Vir Biotechnology Q2 2026 Earnings Report

Vir Biotechnology EPS Results

• Actual EPS: $0.47
• Consensus EPS: $0.33
• Beat/Miss: Beat by +$0.14
• One Year Ago EPS: -$0.80

Vir Biotechnology Revenue Results

• Actual Revenue: $238.95 million
• Expected Revenue: $135.88 million
• Beat/Miss: Beat by +$103.06 million
• YoY Revenue Growth: +19,582.50%

Vir Biotechnology Announcement Details

• Quarter: Q2 2026
• Date: 8/5/2026
• Time: After Market Closes
• Conference Call Date: Wednesday, August 5, 2026
• Conference Call Time: 4:30PM ET

Vir Biotechnology (NASDAQ:VIR) 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. Vir entered into a notable collaboration with GlaxoSmithKline to develop monoclonal antibody therapies against SARS-CoV-2. Beyond its lead COVID-19 antibody program, Vir’s research focuses on next‐generation antiviral treatments and vaccines, employing deep sequencing and single-cell analysis to accelerate discovery. Preclinical and clinical trials are underway across multiple indications, reflecting the company’s commitment to addressing unmet medical needs in infectious diseases.

Founded in 2017, Vir Biotechnology is headquartered in San Francisco, California, and operates research and development facilities in the United States and Europe. The company’s management team comprises experienced leaders in biotechnology and infectious disease research, driving strategic partnerships with academic institutions and global health organizations. Through its integrated platform and collaborative model, Vir aims to rapidly translate scientific insights into therapies that can improve outcomes for patients worldwide.

Vir Biotechnology Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Hepatitis delta efficacy data remained strong: In the 96-week SOLSTICE analysis, 88% of patients receiving elebsiran plus tobevibart achieved undetectable virus versus 53% with tobevibart alone, alongside durable ALT improvements and no treatment-related serious adverse events or discontinuations.
• Positive Sentiment: Vir completed enrollment in all three registrational ECLIPSE studies, with topline data expected from ECLIPSE 1 in the fourth quarter of 2026 and ECLIPSE 2 and 3 in the first quarter of 2027. The company highlighted ECLIPSE 2’s bulevirtide-switch data as a potential launch differentiator.
• Positive Sentiment: The oncology pipeline advanced rapidly following the Astellas collaboration, with VIR-5500 enrolling multiple monotherapy and combination expansion cohorts and potential phase III trials targeted for 2027. Additional data from HER2-targeted VIR-5818 are expected in the second half of 2026.
• Positive Sentiment: Vir ended the quarter with approximately $1.01 billion in cash, cash equivalents, and investments after receiving $315 million from Astellas, extending projected cash runway into the second half of 2028.
• Negative Sentiment: Management acknowledged ongoing senior leadership recruitment, including searches for a new chief medical officer and chief financial officer, while the company continues to manage simultaneous hepatitis delta and oncology development programs.

Presentation

[Operator]

Hello, welcome to Vir Biotechnology's second quarter 2026 financial results and corporate update conference call. As a reminder, this call is being recorded. At this time, all participants are in a listen-only mode. After the speakers' prepared remarks, there will be a question and answer session. I will now turn the call over to Kiki Patel, Head of Investor Relations. You may begin, Kiki.

[Kiki Patel, Head of Investor Relations at Vir Biotechnology]

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.

[Kiki Patel, Head of Investor Relations at Vir Biotechnology]

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.

[Kiki Patel, Head of Investor Relations at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

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.

[Marianne De Backer, CEO at Vir Biotechnology]

To our knowledge, no competing CHD development program is expected to have comparable switch data at launch, which we believe represents a meaningful point of differentiation for the ECLIPSE program and could further strengthen our overall package. Beyond regulatory execution, we continue to advance our manufacturing and commercial readiness activities. Our commercial strategy is designed to support both at-home administration and healthcare provider administration, providing flexibility for both patients and physicians. Through our ongoing interactions with the FDA under Breakthrough Therapy Designation, we are currently conducting human factor studies intended to support at-home administration, which we believe could further enhance patient convenience and access. In addition, we are pursuing co-packaging of elebsiran and tobevibart in the U.S. to help streamline the treatment experience. We believe this could further differentiate the regimen and support adoption.

[Marianne De Backer, CEO at Vir Biotechnology]

As for manufacturing readiness, we are pleased to report that the drug substance process performance qualification, or PPQ, manufacturing activity is now complete for both elebsiran and tobevibart. Successfully completing drug substance manufacturing represents a major accomplishment for the program. Looking ahead, we are now progressing on the drug product PPQ batches as planned. Furthermore, following the license agreement with Norgine late last year, launch preparation activities are well underway across Europe, Australia, and New Zealand. Based on the team in place and collaboration to date, we believe Norgine is well-positioned to support a successful launch of elebsiran and tobevibart in these territories if approved in the EU. Overall, we believe the strength of our efficacy and safety package, coupled with once-monthly subcutaneous dosing and the ability to support both at-home and in-office administration, if approved, could drive strong adoption in the evolving CHD treatment landscape.

[Marianne De Backer, CEO at Vir Biotechnology]

Even with a new treatment option now available in the U.S., KOLs continue to highlight limitations, including the burden of daily administration, treatment fatigue, and uncertainty around treatment discontinuation. Given these dynamics, we believe that if approved, elebsiran and tobevibart will be well-positioned to set a new standard of care in CHD with a differentiated profile that addresses key physician and patient needs. Turning now to our oncology portfolio, where we are building a differentiated and increasingly robust T-cell engager portfolio powered by a proprietary PRO-XTEN dual-masking platform. We believe this technology represents a meaningful advancement in the field and positions us to develop next-generation T-cell engagers across a broad range of cancers. I'll begin with VIR-5500, our PRO-XTEN dual-mask PSMA-targeted T-cell engager, which we are advancing in collaboration with Astellas.

[Marianne De Backer, CEO at Vir Biotechnology]

Following encouraging data at our go-forward dose showing potent antitumor activity, favorable early safety data, and no observed dose-limiting toxicities, we are actively enrolling patients across expansion cohorts with the ambition to initiate phase III registrational trials as early as next year. Currently, we have dosed our first patients with VIR-5500 across three monotherapy populations: taxane-naive mCRPC, radioligand therapy-naive mCRPC, and radioligand therapy-exposed mCRPC. In parallel, we are advancing three combination cohorts. One cohort in taxane-naive mCRPC evaluating VIR-5500 with enzalutamide, which is currently enrolling patients. A second cohort in taxane-naive mCRPC evaluating VIR-5500 with docetaxel, which will be initiated in the coming months. A third cohort in metastatic hormone-sensitive prostate cancer evaluating VIR-5500 with darolutamide, which will be initiated in the coming months. We are evaluating step-up dosing at 800, 2,000, and 3,500 micrograms per kilogram Q3W across both monotherapy and combination therapy cohorts.

[Marianne De Backer, CEO at Vir Biotechnology]

We believe this development plan builds upon the opportunity to unlock VIR-5500's potential across the prostate cancer treatment continuum. Together with Astellas, we have launched scale-up efforts and have secured a manufacturing contract to support the VIR-5500 phase III program. Our goal has been to ensure that CMC readiness advances in parallel with clinical development so that manufacturing does not become rate-limiting as the program progresses. Moving to VIR-5818, our PRO-XTEN dual-masked HER2-targeted T-cell engager VIR-5818 is the first masked T-cell engager in clinical development for HER2-expressing tumors. We view the ongoing phase I trial as a signal-finding study, given the early stage of development and the basket design, where multiple tumor types are evaluated in parallel. We expect to report updated dose escalation data evaluating VIR-5818 monotherapy and combination therapy with pembrolizumab in the second half of 2026.

[Marianne De Backer, CEO at Vir Biotechnology]

This update is intended to inform the dosing regimen we will take forward and help identify which HER2-expressing populations may warrant further study, particularly in areas of high unmet medical need. In parallel, we are also advancing VIR-5525, our PRO-XTEN dual-masked EGFR-targeted T-cell engager. We are continuing dose escalation in the phase I study, evaluating VIR-5525 as both a monotherapy and a combination with pembrolizumab across multiple EGFR-expressing tumor types. The study incorporates learnings from both VIR-5500 and VIR-5818 to support efficient clinical development. Dose escalation is tracking well to plan, and we look forward to sharing updates as the program matures. Beyond our three clinical-stage T-cell engagers, we have a pipeline of seven preclinical assets underscoring both the breadth and scalability of the platform.

[Marianne De Backer, CEO at Vir Biotechnology]

Importantly, the encouraging clinical data generated to date serves as early validation of our platform, reinforcing our confidence in its ability to deliver differentiated profiles across multiple programs. We expect to nominate additional development candidates in 2027, further accelerating the expansion of our pipeline. With that, I'll now hand the call over to Brent for our financial update.

[Brent Sabatini, Interim Principal Financial Officer at Vir Biotechnology]

Thank you, Marianne. I am pleased to share that we saw significant improvement in our cash position over the second quarter of 2026. We ended the quarter with approximately $1.01 billion in cash equivalents, and investments, representing an increase of $198.5 million. During the second quarter, the company received payments of $315 million from Astellas, consisting of a $240 million upfront payment and a $75 million equity investment payment. I would like to note that since December 2025, our collaborations with Astellas and Norgine, together with our follow-on equity offering, have generated more than $500 million in cash, meaningfully strengthening our balance sheet and positioning us to execute across multiple value-creating milestones. Based on our current operating plan, we continue to project cash runway into the second half of 2028. Moving to financial performance.

[Brent Sabatini, Interim Principal Financial Officer at Vir Biotechnology]

We recognized $238.9 million in license and collaboration revenue during the second quarter of 2026, largely related to the $240 million upfront payment we received from Astellas. R&D expense for the second quarter of 2026 was $135.3 million, which included $5.5 million of stock-based compensation expense and $48 million of expense associated with a milestone payment to Sanofi, representing 20% of the $240 million upfront payment we received from Astellas. This compares to $97.5 million for the same period in 2025, which included $6.9 million of non-cash stock-based compensation expense. The year-over-year increase was primarily driven by the milestone payment to Sanofi and, to a lesser extent, hepatitis delta qualification manufacturing costs. SG&A expense for the second quarter of 2026 was $30.2 million, which included $6.9 million of stock-based compensation expense, compared to $22.3 million for the same period in 2025, which included $5.5 million of stock-based compensation expense.

[Brent Sabatini, Interim Principal Financial Officer at Vir Biotechnology]

The increase was primarily due to one-time advisory and legal expenses in connection with the closing of our Astellas agreement in the second quarter of 2026. Net income for the second quarter of 2026 was $80.1 million, compared to a net loss of $111.0 million for the same period last year. The significant improvement in net income was primarily driven by the previously mentioned $238.9 million in Astellas license and collaboration revenue recognized this quarter. With that, I will turn it back over to Marianne to close the call.

[Marianne De Backer, CEO at Vir Biotechnology]

Thank you, Brent. In summary, I am incredibly proud of the strong execution we have delivered in the first half of the year, highlighted by the deal with Astellas on our lead clinical oncology program and the integration of our teams since the close and enrollment of the ECLIPSE studies. Looking ahead, we are positioned for a meaningful sequence of upcoming milestones in hepatitis delta, beginning with top-line data for ECLIPSE 1 in the fourth quarter of this year, followed by ECLIPSE 2 and 3 in the first quarter of 2027. Based on the totality of data generated to date, including our recent presentation at EASL, we believe the dual-acting mechanism of elebsiran and tobevibart has the potential to define a best-in-class profile in an emerging commercial market.

[Marianne De Backer, CEO at Vir Biotechnology]

In oncology, our collaboration with Astellas in prostate cancer has enabled the rapid advancement of VIR-5500 into expansion cohorts, and we are focused on generating the data needed to support our planned transition into registrational trials next year. We believe VIR-5500 has the potential to become a foundational therapy in prostate cancer, with broad applicability across both monotherapy and combination treatment settings. Taken together, we believe we are entering a period of sustained value creation, supported by strong balance sheet and financial discipline, multiple near and midterm catalysts, and a focused approach to execution. We look forward to updating you on our progress over the coming quarters. With that, I'll now turn the call over to Kiki to begin the Q&A session.

[Kiki Patel, Head of Investor Relations at Vir Biotechnology]

Thank you, Marianne. This concludes our prepared remarks. We will now start the Q&A session. Joining me from the Q&A are Marianne and Brent. Please limit questions to two per person so we can get to all of our covering analysts. I'll turn it over to you, operator.

[Operator]

At this time, we will begin conducting our analyst Q&A session. If you would like to ask a question, please press star one to raise your hand, and to withdraw your question, press star one again. We ask that you pick up your handset when asking a question for optimum sound quality, and if muted locally, remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.

[Analyst at Goldman Sachs]

Hey, thank you. This is Eric on for Paul Choi, thanks for taking the question. A question about, after the initial ECLIPSE 1 readout, what is the plan and timing for long-term extension data? Will the follow-up assess the durability of TND and whether patients could eventually discontinue treatment?

[Marianne De Backer, CEO at Vir Biotechnology]

Thank you for that question. I thought a second one was coming, but maybe not. Yeah. Thanks, Eric. We have in our trial design for ECLIPSE 2 and ECLIPSE 3, incorporated the exploration of the potential for finite treatment. This is not something that is incorporated in our ECLIPSE 1 trial design, where we're really comparing the treatment with elebsiran and tobevibart versus deferred treatment. It is something in our overall ECLIPSE program that we will be exploring.

[Analyst at Goldman Sachs]

Oh, thank you.

[Operator]

Your next question comes from the line of Roanna Ruiz with Leerink Partners. Your line is now open. Please go ahead.

[Roanna Ruiz, Analyst at Leerink Partners]

Okay. Hey, everyone. With the enrollment completed for ECLIPSE 2, can you talk a bit about what thresholds you're hoping to see on both efficacy and safety from that particular study, and how the data on switching from bulevirtide could help inform future physician prescribing?

[Marianne De Backer, CEO at Vir Biotechnology]

Thank you, Roanna. ECLIPSE-2, just for everyone, is the trial where we really are looking at patients that fail on bulevirtide and then are switched to our combination regimen of elebsiran and tobevibart. What we're looking at there as an endpoint is after 24 weeks, really target not detected. We think that the bar is considered to be low because our target not detected rates compared to bulevirtide are significantly higher, as you recall. That's really the outcome that we will be watching. Maybe just to add that given the black box warning that bulevirtide has now for switches or discontinuations of bulevirtide, we believe that ECLIPSE-2 data will be very, very valuable. As mentioned in the prepared remarks, we believe that we are the only company that will have that data at the time of launch.

[Roanna Ruiz, Analyst at Leerink Partners]

Yeah. Got it. As another question for VIR-5818, could you talk about how much you hope to share with the upcoming data set in second half 2026, help frame the potentially number of patients or any other insights that you're really hoping to think about as you kind of narrow it down on different tumor types for that program?

[Marianne De Backer, CEO at Vir Biotechnology]

Sure. VIR-5818, our HER2 study, just for everyone's recollection, is a basket trial, it contains a lot of different tumor types. We have a monotherapy escalation cohort and a combination cohort with pembrolizumab. We will be sharing those escalation data. We see it as a signal-seeking study, again, given the heterogeneity of the data. What we hope to show, Roanna, is really a good insight into the dose for any potential next steps, also insight into what exploration, what indications might really be valuable for the program.

[Roanna Ruiz, Analyst at Leerink Partners]

Okay. Got it. Thanks.

[Marianne De Backer, CEO at Vir Biotechnology]

Thank you.

[Operator]

Your next question comes from the line of Cory Kasimov with Evercore. Your line is open. Please go ahead.

[Analyst at Evercore]

Hi, this is Josh on for Cory. I realize this is a difficult question to answer, but we figured it'd be best to ask it here. There's been a significant amount of management turnover this past year. How confident are you that you have the team in place to effectively manage both the two important but distinct clinical programs? How do you envision best bolstering the C-suite ranks in the coming months? Thank you.

[Marianne De Backer, CEO at Vir Biotechnology]

Yes, thank you for that question, Josh. I'm very confident that we have a very strong team in place, as I think is evident from the progress that we are making quarter to quarter. We are looking to bring in a new CMO, as mentioned before, we are looking there for a very strong profile in medical oncology because beyond delta, where we are close to having registrational data coming out this quarter, the fourth quarter and then first quarter next year, the future of our pipeline will nearly entirely be in immuno-oncology. We're looking for a very strong leader in that field. For the CFO, yeah, we have actually started interviews last week. Again, we have a roster of, I think, what are very strong candidates to move forward in the process.

[Analyst at Evercore]

Great. Thank you.

[Marianne De Backer, CEO at Vir Biotechnology]

Sure.

[Operator]

Your next question comes from the line of Alec Stranahan with Bank of America. Your line is open. Please go ahead.

[Alec Stranahan, Analyst at Bank of America]

Hey, guys. Thanks for taking my questions. One on HDV and one on 5500. First on HDV, after the bulevirtide approval and pricing here in the U.S., I guess how is your thinking around competitive positioning for your combo and pricing change, if at all? Then on 5500, just thinking towards the phase III starting next year, I guess, how much will the early line data, including the docetaxel combo, kind of feed into how you design the path forward for pivotal? Thank you.

[Marianne De Backer, CEO at Vir Biotechnology]

Yes, thank you for that question. Maybe first on delta and the impact of bulevirtide approval. As mentioned, what is really helpful now is that there's an increased awareness around the disease. We also know that the bulevirtide price has been set at around $283,000, obviously, with delta being recognized as a rare disease. We believe that we have a potential best-in-class profile. You have seen the phase II data from SOLSTICE at EASL, where we have 88% target not detected at 96 weeks. Very durable data. Even if you use the last observation carried forward analysis, we go up to 97%. Very strong efficacy data combined with monthly dosing and combined with a very good safety and tolerability profile.

[Marianne De Backer, CEO at Vir Biotechnology]

We believe that we have a profile that is significantly differentiated from bulevirtide, and obviously we will be hoping that patients will benefit from that differentiation. For the next question on VIR-5500, yeah, we are very excited that since closing the deal with Astellas in the second quarter, we have been able to bring online now a total of already 4 expansion cohorts, which we are enrolling patients and 2 others that are in preparation. This is exactly what we had hoped to achieve, real acceleration and being able to do quite a number of explorations in parallel so that we can really determine the full scope of possibility for VIR-5500, either as monotherapy or as combination.

[Marianne De Backer, CEO at Vir Biotechnology]

The data that we will be collecting with docetaxel will of course be very important for the design of our pivotal trials, as are of course the data from our other cohorts. We will really be led by what the data will tell us.

[Alec Stranahan, Analyst at Bank of America]

Thank you.

[Operator]

Your next question comes from the line of Philip Nadeau with TD Cowen. Your line is open. Please go ahead.

[Philip Nadeau, Analyst at TD Cowen]

Good afternoon. Thanks for taking our questions. One from us on HDV and one on 5818. On HDV, you mentioned the human factor study. Can you go into a little bit more detail as to how tobevibart are being dosed in the pivotal trials and how you hope to have the commercial formulation dosed in terms of device as well as at home versus in the clinic? Second on 5818, you mentioned this is a signal finding study. Can you give us some sense of what the bar is to moving forward in any individual indication? Do you need to see responses? Is prolonged stable disease enough? Some sense of what you're looking for in the different cohorts. Thank you.

[Marianne De Backer, CEO at Vir Biotechnology]

Sure. Thank you, Phil. Starting with hepatitis delta. In our ECLIPSE trials, the combination of elebsiran and tobevibart is being administered in a hospital setting. What we are doing with the human factor study is really bridging to in-home administration. We've, as mentioned, had a Type B CMC meeting with the FDA, which has been very productive. Basically what the dosing is, of course, it's monthly, it's subcutaneous, it's two injections at the same time. We are looking into co-packaging elebsiran and tobevibart to make it even more convenient for patients to self-administer. One of the really positive things is that even for patients who are not in a position to self-administer, I think our monthly dosing is really opening up that possibility for a dosing in office or in hospital by a physician or a nurse in an ongoing chronic treatment.

[Marianne De Backer, CEO at Vir Biotechnology]

Yeah, we are very optimistic about the progression we are making in our preparation for our human factor study. On 5818, what signal we are looking for, Phil? Obviously, it depends significantly on what kind of indication you're speaking about. As you know, for example, in mCRC, where we showed some initial data last year, and especially microsatellite stable mCRC, the bar is extremely low. You have single-digit ORR. Again, depending on what kind of indication you will be looking at, the signal you will be looking for is a little bit different.

[Philip Nadeau, Analyst at TD Cowen]

That's very helpful. Thank you.

[Operator]

Your next question comes from the line of Etzer Darout with Barclays. Your line is open. Please go ahead.

[Etzer Darout, Analyst at Barclays]

Great. Thanks for taking the question. Maybe just curious if you have any analogs or if you've heard any commentary from key opinion leaders on how quickly the new patient ID and diagnosis methods could be adopted by physicians for HDV. Question on the expenses in the second quarter, and whether or not you can maybe comment on what you see trends are for the balance of the year across R&D and SG&A. Thank you.

[Marianne De Backer, CEO at Vir Biotechnology]

Thank you, Etzer. I'll ask Brent to first maybe answer your second question.

[Brent Sabatini, Interim Principal Financial Officer at Vir Biotechnology]

Sure. Thank you, Marianne. Regarding expenses, we expect, as Marianne said, we finished our PPQ DS batches mostly in the first and second quarter. We are keeping our cash runway into the second half of 2028. With that, I would say we don't give individual quarter guidance, but the bigger DS expenses are behind us. We continue to move forward with our programs.

[Marianne De Backer, CEO at Vir Biotechnology]

Thank you, Brent. To your other question, Etzer, what we have seen, especially since, again, bulevirtide launching a couple of months ago, is that, first of all, we heard, and probably you heard it too in other independent investor call, that some KOLs were mentioning the fact that reflex testing, incorporating that in the guidelines for the U.S. was something that was really getting very acute. Of course, if that happens, that would be a major achievement. We also hear that the number of major sites here in California are already implementing universal reflex testing for Delta now that there is a treatment available. We hear from KOLs, some are also re-screening all their patients in the HBV registry for hepatitis Delta. We think that gradually there's signs that things are going to change.

[Marianne De Backer, CEO at Vir Biotechnology]

They aren't necessarily pointing to analogs, certainly, again, the fact that there is an unmet need, there's a treatment available now in the market. You can see certain things changing, that is exactly what we had hoped for. We hope that, of course, there will be also much more diagnosis and testing happening going forward.

[Etzer Darout, Analyst at Barclays]

Great. Thank you.

[Operator]

Your next question comes from the line of Sean McCutcheon with Raymond James. Your line is open. Please go ahead.

[Sean McCutcheon, Analyst at Raymond James]

Hi, guys. Thanks for the questions. Two from us. First, could you maybe go into some of your efforts to expedite the BLA filing once the ECLIPSE suite of studies is in hand? Second question, can you go into the rationale for starting a darolutamide combo in the hormone-sensitive setting as opposed to a combination with enzalutamide? Thanks.

[Marianne De Backer, CEO at Vir Biotechnology]

Thank you, Sean. Maybe first on efforts to expedite our BLA filing. We have, of course, been very focused on mapping out from last patient, last visit, to database lock and top-line data to filing, what that timing would look like, and we're really looking at that as a matter of hours and days. We have prepared this quite well. Of course, we're trying to really expedite as much as possible and take out any unnecessary downtime in that process. I would say that we're very well equipped as soon as data come in for ECLIPSE 1 in the fourth quarter, ECLIPSE 2 and 3 in the first quarter of next year to move as quickly as possible. Your question, darolutamide. The rationale for combining VIR-5500 with darolutamide is really rooted in what we believe is a complementary mechanism of action.

[Marianne De Backer, CEO at Vir Biotechnology]

We think there's synergy with the AR blockade, but we also believe that darolutamide may increase the PSMA target density. Of course, at the same time, if there's a lower disease burden and a more intact immune context in the case of metastatic hormone-sensitive prostate cancer, we think this might be, in general, a more favorable setting to T-cell engagers.

[Operator]

Your next question comes from the line of Joseph Stringer with Needham. Your line is open. Please go ahead.

[Joseph Stringer, Analyst at Needham]

Hi, thanks for taking our question. One on HDV. Where do you peg the current U.S. HDV diagnosis rate today? I suppose now that there's an approved therapy plus some momentum toward universal testing in the guidelines, where do you think diagnosis rates could realistically plateau and over what timeframe? Thank you.

[Marianne De Backer, CEO at Vir Biotechnology]

Hey, Joe. Thank you for that question. Diagnosis rates for delta in the United States are relatively low. They're around 10%-15% only. We do believe that it can reach maybe about 25% and maybe even more, really depending on the awareness that is going to be created, the ease of testing, of course, the reimbursement related to testing practices. There's still a lot that needs to be put in place, we think there's a lot of low-hanging fruit to improve diagnosis for delta.

[Operator]

Your next question comes from the line of Patrick Trucchio with H.C. Wainwright. Your line is open. Please go ahead.

[Analyst at H.C. Wainwright]

Hi, it's Arabella in for Patrick. Thank you so much for taking the question. Given the field in HDV's kind of shift towards focusing on TND more, I was wondering if the FDA has shared their view on TND alone versus TND plus ALT normalization. Separately, for ECLIPSE 1, could you comment on the BMI and steatotic liver disease distribution and how it compares to SOLSTICE? Thank you so much.

[Marianne De Backer, CEO at Vir Biotechnology]

Thank you, Arabella, for that question. We are very happy to see that there's this broad recognition that getting rid of the virus, really looking at target not detected, is the most important endpoint and related to outcomes. As you know, even in our existing ECLIPSE trials design, ECLIPSE 2 has an endpoint that is only TND. I think, again, we obviously do not know the FDA's position on this topic, but I think the fact that they have accepted our endpoints as we have them today, I think is a good parameter. On your second question related to BMI. Our team has done an analysis of impact on BMI on the data in SOLSTICE.

[Marianne De Backer, CEO at Vir Biotechnology]

We haven't really designed our ECLIPSE trials differently, there isn't going to be a fundamental difference between BMI as you saw it in SOLSTICE versus how we have it in ECLIPSE.

[Operator]

This concludes the Q&A session of the call. Thank you for participating.

Participants

Executives

• Kiki Patel, Head of Investor Relations
• Marianne De Backer, CEO
• Brent Sabatini, Interim Principal Financial Officer

Analysts

• Analyst at Goldman Sachs
• Roanna Ruiz, Analyst at Leerink Partners
• Analyst at Evercore
• Alec Stranahan, Analyst at Bank of America
• Philip Nadeau, Analyst at TD Cowen
• Etzer Darout, Analyst at Barclays
• Sean McCutcheon, Analyst at Raymond James
• Joseph Stringer, Analyst at Needham
• Analyst at H.C. Wainwright