Company: WHWK
Filing Date: 2025-04-25
Form Type: 424B5
Source: 0001193125-25-097064
Chunk: 21

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-04-25
Form: 424B5
Chunk 21
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 exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. On November 22, 2021, the U.S. Food and Drug Administration approved FYARRO sirolimus protein-bound particles for injectable suspension (albumin-bound) for the treatment of adult patients with locally advanced unresectable or metastatic 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 $24.4 million and $15.2 million for the years ended December 31, 2023 and 2022, respectively. In addition to advanced malignant PEComa, based on exploratory data from the completed Phase 2 registrational study, Advanced Malignant PEComa Trial (“AMPECT”) and data for FYARRO in other solid tumors with TSC1 and TSC2 inactivating alterations, we initiated a registration-directed tumor-agnostic Phase 2 study (“PRECISION1”) of FYARRO in patients with Tuberous Sclerosis Complex 1 (“ TSC1”) and Tuberous Sclerosis Complex 2 (“ TSC2”) alterations. The PRECISION1 trial was opened for enrollment in the United States during the first quarter of 2022, with dosing of our first patient 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. With respect to the efficacy of nab-sirolimusin patients with tumors harboring pathogenic inactivating alteration in TSC1, of the 22 patients enrolled, 19 patients received ≥ 1 post baseline scan and were evaluable for efficacy. Observations included:

| • |     | A 26% Overall Response Rate (ORR) including 5 partial responses (PR) with 4 confirmed responses and 1 unconfirmed 
 response (uPR). The patient with uPR remains on treatment and is awaiting a confirmatory scan                     |

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