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TAMPA, Fla., July 1, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc.听(狈础厂顿础蚕:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that the Company has been added to the Russell 3000^庐 Index, with automatic inclusion in the Russell 2000^庐 Index, as a part of the 2025 Russell indexes annual reconstitution. The Company's addition to the Russell 3000^庐 Index and the Russell 2000^庐聽Index was effective as of market close, Friday, June 27^th, 2025.

"The inclusion of TuHURA in the Russell indexes highlights the significant progress we have made in TuHURA's first year as a publicly traded company. We are proud to be added to the indexes, as it is a milestone that confirms the Company's potential for continued momentum and advancement of its development programs," stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. "The remainder of 2025 is an important period for TuHURA, as we continue enrolling patients in our recently initiated Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to Keytruda^庐 (pembrolizumab) as a first line treatment for patients with advanced or metastatic Merkel cell carcinoma (MCC). Additionally, we are very excited to add a novel anti-VISTA antibody from the recently closed acquisition of Kineta, Inc. and currently plan on advancing it into a Phase 2 clinical trial for the treatment of patients with NMPL1-mutated Acute Myeloid Leukemia (AML)."

About the Russell Indexes

The Russell 3000^庐聽Index is a market capitalization-weighted equity index that tracks the performance of the largest 3,000 U.S. stocks. Reconstitution of Russell's U.S. Indexes captures the 4,000 largest U.S. stocks as of the end of April, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000^庐聽Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000^庐聽Index or small-cap Russell 2000^庐聽Index as well as the appropriate growth and value style indexes. The Russell 3000^庐聽also serves as the U.S. component to the Russell Global Index. Membership of the Russell indexes is primarily determined by objective, market-capitalization rankings and style attributes. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.

Russell determines membership for its equity indexes primarily by objective, market capitalization rankings and style attributes. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. Over $10 trillion in assets are benchmarked against Russell's U.S. Indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell 3000^庐 Index, the Russell 2000^庐聽Index, and the Russell Indexes reconstitution, go to the "Russell Reconstitution" section on the聽.

About TBS-2025 (f/k/a KVA12123)

VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells. VISTA is a strong driver of immunosuppression in the tumor microenvironment (TME). VISTA expression is found on infiltrating immune cells, with the highest levels on myeloid lineage cells, including MDSCs. It suppresses T cell function, and high levels of VISTA expression in the human TME have been correlated in most studies with decreased overall survival (OS).

TBS-2025 VISTA-blocking immunotherapy is administered intravenously every 2 weeks (Iadonato et al. Front Immunol 2023). It is an engineered IgG1 mAb with an extended half-life that binds to a unique epitope at both acidic and neutral pH.

TBS-2025 was investigated in a dose escalation Phase 1/2 trial, both as a monotherapy and in combination with pembrolizumab, in patients with relapsed and/or treatment-refractory advanced solid tumors. TBS-2025 was well tolerated at doses up to 1,000mg both in the monotherapy arm (n=24) or in the pembrolizumab combination therapy arm (n=16). Pharmacokinetic and pharmacodynamic data demonstrated greater than 90% receptor occupancy across the every two- week dosing interval. Immunocytokine analysis was consistent with the mechanism of action for VISTA inhibition on immune cells.

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 initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda^庐聽(pembrolizumab) compared to Keytruda^庐聽plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.

In addition to its innate immune agonist product candidates, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates 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聽www.tuhurabio.com聽and connect with TuHURA on聽Facebook,听X, and聽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, Section 21E of the 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. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding TuHURA's IFx-Hu2.0 product candidate and Phase 3 trial, its Delta Opioid Receptor technology, its recent acquisition by merger of Kineta Inc., and any developments or results in connection therewith and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are 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 are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at .

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. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.

Investor Contact:

Monique Kosse
Gilmartin Group
[email protected]

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SOURCE TuHURA Biosciences, Inc.