Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 288

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 288
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, uterus and gastrointestinal tract, and have a 4:1 female predominance.
Malignant PEComas are classified as one of the ultra-rare soft-tissue sarcomas with an estimated annual incidence of roughly 100-300 patients per year in the United States, although formal epidemiology studies
have yet to be conducted.

FYARRO is the first FDA approved treatment specifically for malignant PEComa. The disease is often treated with the cytotoxic
chemotherapy regimens used in soft tissue sarcomas, which have shown only modest benefit for malignant PEComa. PEComas commonly show evidence of mTORC1 activation due at least in part to loss-of-function mutations in or deletions of the TSC1or TSC2genes. In a retrospective analysis, patients with malignant PEComa treated with available mTOR inhibitors (mTORi, sirolimus,
everolimus, and temsirolimus) benefited from treatment suggesting that mTORC1 inhibition may be a promising therapeutic approach for malignant PEComa. As a result, available mTOR inhibitors may also be used to treat malignant PEComa.

In May 2021, we completed the filing of a rolling NDA for FYARRO to the FDA for approval to treat patients with advanced malignant PEComa. The NDA was based
on results from AMPECT, our Phase 2 registration-directed study in advanced malignant PEComa, which met its primary endpoint. In advanced malignant PEComa, other than FYARRO, there are no existing FDA approved therapies or drugs that have been
studied in prospective clinical trials. Following FDA approval, the National Comprehensive Cancer Network (“NCCN”) Sarcoma panel included FYARRO as the only preferred regimen for treatment of malignant PEComa.

On February 22, 2022, we launched FYARRO in the United States for treatment of advanced malignant PEComa and recognized net product sales of
$7.2 million and $18.7 million for the three and nine months ended September 30, 2024, respectively, and $24.4 million and $15.2 million for the years ended December 31, 2023 and 2022, respectively.

FYARRO - Recent Clinical Development

FYARRO in TSC1 and TSC2 inactivating alterations (PRECISION1 Clinical Trial)

PRECISION1 was designed as a registration-directed tumor-agnostic Phase 2 study of
FYARRO in patients with T