Vir Biotechnology (VIR) investor relations material

Key accomplishments and clinical progress

• Advanced three clinical-stage T cell engagers and a registration program for hepatitis delta, with significant milestones in 2025.

• Reported promising early data on masked T cell engagers Vir-5500 (PSMA) and Vir-5818 (HER2) in January.

• Opened a new cohort for Vir-5500 in combination with ARPIs for first-line mCRPC, expanding beyond late-line patients.

• Dosed first patient in phase 1 for EGFR T cell engager program in July.

• Achieved transformative 48-week phase 2 data in hepatitis delta, with 66% of patients virus-free, and completed Eclipse 1 enrollment ahead of schedule.

Differentiation and technology platform

• Dual-masked T cell engager technology (Xtend mask) provides safety and efficacy by activating only in the tumor microenvironment.

• Xtend masks extend half-life to 8–10 days, enabling less frequent dosing and rapid clearance post-activation.

• Platform validated by marketed drug Altuvio, supporting safety and scalability.

• Both masks must be cleaved for activity, confirmed by preclinical and clinical data showing efficacy and safety.

• Early clinical data show 58% PSA50 and 8% PSA90 responses with low, sub-grade 2 CRS rates.

Upcoming data and future outlook

• Next Vir-5500 update in Q1 will include safety, efficacy (PSA, RECIST), dose response, and durability in late-line monotherapy; combination data not yet mature.

• Differentiation from competitors (e.g., JANX) highlighted by dual masking, longer half-life, and potential for less frequent dosing.

• Vir-5500 could be used pre- or post-Pluvicto, aiming for strong efficacy and safety to enable outpatient and combination regimens.

• Hepatitis delta program seen as transformative by KOLs, with strong demand and rapid trial enrollment.

• Anticipated product presentation for hepatitis delta: two subcutaneous injections, with at-home or in-clinic administration flexibility.