TuHURA Biosciences Stock Price, News & Analysis

TuHURA Biosciences (NASDAQ:HURA) announced the FDA's removal of a manufacturing-related partial clinical hold on their Phase 3 accelerated approval trial for IFx-2.0. The trial, conducted under Special Protocol Assessment Agreement, will evaluate IFx-2.0 as adjunctive therapy with Keytruda for first-line treatment of advanced/metastatic Merkel cell carcinoma. The removal triggers a $2.23M funding tranche from a recent $12.5M PIPE financing. The trial will enroll 118 patients across 22-25 U.S. sites, with participants randomized 1:1 to receive either Keytruda+IFx-2.0 or Keytruda+placebo. Primary endpoint is Overall Response Rate, with Progression Free Survival as key secondary endpoint. Trial initiation is expected in June 2025.

TuHURA Biosciences (NASDAQ:HURA) has secured $15.5 million in total funding through a $12.5 million private placement offering and $3.0 million from warrant exercises. The private placement includes 4.6 million shares at $2.65 per share with accompanying warrants at $3.3125 exercise price. The $12.5M will be released in tranches: $9M based on milestones (FDA hold removal, Phase 3 trial initiation, Kineta merger closing) and $3.5M by December 2025. The funding will support the Phase 3 trial of IFx-2.0, Kineta merger completion, advancement of KVA12123 VISTA-inhibiting antibody to Phase 2, and working capital needs. The company expects to achieve all funding milestones by July 2025.

TuHURA Biosciences (NASDAQ:HURA) presented a Phase 3 trial-in-progress poster at ASCO 2025 for IFx-Hu2.0, a novel innate immune agonist being developed as adjunctive therapy with Keytruda in checkpoint inhibitor-naïve patients with advanced Merkel cell carcinoma (MCC). The Phase 3 trial, operating under FDA's Accelerated Approval Pathway and Special Protocol Assessment agreement, will enroll 118 patients across 22-25 U.S. sites. Previous Phase 1b results showed promising efficacy with a 63% overall response rate in MCC patients who progressed on prior therapy. The randomized, double-blinded trial will evaluate IFx-Hu2.0 (0.1mg) administered weekly for three weeks with pembrolizumab versus pembrolizumab plus placebo, with overall response rate as the primary endpoint.

TuHURA Biosciences (NASDAQ:HURA) reported Q1 2025 financial results and corporate updates. The company plans to initiate a Phase 3 accelerated approval trial of IFx-Hu2.0 with Keytruda for Merkel cell carcinoma (MCC) in Q2 2025. TuHURA has already initiated a Phase 1b/2a trial for MCC of unknown primary origin (MCCUP). The company aims to acquire Kineta Inc. in Q2 2025 and launch a Phase 2 trial of Kineta's VISTA inhibitor antibody for NPM1-mutated AML in Q3 2025. Financial results show R&D expenses of $4.6M and G&A expenses of $2.4M for Q1 2025. The company has approximately 43.7M total shares outstanding and expects four major clinical data readouts over the next 24 months.

TuHURA Biosciences (NASDAQ:HURA), a Phase 3 immune-oncology company, announced its participation in the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025. CEO James A. Bianco will present the company overview, focusing on their IFx-Hu2.0 Phase 3 program and first-in-class bi-specific immune modulating ADCs and APCs targeting MDSCs.

The presentation will also cover Kineta's VISTA inhibiting monoclonal antibody program. TuHURA previously announced a definitive agreement to acquire Kineta (OTC Pink: KANT) on December 11, 2024, which includes rights to Kineta's KVA12123 antibody. The merger is expected to close in Q2 2025, subject to closing conditions.

TuHURA Biosciences (NASDAQ:HURA) has initiated a Phase 1b/2a trial evaluating IFx-Hu2.0 in combination with Keytruda® for treating Metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP). The trial will study patients with deep-seated tumors without skin lesions, targeting up to 30% of MCC patients who present without primary skin lesions. The study will enroll nine non-cutaneous MCC patients with hepatic, pulmonary, or retroperitoneal lesions. Results are expected by Q4 2025 or early Q1 2026. Additionally, TuHURA is preparing to launch a Phase 3 accelerated approval trial in Q2 2025, studying IFx-Hu2.0 with Keytruda® versus Keytruda® plus placebo for first-line treatment of advanced/metastatic MCC. The FDA has granted a Special Protocol Assessment Agreement and suggested using the accelerated approval pathway with Objective Response Rate as the primary endpoint.

TuHURA Biosciences (NASDAQ:HURA) and Kineta presented updated results from two clinical studies at the AACR Annual Meeting. The first study, VISTA-101, evaluated KVA12123 (anti-VISTA antibody) alone and with pembrolizumab in advanced solid tumors. At 1,000mg dose every two weeks, KVA12123 achieved >90% VISTA receptor occupancy with no dose-limiting toxicities across 41 total patients.

The second study focused on TuHURA's IFx-Hu2.0 in advanced melanoma patients who previously failed checkpoint inhibitor (CPI) therapy. Three out of four heavily pre-treated patients achieved durable anti-tumor responses when rechallenged with CPI after IFx-Hu2.0 treatment. The therapy demonstrated increased T cell and B cell production with only mild Grade 1 and 2 adverse events.

TuHURA plans to initiate a Phase 3 trial in Merkel cell carcinoma and expects to close its merger with Kineta in Q2 2025, which includes acquiring rights to KVA12123.

TuHURA Biosciences (NASDAQ:HURA) announced two abstracts accepted for poster presentation at the 2025 AACR Annual Meeting in Chicago. The presentations will showcase:

1. Initial results from a Phase 1 study of KVA12123, an anti-VISTA antibody, both as monotherapy and in combination with pembrolizumab for advanced solid tumors, presented by Kineta's CSO.

2. Mechanistic insights into IFx-Hu2.0 therapy responses in patients with prior anti-PD-1 therapy failure in advanced melanoma, presented by Moffitt Cancer Center scientists.

The company also referenced its previously announced definitive agreement from December 11, 2024, to acquire Kineta, including rights to KVA12123, through a merger expected to close in Q2 2025, subject to funding and other closing conditions.

TuHURA Biosciences (NASDAQ: HURA) has appointed Dr. Bertrand Le Bourdonnec as Executive Vice President, Head of Drug Discovery, Early Development, and Program Management. Dr. Le Bourdonnec brings a 20-year career in drug discovery with impressive achievements, including 12 pre-clinical/clinical candidates and 7 investigational new drug applications.

His expertise in Delta Opioid Receptor (DOR) biochemistry and pharmacology aligns perfectly with TuHURA's Antibody Drug Conjugate (ADC) and Antibody Peptide Conjugate (APC) technology platform. Notable achievements include developing first-in-class spirocyclic DOR agonists licensed to Pfizer and leading the benevopran program to positive Phase IIb results, which led to Adolor 's acquisition by Cubist Pharmaceuticals.

Previously, he served as Chief Scientific Officer at HDAX Therapeutics and VP roles at Deciphera Pharmaceuticals and Cubist Pharmaceuticals, demonstrating successful leadership in drug development across multiple therapeutic areas including oncology, pain, and neurodegenerative diseases.