Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 188

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 188
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 to exert anti-tumor effects in a hostile TME. In addition, the safety profile of Kineta’s product candidates may differ in a solid tumor setting. As a result, Kineta’s product candidate may not demonstrate efficacy in solid tumors. If Kineta is unable to make its immuno-oncology product candidate function in tumors, Kineta’s development plans, financial position, results of operations and prospects may be materially adversely affected.

Kineta may experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, which could delay or prevent Kineta’s receipt of necessary regulatory approvals.

Successful and timely completion of clinical trials will require that Kineta enrolls a sufficient number of patients. Patient enrollment, which is an important factor in the timing of clinical trials, is affected by many factors, including the size and nature of the patient population and competition for patients eligible for Kineta’s clinical trials with competitors which may have ongoing clinical trials for product candidates that are under development to treat the same indications as one or more of Kineta’s product candidates, or approved products for the conditions for which Kineta is developing its product candidates.

Trials may be subject to delays as a result of patient enrollment taking longer than anticipated or patient withdrawal. Kineta may not be able to initiate or continue clinical trials for its product candidates if Kineta is unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the**

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FDA, EMA or comparable foreign regulatory authorities. Kineta cannot predict how successful it will be at enrolling subjects in future clinical trials. Subject enrollment is affected by other factors including:

| • |     | the severity and difficulty of diagnosing the disease under investigation; |

| • |     | the eligibility and exclusion criteria for the trial in question; |

| • |     | the size of the patient population and process for identifying patients; |

| • |     | Kineta’s ability to recruit clinical trial investigators with the appropriate competencies and experience; |

| • |     | the design of the trial protocol; |

| • |     | the perceived risks and benefits of the product candidate in the trial; |

| • |     | the availability of competing commercially available therapies and other competing therapeutic candidates’ clinical trials for the disease or condition under investigation; |

| • |     | the willingness of patients to be enrolled in Kineta’s clinical trials; |

| • |     | the efforts to facilitate timely enrollment in clinical trials; |

| •