TuHURA Biosciences

What TuHURA Biosciences does

TuHURA Biosciences is a phase 3 registration-stage immuno-oncology company developing therapeutics designed to overcome primary and acquired resistance to cancer immunotherapies, particularly checkpoint inhibitors. The company is publicly traded on Nasdaq under ticker HURA following the October 2024 merger with Kintara Therapeutics, with corporate headquarters in Tampa, Florida. TuHURA addresses a significant unmet medical need, given that approximately 70-80% of cancers exhibit primary resistance to checkpoint inhibitors, and targets three distinct patient populations: advanced/metastatic Merkel cell carcinoma patients (no approved front-line therapies), stage IIB-IV cutaneous melanoma patients refractory to checkpoint inhibitors, and patients with NPM1- or FLT3-ITD-mutated acute myeloid leukemia (representing 60-70% of AML cases).

The company's portfolio centers on three proprietary first-in-class technology platforms. IFx-2.0, the lead asset, is an innate immune agonist delivered via intratumoral injection of plasmid DNA (pDNA) or messenger RNA (mRNA) encoding the gram-positive bacterial Emm55 protein, which makes tumor cells appear bacterial to the innate immune system, activating pattern recognition receptors (TLR-2), inducing phagocytosis of tumor cells, and generating systemic tumor-specific T cell responses (abscopal effect). TBS-2025, acquired via the June 2025 acquisition of Kineta, is a VISTA-inhibiting monoclonal antibody (>90% receptor occupancy at 1,000mg) targeting immune suppression on myeloid cells and quiescent T cells in blood-related cancers. The DOR (Delta Opioid Receptor) technology platform is a first-in-class bi-specific antibody-peptide conjugate and ADC program targeting tumor-associated myeloid-derived suppressor cells (MDSCs) to prevent T cell exhaustion.

TuHURA operates a pre-revenue clinical-stage business model with future revenue expected from drug development, commercialization, or licensing of approved products. The IFx-2.0 Phase 3 registration trial (initiated June 2025 under FDA SPA) is enrolling ~118 patients across 20-25 US clinical centers as adjunctive therapy to Merck's Keytruda in first-line advanced Merkel cell carcinoma, with potential accelerated approval pathway. R&D expenses of $20.5 million in FY2025 against $3.6 million year-end cash necessitated multiple capital raises totaling over $67 million in 2024-2025 plus a $50 million credit facility in April 2026, extending cash runway into 2028. Commercialization will likely rely on oncology specialty sales teams and potential partnerships with large pharmaceutical companies.

Name

TuHURA Biosciences

Legal name

TuHURA Biosciences, Inc.

Website

https://tuhurabio.com

Company type

Public

Founded year

2023

Operating status

Operating

Headcount range

11–50 employees

Short description

TuHURA Biosciences is a phase 3 immuno-oncology company developing IFx-2.0 (innate immune agonist), TBS-2025 (VISTA antibody), and DOR-targeting bi-specific ADCs to overcome checkpoint inhibitor resistance in Merkel cell carcinoma, melanoma, and AML patients.

Ownership category

akta.pro rank

Product category

Immuno-Oncology Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Therapeutic Vaccines (cancer, chronic infection immunotherapy) (HLAAAEAB)

akta.pro secondary industry

Antibody-Drug Conjugates (ADCs) & Antibody Conjugates (HLAAAAAE)

Keywords

• Immuno-oncology therapeutics
• Cancer immunotherapy
• Monoclonal antibodies
• Antibody drug conjugates
• Clinical stage biopharmaceuticals

Headquarters

HQ city

Tampa

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Drug Development and Commercialization: Pre-revenue clinical-stage biotech company. Revenue expected from potential future drug approvals following successful Phase 3 trials and FDA approval. IFx-2.0 for Merkel cell carcinoma and TBS-2025 for AML represent lead candidates.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

TuHURA Biosciences is a clinical-stage immuno-oncology company developing three proprietary technology platforms to overcome primary and acquired resistance to cancer immunotherapies. The lead candidate IFx-2.0 is a plasmid DNA-based innate immune agonist in Phase 3 registration trial as adjunctive therapy to Keytruda for advanced Merkel cell carcinoma. The pipeline also includes TBS-2025, a VISTA-inhibiting monoclonal antibody for acute myeloid leukemia, and first-in-class bi-specific antibody-drug conjugates targeting the Delta Opioid Receptor on myeloid-derived suppressor cells.

Product overview

TuHURA Biosciences is a Phase 3 immuno-oncology company developing three distinct technologies to overcome primary and acquired resistance to cancer immunotherapies. The company's product portfolio centers on: (1) IFx-2.0, an innate immune agonist (lead product) in Phase 3 for Merkel Cell Carcinoma as adjunctive therapy to Keytruda; (2) TBS-2025, a VISTA-inhibiting antibody acquired from Kineta in June 2025, entering Phase 2 for AML; and (3) Bi-Specific Immune Modulating ADCs leveraging Delta Opioid Receptor (DOR) technology to target MDSCs. The company also acquired Kineta's VISTA-inhibiting antibody program to expand its pipeline into blood-related cancers.

Differentiator

Problem solved

Functional benefit

Brands

• Immune Fx (IFx): Innate immune agonist technology platform designed to make tumor cells appear like bacteria to harness innate immune response against cancer
• TBS-2025
• DOR Technology

Products and services

• IFx-2.0 An innate immune agonist administered via intratumoral injection of plasmid DNA encoding an immunogenic gram-positive bacterial protein (Emm55) that makes tumor cells appear bacterial, activating innate immunity and tumor-specific T cell responses. In Phase 3 for advanced Merkel cell carcinoma and in development for cutaneous melanoma.
• TBS-2025 A VISTA-inhibiting monoclonal antibody (formerly KVA12123) targeting molecularly defined subsets of acute myeloid leukemia and other blood-related cancers. Targets NPM1 and FLT3-ITD mutations present in 60-70% of AML patients. Acquired from Kineta, Inc. in June 2025.
• Bi-Specific Immune Modulating ADCs (DOR Technology) First-in-class bi-specific/bi-functional antibody-peptide conjugates (APCs) and antibody-drug conjugates (ADCs) targeting Delta Opioid Receptor (DOR) on tumor-associated myeloid-derived suppressor cells to inhibit immunosuppressive effects in the tumor microenvironment and prevent T cell exhaustion and acquired resistance to checkpoint inhibitors.

Quantifiable outcome

• Phase 1b trial demonstrated IFx-2.0 overcomes checkpoint inhibitor resistance in Merkel cell carcinoma patients with systemic immune activation (abscopal effect)
• +3 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core and strategic.

• Kineta, Inc.coreStrategic or Co-development Partner · 30 June 2025Completed acquisition of Kineta, Inc. for $10.5 million to gain rights to VISTA-inhibiting antibody TBS-2025 (formerly KVA12123). The acquisition provides Phase 2 ready asset for AML and synergizes with DOR technology providing antibody for ADC program.
• Moffitt Cancer CenterstrategicStrategic or Co-development PartnerCollaborated with scientists at Moffitt Cancer Center, first to describe high differential expression of Delta Opioid Receptor on tumor-associated MDSCs compared to bone marrow or spleen derived MDSCs in murine tumor bearing models.
• Merck (Keytruda/pembrolizumab)coreStrategic or Co-development PartnerIFx-2.0 being developed as adjunctive therapy to Keytruda (pembrolizumab) in Phase 3 registration trial for advanced Merkel cell carcinoma under FDA SPA agreement. Not a formal partnership but Keytruda is the co-administered checkpoint inhibitor in pivotal trial.
• FDA (Oncology Center of Excellence)coreStrategic or Co-development PartnerSpecial Protocol Assessment (SPA) agreement with FDA for Phase 3 trial of IFx-2.0. Working with FDA's Oncology Center of Excellence deputy director on trial design under Project Front Runner initiative. FDA granted Orphan Drug Designation for IFx-2.0 in cutaneous melanoma.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Compugen: Clinical-stage immuno-oncology company using computational platform to identify novel drug targets and develop first-in-class cancer immunotherapies — comparable in IO focus, computational discovery approach, and small-cap profile.
• Cogent Biosciences: Small-cap clinical-stage oncology company developing targeted therapies for genetically defined cancers including hematologic malignancies — comparable scale, stage, and oncology focus, with overlap in AML development.
• Arcus Biosciences: Clinical-stage immuno-oncology biotech of similar size developing checkpoint combinations and adenosine/TIGIT-targeting agents to overcome IO resistance — directly comparable in indication focus, stage, and small-cap public profile to TuHURA.
• Werewolf Therapeutics: Clinical-stage oncology biotech developing tumor-activated immunotherapies (PREDATOR platform) to overcome immunosuppressive tumor microenvironments — comparable in modality, stage, and IO-resistance thesis.
• Inhibrx Biosciences: Clinical-stage biotech developing novel biologics including immuno-oncology candidates using engineered protein scaffolds — comparable in platform-based biologics approach and small-mid cap clinical development profile.
• CytomX Therapeutics: Clinical-stage oncology biotech developing masked antibody therapeutics (Probody platform) designed to be activated in the tumor microenvironment — comparable in IO biologic platform approach and stage.
• Checkpoint Therapeutics: Small-cap immuno-oncology company developing cosibelimab (anti-PD-L1) and other checkpoint agents — directly comparable as a small public IO biotech navigating late-stage trials and commercialization.
• Curis: Clinical-stage oncology biotech developing emavusertib (IRAK4 inhibitor) and other agents targeting immune evasion in hematologic cancers including AML — comparable in IO-resistance focus and AML pipeline overlap with TBS-2025.

Broad incumbents

• Merck & Co. Manufacturer of Keytruda (pembrolizumab), the checkpoint inhibitor used as backbone in TuHURA's IFx-2.0 Phase 3 combination regimen; represents both the combination partner and the dominant incumbent whose IO franchise TuHURA aims to extend.
• Bristol-Myers Squibb: Manufacturer of Opdivo (nivolumab), the other leading PD-1 checkpoint inhibitor and a broader IO franchise including Yervoy — major incumbent competitor in the IO-combination space TuHURA targets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/TuhuraBio
• Facebookfacebook.com/TuhuraBiosciences
• LinkedInlinkedin.com/company/tuhurabio

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries2 records

Funding overview

Funding rounds3 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about TuHURA Biosciences