Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 353

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 353
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 or our ability to commercialize FYARRO for additional indications or for any other product candidates we may develop in the future, including:

| • |     | receipt of feedback from regulatory authorities that require us to modify the design of our clinical trials; |

| • |     | negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or 
 abandon certain drug development programs;                                                                   |

| • |     | the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical               
 trials being slower than anticipated or participants dropping out of these clinical trials at a higher rate than anticipated; |

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| • |     | clinical trial sites or our CRO failing to comply with regulatory requirements or meet their contractual 
 obligations to us in a timely manner, or at all;                                                         |

| • |     | the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or other unexpected characteristics; |

| • |     | the cost of clinical trials of our product candidates being greater than anticipated; |

| • |     | the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our 
 product candidates being insufficient or inadequate; and                                                       |

| • |     | delays due to health epidemics, such as the COVID-19 pandemic, including 
 starting any clinical trials for other indications or programs.          |

For example, we initiated our PRECISION1 Phase 2 study of FYARRO in malignant solid tumors harboring TSC1and TSC2inactivating alterations based on exploratory data from our completed Phase 2 registrational study, Advanced Malignant PEComa Trial (“AMPECT trial”), and data for FYARRO in other solid tumors with TSC1and TSC2inactivating alterations. In August 2024, we had to halt, and subsequently wind-down, the PRECISION1 trial based on interim data and the related analysis by the Independent Data Monitoring Committee, which determined that the study was unlikely to exceed an efficacy threshold necessary to support an accelerated approval, the key goal of the study. Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, EMA, and other comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials. Additionally, while we are aware of several other approved and clinical-stage mTOR inhibitors being developed by multiple other companies, to our