Vir Biotechnology (VIR) Status Update summary

Strategic Focus and Pipeline Progress

• Advancing five clinical-stage assets in infectious diseases and oncology, leveraging AI-driven antibody discovery and protein engineering for immune-targeted therapies, with near-term catalysts expected.

• Infectious disease pipeline includes advanced hepatitis delta and B programs, plus preclinical HIV and RSV efforts.

• Oncology expansion includes three dual-masked T-cell engager programs targeting HER2, PSMA, and EGFR in solid tumors.

• Investments are focused on areas with high unmet medical need, with programs in Phase 2 for HDV and CHB and multiple oncology assets in early clinical development.

Hepatitis Delta (HDV) Clinical Update

• SOLSTICE phase 2 trial shows combination of tobevibart and elebsiran achieves high rates of undetectable HDV RNA and ALT normalization, with 64% target not detected at week 36 and 80% at week 60 in the rollover cohort.

• Efficacy and ALT normalization are consistent across cirrhotic and non-cirrhotic patients, with durable responses up to 60 weeks.

• Combination therapy leads to significant reductions in hepatitis B surface antigen, crucial for HDV suppression.

• Safety profile is favorable, with most adverse events mild to moderate, no grade 2 or higher ALT elevations, and no severe treatment-related adverse events or discontinuations.

• Phase 3 ECLIPSE program to start in 1H 2025, with three trials targeting different patient populations and regulatory needs.

Hepatitis B (HBV/CHB) Clinical Update

• MARCH phase 2b study shows promising surface antigen loss in patients with low baseline antigen: 39% in doublet and 46% in triplet arms.

• Anti-HBs antibody development observed in all arms, highest in triplet regimen (63%), suggesting robust immune response.

• Functional cure data (24 weeks off-treatment) expected in Q2 2025.

• Safety profile generally well tolerated; PEG-IFNα-related adverse events were consistent with its known safety profile.