Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 380

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 380
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 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 If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of the company and our operating results will be adversely affected.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 other product candidate that we may develop in the future, if approved, we may become subject to significant liability. The FDA and other regulatory agencies, including the U.S. Department of Justice, strictly regulate the post-approval marketing and promotional claims that may be made about prescription products, such as for FYARRO. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-labeluses, and a company that is found to have improperly promoted off-labeluses may be subject to significant civil, criminal and administrative penalties. As such, we may not promote our products for indications or uses for which they do not have approval. For example, physicians may, in their practice of medicine, use drug products for their patients in a manner that is inconsistent with the approved label. If we, or any of our contractors or agents acting on behalf of us, are found to