On August 6, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and provided financial results for the second quarter ended June 30, 2025 (Press release, Vir Biotechnology, AUG 6, 2025, View Source [SID1234654891]).

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"We achieved several important milestones across our pipeline, reflecting our commitment to our mission of powering the immune system to transform lives," said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. "The initiation of our Phase 1 study of PRO-XTEN dual-masked VIR-5525 positions us to potentially address the shortcomings of available treatment options across multiple EGFR-expressing solid tumors. The universal PRO-XTEN masking technology represents a next-generation approach to cancer treatment, designed to expand the therapeutic index of T-cell engagers. We now have three clinical trials of PRO-XTEN masked T-cell engagers ongoing, supported by promising early clinical data for VIR-5818 and VIR-5500, and we are leveraging insights from our ongoing programs to efficiently execute clinical trials and expand our oncology portfolio. Additionally, our ECLIPSE registrational program is now fully underway, and we are advancing toward a potentially highly effective, well-tolerated and convenient treatment option for patients with chronic hepatitis delta."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

ECLIPSE registrational program is fully underway following enrollment of the first patients in ECLIPSE 2 and ECLIPSE 3.
ECLIPSE 2 will compare the combination of tobevibart and elebsiran to continued bulevirtide monotherapy in participants with CHD who have not achieved undetectable hepatitis delta virus RNA despite bulevirtide treatment.
ECLIPSE 3 will compare the combination of tobevibart and elebsiran to bulevirtide monotherapy in participants with CHD who have not received bulevirtide before.
ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, including agencies in the U.S. and Europe. ECLIPSE 3 is expected to provide important supportive data to help establish access and reimbursement in key markets.
Solid Tumors

First patient dosed in the Phase 1 clinical study of VIR-5525, the Company’s investigational PRO-XTEN dual-masked T-cell engager (TCE) targeting EGFR.
VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma and cutaneous squamous cell carcinoma.
The Company’s Phase 1 clinical trial of PRO-XTEN masked VIR-5818 evaluates the TCE in multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer.
VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development.
The Company has completed monotherapy dose escalation and is analyzing the data while continuing to dose escalate VIR-5818 in combination with pembrolizumab.
VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, continues to advance through dose escalation.
The Company received Investigational New Drug clearance from the U.S. Food and Drug Administration to evaluate VIR-5500 in combination with androgen receptor pathway inhibitors for earlier lines of metastatic castration-resistant prostate cancer treatment, unlocking new opportunities to transform patient lives.
Early Phase 1 data for VIR-5818 and VIR-5500 reported in January 2025 showed promising safety profiles for both clinical candidates, with maximum tolerated dose not yet reached, no dose-limiting cytokine release syndrome (CRS) observed and no CRS greater than grade 2 reported.
Initial clinical data demonstrate the PRO-XTEN masking technology’s potential to minimize systemic toxicity while enabling selective killing of cancer cells in the tumor microenvironment, minimizing CRS and expanding the therapeutic index compared to traditional therapeutic approaches.
Preclinical Pipeline Candidates

Leveraging its immune system expertise and platform strengths, the Company continues to progress multiple undisclosed PRO-XTEN dual-masked TCEs against clinically validated targets with potential applications across a number of solid tumors. These preclinical candidates integrate the PRO-XTEN masking technology with novel TCEs discovered and engineered using the Company’s antibody discovery platform and proprietary dAIsY (data AI structure and antibody) AI engine.
The Company is advancing its broadly neutralizing antibody development candidate for the treatment of HIV in collaboration with the Gates Foundation.
Second Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2025, the Company had $892.1 million in cash, cash equivalents and investments, representing a decrease of approximately $127.7 million during the second quarter of 2025. The current quarter decrease includes $50.5 million in milestone payments related to the initiation of the ECLIPSE Phase 3 registrational program, which were previously expensed in prior quarters.

In addition to the $892.1 million in cash, cash equivalents and investments, the Company had $95.2 million in restricted cash and cash equivalents as of June 30, 2025. This included a $75.0 million milestone payment due to the former shareholders of Amunix Pharmaceuticals, Inc., upon VIR-5525 achieving "first in human dosing," which occurred in July 2025.

Revenues: Total revenues for the second quarter of 2025 were $1.2 million compared to $3.1 million for the same period in 2024.

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

Research and Development Expenses (R&D): R&D expenses for the second quarter of 2025 were $97.5 million, which included $6.9 million of non-cash stock-based compensation expense, compared to $105.1 million for the same period in 2024, which included $13.1 million of non-cash stock-based compensation expense. The decrease was primarily driven by cost savings from previously announced restructuring initiatives, partially offset by higher clinical expenses from the initiation of our ECLIPSE registrational program for CHD, progression of our oncology programs and an increase in the fair value of contingent payment obligations for our CHD program.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the second quarter of 2025 were $22.3 million, which included $5.5 million of non-cash stock-based compensation expense, compared to $30.3 million for the same period in 2024, which included $9.1 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: Restructuring, long-lived assets impairment and related charges, net for the second quarter of 2025 was $(0.2) million compared to $26.3 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 second quarter of 2025 was $7.6 million compared to $18.7 million for the same period in 2024. The decrease was primarily driven by lower interest income.

(Provision for) Benefit from Income Taxes: The provision for income taxes for the second quarter of 2025 was nominal.

Net Loss: Net loss for the second quarter of 2025 was $111.0 million, or $0.80 per share, basic and diluted, compared to a net loss of $138.4 million, or $1.02 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 second 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.

About VIR-5818, VIR-5500, VIR-5525

VIR-5818, VIR-5500 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the PRO-XTEN masking technology with three different T-cell engagers (TCEs) targeting HER2, PSMA and EGFR, respectively.

TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.

About Tobevibart and Elebsiran

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.