TuHURA Biosciences Stock Price, News & Analysis

TuHURA Biosciences (NASDAQ: HURA) reported significant Q2 2025 developments, highlighted by the completion of Kineta's acquisition and its VISTA inhibiting monoclonal antibody (TBS-2025). The company initiated a Phase 3 accelerated approval trial of IFx-2.0 in combination with Keytruda for Merkel cell carcinoma (MCC) treatment under FDA Special Protocol Assessment.

The company strengthened its financial position through a $12.5 million equity financing and received an additional $3 million from warrant exercises. R&D expenses increased to $4.9 million in Q2 2025, up from $2.8 million in Q2 2024. TuHURA plans to initiate a Phase 2 trial for TBS-2025 in AML treatment in 2H 2025 and expects Phase 3 topline results for IFx-2.0 in 2H 2026.

TuHURA Biosciences (NASDAQ:HURA), a Phase 3 immune-oncology company, has been added to the Russell 3000® and Russell 2000® Indexes as part of the 2025 Russell indexes annual reconstitution, effective June 27th, 2025.

The company is currently conducting a Phase 3 accelerated approval trial of IFx-2.0 in combination with Keytruda® as a first-line treatment for advanced or metastatic Merkel cell carcinoma (MCC). Following its recent acquisition of Kineta, Inc., TuHURA plans to advance a novel anti-VISTA antibody into Phase 2 clinical trials for treating NMPL1-mutated Acute Myeloid Leukemia (AML).

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.