Vir Biotech Reports Strong New Results For Experimental Hepatitis Drug, Shares 2026 Outlook

Vir Biotechnology, Inc. (NASDAQ:VIR) today provided key program updates, including new positive data from the ongoing SOLSTICE Phase 2 trial in chronic hepatitis delta (CHD). Participants receiving the combination therapy of tobevibart, an investigational neutralizing monoclonal antibody (mAb), and elebsiran, an investigational small interfering RNA (siRNA), showed increased and sustained viral suppression of HDV RNA versus treatment with the antibody alone in participants who have reached Week 96 of treatment.

The Company also announced that safety and efficacy data from the Phase 1 trial of VIR-5500, its PSMA-targeted PRO-XTEN® dual-masked T-cell engager (TCE) being evaluated in prostate cancer, will be shared in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February.

"We are poised for a year of significant clinical progress where we will report initial topline data from our Phase 3 program in CHD, present substantive Phase 1 safety and efficacy data from our PSMA-targeted VIR-5500 TCE program and continue to advance our broader portfolio of PRO-XTEN® masked TCEs through dose escalation," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "The latest data from our SOLSTICE Phase 2 trial evaluating tobevibart and elebsiran combination therapy in CHD are very promising, showing that monthly treatment with this combination therapy has the potential to achieve an undetectable viral load in a large number of patients, which could redefine the standard of care in CHD."

Vir Biotechnology will present at the 44ᵗʰ Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 3:45 p.m. PT. The webcast and presentation will be accessible from the Company's website under Events & Presentations.

Recent Updates and 2026 Clinical Milestones

Tobevibart and elebsiran combination therapy for CHD

Data from the Phase 2 SOLSTICE trial to be presented at the 44ᵗʰ Annual J.P. Morgan Healthcare Conference demonstrate that undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) was achieved and maintained by 77% (24/31) of participants receiving the combination of tobevibart and elebsiran at Week 72, and this rate increased to 88% (21/24) in the subset of participants evaluated through Week 96. By contrast, HDV RNA TND was achieved by 53% (17/32) of participants receiving tobevibart antibody monotherapy at Week 72 and 46% (11/24) in the subset of participants evaluated through Week 96. There were no grade 3 or higher treatment-related adverse events in the combination arm, and treatment emergent adverse events were generally mild to moderate and transient. Complete results at Week 96 will be presented at a future medical meeting. Previous positive Phase 2 SOLSTICE data at Week 48 were published in the New England Journal of Medicine.2

The registrational ECLIPSE program in CHD is ongoing, with ECLIPSE 1 and ECLIPSE 3 fully enrolled. Topline data from the ECLIPSE 1 trial is expected in the fourth quarter of 2026. Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.

Last month, Vir Biotechnology granted Norgine Pharma UK Limited, an affiliate of Norgine, an exclusive license for the commercial rights to the combination of tobevibart and elebsiran for the treatment of CHD in Europe, Australia and New Zealand. Vir Biotechnology has retained all commercialization rights for tobevibart and elebsiran in the United States and other markets outside of the Greater China Territory.3

PRO-XTEN® dual-masked TCE immunotherapy portfolio

PSMA-targeted PRO-XTEN® dual-masked TCE VIR-5500 is currently being evaluated as monotherapy and in combination with androgen receptor pathway inhibitors (ARPIs) for the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC). Vir Biotechnology will share updated Phase 1 data at the 2026 ASCO Genitourinary Cancers Symposium in February. The Company previously shared preliminary data from the ongoing trial in January 2025 and will provide an update that includes safety and efficacy data of VIR-5500 monotherapy in the later-line mCRPC patients, including RECIST and PSA responses, durability and dose-response relationship.

Vir Biotechnology is also currently enrolling patients in its Phase 1 dose escalation trials for VIR-5818 in HER2-expressing solid tumors and VIR-5525 in EGFR-expressing solid tumors. Phase 1 dose escalation response data for VIR-5818 are expected in the second half of 2026.

Additionally, the Company is currently progressing a number of PRO-XTEN® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors, including lung, colorectal and bladder. All candidates have been discovered and optimized by leveraging Vir Biotechnology's antibody and TCE discovery and engineering platform, which includes dAIsY™ (data AI structure and antibodY), a proprietary artificial intelligence engine, and the universal PRO-XTEN® masking technology.

2025 ending cash position (unaudited) and runway projection

Cash, cash equivalents and investments were approximately $781 million as of December 31, 2025.1 As a result of the anticipated net cash benefits from the Norgine licensing agreement, and through continued financial discipline, the Company expects cash, cash equivalents and investments to fund operations into the fourth quarter of 2027.