Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 285

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 285
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 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.

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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 known to be activated in many cases of endometrial cancer; approximately 93% of EEC patients have mutations in the PI3k/AKT/mTOR pathway. In previous clinical
trials, mTOR inhibitor everolimus in combination with letrozole (an anti-estrogen agent) has demonstrated efficacy in the EEC population. To preserve cash runway following the halt of our PRECISION1 trial, we paused new enrollment, but continue
dosing previously enrolled patients, in the Phase 2 trials of FYARRO for EEC and neuroendocrine tumors (NETs).

FYARRO in neuroendocrine tumors

In August 2023, we also announced the study of FYARRO in NETs. We have paused new enrollment, but continue dosing previously enrolled patients, in a
Phase 2 multicenter, open-label, single-arm trial to evaluate FYARRO in adult patients with functional or non-functional, well-differentiated, locally advanced
unresectable or metastatic NETs of the GI tract, lung, or pancreas who have received ≤2 prior lines of therapy, excluding somatostatin analogs (SSTa).

NETs develop from neuroendocrine cells found in various organs throughout the body, including the pancreas, gastrointestinal tract, and lung, with
approximately 3,500 cases diagnosed annually in the United States. While NETs are slow