Whitehawk reports Q3 2026 results, starts Phase 1 trial of HWK-206 with Fast Track tag

Whitehawk Therapeutics said it started the Phase 1 clinical trial of HWK-206 in the U.S. and received Fast Track designation from the FDA.¹ The company said this made HWK-206 the third of its original ADC programs to reach clinical development within the past 12 months.¹

HWK-206 is described as a biparatopic antibody drug conjugate targeting SEZ6 that uses the same TOP1i-linker payload found in Whitehawk's first two clinical programs.¹ The program is initially aimed at small-cell lung cancer and other neuroendocrine tumors.¹ Dosing in the new study follows a plan Whitehawk calls an accelerated sequence of dose levels starting at 3 mg/kg, based on experience from the HWK-007 and HWK-016 programs, with the initial escalation phase focused on small-cell lung cancer patients so the drug can be measured against existing clinical benchmarks.¹ Whitehawk said initial Phase 1 data from HWK-206 is expected by year-end 2027.¹

Separately, the company said it filed an IND application for HWK-206 in China and expects to open its first clinical sites there in the first quarter of 2027.¹ For its two lead programs, Whitehawk said it is continuing to dose-escalate patients in the Phase 1 studies of HWK-007 and HWK-016 and remains on track to report initial data in the first half of 2027.¹

On financials, Whitehawk reported cash, cash equivalents and short-term investments of $169.7 million as of September 30, 2026, compared with $145.7 million at the end of 2025.¹ The company said this level of cash is expected to fund operations into the second half of 2028 based on current plans.¹