Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 210

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 210
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. Furthermore, even if Kineta is able to enroll a sufficient number of patients for its clinical trials, Kineta may have difficulty maintaining enrollment of such patients in its clinical trials. If Kineta experiences delays in the completion of, or termination of, any clinical trial of its current product candidates and any future product candidates, the commercial prospects of Kineta’s current product candidates and any future product candidates will be harmed, and Kineta’s ability to generate product revenue from such product candidates could be delayed or prevented. Kineta’s future growth depends, in part, on its ability to penetrate multiple markets in which Kineta would be subject to additional regulatory burdens and other risks and uncertainties. Kineta’s future profitability will depend, in part, on its ability to commercialize its product candidates, if approved, in markets in the United States, Europe, the UK and other countries where Kineta maintains commercialization rights. As Kineta begins to commercialize its product candidates, if approved, in multiple markets, Kineta is subject to additional risks and uncertainties, including:

| • |     | foreign currency exchange rate fluctuations and currency controls; |

| • |     | economic weakness, including inflation, or political instability in particular economies and markets; |

| • |     | potentially adverse and/or unexpected tax consequences, including penalties due to the failure of tax planning or due to the challenge by tax authorities on the basis of transfer pricing and liabilities imposed from inconsistent enforcement; |

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| • |     | the burden of complying with complex and changing regulatory, tax, accounting and legal requirements, many of which vary between countries; |

| • |     | different medical practices and customs in multiple countries affecting acceptance of drugs in the marketplace; |

| • |     | differing payor reimbursement regimes, governmental payors or patient self-pay systems and price controls; |

| • |     | tariffs, trade barriers, import or export licensing requirements or other restrictive actions; |

| • |     | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |

| • |     | workforce uncertainty in countries where labor unrest is common; |

| • |     | reduced or loss of protection of intellectual property rights in some foreign countries, and related prevalence of generic alternatives to therapeutics; and |

| • |     | becoming subject to the different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations. |

These and other risks associated with international operations may adversely affect Kineta