TuHURA Biosciences, Inc. (NASDAQ: HURA) announced the successful completion of the acquisition of Kineta, Inc., the maker of the novel VISTA inhibiting monoclonal antibody (mAb) now renamed as TBS-2025. This acquisition adds a Phase 2 ready drug candidate to TuHURA's late-stage immuno-oncology pipeline. TuHURA plans to initiate a Phase 2 randomized trial involving the VISTA inhibiting antibody in the second half of 2025. Completion of the acquisition unlocks the fourth tranche of funds from $12.5 million aggregate PIPE financing announced on June 3, 2025.

According to James Bianco, M.D., President and Chief Executive Officer of TuHURA, while IFx-2.0 is being investigated for its potential to overcome primary resistance to checkpoint inhibitors in Merkel cell carcinoma, the acquisition of VISTA expands TuHURA's pipeline with a Phase 2 ready drug candidate, TBS-2025. This candidate has the potential to overcome acquired resistance to cancer immunotherapy. The acquisition provides synergies across both TuHURA's therapeutic focus and its antibody drug conjugate (ADC) technology. TBS-2025 can be administered as an intact mAb alone or in combination with other therapeutics, and there is ongoing investigation into its potential as a bi-functional, bi-specific ADC targeting myeloid derived suppressor cells (MDSCs) in the tumor microenvironment (TME).

TuHURA is currently planning to investigate TBS-2025 in a Phase 2 trial in combination with a menin inhibitor in NPM1 mutated AML. VISTA, predominantly expressed on myeloid cells and quiescent T cells, is believed to be the primary mechanism by which leukemic cells escape immune recognition and attack. This results in a low treatment response rate and a high level of relapse in AML. TuHURA believes that a relatively inexpensive, small Phase 2 study can determine if TBS-2025 can augment the response rates seen with menin inhibitors and decrease the rate of relapse in patients with NPM1 mutated relapsed or refractory AML.

Pursuant to the merger agreement, each share of Kineta common stock was converted into the right to receive a specified number of TuHURA common stock shares, with additional shares to be issued after six months, subject to certain conditions. Leerink Partners acted as the exclusive financial advisor to TuHURA on the transaction.

VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells, driving immunosuppression in the tumor microenvironment (TME). TBS-2025 VISTA-blocking immunotherapy is administered intravenously every two weeks. 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. It was well tolerated at doses up to 1,000 mg.

TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy. 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 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, preventing 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, 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 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 the application and use of TBS-2025 in the TuHURA pipeline and the 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 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. 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]

SOURCE TuHURA Biosciences, Inc.

TuHURA Biosciences Completes Acquisition of Kineta

TuHURA Biosciences completed the acquisition of Kineta, Inc., adding its Phase 2-ready drug candidate TBS-2025 to its immuno-oncology pipeline. The deal unlocks $12.5 million in PIPE financing and positions TuHURA to initiate a Phase 2 trial of TBS-2025 in combination with a menin inhibitor for NPM1 mutated AML. The acquisition also expands TuHURA's therapeutic focus and ADC technology.