Core Points - TuHURA Biosciences, Inc. has been added to the Russell 3000® Index and automatically included in the Russell 2000® Index as part of the 2025 annual reconstitution, effective June 27, 2025 [1][2] - The inclusion in the Russell indexes signifies the company's progress in its first year as a publicly traded entity and reflects its potential for continued development [2] - TuHURA is currently enrolling patients in a Phase 3 accelerated approval trial of its lead product IFx-2.0, which is being tested as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel cell carcinoma [2][11] - The company has also acquired a novel anti-VISTA antibody from Kineta, Inc. and plans to advance it into a Phase 2 clinical trial for treating NMPL1-mutated Acute Myeloid Leukemia [2] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing both primary and acquired resistance [10] - The company's lead product, IFx-2.0, is designed to enhance the effectiveness of checkpoint inhibitors [11] - TuHURA is also leveraging its Delta Opioid Receptor technology to create bi-specific antibody drug conjugates aimed at inhibiting immune suppression in the tumor microenvironment [12]

Acquisition Overview - TuHURA Biosciences has successfully completed the acquisition of Kineta, Inc., which includes a novel VISTA inhibiting monoclonal antibody (mAb) now named TBS-2025, enhancing TuHURA's late-stage immuno-oncology pipeline [1][2] - The acquisition allows TuHURA to initiate a Phase 2 randomized trial for TBS-2025 in the second half of 2025 [1] Financial Details - The completion of the acquisition unlocks the fourth tranche of funds from a $12.5 million aggregate PIPE financing announced on June 3, 2025 [1] - Each share of Kineta common stock was converted into the right to receive 0.185298 shares of TuHURA common stock, totaling 2,868,169 shares [3] Product Development - TBS-2025 is positioned to overcome acquired resistance to cancer immunotherapy, particularly in patients with NPM1 mutated acute myeloid leukemia (AML) [2] - The drug is being investigated in combination with a menin inhibitor, aiming to improve response rates and reduce relapse in AML patients [2] Mechanism of Action - VISTA is a significant immune checkpoint expressed on myeloid cells, contributing to immunosuppression in the tumor microenvironment [5] - TBS-2025 is designed to block VISTA, potentially enhancing T cell function and improving treatment outcomes in cancer therapy [5][6] Clinical Trials - TBS-2025 has shown promising results in a Phase 1/2 trial, demonstrating good tolerance and over 90% receptor occupancy [7] - The drug is administered intravenously every two weeks and has been tested both as a monotherapy and in combination with pembrolizumab [6][7] Company Background - TuHURA Biosciences focuses on developing technologies to address primary and acquired resistance to cancer immunotherapy [8] - The company is also working on bi-specific antibody drug conjugates targeting myeloid derived suppressor cells to enhance immune response [10]

TAMPA, Fla. and SEATTLE, June 23, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced with Kineta, Inc. (OTC Pink:KANT) ("Kineta"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, that TuHURA stockholders approved all of the proposals set forth at the C ...

NEW YORK, June 9, 2025 /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to:TuHURA Biosciences, Inc. (NASDAQ: HURA)'s merger with Kineta, Inc. If you are a TuHURA shareholder, click here to learn more about your legal rights and options.Vigil Neuroscience, Inc. (NASDAQ: VIGL)'s sale to Sanofi. Under the terms of the proposed transaction, V ...

Core Viewpoint - TuHURA Biosciences, Inc. has secured $12.5 million in a private offering to fund its operations, including a proposed merger with Kineta, Inc. and the initiation of a Phase 3 trial for its lead product, IFx-2.0 [1][5][9] Funding Details - The private placement involves the issuance of 4.6 million shares of common stock at a price of $2.65 per share, representing a 15% discount to the closing price on June 2, 2025 [1] - Approximately $9.0 million of the total offering will be purchased in four equal tranches based on the achievement of specific milestones, with the remaining $3.5 million to be funded by December 31, 2025 [2][7] - The initial closing of the offering is anticipated on June 4, 2025, subject to customary closing conditions [2] Use of Proceeds - The net proceeds from the offering will be used to fund the merger with Kineta, initiate the Phase 3 trial for IFx-2.0, advance Kineta's VISTA-inhibiting antibody to a Phase 2 trial, and cover other working capital needs [5][9] Milestones for Funding - The funding milestones include: - Notification from the FDA that the company is no longer under a partial clinical hold for the Phase 3 trial of IFx-2.0 [7] - Initiation of the Phase 3 trial for IFx-Hu2.0 [7] - Completion of the merger with Kineta [7] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, particularly through its lead product, IFx-2.0, which is designed to enhance the efficacy of existing treatments [11][12] - The company is also advancing a bi-specific antibody drug conjugate and antibody peptide conjugate targeting immune-suppressing cells in the tumor microenvironment [14]

Phase 3 IFx-Hu2.0 trial as an adjunctive therapy with Keytruda® (pembrolizumab) in checkpoint inhibitor (CPI)-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC) detailed in Trial in Progress Poster at ASCOPhase 3 trial of IFx-Hu2.0 to be conducted under Accelerated Approval Pathway and Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA)TAMPA, Fla., June 2, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncolog ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39473 TUHURA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 99-0360497 ( State or other jurisdiction of incorporation or organization) 10500 University Center Dr., Suite 110 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Nevada 001-37823 99-0360497 (Commission File Number) (IRS Employer (State or Other Jurisdiction of Incorporation) Identification No.) FORM 8-K 10500 University Center Dr., Suite 110 Tampa, Florida 33612 (Address of Principal Executive Offices, including zip code) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Registrant's Telephone Number, Including Area Code: (813) 875-6600 Date of Report (Date of ...

Anticipates initiating the Company's Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as a first-line therapy for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA), in Q2 2025Initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in first-line Merkel cell carcinoma of unknown primary origin (MCCUP) Targeting to close the ...

Phase 1b/2a trial designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytruda® when administered via Interventional Radiology (IR) in patients with deep- seated tumors without associated cutaneous tumorsTAMPA, Fla., May 5, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced the initiation of its Phase 1b/2a trial of ...