VIR

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 4:30 p.m. ET Chief Executive Officer - Marianne De Backer Interim Principal Financial Officer - Brent Sabatini Head of Investor Relations - Kiki Patel Need a quote from a Motley Fool analyst? Email [email protected] 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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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the potential best-in-class profile of the elebsiran and tobevibart regimen to its dual-acting mechanism, which inhibits both HDV entry and HBsAg production. The company is pivoting the HDV treatment paradigm toward 'Target Not Detected' (TND) as the gold standard endpoint, citing expert consensus that viral clearance is more predictive of long-term outcomes than mere suppression. The recent U.S. approval of bulevirtide is viewed as a strategic tailwind that catalyzes disease awareness, testing infrastructure, and established treatment pathways for the HDV community. Operational progress in oncology is driven by the Astellas partnership, enabling the simultaneous launch of multiple expansion cohorts to inform future registrational designs for VIR-5500. The PRO-XTEN platform's dual-masking technology is positioned as a key differentiator to improve the therapeutic index of T-cell engagers across various solid tumor types. Strategic manufacturing readiness has been prioritized, with drug substance process performance qualification (PPQ) now complete for the lead HDV assets to ensure supply does not limit launch. A catalyst-rich period is expected with top-line data from ECLIPSE 1 in Q4 2026, followed by ECLIPSE 2 and 3 readouts in Q1 2027. The company plans to file one of the most comprehensive CHD data packages, specifically highlighting the ECLIPSE 2 'switch' data as a unique competitive differentiator at launch. Phase III registrational trials for VIR-5500 in prostate cancer are targeted for initiation in 2027, contingent on data from ongoing monotherapy and combination expansion cohorts. Cash runway is projected into the second half of 2028, supported by recent capital from collaborations and a follow-on equity offering and disciplined R&D spending following the completion of major manufacturing batches. Future pipeline expansion includes the expected nomination of additional development candidates in 2027, leveraging early clinical validation from the current T-cell engager programs. A $48 million milestone payment was made to Sanofi in Q2 2026, representing 20% of the upfront payment received from the Astellas collaboration. Management is actively addressing C-suite vacancies, specifically seeking a Chief Medical Officer with deep oncology expertise to lead the company's long-term strategic shift toward immuno-oncology. The HDV commercial strategy includes pursuing at-home administration and co-packaging to address the competitive burden of daily administration seen in existing therapies. Current HDV diagnosis rates in the U.S. are approximately 10% to 15%, with management targeting a plateau of 25% or higher through improved screening guidelines and reflex testing. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management emphasized that ECLIPSE 2 provides critical data on patients transitioning from bulevirtide, which is particularly relevant given that drug's black box warning regarding treatment discontinuation. Vir believes it will be the only company with this specific switch data at the time of launch, representing a meaningful point of differentiation for physicians. The ongoing Phase I study is characterized as a 'signal-seeking' basket trial intended to identify specific indications for further exploration. Management noted that the bar for success varies by tumor type; for example, in microsatellite stable mCRC, even single-digit objective response rates are considered meaningful due to the low existing bar. The combination is rooted in a complementary mechanism where AR blockade may increase PSMA target density. Management believes the metastatic hormone-sensitive setting offers a more favorable immune context for T-cell engagers compared to later-line settings. The company has mapped out the transition from database lock to filing as a matter of 'hours and days' to eliminate unnecessary downtime. The goal is to move as quickly as possible once the final ECLIPSE 2 and 3 data are in hand in early 2027.

Vir Biotechnology, Inc. (VIR) came out with quarterly earnings of $0.47 per share, missing the Zacks Consensus Estimate of $0.83 per share. This compares to a loss of $0.8 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -43.37%. A quarter ago, it was expected that this company would post a loss of $0.01 per share when it actually produced a loss of $0.85, delivering a surprise of -8400%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Vir Biotechnology, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $238.95 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 7.51%. This compares to year-ago revenues of $1.21 million. The company has topped consensus revenue estimates just once over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Vir Biotechnology shares have added about 52.1% since the beginning of the year versus the S&P 500's gain of 13%. While Vir Biotechnology has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Vir Biotechnology was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.76 on $0.85 million in revenues for the coming quarter and -$1.81 on $267.04 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Caribou Biosciences, Inc. (CRBU), is yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.33 per share in its upcoming report, which represents a year-over-year change of +5.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Caribou Biosciences, Inc.'s revenues are expected to be $2.5 million, down 6.4% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Vir Biotechnology, Inc. (VIR) : Free Stock Analysis Report Caribou Biosciences, Inc. (CRBU) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vir Biotechnology Inc (NASDAQ:VIR) reported compelling 96-week data from its Phase 2 SOLSTICE trial, showing 88% of patients achieved undetectable virus (TND) with the combination regimen, which a KOL called the best rate in 50 years of HDV treatment. The company completed enrollment in all three registrational ECLIPSE trials, positioning it for a catalyst-rich period with top-line data expected from ECLIPSE 1 in Q4 2026 and ECLIPSE 2 and 3 in Q1 2027. Vir Biotechnology Inc (NASDAQ:VIR) strengthened its balance sheet significantly, ending Q2 2026 with approximately $1.01 billion in cash after receiving $315 million from Astellas, extending its cash runway into the second half of 2028. The company is rapidly advancing its oncology pipeline, with VIR-5500 now enrolling patients in multiple expansion cohorts, including monotherapy and combination settings, with the ambition to initiate Phase 3 registrational trials as early as next year. Vir Biotechnology Inc (NASDAQ:VIR) completed Drug Substance Process Performance Qualification (PPQ) manufacturing for both elapsiran and tobevibart, a major milestone that de-risks the manufacturing process ahead of potential regulatory submissions. The company believes its ECLIPSE 2 study, which includes patients switching from the approved therapy bulevirtide, provides a unique differentiation point as no competing program is expected to have comparable switch data at launch. Vir Biotechnology Inc (NASDAQ:VIR) faces significant management turnover, with the company actively searching for a new CMO and CFO, which could create uncertainty in execution. The company's R&D expenses increased significantly year-over-year, driven by a $48 million milestone payment to Sanofi and higher manufacturing costs, which could pressure future margins. The current U.S. HDV diagnosis rate remains low at approximately 10-15%, and despite efforts to improve testing, the company acknowledges it may only realistically plateau at around 25%, limiting the potential addressable market. Vir Biotechnology Inc (NASDAQ:VIR) faces competitive pressure from the recently approved bulevirtide, which has a high price point of around $283,000, and the company must demonstrate its differentiation to drive adoption. The company's VIR-5818 program is still in early-stage signal-finding development, and the upcoming data update in the second half of 2026 is intended to inform dosing and identify which HER2-expressing populations warrant further study, indicating uncertainty about its path forward. The company's financial performance is heavily reliant on collaboration revenue, as evidenced by the $238.9 million in license revenue recognized in Q2 2026, which may not be sustainable on a recurring basis. Warning! GuruFocus has detected 6 Warning Signs with VIR. Is VIR fairly valued? Test your thesis with our free DCF calculator. Q: With enrollment complete for ECLIPSE 2, what efficacy and safety thresholds are you hoping to see from the study, and how could the data on switching from Bulevirtide inform future physician prescribing?A: (CEO Dr. Marianne DeVacher) ECLIPSE 2 evaluates patients who failed on Bulevirtide and switched to our combination of elapsiran and tobevibart. The primary endpoint is Target Not Detected (TND) after 24 weeks. We believe the bar is low because our TND rates are significantly higher than Bulevirtide's. Given the black box warning on Bulevirtide for discontinuation, we believe this data will be very valuable, and we are the only company expected to have this switch data at the time of launch. Q: After the initial ECLIPSE 1 readout, what is the plan and timing for long-term extension data, and will the follow-up assess durability of TND and whether patients could eventually discontinue treatment?A: (CEO Dr. Marianne DeVacher) The exploration of finite treatment is incorporated into the trial design of ECLIPSE 2 and ECLIPSE 3, but not in ECLIPSE 1, which compares the combination against deferred treatment. The overall ECLIPSE program will explore this potential for finite treatment. Q: After the Bulevirtide approval and pricing in the US, how has your thinking around competitive positioning and pricing for your combo changed? And for VIR-5500, how will early-line data, including the docetaxel combo, feed into the design of the pivotal path forward?A: (CEO Dr. Marianne DeVacher) The Bulevirtide approval has increased disease awareness, and its price is set at around $283,000. We believe our profile is significantly differentiated with 88% TND at week 96, monthly dosing, and a good safety profile. For VIR-5500, we have brought four expansion cohorts online and are preparing two others. The data collected, especially with docetaxel, will be critical for designing our pivotal trials, and we will be led by what the data tells us. Q: Can you provide more detail on the human factor study for HDV, specifically how tobevibart and elapsiran are being dosed in pivotal trials and how you hope to have the commercial formulation dosed? And for VIR-5818, what is the bar to moving forward in any individual indication?A: (CEO Dr. Marianne DeVacher) In the ECLIPSE trials, the combination is administered in a hospital. The human factor study is bridging to in-home administration. We are looking into co-packaging elapsiran and tobevibart for convenience. Monthly subcutaneous dosing also opens up the possibility for in-office administration. For VIR-5818, the signal we are looking for depends on the indication. For example, in microsatellite stable MCRC, the bar is extremely low given single-digit ORR, so the signal sought varies by tumor type. Q: Do you have any analogs or commentary from KOLs on how quickly new patient ID and diagnosis methods could be adopted for HDV? And can you comment on expense trends for the balance of the year?A: (CEO Dr. Marianne DeVacher & CFO Brent Sabatini) Since Bulevirtide launched, KOLs have mentioned that incorporating reflex testing into US guidelines is becoming acute. Major sites in California are already implementing universal reflex testing, and some are rescreening their HBV registry patients for HDV. We see gradual signs of change. On expenses, we finished our PPQ DS batches mostly in the first and second quarter. We don't give quarterly guidance, but the bigger DS expenses are behind us, and we maintain our cash runway into the second half of 2028. Q: Can you go into your efforts to expedite the BLA filing once the ECLIPSE suite of studies is in hand? And what is the rationale for starting a darolutamide combo in the hormone-sensitive setting as opposed to a combination with enzalutamide?A: (CEO Dr. Marianne DeVacher) We have mapped out the timing from last patient, last visit to database lock and filing, looking at it as a matter of hours and days to take out unnecessary downtime. We are well equipped to move quickly after ECLIPSE 1 data in Q4 and ECLIPSE 2 and 3 in Q1 2027. For darolutamide, the rationale is a complementary mechanism of action with AR blockade, and it may increase PSMA target density. The lower disease burden and more intact immune context in metastatic hormone-sensitive prostate cancer may be a more favorable setting for T-cell engagers. Q: Where do you peg the current US HDV diagnosis rate today, and where do you think diagnosis rates could realistically plateau given improved therapy and momentum toward universal testing?A: (CEO Dr. Marianne DeVacher) Diagnosis rates for HDV in the US are relatively low, around 10% to 15%. We believe it can reach about 25% or maybe more, depending on awareness, ease of testing, and reimbursement. There is a lot of low-hanging fruit to improve diagnosis for HDV. Q: Given the field's shift towards focusing on TND, has the FDA shared their view on TND alone versus TND plus ALT normalization? And for ECLIPSE 1, could you comment on the BMI and cirrhotic liver disease distribution compared to SOLSTICE?A: (CEO Dr. Marianne DeVacher) We are happy to see broad recognition that TND is the most important endpoint. ECLIPSE 2 has an endpoint that is only TND. While we don't know the FDA's position, the fact that they have accepted our endpoints as they are today is a good parameter. On BMI, our team has analyzed its impact on SOLSTICE data, but we haven't designed the ECLIPSE trials differently, so there won't be a fundamental difference in BMI distribution between SOLSTICE and ECLIPSE. Q: There has been significant management turnover this past year. How confident are you that you have the team in place to manage both distinct clinical programs, and how do you plan to bolster the C-suite?A: (CEO Dr. Marianne DeVacher) I am very confident For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Vir Biotechnology, Inc.? Here are five stocks we like better. Hepatitis delta program advances: Vir completed enrollment in its final ECLIPSE registrational study and expects data from ECLIPSE 1 in Q4 2026, followed by ECLIPSE 2 and 3 in Q1 2027. In Phase II SOLSTICE, the elebsiran-tobevibart combination produced higher rates of undetectable virus at 96 weeks than tobevibart alone and was generally well tolerated. Oncology pipeline expands: Vir and Astellas began enrolling multiple monotherapy and combination cohorts for prostate cancer candidate VIR-5500, with Phase III trials potentially starting as early as 2027. Updated dose-escalation data for HER2-targeted VIR-5818 are expected in the second half of 2026. Strong financial position: Cash, equivalents and investments reached approximately $1.01 billion after $315 million in Astellas payments, while Q2 net income was $80.1 million versus a $111 million loss a year earlier. Management expects the cash runway to extend into the second half of 2028. From laggards to leaders: Small caps on the rise Vir Biotechnology (NASDAQ:VIR) reported second-quarter 2026 results alongside updates on its chronic hepatitis delta and oncology programs, highlighting completed enrollment in a key hepatitis delta study, plans for multiple data readouts, and expanded development activity for its prostate cancer candidate VIR-5500. The company ended the quarter with approximately $1.01 billion in cash, cash equivalents and investments, up $198.5 million from the prior quarter. The increase reflected payments from Astellas totaling $315 million, including a $240 million upfront payment and a $75 million equity investment. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Virios Therapeutics Up 75% on Fibromyalgia Phase 3 Proposal Chief Executive Officer Marianne De Backer said Vir completed enrollment in ECLIPSE 2 during the second quarter. With enrollment completed across all three registrational ECLIPSE studies, the company expects top-line results from ECLIPSE 1 in the fourth quarter of 2026, followed by ECLIPSE 2 and ECLIPSE 3 data in the first quarter of 2027. The studies are evaluating elebsiran and tobevibart for chronic hepatitis delta, or CHD. ECLIPSE 2 is designed to assess patients who did not achieve viral suppression while receiving bulevirtide and are switched to Vir’s combination regimen. De Backer said the study’s endpoint is target not detected, or TND, after 24 weeks. → 3 Drone Stocks That Should Soar After the Summer Slump Vir also presented complete 96-week Phase II SOLSTICE data at the EASL Congress. In the intention-to-treat analysis, 88% of patients receiving elebsiran plus tobevibart achieved undetectable virus at week 96, compared with 53% of patients receiving tobevibart alone. In a last-observation-carried-forward analysis, 97% of combination-treated patients achieved undetectable virus at week 96. Approximately 90% of patients receiving the combination achieved hepatitis B surface antigen levels below 10 IUs per mL at week 96, versus 25% for antibody monotherapy, according to the company. ALT normalization was reported in 53% of combination-treated patients. About half of the SOLSTICE population had cirrhosis classified as Child-Pugh class A. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth De Backer said the combination was generally well tolerated. The most common treatment-emergent adverse event was mild-to-moderate flu-like symptoms that were transient and resolved after the first dose. The company reported no treatment-related serious adverse events or discontinuations. Vir said it is conducting human-factor studies intended to support at-home administration under its Breakthrough Therapy Designation interactions with the FDA. The company is also pursuing U.S. co-packaging of elebsiran and tobevibart. In the registrational ECLIPSE studies, the treatment is administered in a hospital setting; the potential commercial regimen would involve two monthly subcutaneous injections administered at the same time. The company completed drug-substance process performance qualification manufacturing for both treatments and is progressing drug-product PPQ batches. Vir’s partner Norgine is preparing for potential launches in Europe, Australia and New Zealand if the regimen receives EU approval. Management said the recent U.S. approval of bulevirtide could raise awareness and testing for hepatitis delta. De Backer cited European experience in which the first approved hepatitis delta therapy was associated with reported increases in testing and diagnosis rates of fivefold to tenfold in certain areas. The company said experts have discussed potential updated AASLD screening and treatment guidelines, including double reflex testing. Under that approach, patients who test positive for hepatitis B surface antigen would automatically receive hepatitis delta antibody testing, followed by hepatitis delta RNA testing if the antibody result is positive. During the question-and-answer session, De Backer said U.S. hepatitis delta diagnosis rates are currently around 10% to 15%. She said Vir believes the rate could reach approximately 25% or higher, depending on awareness, testing access and reimbursement practices. Vir and Astellas are advancing VIR-5500, a PRO-XTEN dual-masked PSMA-targeted T-cell engager for prostate cancer. The company has started enrolling patients in three monotherapy expansion cohorts: taxane-naive metastatic castration-resistant prostate cancer, radioligand therapy-naive metastatic castration-resistant prostate cancer, and radioligand therapy-exposed metastatic castration-resistant prostate cancer. Vir is also enrolling a taxane-naive metastatic castration-resistant prostate cancer combination cohort pairing VIR-5500 with enzalutamide. A docetaxel combination cohort in the same population and a darolutamide combination cohort in metastatic hormone-sensitive prostate cancer are expected to begin in coming months. The company is evaluating step-up doses of 800, 2,000 and 3,500 micrograms per kilogram every three weeks across monotherapy and combination cohorts. De Backer said data from the expansion program, including the docetaxel combination, will help guide the design of anticipated pivotal studies. Vir aims to initiate Phase III registrational trials for VIR-5500 as early as 2027 and has secured manufacturing capacity intended to support that program. Vir also expects to report updated dose-escalation results during the second half of 2026 for VIR-5818, a HER2-targeted T-cell engager being studied alone and in combination with pembrolizumab. The company described the Phase I basket study as a signal-finding effort across multiple HER2-expressing tumor types. VIR-5525, an EGFR-targeted T-cell engager, remains in Phase I dose escalation as monotherapy and in combination with pembrolizumab. Vir recognized $238.9 million in license and collaboration revenue during the second quarter, largely tied to the Astellas upfront payment. Research and development expense was $135.3 million, up from $97.5 million a year earlier. The expense included a $48 million milestone payment to Sanofi, representing 20% of the Astellas upfront payment, as well as hepatitis delta qualification manufacturing costs. Selling, general and administrative expense rose to $30.2 million from $22.3 million in the prior-year period, primarily due to one-time advisory and legal costs related to the Astellas agreement. Vir reported net income of $80.1 million for the quarter, compared with a net loss of $111 million a year earlier. Interim Principal Financial Officer Brent Sabatini said that, based on the current operating plan, Vir expects its cash runway to extend into the second half of 2028. Vir Biotechnology, Inc is a clinical‐stage immunology company dedicated to developing therapies that prevent and treat serious infectious diseases. The company leverages a suite of proprietary technology platforms—ranging from antibody isolation and screening tools to cell‐based assays and bioinformatics—to identify and advance antiviral and antibacterial candidates. Its scientific approach centers on harnessing the human immune system through monoclonal antibodies and immunomodulatory agents. The company's pipeline includes product candidates targeting influenza A, COVID‐19, HIV, hepatitis B, and tuberculosis. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Vir Biotechnology Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

- Phase 2 SOLSTICE data presented at the EASL Congress showed that elebsiran and tobevibart achieved undetectable HDV RNA in 88% of participants with chronic hepatitis delta (CHD) at Week 96 of treatment - Topline data from Phase 3 ECLIPSE 1 trial expected in the fourth quarter of 2026 - Closed global strategic collaboration with Astellas and initiated additional VIR-5500 Phase 1 monotherapy and combination therapy dose-expansion cohorts in patients with metastatic prostate cancer - Ended quarter with over $1.0 billion in cash, cash equivalents and investments - Conference call scheduled for August 5, 2026, at 4:30 p.m. ET / 1:30 p.m. PT SAN FRANCISCO, August 05, 2026--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR), today provided a corporate update and reported financial results for the second quarter ended June 30, 2026. "This is a pivotal time for the CHD community, when availability of new therapies could improve awareness, testing and access to care. At EASL, experts emphasized that achieving durable suppression of hepatitis delta virus to undetectable levels is a key predictor of improved clinical outcomes for people with CHD. Our Week 96 SOLSTICE results demonstrate the potential of our dual-acting elebsiran and tobevibart combination regimen to rapidly achieve undetectable virus in most patients and raise the bar for treatment of this devastating condition," said Marianne De Backer, Chief Executive Officer of Vir Biotechnology. "Beyond CHD, we remain focused on rapid execution of our joint clinical program with Astellas in prostate cancer and have initiated monotherapy and combination therapy dose-expansion cohorts in our VIR-5500 Phase 1 study that will help inform pivotal trial design." Pipeline Programs Chronic Hepatitis Delta (CHD) The Company completed enrollment in the Phase 3 ECLIPSE 2 trial, and the entire ECLIPSE registrational program is now fully enrolled. ECLIPSE 2 evaluates the efficacy and safety of switching from bulevirtide to elebsiran and tobevibart in people with CHD who have not achieved viral suppression with bulevirtide therapy and is intended support medication transitions as appropriate. These data, along with data from ECLIPSE 1 and 3, will be part of a comprehensive global filing package. The Company presented complete Week 96 Phase 2 SOLSTICE data at the European Association for the Study of the Liver (EASL) Congress in May 2026. Solid Tumors VIR-5500 The Company closed its global strategic collaboration with Astellas to advance PSMA-targeted, PRO-XTEN® dual-masked T-cell engager (TCE) VIR-5500 for the treatment of prostate cancer. The companies have built a strong operational infrastructure for collaboration and rapidly worked together on Phase 1 trial design to advance the dose-expansion cohorts. The Company initiated additional Phase 1 dose-expansion cohorts evaluating VIR-5500 at Q3W 800/2000/3500 µg/kg step-up dosing. The first patients were dosed in three monotherapy cohorts evaluating VIR-5500 in taxane naïve metastatic castration-resistant prostate cancer (mCRPC), radioligand therapy naïve mCRPC and radioligand therapy exposed mCRPC, and one combination cohort evaluating VIR-5500 in combination with enzalutamide in early-line mCRPC. The Company anticipates initiating two additional Phase 1 dose-expansion cohorts, including VIR-5500 in combination with docetaxel in early-line mCRPC and VIR-5500 in combination with darolutamide in metastatic hormone-sensitive prostate cancer. The Company anticipates initiating pivotal Phase 3 trials in 2027. VIR-5818 The Company expects to report updated dose-escalation data from its Phase 1 trial evaluating VIR-5818, a HER2-targeted PRO-XTEN® dual-masked TCE, as a monotherapy and in combination with pembrolizumab, in the second half of 2026. The dose-escalation parts of the Phase 1 trial have a basket design, enrolling across multiple tumor types. VIR-5525 The Phase 1 trial of VIR-5525, an EGFR-targeted PRO-XTEN® dual-masked TCE, as a monotherapy and in combination with pembrolizumab continues enrollment as expected. Preclinical Pipeline Candidates The Company is currently progressing a number of PRO-XTEN® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors. Corporate Update The Company appointed Timothy Coughlin, CPA to its Board of Directors and as Chair of the Audit Committee. Second Quarter 2026 Financial Results Cash, Cash Equivalents and Investments: As of June 30, 2026, the Company had approximately $1.01 billion in cash, cash equivalents and investments, representing an increase of approximately $198.5 million during the second quarter of 2026. During the second quarter of 2026, the Company received a $240.0 million upfront payment and a $75 million equity investment payment from Astellas and made a $48.0 million pass-through payment to Sanofi. Revenues: Total revenues for the second quarter of 2026 were $238.9 million, primarily reflecting license and collaboration revenue recognized in connection with the $240.0 million upfront payment received from Astellas in the quarter. Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $135.3 million, which included $5.5 million of non-cash stock-based compensation expense, compared to $97.5 million for the same period in 2025, which included $6.9 million of non-cash stock-based compensation expense. The increase was primarily driven by a $48.0 million milestone payment to Sanofi triggered by the closing of our agreement with Astellas, as well as higher CHD contract manufacturing costs associated with process performance qualification batches in preparation for commercialization. Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2026 were $30.2 million, which included $6.9 million of non-cash stock-based compensation expense, compared to $22.3 million for the same period in 2025, which included $5.5 million of non-cash stock-based compensation expense. The increase was primarily due to one-time advisory and legal fees in connection with the closing of our Astellas agreement. Net Income (Loss): Net income for the second quarter of 2026 was $80.1 million, or $0.48 per share, basic and $0.47 per share, diluted, compared to a net loss of $111.0 million, or $0.80 per share, basic and diluted for the same period in 2025. The change from net loss to net income was primarily driven by $238.9 million in license and collaboration revenue recognized this quarter from the $240.0 million Astellas upfront payment. 2026 Financial Guidance Based on our current operating plans, including the net effects of the Astellas global collaboration, the Company expects its cash, cash equivalents and investments to fund operations into the second half of 2028. Conference Call Vir Biotechnology will host its second quarter 2026 financial results conference call at 4:30 p.m. ET / 1:30 p.m. PT today. A live webcast will be available at https://investors.vir.bio and will be archived for 30 days. About the ECLIPSE Registrational Program ECLIPSE is a registrational program to evaluate the safety and efficacy of elebsiran in combination with tobevibart in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of elebsiran in combination with tobevibart compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating the efficacy and safety of switching to elebsiran and tobevibart in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a Phase 2b head-to-head trial evaluating combination elebsiran and tobevibart compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets. About Elebsiran and Tobevibart Elebsiran and tobevibart are investigational agents being evaluated as a novel combination regimen administered monthly as two separate sequential subcutaneous injections for the treatment of chronic hepatitis delta (CHD). The combination is designed to disrupt the hepatitis delta virus (HDV) life cycle at multiple points by addressing both viral entry and the sustained presence of hepatitis B surface antigen (HBsAg) that enables ongoing HDV replication. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg. Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting HBsAg. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. About Chronic Hepatitis Delta (CHD) CHD is the most severe form of chronic viral hepatitis1 and was recently classified as carcinogenic by the International Agency for Research on Cancer.2 People living with the disease rapidly progress to cirrhosis, liver failure3 and liver-related death.1 Because ongoing hepatitis delta virus (HDV) replication drives disease progression, achieving undetectable virus, as defined by HDV RNA TND (target not detected), is considered an important virologic marker associated with improved clinical outcomes in CHD.4 Individuals with CHD who have detectable HDV RNA are at a higher risk of experiencing any liver-related event, including developing compensated and decompensated cirrhosis, hepatocellular carcinoma, liver transplantation and mortality, compared to patients with undetectable HDV RNA.4 There are currently limited approved treatments in the U.S. and globally. About VIR-5500, VIR-5818 and VIR-5525 VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO-XTEN® masking technology and target PSMA, HER2 and EGFR, respectively. T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The universal PRO-XTEN® masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians. About Advanced Prostate Cancer Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.5 While diagnostic and therapeutic advances like androgen-directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).6 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).7 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.8 There is a critical need for safer, more effective and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. References: 1 National Institute of Diabetes and Digestive and Kidney Diseases. Hepatitis D. NIDDK. Published November 2024. Accessed September 2025. Hepatitis D - NIDDK (nih.gov).2 Karagas, Margaret R et al., "Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus" The Lancet Oncology, vol. 26, no. 8 (2025): 994 – 995. doi: 10.1016/S1470-2045(25)00403-6.3 Center for Disease Control and Prevention. Hepatitis D FAQs. CDC. Published March 2020. Accessed September 2025. What is Hepatitis D - FAQ | CDC.4 Gish R. (2024). Association of hepatitis delta virus with liver morbidity and mortality: A systematic literature review and meta-analysis. Hepatology. 79:1129-1140.5 Kratzer TB, et. al. "Prostate cancer statistics, 2025." CA Cancer J Clin. vol. 75 no. 6 (2025): 485-497. doi:10.3322/caac.70028.6 Bernard-Terrier A & Beltran H. "Exploring the biology of metastatic hormone-sensitive prostate cancer: on the road to precision medicine." J Clin Invest. vol. 136 no. 3 (2026):e200920. doi: 10.1172/JCI200920.7 Leith A, et. al. "Real-World Treatment Patterns in Metastatic Castration-Resistant Prostate Cancer Across Europe (France, Germany, Italy, Spain, and the United Kingdom) and Japan." Adv Ther. vol. 39 (2022): 2236-2255. doi: 10.1007/s12325-022-02073-w.8 Huo, X et al. "Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram." Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "should," "could," "may," "might," "will," "plan," "potential," "aim," "expect," "anticipate," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: Vir Biotechnology’s cash balance and anticipated runway; the potential for new therapies to improve awareness, testing and access to care for the CHD community; Vir Biotechnology’s future financial and operating results and its expectations related thereto, including Vir Biotechnology’s financial guidance; the therapeutic and commercial potential of Vir Biotechnology's CHD program, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the therapeutic and commercial potential of VIR-5500 and the other assets in Vir Biotechnology's oncology solid tumor clinical portfolio, preclinical pipeline and the PRO-XTEN® masking technology, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the potential of and Vir Biotechnology’s expectations for its other pipeline programs; Vir Biotechnology’s plans and expectations for its clinical development programs, including protocols for and enrollment into ongoing and planned clinical studies, potential partnering opportunities, and data readouts and presentations, as well as anticipated timelines; the potential benefits, safety and efficacy of Vir Biotechnology’s investigational therapies; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; the timing and amount of Vir Biotechnology’s actual operating expenses, as determined in accordance with U.S. Generally Accepted Accounting Principles; difficulties in collaborating with other companies, some of whom may be competitors of Vir Biotechnology or otherwise have divergent interests, and uncertainty as to whether the benefits of Vir Biotechnology’s various collaborations can ultimately be achieved in the amounts and on the timeline Vir Biotechnology expects; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors, as well as changes in expected or existing competition; Vir Biotechnology’s use of AI and machine learning in its efforts to engineer next-generation proteins and in other research and development efforts; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later-stage or larger-scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. View source version on businesswire.com: https://www.businesswire.com/news/home/20260805596908/en/ Contacts Media Contact Caren ScannellDirector, [email protected] Investor Contact Kiki Patel, PharmDHead of Investor [email protected]

It's been a mediocre week for Vir Biotechnology, Inc. (NASDAQ:VIR) shareholders, with the stock dropping 10% to US$9.12 in the week since its latest first-quarter results. It was a pretty bad result overall, with revenues coming in 100% lower than the analysts predicted. Unsurprisingly, the statutory profit the analysts had been forecasting evaporated, turning into a loss of US$0.85 per share. The analysts typically update their forecasts at each earnings report, and we can judge from their estimates whether their view of the company has changed or if there are any new concerns to be aware of. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Taking into account the latest results, the consensus forecast from Vir Biotechnology's five analysts is for revenues of US$249.4m in 2026. This reflects a sizeable 281% improvement in revenue compared to the last 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 45% to US$1.45. Before this latest report, the consensus had been expecting revenues of US$244.0m and US$1.39 per share in losses. Overall it looks as though the analysts were a bit mixed on the latest consensus updates. Although there was a nice uplift to revenue, the consensus also made a moderate increase in its losses per share forecasts. Check out our latest analysis for Vir Biotechnology The consensus price target stayed unchanged at US$20.56, seeming to suggest that higher forecast losses are not expected to have a long term impact on the valuation. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. Currently, the most bullish analyst values Vir Biotechnology at US$30.00 per share, while the most bearish prices it at US$16.00. Note the wide gap in analyst price targets? This implies to us that there is a fairly broad range of possible scenarios for the underlying business. Looking at the bigger picture now, one of the ways we can make sense of these forecasts is to see how they measure up against both past performance and industry growth estimates. For example, we noticed that Vir Biotechnology's rate of growth is expected to accelerate meaningfully, with revenues forecast to exhibit 5x growth to the end of 2026 on an annualised basis. That is well above its historical decline of 46% a year over the past five years. By contrast, our data suggests that other companies (with analyst coverage) in the industry are forecast to see their revenue grow 22% per year. So it looks like Vir Biotechnology is expected to grow faster than its competitors, at least for a while. The most important thing to note is the forecast of increased losses next year, suggesting all may not be well at Vir Biotechnology. Pleasantly, they also upgraded their revenue estimates, and their forecasts suggest the business is expected to grow faster than the wider industry. The consensus price target held steady at US$20.56, with the latest estimates not enough to have an impact on their price targets. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. We have estimates - from multiple Vir Biotechnology analysts - going out to 2028, and you can see them free on our platform here. We don't want to rain on the parade too much, but we did also find 5 warning signs for Vir Biotechnology (1 makes us a bit uncomfortable!) that you need to be mindful of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Interested in Vir Biotechnology, Inc.? Here are five stocks we like better. Astellas collaboration closes: Vir and Astellas will co-develop and co-commercialize VIR-5500 in a deal worth up to $1.7 billion (U.S. profits 50/50); phase I showed a favorable safety profile with outpatient potential, Vir has begun monotherapy expansion dosing and is targeting a registrational phase III program in 2027 pending data. HDV program momentum: The tobevibart+elebsiran combination produced strong viral suppression in SOLSTICE (88% TND at 96 weeks vs 46% for monotherapy; 41% at 24 weeks), and all three ECLIPSE registrational studies are on track with ECLIPSE 1 topline expected Q4 2026 and Vir stating ECLIPSE 1+2 would be needed for filing. Financial position and runway: Vir held about $809.3 million cash at March 31 (pre-Astellas proceeds), received $75 million at deal close and expects $240 million upfront soon, and says its cash runway now extends into the second half of 2028. From laggards to leaders: Small caps on the rise Vir Biotechnology (NASDAQ:VIR) reported first-quarter 2026 financial results and provided pipeline updates, highlighting progress across its oncology programs and its registrational hepatitis delta virus (HDV) effort. Management also discussed the closing of a global collaboration with Astellas focused on VIR-5500, the company’s PSMA-targeted T-cell engager in prostate cancer. CEO Marianne De Backer said Vir has remained focused on executing across oncology and HDV programs since the company’s prior update in February. She began by reviewing the Astellas partnership, which she described as “a deal valued at up to $1.7 billion,” and noted the transaction “successfully closed on April 15.” Under the agreement, Vir and Astellas will co-develop and co-commercialize VIR-5500, a “PRO-XTEN dual masked PSMA-targeted T-cell engager,” with U.S. commercial profits split 50/50 and an option for Vir to co-promote. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? Virios Therapeutics Up 75% on Fibromyalgia Phase 3 Proposal De Backer emphasized the rationale for partnering, citing Astellas’ presence in prostate cancer and “decade-long track record” co-developing therapies such as XTANDI. She framed metastatic castration-resistant prostate cancer (mCRPC) as an area of high unmet need, referencing a “five-year survival rate of only 30%.” Discussing previously presented phase I data, De Backer said VIR-5500 showed a “favorable safety and tolerability profile with no observed dose-limiting toxicities.” At dose levels of 3,000 mcg/kg and above, she said the company saw “mostly grade 1 cytokine release syndrome” and “did not observe any grade 3 CRS at this dose.” She highlighted the absence of mandatory steroid pre-medication in the protocol, which she called a “meaningful differentiator,” and suggested steroid sparing could preserve T-cell function and simplify administration. → A Prada Payday: Is AMC Back in Style? De Backer said the safety profile could support outpatient administration and potentially allow use across settings “both the pre as well as post radioligand therapy (RLT).” On efficacy, she said the company observed “depth of PSA and RECIST responses,” with several patients sustaining responses “for up to 27 weeks,” and noted “emerging signs of durability up to eight and 12 months” in extended follow-up cases. She also pointed to activity in heavily pretreated patients, including those with liver metastases, and referenced a complete response in a patient who had relapsed after an actinium-based PSMA radioligand. The company has now dosed the first patient in phase I dose expansion cohorts for VIR-5500 monotherapy in late-line mCRPC. In expansion, Vir is evaluating a “Q3 week, 800, 2,000, 3,500 mcg/kg step-up dosing” approach in patients refractory after multiple prior lines, including at least one second-generation androgen receptor pathway inhibitor and one taxane regimen. The expansion includes cohorts for patients who are RLT-naïve and those who previously received RLT. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% De Backer also said dose escalation continues for VIR-5500 in combination with enzalutamide in earlier-line mCRPC, and that the company anticipates dosing the first patient in combination dose expansion cohorts “in both early-line mCRPC and metastatic hormone-sensitive prostate cancer over the coming months.” Vir continues to target initiation of a registrational phase III program for VIR-5500 in 2027, pending data. During Q&A, De Backer said the decision to move into phase III will be based on “the totality of the data,” including “PSA, RECIST, our PFS,” and that the monotherapy expansion is intended to deepen the pre- and post-RLT data set. Asked about durability expectations, she said there was not a single threshold but that the company will look for “durability more consistency across the entire expansion cohort.” Beyond VIR-5500, De Backer provided updates on Vir’s other PRO-XTEN T-cell engager programs. VIR-5818 is the company’s masked HER2-targeted T-cell engager being studied in a basket trial design across multiple tumor types. Vir expects to report preliminary response data for VIR-5818 monotherapy and in combination with pembrolizumab in the second half of 2026. De Backer characterized the study as “signal-seeking,” intended to inform dose and identify HER2-expressing populations that may warrant further study. In response to a question on potential development in HER2-positive breast cancer, De Backer said the “bar is high” given available therapies, but added that there remains opportunity to improve treatment outcomes. She said Vir would provide additional guidance after the second-half data update. On VIR-5525, a dual-masked EGFR-targeted T-cell engager, De Backer said phase I enrollment is progressing as expected, with a design incorporating learnings from VIR-5818 and VIR-5500. The study includes both monotherapy and pembrolizumab combination arms across multiple EGFR-expressing tumor types, including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and cutaneous squamous cell carcinoma. Asked about another company discontinuing an EGFR T-cell engager, De Backer said the “surprising” element was musculoskeletal issues being cited as dose-limiting toxicity, which she said Vir will monitor. She argued Vir’s masking approach is differentiated, saying the company uses steric hindrance and applies “the same PRO-XTEN mask across all of our clinical programs,” enabling dosing flexibility. She added that based on experience with VIR-5500, the masking technology “allows you to dose much higher,” which she linked to potential improvements in therapeutic index. De Backer said the HDV community remains underserved and estimated “approximately 180,000 actively viremic patients across the United States, U.K., and E.U.” She described Vir’s regimen—tobevibart (a neutralizing monoclonal antibody) plus elebsiran (a small interfering RNA)—as positioned with two key advantages versus competitors: potential best-in-class efficacy and a strong safety profile, along with monthly subcutaneous dosing that may enable both at-home and in-office administration. De Backer emphasized “target not detected (TND)” as the “gold standard measure” of viral clearance and cited peer-reviewed evidence linking undetectable virus with improved long-term outcomes. She reviewed a subset of phase II SOLSTICE data at 96 weeks that Vir reported in January, stating that 88% of evaluable participants on the combination achieved undetectable virus versus 46% on tobevibart monotherapy. She also cited 41% undetectable virus at 24 weeks, describing a rapid onset and a time-dependent increase in viral suppression with combination therapy. She added that efficacy appeared similar in cirrhotic patients, which she expects to be a significant cohort at launch because of delayed diagnosis. On safety, De Backer said the combination was well-tolerated with “no grade 3 or higher treatment-related adverse events and discontinuations.” She also reiterated the administration profile: “monthly,” consisting of “two subcutaneous injections to be administered at the same time,” compared with competitive regimens that require daily or weekly injections. Vir plans to present the complete 96-week SOLSTICE phase II data in an oral presentation at EASL 2026 on May 29 in Barcelona, and a poster on a 48-week subgroup analysis focused on BMI and ALT normalization after viral control. For the registrational program, De Backer said all three ECLIPSE studies are on track: ECLIPSE 1: Enrollment complete at approximately 120 participants randomized 2:1 (combination therapy vs deferred treatment). Primary endpoint is a composite of TND plus ALT normalization at week 48. Vir expects top-line data in the fourth quarter of 2026. ECLIPSE 2: Enrollment ongoing across European sites; approximately 150 patients randomized 2:1 to evaluate switching to the combination in patients with inadequate response to bulevirtide. Primary endpoint is TND at week 24. ECLIPSE 3: Enrollment complete at approximately 100 patients randomized 2:1 in a head-to-head comparison versus bulevirtide. Primary endpoint is TND at week 48. During Q&A, De Backer said Vir’s “guidance is that we would need a combination of ECLIPSE 1 and ECLIPSE 2 for filing,” with ECLIPSE 1 in the fourth quarter and ECLIPSE 2 expected in the first quarter of next year. She also discussed the competitive backdrop, calling Gilead’s expected U.S. launch of bulevirtide a positive for market development, including increased awareness and screening. De Backer said Vir estimates about 61,000 actively viremic patients in the U.S., with only “about 10%–15%” currently diagnosed. She pointed to potential improvements from streamlined testing such as reflex testing after a positive hepatitis B result. On pricing, De Backer said HDV is an orphan disease and referenced bulevirtide pricing outside the U.S., citing Europe prices “somewhere between $60,000 and $165,000” and Canada at “$115,000.” She added that analyst estimates she has seen range from “$150,000 to $250,000,” which she said Vir views as “very adequate” for a severe orphan disease. CFO Jason O’Byrne reported that Vir ended the first quarter with approximately $809.3 million in cash, cash equivalents, and investments, including proceeds from a February follow-on equity offering that generated gross proceeds of about $172.5 million before fees and expenses. He said the proceeds are intended to fund Vir’s share of VIR-5500 development costs, support the broader T-cell engager platform, and provide working capital. O’Byrne noted that the Astellas collaboration closed after quarter end and that the $315 million in proceeds from that transaction were not reflected in the March 31 cash balance. He said the company received a $75 million cash payment tied to Astellas’ equity investment upon closing and expects a $240 million upfront payment within 30 days of closing. Vir is also eligible for a $20 million manufacturing tech transfer milestone in 2027, and the companies will share global development costs 40% (Vir) and 60% (Astellas). Vir is eligible for up to $1.37 billion in additional development, regulatory, and ex-U.S. sales milestones, as well as tiered double-digit royalties on ex-U.S. net sales, with a portion of certain proceeds shared with Sanofi under an existing license agreement. For the quarter, Vir reported R&D expense of $108.9 million (including $6 million of stock-based compensation) versus $118.6 million a year ago, and SG&A expense of $23.3 million (including $6.1 million of stock-based compensation) versus $23.9 million a year ago. Operating expenses totaled $132.3 million, down $10.3 million year over year. Net loss was $125.7 million, compared with a net loss of $121 million in the prior-year quarter. O’Byrne said that, based on the current operating plan and including the net effects of the Astellas agreement and capital raise, Vir expects its cash runway to extend into the second half of 2028. In closing remarks, De Backer said that since December 2025, collaborations with Norgine and Astellas, along with financing activity, have generated “over a half of a billion dollars in capital,” strengthening Vir’s balance sheet. She said Vir is advancing seven preclinical T-cell engager assets using the PRO-XTEN platform and highlighted upcoming catalysts across both oncology and HDV programs, with priorities focused on rapid clinical execution, advancing expansion and registrational-enabling studies, and disciplined capital deployment. Vir Biotechnology, Inc is a clinical‐stage immunology company dedicated to developing therapies that prevent and treat serious infectious diseases. The company leverages a suite of proprietary technology platforms—ranging from antibody isolation and screening tools to cell‐based assays and bioinformatics—to identify and advance antiviral and antibacterial candidates. Its scientific approach centers on harnessing the human immune system through monoclonal antibodies and immunomodulatory agents. The company's pipeline includes product candidates targeting influenza A, COVID‐19, HIV, hepatitis B, and tuberculosis. The article "Vir Biotechnology Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

- Global strategic collaboration with Astellas to advance PSMA-targeted, PRO-XTEN® dual-masked T-cell engager (TCE) VIR-5500 closed and first patient dosed in Phase 1 dose-expansion cohorts in patients with late-line metastatic prostate cancer - Company will present complete Week 96 Phase 2 SOLSTICE data on its combination regimen for chronic hepatitis delta (CHD) at the European Association for the Study of the Liver (EASL) Congress - Strong financial position with $809.3 million in cash and investments as of March 31, 2026, excluding $315 million combined Astellas upfront payment1 and equity investment to be received in the second quarter of 2026 - Conference call scheduled for May 6, 2026, at 4:30 p.m. ET / 1:30 p.m. PT SAN FRANCISCO, May 06, 2026--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR), today provided a corporate update and reported financial results for the first quarter ended March 31, 2026. "Vir Bio delivered incredible momentum during the first quarter with positive, new VIR-5500 Phase 1 data and execution of a global agreement with Astellas in prostate cancer. The closing of our collaboration with Astellas in April has ignited the next stage of development work, bolstering our ability to move faster and think bigger together," said Marianne De Backer, Chief Executive Officer of Vir Biotechnology. "We also announced promising updated Phase 2 data on our combination regimen in CHD and will be presenting complete Week 96 data at the EASL Congress later this month. CHD is the most severe form of hepatitis. We believe our well-tolerated combination regimen is uniquely positioned to change the standard of care, bringing together robust efficacy with the potential for self-administration at home with once monthly subcutaneous dosing." Pipeline Programs Chronic Hepatitis Delta (CHD) The Company will present additional data from the Phase 2 SOLSTICE trial evaluating the combination of tobevibart and elebsiran for CHD at the EASL Congress taking place May 27-30, 2026. Earlier this year, the Company reported Phase 2 SOLSTICE data showing that the monthly combination of tobevibart and elebsiran was highly efficacious and well-tolerated. Undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) was achieved and maintained by 77% (24/31) of participants receiving the combination regimen at Week 72. This rate increased to 88% (21/24) in the subset of participants evaluated through Week 96. Topline data from the Phase 3 ECLIPSE 1 trial are expected in the fourth quarter of 2026. Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027. Solid Tumors VIR-5500 The Company closed its global strategic collaboration with Astellas to advance PSMA-targeted, PRO-XTEN® dual-masked TCE VIR-5500 for the treatment of prostate cancer. The first patient was dosed in the Phase 1 dose-expansion cohorts evaluating the safety, pharmacokinetics and preliminary efficacy of VIR-5500 in prostate cancer. The first expansion cohort will evaluate VIR-5500 monotherapy in Q3W 800/2000/3500 µg/kg step-up dosing in late-line metastatic castration-resistant prostate cancer (mCRPC). The Company anticipates initiating pivotal Phase 3 trials in 2027. Positive updated Phase 1 data for VIR-5500 monotherapy showed dose-dependent anti-tumor activity and a well-tolerated safety profile in patients with mCRPC. The data were presented in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. VIR-5818 Phase 1 dose-escalation of VIR-5818, a HER2-targeted PRO-XTEN® dual-masked TCE, in combination with pembrolizumab continues, with response data expected in the second half of 2026. VIR-5525 The Phase 1 study of VIR-5525, an EGFR-targeted PRO-XTEN® dual-masked TCE, continues enrollment as expected. Preclinical Pipeline Candidates The Company is currently progressing a number of PRO-XTEN® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors, including lung, colorectal and bladder. Corporate Update The Company completed a follow-on public offering of common stock with gross proceeds of $172.5 million, before deducting underwriting discounts and commissions and offering expenses. First Quarter 2026 Financial Results Cash, Cash Equivalents and Investments: As of March 31, 2026, the Company had $809.3 million in cash, cash equivalents and investments, representing an increase of approximately $27.7 million during the first quarter of 2026. During the first quarter of 2026, the Company completed a public offering of its common stock with gross proceeds of $172.5 million, before deducting underwriting discounts and commissions and offering expenses. Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $108.9 million, which included $6.0 million of non-cash stock-based compensation expense, compared to $118.6 million for the same period in 2025, which included $7.0 million of non-cash stock-based compensation expense. The decrease was primarily driven by a $30.0 million expense in the first quarter of 2025 in connection with signing the restated Alnylam agreement, partially offset by higher CHD contract manufacturing costs associated with process performance qualification batches in preparation for commercialization, and to a lesser extent, higher clinical expenses from the progression of both our CHD and oncology programs in the first quarter of 2026. Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2026 were $23.3 million, which included $6.1 million of non-cash stock-based compensation expense, compared to $23.9 million for the same period in 2025, which included $7.1 million of non-cash stock-based compensation expense. Net Loss: Net loss for the first quarter of 2026 was $125.7 million, or $0.85 per share, basic and diluted, compared to a net loss of $121.0 million, or $0.88 per share, basic and diluted for the same period in 2025. 2026 Financial Guidance Based on our current operating plans, including the net effects of the Astellas global collaboration, the Astellas equity investment and the completion of the recent equity financing, the Company expects its cash, cash equivalents and investments to fund operations into the second half of 2028. Conference Call Vir Biotechnology will host its first quarter 2026 financial results conference call at 4:30 p.m. ET / 1:30 p.m. PT today. A live webcast will be available at https://investors.vir.bio and will be archived for 30 days. About the ECLIPSE Registrational Program ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a Phase 2b head-to-head trial evaluating combination tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. About Chronic Hepatitis Delta (CHD) CHD is the most severe form of chronic viral hepatitis2 and was recently classified as carcinogenic by the International Agency for Research on Cancer.3 People living with the disease rapidly progress to cirrhosis, liver failure4 and liver-related death.2 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally. About VIR-5500, VIR-5818 and VIR-5525 VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO-XTEN® masking technology and target PSMA, HER2 and EGFR, respectively. TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The universal PRO-XTEN® masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians. About Advanced Prostate Cancer Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.5 While diagnostic and therapeutic advances like androgen-directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).6 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).7 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.8 There is a critical need for safer, more effective, and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. Footnotes and references: 1 Under the terms of Vir Biotechnology's licensing agreement with Sanofi, we will share with Sanofi 20% of certain future collaboration proceeds from the Astellas collaboration agreement. 2 National Institute of Diabetes and Digestive and Kidney Diseases. Hepatitis D. NIDDK. Published November 2024. Accessed September 2025. Hepatitis D - NIDDK (nih.gov). 3 Karagas, Margaret R et al., "Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus" The Lancet Oncology, vol. 26, no. 8 (2025): 994 – 995. doi: 10.1016/S1470-2045(25)00403-6. 4 Center for Disease Control and Prevention. Hepatitis D FAQs. CDC. Published March 2020. Accessed September 2025. What is Hepatitis D - FAQ | CDC. 5 Kratzer TB, et. al. "Prostate cancer statistics, 2025." CA Cancer J Clin. vol. 75 no. 6 (2025): 485-497. doi:10.3322/caac.70028. 6 Bernard-Terrier A & Beltran H. "Exploring the biology of metastatic hormone-sensitive prostate cancer: on the road to precision medicine." J Clin Invest. vol. 136 no. 3 (2026):e200920. doi: 10.1172/JCI200920. 7 Leith A, et. al. "Real-World Treatment Patterns in Metastatic Castration-Resistant Prostate Cancer Across Europe (France, Germany, Italy, Spain, and the United Kingdom) and Japan." Adv Ther. vol. 39 (2022): 2236-2255. doi: 10.1007/s12325-022-02073-w. 8 Huo, X et al. "Predicting Survival in Metastatic Castration-Resistant Prostate Cancer Patients: Development of a Prognostic Nomogram." Studies in health technology and informatics vol. 323 (2025): 164-168. doi:10.3233/SHTI250070. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "should," "could," "may," "might," "will," "plan," "potential," "aim," "expect," "anticipate," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: Vir Biotechnology’s cash balance and anticipated runway; Vir Biotechnology’s collaboration with Astellas, including potential payments to be made to Vir Biotechnology under such collaboration; Vir Biotechnology’s future financial and operating results and its expectations related thereto, including Vir Biotechnology’s financial guidance; the therapeutic and commercial potential of Vir Biotechnology's CHD program, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the therapeutic and commercial potential of VIR-5500 and the other assets in Vir Biotechnology's oncology solid tumor clinical portfolio, preclinical pipeline and the PRO-XTEN® masking technology, as well as Vir Biotechnology's strategy, plans and expectations related thereto; the potential of and Vir Biotechnology’s expectations for its other pipeline programs; Vir Biotechnology’s plans and expectations for its clinical development programs, including protocols for and enrollment into ongoing and planned clinical studies, potential partnering opportunities, and data readouts and presentations, as well as anticipated timelines; the potential benefits, safety and efficacy of Vir Biotechnology’s investigational therapies; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; the timing and amount of Vir Biotechnology’s actual operating expenses, as determined in accordance with U.S. Generally Accepted Accounting Principles; difficulties in collaborating with other companies, some of whom may be competitors of Vir Biotechnology or otherwise have divergent interests, and uncertainty as to whether the benefits of Vir Biotechnology’s various collaborations can ultimately be achieved in the amounts and on the timeline Vir Biotechnology expects; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology’s planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors, as well as changes in expected or existing competition; Vir Biotechnology’s use of AI and machine learning in its efforts to engineer next-generation proteins and in other research and development efforts; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later-stage or larger-scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. View source version on businesswire.com: https://www.businesswire.com/news/home/20260506099842/en/ Contacts Media Contact Caren Scannell Director, Communications [email protected] Investor Contact Kiki Patel, PharmD Head of Investor Relations [email protected]