Company: HURA
Filing Date: 2025-02-07
Form Type: S-4
Source: 0001193125-25-022803
Chunk: 185

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-02-07
Form: S-4
Chunk 185
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 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; |

| • |     | potential disruptions caused by pandemics or other public health crises, including difficulties in initiating clinical sites, enrolling and retaining participants, diversion of healthcare resources away from clinical trials, travel or quarantine policies that may be implemented, and other factors; |

| • |     | the patient referral practices of physicians; |

| • |     | the ability to monitor patients adequately during and after treatment; and |

| • |     | the proximity and availability of clinical trial sites for prospective patients. |

Kineta’s inability to enroll a sufficient number of patients for clinical trials would result in significant delays and could require Kineta to abandon one or more clinical trials altogether. Enrollment delays in these clinical trials may result in increased development costs for Kineta’s product candidates, which would cause the value of the Company to decline and limit Kineta’s ability to obtain additional financing. Furthermore, Kineta expects to rely on Contract Research Organizations (CROs) and clinical trial sites to ensure the proper and timely conduct of its clinical trials and Kineta will have limited influence over their performance. Kineta may not be able to submit INDs to commence additional clinical trials on the timelines Kineta expects and, even