TuHURA: preliminary partial responses in 3 patients
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
TuHURA Biosciences, Inc. (HURA) reported third-quarter 2026 results and clinical updates. Preliminary results from its open-label, first-line IFx-2.0 study with Keytruda® in metastatic Merkel cell carcinoma showed major objective partial responses in each of the first three patients; all responses were ongoing for more than six months. The company received an FDA “Study May Proceed” notice and IND clearance for a Phase 1b evaluation of TBS-2025 in relapsed/refractory mutNPM1 acute myeloid leukemia.
Cash and cash equivalents were $1.9 million at September 30, 2026. Third-quarter research and development expense was $3.7 million, versus $5.0 million a year earlier; general and administrative expense was $2.0 million, versus $1.6 million. Nine-month operating cash outflows were $18.1 million, versus $22.1 million. The Parkview loan facility contributed $5.6 million in financing during the quarter, with $9.2 million in gross proceeds received as of quarter-end. TuHURA said it continues to have access to a $50 million credit facility from its largest shareholder.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointNine-month operating cash outflows narrowed to $18.1 million from $22.1 million.
Negative
- None.
8-K Event Classification
Key Figures
Key Terms
IND clearance regulatory
open-label medical
mutNPM1 medical
myeloid-derived suppressor cells (MDSCs) medical
Delta Opioid Receptor (DOR) technical
antibody drug conjugates (ADCs) technical
Earnings Snapshot
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were TuHURA's third-quarter 2026 financial results?
What did TuHURA report from the first three patients in its IFx-2.0 study?
What will TBS-2025 test in TuHURA's newly cleared AML study?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 13, 2026, TuHURA Biosciences, Inc. issued a press release reporting its financial results for the three months ended September 30, 2026, and providing a corporate update. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The information contained in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No. Document
99.1 Press Release, dated November 13, 2026
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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 hereunto duly authorized.
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TUHURA BIOSCIENCES, INC. |
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November 13, 2026 |
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Name: Dan Dearborn |
TuHURA Biosciences Reports Third Quarter 2026 Financial Results and Provides a Corporate Update
TAMPA, Fla., Nov. 13, 2026 -- TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA” or the “Company”), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today reported financial results for the Company's third quarter ended September 30, 2026, and provided a corporate update.
"We continue to make significant progress across each of our programs. In October, we shared our first look at data from our open-label front line study of IFx-2.0 with Keytruda® in patients with deep-seated metastatic Merkel cell carcinoma, which showed durable, major objective anti-tumor responses in the first three patients with all responses ongoing for more than six months," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "Working collaboratively with the FDA, we received clearance to begin our Phase 1b study of TBS-2025, our VISTA-inhibiting antibody, in relapsed/refractory mutNPM1 acute myeloid leukemia (AML), a molecularly defined subset of AML where the presence of VISTA on leukemic cells is associated with poor response to therapy and survival.”
Dr. Bianco continued, “We will have a strong presence again this year at the upcoming American Society of Hematology (ASH) Annual Meeting in December with 3 poster presentations highlighting our Delta Opioid Receptor (DOR) technology. The ASH scientific review committee recognized the importance of our discoveries of the central role the DOR plays in controlling proliferation, recruitment and immunosuppressive capabilities of MDSCs, the body’s main cell type for suppressing immune responses leading to acquired resistance to cancer immunotherapies.”
“With meaningful progress having been made in each of our programs, we believe we are well positioned to deliver on several transformational potential milestones. Having continuing access to a $50mm credit facility from our largest shareholder has allowed us to fund operations in a non-dilutive manner benefiting shareholders as we continue driving towards these value-creating events,” Dr. Bianco concluded.
Third Quarter and Recent Corporate Highlights:
Currently Anticipated Milestones by Program
IFx-2.0 (Innate Immune Agonist)
TBS-2025 (VISTA inhibiting mAb)
MDSC Inhibitors (Bi-specific ADCs)
Summary of Financial Results for the Third Quarter 2026
Cash and cash equivalents of $1.9 million at September 30, 2026. The Company received $9.2 million in gross proceeds as of September 30, 2026, on the Parkview credit facility.
Research and development expenses were $3.7 million and $5.0 million for the 3 months ended September 30, 2026, and 2025, respectively. The decrease of $1.3 million was due to lower manufacturing costs, which are expected to resume in the next quarter with the start of the TBS-2025 clinical trial material manufacturing campaign.
General and administrative (G&A) expenses were $2.0 million and $1.6 million for the 3 months ended September 30, 2026, and 2025, respectively. The increase of $0.4 million was primarily due to increases in non-cash stock compensation expense and costs associated with being a public company.
Net cash outflows from operating activities were ($18.1) million and ($22.1) million for the 9 months ended September 30, 2026, and 2025, respectively.
Net cash flows from financing activities were $16.5 million and $13.4 million for the 9 months ended September 30, 2026, and 2025, respectively.
Total common shares outstanding were approximately 65.8 million at September 30, 2026.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. (NASDAQ: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.
TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.
In addition to its innate immune agonist product candidates, TuHURA is developing TBS-2025, its VISTA-inhibiting mAb in a Phase 1b clinical trial in patients with mutNPM1 r/r AML, a molecularly defined subgroup that represents approximately 35% of patients with AML. TuHURA is also leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional antibody drug conjugates (ADCs) targeting Myeloid-Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are
based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely," or the negative or plural of these words or similar expressions. Our statements in this press release regarding our ongoing research programs and studies are an example of such forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include, among others, the risk that funds available under the Company’s credit facility may be insufficient to fund the Company’s operations and development programs to the extent anticipated; risks associated with conducting the ongoing Phase 3 trial for IFx.20; the risks associated with continuing the development of TBS-2025 and our DOR technologies and our planned Phase 1b trial for TBS-2025; risks related to patient enrollment, trial design, data outcomes and regulatory interactions; uncertainty regarding the timing and likelihood of milestones and regulatory approvals; and the other risks described from time to time in detail in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed on March 31, 2026, and TuHURA's other reports and filings with the SEC from time to time, which are available on TuHURA's website and at www.sec.gov.
The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.
Investor Contact:
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com