Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 184

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 184
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 the necessary preclinical studies and clinical trials; |

| • |     | obtaining and maintaining patent, trademark and trade secret protection and regulator exclusivity for Kineta’s product candidates and otherwise protecting its rights in its intellectual property portfolio; |

| • |     | submission of INDs and Clinical Trial Applications for and receipt of allowance to proceed with Kineta’s planned clinical trials or other future clinical trials; |

| • |     | initiating, enrolling, and successfully completing clinical trials; |

| • |     | obtaining positive results from Kineta’s preclinical studies and clinical trials that support a demonstration of efficacy, safety, and durability of effect for its product candidates; |

| • |     | receiving approvals for commercialization of Kineta’s product candidates from applicable regulatory authorities; |

| • |     | the outcome, timing and cost of meeting regulatory requirements established by the FDA, European Commission (based on recommendation from the EMA), and other regulatory authorities; |

| • |     | establishing sales, marketing and distribution capabilities and successfully launching commercial sales of Kineta’s products, if and when approved, whether alone or in collaboration with others; |

| • |     | maintaining a continued acceptable safety, tolerability and efficacy profile of any approved products; |

| • |     | setting acceptable prices for Kineta’s product and obtaining coverage and adequate reimbursement from third-party payors; |

| • |     | acceptance of Kineta’s products, if and when approved, by patients, the medical community and third-party payors; |

| • |     | manufacturing Kineta’s product candidates at an acceptable cost; and |

| • |     | maintaining and growing an organization of scientists, medical and clinical professionals and business people who can develop and commercialize Kineta’s products and technology. |

**Many of these factors are beyond Kineta’s control, including the time needed to adequately complete clinical testing, the regulatory submission process and potential threats to Kineta’s intellectual property rights. It is possible that none of Kineta’s product candidates will ever obtain regulatory approval, even if Kineta expends substantial time and resources seeking such approval. If Kineta does not achieve one or more of these factors in a timely manner or at all, or any other factors impacting the successful development of biopharmaceutical products, Kineta could experience significant delays or an inability to successfully develop its product candidates, which would materially harm Kineta’s business. The results of preclinical studies and early clinical trials are not always predictive of future results. Any product candidate that Kin