Vir Biotechnology, Inc. Common Stock 2026 Q2 Earnings Call

You may begin, Kiki. Thank you, operator, welcome everyone.

Earlier today, we issued a press release reporting our second quarter 2026 financial results and corporate update. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under applicable securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, collaboration outcomes, future results, performance, or achievements to differ significantly from those expressed or implied in such forward-looking statements.

Forward-looking statements include, are not limited to, statements regarding the potential for new therapies to improve awareness, testing, and access to care for the chronic hepatitis delta community, the therapeutic and commercial potential of our CHD program, the therapeutic and commercial potential of VIR-5500, and the other clinical and preclinical assets in our oncology solid tumor portfolio, as well as the PRO-XTEN masking technology, our development plans and timelines, the potential benefits of our collaborations with other companies, including financial terms and milestone payments, and our cash runway and capital allocation priorities. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including our Forms 10-K, 10-Q, and 8-K. Joining me on today's call from Vir Biotechnology are Dr. Marianne De Backer, our Chief Executive Officer, and Brent Sabatini, our Interim Principal Financial Officer.

The agenda for our call today is as follows. First, Marianne will provide an update on the meaningful progress we've achieved across our hepatitis delta program and outline how we're positioning the program for a successful regulatory submission. Next, she will provide an update on our dual mask T-cell engager programs utilizing our best-in-class PRO-XTEN platform. Brent will provide a summary of our second quarter 2026 financial results. Finally, Marianne will close the call, and we'll open the line for Q&A. With that, I'll now turn the call over to Marianne.

Thank you, Kiki. Good afternoon, everyone, and thank you for joining us for Vir Biotechnology's second quarter 2026 earnings call. During the quarter, we continued to execute across our portfolio, demonstrating meaningful progress in both hepatitis delta and oncology, while further strengthening our regulatory and commercial readiness. In the second quarter, we presented compelling data for our hepatitis delta program on the complete 96-week SOLSTICE trial at the EASL Congress in Barcelona. These data generated excitement from leading KOLs across the U.S. and Europe, emphasizing the potential best-in-class profile of our hepatitis delta regimen. Against this backdrop, our focus remains on executing our registrational program. We are pleased to share that we completed enrollment in ECLIPSE 2 during the second quarter.

With enrollment now complete across all three registrational ECLIPSE studies, we are entering a catalyst-rich period for hepatitis delta, with top-line data expected first from ECLIPSE 1 in the fourth quarter of this year, followed by readouts from ECLIPSE 2 and ECLIPSE 3 in the first quarter of 2027. In parallel, we are rapidly advancing our oncology pipeline and have entered the next phase of development for our PRO-XTEN dual masked PSMA-targeted T-cell engager VIR-5500 in partnership with Astellas. We are accelerating our clinical development plan in prostate cancer and have started enrolling patients into multiple expansion cohorts, both as monotherapy and combination therapy in parallel. We believe these efforts can inform future registrational development while positioning VIR-5500 as a potential best-in-class therapy across the prostate cancer landscape. I'll begin with updates on our hepatitis delta program. Patients living with chronic hepatitis delta continue to face significant unmet need.

Importantly, the recent approval of bulevirtide marks a major milestone for the hepatitis delta field and serves as a meaningful tailwind for the entry of our regimen. We know from the European experience that the approval of the first hepatitis delta therapy led to a substantial increase in disease awareness, with testing and diagnosis rates reportedly increasing by as much as five to tenfold in certain territories. That experience underscores how therapeutic innovation can catalyze activity across the entire care ecosystem. During independent investor events this quarter involving leading hepatitis delta KOLs from across the U.S. and Europe, experts highlighted the updated AASLD guidelines addressing HDV screening and treatment are expected in the near term.

They also emphasized the potential impact of double reflex testing, in which hepatitis B surface antigen-positive patients automatically receive HDV antibody testing, and if antibody positive, reflex directly to HDV RNA testing without additional physician orders. Taken together, we believe the availability of the first approved therapy in the U.S., expected updates to AASLD screening and treatment guidelines, and the implementation of double reflex testing have the potential to meaningfully accelerate disease awareness, expand patient identification and diagnosis, and establish treatment pathways for a disease that has historically been significantly underdiagnosed and undertreated. Against this evolving backdrop, we believe it is important to consider the ultimate goal of therapy. In hepatitis delta, as with other chronic viral diseases, the objective is not simply viral suppression, but viral clearance.

In conjunction with our EASL presentation, we conducted an advisory board with leading hepatitis delta experts from the U.S. and Europe. A clear theme emerged from these discussions. Physicians consistently viewed undetectable virus as the most meaningful measure of disease control and the endpoint most predictive of favorable long-term outcomes, including lower rates of cirrhosis, of hepatocellular carcinoma, liver transplantation, and mortality. Several experts described Target Not Detected, or TND, as the gold standard endpoint in hepatitis delta, with one KOL emphasizing that the only good virus is a dead virus. Notably, our clinical data package continues to show progress toward this elevated treatment goal. At this year's EASL Congress, we presented complete week 96 results from our phase II SOLSTICE study during an oral presentation. The data show robust rates of undetectable virus with elebsiran and tobevibart, reinforcing our confidence in the potential of our dual-acting regimen.

Overall, the results continue to show durable viral suppression, a favorable safety profile, and increasing rates of undetectable virus over time. By week 96, 88% of patients in the intention to treat analysis receiving elebsiran and tobevibart achieved undetectable virus, compared with 53% of patients receiving tobevibart monoclonal antibody therapy alone. In the last observation carried forward analysis, 97% of patients receiving the combination achieved undetectable virus at week 96. This underscores the scientific rationale of combining two drugs with complementary mechanisms of action to inhibit both entry of HDV and production of hepatitis B surface antigen. HDV relies on circulating hepatitis B surface antigen to replicate and complete its life cycle. We observed rapid and durable reductions in hepatitis B surface antigen with the combination regimen compared with tobevibart antibody monotherapy.

By week 96, approximately 90% of patients receiving combination therapy achieved hepatitis B surface antigen levels below 10 IUs per mL versus only 25% with antibody monotherapy alone. Importantly, the antiviral activity observed with the combination therapy was accompanied by an ALT normalization rate of 53%. These effects were observed in a study population in which approximately 50% of patients had cirrhosis, as defined by Child-Pugh class A, underscoring the activity of the regimen in patients with more advanced liver disease. ALT declines remained durable through week 96, further supporting the overall clinical activity of the regimen. Overall, the combination continues to be generally well-tolerated. The most common treatment-emergent adverse event was flu-like symptoms, which were mild to moderate in severity, transient, and resolved after the first dose of treatment. There have been no treatment-related serious adverse event or discontinuations.

Taken together, we believe the complete SOLSTICE dataset presented at EASL reinforces elebsiran and tobevibart's best-in-class potential. As one leading hepatologist emphasized in a recent independent investor event, 88% target not detected at week 96 with the VIR combination is the best ever target not detected rate in 50 years of HDV treatment experience. It is something that must be acknowledged. Looking ahead, given how swiftly we have been able to enroll patients in our ECLIPSE trials, we can now file one of the most comprehensive clinical data packages in CHD, drawing on data from all three ECLIPSE studies. Collectively, ECLIPSE 1, 2, and 3 are designed to provide evidence across key patient populations, including treatment-naive patients switching from bulevirtide, and patients enrolled in a head-to-head comparison against bulevirtide.

We continue to maintain close engagement with regulatory authorities in both the U.S. and Europe, including a formal interaction with the FDA for a Type B CMC meeting in July. Together, we believe these interactions and breadth of evidence positions us well to support broad regulatory submissions globally. As I mentioned earlier, we have completed enrollment in ECLIPSE 2, our phase III study evaluating elebsiran and tobevibart in patients who have not achieved viral suppression with bulevirtide therapy. The bulevirtide switch cohort is an important component of our overall data package because it is designed to provide information on outcomes in patients transitioning from the only approved therapy for CHD. This data set is relevant given the boxed warning on the current bulevirtide label regarding the risk of severe acute exacerbations of hepatitis D and hepatitis B following treatment discontinuation.