On November 5, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and announced financial results for the third quarter ended September 30, 2025.

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"Our third quarter demonstrated exceptional execution across our clinical portfolio," said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. "We completed ECLIPSE 1 enrollment approximately two months ahead of schedule and continue to see strong momentum across ECLIPSE 2 and 3, positioning us well for our hepatitis delta regulatory submissions. We are excited to provide guidance for a comprehensive VIR-5500 data update in the first quarter of 2026, and we recently expanded into first-line prostate cancer with our ARPI combination study. These achievements reflect our team’s commitment to delivering transformative therapies to patients with significant unmet medical needs."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

The ECLIPSE 1 Phase 3 trial has completed enrollment approximately two months ahead of the Company’s internal projections. Primary completion is expected in the fourth quarter of 2026, with topline data expected in the first quarter of 2027. ECLIPSE 1 evaluates the combination of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or in other regions where its use is limited.
The ECLIPSE 2 Phase 3 trial continues enrolling well, and topline data are expected in the first quarter of 2027. ECLIPSE 2 evaluates the switch to the combination of tobevibart and elebsiran in participants who have not achieved undetectable hepatitis delta virus RNA with bulevirtide treatment.
The ECLIPSE 3 Phase 2b trial is progressing ahead of schedule with strong enrollment momentum, and topline data are expected in the first quarter of 2027. ECLIPSE 3 evaluates the combination of tobevibart and elebsiran compared to bulevirtide monotherapy in bulevirtide treatment-naïve participants.
Following positive data presented at American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2024, the Company will present Week 48 endpoint results from its SOLSTICE Phase 2 clinical study, in patients with CHD at AASLD The Liver Meeting 2025. The oral presentation will take place on Sunday, November 9.
Solid Tumors

VIR-5500, a PRO-XTEN dual-masked T-cell engager (TCE) targeting prostate-specific membrane antigen (PSMA), continues to advance through Phase 1 dose escalation as a monotherapy in heavily pre-treated patients with metastatic castration-resistant prostate cancer (mCRPC) and has demonstrated promising early anti-tumor activity and a favorable safety profile.
First patient dosed in Phase 1 clinical study of VIR-5500 in combination with ARPIs in first-line mCRPC.
The Company plans to share a comprehensive VIR-5500 data update in late-line patients in the first quarter of 2026.
VIR-5818, a PRO-XTEN dual-masked TCE targeting HER2, continues in a Phase 1 dose escalation study in combination with pembrolizumab.
VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development and is being evaluated in multiple tumor types, including metastatic colorectal cancer (CRC).
VIR-5525, a PRO-XTEN dual-masked TCE targeting EGFR, continues enrollment in the Phase 1 trial as expected.
VIR-5525 leverages learnings from VIR-5500 and VIR-5818 and is being evaluated in a variety of EGFR-expressing solid tumors in areas of high unmet need, such as non-small cell lung cancer, CRC, head and neck squamous cell carcinoma, and cutaneous squamous cell carcinoma.
Preclinical Pipeline Candidates

Harnessing the Company’s deep immune system expertise combined with its discovery and engineering platform and proprietary dAIsY (data AI structure and antibody) AI engine, the Company continues to advance multiple undisclosed PRO-XTEN masked TCEs directed toward validated targets with potential application across a number of solid tumors.
Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2025, the Company had $810.7 million in cash, cash equivalents and investments, representing a decrease of approximately $81.4 million during the third quarter of 2025.

Revenues: Total revenues for the third quarter of 2025 were $0.2 million compared to $2.4 million for the same period in 2024.

Cost of Revenue: The change in cost of revenue for the third quarter of 2025 compared to the same period in 2024 was nominal.

Research and Development Expenses (R&D): R&D expenses for the third quarter of 2025 were $151.5 million, which included $5.5 million of non-cash stock-based compensation expense, and $75.0 million of milestone payments paid from restricted cash, compared to $195.2 million for the same period in 2024, which included $8.9 million of non-cash stock-based compensation expense and $102.8 million of license expenses. The decrease was primarily driven by lower license expenses and cost savings from previously announced restructuring initiatives, partially offset by higher clinical expenses from our ECLIPSE registrational program for CHD and progression of our oncology programs.

The $75.0 million milestone payment to former shareholders of Amunix Pharmaceuticals, Inc. was triggered by VIR-5525 achieving first-in-human dosing and was paid from restricted cash held in escrow since the execution of the license agreement with Sanofi S.A. (Sanofi), therefore having no impact on our reported cash position or runway. The prior year license expenses were primarily due to the recognition of the $102.8 million Sanofi upfront payment as in-process research and development expense in the third quarter of 2024.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the third quarter of 2025 were $22.2 million, which included $5.8 million of non-cash stock-based compensation expense, compared to $25.7 million for the same period in 2024, which included $7.8 million of non-cash stock-based compensation expense. The decrease was largely due to efficiencies and cost savings from previously announced restructuring initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges, Net: The Company incurred no restructuring, long-lived assets impairment and related charges, net for the third quarter of 2025 compared to $12.7 million for the same period in 2024. The decrease was due to the fact that our restructuring initiatives implemented in prior years were substantially completed by the end of 2024.

Other Income: Other income for the third quarter of 2025 was $10.5 million compared to $17.8 million for the same period in 2024. The decrease was primarily driven by lower interest income.

Provision for Income Taxes: The provision for income taxes for the third quarter of 2025 was nominal.

Net Loss: Net loss for the third quarter of 2025 was $163.1 million, or $1.17 per share, basic and diluted, compared to a net loss of $213.7 million, or $1.56 per share, basic and diluted for the same period in 2024.

2025 Financial Guidance

Based on current operating plans, the Company expects its cash, cash equivalents and investments to fund operations into mid-2027.

Conference Call

Vir Biotechnology will host a conference call to discuss the third quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on View Source and will be archived for 30 days.

(Press release, Vir Biotechnology, NOV 5, 2025, View Source [SID1234659492])