Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 374

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 374
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questration, such as ones that occurred during 2013, 2018 and 2019, or the diversion of resources to handle the COVID-19public health emergency and pandemic may result in significant reductions to the FDA’s budget, employees and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to obtain regulatory approval for our product candidates. In addition, the impact of COVID-19may cause the FDA to allocate additional resources to product candidates focused on treating related illnesses, which could lead to longer approval processes for our product candidates. Finally, our competitors may file citizens’ petitions with the FDA in an attempt to persuade the FDA that our product candidates, or the clinical trials that support their approval, contain deficiencies. Such actions by our competitors could delay or even prevent the FDA from approving any of our NDAs. Applications for any future product candidates could fail to receive regulatory approval for many reasons, including the following:

| • |     | the FDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or 
 results of our clinical trials;                                                                                 |

| • |     | the FDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not                                                                                                            
 safe or effective, are only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude us from obtaining regulatory approval or prevent or limit commercial use; |

| • |     | the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy 
 and safety in the full population for which we seek approval;                                                   |

| • |     | the FDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from 
 preclinical studies or clinical trials;                                                                           |

| • |     | we may be unable to demonstrate to the FDA, EMA or other comparable foreign regulatory authorities that our 
 product candidate’s risk-benefit ratio for our proposed indication is acceptable;                           |

| • |     | the FDA, EMA or other comparable foreign regulatory authorities may find deficiencies with or fail to approve the                                                   
 manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; |

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| • |     | the FDA, EMA or other comparable regulatory authorities may fail to approve companion diagnostic tests for our 
 product candidates, if required; and                                                                           |

| • |     | the approval policies or regulations of the FDA, EMA or other comparable foreign regulatory authorities may