Company: HURA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047921
Chunk: 133

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 133
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). The partial hold required us to provide additional CMC information from our contract manufacturers for the Phase 3 trial, complete and qualify a potency assay, and qualify the mixing process for IFx-2.0 at the clinical site prior to initiating the trial.  We have reached agreement with FDA on the requirements for lifting the partial clinical hold and believe we will meet the requirements, but there is no assurance that we will be able to complete these requirements on a timely basis, which could delay our expected timetable to complete the trial, or if we are unable to complete these requirements, we will not be able to proceed with the trial.

Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of marketing approval for our product candidates.

Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue. In addition, if we make manufacturing or formulation changes to our product candidates, we may be required to, or it may elect to, conduct additional trials to bridge our modified product candidates to earlier versions. Clinical trial delays could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

If we do not achieve our projected development and commercialization goals in accordance with our expected and announced timeframes, the commercialization of any of our product candidates may be delayed, and our business will be harmed.

Elsewhere in this Annual Report, we have provided timing estimates regarding the initiation of clinical trials and clinical development milestones, and the expected availability of data resulting from these trials for certain of our product candidates. We expect to continue to estimate the timing of these types of development milestones and our expected timing for the accomplishment of various other scientific, clinical, regulatory, and other product development objectives. From time to time, we may publicly announce the expected timing of some of these events. However, the achievement of many of these milestones and events may be outside of our control. These timing estimations are based on a variety of assumptions we make, which may cause the actual timing of these events to differ from the timing it expects, including:

•our available capital resources and our ability to obtain additional funding as needed;

•the rate of progress, costs, and results of our clinical trials and research and development activities;

•our ability to identify and enroll patients who meet clinical