Vir Biotechnology Q2 Earnings Call Highlights

Key Points

• Hepatitis delta program advances: Vir completed enrollment in its final ECLIPSE registrational study and expects data from ECLIPSE 1 in Q4 2026, followed by ECLIPSE 2 and 3 in Q1 2027. In Phase II SOLSTICE, the elebsiran-tobevibart combination produced higher rates of undetectable virus at 96 weeks than tobevibart alone and was generally well tolerated.
• Oncology pipeline expands: Vir and Astellas began enrolling multiple monotherapy and combination cohorts for prostate cancer candidate VIR-5500, with Phase III trials potentially starting as early as 2027. Updated dose-escalation data for HER2-targeted VIR-5818 are expected in the second half of 2026.
• Strong financial position: Cash, equivalents and investments reached approximately $1.01 billion after $315 million in Astellas payments, while Q2 net income was $80.1 million versus a $111 million loss a year earlier. Management expects the cash runway to extend into the second half of 2028.

Vir Biotechnology NASDAQ: VIR reported second-quarter 2026 results alongside updates on its chronic hepatitis delta and oncology programs, highlighting completed enrollment in a key hepatitis delta study, plans for multiple data readouts, and expanded development activity for its prostate cancer candidate VIR-5500.

The company ended the quarter with approximately $1.01 billion in cash, cash equivalents and investments, up $198.5 million from the prior quarter. The increase reflected payments from Astellas totaling $315 million, including a $240 million upfront payment and a $75 million equity investment.

Hepatitis Delta Program Approaches Key Readouts

Chief Executive Officer Marianne De Backer said Vir completed enrollment in ECLIPSE 2 during the second quarter. With enrollment completed across all three registrational ECLIPSE studies, the company expects top-line results from ECLIPSE 1 in the fourth quarter of 2026, followed by ECLIPSE 2 and ECLIPSE 3 data in the first quarter of 2027.

The studies are evaluating elebsiran and tobevibart for chronic hepatitis delta, or CHD. ECLIPSE 2 is designed to assess patients who did not achieve viral suppression while receiving bulevirtide and are switched to Vir’s combination regimen. De Backer said the study’s endpoint is target not detected, or TND, after 24 weeks.

Vir also presented complete 96-week Phase II SOLSTICE data at the EASL Congress. In the intention-to-treat analysis, 88% of patients receiving elebsiran plus tobevibart achieved undetectable virus at week 96, compared with 53% of patients receiving tobevibart alone. In a last-observation-carried-forward analysis, 97% of combination-treated patients achieved undetectable virus at week 96.

Approximately 90% of patients receiving the combination achieved hepatitis B surface antigen levels below 10 IUs per mL at week 96, versus 25% for antibody monotherapy, according to the company. ALT normalization was reported in 53% of combination-treated patients. About half of the SOLSTICE population had cirrhosis classified as Child-Pugh class A.

De Backer said the combination was generally well tolerated. The most common treatment-emergent adverse event was mild-to-moderate flu-like symptoms that were transient and resolved after the first dose. The company reported no treatment-related serious adverse events or discontinuations.

Vir said it is conducting human-factor studies intended to support at-home administration under its Breakthrough Therapy Designation interactions with the FDA. The company is also pursuing U.S. co-packaging of elebsiran and tobevibart. In the registrational ECLIPSE studies, the treatment is administered in a hospital setting; the potential commercial regimen would involve two monthly subcutaneous injections administered at the same time.

The company completed drug-substance process performance qualification manufacturing for both treatments and is progressing drug-product PPQ batches. Vir’s partner Norgine is preparing for potential launches in Europe, Australia and New Zealand if the regimen receives EU approval.

Diagnosis and Market Development Efforts

Management said the recent U.S. approval of bulevirtide could raise awareness and testing for hepatitis delta. De Backer cited European experience in which the first approved hepatitis delta therapy was associated with reported increases in testing and diagnosis rates of fivefold to tenfold in certain areas.

The company said experts have discussed potential updated AASLD screening and treatment guidelines, including double reflex testing. Under that approach, patients who test positive for hepatitis B surface antigen would automatically receive hepatitis delta antibody testing, followed by hepatitis delta RNA testing if the antibody result is positive.

During the question-and-answer session, De Backer said U.S. hepatitis delta diagnosis rates are currently around 10% to 15%. She said Vir believes the rate could reach approximately 25% or higher, depending on awareness, testing access and reimbursement practices.

Oncology Portfolio Expands

Vir and Astellas are advancing VIR-5500, a PRO-XTEN dual-masked PSMA-targeted T-cell engager for prostate cancer. The company has started enrolling patients in three monotherapy expansion cohorts: taxane-naive metastatic castration-resistant prostate cancer, radioligand therapy-naive metastatic castration-resistant prostate cancer, and radioligand therapy-exposed metastatic castration-resistant prostate cancer.

Vir is also enrolling a taxane-naive metastatic castration-resistant prostate cancer combination cohort pairing VIR-5500 with enzalutamide. A docetaxel combination cohort in the same population and a darolutamide combination cohort in metastatic hormone-sensitive prostate cancer are expected to begin in coming months.

The company is evaluating step-up doses of 800, 2,000 and 3,500 micrograms per kilogram every three weeks across monotherapy and combination cohorts. De Backer said data from the expansion program, including the docetaxel combination, will help guide the design of anticipated pivotal studies. Vir aims to initiate Phase III registrational trials for VIR-5500 as early as 2027 and has secured manufacturing capacity intended to support that program.

Vir also expects to report updated dose-escalation results during the second half of 2026 for VIR-5818, a HER2-targeted T-cell engager being studied alone and in combination with pembrolizumab. The company described the Phase I basket study as a signal-finding effort across multiple HER2-expressing tumor types. VIR-5525, an EGFR-targeted T-cell engager, remains in Phase I dose escalation as monotherapy and in combination with pembrolizumab.

Financial Results and Cash Runway

Vir recognized $238.9 million in license and collaboration revenue during the second quarter, largely tied to the Astellas upfront payment. Research and development expense was $135.3 million, up from $97.5 million a year earlier. The expense included a $48 million milestone payment to Sanofi, representing 20% of the Astellas upfront payment, as well as hepatitis delta qualification manufacturing costs.

Selling, general and administrative expense rose to $30.2 million from $22.3 million in the prior-year period, primarily due to one-time advisory and legal costs related to the Astellas agreement. Vir reported net income of $80.1 million for the quarter, compared with a net loss of $111 million a year earlier.

Interim Principal Financial Officer Brent Sabatini said that, based on the current operating plan, Vir expects its cash runway to extend into the second half of 2028.

About Vir Biotechnology (NASDAQ:VIR)

Vir Biotechnology, Inc is a clinical‐stage immunology company dedicated to developing therapies that prevent and treat serious infectious diseases. The company leverages a suite of proprietary technology platforms—ranging from antibody isolation and screening tools to cell‐based assays and bioinformatics—to identify and advance antiviral and antibacterial candidates. Its scientific approach centers on harnessing the human immune system through monoclonal antibodies and immunomodulatory agents.

The company's pipeline includes product candidates targeting influenza A, COVID‐19, HIV, hepatitis B, and tuberculosis.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.

Continue following MarketBeat

Add MarketBeat as your preferred source on Google to see our latest stories in your feed.

Add As Preferred Source