Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 343

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 343
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| • |     | the timely manufacture of sufficient quantities of a product candidate for use in clinical trials; and |

| • |     | generating sufficient safety and efficacy data to warrant continued development and which are satisfactory to the 
 FDA or any other regulatory authority for marketing approval.                                                     |

Even if we successfully advance any other product candidates into clinical development, their success will be subject to all of the clinical, regulatory and commercial risks described elsewhere in this “Risk Factors” section. Accordingly, we cannot assure you that we will ever be able to discover, develop, obtain regulatory approval of, commercialize or generate significant revenue from any additional product candidates beyond FYARRO for advanced malignant PEComa. FYARRO or any other product candidates we may develop in the future may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success, which would limit the revenue that we generate from our sales. Even though FYARRO has been approved for advanced malignant PEComa, and even if any other product candidates that we may develop in the future receive regulatory approval, such approved product candidates may not gain adequate market acceptance among physicians, patients, third-party payors and others in the medical community. The degree of market acceptance of any of our approved product candidates will depend on a number of factors, including, among others:

| • |     | the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments; |

| • |     | the timing of market introduction of the product candidate as well as competitive products; |

| • |     | the clinical indications for which a product candidate is approved; |

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| • |     | restrictions on the use of product candidates in the labeling approved by regulatory authorities, such as boxed                                                               
 warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor products; |

| • |     | the potential and perceived advantages of our product candidates over alternative treatments; |

| • |     | the cost of treatment in relation to alternative treatments; |

| • |     | the availability of coverage and adequate reimbursement by third-party payors, including government authorities 
 or the willingness of patients to pay out-of-pocket in the absence of third-party payor coverage;               |

| • |     | the availability of an approved product candidate for use as a combination therapy; |

| • |     | the prevalence and severity of any adverse effects associated with any approved