Company: HURA
Filing Date: 2025-08-12
Form Type: S-1
Source: 0001193125-25-179009
Chunk: 51

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-08-12
Form: S-1
Chunk 51
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’s technologies obsolete or less attractive. New technology could emerge at any point in the development cycle of TuHURA’s product candidates.

If TuHURA’s clinical trials with its immune-oncology product TBS-2025does not show any functionality in the ME tumor microenvironment (“TME”), TuHURA’s development plans, financial position, results of operations and prospects may be materially adversely affected.

While TuHURA plans to develop product candidates for use in solid tumors, including TBS-2025 acquired in the Kineta Merger, TuHURA’s immuno-oncology product candidate may not show any functionality in the TME. The cellular environment in which solid tumor cells thrive is generally hostile to T cells due to factors such as the presence of immunosuppressive cells, humoral factors and limited access to nutrients. TuHURA’s product candidates may not be able to access the solid tumor, and even if they do, they may not be able to exert anti-tumor effects in a hostile TME. In addition, the safety profile of TuHURA’s product candidates may differ in a solid tumor setting. As a result, TuHURA’s product candidate may not demonstrate efficacy in solid tumors. If TuHURA is unable to make its immuno-oncology product candidate function in tumors, TuHURA’s development plans, financial position, results of operations and prospects may be materially adversely affected.

TuHURA’s Risks Relating to Government Regulation

The FDA regulatory approval process is lengthy, time-consuming, and inherently unpredictable, and TuHURA may experience significant delays in the clinical development and regulatory approval, if any, of its product candidates.

The research, testing, manufacturing, labeling, approval, selling, import, export, adverse event reporting, record keeping, advertising, promotion, and distribution of drug products, including biologics, are subject to**

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extensive regulation by the FDA and other regulatory authorities in the United States. TuHURA is not permitted to market any biological drug product in the United States until TuHURA receives a Biologics License from the FDA. TuHURA has not previously submitted a BLA to the FDA, or similar approval filings to comparable foreign authorities. However, A BLA must include extensive preclinical and clinical data and supporting information to establish that the product candidate is safe, pure, potent, and effective for each desired indication. The BLA must also include significant information regarding the chemistry, manufacturing, and controls for