Strong BI-1808 clinical efficacy in ovarian cancer (combo with pembrolizumab)
Phase IIa combination data in recurrent ovarian cancer: 24% overall response rate (ORR) and 57% disease control rate (DCR) with 21 evaluable ovarian cancer patients; dataset maturing with additional partial response and conversion of stable disease to PR, and a favorable safety profile.
Robust BI-1808 single-agent activity in T‑cell lymphoma (CTCL)
Monotherapy data in CTCL: 46% ORR and 92% DCR in 13 evaluable CTCL patients, with durable responses (including a complete response in Sézary Syndrome lasting >1 year); EMA orphan drug designation granted for BI-1808 in CTCL.
BI-1206 triplet shows high activity in non-Hodgkin lymphoma
Triplet (BI-1206 + rituximab + acalabrutinib) across follicular, marginal zone and mantle cell lymphoma: maintained ~80% ORR and 100% disease control rate; incremental 4 partial responses and 1 additional stable disease vs prior dataset, demonstrating activity across subtypes and encouraging duration.
Promising solid tumor signals for BI-1206 and advancement to first-line studies
Dose-escalation signals in PD-1/PD-L1 refractory solid tumors (complete and partial responses) supported opening a Phase IIa first-line program with pembrolizumab in non‑small cell lung cancer (NSCLC) and uveal melanoma; first readout expected H2 2026.
Strategic collaborations with large pharma
Supply and collaboration agreements in place with Merck (pembrolizumab combinations) and AstraZeneca (acalabrutinib supply for NHL), enabling first-line combination studies and providing strong external validation for programs.
Dense forward-looking clinical milestone timetable
Multiple near-term catalysts: additional BI-1808 combo and monotherapy Phase IIa readouts mid/late 2026; BI-1206 NHL update mid-2026; first-line BI-1206+KEYTRUDA readout H2 2026; potential pivotal starts in 2027 contingent on data.
Board strengthening and scientific depth
Two experienced board nominees (Kate Hermans, Scott Zinober) and publication of mechanistic/preclinical work that deepens scientific credibility and supports partnering discussions.
Improved full-year net sales (driven by one-time items) and short-term liquidity
Net sales for Jan–Dec 2025 were SEK 226 million vs SEK 45 million in 2024 (increase of SEK 181 million, ~+402%), driven mainly by a SEK 20 million payment (XOMA Royalty transaction) and a SEK 1 million milestone; liquid funds and current investments SEK 593 million at 31 Dec 2025 and company assessed as financed for the coming 12 months.