Vir(US:VIR)2025-05-07 20:13markdown [Corporate and Pipeline Highlights](index=1&type=section&id=Corporate%20and%20Pipeline%20Highlights) Vir initiated a Phase 3 trial for chronic hepatitis delta, advanced oncology T-cell engagers, and holds $1.0 billion in cash - Initiated the Phase 3 registrational ECLIPSE program for chronic hepatitis delta (CHD), which has received U.S. FDA Breakthrough and Fast Track designations, as well as EMA PRIME and Orphan Drug designations[1](index=1&type=chunk) - Dose escalation is ongoing for two PRO-XTEN™ dual-masked T-cell engagers: VIR-5818 (HER2-targeting) and VIR-5500 (PSMA-targeting)[1](index=1&type=chunk)[2](index=2&type=chunk) - A Phase 1 study of VIR-5525, an EGFR-targeting T-cell engager, is on track to begin in the second quarter of 2025[1](index=1&type=chunk)[2](index=2&type=chunk) - The company holds a strong financial position with approximately **$1.0 billion** in cash and investments, providing an operational runway into mid-2027[1](index=1&type=chunk) [Pipeline Programs](index=1&type=section&id=Pipeline%20Programs) The company advances its clinical pipeline, highlighted by a Phase 3 CHD program, oncology TCEs, and CHB partnership efforts [Chronic Hepatitis Delta (CHD)](index=1&type=section&id=Chronic%20Hepatitis%20Delta%20(CHD)) - The first Phase 3 trial, ECLIPSE 1, enrolled its first patient in March 2025 to assess the efficacy and safety of tobevibart and elebsiran[3](index=3&type=chunk) - A second Phase 3 trial, ECLIPSE 2, is planned to evaluate switching to tobevibart and elebsiran in patients who have not achieved viral suppression with existing therapy[3](index=3&type=chunk) - The combination therapy is supported by multiple key regulatory designations, including FDA Breakthrough Therapy, FDA Fast Track, EMA PRIME, and EMA Orphan Drug designations, highlighting the significant unmet need[4](index=4&type=chunk) [Solid Tumors](index=2&type=section&id=Solid%20Tumors) - VIR-5818 (HER2-targeting TCE) and VIR-5500 (PSMA-targeting TCE) are advancing through dose escalation[6](index=6&type=chunk) - Early Phase 1 data for VIR-5818 showed tumor shrinkage in **50% (10/20)** of participants at doses ≥400 µg/kg[6](index=6&type=chunk) - Early Phase 1 data for VIR-5500 showed PSA reductions in **100% (12/12)** of mCRPC patients after an initial dose ≥120 µg/kg[6](index=6&type=chunk) - A Phase 1 study of VIR-5525, an EGFR-targeting TCE, is planned to initiate in Q2 2025[6](index=6&type=chunk) [Chronic Hepatitis B (CHB)](index=2&type=section&id=Chronic%20Hepatitis%20B%20(CHB)) - Functional cure data from the 24-week follow-up of the Phase 2 MARCH study will be presented at the EASL Congress on May 9, 2025[6](index=6&type=chunk) - Future advancement of the CHB program is contingent on securing a worldwide development and commercialization partner[6](index=6&type=chunk) [Preclinical Pipeline Candidates](index=3&type=section&id=Preclinical%20Pipeline%20Candidates) - The company is progressing multiple undisclosed PRO-XTEN™ dual-masked TCEs against clinically validated targets for various solid tumors[14](index=14&type=chunk) - In collaboration with the Gates Foundation, a broadly neutralizing antibody has been advanced to development candidate status in the HIV cure program[14](index=14&type=chunk) [Corporate Update](index=3&type=section&id=Corporate%20Update) Vir amended its Alnylam collaboration, assuming sole responsibility for elebsiran development and commercialization - Vir and Alnylam amended their collaboration agreement after Alnylam elected not to opt-in to its profit-sharing option for elebsiran in CHB and CHD[14](index=14&type=chunk) - Vir is now solely responsible for all development, manufacturing, and commercialization activities for elebsiran[12](index=12&type=chunk) [First Quarter 2025 Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) Vir reported Q1 2025 revenues of $3.0 million, a sharp decrease, and a net loss of $121.0 million, maintaining $1.02 billion cash | Financial Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenues | $3.0M | $56.4M | -94.6% | | R&D Expenses | $118.6M | $100.1M | +18.5% | | SG&A Expenses | $23.9M | $36.3M | -34.2% | | Net Loss | $121.0M | $65.3M | +85.3% | | Net Loss Per Share | $(0.88) | $(0.48) | +83.3% | - Cash, cash equivalents, and investments totaled approximately **$1.02 billion** as of March 31, 2025[9](index=9&type=chunk) - The decrease in revenue was primarily due to **$51.7 million** of deferred revenue recognized in Q1 2024 from the expiration of a GSK agreement option[10](index=10&type=chunk) - The increase in R&D expenses was mainly driven by a **$30.0 million** expense to Alnylam and costs to initiate the ECLIPSE Phase 3 program[11](index=11&type=chunk) [2025 Financial Guidance](index=4&type=section&id=2025%20Financial%20Guidance) Vir Biotechnology expects its existing cash and investments to fund operations into mid-2027 based on current plans - The Company expects its cash, cash equivalents and investments to fund its operations into mid-2027[18](index=18&type=chunk) [About Key Programs](index=4&type=section&id=About%20Key%20Programs) Key programs include PRO-XTEN™ T-cell engagers for solid tumors and a tobevibart/elebsiran combination for chronic hepatitis [About PRO-XTEN™ T-cell Engagers (VIR-5818, VIR-5500, VIR-5525)](index=4&type=section&id=About%20VIR-5818,%20VIR-5500,%20VIR-5525) - These are investigational T-cell engagers (TCEs) targeting HER2, PSMA, and EGFR, respectively, for the treatment of solid tumors[20](index=20&type=chunk) - The PRO-XTEN™ masking technology is designed to keep the TCEs inactive until they reach the tumor microenvironment, where they are activated to kill cancer cells. This aims to minimize systemic toxicity and expand the therapeutic index[21](index=21&type=chunk) [About Tobevibart and Elebsiran](index=4&type=section&id=About%20Tobevibart%20and%20Elebsiran) - Tobevibart is an investigational monoclonal antibody designed to inhibit hepatitis B and delta virus entry into liver cells and reduce the level of circulating viral particles[22](index=22&type=chunk) - Elebsiran is an investigational siRNA designed to degrade hepatitis B virus RNA, thereby limiting the production of hepatitis B surface antigen (HBsAg)[23](index=23&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) Condensed Q1 2025 financial statements show total assets of $1.31 billion, liabilities of $263.9 million, and a $121.0 million net loss [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Balance Sheet (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash, cash equivalents & investments** | $1,024,078 | $1,151,391 | | **Total Assets** | **$1,307,727** | **$1,398,813** | | Total Current Liabilities | $137,286 | $119,662 | | **Total Liabilities** | **$263,908** | **$248,428** | | **Total Stockholders' Equity** | **$1,043,819** | **$1,150,385** | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) | Statement of Operations (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total Revenues | $3,032 | $56,376 | | Total Operating Expenses | $142,579 | $136,457 | | Loss from Operations | $(139,547) | $(80,081) | | **Net Loss** | **$(120,965)** | **$(65,276)** | | **Net Loss Per Share** | **$(0.88)** | **$(0.48)** |