Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 405

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 405
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 regulations. We will also need to verify, such as through a bridging study, that any new manufacturing process will produce FYARRO or any other product candidate we may develop in the future, if approved, according to the specifications previously submitted to the FDA or another regulatory authority. If we were to experience an unexpected loss of supply of FYARRO or any other product candidate that we may develop in the future for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, we could experience delays, disruptions, suspensions or terminations in commercializing FYARRO for advanced malignant PEComa, or be required to restart or repeat, any future clinical trials for FYARRO in other indications or for any other product candidates we may develop in the future, in a timely manner or on budget. Moreover, if we are unable to keep up with demand for FYARRO, our revenue could be impaired, market acceptance for FYARRO could be adversely affected. We may be unable to maintain or establish required agreements with third-party manufacturers or to do so on acceptable terms. Further, any delay in identifying and qualifying a manufacturer for commercial production could negatively impact the commercialization of FYARRO, and, in the event that we do not have sufficient product to complete clinical trials, it could delay such trials. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

| • |     | the failure of the third party to manufacture FYARRO or any of our other product candidates that we may develop                                                                                                   
 in the future according to our schedule and specifications, or at all, including if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do 
 not satisfactorily perform according to the terms of the agreements between us and them;                                                                                                                          |

| • |     | the termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is 
 costly or inconvenient for us;                                                                               |

| • |     | the breach by the third-party contractors of our agreements with them; |

| • |     | the failure of third-party contractors to comply with applicable regulatory requirements, including manufacturing 
 drug supply pursuant to strictly enforced cGMPs;                                                                  |

| • |     | the failure of the third-party contractor to manufacture FYARRO or any of our other product candidates that we 
 may develop in the future according to our specifications;                                                     |

| • |     | the mis