Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 347

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 347
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 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 product candidate; |

| • |     | any restrictions on the use of our product candidates together with other medications; |

| • |     | relative convenience and ease of administration; |

| • |     | the willingness of the target patient population to try new therapies and undergo required diagnostic screening 
 to determine treatment eligibility and of physicians to prescribe these therapies and diagnostic tests;         |

| • |     | the effectiveness of sales and marketing efforts; |

| • |     | unfavorable publicity relating to our product candidates; and |

| • |     | the approval of other new therapies for the same indications. |

Even though FYARRO is approved for advanced malignant PEComa, it may never achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, and we may not generate or derive sufficient revenue from that product and our financial results could be negatively impacted. Before granting reimbursement approval, healthcare payors may require us to demonstrate that FYARRO or any other product candidates that we may develop in the future, in