Company: HURA
Filing Date: 2025-05-23
Form Type: 424B3
Source: 0001193125-25-125499
Chunk: 101

Company: TuHURA Biosciences, Inc./NV
Filing Date: 2025-05-23
Form: 424B3
Chunk 101
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, sufficient clinical efficacy and prove the required level of safety in order to receive FDA approval or any other required regulatory approval. In addition, we have entered into a Special Protocol Assessment (“SPA”) agreement with the FDA regarding the initiation of a single registration-directed trial utilizing the FDA’s accelerated approval pathway for IFx-2.0.An SPA agreement for such a trial does not increase the likelihood of marketing approval for the product and may not lead to a faster or less costly development, review, or approval process. Even if TuHURA is successful in getting market approval, commercial success of any of its product candidates will also depend in large part on the availability of coverage and adequate reimbursement from third-partypayors, including government payors such as the Medicare and Medicaid programs and managed care organizations, which may be affected by existing and future health care reform measures designed to reduce the cost of health care. Third-party payors could require TuHURA to conduct additional studies, including post-marketingstudies related to the cost effectiveness of a product, to qualify for reimbursement, which could be costly and divert TuHURA’s resources. If government and other health care payors were not to provide adequate coverage and reimbursement levels for any of TuHURA’s products once approved, market acceptance and commercial success would be reduced. TuHURA’s technology platforms, including its proprietary, multi-indication immunomodulatory platform (ImmuneFx IFx, and Delta receptor targeting ADCs) technologies are a new approach to treat cancer and other immune-related diseases that present significant challenges. TuHURA has concentrated its research and development efforts on advancing a new generation of immunotherapies based on the IFx and Delta receptor antibody drug conjugates (“ADC”) platforms, and its future success is highly dependent on the successful development of its product candidates, which target cancer and other immune-related diseases. TuHURA cannot be sure that its IFx or Delta receptor ADC platforms will yield satisfactory products that are safe and effective, scalable, or profitable. TuHURA’s technology could become subject to many of the challenges and risks that gene therapies face, including:

| • |     | regulatory requirements governing gene and cell therapy products have changed frequently and may continue to 
 change in the future;                                                                                        |

| • |     | the FDA could recommend follow-up observation period of up to 15 years                                                               
 for all patients who receive TuHURA’s treatment. TuHURA may need to adopt such an observation period for its product candidates; and |

| • |     | clinical trials