Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 253

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 253
---
 discussed throughout this document.

Overview

We are a precision oncology company making bold
choices in applying technology to efficiently deliver improved therapies for people living with difficult-to-treat cancers. We have deep experience in chemistry, formulation, and drug delivery, as well as research, clinical, and commercial
pharmaceutical development, successfully taking product candidates from the clinic to approval, launch, and commercialization. Our lead drug product, FYARRO (sirolimus protein-bound particles
for injectable suspension (albumin-bound); nab-sirolimus), combines two established technologies - nanoparticle albumin-bound (nab) technology and the
anti-cancer agent, sirolimus. Nab-sirolimus is a potent inhibitor of the mTOR biological pathway with demonstrated anti-cancer activity in our lead indication, advanced malignant perivascular
epithelioid cell tumor (“PEComa”), a rare cancer. We exclusively license 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 November 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”). 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. See “Results of Consolidated Operations” for further discussion of our results.

We recently
entered into the License Agreement, an intellectual property license agreement with WuXi Biologics, for the development and global commercialization of a portfolio of three next generation antibody drug conjugates (ADCs) targeting clinically
validated, broadly overexpressed tumor antigens in high potential

- 179 -

cancer indications with significant unmet need. The License Agreement is described further below. These ADCs are constructed utilizing an advanced linker-payload platform called CPT113 that has been shown to provide high stability in blood circulation and deliver targeted release of a Topoisomerase I (TOPO1)