Company: HURA
Filing Date: 2025-09-18
Form Type: S-1/A
Source: 0001193125-25-207395
Chunk: 26

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-09-18
Form: S-1/A
Chunk 26
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| • |     | patients dropping out of a trial; |

| • |     | occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits; |

| • |     | changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; |

| • |     | changes in the standard of care on which a clinical development plan was based, which may require new or additional trials; |

| • |     | the cost of clinical trials of TuHURA’s product candidates being greater than TuHURA anticipates; |

| • |     | clinical trials of TuHURA’s product candidates producing negative or inconclusive results, which may result in TuHURA deciding, or regulators requiring it, to conduct additional clinical trials or abandon product development programs; |

| • |     | delays in developing TuHURA’s manufacturing processes and transferring to new third-party facilities to support future development activities and commercialization that are operated by contract manufacturing organizations (“CMOs”), in a manner compliant with all regulatory requirements; and |

| • |     | delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of TuHURA’s product candidates for use in clinical trials or the inability to do any of the foregoing. |

For example, TuHURA’s IND for its planned Phase 3 trial for IFx-2.0 contemplatedby its SPA agreement with the FDA was subject to a partial clinical trial hold as described in a January 2024 letter from the FDA that relates to certain CMC matters for the trial. The FDA lifted the partial clinical hold and TuHURA initiated the Phase 3 trial in June 2025. A partial clinical hold means that the FDA suspends part of the clinical work requested under an IND (i.e., a specific protocol or part of a protocol is not allowed to proceed). The partial hold requires TuHURA to provide additional CMC information from its contract manufacturers for the Phase 3 trial, complete and qualify a potency assay, and qualify the mixing process for IFx-2.0 atthe clinical site prior to initiating the trial. Although TuHURA currently is working with its contract manufacturers to provide the additional required information, and has planned and is undertaking ongoing in vitro testing, development, and validation intended to address the other requirements, there is no assurance that TuHURA will be able to complete these requirements on a timely basis, which could delay TuHURA’s expected timetable to complete the trial, or if TuHURA