Company: HURA
Filing Date: 2025-05-06
Form Type: S-4/A
Source: 0001193125-25-113920
Chunk: 183

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-06
Form: S-4/A
Chunk 183
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 you that the measures it has taken to date, together with any measures it may take in the future, will be sufficient to remediate the control deficiency that led to the material weaknesses in Kineta’s internal control over financial reporting or to avoid potential future material weaknesses. If Kineta is unable to successfully remediate its existing or any future material weakness in Kineta’s internal control over financial reporting, or if Kineta identifies any additional material weakness, the accuracy and timing of Kineta’s financial reporting may be adversely affected, Kineta may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in Kineta’s financial reporting, and Kineta’s stock price may decline as a result. Kineta also could become subject to investigations by the SEC, or other regulatory authorities.

Risks Relating to the Discovery, Development and Regulatory Approval of Kineta’s Product Candidates

Kineta’s development efforts are in the early stages. Kineta’s product candidate is in clinical development. If Kineta is unable to advance its product candidate through clinical development, obtain regulatory approval and ultimately commercialize its product candidate, or experience significant delays in doing so, Kineta’s business will be materially harmed.

There is no assurance that clinical trials of Kineta’s product candidate, or any other future clinical trials of Kineta’s product candidate, will be successful or will generate positive clinical data and Kineta may not receive marketing approval from the FDA, European Commission, or other regulatory authorities for its product candidate. Kineta has limited experience submitting INDs to the FDA. KVA12123 is in clinical development. There can be no assurance that the FDA will permit any of Kineta’s future INDs to go into effect in a timely manner or at all. Without an IND for a product candidate, Kineta will not be permitted to conduct clinical trials in the United States of such product candidate.

Biopharmaceutical development is a difficult, long, time-consuming, expensive and uncertain process, and delay or failure can occur at any stage of any of Kineta’s clinical trials. Failure to obtain regulatory approval for**

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Kineta’s product candidate will prevent it from commercializing and marketing its product candidate. The success in the development of Kineta’s product candidate will depend on many factors, including:

| • |     | timely and successful completion of preclinical studies; |

| • |     | sufficiency of Kineta’s financial and other resources to complete