Company: HURA
Filing Date: 2025-02-07
Form Type: S-4
Source: 0001193125-25-022803
Chunk: 174

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-02-07
Form: S-4
Chunk 174
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 and commercialization of the product candidates that Kineta discovers with this engine. Kineta has no products approved for commercial sale and does not anticipate generating any revenue from product sales in the near term, if ever. Kineta’s ability to generate revenue and achieve profitability depends significantly on its ability to achieve several objectives, including:

| • |     | successful and timely completion of preclinical and clinical development of Kineta’s next generation immunotherapies, other research programs from Kineta’s development platform, and any other future programs; |

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| • |     | establishing and maintaining relationships with contract research organizations (“CROs”) and clinical sites for the clinical development of our product candidates and our future product candidates; |

| • |     | timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which Kineta successfully completes clinical development; |

| • |     | transferring Kineta’s manufacturing process to a commercial contract development and manufacturing company, including obtaining finished products that are appropriately packaged for sale; |

| • |     | establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for Kineta’s product candidates, if approved; |

| • |     | meeting milestones for licensed programs; |

| • |     | successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators; |

| • |     | a continued acceptable safety profile following any marketing approval of Kineta’s product candidates; |

| • |     | commercial acceptance of Kineta’s product candidates by patients, the medical community and third-party payors; |

| • |     | satisfying any required post-marketing approval commitments to applicable regulatory authorities; |

| • |     | identifying, assessing and developing new product candidates from Kineta’s development platform; |

| • |     | obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally; |

| • |     | defending against third-party interference or infringement claims, if any; |

| • |     | entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize Kineta’s product candidates; |

| • |     | obtaining coverage and adequate reimbursement by third-party payors for Kineta’s product candidates; |

| • |     | addressing any competing therapies and technological and market developments