BioInvent International (BINV) Jefferies London Healthcare Conference 2025 summary

Company overview, platform, and technology

• Integrated operations and the F.I.R.S.T. platform enable rapid discovery and development of novel immuno-oncology therapies, with in-house GMP manufacturing and licensing opportunities.

• Strategic partnerships with major pharma companies, including Merck and AstraZeneca, support clinical development, validation, and deal-making.

• Strong international shareholder base, with a financial runway into Q1 2027 and a cash position of SEK 690M (~$73M) as of September 30, 2025.

• Fast Track and Orphan Drug Designations granted for both lead clinical programs, supporting regulatory pathways.

Clinical development, pipeline, and data highlights

• BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB) are the main clinical-stage assets, both in multiple Phase 2 studies for lymphoma and solid tumors, with data readouts expected in H2 2025 and H1 2026.

• BI-1808 shows exceptional safety and efficacy in CTCL and solid tumors, with over 40% response rate in CTCL and 100% DCR in initial Phase 2a CTCL data.

• BI-1206 demonstrates strong efficacy and safety in NHL, with 59% ORR and 41% CRR in relapsed/refractory FL patients, and 100% DCR in triple combination with rituximab and acalabrutinib.

• Both assets are being tested as single agents and in combination with pembrolizumab or other partner drugs, with combination data expected by year-end and further data in H2 2025 and H2 2026.

• Subcutaneous formulation of BI-1206 offers convenience and safety, with no cytokine release syndrome or neurotoxicity observed.

Commercial strategy, market positioning, and future plans

• Initial focus on quick-to-market opportunities in second-line settings (CTCL for BI-1808, follicular lymphoma for BI-1206), with expansion to first-line and larger solid tumor indications.

• Market opportunities include $500 million for second-line follicular lymphoma and significant potential in ovarian and lung cancers.

• Ongoing and upcoming data releases at major conferences (ASH, EHA) and key readouts expected by end of 2024, mid-2025, and H2 2026.

• Plans to initiate pivotal Phase 2 and confirmatory Phase 3 studies for both assets in 2026–2027, with potential BLA submission and approval timelines from 2026 onward.

• Broad mechanism of action allows for potential expansion into additional cancer indications beyond current focus.