Company: HURA
Filing Date: 2025-02-07
Form Type: S-4
Source: 0001193125-25-022803
Chunk: 209

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-02-07
Form: S-4
Chunk 209
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 candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. Such changes may also require additional testing, or notification to, or approval by the FDA, European Commission, EMA or a comparable foreign regulatory authority. This could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of one or more clinical trials, increase clinical trial costs, delay approval of Kineta’s current product candidates and any future product candidates and/or jeopardize Kineta’s ability to commence product sales and generate revenue. Even if any of Kineta’s product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. Even if Kineta obtains marketing approvals from the FDA, the European Commission (based on recommendation from the EMA) or other comparable foreign regulatory agencies and is able to initiate commercialization of Kineta’s clinical-stage product candidates or any other product candidates Kineta develops, the product candidate may not achieve market acceptance among physicians, patients, hospitals, including pharmacy directors, and third-party payors and, ultimately, may not be commercially successful. The degree of market acceptance of Kineta’s product candidates, if approved for commercial sale, will depend on a number of factors, including:

| • |     | the clinical indications for which Kineta’s product candidates are approved; |

| • |     | physicians, hospitals, cancer treatment centers and patients considering Kineta’s product candidates as a safe and effective treatment; |

| • |     | the potential and perceived advantages of Kineta’s product candidates over alternative treatments; |

| • |     | the prevalence and severity of any side effects; |

| • |     | product labeling or product insert requirements of the FDA, European Commission, EMA or other comparable foreign regulatory authorities; |

| • |     | limitations or warnings contained in the labeling approved by the FDA, European Commission, EMA or other comparable foreign regulatory authorities; |

| • |     | the timing of market introduction of Kineta’s product candidates as well as competitive products; |

| • |     | the cost of treatment in relation to alternative treatments; |

| • |     | the amount of upfront costs or training required for physicians to administer Kineta’s product candidates; |

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| • |     | the availability of coverage, adequate reimbursement from, and Kineta’s ability to negotiate pricing with, third-party payors and government authorities