Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 290

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 290
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 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 growing, they may result in a variety of severe symptoms, including pain, organ dysfunction, and in the case of functional (hormone secreting) NETs, intractable
diarrhea, refractory gastric ulcers, or uncontrolled glucose levels that may respond poorly to treatment. While everolimus is approved for NETs based on a progression free survival benefit over placebo, we believe, based in part on everolimus’s
preclinical studies results, that there is an opportunity for nab-sirolimus to provide enhanced therapeutic benefit.

FYARRO - Historical Clinical Development

Advanced Malignant PEComa Trial (AMPECT)

PEComa.AMPECT was the first prospective clinical trial in advanced malignant PEComa. Patients with metastatic or inoperable locally advanced disease
were treated with FYARRO at 100 mg/m2 administered as an IV infusion over 30 minutes on Days 1 and 8 of a 21-day cycle. The primary endpoint for the study was ORR evaluated by independent radiology review.
Secondary efficacy endpoints included duration of response (“DOR