Vir Biotechnology Q2 FY26 earnings call VIR

Vir Biotechnology completed enrollment across all three registrational ECLIPPS studies for its Hepatitis Delta program (Elapseron and Tobevibart), with top-line data for ECLIPPS 1 expected in Q4 2026 and ECLIPPS 2 and 3 in Q1 2027. The company presented compelling Week 96 results from the Phase II Solstice study at EASL, showing 88% of patients achieving undetectable virus (97% with LOCF analysis) and approximately 90% achieving HBsAg levels below 10 IU/ml with the combination therapy. A formal Type B CMC meeting with the FDA was held in July, and efforts are underway for co-packaging and human factor studies to support at-home administration, aiming for broad regulatory submissions globally.

The company is rapidly advancing its oncology pipeline, particularly with VIR5500, a ProX10 dual-masked PSMA-targeted T-cell engager, in collaboration with Astellas. Following encouraging early data, VIR5500 is now enrolling patients into multiple expansion cohorts for prostate cancer, including monotherapy and combination therapies (e.g., with enzalutamide, docetaxel, darolutamide), with the ambition to initiate Phase 3 registration trials next year. Other T-cell engagers, VIR5818 (HER2-targeted) and VIR5525 (EGFR-targeted), are progressing in Phase 1 studies, with updated data for VIR5818 expected in H2 2026. The platform also has seven preclinical assets, with additional development candidates expected in 2027.

Vir Biotechnology significantly improved its cash position, ending Q2 FY26 with $1.01 billion in cash, cash equivalents, and investments, an increase of $198.5 million from the previous quarter. This was largely driven by $315 million received from Astellas, comprising a $240 million upfront payment and a $75 million equity investment. The company recognized $238.9 million in license and collaboration revenue for the quarter, leading to a net income of $80.1 million compared to a net loss in the prior year. The cash runway is projected into the second half of 2028, supported by over half a billion dollars generated from collaborations and offerings since December 2025.

The recent approval of bulevertide in the US has increased disease awareness, with testing and diagnosis rates reportedly increasing 5 to 10-fold in some European territories post-approval. Expected updates to AASLD guidelines and the implementation of double reflex testing (automatic HDV antibody and RNA testing for HBsAg positive patients) are anticipated to further accelerate patient identification and diagnosis. Management believes their regimen, with its high TND rates, monthly subcutaneous dosing, and potential for at-home administration, is well-positioned to set a new standard of care, addressing limitations of existing therapies like daily administration and treatment fatigue.