BioInvent International (BINV) Q3 2026 earnings summary

Executive summary

• BI-1808 is the lead clinical priority, with FDA Fast Track designation for recurrent ovarian cancer and positive Phase 2a data in heavily pretreated platinum-resistant disease.

• A proposed SEK 430m rights issue, with SEK 350m covered by commitments and guarantees, is intended to fund priority programs; successful completion of the covered portion would extend runway to year-end 2027.

• Development focus is BI-1808 first and BI-1206 second, with partnering sought for BI-1206 and further development of BI-1808 planned.

Financial highlights

• Q3 2026 net sales were SEK 10.8m versus SEK 3.3m; net loss was SEK 118.9m versus SEK 129.2m.

• 9M 2026 net sales were SEK 37.0m versus SEK 223.5m; 9M 2025 included SEK 191.0m from XOMA's purchase of future mezagitamab royalty and milestone interests.

• 9M net loss was SEK 361.0m versus SEK 207.1m; operating costs were SEK 403.8m versus SEK 445.5m.

• Q3 total costs were SEK 131.0m versus SEK 137.2m; R&D costs were SEK 115.0m versus SEK 119.5m.

Outlook and guidance

• BI-1808 randomized Part C is planned to start in Q1 2027, with initial data expected in H2 2027; the three-arm study will test 500mg and 1,000mg doses against control with pembrolizumab and weekly paclitaxel, with or without bevacizumab.

• Part C will use the KEYNOTE-B96 patient population; bevacizumab is at investigator discretion and expected in ~70% of patients, with arms balanced for its use.

• Management targets at least 3 months of added PFS and ORR in the high-50% to 60% range; PFS is viewed as the key differentiating endpoint.

• BI-1206 first-line NSCLC and uveal melanoma readouts are expected in H1 2027, following ongoing follow-up and recruitment.

• BI-1808 CTCL dose-optimization data are expected in H1 2027; preparation for a potential pivotal study is planned for H2 2027 and would require a partner.