Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 345

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 345
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, 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 to successfully commercialize FYARRO for multiple indications in a timely manner or at all, which would materially harm our business. If we do not receive regulatory approvals for FYARRO in additional indications or for other product candidates, we may not be able to continue our operations. - 237 -

In addition to FYARRO, our prospects depend in part upon discovering, developing and commercializing additional product candidates, which may fail in development or suffer delays that adversely affect their commercial viability. Our future operating results are dependent on our ability to successfully discover, develop, obtain regulatory approval for and/or commercialize product candidates other than FYARRO. Prior to initiating clinical trials with product candidates, we will need to file an IND or similar application to the FDA or regulatory authorities in other jurisdictions. We may not be able to file future INDs for product candidates on the timelines we expect. For example, we may experience manufacturing delays or other delays with IND-enablingstudies. Moreover, we cannot be sure that submission of an IND will result in