Vir Biotechnology (VIR) Q2 2026 Earnings Call Transcript

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DATE

Wednesday, Aug. 5, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer - Marianne De Backer
• Interim Principal Financial Officer - Brent Sabatini
• Head of Investor Relations - Kiki Patel

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TAKEAWAYS

• Cash and Investments -- $1.01 billion as of June 30, 2026, reflecting capital generated from the global strategic collaboration with Astellas and a follow-on equity offering.
• Revenue -- $238.9 million, primarily reflecting the recognition of a $240 million upfront payment from the Astellas collaboration.
• Net Income -- $80.1 million, or $0.47 per diluted share, representing a significant improvement from a net loss of $111.0 million in the prior year period.
• R&D Expenses -- $135.3 million, which included a $48 million milestone payment to Sanofi triggered by the Astellas agreement.
• SG&A Expenses -- $30.2 million, an increase from $22.3 million in the second quarter of 2025 due to one-time advisory and legal fees related to the Astellas transaction.
• Cash Runway -- Projecting sufficient capital to fund operations into the second half of 2028 based on the current operating plan.
• HDV Undetectable Virus Rate -- 88% of participants receiving elebsiran and tobevibart achieved undetectable hepatitis delta virus RNA at 96 weeks, compared to 53% for antibody monotherapy.
• HDV HBsAg Reduction -- 90% of patients receiving combination therapy achieved HBsAg levels below 10 IUs per ml by week 96, versus 25% with monotherapy.
• HDV ALT Normalization -- 53% of patients in the combination group achieved ALT normalization by week 96, supporting the clinical activity of the regimen.
• ECLIPSE 1 Timeline -- Top-line data for the Phase 3 study comparing the combination regimen to deferred treatment are expected in the fourth quarter of 2026.
• ECLIPSE 2 and 3 Timelines -- Top-line data for both studies are anticipated in the first quarter of 2027, following the completion of enrollment for the entire registrational program.
• HDV Manufacturing -- Process performance qualification manufacturing is complete for drug substance for both elebsiran and tobevibart, advancing commercial readiness.
• VIR-5500 Expansion -- Dosing has been initiated in three monotherapy cohorts and one combination cohort with enzalutamide for the PSMA-targeted T-cell engager.
• VIR-5500 Phase 3 -- Management plans to initiate registrational trials in 2027, supported by ongoing scale-up efforts and a manufacturing contract.
• VIR-5818 Data -- Updated dose-escalation data from the Phase 1 trial evaluating the HER2-targeted candidate are expected in the second half of 2026.
• HDV Diagnosis Rate -- Management estimated current U.S. diagnosis rates between 10% and 15%, noting potential growth from universal reflex testing and updated clinical guidelines.
• LOCF Efficacy -- 97% of patients reached undetectable virus at 96 weeks in the last observation carried forward analysis of the Phase 2 SOLSTICE trial.
• Astellas Payment Breakdown -- Received a $240 million upfront payment and a $75 million equity investment payment during the second quarter.
• Cash Generation -- Over $500 million in cash has been generated through collaborations and equity offerings since Dec. 2025.
• SOLSTICE Safety -- Treatment-emergent adverse events were reported as mild to moderate, with no treatment-related serious adverse events or discontinuations.
• VIR-5525 Progress -- Dose escalation in the Phase 1 study for the EGFR-targeted candidate is tracking to plan as both monotherapy and combination therapy.

SUMMARY

Management reported on the progress of the chronic hepatitis delta registrational program and the advancement of the oncology pipeline through a global collaboration with Astellas. The company stated that completion of enrollment across all three ECLIPSE studies facilitates a comprehensive regulatory filing strategy. Leadership highlighted the transition toward immuno-oncology development and the stabilization of the balance sheet through recent capital infusions and milestone payments. Clinical efforts are now focused on top-line readouts for the lead hepatitis programs and the dose-expansion phases for multiple T-cell engager candidates.

• CEO De Backer highlighted the efficacy of the combination regimen, stating that the 88% target not detected rate at week 96 "is the best-ever target not detected rate in 50 years of HDV treatment experience."
• Management reported that human factor studies are currently underway to bridge from clinical hospital administration to in-home self-administration, potentially involving monthly co-packaged doses.
• De Backer noted that disease awareness and testing in certain territories increased by as much as fivefold to tenfold following the European approval of the first hepatitis delta therapy.
• The company has initiated patient interviews for a new Chief Financial Officer and is seeking a Chief Medical Officer with a "very strong profile in medical oncology" to lead the pipeline transition.
• The development plan for VIR-5500 includes combinations with enzalutamide, docetaxel, and darolutamide to explore potential synergies and increased target density across the prostate cancer continuum.
• De Backer emphasized that "the only good virus is a dead virus," underlining viral clearance as the primary therapeutic goal over simple suppression.
• The Phase 2b ECLIPSE 3 study is designed as a head-to-head trial against bulevirtide to provide data for access and reimbursement in key global markets.

INDUSTRY GLOSSARY

• CHD: Chronic hepatitis delta, a severe form of viral hepatitis often leading to cirrhosis and liver failure.
• TND: Target not detected; a virologic marker indicating that viral levels are below the limit of detection.
• HBsAg: Hepatitis B surface antigen, a protein required for the replication and assembly of the hepatitis delta virus.
• PSMA: Prostate-specific membrane antigen, a protein overexpressed in most prostate cancer cells.
• TCE: T-cell engager, a type of immunotherapy that redirects T-cells to attack and kill cancer cells.
• PRO-XTEN: A proprietary masking technology designed to keep T-cell engagers inactive until they reach the tumor microenvironment.
• mCRPC: Metastatic castration-resistant prostate cancer.
• ALT: Alanine aminotransferase, a liver enzyme used as a standard marker for liver inflammation and health.
• PPQ: Process performance qualification, a critical step in manufacturing to ensure a process can consistently produce drug substance.
• siRNA: Small interfering ribonucleic acid, used to silence specific genes involved in disease pathways.
• mAb: Monoclonal antibody, a laboratory-produced molecule designed to serve as substitute antibodies.
• EASL: European Association for the Study of the Liver.
• AASLD: American Association for the Study of Liver Diseases.
• mHSPC: Metastatic hormone-sensitive prostate cancer.

Full Conference Call Transcript

Operator: Hello and welcome to Vir Biotechnology's Second Quarter 2026 Financial Results and Corporate Update Conference Call. As a reminder, this call is being recorded. [Operator Instructions] I will now turn the call over to Kiki Patel, Head of Investor Relations. You may begin, Kiki.

Kiki Patel: Thank you, Operator, and 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 but 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-masked T-cell engager programs utilizing our best-in-class PRO-XTEN platform.

Then Brent will provide a summary of our second quarter 2026 financial results. And finally, Marianne will close the call and will open the line for Q&A. With that, I'll now turn the call over to Marianne.

Marianne De Backer: 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 continue 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 a 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 remained 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 3 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, and 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 2 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 1 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 1 of the most comprehensive clinical data packages in CHD, drawing on data from all 3 ECLIPSE studies.

Collectively, ECLIPSE 1, 2 and 3 are designed to provide evidence across key patient populations, including treatment-naive patients, 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 dataset is relevant given the box warning on the current bulevirtide label regarding the risk of severe acute exacerbations of hepatitis D and hepatitis B following treatment discontinuation. 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 health care 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. 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.

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-masked PSMA-targeted T-cell engager, which we are advancing in collaboration with Astellas. Following encouraging data at our go-forward dose showing potent anti-tumor 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 next year. Currently, we have dosed our first patients with VIR-5500 across 3 monotherapy populations: taxane-naive mCRPC, radioligand therapy-naive mCRPC and radioligand therapy-exposed mCRPC.

In parallel, we are advancing 3 combination cohorts: 1 cohort in taxane-naive mCRPC evaluating VIR-5500 with enzalutamide, which is currently enrolling patients; the second cohort, in taxane-naive mCRPC evaluating VIR-5500 with docetaxel, which will be initiated in the coming months; and the 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, Q3 weekly across both monotherapy and combination therapy cohorts. We believe this development plan builds upon the opportunity to unlock VIR-5500's potential across the prostate cancer treatment continuing.

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. 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 3 clinical stage T-cell engagers, we have a pipeline of 7 preclinical assets underscoring both the breadth and scalability of the platform. 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: 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, 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 $0.5 billion 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. Now moving to financial performance. 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. The increase was primarily due to onetime 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'll turn it back over to Marianne to close the call.

Marianne De Backer: 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. 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 a strong balance sheet and financial discipline, multiple near- and mid-term 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: 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. [Operator Instructions] I'll turn it over to you, operator.

Operator: [Operator Instructions] Your first question comes from the line of Paul Choi with Goldman Sachs.

Unknown Analyst: This is [ Eric ] on for Paul Choi. Question about -- after the initial ECLIPSE 1 readout, what is the plan and timing for long-term extension data? And will the follow-up assess the durability of TND and whether patients could eventually discontinue treatment?

Marianne De Backer: Thank you for that question. I thought a second one was coming but maybe not. Yes, so thanks, [ Eric ]. So 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 the deferred treatment. But it is something in our overall ECLIPSE program that we will be exploring.

Operator: Your next question comes from the line of Roanna Ruiz with Leerink Partners.

Roanna Clarissa Ruiz: So 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: Yes, thank you, Roanna. So 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. And what we're looking at there as an endpoint is after 24 weeks really target not detected. So 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. So that's really the outcome that we will be watching.

And maybe just to add that given the black box warning that bulevirtide has now for switches or discontinuations of bulevirtide, we believe that the ECLIPSE 2 data will be very, very valuable. And 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 Clarissa Ruiz: Yes, got it. And as another question for 5818, could you talk about how much you hope to share with the upcoming data set in second half '26? 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: Sure. So 5818, our HER2 study, just for everyone's recollection, is a basket trial, so it's -- contains a lot of different tumor types. And we have a monotherapy escalation cohort and a combination cohort with pembrolizumab. So we will be sharing those escalation data. We see it as a signal-seeking study, again, given the heterogeneity of the data. And what we hope to show, Roanna, is really a good insight into the dose for any potential next steps and then also insight into what exploration, what indications might really be valuable for the program.

Operator: Your next question comes from the line of Cory Kasimov with Evercore.

Mario Joshua Chazaro Cortes: This is Josh on for Cory. Question for you, Marianne. And 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 2 important but distinct clinical programs? And how do you envision best bolstering the C-suite ranks in the coming months?

Marianne De Backer: 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. And 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 and -- the fourth quarter and then first quarter next year, the future of our pipeline will nearly entirely be in immuno-oncology. So we're looking for a very strong leader in that field.

And for the CFO, yes, we have actually started interviews last week, and again, we have a roster of, I think, what are very strong candidates to move forward in the process.

Operator: Your next question comes from the line of Alec Stranahan with Bank of America.

Alec Stranahan: One on HDV and one on 5500. So first on HDV, after the bulevirtide approval and pricing here in the U.S., I guess, how has your thinking around competitive positioning for your combo and pricing changed if at all? And 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?

Marianne De Backer: 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, so very durable data.

And even if you use the last observation carried forward analysis, we can go up to 97%, so very strong efficacy data combined with monthly dosing and combined with a very, very good safety and tolerability profile. So 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 5500, yes, so 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. And 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.

Operator: Your next question comes from the line of Philip Nadeau with TD Cowen.

Philip Nadeau: 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 tobevi-eleb are being dosed in the pivotal trials and what -- how you hope to have the commercial formulation dose in terms of device as well as at home versus in the clinic. And then 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.

Marianne De Backer: Sure, thank you Phil. So starting with hepatitis delta. So in our ECLIPSE trials, the combination of elebsiran and tobevibart is being administered in a hospital setting. And what we are doing with the human factor study is really bridging to human to in-home administration. We've had, as mentioned, had a Type B CMC meeting with the FDA, which has been very, very productive. Basically, what the dosing is, of course, it's monthly. It's subcutaneous. It's 2 injections at the same time. So we are looking into co-packaging elebsiran and tobevibart to make it even more convenient for patients to self-administer.

And 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 dosing by -- in office or in hospital by a physician or a nurse in an ongoing chronic treatment. So yes, we are very optimistic about the progression we are making in our preparation for our human factor study. Then on 5818, so 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.

I mean you have single-digit ORR. So again, depending on what kind of indication you will be looking at, the signal you will be looking for is a little bit different.

Operator: Your next question comes from the line of Etzer Darout with Barclays.

Etzer Darout: 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. And then question on the expenses in the second quarter and whether or not you can maybe comment on what you see sort of trends are for the balance of the year across R&D and SG&A.

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

Brent Sabatini: Sure. Thank you, Marianne. Yes, regarding expenses, so we expect -- as Marianne said, we finished our PPQ DS batches mostly in the first and second quarter. And then we are keeping our cash runway into the second half of 2028. So with that, I would say we don't give individually quarter guidance, but the bigger DS expenses are behind us, and we continue to move forward with our programs.

Marianne De Backer: Thank you, Brent. And then to your other question, Etzer, so 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 testing for reflex testing, incorporating that in the guidelines for the U.S. was something that was really getting very acute. I mean, of course, if that happens, that would be a major achievement. We also hear that a number of major sites here in California are already implementing universal reflex testing for delta now that there is a treatment available.

And some are also -- we hear from KOLs, some are also rescreening all their patients in the HBV registry for hepatitis delta. So we think that gradually there's signs that things are going to change. They aren't necessarily pointing to analogs, but 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, and that is exactly what we had hoped for. And we hope that, of course, there will be also much more diagnosis and testing happening going forward.

Operator: Your next question comes from the line of Sean McCutcheon with Raymond James.

Sean McCutcheon: 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? And then 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?

Marianne De Backer: Thank you, Sean. So maybe first on efforts to expedite our BLA filing. So 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, so we have prepared this quite well. And of course, we are trying to really expedite as much as possible and take out any unnecessary downtime in that process.

So I would say that we're very well equipped as soon as data come in for ECLIPSE 1 in the fourth quarter and then ECLIPSE 2 and 3 in the first quarter of next year to move as quickly as possible. Then your question on darolutamide, so the rationale for combining VIR-5500 with darolutamide is really rooted in what we believe is a complementary mechanism of action. So we think there's synergy with the AR blockade, but we also believe that darolutamide may increase the PSMA target density.

And of course, at the same time, if there is 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.

Joseph Stringer: One on HDV. Where do you peg the current U.S. HDV diagnosis rate today? And 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 time frame?

Marianne De Backer: Joe, thank you for that question. Yes, so diagnosis rates for delta in the United States are relatively low. I mean, they're around 10% to 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. So there's still a lot that needs to be put in place, but 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.

Unknown Analyst: It's [ Arabella ] on for Patrick. I guess given the field in HDV 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. And then separately for ECLIPSE 1, could you comment on the BMI and steatotic liver disease distribution and how it compares to SOLSTICE?

Marianne De Backer: Okay. Thank you, [ Arabella ], for that question. Yes, we are very happy to see that there is this broad recognition that getting rid of the virus, so really looking at target not detected, is the most important endpoint and related to outcomes. So as you know, even in our existing ECLIPSE trials design, ECLIPSE 2 has an endpoint that is only TND. So 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, so yes, our team has done an analysis of impact on BMI on the data in SOLSTICE. We haven't really designed our ECLIPSE trials differently, so 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. You may now disconnect.

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