Tuhura Biosciences Inc.

08/14/2026 | Press release | Distributed by Public on 08/14/2026 05:50

TuHURA Biosciences Reports Second Quarter 2026 Financial Results and Provides a Corporate Update (Form 8-K)

TuHURA Biosciences Reports Second Quarter 2026 Financial Results and Provides a Corporate Update

TAMPA, Fla., August 14, 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 second quarter ended June 30, 2026, and provided a corporate update.

"We have made significant progress in advancing all our programs forward and are positioned to continue driving towards several anticipated milestones targeted for the second half of the year," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "In the second half, we anticipate receiving safe-to-proceed feedback from FDA and to initiating our Phase 1b/2 trial of VISTA in mutNPM1 r/r AML, initiating our in vivo POC studies for MDSC Inhibitors (Bi-specific antibody drug conjugates (ADCs)), potentially receiving orphan drug designation in Merkel cell carcinoma (MCC) for IFx-2.0, and potentially receiving orphan drug designation in AML for TBS-2025. The recent $50 million term credit facility made available to us by our largest shareholder provides us a non-convertible source of operating capital with adequate runway for us to achieve our strategic objectives and execute on our goals."

Second Quarter and Recent Corporate Highlights:

•
Filed Investigational New Drug (IND) Application for Evaluation of the TBS-2025 VISTA Inhibiting Antibody in Molecularly Defined Subsets of AML and other Blood Related Cancers. The IND is aligned with guidance previously provided by the U.S. Food and Drug Administration (FDA) on the development pathway for both monotherapy and combination with menin inhibitors for Acute Myeloid Leukemia (AML). The FDA noted that the previously planned IND meeting would not be necessary and instead the FDA provided written responses to questions and information related to the Company's proposed Phase 1b/2 development plan for TBS-2025 in AML.
•
In April 2026, the Company announced a $50 million credit facility and royalty transaction extending its anticipated cash runway into 2028. Under the terms of the loan agreement for the credit facility, TuHURA will have the ability to draw down on the facility on an as-needed basis to fund monthly expenses for ongoing clinical development and operations. The facility bears a 12% annual interest rate on outstanding funds drawn, with interest paid monthly and principal repayment due
at a 5-year maturity date for April 21, 2031. The facility was provided by TuHURA's largest shareholder.

Currently Anticipated Milestones by Program

IFx-2.0 (Innate Immune Agonist)

•
2H 2026: Expect to receive orphan drug designation in MCC
•
1H2027: Expect preliminary results from IR study IFX-2.0 with Keytruda® for deep seated MCC
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2H 2027: Expect to complete enrollment in the Phase 3 study of IFx-2.0

TBS-2025 (VISTA inhibiting mAb)

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2H 2026: Expect to initiate Phase 1b/2 trial of VISTA in mutNPM1 r/r AML
•
2H 2026: Expect to receive orphan drug designation in AML
•
1H 2027: Expect preliminary safety and response data for VISTA in mutated NMP1 r/r AML

MDSC Inhibitors (Bi-specific ADCs)

•
2H 2026: Presentations at key scientific meetings
•
2H 2026: Initiation of ADC in vivo POC studies

Summary of Financial Results for the Second Quarter 2026

Cash and cash equivalents of $1.0 million at June 30, 2026. In April 2026 and July 2026, the Company received $0.3 million and $0.1 million, respectively, in gross proceeds under the ATM Program. Additionally, the Company has received $5.7 million in gross proceeds to date on the Parkview credit facility, which includes $2.15 million subsequent to June 30, 2026. TuHURA's total common shares outstanding were approximately 63.7 million at June 30, 2026.

Research and development expenses were $6.6 million and $4.9 million for the 3 months ended June 30, 2026, and 2025, respectively. The increase of $1.7 million was related to an increase in clinical development activity the Company's ongoing and planned clinical trials.

General and administrative (G&A) expenses were $2.1 million and $1.9 million for the 3 months ended June 30, 2026, and 2025, respectively. The increase of $0.3 million was primarily due to increases in non-cash stock compensation expense and costs associated with being a public company.

Net cash outflows from operating activities were ($13.0) million and ($10.9) million for the 6 months ended June 30, 2026, and 2025, respectively.

Net cash flows from financing activities were $10.6 million and $8.1 million for the 6 months ended June 30, 2026, and 2025, respectively.

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 is enrolling patients in its 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, a VISTA inhibiting mAb moving into dose escalation/optimization Phase 1b trial in mutNPM1 r/r AML, a molecularly defined subgroup representing 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 MDSCs 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.

Tuhura Biosciences Inc. published this content on August 14, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on August 14, 2026 at 11:50 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]