Vir Biotechnology (Nasdaq: VIR) announced its third-quarter 2024 financial results and provided a corporate update, highlighting a transformational quarter marked by a strategic shift towards oncology and infectious diseases with high unmet needs. The company closed an exclusive worldwide licensing agreement with Sanofi for three clinical-stage dual-masked T-cell engagers, bolstering its pipeline in solid tumors. Simultaneously, Vir is advancing its hepatitis programs, with promising data emerging from the Phase 2 SOLSTICE trial in chronic hepatitis delta.
Financial Overview
For Q3 2024, Vir Biotechnology reported a net loss of $213.7 million, or $1.56 per share, compared to a net loss of $163.4 million, or $1.22 per share, for the same period in 2023. Total revenues were $2.4 million, a slight decrease from $2.6 million year-over-year. Despite the losses, the company maintains a strong cash position with $1.19 billion in cash, cash equivalents, and investments as of September 30, 2024.
Strategic Shift and Pipeline Development
The licensing agreement with Sanofi marks a significant pivot for Vir, providing access to three dual-masked T-cell engagers (TCEs) targeting HER2, PSMA, and EGFR. These TCEs, designated VIR-5818, VIR-5500, and VIR-5525, are designed to minimize off-tumor toxicity and enhance efficacy in treating various solid tumors. Initial clinical data for VIR-5818 and VIR-5500 are expected in the first quarter of 2025.
In parallel, Vir is making strides in its hepatitis programs. Preliminary data from the Phase 2 SOLSTICE study in chronic hepatitis delta demonstrated high rates of virologic response and ALT normalization with tobevibart, both as a monotherapy and in combination with elebsiran. The combination therapy has received Fast Track Designation from the U.S. FDA, expediting its development for patients with this severe liver disease. Additional data from the SOLSTICE trial will be presented at the upcoming AASLD meeting in November 2024.
Corporate Restructuring and Future Outlook
To streamline operations and prioritize its clinical-stage pipeline, Vir Biotechnology has implemented a strategic restructuring, reducing its workforce by approximately 25%. This move is intended to optimize capital allocation and focus resources on the most promising therapeutic areas. The company has updated its GAAP operating expense guidance to $660-680 million for 2024, which includes the upfront in-process research and development expense associated with the Sanofi agreement.
"This quarter was transformational for Vir," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer of Vir Biotechnology. "We have bolstered our clinical pipeline with three potential best-in-class dual-masked T-cell engagers in oncology and have sharpened our focus within infectious diseases to the areas where we believe we can make the most significant impact for patients."
Looking ahead, Vir Biotechnology anticipates critical data readouts from its hepatitis programs in the fourth quarter of 2024 and initial clinical data from its dual-masked T-cell engagers in the first quarter of 2025. The company will host investor events to provide detailed updates on these programs.
