Whitehawk Therapeutics, Inc. (NASDAQ: WHWK)

Whitehawk Therapeutics, Inc. is a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to deliver improved cancer treatments. The company focuses on the development and potential commercialization of next-generation antibody-drug conjugates (ADCs) targeting clinically validated tumor antigens. Its core activities involve leveraging deep expertise in chemistry, formulation, drug delivery, and clinical development to advance product candidates from preclinical research through clinical trials and toward regulatory approval.

Whitehawk Therapeutics generates revenue primarily through the potential future commercialization of its ADC Therapies, which are designed to treat solid tumors with high unmet medical need. The company does not currently generate product revenue from its pipeline assets, as all candidates remain in clinical development. Historically, the company derived revenue from the sale of FYARRO® (nab-sirolimus) for the treatment of advanced malignant PEComa, but this business was divested in March 2025, and Whitehawk no longer operates the FYARRO Business.

The company operates through the following segments: ADC Therapies and Legacy FYARRO Business.

• ADC Therapies: This segment encompasses the development and planned commercialization of three next-generation antibody-drug conjugates targeting PTK7, MUC16, and SEZ6. These product candidates are designated as HWK-007, HWK-016, and HWK-206, respectively. Each utilizes the CPT113 linker-payload platform from Hangzhou DAC, which delivers a Topoisomerase I inhibitor payload with enhanced stability and controlled release.

• Legacy FYARRO Business: This segment historically involved the development, production, and commercial sale of FYARRO® (sirolimus protein-bound particles for injectable suspension), an albumin-bound formulation of sirolimus. FYARRO® combines nanoparticle albumin-bound (nab) technology with the mTOR inhibitor sirolimus. The product was launched in the United States in February 2022 for the treatment of advanced malignant PEComa, a rare cancer, prior to its divestiture to KAKEN in March 2025.

Whitehawk Therapeutics positions itself as an innovator in the next-generation ADC space, leveraging a differentiated linker-payload platform to address limitations of first-generation ADCs such as payload instability and narrow therapeutic index. The company competes with other biotechnology and pharmaceutical firms developing ADCs, including AbbVie, Daiichi Sankyo, Eli Lilly, Kelun Biotech, Mersana, Roche, and Ideaya Biosciences, among others. Its competitive advantages stem from the CPT113 platform’s carbon bridge cysteine re-pairing technology, which enhances antibody stability, reduces free payload circulation, and improves safety margins compared to conventional TOP1-based ADCs.

The company serves patients with advanced or metastatic solid tumors, particularly those expressing PTK7, MUC16, or SEZ6, including non-small cell lung cancer, ovarian cancer, endometrial cancer, and small cell lung cancer. Whitehawk Therapeutics does not currently disclose specific customer names, as its products are not yet commercially available and remain in clinical development. Future customers are expected to include hospitals, oncology clinics, and healthcare providers administering cancer therapies.