Company: HURA
Filing Date: 2025-09-18
Form Type: S-1/A
Source: 0001193125-25-207395
Chunk: 51

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-09-18
Form: S-1/A
Chunk 51
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 target the tumor microenvironment (“TME”), which makes it difficult to predict the results, timing and cost of product candidate development and likelihood of obtaining regulatory approval.

TuHURA’s TBS-2025, acquired in the acquisition of Kineta in June 2025, target the TME which is highly immunosuppressive. TuHURA has not yet succeeded and may not succeed in demonstrating efficacy and safety for any product candidates based on its platform technologies in clinical trials or in obtaining marketing approval thereafter, and use of TuHURA’s platform technologies may not ever result in marketable products.

In addition, the clinical trial requirements of the FDA and other regulatory authorities and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential products. The regulatory approval process for novel product candidates such as TuHURA’s can be less predictable, more expensive and longer than for other, better known or extensively studied pharmaceutical or other product candidates.

The immuno-oncology industry is also rapidly developing, and TuHURA’s competitors may introduce new technologies improving the immune response to cancer that render TuHURA’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