TuHURA Biosciences Stock Price, News & Analysis

TuHURA Biosciences (NASDAQ:HURA) has successfully completed the acquisition of Kineta, Inc. (OTCPK:KANT), adding a Phase 2 ready VISTA inhibiting monoclonal antibody to its immuno-oncology pipeline. The acquired drug candidate, formerly known as KVA1213, has been renamed to TBS-2025.

The acquisition unlocks the fourth tranche of funds from a previously announced $12.5 million PIPE financing. TuHURA plans to initiate a Phase 2 randomized trial in the second half of 2025, investigating TBS-2025 in combination with a menin inhibitor for NPM1 mutated AML treatment.

The strategic acquisition provides synergies with TuHURA's antibody drug conjugate (ADC) technology. The company is exploring the possibility of conjugating TBS-2025 with Delta Opioid Receptor inhibitors to create a bi-functional, bi-specific ADC targeting myeloid derived suppressor cells in the tumor microenvironment.

TuHURA Biosciences (NASDAQ:HURA) has launched its Phase 3 accelerated approval trial for IFx-2.0, an innate immune agonist designed to overcome resistance to checkpoint inhibitors. The trial will evaluate IFx-2.0 as an adjunctive therapy to Keytruda® in first-line treatment of advanced or metastatic Merkel cell carcinoma (MCC).

The study, conducted under an FDA Special Protocol Assessment (SPA), will enroll 118 participants across 22-25 U.S. sites. Previous Phase 1b results showed a 63% overall response rate with durable responses. The trial's success could lead to accelerated approval based on Overall Response Rate (ORR), with Progression Free Survival (PFS) potentially supporting conversion to regular approval without additional confirmatory trials.

The trial initiation triggers a $2.23 million funding tranche from the company's recent $12.5 million PIPE financing.

TuHURA Biosciences (NASDAQ:HURA), a Phase 3 immune-oncology company, and Kineta (OTC Pink:KANT), a clinical-stage biotechnology company, announced that stockholders of both companies have approved their proposed merger. At TuHURA's Special Meeting, stockholders approved increasing authorized shares to 200 million and reincorporating in Delaware. The merger is expected to close upon satisfaction of remaining closing conditions.

Both companies specialize in developing novel immunotherapies in oncology, focusing on addressing cancer immune resistance. The final voting results will be reported in Current Reports on Form 8-K with the SEC.

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.