Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 301

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 301
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”), 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; |

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| • |     | 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 IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-daytime period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial. Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include the requirement that all