Vir Biotechnology, Inc.

Hello, and welcome to Veer Biotechnology's first 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 presentation, 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 first 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 by such forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the potential benefits of our collaboration with Astellas, the therapeutic potential of VEER 5500 and our Pro X STEM platform, our development plans and timelines, 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 forms 10-K, 10-Q, and 8-K. Joining me on today's call from Veer Biotechnology are Dr. Marianne DeBacher, our Chief Executive Officer, and Jason O'Byrne, our Chief Financial Officer. During the first quarter of 2026, the VR bio team delivered meaningful advances across our T-cell engager and hepatitis delta programs, underscoring our ability to execute towards key clinical and corporate priorities. The agenda for our call today is as follows. First, Marianne will share an update on our recent landmark global strategic collaboration with Astellas and our prostate cancer program. Next, she will provide an update on our Hepatitis Delta program, evaluating Tobivibart, an investigational neutralizing monoclonal antibody, and Alepsarin, an investigational small interfering RNA. Then, Jason will provide an overview of our first quarter 2026 financial results. And finally, Mary Ann will close the call and will open the line for Q&A. With that, I'll now turn the call over to Mary Ann.

Thank you, Kiki. Good afternoon, everyone, and thank you for joining us for Vierbui Technologies' first quarter 2026 earnings call. Since our last earnings call in February, we have remained highly focused on execution as we advance both our oncology and hepatitis delta programs with speed and focus. I will begin by providing a brief update on the current status of our recent collaboration with us tell us a deal valued at up to $1.7 billion. In addition, in the US commercial profits will be split 5050 between the parties with fear bio having the option to co promote alongside us tell us. As a reminder, on February 23rd, we announced that we entered into a collaboration with Astellas to co-develop and co-commercialize VEER 5500, our pro-extend, dual-masked, PSMA-targeted T-cell engager. Since then, the transaction successfully closed on April 15, marking an important transition from deal announcement to deal execution. With the deal closed, our joint teams are operational and partnering closely on a shared clinical development plan to enable rapid expansion and accelerate delivery to patients. This collaboration brings together Astella's global leadership in prostate cancer with our differentiated ProX10-enabled T-cell engager. We chose to partner with Astellas because of their decade-long track record of successfully co-developing category-defining therapies, including Xtendi, the world's number one prostate cancer drug. Metastatic castration-resistant prostate cancer, or MCRPC, remains a significant unmet need, with a five-year survival rate of only 30%, underscoring the urgency for new treatment options that can deliver even deeper, more durable disease control and improved quality of life. VIR5500 is the most advanced dual-mask T-cell engager currently under evaluation in prostate cancer. The foundational driver of the ASTELLAS collaboration shaping our development strategy going forward is our phase one data for VIR5500. Dr. Johan de Bono shared an update from this study evaluating patients with advanced MCRPC as an all presentation at ESCO GU in February. Today, I'll highlight key takeaways from the data. For a more comprehensive update from the trial, please refer to our fourth quarter earnings call from February 23rd. Overall, the VIR5500 data showed a favorable safety and tolerability profile with no observed dose-limiting toxicities. At the dose levels of 3,000 micrograms per kilogram and above, we saw mostly grade 1 cytokine release syndrome, or CRS, defined as fever-only. We did not observe any grade three CRS at this dose, reinforcing the potential of the ProX10 dual masking platform to widen the therapeutic index of our T-cell engagers. We view the absence of high grade CRS at our go-forward monotherapy dose together with a lack of mandatory steroid pre-medication in our protocol as a meaningful differentiator for VIR5500. We believe that sparing steroids may help preserve T cell function and reduce treatment complexity for both patients and physicians. Collectively, these attributes support the potential for outpatient administration and could translate into significant clinical and commercial advantages over time. Importantly, this profile may support positioning VIR5500 in both the pre- as well as post-radioligand therapy, or RLT, settings, offering flexibility across the treatment continuum and potential use in routine care settings relative to the specialized infrastructure required for RLT administration. Furthermore, the depth of PSA and resist responses we observed were particularly encouraging with several patients sustaining responses for up to 27 weeks. Additionally, we saw emerging signs of durability up to 8 and 12 months respectively in patient cases with extended follow-up. One of the most compelling aspects of our data is that these deep responses were observed in heavily pretreated patients with advanced poor prognosis disease, including liver metastasis. This is historically the most difficult population to treat and resistant to immunotherapies, underscoring the clinical significance of the activity we are seeing. Additionally, we observed a complete response for a patient who previously relapsed on an actinium-based PSMA-directed radioligand. We view these findings as especially meaningful given historically poor outcomes and limited responsiveness of this patient population to subsequent therapies. Building on these encouraging phase one dose escalation monotherapy results, we have dosed a first patient in our phase one dose expansion cohorts for VIEW 5500 in late-line patients. This milestone represents an important step in further evaluating VIEW 5500's best-in-class potential for people living with prostate cancer. In the monotherapy expansion cohorts, we are evaluating Q3 week 800, 2000, 3500 microgram per kilogram step-up dosing. This study will measure safety and efficacy, including PSA responses and objective response rate or ORR of your 5500 in patients with MCRPC who are refractory following treatment. These patients will have had exposure to multiple prior lines of therapy, including at least one second-generation androgen receptor pathway inhibitor and one taxane regimen. The expansion includes two distinct cohorts, patients who are naive to prior RLT and patients who have previously received RLT in any treatment setting. Dose escalation of year 5500 in combination with enzalutamide continues in early-line MCRPC patients. We anticipate dosing first patient in the combination dose expansion cohorts in both early-line MCRPC and metastatic hormone-sensitive prostate cancer over the coming months. Together, these cohorts highlight the potential of VIR5500 across the prostate cancer continuum, including in the frontline setting. Without the challenges associated with RLTs, such as radioactivity and restricted settings of care, we believe masked T-cell engagers represent the long-term future in this space, and that VIR5500 has the potential to be a best-in-class T-cell engager. We anticipate initiating our Registrational Phase III program for FEAR 5500 in 2027. These results provide validation of our broader ProX10 platform, unlocking significant opportunities to develop next-generation mask T-cell engagers in other solid tumor types. Turning now to the rest of our clinical stage T-cell engager programs. VR5818 is our ProX10-masked HER2-targeted T-cell engager. We view this 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 preliminary response data evaluating 5818 monotherapy and combination therapy with pembrolizumab in the second half of 2026. This update is intended to inform our understanding of dose and help identify which HER2-expressing populations may warrant further study, particularly in areas of high unmet medical need. For VIR5525, our ProX10 dual-MAST EGFR-targeted T-cell engager, Phase 1 study enrollment is progressing as expected. The study design incorporates learnings from VIR5818 and VIR5500 to enable efficient dose escalation. We are evaluating both monotherapy and combination with pembrolizumab 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. We believe this program has the potential to address significant unmet medical need in these indications. where existing EGFR targeted approaches have limitations. Turning now to our Hepatitis Delta program. The Hepatitis Delta community is severely underserved with approximately 180,000 actively viramic patients across the United States, UK and EU based on a composite of high quality epidemiology sources. In the US, the patient population is highly concentrated in major urban centers and can be supported by an efficient commercial approach with a targeted specialty sales organization focused on hepatologists, gastroenterologists, and infectious disease specialists. Overall, we expect our Tubavibard plus elapseran combination to have two clear advantages in chronic hepatitis delta versus our competitors. The first is that we are seeing potential best in class efficacy with a strong safety profile. The second that our regimen is designed with once monthly subcutaneous dosing and the potential for both at home and in office administration. For viral infectious diseases, clearing the virus is the key to improving long-term outcomes. KOLs in the chronic hepatitis delta space highlight undetectable virus as measured by target not detected, or TND, as the gold standard measure of viral clearance. Achieving undetectable HDV by this measure is the most stringent threshold available and means that the Delta virus is completely cleared from the bloodstream. As the Delta virus replicates so aggressively, patients need HDV to be completely undetectable for positive clinical outcomes and to avoid rebounds. Peer-reviewed evidence suggests that patients with hepatitis delta who achieve undetectable virus have significantly improved long-term clinical outcomes, including reduced progression to cirrhosis, hepatocellular carcinoma, liver transplantation, and death, compared with patients in whom virus remains detectable. These data support undetectable virus as a key clinically meaningful goal of antiviral therapy for patients with hepatitis delta. In January, we reported potential best-in-class efficacy in our Phase II solstice trial in patients with chronic hepatitis delta for a subset of patients at 96 weeks. Evaluated participants receiving the combination therapy of Tobevibart and Elapsiran showed increased and sustained viral suppression of HDV RNA versus treatment with the antibody alone. The data showed 88% of evaluable participants achieved undetectable virus compared to 46% on Tobevibart monotherapy alone. Additionally, we saw rapid onset of viral suppression, achieving already 41% undetectable virus within 24 weeks. These results underscore the limited efficacy of hepatitis delta treatment with antibody monotherapy alone. In contrast, combining complementary mechanisms of action with tobevibart plus dilapseron raises the rate of undetectable virus to approximately 90%. Importantly, we see similar efficacy in cirrhotic patients, which will be a significant patient cohort at launch due to the delayed diagnosis of most hepatitis delta patients to date. The combination was well tolerated with no grade three or higher treatment related adverse events and discontinuations. The second key differentiator is that Tobivibard plus Elapseron will only be administered monthly, consisting of two subcutaneous injections to be administered at the same time. As a reminder, competitors' lead regiments require either daily or weekly injections. For the hepatitis delta patient population, this frequency will be a significant challenge, so we see monthly dosing as an additional meaningful differentiator for our regimen. Additionally, due to the need for a higher dosing frequency of competitive regimens, the Bevibard Plus Elapseron may have the potential to be the only product conveniently enabling both self-administration at home and physician administration in office. This is important because physicians have indicated that up to 20% of hepatitis delta patients might not be able to self-administer. So to bevibard plus elapseron may be the only treatment available for this group of patients. Our hepatitis delta regimen has already been recognized by multiple global regulators with FDA breakthrough therapy and false track designations, as well as EMA prime and orphan drug designation, underscoring both the unmet need and the strength of the data package. These designations provide ongoing engagement with both agencies and support a high level of confidence in our ability to achieve broad labels for our regimen. We are pleased to share that we will be presenting the complete 96 week solstice phase two data in an oral presentation at the upcoming easel 2026 annual meeting in Barcelona on May 29th. We will also be presenting a poster of a 48 week subgroup analysis evaluating the impact of BMI on ALT normalization after successful viral control. As we look ahead to our ongoing registrational program, all three of our Eclipse studies are on track. Eclipse 1 enrollment is complete with approximately 120 participants randomized two to one to our combination therapy versus deferred treatment. The primary endpoint is a composite of undetectable virus as measured by HDV RNA target not detected plus ELT normalization at week 48. We expect to report top-line data from Eclipse 1 in the fourth quarter of this year. Eclipse 2 enrollment continues on track across multiple European sites. This study will enroll approximately 150 patients who are being randomized 2 to 1, evaluating the switch to our combination therapy in patients who have not adequately responded to Belevertide. The primary endpoint for the trial is undetectable virus as measured by HDV RNA target not detected at week 24. The strong enrollment momentum we are seeing in Europe reflects an important unmet need in patients previously treated with blevartide. For Eclipse 3, our Phase 2b head-to-head comparison, enrollment is complete with approximately 100 patients randomized 2 to 1 to our combination therapy versus Belevertide. The primary endpoint for the trial is undetectable virus as measured by HDV RNA target not detected at week 48. In general, we view Gilead's expected US launch of Belevertide as a positive for the hepatitis delta market overall, and one that helps pave the way for next-generation therapies like ours. Hepatitis delta remains significantly underdiagnosed and undertreated, and the introduction of the first approved therapy in the US should meaningfully raise disease awareness, expand screening, and establish treatment pathways among treating physicians. Complementing this, we have an experienced commercialization partner through our collaboration with Norgene, who holds an exclusive license across Europe, Australia, and New Zealand. Norgene's established infrastructure and expertise in specialty pharma and hepatology positions us to maximize the commercial opportunity of our HDV regimen across these geographies. In summary, we have made exceptional progress across our entire clinical portfolio, and we believe these advancements leave us well-positioned to deliver on our clinical and corporate objectives. With that, I'll now hand the call over to Jason for our financial update.