Vir(VIR) - 2025 Q2 - Quarterly Results

Corporate Update and Financial Highlights Executive Summary Vir Biotechnology reported significant progress in its clinical pipeline during Q2 2025, including the full initiation of the ECLIPSE registrational program for chronic hepatitis delta and the dosing of the first patient in a Phase 1 study for its oncology candidate, VIR-5525. The company maintains a strong financial position with $892.1 million in cash and investments, providing a projected operational runway into mid-2027 - The ECLIPSE registrational program for chronic hepatitis delta is now fully underway[1] - The company has initiated a Phase 1 study for VIR-5525, an EGFR-targeting T-cell engager for solid tumors, marking the third ongoing Phase 1 study in its oncology pipeline[1][2] Key Financial Metrics | Metric | Value | | :--- | :--- | | Cash and Investments (as of June 30, 2025) | $892.1 million | | Financial Runway | Into mid-2027 | - CEO Marianne De Backer highlighted the advancement of the PRO-XTEN™ dual-masked T-cell engager platform, which aims to expand the therapeutic index and address shortcomings of existing cancer treatments[2] Pipeline Programs Chronic Hepatitis Delta (CHD) The ECLIPSE registrational program for Chronic Hepatitis Delta (CHD) is now fully active, with patient enrollment initiated in the ECLIPSE 2 and ECLIPSE 3 trials. These studies are evaluating the combination of tobevibart and elebsiran against bulevirtide monotherapy in different patient populations. The program is designed to generate efficacy and safety data for global regulatory submissions and to support market access - The ECLIPSE registrational program is fully underway with the enrollment of the first patients in the ECLIPSE 2 and ECLIPSE 3 trials[3] - ECLIPSE 2 will assess the combination therapy in patients who have not responded to bulevirtide treatment, while ECLIPSE 3 will evaluate it in patients new to bulevirtide[3] - The program is structured to provide registrational data for US and European agencies (ECLIPSE 1 & 2) and supportive data for reimbursement in key markets (ECLIPSE 3)[3] Solid Tumors The company's oncology pipeline, centered on the PRO-XTEN™ dual-masked T-cell engager (TCE) platform, has advanced with the first patient dosed in the Phase 1 study of VIR-5525 (EGFR-targeting). Progress continues in the Phase 1 trials for VIR-5818 (HER2-targeting) and VIR-5500 (PSMA-targeting), with early data showing promising safety profiles and no dose-limiting toxicities. The platform is designed to minimize systemic toxicity while enabling selective cancer cell killing - First patient dosed in the Phase 1 study of VIR-5525, a PRO-XTEN™ dual-masked TCE targeting EGFR for various solid tumors like non-small cell lung cancer and colorectal cancer[7] - The Phase 1 trial of VIR-5818 (HER2-targeting) has completed monotherapy dose escalation and is now evaluating the candidate in combination with pembrolizumab[7] - VIR-5500 (PSMA-targeting) received FDA clearance to be evaluated in combination with androgen receptor pathway inhibitors for earlier lines of prostate cancer[7] - Early Phase 1 data for both VIR-5818 and VIR-5500 demonstrated promising safety, with no dose-limiting cytokine release syndrome (CRS) observed[7] Preclinical Pipeline Candidates Vir is leveraging its immune system expertise and proprietary dAIsY™ AI engine to advance multiple undisclosed PRO-XTEN™ dual-masked T-cell engagers against clinically validated targets in solid tumors. In parallel, the company is progressing a broadly neutralizing antibody for HIV treatment in collaboration with the Gates Foundation - The company is developing multiple undisclosed PRO-XTEN™ dual-masked TCEs using its antibody discovery platform and proprietary dAIsY™ AI engine[7] - A broadly neutralizing antibody candidate for HIV treatment is being advanced in collaboration with the Gates Foundation[7] Second Quarter 2025 Financial Results Financial Position and Guidance As of June 30, 2025, Vir Biotechnology reported $892.1 million in cash, cash equivalents, and investments. The cash position decreased by $127.7 million during the quarter, partly due to $50.5 million in milestone payments for the ECLIPSE program. The company reaffirms its financial guidance, expecting its current cash reserves to fund operations into mid-2027 Financial Position (as of June 30, 2025) | Financial Position (as of June 30, 2025) | Amount | | :--- | :--- | | Cash, Cash Equivalents and Investments | $892.1 million | | Restricted Cash and Cash Equivalents | $95.2 million | | Quarterly Cash Decrease | $127.7 million | - The company expects its cash, cash equivalents, and investments to be sufficient to fund operations into mid-2027[15] Operating Results For the second quarter of 2025, Vir reported total revenues of $1.2 million, a decrease from $3.1 million in the prior-year period. The company significantly narrowed its net loss to $111.0 million, or $0.80 per share, compared to a net loss of $138.4 million, or $1.02 per share, in Q2 2024. The improvement was primarily driven by reduced R&D and SG&A expenses resulting from cost-saving initiatives Operating Results (in millions, except per share) | Metric (in millions, except per share) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Revenues | $1.2 | $3.1 | | R&D Expenses | $97.5 | $105.1 | | SG&A Expenses | $22.3 | $30.3 | | Net Loss | $(111.0) | $(138.4) | | Net Loss Per Share | $(0.80) | $(1.02) | - The decrease in R&D expenses was primarily due to cost savings from restructuring, partially offset by higher clinical expenses for the ECLIPSE and oncology programs[10] - SG&A expenses decreased due to efficiencies and cost savings from previously announced restructuring initiatives[11] Financial Statements Condensed Consolidated Balance Sheets The company's balance sheet as of June 30, 2025, showed total assets of $1.19 billion, down from $1.40 billion at year-end 2024. The decrease was mainly driven by a reduction in cash and investments. Total liabilities remained relatively stable at $245.1 million, while total stockholders' equity decreased to $947.5 million from $1.15 billion Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Current Assets | $735,706 | $1,042,458 | | Cash and cash equivalents | $211,104 | $222,947 | | Short-term investments | $387,645 | $678,051 | | Total Assets | $1,192,532 | $1,398,813 | | Total Liabilities | $245,060 | $248,428 | | Total Stockholders' Equity | $947,472 | $1,150,385 | Condensed Consolidated Statements of Operations For the three months ended June 30, 2025, Vir Biotechnology generated $1.2 million in total revenues. Total operating expenses were $119.6 million, a significant reduction from $161.7 million in the same period of 2024, primarily due to the completion of prior restructuring activities. This led to a net loss of $111.0 million, or $0.80 per share Condensed Consolidated Statements of Operations (in thousands) | Statement of Operations (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenues | $1,214 | $3,075 | | Total operating expenses | $119,631 | $161,705 | | Loss from operations | $(118,417) | $(158,630) | | Net loss | $(110,958) | $(138,378) | | Net loss per share, basic and diluted | $(0.80) | $(1.02) |