{"id":910103,"date":"2025-11-14T07:46:27","date_gmt":"2025-11-14T12:46:27","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tuhura-biosciences-inc-reports-third-quarter-2025-financial-results-and-provides-a-corporate-update\/"},"modified":"2025-11-14T07:46:27","modified_gmt":"2025-11-14T12:46:27","slug":"tuhura-biosciences-inc-reports-third-quarter-2025-financial-results-and-provides-a-corporate-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tuhura-biosciences-inc-reports-third-quarter-2025-financial-results-and-provides-a-corporate-update\/","title":{"rendered":"TuHURA Biosciences, Inc. Reports Third Quarter 2025 Financial Results and Provides a Corporate Update"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Phase 3 accelerated approval trial of IFx-2.0 as adjunctive therapy with\u00a0Keytruda\u00ae<\/sup> (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC) is underway, conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA)<\/i>\n <\/p>\n

\n Company’s Delta\u00a0Opioid Receptor (DOR) technology selected for an oral presentation, along with 2 poster presentations at the 67th<\/sup> Annual American Society of Hematology (ASH) Annual Meeting and Exposition, taking place in Orlando, Florida<\/span> on December 6-9, 2025<\/span><\/i>\n <\/p>\n

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\n TAMPA, Fla.<\/span>
\n <\/span>, Nov. 14, 2025<\/span><\/span> \/PRNewswire\/ — TuHURA Biosciences, Inc.<\/b>\u00a0(NASDAQ:HURA) (“TuHURA”), 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, 2025<\/span>, and provided a corporate update.<\/p>\n

“TuHURA remains highly focused on the execution of its clinical development programs, including enrollment in our Phase 3 pivotal trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in the first line treatment of patients with advanced or metastatic MCC. This accelerated, registration-directed trial, conducted under an SPA Agreement with the FDA, has the potential, if successful, to satisfy the requirements for both accelerated and regular approval without the need to conduct a post-approval confirmatory trial,” stated Dr. James Bianco<\/span>, President and Chief Executive Officer of TuHURA. “In parallel to advancing our late-stage development candidate IFx-2.0, we are working with experts in the treatment of AML to complete the protocol design for our Phase 2 study of TBS-2025, our VISTA inhibiting antibody, in patients with NPM1 mutated AML. We are on track to submit our proposed Phase 2 plan to FDA next month and initiate the Phase 2 randomized study in the first quarter of next year.”<\/p>\n

Dr. Bianco continued, “In addition to our clinical programs, we were excited to see validation of the scientific merit related to our discovery of the potential role of the DOR expression on Myeloid Derived Suppressor Cells (MDSCs) by being selected by the Joint Program Committees of the ASH 2025 Annual Meeting for an oral presentation. We look forward to presenting our data demonstrating that the DOR is a potential novel target to reprogram the immune suppressing capabilities of MDSCs and tumor-associated macrophages (TAMs). Together with regulatory T cells (Tregs), these immunosuppressive cells are collectively responsible for acquired resistance to cancer immunotherapies. The DOR technology is the backbone of our program to develop first-in-class bi-specific, bi-functional immune modulating antibody drug conjugates (ADCs). TuHURA’s oral presentation at the ASH 2025 Annual Meeting is on December 7<\/span>th<\/sup> at 5:15pm ET<\/span>.”<\/p>\n

\n Corporate Highlights<\/b>\n <\/p>\n