Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 296

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 296
---
 or distribution, injunctions, debarment, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. U.S. Drug Development In the U.S., the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations. Drugs are also subject to other federal, state, and local statutes and regulations. Drugs must be approved by the FDA through the NDA process before they may be legally marketed in the U.S. The process required by the FDA before a drug may be marketed in the U.S. generally involves the following:

| • |     | completion of extensive preclinical, sometimes referred to as nonclinical, laboratory tests, animal studies, and                               
 formulation studies all performed in accordance with applicable regulations, including the FDA’s good laboratory practice (“GLP”) regulations; |

| • |     | submission to the FDA of an investigational new drug application (“IND”), which must become effective               
 before human clinical trials may begin and must be updated annually and amended in accordance with the regulations; |

| • |     | performance of adequate and well-controlled human clinical trials in accordance with applicable IND and other                                                                            
 clinical trial-related regulations, sometimes referred to as good clinical practices (“GCPs”), to establish the safety and efficacy of the proposed drug for its proposed indication(s); |

| • |     | submission to the FDA of an NDA for a new drug; |

| • |     | a determination by the FDA within 60 days of its receipt of an NDA to file the NDA for review; |

- 210 -

| • |     | satisfactory completion of an FDA pre-approval inspection of the                                                                                                                                                                 
 manufacturing facility or facilities at which the active pharmaceutical ingredient (“API”) and finished drug product are produced to assess compliance with the FDA’s current good manufacturing practice requirements (“cGMP”); |

| • |     | potential FDA audit of the testing laboratories and clinical trial sites that generated the data in support of 
 the NDA; and                                                                                                   |

| • |     | FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the U.S. |

Prior to beginning a clinical trial with a product candidate in the United States, companies must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. The central focus of an