Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 284

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 284
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 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 TSC1and 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