Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 376

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 376
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| • |     | issuance of warning letters, safety alerts, dear-healthcare-provider letters, press releases or other 
 communications containing warnings regarding the product that would result in adverse publicity;      |

| • |     | voluntary or mandatory product recalls and publicity requirements or withdrawal of FYARRO from the market; |

| • |     | suspension or withdrawal of marketing or regulatory approvals or other permits or voluntary; |

| • |     | product seizures, detentions or import bans; |

| • |     | total or partial suspension of production; |

| • |     | imposition of restrictions on operations, including costly new manufacturing requirements; |

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| • |     | requirement to establish or modify a REMS; |

| • |     | requirement to conduct post-marketing studies or surveillance; |

| • |     | restrictions on drug distribution or use; |

| • |     | requirements to conduct post-marketing studies or clinical trials; |

| • |     | refusal to approve pending applications or supplements to approved applications that we submit and other delays; |

| • |     | delays in or the rejection of approvals of additional indications for FYARRO; |

| • |     | restrictions on our ability to conduct clinical trials, including full or partial clinical holds on, or the 
 suspension or termination of, future trials;                                                                |

| • |     | fines, restitution or disgorgement of profits or revenue; |

| • |     | reputational harm; |

| • |     | refusal of government contracts or future orders under existing contracts, exclusion from participation in 
 federal health care programs; or                                                                           |

| • |     | injunctions or the imposition of civil or criminal penalties, including False Claims Act liability. |

The holder of an approved NDA or comparable regulatory approval must submit new or supplemental applications and obtain approval for certain changes to the approved product, product labeling, or manufacturing process and the FDA or comparable foreign regulatory authority may refuse to approve pending applications or supplements to approved applications filed by us. The occurrence of any event or penalty described above may inhibit our ability to commercialize FYARRO and any other product candidates that we may develop in the future, if approved, and generate revenue. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of the company and our operating results will be adversely affected. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-labeluses. If we are found to have improperly promoted off-labeluses of FYARRO or any