Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 339

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 339
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 FDA for approval to treat patients with advanced malignant PEComa and the FDA approved
FYARRO for advanced malignant PEComa in November 2021. Our NDA was based on results from our AMPECT trial, which involved patients for whom there were no approved therapies in the United States. FYARRO will require additional clinical development,
expansion of manufacturing capabilities, regulatory approval from foreign regulatory authorities in jurisdictions outside of the United States where we plan to market FYARRO for advanced malignant PEComa and potentially

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in additional indications, if approved, substantial investment and significant marketing efforts before we can generate any substantial revenues from product sales. We are not permitted to market or promote FYARRO for any non-PEComaindications, until we receive regulatory approval from the FDA and comparable foreign regulatory authorities for any such additional indication, and we may never receive such regulatory approvals. The success of FYARRO will depend on several factors, including the following:

| • |     | the efficacy and safety of 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; |