Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 289

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 289
---
SC1and TSC2inactivating alterations that was based on evidence of activity seen in patients with TSC1and TSC2inactivating alterations from the completed AMPECT trial (presented at the
Connective Tissue Oncology Society (CTOS) Annual Meeting in 2020) and our expanded access program (presented at the ASCO Annual Meeting in 2021). We have completed a Type B meeting with the FDA in which we discussed the trial design with the FDA.
The PRECISION1 trial opened for enrollment in the United States during the first quarter of 2022 and the first patient was dosed in March 2022.

On
December 14, 2023, we reported results from a planned interim analysis on the first third of participants in the PRECISION1 trial. The interim analysis included data from the first third of trial participants (n=40) with a minimum of 4.5 months
of follow-up, including investigator-assessed response and safety analyzed separately in each of the TSC1and TSC2arms. Nine different tumor types were enrolled in the TSC1arm and 13
tumor types were enrolled in the TSC2arm.

On August 20, 2024, we halted the PRECISION1 trial based on efficacy results from a planned
interim analysis of efficacy results from two-thirds of participants in the trial. An analysis by the Independent Data Monitoring Committee demonstrated that the study was unlikely to exceed an efficacy
threshold necessary to support an accelerated approval, the key goal of this Phase 2 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.

- 201 -

FYARRO in endometrial cancer

In August 2023, we announced the expansion of our FYARRO clinical pipeline through the further investigation of mTOR pathway inhibition by studying FYARRO in
endometrioid endometrial cancer (EEC). We have paused new enrollment, but continue dosing previously enrolled patients, in a Phase 2 open-label, multi-institutional study to evaluate the efficacy and safety of the combination of FYARRO with
letrozole for the treatment of advanced or recurrent EEC.

Endometrial cancer is the most common cancer of the female reproductive organs, with an
estimated 10,000 cases of EEC diagnosed annually in the United States. The mTOR pathway is