Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 344

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 344
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 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 - 236 -

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 FYARRO and may harm our business, results of operations and prospects. Events that may result in a delay or unsuccessful completion of additional clinical development of FYARRO include, among other things:

| • |     | unexpectedly high rate of patients withdrawing consent or being lost to 
 follow-up;                                                              |

| • |     | feedback from the FDA and foreign regulatory authorities, institutional review boards (“IRBs”), or a                        
 data safety monitoring board, or results from clinical trials that might require modification to a clinical trial protocol; |

| • |     | imposition of a clinical hold by the FDA or other regulatory authorities, a decision by the FDA, other regulatory                                                    
 authorities, IRBs or us, or a recommendation by a data safety monitoring board to suspend or terminate trials at any time for safety issues or for any other reason; |

| • |     | deviations from the trial protocol by clinical trial sites and investigators or failure to conduct the trial in 
 accordance with regulatory requirements;                                                                        |

| • |     | failure of third parties