Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 72

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 72
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 Kaken the termination fee of $3.5 million.

Background of the Divestiture

In an effort to enhance stockholder value, Aadi’s board of directors and management regularly review and discuss its near and long-term operating and
strategic priorities. Among other things, these reviews and discussions focus on the opportunities and risks associated with Aadi’s development programs, financial condition, and its strategic relationships and potential long-term strategic
options.

In the fourth quarter of 2021, the U.S. Food and Drug Administration (the “FDA”) approved FYARRO sirolimus protein-bound particles for
injectable suspension (albumin-bound) for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (“PEComa”), a rare cancer. Aadi exclusively licenses FYARRO
(previously called ABI-009, nab-sirolimus), from Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of
Bristol-Myers Squibb Company (“BMS”). In the first quarter of 2022, Aadi launched FYARRO in the United States for the 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, and $18.7 million for the nine months ended September 30, 2024. Also in the first quarter of 2022, Aadi initiated a registration-directed tumor-agnostic Phase 2 study
(“PRECISION1”) of FYARRO in patients with Tuberous Sclerosis Complex 1 and 2 (“TSC1” & “TSC2”) alterations.

In the
third quarter of 2023, Aadi expanded its FYARRO pipeline through the further investigation of mTOR pathway inhibition in endometrial cancer and neuroendocrine tumors (NETs). Aadi initiated 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 endometrioid-type endometrial cancer (EEC) and 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,