Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 341

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 341
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 FYARRO and may harm our business, results of operations and prospects. Events that may result in a delay or unsuccessful completion of additional clinical development of FYARRO include, among other things:

| • |     | unexpectedly high rate of patients withdrawing consent or being lost to 
 follow-up;                                                              |

| • |     | feedback from the FDA and foreign regulatory authorities, institutional review boards (“IRBs”), or a                        
 data safety monitoring board, or results from clinical trials that might require modification to a clinical trial protocol; |

| • |     | imposition of a clinical hold by the FDA or other regulatory authorities, a decision by the FDA, other regulatory                                                    
 authorities, IRBs or us, or a recommendation by a data safety monitoring board to suspend or terminate trials at any time for safety issues or for any other reason; |

| • |     | deviations from the trial protocol by clinical trial sites and investigators or failure to conduct the trial in 
 accordance with regulatory requirements;                                                                        |

| • |     | failure of third parties, such as CROs, to satisfy their contractual duties or meet expected deadlines; |

| • |     | delays in the testing, validation, manufacturing and delivery of FYARRO to customers or the clinical trial sites; |

| • |     | delays caused by patients dropping out of a trial due to side effects, disease progression or other reasons; |

| • |     | unacceptable risk-benefit profile or unforeseen safety issues or adverse drug reactions; |

| • |     | failure to demonstrate the efficacy of FYARRO; |

| • |     | changes in government regulations or administrative actions or lack of adequate funding to continue the trials; 
 or                                                                                                              |

| • |     | business interruptions resulting from geo-political actions, including                                                                                    
 war and terrorism, such as the conflicts in Ukraine and the Middle East, or natural disasters and public health epidemics, such as the COVID-19 pandemic. |

An inability by us to timely complete clinical development could result in additional costs to us or impair our ability to generate substantial product sales or development, regulatory, commercialization and sales milestone payments and royalties on product sales. We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, and we could face potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of our current or any future collaborators. If we are not successful with respect to one or more of these factors, we could experience significant delays or an inability