Vir Biotechnology Corporate Update and Third Quarter 2026 Financial Results - VIR BIOTECHNOLOGY INC

Hello, and welcome to Veer Biotechnology's third quarter 2026 Financial Results and Corporate Update Conference call. As a reminder, this call is being recorded. At this time, all participants are in a listen-only mode. After the speaker's prepared remarks, there will be a question-and-answer session. I will now turn the call over to Kiki Patel, Head of Investor Relations. You may begin, Kiki. Thank you, Operator, and welcome everyone. Earlier today, we issued a press release reporting our third quarter 2026 financial results and corporate update. Before we begin, I'd like to remind everyone that some of the statements we are making today are forward-looking statements under applicable securities laws. Forward-looking statements include but are not limited to statements regarding the therapeutic and commercial potential of our clinical and preclinical programs, our development plans and timelines, our collaborations with other companies, our cash runway and capital allocation priorities, and as otherwise described in the legal disclaimers accompanying our public presentations. These forward-looking statements involve substantial risks and uncertainties, which are described in our reports filed with the Securities and Exchange Commission, including our Forms 10-K, 10-Q, and 8-K and could cause future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. Joining me on today's call from Vier Biotechnology are Dr. Marianne DeBacher, our President and Chief Executive Officer, and Aziz Sawaf, our Chief Financial Officer. The agenda for our call today is as follows. First, Marianne will provide a strategic update on where VeerBio stands today, including an overview of our Phase 3 Registrational Program in Hepatitis Delta. Next, she will review the latest updates across the ProX10 Dual Mass T-Cell Engager Programs and present the highlights of our recently announced preclinical collaboration with Gilead. Next Aziz will review The Financial Terms of our recent collaboration with Giliad and provide a summary of our third quarter 2026 financial results. And finally, Marianne will close the call and we'll open the line for Q&A. With that, I'll now turn the call over to Marianne. Thank you, Kiki. Good afternoon, everyone, and thank you for joining us for VIRBIO Technologies' third quarter 2026 Financial Results Conference Call. We are entering a pivotal period for Virbio with the potential to transform hepatitis delta treatment while building a differentiated oncology franchise. Today, I will highlight significant progress across both those areas and why we believe your bio is well positioned for meaningful value creation ahead. First, we've expanded our leadership team with the addition of Aziz Sawaf as Chief Financial Officer and Dr. David Liu as Chief Medical Officer. Both bring more than 20 years of experience in their respective fields, further bolstering our capabilities as we enter an important period for Veerbio. With our leadership team strengthened, we are well positioned to execute against the significant opportunities and catalysts ahead. Second, our Hepatitis Delta program continues to advance through Phase 3 development. We expect to report top-line data from Eclipse 1 this quarter, followed by top-line data from Eclipse 2 and Eclipse 3 in the first quarter of 2027. We will also present expanded 96-week Phase 2 solstice results in an oral presentation at AASLD this weekend. Third, we have made meaningful progress across our oncology portfolio. Astellas recently announced that FEAR 5500 achieved proof-of-concept, reinforcing the scientific rationale for advancing the program into late-stage development. In addition, we are pleased to share that the FDA granted FAST-TRACK designation to VIR-5500 for the treatment of late-line metastatic castration-resistant prostate cancer. And finally, our recent research collaboration with Gilead underscores the potential of our ProX10 platform and highlights the strength of our integrated AI-enabled capabilities in T-cell engager discovery and optimization. This collaboration represents the second major external validation of the ProX 10 masking technology in the last eight months, following our partnership with Astellas on VR5500 in February. Overall, these achievements position as well to execute on our strategic priorities and deliver against the important catalysts ahead. Now starting with our Hepatitis Delta program. Chronic Hepatitus Delta remains one of the most severe and underserved forms of viral liver disease. October was Liver Cancer Awareness Month and the World Hepatritis Alliance has focused on amplifying the message that hepatitis elimination is liver cancer prevention. Hepatitis delta is associated with a two to six-fold higher risk of liver cancer compared to hepatitis B alone and was classified as carcinogenic by the World Health Organization's International Agency for Research on Cancer last year. While recent advances have expanded treatment options for patients, there remains a critical need for therapies capable of delivering deeper antiviral activity and more complete disease control. Current approaches have generally focused on decreasing the viral load, but many patients continue to have detectable HDV RNA despite treatment. Hepatologists and treating physicians believe that achieving complete viral elimination to where the virus is undetectable, defined by HDV, RNA target not detected, or TND, represent an important next frontier in hepatitis delta care, representing deeper disease control and potential clinical benefit for patients. Building on the encouraging TND results observed in our Phase II solstice trial, the ECLIPSE program is designed to determine whether this approach can consistently deliver profound viral suppression across key populations. ECLIPSE-1 is designed to provide the first phase 3 assessment of the proportion of patients who can achieve undetectable HDV RNA after 48 weeks of treatment with our combination regimen of elapseram and bevibart. The trial has enrolled approximately 120 participants, randomized 2-to-1, to monthly subcutaneous dosing of our combination regimen versus deferred treatment in treatment-naive patients with chronic hepatitis delta. The primary endpoint is a composite of HD-VRNA T and D together with ALT normalization at week 48. ECLIPSE-2 has enrolled approximately 150 patients who are being randomized two-to-one, evaluating the switch to our combination therapy in patients who have an inadequate response to bulevitide. The primary endpoint for the trial is undetectable virus as defined by HDV, RNA, TND at week 24. The pace of enrollment we observed in Europe for this trial reflects an important unmet need in patients previously treated with bulevertide. Eclipse 3 is our pivotal head-to-head trial against bulebertide in treatment-naive patients. We have enrolled approximately 100 patients, randomized two-to one, to our combination therapy versus bulepertide. The primary endpoint for the trial is undetectable virus, as defined by HDV, RNA, TND at week 48. Together, Eclipse 1, 2, and 3 are expected to provide a comprehensive data package, generating data in treatment-naive patients, patients switching from bulevertide, and patients enrolled in a head-to-head comparison against bulebertide. As belevitite utilization grows, physicians will need evidence-based guidance on how best to manage patients who do not achieve adequate viral suppression or who require an alternative treatment approach. To our knowledge, no other late-stage HDV development program is expected to include comparable belevitide switch or head-to-head data in its regulatory submission package, potentially providing a uniquely comprehensive evidence base for physicians, payers, and regulators. Collectively, these studies are designed to position our program at the very forefront of the evolving hepatitis delta treatment landscape and ultimately improve outcomes for patients living with this devastating disease. Turning now to oncology. FEAR5500 is our ProX10 dual-masked PSMA-targeted T-cell engager, which we are advancing in a global co-development and co-commercialization collaboration with Astellas for prostate cancer. Astellos already shared on its earnings call yesterday that FEAR5500 has achieved proof-of-concept, reinforcing the scientific rationale for advancing the program into registrational trials. This assessment reflects the totality of the clinical, safety, pharmacology, and biomarker data generated to date and supports continued investment in the registrational planning and execution. We also recently announced that the FDA granted FAST-TRACK designation to VIR-5500 for the treatment of late-line metastatic castration-resistant prostate cancer, or MCRPC, underscoring VIR PURE5500's potential to address a significant unmet need in patients who have limited treatment options. Both of these milestones highlight the strong progress we have made with our partner Astellas as we advance the program toward pivotal trials. PURE5500 is currently being evaluated in a phase one trial as both a monotherapy and combination therapy across six dose expansion cohorts. Indications include texane-naive MCRPC, radioligand therapy-nave MCRTC, radioligan therapy-exposed MCRCC, and metastatic hormone-sensitive prostate cancer. These expansion studies are designed to inform the next phase of development with the goal of initiating multiple phase 3 studies spanning both early-line and late-line settings in 2027. In parallel, we are focused on advancing manufacturing readiness in collaboration with Acelas. Importantly, our plans to pursue first-line MCRPC reflect our belief that VIR5500 has the potential to become a foundational therapy across the prostate cancer treatment continuum. Moving now to VIR5818, our HER2-targeted T-cell engager. This program is currently being evaluated in a phase one trial with dose escalation and signal finding components, both as monotherapy and in combination with pembrolizumab. The trial has enrolled patients with a variety of HER2-expressing cancers. During our last update on the program, we shared encouraging anti-tumor activity and a generally well-tolerated safety profile. While we had previously anticipated providing a data update on the program this year, recent FDA feedback on the monotherapy arm has led us to refine the study. We intend to add backfill cohorts in a more homogeneous patient population to help determine the optimal dose and schedule, which is aligned with FDA's Project Optimus, an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. As a result, the study remains ongoing and the data set is not yet complete. In parallel, dose escalation and optimization of VIR5818 in combination with pembrolizumab is ongoing. We anticipate presenting a meaningful update on VIR 5818 at a future scientific conference. Finally, PIR5525, our EGFR-targeted T-cell engager, continues to progress through dose escalation in both monotherapy and combination therapy with pembrolizumab across lung cancer, colorectal cancer, head and neck squamous cell carcinoma, and cutaneous squamous cell carzinoma. Looking ahead, our preclinical immuno-oncology pipeline is fueling a growing oncology portfolio. We are in a fortunate position where the breadth of opportunities generated by our scientific platform exceeds what we can advance independently, allowing us to be strategic about which programs we progress ourselves. In the first quarter of 2027, we plan to provide a more comprehensive view of the next chapter of our cancer immunotherapy strategy at a virtual research investor event. We will provide investors with a roadmap for how we plan to build and scale a world-class immuno-oncology franchise. The breadth of our pipeline does not mean we will advance every opportunity ourselves. We intend to be disciplined in how we allocate capital, concentrating investment where our capabilities are most differentiated, and partnering strategically where collaboration can accelerate development, expand reach, and maximize the impact of our platform for patients. Our research collaboration with Gilead is an example of this strategy in action, providing further external validation of the ProX10 platform and the potential to deliver T-cell engagers with an improved safety profile. This preclinical multi-program collaboration leverages Virebio's integrated expertise in T-cell engager discovery and protein engineering, our proprietary DAISY AI platform for rapid multi-parameter optimization of high-quality T-cel engagers, and the ProX10 masking technology to develop next-generation T-Cell engagers across multiple solid tumor targets. Under the agreement with Gilead, VireBio will be responsible for the discovery, design, and optimization of three ProX10 mass T-cell engager development candidates with the potential to address multiple solid tumor indications with significant unmet medical need. Gilead will have the exclusive right to advance candidates generated through the collaboration and will be responsible for subsequent development, manufacturing, and commercialization. With that, I'll now hand the call over to Aziz, who will walk through the financial terms of our Gilead collaboration and our third quarter financial results. Thanks, Marianne. Before I begin, I'd like to say how pleased I am to have joined VeerBio at this exciting time for the company. I look forward to working with the team to build on the company's progress and help translate the strength of the portfolio into long-term value for shareholders and patients. The Gilead collaboration is a strong example of that opportunity. As Marianne discussed, the agreement provides further validation of our oncology platform while increasing our financial flexibility. It also demonstrates how selective partnerships can preserve meaningful long-term value and support disciplined capital allocation. Under the agreement, we received $90 million, consisting of $65 million up front and a $25 million equity investment at a 30% premium. We are also eligible to receive up to 45 million in near-term preclinical milestones. Beyond that, we have the potential to receive up to $1.74 billion in additional development, regulatory, and commercial milestones, along with tiered high single to low double-digit royalties. Importantly, the 20% pass-through economics to Sanofi has expired, and we're no longer in effect at the time of the agreement. As a result, none of the milestone payments from this collaboration will be shared with Sanofi. Turning to our Q3 financial results, where I'll focus on a few key metrics, R&D expense was $80 million, compared with $151 million for the same period in 2025. The reduction was primarily driven by a one-time $75 million milestone payment, recognized in the third quarter of 2025, following the first patient dose with VIR 5525. SG&E expense was $24 million, compared with $22 million for the same period in 2025. The increase was primarily due to higher advisory and legal fees. We ended the quarter with $901 million in cash, cash equivalents, and investments. Importantly, this balance does not include the $90 million upfront from the Gilead collaboration, which was received in October. Based on our current operating plan, we project that our cash will fund operations into the second half of 2028. As we look ahead, we will remain thoughtful and disciplined in how we deploy capital. Our focus will be on supporting the company's highest priority programs, preserving financial flexibility around important inflection points, and ensuring that our investments remain aligned with the potential to create long-term value for shareholders and patients. With that, I'll turn the call back to Marianne to conclude. Marianne? Thank you, Aziz. In summary, I'm incredibly proud of the strong execution we have delivered in the third quarter of this year. In hepatitis delta, the totality of evidence generated from our solstice program continues to reinforce our confidence in the potential of elapseron and to BevyBard to offer a highly differentiated treatment profile. Combined with once-monthly subcutaneous administration and the potential for both at-home or healthcare provider administration, we believe our regimen could become a best-in-class treatment option capable of redefining expectations for patients. We look forward to sharing the top-line results of our Phase 3 Eclipse 1 trial later this quarter and Eclipse 2 and 3 trials in the first quarter of next year. In oncology, VIR 5500 continues to advance rapidly. Following the FAST-TRACK designation granted last month and with expansion cohorts actively enrolling, we and Astellas look forward to sharing more on our registrational development plans next year, furthermore the collaboration we announced with Gilead further validates our integrated drug discovery capabilities and demonstrates our ability to create value through strategic partnerships that both extend the reach of our technology and help support investment in our wholly owned oncology portfolio. Taken together, these developments reinforce our confidence in the breadth of the platform and help further define the path forward for the program. I'm excited about what we have built and the opportunity ahead. We have the potential to redefine the treatment paradigm in hepatitis delta, advance a new treatment approach in prostate cancer, and bring other important new therapies to patients. And finally, we are entering this next phase from a position of financial strength, while capitalized and poised for what we believe will be a transformative period in our company's history. With that, I'll turn the call over to Kiki to begin the Q&A session. Thank you, Marianne. This concludes our prepared remarks and we will now start the Q & A session. Joining me for the Q and A are Marianne and Aziz. Please limit questions to two per person so we can get to all of our covering analysts. I'll turn it over to you operator. Thank you. At this time we will begin conducting our analyst Q&A session. If you would like to ask a question please press star 1 to raise your hand. To withdraw your question press star 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality and if muted locally, remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Corey Kasimov with Evercore ICI. Your line is open. Please go ahead. Hey, it's Johnny off for Corey. Thanks for taking the question. Regarding 5500, if anything could tell us about the durability of responses that you're seeing already in the current trial. Thank you. sorry i did not get uh your your name oh sorry um sorry it's shiny on for corey um okay okay regarding yeah okay great yes thank you for that question so um we are not sharing any updated uh information on your 5500 at this time. But as you have seen, we have made some really remarkable progress, the FOSTRAC designation by the FDA for late-time MCRPC patients. And then Astellas yesterday already shared in their earnings call that we have designated the program as having achieved proof of concept. So that is a very important hurdle to prepare for our pivotal trials next year. And so, you know, in the course of next year, prior to our pivotal trials, we will be in a position to potentially share more. Great, thank you. Your next question comes from the line of Mike Ulls with Morgan Stanley. Your line is open, please go ahead. Hey, it's Avi Novick on the line for Mike. Thank you for taking our questions and congrats on all the progress. I guess as I'm sure you've seen a competitor recently shared their phase three HDB data. So I was wondering that it gets your thought, updated thoughts on competitive positioning. Does this change the competitive bar in your view for your phase three child, you know, acknowledging that there is a, you now, of course, a difference in your end points and how you're defining a responder, thanks. Yes, thank you for that question, Avi. So as you recall in our phase two solstice data, we have shown to be in a possibility to achieve 60-60% of target not detected. So really getting rid of the virus in 66% of the patients after 48 weeks of treatment. And what you have seen from the competition, I think, for the 24-week endpoint is, I believe, 17% target not detect it. So we still believe that, you know, from an efficacy perspective and everything we have shown from the solstice data, that we have the potential to be a best-in-class treatment and, you know, having shown very fast and deep antiviral efficacy. All right, great. Thank you for taking our questions. Your next question comes from the line of Phil Nadeau with TD Cohen. Your line is open. Please go ahead. Great. Thanks for taking our questions. Two from us. So you mentioned Estellas and Veer have noted that 5500 achieved proof of concept. We're curious whether you'd be willing to share any of the criteria for proof of concepts or even what categories were analyzed from response to duration to safety, things like that. That's the first question. And then second on HDV, we're curious what pre-launch activities you can do or you have been doing to work with payers and clinics to define reimbursement and identify patients. Any information you could share would be helpful. Thank you. DR. Yes. Thank you for those questions, Phil. On your first one, Acelos and ourselves have indeed designated your 5500 to have achieved proof of concept. Obviously, I cannot go into the details of the criteria that we had pre-set to be achieved, But I can tell you it's really the combination holistically of, you know, the efficacy, the safety, the pharmacology, biomarker data that have led us to decide on the proof of concept being achieved. And then as to your question on Delta pre-launch activities. So we have actually done quite a bit of work already. You know, we have done market research with health care professionals. We have done work related to payers. We have been looking at, of course, diagnosis and what is changing in that landscape. What is very positive is, I think, that post the launch of Hepcudex earlier this year by Gilead, that we have seen a market increase in in um in hdv rna um testing so we think that is a very positive evolution and will obviously help with diagnosis and we have also looked into you know distribution channel uh both for in-home administration and administration by a healthcare professional so yeah quite a bit of pre-launch work that that we we have started that is ongoing. Dr. That's very helpful. Thanks and congrats on the progress. Dr. Thank you. Your next question comes from the line of Roana Ruiz with LHERNC. Your line is open. Please go ahead. Hi. This is Anna on for Roana. Thanks so much for taking our question. Just starting with 5500, just curious, when you mentioned multiple pivotal trials are expecting next year can you help us narrow down which settings are maybe likely to lead and what remains outstanding before the first study can begin yes thank you anna um so we will be sharing more information on that of course together with our partner astellas what i can tell you is as you know we are exploring your 5500 boat for a late line population and that's where we achieved the fast track designation lately but we're also exploring it both as monotherapy and combination in an early line set of patients. So obviously we are aiming to target both early and late line and we will be sharing more information on pivotal trial design in the course of next year. Your next question comes from the line of Sean McCutcheon with Raymond James. Your line is open. Please go ahead. Hey, guys. Jacob Wark was here on for Sean McCutcheon. Thanks for the question. We're wondering here if we could probe a little bit into the market opportunity, specifically if there are any early indicators you've seen from the Hep-Clue-X launch in the U.S. and whether or not you've gotten any feedback on whether there's a desire to switch patients on to a more convenient therapy. Thanks. Yeah, thank you. So I would say that one sort of leading indicator is that in our ECLIPSE 2 program, where we are looking to switch patients from a bilevertide, you know, patients that cannot get adequately controlled on bilevertides to our Elapseran plus Tobivibart regimen. As you have seen, we have had a very swift enrollment in that trial. So I think it's a bit of a leading indicator that there was really a need for this. In addition, you know, given sort of the black box warning associated with hep crudex and the, you know, sort of anxiety around switching patients and potential flares, we are generating that data in the Eclipse 2 trial, and I think that would be very helpful for healthcare providers to use. So we think that, you know, the market opportunity for patients that, again, cannot be adequately controlled on bilivertide or cannot, you know, take sort of the burden of a daily injection as a chronic treatment is an important opportunity for us. Great, thank you. Your next question comes from the line of Patrick Trucchio with HC Wainwright. Your line is open. Please go ahead. Hi. Thank you for taking that question. This is Luis for Patrick. I would continue on on HDV, and can you clarify the FDA-agreed statistical hierarchy for the week 48 TND plus ALT endpoints versus TND alone? And I was wondering if you could also tell us a little bit about the finite treatments exploration for Eclipse 2 and 3, and what qualifies a patient to stop, which agents withdrawn and how long they'll be followed. Thank you so much. Yes, thank you, Louise. So as you know, as part of our registrational package for hepatitis delta, we have three trials with different endpoints. And what we have agreed with FDA is that for eclipse one and three, we have a 48-week endpoint. For eclipse two, we Have a 24-week end point. And the endpoints are different for eclipse one our primary endpoint is a combination of tnd plus alt at 48 weeks and we have a secondary endpoint of t and d alone and then for eclipse two we have as i said the endpoint is already at 24 weeks and it's only tnd and then also for eclipse three the endpoint is at 48 weeks and is also only target not detected so really getting with rid of the viral virus viral elimination. So that is agreed, obviously, with the FDA. And obviously, we are looking forward to reporting our data on Eclipse 1 in the fourth quarter of this year, and then for Eclipse 2 and 3 in the first quarter of next year. As to your question on finite treatments, we will be sharing more information on that in the future. But you are absolutely correct that as part of our Eclipse 2 and E3 trial design, we ARE looking into that potential exploration. Thank you so much, very helpful. Your next question comes from the line of Joseph Stringer with Needham. Your line is open. Please go ahead. Joseph Stinger, Needham Medical Center, Hi, thanks so much for taking our question. Just looking ahead to Eclipse 3, the head-to-head versus the Lebertide, what treatment delta on the T and D primary endpoint, do you consider the bar for success there? I guess, how much better than Belevertide does your combo therapy have to be on that endpoint for it to be considered clinically and commercially meaningful? Yeah, thank you for that question. So as you know, sort of the levels of target not detected or viral elimination that Belevetide has been reporting depending on the dose, is somewhere between 12% and 20% after 48 weeks of treatment. What we have shown in our SALSTIS trial is target not detected levels, as mentioned earlier, after 48 years of around 66%. So I'm not going into the detail of how much differentiation you would need to see. But of course, on a viral efficacy level, there's a fundamental potential difference here. Also, the frequency of administration. Sobilever type is a daily injection that patients need to make chronically for the rest of their lives, given it's intended to be a treatment for chronic hepatitis delta. And in our case, it's monthly to injections. So I think from a convenience perspective, also, this is fundamentally a very, very different regimen. Your next question comes from the line of Etzer DeRoute with Barclays. Your line is open. Please go ahead. Great. Thanks for taking the question. Just curious about the Eclipse 1 disclosure package for the top line. How much data can we expect there? we expect individual components like RNA undetectable and or optimalization beyond the combined response endpoint? And also, could we learn anything about cirrhosis sub-results as well as the full safety on the top line? Anything there would be helpful. Thank you. Yes, thank you, Ed, sir. Yes, for Eclipse 1, so as you know, we have approximately 120 patients in that trial, and we'll be reporting out data on that. We will be reporting out, obviously, on the primary endpoint, which is a combination of target not detected viral elimination combined with ALT normalization. And we will also be sharing information on the secondary endpoint, to your point, cirrhosis, patients with cirrhoses, and, of course, safety and tolerability profile. thank you sure this concludes the q a session of the call i will now turn it back to kiki patel to close the call thank you for joining us today and for your continued interest in veer biotechnology we look forward to keeping you updated in the quarters ahead this concludes today's call.