Vir Biotechnology, Inc. Q4 FY2025 earnings call

Marianne De Backer started by discussing the strategic collaboration with Astellas for VIR-5500, highlighting its potential as a best-in-class T cell engager for prostate cancer. Mark Eisner reviewed Phase I clinical data for VIR-5500, noting a favorable safety and efficacy profile with dose-dependent antitumor activity. Dr. Johann de Bono shared case studies illustrating impressive responses. Jason O'Byrne discussed the Astellas collaboration deal terms and financial results, including R&D and SG&A expense reductions. Marianne also mentioned the broader PRO-XTEN platform and future pipeline plans.

Anticipate initiating VIR-5500 dose expansion cohorts in the second quarter of 2026, plan to continue dose optimization in parallel to support Phase III development in 2027. Cash runway extends into the second quarter of 2028 based on current operating plan and agreements.

Forward-looking statements involve substantial risks and uncertainties, including clinical development program outcomes, collaboration outcomes, future results, performance or achievements differing from forward-looking statements. Risks described in company reports filed with SEC, including Forms 10-K, 10-Q and 8-K.

Q: Can you comment on PSA responses by prior line of therapies and probability of success for other T-cell engager programs?

A: Marianne and Mark discussed PSA responses in heavily pretreated patients and validation of PRO-XTEN platform for other programs.

Q: What are next steps before moving to Phase III and plans for dosing schemes?

A: Mark mentioned plans to enter expansion cohorts in Q2, work with Astellas to accelerate development.

Q: How to unlock resources for PRO-XTEN platform and position VIR-5500?

A: Marianne and Mark talked about collaboration helping accelerate VIR-5500 and resourcing other programs, and VIR-5500's position in treatment paradigms.

Q: Thoughts on durability and go-forward dose?

A: Mark discussed confidence in durability and details on go-forward dose.

Q: Go-forward dose in combination and potential for flat dose?

A: Mark addressed go-forward dose in combination and no current plan for flat dose.

Q: Impact on rest of oncology pipeline and read-through for VIR-5500 in earlier lines?

A: Marianne and Mark talked about strategic partnership and potential in earlier lines.

Q: Co-promotion option in U.S. and confidence in frontline potential?

A: Marianne discussed co-promotion option timeline and Mark talked about frontline potential.

Q: Higher end dose escalation and partnership combination strategy?

A: Marianne and Mark discussed dose escalation limits and partnership combination strategy.

Q: Durability data and RECIST evaluability?

A: Mark discussed durability data availability and RECIST evaluability in patients.