Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 340

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 340
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| • |     | the successful and timely completion of the required preclinical studies and clinical trials of FYARRO for 
 current and future indications;                                                                            |

| • |     | INDs going into effect with the FDA for future clinical trials; |

| • |     | the initiation and successful patient enrollment and completion of additional clinical trials of FYARRO on a 
 timely basis;                                                                                                |

| • |     | maintaining and establishing relationships with CROs and clinical sites for the development of FYARRO both in the 
 United States and internationally;                                                                                |

| • |     | the type, frequency and severity of adverse events in clinical trials; |

| • |     | demonstrating efficacy and safety profiles that are satisfactory to the FDA and any comparable foreign regulatory 
 authority for regulatory approval;                                                                                |

| • |     | obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the 
 United States and internationally;                                                                           |

| • |     | a continued acceptable safety profile following our current and future regulatory approval; and |

| • |     | our ability to compete with other therapies. |

We are not currently enrolling patients in clinical trials with respect to FYARRO. In August 2024, we halted our Phase 2 study of FYARRO in malignant solid tumors harboring Tuberous Sclerosis Complex 1 (“ TSC1”) and - 237 -

Tuberous Sclerosis Complex 2 (“ TSC2”) inactivating alterations (“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. We are completing the wind-down of the PRECISION1 trial and all patients who were still receiving benefit at the time the study was halted were transitioned to an expanded access protocol. In addition, we paused new enrollment, but continue dosing previously enrolled patients, in our (i) Phase 2 studies in EEC and NETs. Both studies have enrolled sufficient patients (n=24 and n=12 for EEC and NETs, respectively) to assess initial efficacy signals, with results expected to be reported at a later date. Our product development costs could increase if we experience further delays. Significant trial delays also could shorten any periods during which we may have the exclusive right to commercialize FYARRO or allow our competitors to bring products to market before we do, which would impair our ability to successfully capitalize on