Vir Biotechnology Q3 2024 Financial Results and Corporate Update

Vir Biotechnology, Inc. recently shared a significant update on its corporate activities and financial performance for the third quarter ending September 30, 2024. The biotechnology firm has taken notable strides in both its clinical and corporate operations, particularly focusing on advancements in its oncology and infectious disease programs.

In the third quarter, Vir Biotechnology made significant progress in its clinical pipeline, especially highlighting three dual-masked T-cell engagers in oncology. Additionally, the company has refined its focus within infectious diseases, targeting areas where they can make the most substantial impact. A key corporate change includes the appointment of Jason O’Byrne as Chief Financial Officer, bringing extensive financial leadership to the firm.

Looking forward, the company is anticipating pivotal data in its hepatitis programs in the fourth quarter and aims to release initial clinical data from its dual-masked T-cell engagers in early 2025.

**Pipeline Programs**

**Chronic Hepatitis Delta (CHD):** Data from the Phase 2 SOLSTICE study was presented at the European Study of the Liver Meeting in June 2024. Results indicated that tobevibart, both as a monotherapy and in combination with elebsiran, showed high rates of virologic response and ALT normalization over 12 and 24 weeks, without serious adverse events. The combination therapy has received Fast Track Designation by the U.S. FDA. Further data will be presented at the American Association for the Study of Liver Diseases (AASLD) meeting in November 2024.

**Chronic Hepatitis B (CHB):** Vir plans to present end-of-treatment data from the Phase 2 MARCH Part B trial at the AASLD meeting. The trial evaluates the safety and antiviral activity of combining tobevibart and elebsiran with peginterferon alfa-2a in approximately 30 participants. Additional data on a potential functional cure are expected in mid-2025.

**Solid Tumors:** Vir Biotechnology is advancing three oncology candidates. VIR-5818, targeting HER2, is in a Phase 1 study for various cancers, including metastatic breast and colorectal cancers. VIR-5500, targeting PSMA, is also in a Phase 1 dose-escalation study for prostate cancer. Finally, VIR-5525, targeting EGFR, is set to begin a Phase 1 study in early 2025 for several solid tumors.

**Preclinical Pipeline Candidates:** The company continues its preclinical work on respiratory syncytial virus in collaboration with GSK and an HIV cure in partnership with the Bill & Melinda Gates Foundation.

**Corporate Update:** Vir announced an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers and the PRO-XTEN™ masking platform, closing the agreement in September 2024. Alongside this strategic move, Vir is phasing out clinical programs in influenza, COVID-19, and its T-cell-based viral vector platform, with efforts to find partners for these projects. Additionally, there was a significant workforce reduction of approximately 25%, with the headcount expected to be around 435 by the end of 2024.

**Financial Highlights:**

**Cash, Cash Equivalents, and Investments:** As of September 30, 2024, the company had $1.19 billion in cash, cash equivalents, and investments, down by $245.1 million from the previous quarter. This decrease includes a $103.7 million upfront payment to Sanofi and a $75.0 million milestone payment reclassified to restricted cash.

**Revenues:** The total revenue for the quarter was $2.4 million, compared to $2.6 million in the same period in 2023.

**Research and Development Expenses:** R&D expenses were $195.2 million, a significant increase from $145.0 million the previous year, primarily due to the Sanofi upfront payment.

**Selling, General and Administrative Expenses:** SG&A expenses were $25.7 million, down from $40.9 million the previous year, owing to cost-saving initiatives.

**Net Loss:** The net loss for the third quarter of 2024 was $(213.7) million, or $(1.56) per share, compared to $(163.4) million, or $(1.22) per share, in the same period in 2023.

**2024 Financial Guidance:** The company updated its operating expense guidance for 2024, anticipating GAAP operating expenses between $660 million and $680 million. This includes the upfront payment to Sanofi recognized as an R&D expense.

Vir Biotechnology is set to host two virtual investor events to provide updates on its hepatitis programs and masked T-cell engager programs, with the first event scheduled for November 2024 and the second in early 2025.