VIR earnings call transcript, November 4, 2026

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 VIRBIO 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 VIRBIO. 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 VIR 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 VIR5500 for the treatment of late-line metastatic castration-resistant prostate cancer.

And finally, our recent research collaboration with Gilead underscores the potential of our... ...extend 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 PRO-X10 masking technology in the last eight months, following our partnership with Astellas on VIR 5500 in February. Overall, these achievements position us well to execute... ...our strategic priorities and deliver against the important catalysts ahead. Now, starting with our Hepatitis Delta program. Chronic Hepatitis Delta remains one of the most severe and underserved forms. ...of viral liver disease. October was Liver Cancer Awareness Month, and the World Hepatitis Alliance has focused on amplifying the message that hepatitis elimination is liver cancer prevention. Hepatitis Delta is associated with a 2 to 6-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, represents 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 2... ...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 Elapsiram and Tubevibart. The trial has... ...enrolled approximately 120 participants, randomized 2 to 1, to monthly subcutaneous dosing of our combination regimen versus deferred treatment in treatment-naïve patients with chronic hepatitis. ...delta. The primary endpoint is a composite of HD-vRNA TND together with ALT normalization at week 48. Eclipse 2 has enrolled approximately 150 patients who are being... ...pandamized 2 to 1, evaluating the switch to our combination therapy in patients who have an inadequate response to Bilevertide. The primary endpoint for the trial is undetectable virus... ...as defined by HDV, RNA, T and D at week 24. The pace of enrollment we observed in Europe for this trial reflects an important unmet need in patients previously treated with Bilevertide.

Eclipse 3 is our pivotal head-to-head... ...trial against Bilevertide in treatment-naive patients. We have enrolled approximately 100 patients, randomized 2 to 1, to our combination therapy versus Bilevertide. The primary... ...point for the trial is undetectable virus, as defined by HDV, RNA, T and D 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 Bulevertide. As Bulevertide utilisation 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 programme... ...is expected to include comparable Bilevertite 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, PIR 5500 is our pro-X10 dual-masked PSMA-targeted T-cell engager, which we are advancing in... ...in a global co-development and co-commercialization collaboration with Astellas for prostate cancer.

Astellas already shared on its earnings call yesterday that PIR 5500 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... ...the treatment of late-line metastatic castration-resistant prostate cancer, or MCRPC, underscoring VIR 5500's potential to address a significant unmet need in patients who have limited... ...the 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. VIR 5500 is currently being evaluated... ...in a Phase I trial as both a monotherapy and combination therapy across six dose expansion cohorts. Indications include taxane-naive, MCRPC, radio-like... ...ligand therapy-naive, MCRPC, radio-ligand therapy-exposed, MCRPC, and metastatic hormone-sensitive prostate cancer. These expansion studies are designed to inform the next phase of the... ...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...

...Astelos. Importantly, our plans to pursue first-line MCRPC reflect our belief that VIR 5500 has the potential to become a foundational therapy across the... ...prostate cancer treatment continuum. Moving now to VIR 5818, our HER2-targeted T-cell engager. This program is currently being evaluated in a Phase I 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... ...of 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... ...the 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 VIR 5818 in combination with pembrolizumab is ongoing. We anticipate presenting a meaningful update on VIR 5818 at a future scientific conference. Finally, VIR 5525, 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 carcinoma. Looking ahead, our preclinical immuno-oncology pipeline is fueling a growing... ...cology 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 PRO-X10 platform... ...and the potential to deliver T-cell engagers with an improved... ...safety profile. This pre-clinical, multi-program collaboration leverages VIRBIO's integrated expertise in T-cell engager discovery and protein engineering. Our proprietary DAISY...

...a multi-AI platform for rapid multi-parameter optimization of high-quality T-cell engagers and the Pro-X10 masking technology to develop next-generation T-cell engagers across multiple... ...tumor targets. Under the agreement with Gilead, VIR-Bio will be responsible for the discovery, design and optimization of three Pro-X10 mask 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... ...with 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.

Thank you, Aziz.

Thank you, Marianne.

This concludes our prepared remarks and we will now start the Q&A session. Joining me for the Q&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 one to raise your hand. Withdraw your question, press star one 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 next question comes from the line of Mike Ulls with more.

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 HDD data. So I was wondering, I guess your thoughts, 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 of course the 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. 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 detected. 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 question.

Your next question comes from the line of Phil Nadeau with TD Cohen. Your line is open. Please go ahead.

Your next question comes from the line of Roana Ruiz with Leerink. Your line is open. Please go ahead.

Your next question comes from the line of Sean McCutcheon with Raymond James. Your line is open. Please go ahead.

Your next question comes from the line of Patrick Trucchio with H.C. Wainwright. Your line is open.

Your next question comes from the line of Joseph Stringer with Needham. Your line is open. Please go ahead.

Your next question comes from the line.

Great.

Thanks for taking the question.

Just curious about the Eclipse one disclosure package for the top line. How much data can we expect there? Should we expect individual components like RNA undetectable and or optimalization beyond the combined response endpoint? And also, could we learn anything about cirrhosis subgroups? As well as the full safety on the top line. Anything there would be helpful. Thank you.

Yes, thank you, Edsar. Yes, for Eclipse 1, so as you know, we have approximately 120 patients. In that trial, and we'll be reporting our 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 secondary endpoint, to your point, cirrhosis, patients with cirrhosis, 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 VIR biotechnology. We look forward to keeping you updated in the quarters ahead.

This concludes today's call.