Duality Biotherapeutics (DualityBio, 09606) reported audited results for the year to 31 December 2025:
Financial performance • Revenue slipped 4.60 % to RMB 1.85 billion, reflecting lower milestone receipts. • Gross margin narrowed to 31.8 % (2024: 40.4 %), as reimbursable R&D made up a larger sales mix. • R&D expenditure was broadly flat at RMB 0.84 billion, while administrative costs rose 35.20 % to RMB 0.21 billion on head-count expansion and listing expenses. • Statutory net loss widened to RMB 2.59 billion (2024: RMB 1.05 billion) after a RMB 2.21 billion non-cash fair-value loss on pre-IPO preferred shares. Excluding this item, adjusted loss increased to RMB 0.39 billion (2024: RMB 0.18 billion). • Operating loss before fair-value movements was RMB 0.49 billion versus RMB 0.19 billion a year earlier. • Finance income more than doubled to RMB 0.10 billion on higher cash balances.
Balance-sheet highlights • Cash, cash equivalents, restricted cash and term deposits rose to RMB 3.32 billion, bolstered by April 2025’s HK$1.75 billion IPO. • Total equity turned positive at RMB 2.43 billion (2024: negative RMB 2.02 billion) following conversion of preferred shares at listing. • Current ratio improved to 3.6 from 0.5.
Cash flow • Operating activities generated RMB 0.19 billion. • Investing outflow reached RMB 1.91 billion, mainly placement of longer-dated deposits. • Financing inflow of RMB 1.81 billion reflected IPO proceeds.
Use of IPO proceeds As at year-end, DualityBio had deployed HK$689.90 million (39 % of net proceeds), primarily to fund phase-3 trials for trastuzumab pamirtecan (DB-1303/BNT323) and DB-1311/BNT324, other key ADC programs, and platform expansion. The remainder is earmarked for ongoing R&D, commercialization preparation and working capital over the next two to four years.
Clinical and regulatory milestones • Trastuzumab pamirtecan met its primary PFS endpoint versus T-DM1 in a China phase-3 breast-cancer study; a BLA has been filed with the NMPA. • DB-1311 showed a median rPFS of 11.3 months and median OS of 22.5 months in heavily pre-treated metastatic castration-resistant prostate-cancer patients; global phase-3 initiation is planned for 2026. • DB-1310 received two U.S. FDA Fast Track designations (EGFR-mutant NSCLC; HR+/HER2- breast cancer) and posted a 55.6 % unconfirmed ORR in late-line HR+/HER2- breast cancer. • Ten antibody-drug conjugates are in clinical development, with more than 3,200 patients enrolled to date; next-generation platforms (BsADC, immune-modulating ADC and novel payloads) progressed into early-stage trials.
Outlook Management expects to fund operations for at least the next 12 months with existing liquidity and continues to prioritise late-stage development and China launch preparations for trastuzumab pamirtecan, alongside global advancement of key ADC assets through partnerships with BioNTech, GSK, Avenzo and others.
No final dividend was proposed for 2025.
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