Duality Biotherapeutics (9606) H1 2026 earnings summary

Executive summary

• Achieved first BLA acceptance for trastuzumab pamirtecan (HER2 ADC) in China and initiated first global Phase 3 trial for elfetabart drozuntecan (B7-H3 ADC), which also received Breakthrough Therapy Designation.

• Expanded global clinical network to 20 countries with over 3,500 patients enrolled, about half outside China.

• Entered new global R&D collaboration with Genentech for next-generation ADCs, with potential milestone payments exceeding US$1 billion and total partnership value over US$7 billion.

• Exercised exclusive cost and profit/loss sharing option for elfetabart drozuntecan in the U.S. market.

• Embarked on dual-capital-market strategy with A-share listing application accepted by Shanghai Stock Exchange.

Financial highlights

• Revenue for H1 2026 was RMB219.3 million, down from RMB1,228.9 million in H1 2025, mainly due to a one-off revenue deduction of RMB290.7 million from the U.S. profit/loss sharing option and lower milestone payments.

• Gross loss of RMB233.4 million (gross margin -106.4%) versus gross profit of RMB589.4 million (margin 48.0%) in H1 2025.

• R&D expenses increased to RMB606.7 million from RMB349.4 million year-over-year, reflecting expanded clinical activity and staff costs.

• Administrative expenses decreased to RMB81.5 million from RMB125.5 million.

• Loss for the period narrowed to RMB917.5 million from RMB2,073.9 million, mainly due to the absence of prior year’s fair value loss on financial liabilities; adjusted loss (non-HKFRS) for H1 2026 was RMB626.9 million.

• Cash and bank balances stood at RMB3,324.5 million as of June 30, 2026.

Outlook and guidance

• Interim data from the global Phase 3 trial of trastuzumab pamirtecan in breast cancer expected in Q4 2026.

• Initial commercialization of trastuzumab pamirtecan in China anticipated in 2027, pending regulatory approval.

• Elfetabart drozuntecan expected to reach commercialization by 2031, subject to trial outcomes and approvals.

• Sufficient funds available to meet working capital and capital expenditure needs for the remainder of 2026.

• Plans to utilize remaining IPO proceeds within three years, focusing on clinical trials, commercialization, and platform development.