WHWK

Business Context and Reporting Period

Company: Whitehawk Therapeutics, Inc. (formerly Aadi Bioscience, Inc.)
Filing Type: Form 10-K (Annual Report)
Period Ended: December 31, 2025
Business Overview: Whitehawk is a clinical-stage oncology therapeutics company. In March 2025, the company completed the divestiture of its legacy FYARRO business to KAKEN Investments Inc. for $102.4 million. The company has pivoted to a new pipeline consisting of three in-licensed next-generation antibody-drug conjugates (ADCs) targeting PTK7, MUC16, and SEZ6, acquired via a license agreement with WuXi Biologics in late 2024.

Key Financial Metrics

Note: The 2025 Net Loss includes a non-cash gain on the sale of the FYARRO business of $87.3 million. Without this gain, the operating loss was significantly higher.

Material Changes vs. Prior Period

• Divestiture of FYARRO: The company sold its FYARRO business on March 25, 2025, resulting in a one-time gain of $87.3 million. Consequently, revenue from product sales ceased after the divestiture date, dropping from $26.0 million in 2024 to $7.1 million in 2025.
• Strategic Pivot to ADCs: The company entered a license agreement with WuXi Biologics for three ADC therapies. This drove a significant increase in R&D expenses ($40.0 million increase year-over-year), primarily due to a $38.0 million upfront license fee and $5.0 million in milestone expenses.
• Liquidity Position: Cash and short-term investments increased significantly to $145.7 million, bolstered by the $102.4 million divestiture proceeds and a $94.4 million PIPE financing completed in March 2025.
• Expense Reduction: SG&A expenses decreased by $6.9 million due to the divestiture, which eliminated commercial and marketing costs associated with FYARRO.

Guidance, Outlook, and Risks

Outlook and Guidance:

• Cash Runway: Management believes existing cash, cash equivalents, and short-term investments ($145.7 million) are sufficient to fund planned operations into 2028.
• Clinical Milestones:
  • HWK-007 (PTK7) & HWK-016 (MUC16): IND applications cleared by the FDA in Q4 2025; Phase 1 trials are actively recruiting. Data readouts expected in the first half of 2027.
  • HWK-206 (SEZ6): IND submission anticipated in mid-2026.

Key Risks and Contingencies:

• Capital Requirements: The company expects to continue incurring significant net losses and will require additional capital to complete development and commercialization of the ADC portfolio.
• Regulatory Approval: Success depends on obtaining FDA approval for the ADC Therapies, which are currently in early clinical development.
• Third-Party Reliance: The company relies on WuXi Biologics and Hangzhou DAC (both based in China) for manufacturing and technology, exposing the business to geopolitical risks and supply chain disruptions.
• Intellectual Property: The business model relies heavily on in-licensed IP; termination of the WuXi license would be catastrophic.

Investor Verification Checklist

• Divestiture Accounting: Verify the classification of the $87.3 million gain on the sale of FYARRO and confirm it is treated as a non-recurring item.
• License Agreement Terms: Review the specific development and commercial milestone obligations (up to $805 million total) owed to WuXi Biologics under the ADC license.
• Cash Burn Rate: Assess the projected cash burn rate for the ADC programs to validate the "into 2028" runway estimate.
• Manufacturing Dependencies: Evaluate the risks associated with reliance on Chinese-based contract manufacturers (WuXi/Hangzhou DAC) in the context of current U.S.-China trade relations and the BIOSECURE Act.
• Pre-Funded Warrants: Confirm the status and dilution impact of the 20,076,500 pre-funded warrants outstanding from the 2024 PIPE financing.