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General and administrative expenses |
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2,297,358 |
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2,016,309 |
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Operating Loss |
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(7,529,899 |
) |
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(7,017,023 |
) |
Other (Expense) Income: |
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Grant income |
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- |
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252,554 |
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Interest expense |
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(27,974 |
) |
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- |
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Interest income |
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21,275 |
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100,098 |
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Total Other (Expense) Income |
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(6,699 |
) |
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352,652 |
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Net Loss |
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$ |
(7,536,598 |
) |
|
$ |
(6,664,371 |
) |
Series A Preferred cash dividend |
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|
(2,089 |
) |
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|
(2,089 |
) |
Net Loss attributable to common stockholders |
|
$ |
(7,538,687 |
) |
|
$ |
(6,666,460 |
) |
Net Loss per share, basic and diluted |
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$ |
(0.13 |
) |
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$ |
(0.15 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
60,010,237 |
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43,404,947 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
TuHURA Biosciences, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
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Additional |
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Accumulated |
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Total |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Paid in |
|
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Due from |
|
|
Equity |
|
|
Stockholders’ |
|
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Shares |
|
|
Dollars |
|
|
Shares |
|
|
Dollars |
|
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Capital |
|
|
Stockholders |
|
|
(Deficit) |
|
|
Equity |
|
Balances at January 1, 2025 |
|
278,530 |
|
|
$ |
278,530 |
|
|
|
42,323,759 |
|
|
$ |
42,324 |
|
|
$ |
125,397,691 |
|
|
$ |
- |
|
|
$ |
(111,124,569 |
) |
|
$ |
14,593,976 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Issuance of common shares for warrants exercised |
|
- |
|
|
|
- |
|
|
|
1,208,104 |
|
|
|
1,208 |
|
|
|
3,560,907 |
|
|
|
(3,057,904 |
) |
|
|
- |
|
|
|
504,211 |
|
Stock options exercised, cashless |
|
|
|
|
|
|
|
148,533 |
|
|
|
148 |
|
|
|
(148 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
Stock compensation expense |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,424,736 |
|
|
|
- |
|
|
|
- |
|
|
|
1,424,736 |
|
Series A Preferred Stock cash dividend |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,089 |
) |
|
|
(2,089 |
) |
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(6,664,371 |
) |
|
|
(6,664,371 |
) |
Balances at March 31, 2025 |
|
278,530 |
|
|
$ |
278,530 |
|
|
|
43,680,396 |
|
|
$ |
43,680 |
|
|
$ |
130,383,186 |
|
|
$ |
(3,057,904 |
) |
|
$ |
(117,791,029 |
) |
|
$ |
9,856,463 |
|
|
|
|
|
|
|
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Additional |
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Accumulated |
|
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Total |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Paid in |
|
|
Due from |
|
|
Equity |
|
|
Stockholders’ |
|
|
Shares |
|
|
Dollars |
|
|
Shares |
|
|
Dollars |
|
|
Capital |
|
|
Stockholders |
|
|
(Deficit) |
|
|
Equity |
|
Balances at January 1, 2026 |
|
278,530 |
|
|
$ |
278,530 |
|
|
|
59,336,104 |
|
|
$ |
59,336 |
|
|
$ |
161,779,364 |
|
|
$ |
- |
|
|
$ |
(141,184,902 |
) |
|
$ |
20,932,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares in RDO, net of issuance costs |
|
- |
|
|
|
- |
|
|
|
4,242,424 |
|
|
|
4,242 |
|
|
|
6,995,758 |
|
|
|
- |
|
|
|
- |
|
|
|
7,000,000 |
|
Stock compensation expense |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,796,240 |
|
|
|
- |
|
|
|
- |
|
|
|
2,796,240 |
|
Series A Preferred Stock cash dividend |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,089 |
) |
|
|
(2,089 |
) |
Net loss |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(7,536,598 |
) |
|
|
(7,536,598 |
) |
Balances at March 31, 2026 |
|
278,530 |
|
|
$ |
278,530 |
|
|
|
63,578,528 |
|
|
$ |
63,578 |
|
|
$ |
171,571,362 |
|
|
$ |
- |
|
|
$ |
(148,723,589 |
) |
|
$ |
23,189,881 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
TuHURA Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2026 |
|
|
2025 |
|
Cash flows from Operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(7,536,598 |
) |
|
$ |
(6,664,371 |
) |
Adjustments to reconcile net loss to cash |
|
|
|
|
|
|
used in operating activities: |
|
|
|
|
|
|
Stock compensation expense |
|
|
2,796,240 |
|
|
|
1,424,736 |
|
Depreciation and amortization |
|
|
23,472 |
|
|
|
14,058 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Other current assets |
|
|
(182,970 |
) |
|
|
(29,998 |
) |
Other noncurrent assets |
|
|
34,897 |
|
|
|
71,612 |
|
Accounts payable and accrued expenses |
|
|
452,006 |
|
|
|
445,541 |
|
Net cash flows from operating activities |
|
|
(4,412,953 |
) |
|
|
(4,738,422 |
) |
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
Cash paid for business acquisition, net of cash received from Kineta |
|
|
- |
|
|
|
(1,108,375 |
) |
Purchase of property and equipment |
|
|
(48,846 |
) |
|
|
(42,672 |
) |
Net cash flows from investing activities |
|
|
(48,846 |
) |
|
|
(1,151,047 |
) |
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
Cash dividend payment of preferred stock Series A |
|
|
(2,089 |
) |
|
|
(2,089 |
) |
Proceeds from warrants exercised |
|
|
- |
|
|
|
504,211 |
|
Proceeds from issuance of common stock |
|
|
7,500,000 |
|
|
|
- |
|
Payments made on Kineta severance promissory notes |
|
|
(197,354 |
) |
|
|
- |
|
Payment of transaction costs related to Kintara merger |
|
|
- |
|
|
|
(500,000 |
) |
Principal payments of finance lease |
|
|
(10,845 |
) |
|
|
- |
|
Payment of placement agent fees and offering costs |
|
|
(149,735 |
) |
|
|
- |
|
Payment of net liabilities assumed in reverse recapitalization with Kintara |
|
|
- |
|
|
|
(550,000 |
) |
Net cash flows from financing activities |
|
|
7,139,977 |
|
|
|
(547,878 |
) |
|
|
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
2,678,178 |
|
|
|
(6,437,347 |
) |
Cash and cash equivalents at the beginning of the period |
|
|
3,619,949 |
|
|
|
12,657,178 |
|
Cash and cash equivalents at the end of the period |
|
$ |
6,298,127 |
|
|
$ |
6,219,831 |
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
27,924 |
|
|
$ |
- |
|
Supplemental non-cash activity |
|
|
|
|
|
|
Due from stockholders not yet received for warrant exercises |
|
$ |
- |
|
|
$ |
3,057,904 |
|
Deferred offering costs not yet paid |
|
|
314,168 |
|
|
|
13,965 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
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 (the “Company”), is a clinical stage immuno-oncology company with three distinct technologies focused on the development of novel therapeutics designed to overcome primary and acquired resistance to cancer immunotherapies.
Our proprietary Immune FxTM technology platform, or IFx, is an innate immune agonist technology designed to “trick” the body’s immune system to attack tumor cells by making tumor cells look like bacteria. Our lead product candidate, IFx-2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. In June 2025, we initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for patients with advanced or metastatic Merkel cell carcinoma who are checkpoint inhibitor naïve utilizing the FDA’s accelerated approval pathway. We anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 in the second half of 2027.
In addition to our IFx technology platform, in June 2025 we acquired the rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody formerly known as KVA12123, through our acquisition of Kineta, Inc. (“Kineta”) via merger on June 30, 2025 (the “Kineta Merger”). VISTA (otherwise referred to as V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells that is believed to be a strong driver of immunosuppression in the tumor microenvironment and is believed to be a primary mechanism by which leukemic blasts escape immune recognition contributing to low response rates and high rates of recurrence in acute myeloid leukemia, or AML. Following our acquisition of Kineta, we are currently planning on investigating TBS-2025 in a Phase 1b/2 trial in patients with r/r mutNPM1 AML.
In addition to IFx and TBS-2025, we are leveraging our Delta Opioid Receptor (DOR) technology to develop first-in-class bi-functional, bi-specific antibody-drug conjugates (“ADCs”) targeting the DOR on Myeloid Derived Suppressor Cells (“MDSCs”) to modulate their immunosuppressive influence on the bone marrow and tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
Note 2—Summary of significant accounting policies
Basis for Consolidation – The condensed consolidated financial statements of the Company have been prepared in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAP”) and are presented in United States dollars. The functional currency of the Company and each of its subsidiaries is the United States dollar.
The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Adgero Biopharmaceuticals Holdings Inc., Adgero Biopharmaceuticals, Inc., Kineta, LLC, and TuHURA Biosciences, Inc., a Delaware corporation (“Legacy TuHURA”). All intercompany balances and transactions have been eliminated in consolidation.
The Company’s significant accounting policies are described herein and in Note 2, “Summary of significant accounting policies,” in the 2025 Annual Report. There have been no changes to the significant accounting policies during the three months ended March 31, 2026.
Reclassification – The Company reclassified the break-out of $419,042 merger-related costs for 2025 into a separate line item in the unaudited consolidated statement of operations. In the prior year, such amount had been included in the line item "general and administrative expenses".
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.
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 $250,000. As of March 31, 2026, the uninsured portion of cash held by the Company was approximately $5,792,000.
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.
ASC 805, Business Combinations, provides a model for determining whether an acquisition represents a business combination. In order to be a business, the integrated set of activities of the acquired entity needs to have an input and a substantive process that together significantly contribute to the ability to create outputs. The acquired entity must also pass the “Screen Test” which involves determining whether the acquisition represents an in-substance asset acquisition based on whether the fair value of the gross assets acquired is “substantially all” concentrated in a single asset or group of similar assets. This evaluation excludes certain acquired assets such as cash, deferred taxes, and goodwill associated with deferred taxes, but includes all other gross assets, including any consideration transferred in excess of the identified assets.
Indefinite-Lived Intangible Assets – Indefinite-lived intangible assets consist of In-Process Research and Development (“IPR&D”). The fair values of IPR&D project assets acquired in business combinations are capitalized. We utilized the Cost Method to determine the estimated fair value of the IPR&D assets acquired in our recent business combination with Kineta. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate.
Intangible assets with indefinite lives, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. However, an entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that an indefinite-lived intangible asset’s fair value is less than its carrying amount. Otherwise, no further impairment testing is required. The indefinite-lived intangible asset impairment test consists of a one-step analysis that compares the fair value of the intangible asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. The Company considers many factors in evaluating whether the value of our intangible assets with indefinite lives may not be recoverable, including, but not limited to, the cost of equity and debt capital, general economic conditions, outlook and market performance of the Company’s industry and recent and forecasted financial performance.
We will evaluate indefinite-lived intangible assets for impairment at least annually and whenever facts and circumstances indicate that their carrying amounts may not be recoverable. The Company did not identify any triggering events that occurred during the three months ended March 31, 2026.
Goodwill – Goodwill represents the amount of consideration paid in excess of the fair value of net assets acquired as a result of the Company’s business acquisitions accounted for using the acquisition method of accounting. Goodwill is not amortized and is subject to impairment testing at a reporting unit level on an annual basis or when a triggering event occurs that may indicate the carrying value of the goodwill is impaired. An entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that the fair value of the reporting units is less than its carrying amount.
We will evaluate goodwill for impairment at least annually and whenever facts and circumstances indicate that their carrying amounts may not be recoverable. The Company did not identify any triggering events that occurred during the three months ended March 31, 2026.
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 chief executive officer, who reviews and evaluates consolidated net loss for purposes of assessing performance, making operating decisions, allocating resources and planning and forecasting for future periods. The measure of segment assets is reported on the balance sheet as total assets. There is no segment revenue for the three months ended March 31, 2026, and 2025. The accounting policies of the cancer treatment segment are the same as those described in the summary of significant accounting policies. All tangible assets are held in the United States.
Net Loss Per Share – Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the Company has reported net losses for each period presented.
Note 3—Liquidity and management’s plans
The Company has been engaged in research and development activities related to Immune Fx, TBS-2025, and ADCs, which will require additional investment until revenue-generating activities can begin.
The Company has historically incurred negative cash flows from operations, which have been funded through a combination of debt and equity financings.
For the three months ended March 31, 2026, the Company incurred $4.4 million of negative cash flows from operations. The Company has approximately $6.3 million of cash and cash equivalents on hand at March 31, 2026. The Company expects that its existing capital resources, including the future expected cash proceeds from the Company's revolving line of credit with Parkview Holdings One LLC discussed in Note 14, will be sufficient to fund the Company’s planned future operations into the end of 2028.
The Company expects to raise cash through the sale of capital stock and warrants, 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.
Note 4—Acquisition
On June 30, 2025, the Company acquired 100% of the issued and outstanding capital stock of Kineta pursuant to the terms of 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 direct wholly-owned subsidiary of the Company, Hura Merger Sub II, LLC, a Delaware limited liability company and direct wholly-owned subsidiary of the Company, Kineta and Craig Philips, solely in his capacity as the representative, agent and attorney-in-fact of the stockholders of Kineta . Kineta is a clinical-biotechnology company, with a mission to develop next-generation immunotherapies, focused on discovering and developing potentially differentiated immunotherapies that address the mechanism of cancer immune resistance. Kineta’s VISTA blocking immunotherapy, KVA12123 (which has since been renamed TBS-2025), was acquired along with worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets derived from the development program. The Company anticipates synergies, such as having control over the VISTA blocking immunotherapy development program, the continuing employment of Kineta’s former CEO, and a consulting agreement with Kineta’s former CSO, will further enhance our activities advancing therapies for cancer treatment.
Goodwill will not be deductible for tax purposes.
The allocation of the consideration for the net assets acquired for the acquisition of Kineta was as follows.
|
|
|
|
|
|
|
June 30, |
|
|
|
2025 |
|
Purchase Consideration |
|
|
|
Exclusivity cash deposit |
|
$ |
5,994,502 |
|
Equity issued to Kineta shareholders |
|
|
6,396,017 |
|
Holdback liability issued in equity |
|
|
2,519,644 |
|
Cash previously advanced for clinical trial funding and working capital |
|
|
1,650,000 |
|
Fair value of consideration |
|
$ |
16,560,163 |
|
Assets Acquired: |
|
|
|
Cash |
|
$ |
390,721 |
|
Acquired in-process research and development |
|
|
11,275,000 |
|
Total assets acquired |
|
|
11,665,721 |
|
Liabilities Assumed: |
|
|
|
Accrued expenses, assumed debt, and severance liabilities |
|
$ |
(5,645,721 |
) |
Deferred tax liability |
|
$ |
(197,919 |
) |
Total liabilities assumed |
|
|
(5,843,640 |
) |
Net assets acquired |
|
|
5,822,081 |
|
Goodwill |
|
$ |
10,738,082 |
|
|
|
|
|
The fair value of equity was determined based on the closing price of the Company’s common stock immediately prior to the Kineta Merger, and included approximately 4.0 million shares of common stock at $2.23 per share, subject to a six-month holdback of 1.1 million shares of common stock of delayed consideration to satisfy any necessary adjustments, including any net working capital adjustments, and recorded at its acquisition date fair value and classified as a liability within current liabilities as holdback liability on the Company’s consolidated balance sheets at the acquisition date. As of December 31, 2025, the Company issued all of the shares of merger consideration, consistent of all of the shares of the Company’s common stock (adjusted for fractional shares) under the TuHURA-Kineta Merger Agreement.
The delayed consideration was settled in Company shares of common stock and recorded at its fair value through the settlement date of December 30, 2025 with changes recorded to earnings. Additionally, the estimated fair value of the delayed consideration settled in equity used 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 considered a Level 3 measurement as defined in ASC 820. Changes in fair value are recognized in the consolidated statements of operations under change in fair value of Kineta merger holdback shares. On December 30, 2025, the Company issued approximately 1.1 million shares using a closing price of $0.76 and recognized a gain of $1,590,949 for the year ended December 31, 2025 due to the change in fair value.
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 Company estimated the fair value of the IPR&D assets using the cost approach, which is based on the amount that a market participant would incur to recreate the assets, adjusted for obsolescence, inefficiencies, and the current stage of completion of the underlying development efforts. Significant assumptions used in the valuation included estimates of direct and indirect development costs and the Company's weighted average cost of capital.
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 Company incurred less than $0.1 million and $0.4 million in transaction costs for the Kineta Merger during the three months ended March 31, 2026 and 2025, respectively, and recorded as acquisition-related costs in the Company's condensed consolidated statements of operations.
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, 2025. The pro forma information includes acquisition-related expenses. The pro forma financial information is not necessarily indicative of the results of operations as they would have been had the transaction been effected on the assumed date.
|
|
|
|
|
Three Months Ended March 31, |
|
|
2025 |
|
|
|
|
Operating expenses: |
|
|
Research and development expenses |
|
5,198,230 |
|
General and administration expenses |
|
3,837,898 |
|
Operating Loss |
|
(9,036,128 |
) |
Other (Expense) Income: |
|
|
Gain on sale of assets |
|
500,000 |
|
Grant income |
|
252,554 |
|
Interest income (expense), net |
|
44,757 |
|
Total Other (Expense) Income |
|
797,311 |
|
Net Loss |
$ |
(8,238,817 |
) |
|
|
|
Note 5—Net loss per share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows:
|
|
|
|
|
|
|
|
|
Three months ended March 31 |
|
|
2026 |
|
|
2025 |
|
Numerator: |
|
|
|
|
|
Net loss attributable to common stockholders |
$ |
(7,538,687 |
) |
|
$ |
(6,666,460 |
) |
Denominator: |
|
|
|
|
|
Weighted-average common shares outstanding - basic and diluted |
|
60,010,237 |
|
|
|
43,404,947 |
|
Net loss per share attributable to common shareholders - basic and diluted |
$ |
(0.13 |
) |
|
$ |
(0.15 |
) |
Common stock warrants in the amount of 297,029 issued to our financial advisor, Wainwright, were not outstanding as shares of common stock as of March 31, 2026, however, they are included in the weighted-average common shares outstanding – basic and diluted, as if they were considered outstanding, as the $0.01 exercise price is economically equivalent to issued shares.
The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. For the three months ended March 31, 2026 and 2025, the Company excluded the following potential common shares from the computation of diluted net loss per share attributable to common stockholders for the period because including them would have had an anti-dilutive effect:
|
|
|
|
|
|
|
|
|
As of March 31 |
|
|
2026 |
|
|
2025 |
|
Stock options issued and outstanding |
|
19,974,881 |
|
|
|
6,511,437 |
|
Unvested restricted stock units |
|
57 |
|
|
|
114 |
|
Warrants |
|
32,072,280 |
|
|
|
8,335,078 |
|
Total |
|
52,047,218 |
|
|
|
14,846,629 |
|
Note 6—Other current assets
Other current assets consist of the following as of March 31, 2026, and December 31, 2025:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2026 |
|
|
2025 |
|
Prepaid insurance |
|
$ |
148,985 |
|
|
$ |
159,214 |
|
Clinical trial deposit |
|
|
167,661 |
|
|
|
167,661 |
|
Other current assets |
|
|
367,510 |
|
|
|
174,312 |
|
|
|
$ |
684,156 |
|
|
$ |
501,187 |
|
Note 7—Property and equipment, net
Property and equipment, net consists of the following as of March 31, 2026, and December 31, 2025:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2026 |
|
|
2025 |
|
Furniture and fixtures |
|
$ |
170,607 |
|
|
$ |
170,607 |
|
Leasehold improvements |
|
|
544,629 |
|
|
|
544,629 |
|
Machinery and office equipment |
|
|
1,720,567 |
|
|
|
1,671,721 |
|
Software |
|
|
72,394 |
|
|
|
72,394 |
|
|
|
|
2,508,197 |
|
|
|
2,459,351 |
|
Less accumulated depreciation and amortization |
|
|
(2,182,185 |
) |
|
|
(2,158,712 |
) |
|
|
$ |
326,012 |
|
|
$ |
300,639 |
|
Depreciation and amortization of property and equipment totaled approximately $23,000 for the three months ended March 31, 2026, and approximately $14,000 for the three months ended March 31, 2025.
Note 8—Accounts payable and accrued expenses
Accounts payable and accrued expenses consist of the following as of March 31, 2026, and December 31, 2025:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2026 |
|
|
2025 |
|
Trade accounts payable |
|
$ |
3,954,204 |
|
|
$ |
3,770,124 |
|
Accrued compensation |
|
|
1,708,257 |
|
|
|
1,525,139 |
|
Other accrued expenses |
|
|
197,592 |
|
|
|
227,624 |
|
|
|
$ |
5,860,053 |
|
|
$ |
5,522,887 |
|
Note 9—Income taxes
Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to be reversed. Valuation allowances are provided if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, including its net operating losses. Based on its history of operating losses, the Company believes that it is more likely than not that the benefit of its deferred tax assets will not be realized. Accordingly, the Company has provided a full valuation allowance for deferred tax assets as of March 31, 2026, and December 31, 2025.
Note 10—Stockholders’ equity
As of March 31, 2026, the Company had two classes of stock authorized in its Articles of Incorporation, as amended (the “Articles”).
Common Stock
The Company is authorized to issue up to 200,000,000 shares of common stock pursuant to its Articles. Holders of common stock are entitled to one vote for each share of common stock. As of March 31, 2026, there were 63,578,528 shares of common stock outstanding.
Preferred Stock
The Company is authorized to issue up to 5,000,000 shares of Preferred Stock pursuant to its Articles.
The historical Kintara Series A Preferred Stock were assumed in connection with the Kintara Merger and 278,530 are outstanding and have a stated value of $278,530 as of March 31, 2026, and December 31, 2025.
ATM Program
On November 3, 2025, the Company and Wainwright entered into an At-The-Market Offering Agreement (the “Offering Agreement”) with respect to an at-the-market offering program (the “ATM Program”) under which the Company may sell shares of its common stock having an aggregate offering price of up to $50,000,000 through Wainwright as its sales agent. During the three months ended March 31, 2026, the Company did not receive any proceeds under the Offering Agreement and no shares of common stock were issued. The Company began making sales under the Offering Agreement in April 2026, selling an aggregate of 104,000 shares of common stock at a weighted average price of $3.09 per share for gross proceeds of approximately $321,000.
Warrants
The following table summarizes the Company’s outstanding common stock warrants as of March 31, 2026
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding |
|
|
Weighted average exercise price |
|
|
Expiration dates |
Legacy TuHURA common stock warrants |
|
|
7,604,437 |
|
|
$ |
4.58 |
|
|
June 2026 to December 2030 |
Historical Kintara common stock warrants |
|
|
10,199 |
|
|
$ |
757.65 |
|
|
June 2026 to April 2027 |
2024 common stock warrants issued to financial advisor |
|
|
297,029 |
|
|
$ |
0.01 |
|
|
April 2027 |
2025 PIPE investors common stock warrants |
|
|
4,759,309 |
|
|
$ |
3.31 |
|
|
December 2030 |
2025 PIPE placement agent common stock warrants |
|
|
189,616 |
|
|
$ |
3.31 |
|
|
December 2030 |
Bridge loan warrants |
|
|
300,000 |
|
|
$ |
1.92 |
|
|
October 2027 to December 2027 |
2025 RDO Series A investors common stock warrants |
|
|
9,462,423 |
|
|
$ |
1.95 |
|
|
June 2031 |
2025 RDO Series B investors common stock warrants |
|
|
9,462,423 |
|
|
$ |
1.95 |
|
|
December 2027 |
2025 RDO placement agent common stock warrants |
|
|
283,873 |
|
|
$ |
2.06 |
|
|
December 2030 |
Total warrants outstanding at March 31, 2026 |
|
|
|
32,369,309 |
|
|
$ |
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
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 three months ended March 31, 2026 and 2025:
|
|
|
|
|
|
|
|
|
|
|
|
|
2026 |
|
|
2025 |
|
Common stock fair value (weighted-average) |
|
|
$ |
0.91 |
|
|
$ |
3.39 |
|
Risk free interest rate |
|
|
3.82% - 3.86% |
|
|
4.04% - 4.66% |
|
Expected dividend yield |
|
|
0% |
|
|
0% |
|
Expected term |
|
|
6.0 years |
|
|
6.0 years |
|
Expected stock volatility |
|
|
105.1% - 105.6% |
|
|
101.9% - 103.0% |
|
Below is a summary of stock option activity for the three months ended March 31, 2026:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
Number |
|
|
Average |
|
|
Average |
|
of options |
|
|
Exercise Price |
|
|
Contractual Life |
Outstanding at December 31, 2025 |
|
18,031,425 |
|
|
$ |
2.35 |
|
|
8.91 years |
|
|
|
|
|
|
|
|
Forfeited and cancelled |
|
(524,177 |
) |
|
$ |
2.98 |
|
|
|
Exercised |
|
- |
|
|
$ |
0.00 |
|
|
|
Granted |
|
2,467,633 |
|
|
$ |
0.91 |
|
|
|
Outstanding at March 31, 2026 |
|
19,974,881 |
|
|
$ |
2.15 |
|
|
9.03 years |
Exercisable at March 31, 2026 |
|
3,022,141 |
|
|
$ |
3.89 |
|
|
6.39 years |
Options outstanding had an intrinsic value of $9,500,000 and $0 as of March 31, 2026 and December 31, 2025, respectively. As of March 31, 2026, there was approximately $21,400,000 of unrecognized stock compensation, which will be recognized over the next three years.
Stock compensation expense
Total stock-based compensation expense for the three months ended March 31, 2026 and 2025 was allocated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
2026 |
|
|
2025 |
|
General and administrative |
|
|
$ |
973,115 |
|
|
$ |
488,646 |
|
Research and development |
|
|
|
1,823,125 |
|
|
|
936,090 |
|
Total stock-based compensation expense |
|
|
$ |
2,796,240 |
|
|
$ |
1,424,736 |
|
Note 12—Commitments and contingencies
Lease Commitments – The Company leases facilities under non-cancelable operating leases for the laboratory and offices in Tampa, Florida, and finance leases for laboratory equipment. The current operating lease expires in March 2028 and finance lease expires in June 2028. Operating leases are included in Operating right of use assets, Lease liabilities, current and Lease liability, long term. Finance leases are included in Property and equipment, net, Lease liabilities, current and Lease liability, long term.
Future minimum lease payments under these leases are as follows:
|
|
|
|
|
|
|
|
|
Finance |
|
|
Operating |
|
Year ending December 31, 2026 (9 months) |
$ |
38,978 |
|
|
$ |
141,813 |
|
Year ending December 31, 2027 |
|
51,971 |
|
|
|
196,221 |
|
Year ending December 31, 2028 |
|
25,985 |
|
|
|
49,650 |
|
Interest portion of right of use liability |
|
(9,641 |
) |
|
|
(38,051 |
) |
Lease liabilities |
$ |
107,293 |
|
|
$ |
349,633 |
|
Operating leases –Total lease expense for the operating lease was approximately $62,000 and $70,000 for the three months ended March 31, 2026 and 2025, respectively.
Cash paid for amounts included in the measurement of operating lease liabilities was approximately $44,000 and $43,000 for the three months ended March 31, 2026 and 2025, respectively.
For the current operating lease, the weighted-average lease term is 2.0 years and 1.0 years and the weighted average discount rate is 10.0% and 10.0% as of March 31, 2026 and 2025.
Finance leases – Cash paid for amounts included in the measurement of finance lease liabilities was $10,845 for the three months ended March 31, 2026. There were no finance leases for the three months ended March 31, 2025. Interest on the finance lease liabilities amounted to approximately $2,000 for the three months ended March 31, 2026.
For the current finance lease, the weighted-average lease term is 2.25 years and the weighted average discount rate is 7.5% as of March 31, 2026.
Employment Agreements – The Company maintains employment agreements with its Chief Executive Officer and Chief Financial Officer, each entered into in May 2023 by Legacy TuHURA, as amended and as subsequently assumed by the Company in connection with the closing of the Kintara Merger.
Future minimum payments under these employment agreements are as follows:
|
|
|
|
|
|
Year ending December 31, 2026 (9 months) |
|
|
$ |
757,224 |
|
Year ending December 31, 2027 |
|
|
|
1,009,632 |
|
|
|
|
$ |
1,766,856 |
|
Note 13—Related Party Transactions
On March 18, 2026, we entered into a Consulting Agreement with Tendler Biotech Consulting LLC (“Tendler Biotech”), an entity owned by one of the Company's directors, Dr. Craig Tendler. Under this agreement, Dr. Tendler provides, through Tendler Biotech, specified consulting services on an as-requested basis relating to the Company’s development strategy and operations in connection with the Company’s product pipeline. Under this agreement, Tendler Biotech is entitled to receive an hourly fee of $1,250 and reimbursement of reasonable out-of-pocket expenses. The Consulting Agreement has a term of two years but may be terminated early by either party at any time upon at least 15 days’ prior written notice. There have been no fees paid or accrued to Tendler Biotech under this Agreement through March 31, 2026.
Note 14—Subsequent events
Subsequent events – The Company has evaluated subsequent events through May 15, 2026 in connection with the preparation of these unaudited condensed consolidated financial statements, which is the date they were available to be issued.
Parkview Credit Facility
On April 21, 2026, the Company entered into a Loan Agreement with Parkview Holdings One LLC (“Parkview”), an affiliate of K&V Investment LLC (“K&V Investment One”) (a holder of more than 5% of the Company’s fully diluted capital stock and an entity owned by Vijay Patel), pursuant to which Parkview agreed to extend a $50 million revolving credit facility to the Company maturing on April 21, 2031. Borrowings under the facility bear interest at 12% per annum (plus an additional 6% during any event of default), payable monthly in arrears, and are secured by substantially all assets of the Company and its subsidiaries. The Company is
obligated to repay principal equal to 75% of net profits from pharmaceutical product sales from the prior quarter if it achieves net profits for two consecutive fiscal quarters.
Each borrowing shall be an amount not to exceed the greater of (i) $1.7 million and (ii) the monthly budgeted expense amount in the Company’s expense budget (which will be subject to agreement of the Company and Parkview) for the immediately subsequent month. There have been no proceeds received to date under this Loan Agreement.
In connection with the Loan Agreement, the Company and Parkview entered into: (i) a Fee Letter pursuant to which the Company agreed to pay a one-time commitment fee of $5 million, which the Company elected to pay by issuing 1,878,287 shares of Company common stock to Parkview (subject to stockholder approval) and an annual facility fee of 1.5% of the total commitment beginning on the first anniversary; (ii) a Royalty Agreement granting Parkview an annual royalty in the low to mid-single digits on Net Sales (as defined therein) of products based on the Company’s IFx-2.0 intellectual property, up to $450 million in Net Sales per year, continuing through the last-to-expire patent covering IFx-2.0; and (iii) two Warrant Amendment Agreements extending to April 21, 2031, the exercise period for an aggregate of 4,364,873 warrants to purchase common stock held by K&V Investment One (3,049,432 warrants at $3.69 per share and 1,315,441 warrants at $5.70 per share).
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and audited consolidated financial statements in the Annual Report on Form 10-K filed with the SEC on March 31, 2026 (the “2025 Annual Report”). Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth under the heading “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, as well as those set forth under the heading “Risk Factors” in Part I, Item 1A in the 2025 Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. See also “Special Note Regarding Forward-Looking Statements”.
In this section, we discuss our financial condition, changes in financial condition and results of our operations for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. References to periods prior to the closing of the Kintara Merger refer to Legacy TuHURA, and to TuHURA Biosciences, Inc. (formerly Kintara Therapeutics, Inc., “Kintara”) for all other periods, as the context requires.
Overview
We are a clinical stage immuno-oncology company developing novel technologies designed to overcome primary and acquired resistance to cancer immunotherapies. Our proprietary Immune FxTM technology platform, or IFx, is an innate immune agonist technology designed to “trick” the body’s immune system to attack tumor cells by making tumor cells look like bacteria. Our lead product candidate, IFx-2.0, is an innate immune agonist designed to overcome primary resistance to checkpoint inhibitors. In June 2025, we initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for patients with advanced or metastatic Merkel cell carcinoma who are checkpoint inhibitor naïve utilizing the FDA’s accelerated approval pathway. In addition to our IFx technology platform, in June 2025 we acquired the rights to TBS-2025, a novel VISTA-inhibiting monoclonal antibody formerly known as KVA12123, through our acquisition of Kineta, Inc. (“Kineta”) on June 30, 2025 (the “Kineta Merger”). VISTA (otherwise referred to as V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells that is believed to be a strong driver of immunosuppression in the tumor microenvironment and is believed to be a primary mechanism by which leukemic blasts escape immune recognition contributing to low response rates and high rates of recurrence in acute myeloid leukemia, or AML. Following our acquisition of Kineta, we are currently planning on investigating TBS-2025 in a randomized Phase 2 trial in combination with a menin inhibitor vs menin inhibitor alone in mutated NPM1 (mutNPM1) AML.
To date, we have devoted substantially all of our resources to organizing and staffing, business planning, raising capital, identifying and developing product candidates, enhancing our intellectual property portfolio, undertaking research, conducting preclinical studies and clinical trials, and securing manufacturing for our development programs. We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations primarily through the issuance of capital stock, warrants and convertible notes.
We are not profitable and have incurred significant operating losses in each period since our inception, including net losses of $7.5 million for the three months ended March 31, 2026, and $30.1 million for the year ended December 31, 2025. As of March 31, 2026, we had an accumulated deficit of $148.7 million. Our operating losses may fluctuate significantly from quarter-to-quarter and year-to-year as a result of several factors, including the timing of our preclinical studies and clinical trials and the expenditures related to other research and development activities. We expect to continue to incur operating losses. We anticipate these losses will increase substantially as we advance our product candidates through preclinical and clinical development, develop additional product candidates and seek regulatory approvals for our product candidates. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more product candidates. In addition, if we obtain marketing approval for any product candidate, we expect to incur pre-commercialization expenses and significant commercialization expenses related to marketing, sales, manufacturing and distribution. We may also incur expenses in connection with the in-licensing of additional product candidates.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity offerings, debt financings, collaborations and licensing arrangements or other capital sources. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements as and when needed would have a negative impact on our financial condition and could force 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 March 31, 2026, we had cash and cash equivalents of $6.3 million. See “ — Liquidity and Capital Resources” below.
Recent Developments
Parkview Credit Facility
On April 21, 2026, the Company entered into a Loan Agreement (the “Loan Agreement”) with Parkview Holdings One LLC (“Parkview”), an affiliate of K&V Investment LLC (“K&V Investment One”) (a holder of more than 5% of the Company’s fully diluted capital stock and an entity owned by Mr. Vijay Patel), pursuant to which Parkview agreed to extend a $50 million revolving credit facility to the Company maturing on April 21, 2031. Borrowings under the facility bear interest at 12% per annum (plus an additional 6% during any event of default), payable monthly in arrears, and are secured by substantially all assets of the Company and its subsidiaries. The Company is obligated to repay principal equal to 75% of net profits from pharmaceutical product sales from the prior quarter if it achieves net profits for two consecutive fiscal quarters. As of the date of this Quarterly Report on Form 10-Q, Parkview has not advanced any funds under the Loan Agreement to the Company.
In connection with the Loan Agreement, the Company and Parkview entered into: (i) a Fee Letter pursuant to which the Company agreed to pay a one-time commitment fee of $5 million, which the Company elected to pay by issuing 1,878,287 shares of common stock to Parkview (subject to stockholder approval), and an annual facility fee of 1.5% of the total commitment beginning on the first anniversary; (ii) a Royalty Agreement granting Parkview an annual royalty in the low to mid-single digits on Net Sales (as defined therein) of products based on the Company’s IFx-2.0 intellectual property, up to $450 million in Net Sales per year, continuing through the last-to-expire IFx-2.0 patent; and (iii) two Warrant Amendment Agreements extending to April 21, 2031 the exercise period for 4,364,873 warrants to purchase common stock held by K&V Investment One (3,049,432 warrants at $3.69 per share and 1,315,441 warrants at $5.70 per share).
ATM Program
On November 3, 2025, the Company and H.C. Wainwright & Co., LLC (“Wainwright”) entered into an At-The-Market Offering Agreement (the “Offering Agreement”) with respect to an at-the-market offering program (the “ATM Program”) under which the Company may sell shares of its common stock having an aggregate offering price of up to $50,000,000 through Wainwright as its sales agent. On April 8, 2026, the Company filed a prospectus supplement to the Company’s shelf registration statement on Form S-3 filed with the SEC on November 3, 2025 (File No. 333-291239) relating to the shares of common stock available for sale under the Offering Agreement. The Company began making sales under the Offering Agreement in April 2026, selling an aggregate of 104,000 shares of common stock at a weighted average price of $3.09 per share for gross proceeds of approximately $321,000 since the program’s inception.
Components of Our Results of Operations
Revenue
We did not generate any revenue and do not expect to generate any revenue from the sale of products in the near future.
Research and Development Expenses
To date, our research and development expenses have related primarily to the development of IFx-2.0, IFx-3.0 (which we are no longer advancing), TBS-2025, manufacturing, clinical studies, and other early pre-clinical activities related to our portfolio. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
Research and development expenses include:
•salaries, payroll taxes, employee benefits;
•external research and development expenses incurred under agreements with contract research organizations (“CROs”), and consultants to conduct our clinical studies;
•costs related to manufacturing product candidates, including fees paid to third-party manufacturers and raw material suppliers;
•stock-based compensation charges for those individuals involved in research and development efforts; and
•facilities, depreciation, and other allocated expenses, which include direct and allocated expenses for rent.
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:
•per-patient trial costs;
•the number of trials required for regulatory approval;
•the number of sites included in the trials;
•the countries in which the trials are conducted;
•the length of time required to enroll eligible patients;
•the number of patients that participate in the trials;
•the number of doses that patients receive;
•the drop-out or discontinuation rates of patients;
•potential additional safety monitoring requested by regulatory agencies;
•the phase of development of the product candidate; and
•the efficacy and safety profile of the product candidate.
Acquisition-related costs
Acquisition-related costs, consisting of expenses incurred to effect a business combination, including legal, advisory, accounting, and valuation fees, are expensed as incurred.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and employee-related costs, including stock-based compensation, for personnel in our executive, finance, and other administrative functions. Other significant costs include facility related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services and insurance costs. We anticipate that our general and administrative expenses will increase in the future to support our continued research and development activities, and, if any product candidates receive marketing approval, commercialization activities. We also anticipate increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums and investor relations costs associated with operating as a public company.
Other Income (Expense)
Other income (expense) consists of interest income on our cash and cash equivalents, interest expense on the issued notes payable to the former Kineta employees, grant income from our NIH-funded research grant assumed in our October 2024 reverse merger transaction with Kintara Therapeutics, Inc. (“Kintara”, and such merger, the “Kintara Merger”).
Results of Operations
Comparisons for the Three Months Ended March 31, 2026, and March 31, 2025
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Change |
|
|
|
2026 |
|
|
2025 |
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
5,232,541 |
|
|
$ |
4,581,672 |
|
|
$ |
650,869 |
|
Acquisition-related costs |
|
|
- |
|
|
|
419,042 |
|
|
|
(419,042 |
) |
General and administrative |
|
|
2,297,358 |
|
|
|
2,016,309 |
|
|
|
281,049 |
|
Total operating expenses |
|
|
7,529,899 |
|
|
|
7,017,023 |
|
|
|
512,876 |
|
Loss from operations |
|
|
(7,529,899 |
) |
|
|
(7,017,023 |
) |
|
|
(512,876 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
Grant income |
|
|
- |
|
|
|
252,554 |
|
|
|
(252,554 |
) |
Interest expense |
|
|
(27,974 |
) |
|
|
- |
|
|
|
(27,974 |
) |
Interest income |
|
|
21,275 |
|
|
|
100,098 |
|
|
|
(78,823 |
) |
Total other income (expense) |
|
|
(6,699 |
) |
|
|
352,652 |
|
|
|
(359,351 |
) |
Net loss |
|
$ |
(7,536,598 |
) |
|
$ |
(6,664,371 |
) |
|
$ |
(872,227 |
) |
Series A Preferred cash dividend |
|
|
(2,089 |
) |
|
|
(2,089 |
) |
|
|
- |
|
Net loss attributable to common shareholders |
|
$ |
(7,538,687 |
) |
|
$ |
(6,666,460 |
) |
|
$ |
(872,227 |
) |
Research and Development Expenses. The following table summarizes our research and development expenses by program for the periods presented.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
|
March 31, |
|
|
Change |
|
|
|
2026 |
|
|
2025 |
|
|
|
|
Direct program costs: |
|
|
|
|
|
|
|
|
|
IFx-2.0 |
|
$ |
1,330,710 |
|
|
$ |
2,080,844 |
|
|
$ |
(750,134 |
) |
TBS-2025 |
|
|
518,308 |
|
|
|
- |
|
|
|
518,308 |
|
Preclinical research costs |
|
|
276,975 |
|
|
|
425,555 |
|
|
|
(148,580 |
) |
Indirect program costs: |
|
|
|
|
|
|
|
|
|
Personnel and facilities related costs |
|
|
3,106,548 |
|
|
|
2,075,273 |
|
|
|
1,031,275 |
|
Total research and development expenses |
|
$ |
5,232,541 |
|
|
$ |
4,581,672 |
|
|
$ |
650,869 |
|
Research and development expenses were $5.2 million and $4.6 million for the three months ended March 31, 2026, and 2025, respectively. The increase of $0.7 million related to the following.
•a decrease of approximately $0.8 million due to ongoing clinical development of IFx-2.0;
•an increase of approximately $0.5 million due to ongoing clinical development of TBS-2025;
•a decrease of approximately $0.1 million due to preclinical research of IFx-3.0 and MDSCs; and
•an increase of approximately $1.0 million in facilities, salary and personnel related costs due to increases in headcount and non-cash stock compensation expense.
Acquisition-related costs. Acquisition related costs were $0.0 million and $0.4 million for the three months ended March 31, 2026, and 2025, respectively and represent costs incurred in relation to the Kineta Merger.
General and Administrative Expenses. General and administrative expenses were $2.3 million and $2.1 million for the three months ended March 31, 2026, and 2025, respectively. The increase of $0.3 million was primarily due to increases in non-cash stock compensation expense and increases in costs associated with being a public company.
Grant Income. Grant income was $0.3 million for the three months ended March 31, 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 less than $0.1 million for the three months ended March 31, 2026 due primarily 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 March 31, 2026 and 2025, respectively, related primarily to interest income earned on deposits at various banks.
Preferred Stock Series A cash dividend. The holder of our Series A Preferred Stock received cash dividends payable quarterly in arrears, at an annual rate of 3% of the Series A Stated Value.
Liquidity and Capital Resources
We have incurred net losses and negative cash flows from operations since our inception and we anticipate that we will continue to incur net losses for the foreseeable future. We incurred net losses of $30.1 million and $22.6 million for the years ended December 31, 2025, and 2024, respectively, and incurred net losses of $7.5 and $6.7 million for the three months ended March 31, 2026 and 2025, respectively. Additionally, we used $27.6 million and $14.7 million from our operating activities for the years ended December 31, 2025, and 2024, respectively, and used $4.4 million and $4.7 million from our operating activities for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $148.7 million.
As of March 31, 2026, we had cash and cash equivalents of $6.3 million. In April 2026, we received $0.3 million in gross proceeds under the ATM Program. Additionally, we have not received any proceeds to date on the Parkview credit facility. 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 $29.2 million in aggregate principal amount through the issuance of common stock and bridge financings.
Parkview Credit Facility
On April 21, 2026, the Company entered into the Loan Agreement with Parkview, pursuant to which Parkview agreed to extend a $50 million revolving credit facility to the Company maturing on April 21, 2031. Borrowings under the facility bear interest at 12% per annum (plus an additional 6% during any event of default), payable monthly in arrears, and are secured by substantially all assets of the Company and its subsidiaries. The Company is obligated to repay principal equal to 75% of net profits from pharmaceutical product sales from the prior quarter if it achieves net profits for two consecutive fiscal quarters.
ATM Program
On November 3, 2025, the Company and Wainwright entered into the Offering Agreement with respect to an at-the-market offering program under which the Company may sell shares of its common stock having an aggregate offering price of up to $50,000,000 through Wainwright as its sales agent. As of the date of this Quarterly Report, we have sold 104,000 shares of common stock through the program.
December 2025 Registered Direct Offering
On December 9, 2025, we entered into a securities purchase agreement (the “Purchase Agreement”) with certain investors (collectively, the “RD Purchasers”). The Purchase Agreement relates to the sale and issuance in a registered direct offering (such sale and issuance, the “Registered Direct Offering”), by the Company of an aggregate of: (i) 9,462,423 shares of the Company’s common stock, (ii) Series A common stock purchase warrants to purchase up to 9,462,423 shares of common stock (the “Series A Warrants”), and (iii) Series B common stock purchase warrants to purchase up to 9,462,423 shares of common stock (the “Series B Warrants”, and together with the Series A Warrants, the “Common Warrants”). The offering price for each share of common stock and accompanying Series A Warrant and Series B Warrant was $1.65. Each Common Warrant has an exercise price of $1.95 per share and is exercisable beginning six months after the date of issuance. The Registered Direct Offering resulted in gross proceeds to the Company of approximately $15.6 million, before deducting the placement agents’ fees and other offering expenses payable by the Company.
June 2025 Offering
On June 2, 2025, the Company and the certain accredited investors (the “Purchasers”) entered into a securities purchase agreement pursuant to which we agreed to issue and sell to the Purchasers, in a private placement, an aggregate of 4,759,309 shares of the Company’s common stock, together with warrants to purchase an equal number of shares of common stock at an exercise price of $3.3125 (the “Offering Warrants”), for an aggregate offering amount of $12.6 million (the “Private Placement”). The combined effective offering price for each share and accompanying Offering Warrant in the offering was $2.65.
Warrant Exercise Notes
On February 12, 2025, four holders (the “Makers”) of common stock purchase warrants (the “Warrants”) of the Company made and issued to the Company secured promissory notes (the “Warrant Exercise Notes”) in the aggregate principal amount of $3.0 million as payment of the exercise price of an aggregate of 1,034,836 Warrants held by the Makers. The Makers were comprised of KP Biotech Group, LLC, CA Patel F&F Investments, LLC, Dr. Kiran C. Patel and Donald Wojnowski. Upon the exercise of the Warrants, the Company issued to the Makers an aggregate of 1,034,836 shares of common stock, all of which are “restricted securities” within the meaning of the federal securities laws. The amounts due under the Warrant Exercise Notes were collected in full in the second quarter of 2025.
Cash Flows
The following table sets forth a summary of the net cash flow activity for the three months ended March 31, 2026 and 2025, respectively:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2026 |
|
|
2025 |
|
Net cash provided by (used in): |
|
|
|
|
|
|
Operating activities |
|
$ |
(4,412,953 |
) |
|
$ |
(4,738,422 |
) |
Investing activities |
|
|
(48,846 |
) |
|
|
(1,151,047 |
) |
Financing activities |
|
|
7,139,977 |
|
|
|
(547,878 |
) |
Net increase (decrease) in cash |
|
$ |
2,678,178 |
|
|
$ |
(6,437,347 |
) |
Operating Activities
For the three months ended March 31, 2026, net cash used in operating activities was $4.4 million, which primarily consisted of a net loss of $7.5 million, a change in net operating assets and liabilities of $0.3 million, and by non-cash charges of $2.8 million. The net non-cash charges were primarily related to depreciation and amortization expense of less than $0.1 million, and stock-based compensation of $2.8 million. The $0.3 million net change in operating assets and liabilities is primarily due to increases in accounts payable and accrued expenses of approximately $0.5 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately $0.2 million.
For the three months ended March 31, 2025, net cash used in operating activities was $4.7 million, which primarily consisted of a net loss of $6.7 million, a change in net operating assets and liabilities of $0.5 million, and by non-cash charges of $1.4 million. The net non-cash charges were primarily related to depreciation and amortization expense of less than $0.1 million, and stock-based compensation of $1.4 million. The $0.5 million net change in operating assets and liabilities is primarily due to increases in accounts payable and accrued expenses of approximately $0.5 million due to timing of invoices and vendor payments, and an increase in current and non-current assets of approximately less than $0.1 million.
Investing Activities
For the three months ended March 31, 2026 and 2025, net cash used in investing activities was less than $0.1 million and $1.2 million, which consisted of purchases of property and equipment and deposits and payments in connection with the Kineta acquisition.
Financing Activities
For the three months ended March 31, 2026, net cash provided by financing activities was $7.1 million, which consisted of $7.0 million and $0.5 million in proceeds from the issuances of common stock attributable to the Registered Direct Offering and Private Placement, respectively, received in the first quarter of 2026, offset by $0.2 million in payments for deferred offering costs attributable to the Registered Direct Offering and Private Placement, and $0.2 million principal payment of note payables to former Kineta employees.
For the three months ended March 31, 2025, net cash used in financing activities was $0.6 million, which consisted $0.5 million proceeds from warrants exercises, offset by $1.1 million in merger transaction costs and net liabilities attributable to Kintara..
Funding Requirements
We expect to incur costs associated with operating as a public company. In addition, we anticipate that we will need substantial additional funding in connection with our development programs and continuing operations. We believe that our existing cash and cash equivalents, together with the ATM Program and $50.0 million revolving credit facility with Parkview, will be sufficient to meet our anticipated cash requirements into the end of 2028.
Our forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. Management based projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and
we may deplete our available capital resources sooner than management expects. Our future capital requirements will depend on many factors, including:
•the initiation, progress, timing, costs and results of drug discovery, preclinical studies and clinical trials of IFx-2.0, TBS-2025, and any other future product candidates;
•the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase;
•the outcome, timing and costs of seeking regulatory approvals;
•the cost of manufacturing IFx-2.0, TBS-2025, and future product candidates for clinical trials in preparation for marketing approval and in preparation for commercialization;
•the emergence of competing therapies and other adverse market developments;
•the ability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements; and
•the costs of operating as a public company.
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 March 31, 2026, contained in Part I, Item 1 in this Quarterly Report on Form 10-Q, we believe the following accounting policies and estimates to be most critical to the preparation of our financial statements.
Stock-Based Compensation Expense
Stock-based compensation expense represents the cost of the grant date fair value of equity awards recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. We estimate the fair value of equity awards using the Black-Scholes option pricing model and 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.
Kineta Acquisition and Valuation of Intangible Assets
On June 30, 2025 we completed the Kineta Merger contemplated by the TuHURA-Kineta Merger Agreement, pursuant to which the Company acquired Kineta in a cash and stock transaction through a series of merger transactions, with Kineta surviving the mergers as a wholly-owned subsidiary of ours.
Upon completion of the Kineta Merger, pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each share of Kineta common stock issued and outstanding immediately prior to the merger (a “Kineta Share”), was converted into the right to receive 0.185298 shares of our common stock for an aggregate of approximately 2.9 million shares of our common stock. Also pursuant to the terms and conditions of the TuHURA-Kineta Merger Agreement, each Kineta Share received its pro rata portion of approximately 1.1 million shares of our common stock in December 2025, in accordance with the terms of the TuHURA-Kineta Merger Agreement. In addition, each Kineta Share is entitled to the right to its pro rata share of cash consideration received by Kineta pursuant to disposed asset payments related to legacy Kineta assets. Such payments, if any, will be made at a later date and in accordance with the terms of the TuHURA-Kineta Merger Agreement. In each case, in lieu of the issuance of any fractional shares of our common stock, we will pay an amount equal to the product of (A) such fractional share and (B) $5.7528.
The estimated fair value of the aggregate share component of the Kineta Merger was calculated using the closing stock price on the date of the Kineta Merger.
We recognized in-process research and development (“IPR&D”) in connection with the acquisition. We estimated the fair value of the IPR&D assets using the cost approach, which is based on the amount that a market participant would incur to recreate the assets, adjusted for obsolescence, inefficiencies, and the current stage of completion of the underlying development efforts.
Goodwill and other intangible assets comprised of IPR&D on our balance sheet as of March 31, 2026 and December 31, 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 test indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If we conclude it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed.
Recently Issued and Adopted Accounting Pronouncements
There are no recently issued and adopted accounting pronouncements that have a material effect on the Company 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.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate risks and inflation risks. Periodically, we maintain deposits in accredited financial institutions in excess of federally insured limits. We deposit our cash in financial institutions that we believe have high credit quality and have not experienced any losses on such accounts and do not believe we are exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Interest Rate Risk
Our cash consists of cash in readily-available checking accounts. We may also invest in short- term money market fund investments. Such interest-earning instruments carry a degree of interest rate risk; however, historical fluctuations in interest income have not been significant.
Inflation Risk
Inflation generally affects us by increasing our cost of labor and research and development contract costs. We do not believe inflation has had a material effect on our results of operations during the periods presented.
Item 4. Controls and Procedures.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Evaluation of Disclosure Controls and Procedures
Our management has evaluated, with the participation of the Chief Executive Officer (our principal executive officer) and the Chief Financial Officer (our principal financial officer), the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our Chief Executive Officer and the Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2026.
Management’s 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 March 31, 2026 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 March 31, 2026, our internal control over financial reporting was effective.
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.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may be involved in various disputes and litigation matters that arise in the ordinary course of business. As of the date of this Quarterly Report on Form 10-Q, we are not party to any material legal matters or claims.
Item 1A. Risk Factors.
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, 2025 filed with the SEC on March 31, 2026. 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.
Our credit facility with Parkview Holdings One, LLC, which is secured by substantially all of our assets, together with the related royalty agreement with Parkview, could materially and adversely our financial condition and future operations and may cause substantial dilution to our stockholders.
In April 2026, we entered into a revolving credit facility with Parkview Holdings One LLC (“Lender”), an affiliate of the Company’s largest stockholder, with an aggregate commitment of up to $50.0 million. Our obligations under the facility bear interest at 12% per annum and matures on April 21, 2031. To secure our obligations, we and our subsidiaries granted the Lender a first‑priority lien on substantially all of our and our subsidiaries’ assets, including our intellectual property. The loan documents also contain extensive affirmative and negative covenants that, among other things, limit our ability to incur additional debt or liens, dispose of assets, make investments or restricted payments, transfer material intellectual property, or enter into affiliate transactions, in each case subject to limited exceptions. The loan documents include customary events of default and provide that, upon an event of default, the Lender may accelerate the indebtedness, terminate its commitments and exercise remedies against the collateral, including foreclosing on our and our subsidiaries’ assets. In addition, upon a specified event of default and only if our stockholders approve the conversion in accordance with applicable Nasdaq rules, the Lender may elect to convert all or a portion of the outstanding principal and accrued interest into shares of our common stock at a fixed conversion price, which could result in significant dilution to our stockholders. Further, if we generate positive Net Profits (as defined in the loan agreement) from the sale of pharmaceutical products for two consecutive fiscal quarters, we are required to make an additional prepayment equal to 75% of Net Profits for the last fiscal quarter in which the trigger occurred (up to the outstanding principal), which would reduce cash that would otherwise be available for our operations and growth initiatives. These restrictions and obligations could impair our ability to finance our business, pursue acquisitions or strategic transactions, develop and commercialize our product candidates, or otherwise operate our business in accordance with our strategy. If we are unable to borrow sufficient funds under the credit facility to fund our operations, our financial position and development and operating activities will be adversely affected.
Concurrently with the loan facility, we entered into a separate royalty agreement (the “Royalty Agreement”) with the Lender under which we (and, in certain cases, our sublicensees or affiliates) agreed to pay annual royalties on worldwide Net Sales of products that use our IFx‑2.0 technology, subject to specified tiered rates, deductions and offsets. Royalty payments are due within 90 days after each royalty year and any late payments accrue interest. Our obligation to pay royalties, which is separate and apart from our debt service obligations under the credit facility, will reduce the net revenues we retain from future commercialization, may materially and adversely affect our liquidity, and could create tension with our debt covenants and operating needs, particularly if commercialization commences before we are profitable or if commercialization is slower than expected.
If we fail to comply with the covenants under the credit facility or the terms of the Royalty Agreement, or if an event of default occurs under the loan documents, the Lender could accelerate the indebtedness, exercise remedies against substantially all of our and our subsidiaries’ assets and, in certain circumstances and subject to stockholder approval, convert debt to equity at a fixed price, any of which could materially adversely affect our business, financial condition, results of operations, and prospects and could force us to curtail or cease operations, seek additional financing on unfavorable terms, or seek protection under bankruptcy or other insolvency laws, all of which could materially and adversely affect our cash flows, business, results of operations and financial condition.
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)
On May 15, 2026, the Company and Parkview Holdings One LLC (“Parkview”) entered into a First Amendment to Loan Agreement (the “Amendment”) which amends the Company’s Loan Agreement dated April 21, 2026, with Parkview (the “Loan Agreement”). The Amendment clarifies that the restriction on selling or issuing equity interests set forth in Section 7.05 of the Loan Agreement does not apply to sales or issuances of the capital stock of the Company.
(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, adopted or terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 408(c) of Regulation S-K, during the three months ended March 31, 2026.
Item 6. Exhibits.
|
|
|
Exhibit Number |
|
Description |
3.1 |
|
Articles of Incorporation of TuHURA Biosciences, Inc. (f/k/a Kintara Therapeutics, Inc.), as amended (incorporated by reference to Exhibit 3.1 to TuHURA’s Registration Statement on Form S-1 filed with the SEC on August 12, 2025) |
3.2 |
|
Amended and Restated Bylaws of TuHURA Biosciences, Inc. (f/k/a Kintara Therapeutics, Inc.) (incorporated by reference to Exhibit 3.1 to TuHURA’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2022) |
10.1* |
|
First Amendment to Loan Agreement, dated as of May 15, 2026, between TuHURA Biosciences, Inc. and Parkview Holdings One LLC. |
10.2* |
|
Consulting Agreement, dated March 18, 2026, between TuHURA Biosciences, Inc. and Tendler Biotech Consulting, LLC. |
31.1* |
|
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2* |
|
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1** |
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2** |
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101.INS |
|
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 |
|
Inline XBRL Taxonomy Extension Schema Document |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
** This certification is being furnished solely to accompany this Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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: May 15, 2026 |
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By: |
/s/ James A. Bianco, M.D. |
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James A. Bianco |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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Dated: May 15, 2026 |
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By: |
/s/ Dan Dearborn |
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Dan Dearborn |
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Chief Financial Officer |
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(Principal Financial Officer) |