Vir Biotechnology, Inc.

Hello and welcome to VEER Biotechnology's second quarter 2026 financial results and corporate update conference call. As a reminder, this call is being recorded. At this time, all participants are in the 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 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. More 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 ProX10 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 Vier 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-mass T-cell engager program utilizing our best-in-class ProXM 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.

Thank you, Kiki. Good afternoon, everyone, and thank you for joining us for VIA 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 96-week solstice trial at the ETHEL 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 regimens. Against this backdrop, our focus remains on executing our registrational program. We are pleased to share that we completed enrollment in ECLIPSE II during the second quarter. With enrollment now complete across all three registrational ECLIPSE studies, we are entering a catalyst-rich period for hepatitis delta. With top-line data expected first from ECLIPSE I 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 ProXM dual-masked PSMA-targeted T-cell engager PIR5500 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 VR5500 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 Belabratide 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 5 to 10 fold in certain territories. That experience underscores how therapeutic innovation can capitalize 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 easel 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 1KOL 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 EZL 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 Alepsiran and Tobevibar 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 Elapseron and Tobivart achieved undetectable virus. compared with 53% of patients receiving 2-Bevibard monoclonal antibodies therapy alone. In the last observation carried forward analysis, 97% of patients receiving the combination achieved undetectable virus at week 96. This underscores the scientific rationale of combining two drugs with complementary mechanisms of action to inhibit both entry of HDV and production of hepatitis B surface antigen. HDV relies on circulating hepatitis B surface antigen to replicate and complete its life cycle. We observed rapid and durable reductions in hepatitis B surface antigen with the combination regimen compared with the Bebibart 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 and defined by Charles 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 had been no treatment-related serious adverse event or discontinuations. Taken together, we believe the complete solstice data set presented at EASL reinforces Elapsaran and Tobevibar's best-in-class potential. As one leading hepatologist emphasized in a recent independent investor event, 88% Target not detected at week 96 with severe combination is the best ever target not detected rate in 50 years of HDV treatment experience. It is something that must be acknowledged. Looking ahead, given how swiftly we have been able to enroll patients in our Eclipse trials, we can now file one of the most comprehensive clinical data packages in CHD drawing on data from all three Eclipse studies. Collectively, Eclipse 1, 2, and 3 are designed to provide evidence across key patient populations, including treatment-naive patients, patients switching from blevotide, and patients enrolled in a head-to-head comparison against blevotide. 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 3 study, evaluating elapseran and tobevibart in patients who have not achieved viral suppression with belabratide therapy. The belabratide switch cohort is an important component of our overall data package, because it is designed to provide information on outcomes in patients transitioning from the only approved therapy for CHD. This data set is relevant given the boxed warning on the current colabratide label regarding the risk of severe acute exacerbations of hepatitis B and hepatitis B following treatment discontinuations. To our knowledge, no competing CHD development program is expected to have comparable switch data at launch, which we believe represents a meaningful point of differentiation for the Eclipse program and could further strengthen our overall package. Beyond regulatory execution, we continue to advance our manufacturing and commercial readiness activities. Our commercial strategy is designed to support both at-home administration and Healthcare Provider Administration, providing flexibility for both patients and physicians. Through our ongoing interactions with the FDA under Breakthrough Therapy designation, we are currently conducting human factor studies intended to support at-home administration, which we believe could further enhance patient convenience and access. In addition, we are pursuing co-packaging of Elapseron and Sobevibar 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 Elefstrand 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 Norgene 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 Norgene is well positioned to support a successful launch of Elapsuram and Tobevibar 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, Elapshron 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-engagered portfolio 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 Vio5500, our ProX10 dual-mask 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 early as next year. Currently, we have dosed our first patients with FEAR 5500 across three monotherapy populations. Taxenaive MCRPC, Radioligant Therapy Naive MCRPC, and Radioligant Therapy Exposed MCRPC. In parallel, we are advancing three combination cohorts. One cohort in Taxenaive MCRPC evaluating VIR5500 with enzalutamide, which is currently enrolling patients. A second cohort in Taxe Naive MCRPC, evaluating VIR5500 with docetaxel, which will be initiated in the coming months. And a third cohort in metastatic hormone-sensitive prostate cancer, evaluating VIR5500 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 your 5500's potential across the prostate cancer treatment continuing. Together with Ostellos, we have launched scale-up efforts and have secured a manufacturing contract to support your 5500 phase 3 program. Our goal has been to ensure that CMC readiness and many more. Moving to VR5818, our ProX10 dual-masked HER2-targeted T-cell engager. VR5818 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 view 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 VIR5525, our ProExten dual-MOS EGFR targeted T-cell engager. We are continuing dose escalation in the Phase I study, evaluating VIR5525 as both a monotherapy and a combination with pembrolizumab across multiple EGFR-expressing tumor types. The study incorporates learnings from both VIR 5500 and VIR 5818 to support efficient clinical development. Dose escalation is tracking well to plan, and we look forward to sharing updates as the program matures. Beyond our three clinical stage desalignators, we have a pipeline of seven preclinical assets underscoring both the breadth and scalability of the platform. Importantly, the encouraging clinical data Thank you, Marianne.