Vir Biotechnology (VIR) TD Cowen 46th Annual Health Care Conference summary

Key clinical data and technology highlights

• VIR-5500 demonstrated strong efficacy in late-stage prostate cancer, with PSA50 at 82%, PSA90 at 53%, and PSA99 at 29%; RECIST ORR was 45% in a heavily pretreated population.

• Safety profile was favorable, with no grade 3 CRS at go-forward dosing and minimal use of prophylactic steroids or anti-IL-6.

• Dual masking technology enables higher dosing and improved safety by activating T-cell engagers only in the tumor microenvironment.

• Early signs of durable responses, with some patients showing 8–12 months of benefit after multiple prior therapies.

• Expansion cohorts will begin next quarter, including monotherapy and combinations, with pivotal trials expected next year.

Strategic partnerships and financial terms

• Astellas partnership enables accelerated development, parallel indication exploration, and a 50/50 US profit split; ex-US royalties and co-promotion option included.

• Deal includes $1.7B in milestones and upfronts, with $240M cash upfront, $75M equity at a premium, and a $20M manufacturing milestone.

• Joint governance structure ensures equal say in development, manufacturing, and commercialization decisions.

• Sanofi receives 20% of certain proceeds from the Astellas deal due to prior licensing terms.

• Cash runway extended to Q2 2028 post-Astellas deal and recent $173M equity raise.

Pipeline and platform development

• Pipeline includes HER2 (VIR-5818) and EGFR (VIR-5525) T-cell engagers, both in Phase I, plus seven preclinical oncology assets using the PRO-XTEN platform.

• HER2 program showed 33% ORR in early metastatic CRC data; further data and plans to be shared in H2 2024.

• EGFR program is dosing in multiple tumor types; data release pending maturity.

• Platform technology validated by VIR-5500 results, supporting rapid advancement of additional candidates.