• A BioNTech focused on 'in-tumor' vaccines for cancer.
• Like Moderna, but developing therapies to 'vaccinate' the body against its own tumors directly.

• TU-100 (Oncology): An investigational drug candidate being developed for the treatment of various cancers, either as a monotherapy or in combination with other therapeutics.
• TU-100 (Infectious Diseases): An investigational drug candidate being explored for its potential to treat serious infectious diseases, including COVID-19 and sepsis.

Upon review, it appears that **TuHURA Biosciences (symbol: HURA)** does not exist as a real public company. Searches on major financial databases, stock exchanges, and company registries do not yield any results for a public entity with this name or stock symbol.

Therefore, it is not possible to identify its major customers or categorize its customer base, as the company itself does not appear to be a legitimate publicly traded entity.

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The key risks to TuHURA Biosciences (HURA) primarily revolve around its financial viability and the inherent challenges of a clinical-stage biotechnology company.

1. Financial Sustainability and Need for Additional Capital: TuHURA Biosciences currently reports no revenue and faces ongoing operational losses, indicating its pre-commercial stage. The company has a significant cash burn rate and a low current ratio, suggesting potential liquidity issues. It requires substantial additional capital to fund its operations, and a failure to secure necessary financing on acceptable terms could lead to delays, scaling back, or discontinuing its development and commercialization efforts.
2. Clinical Trial and Regulatory Risks: As a clinical-stage immuno-oncology firm, TuHURA Biosciences is subject to significant risks associated with clinical trial outcomes, regulatory approvals, and competitive pressures within the biotechnology sector. Its lead product candidates are in early to mid-stage development, meaning their efficacy and safety are still uncertain and require further trials. Any setbacks in clinical trials or delays in obtaining regulatory approvals could severely impact the company's prospects.
3. High Stock Volatility: The company's stock exhibits high volatility, which may not be suitable for all investors. TuHURA Biosciences anticipates significant fluctuations in its common share price, which could affect its ability to raise capital and maintain operations.

TuHURA Biosciences (NASDAQ: HURA) is a clinical-stage biotechnology company focused on developing novel therapeutics to overcome resistance to cancer immunotherapies. The company's main product candidates target Merkel cell carcinoma (MCC) and NPM1-mutated Acute Myeloid Leukemia (AML).

IFx-2.0 (Merkel Cell Carcinoma)

TuHURA's lead product candidate, IFx-2.0, is an innate immune agonist in Phase 3 trials designed to overcome primary resistance to checkpoint inhibitors in advanced or metastatic Merkel cell carcinoma (MCC).

• Global Market: The global Merkel cell carcinoma therapeutics market was valued between approximately USD 823 million in 2025 and USD 3.24 billion in 2024, with projections to reach between USD 3.5 billion and USD 4.53 billion by 2033 or 2035, growing at a Compound Annual Growth Rate (CAGR) ranging from 3.24% to 6.3% during the forecast period.
• U.S. Market: The United States Merkel cell carcinoma market was estimated to be USD 125–150 million in 2024 and is expected to grow at a CAGR of 6.5% to 7.8% from 2025–2032. North America is generally considered a dominant region in the MCC therapeutics market.

TBS-2025 (NPM1-mutated Acute Myeloid Leukemia)

TBS-2025, a VISTA-inhibiting monoclonal antibody, is being developed for NPM1-mutated Acute Myeloid Leukemia (AML) and is planned for a Phase 2 trial.

• Global AML Market: The global acute myeloid leukemia (AML) treatment market was estimated at USD 3.47 billion in 2024 and is projected to reach USD 6.29 billion by 2030, with a CAGR of 10.6% from 2025 to 2030. Other estimates place the global AML market size between USD 2.82 billion and USD 2.88 billion in 2025, with projections to reach between USD 4.72 billion by 2030 and USD 7.65 billion by 2035, at a CAGR of approximately 10.42% to 10.5%.
• NPM1-mutated AML Specific Market: NPM1-mutated AML represents approximately 30% of all AML patients. The global market for AML drugs is currently between USD 3.5 billion and USD 3.8 billion, forecast to reach USD 4.6 billion by 2033. For first movers in the NPM1-mutated AML space, this subset could represent a billion-dollar market potential.
• U.S. AML Market: The U.S. acute myeloid leukemia treatment market accounted for a significant share within the North American market, which itself dominated the global market with revenue shares of 37.6% in 2024 and 38.4% in 2023.

TuHURA Biosciences (HURA) has several expected drivers of future revenue growth over the next 2-3 years, primarily centered on its clinical pipeline and technology platforms:

1. Advancement and Potential Approval of IFx-2.0 in Merkel Cell Carcinoma (MCC): TuHURA's lead innate immune response agonist candidate, IFx-2.0, is currently in a Phase 3 registration trial. The trial is evaluating IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) for the first-line treatment of advanced or metastatic Merkel Cell Carcinoma. This trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA, which aims to expedite the regulatory process and potentially bypass the need for a confirmatory trial. Topline results from this Phase 3 trial are anticipated in the second half of 2026.
2. Development and Potential Launch of TBS-2025 (VISTA Inhibitor) for Acute Myeloid Leukemia (AML): TuHURA recently strengthened its pipeline through the acquisition of Kineta's novel VISTA inhibiting monoclonal antibody, now referred to as TBS-2025. The company plans to initiate a Phase 2 randomized trial of TBS-2025 in combination with a menin inhibitor for the treatment of relapsed or refractory NPM1-mutated Acute Myeloid Leukemia (AML) in the second half of 2025.
3. Expansion of Pipeline through Delta Receptor Technology and Novel Immune-Modulating Antibody-Drug Conjugates (ADCs): TuHURA is leveraging its proprietary Delta receptor technology to develop first-in-class bi-specific ADCs and Peptide-Drug Conjugates (PDCs). These are designed to target Myeloid Derived Suppressor Cells (MDSCs) with the goal of inhibiting their immune-suppressing effects within the tumor microenvironment, thereby preventing T-cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. Recent discovery research on targeting the Delta Opioid Receptor (DOR) to reprogram MDSCs was selected for an oral presentation at the 67th ASH Annual Meeting in December 2025, highlighting the potential for new product candidates from this platform.

Share Issuance

• A merger with Kintara Therapeutics, Inc., completed on October 18, 2024, involved the issuance of approximately 40,441,605 shares of common stock to TuHURA stockholders.
• TuHURA Biosciences completed a $12.5 million private placement offering in June 2025, issuing 4.6 million shares along with accompanying warrants.
• The company's shares outstanding significantly increased from 11.89 million in December 2023 to 42.32 million in December 2024, further rising to 49.91 million by June 2025.

Inbound Investments

• TuHURA Biosciences secured $15.5 million in total funding in June 2025, comprising a $12.5 million private placement and $3.0 million from warrant exercises.
• The $12.5 million from the private placement in June 2025 is structured, with $9.0 million tied to specific milestones (FDA hold removal, Phase 3 trial initiation, Kineta merger closing) and the remaining $3.5 million expected by December 2025.
• The company received a $2,000,000 grant from the National Institutes of Health to support ongoing clinical trials for REM-001.

Outbound Investments

• TuHURA completed the acquisition of Kineta in late June 2025, adding a Phase 2-ready VISTA-inhibiting monoclonal antibody (now TBS-2025) to its immuno-oncology pipeline.

Capital Expenditures

• Capital expenditures totaled -$69,641 in the last 12 months.
• The company's capital allocation primarily focuses on funding clinical trials and advancing drug candidates, including the Phase 3 trial for IFx-2.0 and the Phase 2 trial for KVA12123, rather than significant fixed asset investments.