Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 343

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 343
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 FYARRO in a larger number of patients in a      
 non-clinical trial setting than those demonstrated in our clinical trials; |

| • |     | the effectiveness of our sales, marketing and distribution efforts; |

| • |     | the maintenance of existing or the establishment of new supply arrangements with third-party drug product     
 suppliers and manufacturers for sufficient commercial supplies and additional clinical development of FYARRO; |

| • |     | the success of our commercial sales, including the ongoing development of a commercial infrastructure, whether in-house or with one or more collaborators; |

| • |     | the timely receipt of regulatory approval for FYARRO from applicable foreign regulatory authorities for advanced 
 malignant PEComa;                                                                                                |

| • |     | the successful completion of any clinical trials, regulatory approval and commercialization of FYARRO for one or 
 more label expansion indications;                                                                                |

| • |     | the extent of any required post-regulatory approval commitments to applicable regulatory authorities; |

| • |     | the willingness of medical professionals to prescribe and patients to use FYARRO and continue to use FYARRO; |

| • |     | the availability of coverage and adequate reimbursement and pricing by private and government payors; |

| • |     | the prevalence and severity of adverse side effects; |

| • |     | the convenience of prescribing, administrating and initiating patients on FYARRO; |

| • |     | the potential and perceived value and relative cost of FYARRO; |

| • |     | the successful and timely completion of the required preclinical studies and clinical trials of FYARRO for 
 current and future indications;                                                                            |

| • |     | INDs going into effect with the FDA for future clinical trials; |

| • |     | the initiation and successful patient enrollment and completion of additional clinical trials of FYARRO on a 
 timely basis;                                                                                                |

| • |     | maintaining and establishing relationships with CROs and clinical sites for the development of FYARRO both in the 
 United States and internationally;                                                                                |

| • |     | the type, frequency and severity of adverse events in clinical trials; |

| • |     | demonstrating efficacy and safety profiles that are satisfactory to the FDA and any comparable foreign regulatory 
 authority for regulatory approval;                                                                                |

| • |     | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the 
 United States and internationally;                                                                           |

| • |     | a continued acceptable safety profile following our current and future regulatory