Vir Biotechnology, Inc.

Good afternoon and welcome to Veer Biotechnology's conference call to discuss the company's Veer 5500 strategic collaboration with Astellas in positive phase one data and 2025 financial results. As a reminder, this conference 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 three press releases, including a joint release with Astellas announcing a strategic collaboration with our PSMA-directed T-cell engager, VIR 5500. A second release reporting the Phase 1 VIR 5500 data that will be presented at ASCO GU, and a third release reporting our fourth quarter and year-end earnings. 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 benefits of our collaboration with Astellas, that the closing of the Astellas collaboration is subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the therapeutic potential of BEER 5500, our ProX10 platform, our development plans and timelines, financial terms and milestone payments, and our cash runway and capital allocation priorities. These risks and uncertainties 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 Beer Biotechnology are Dr. Marianne DeBoffer, our Chief Executive Officer, Dr. Mark Eisner, our Chief Medical Officer, and Jason O'Byrne, our Chief Financial Officer. Additionally, Dr. Johan de Bono from the Institute of Cancer Research in the UK is joining us for our prepared remarks to provide a clinical and investigator perspective. Let me briefly outline today's agenda. Marianne will start by sharing a high-level overview of the strategic collaboration with Astellas and discuss how VIR5500 has the potential to be a best-in-class T-cell engager to address the significant unmet need in metastatic castration-resistant prostate cancer, or MCRPC. Mark will then review the Phase I clinical data for VIR5500, and he'll invite Dr. Dabona to walk through illustrative case examples. Mark will then summarize the broader data set and outline next steps for the program. Jason will cover the financial terms of the collaboration and provide an update on our 2025 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. Today marks a pivotal moment for VIR biotechnology, as we announce a landmark strategic collaboration with Astellas to advance the global development and commercialization of VIR 5500, our ProX10 dual-masked PSMA-targeting T-cell engager for prostate cancer. VIR 5500 is our most advanced immuno-oncology asset, and today we are sharing new Phase 1 data that will be further presented by Dr. De Bono at ASCO-GU this Thursday, February 26th. Together, we believe these milestones position VIR 5500 for rapid advancement and allow us to move forward with both urgency and discipline. The collaboration we've announced with Astellas combines their deep global experience in prostate cancer with our differentiated T-cell engager powered by the ProX10 masking technology. Structurally, the collaboration is designed to accelerate the development of the 5500 across both earlier and later lines of prostate cancer, unlocking a significant market opportunity while meaningfully de-risking our pipeline of cancer immunotherapies more broadly. Importantly, the new phase one data that we are sharing today show a compelling emerging safety and efficacy profile. While still early, these data increase our confidence that VIR5500 has the potential to be a best-in-class T-cell engager for the treatment of prostate cancer. And finally, today's update is also an important validation for the broader ProX10 platform approach, which we believe can unlock opportunities to develop next-generation T-cell engagers in solid tumors. To understand the significance of this opportunity, it's important to consider the current landscape in prostate cancer. Prostate cancer remains a significant global health burden, representing the most common diagnosed cancer among men, with one in eight men being diagnosed in their lifetime. Despite significant progress in treatment, the five-year survival for patients with MCRPC is only 30%, with an estimated 100,000 MCRPC patients in the US and Europe. Across the prostate cancer continuum, there is a substantial and growing unmet need for novel solutions capable of improving long-term disease control as well as quality of life. T-cell engagers, which activate the human body's own immune cells in situ to fight cancer, have transformed outcomes in several hematologic malignancies, and there are multiple products on the market today. In solid tumors, however, use has been limited by toxicity challenges, including off-tumor activation and cytokine release syndrome. We believe VIR5500, powered by the ProX10 technology, has the potential to address these challenges. The ProX10 platform leverages a universal dual-masking approach, which consists of a T-cell engager that simultaneously targets both the tumor antigen, shown here in blue, and CD3 on T-cells, shown here in orange, and the ProX10 masks in gray, which shields the T-cell engager through a unique steric hindrance mechanism. As you can see on the left side of the slide, the large hydrophilic polypeptide extend masks surround and sterically hinder the CD3 and tumor-associated antigen binding sites. Upon reaching the tumor microenvironment, proteases cleave the linkers, here shown in pink, unmasking the active molecule precisely where it's needed. And once unmasked, the molecule combined for tumor cells and T-cells, promoting targeted cancer cell killing. In healthy tissue, the Xtend mask remained intact, dramatically reducing interactions with normal cells and minimizing systemic T-cell activation and subsequent cytokine release. The dual masking approach is designed to reduce toxicity, enabling higher dosing and a wider therapeutic window. Additionally, the X10 masks themselves provide an extended half-life of the molecules, supporting optimization of dosing schedules for patients. And as you'll see later in this call, this hypothesis is translated directly into our VIR5500 Phase 1 clinical study results. In the trial, VIR5500 affirmed early signals of a favorable safety and efficacy profile. Treatment with VIR5500 also showed a dose-dependent anti-tumor activity as measured by PSA declines, radiographic resist responses, as well as PSMA PET responses. Well, let me turn to the collaboration with Acelos and why we believe they are the partner of choice for VIR5500. First, Astellas is the market leader in prostate cancer. Xtendi remains the number one therapy globally in this space, having treated more than one and a half million men worldwide. This commercial success demonstrates deep experience in bringing important prostate cancer therapies to patients at scale. Second, Astellas has repeatedly proven its abilities to successfully co-develop blockbuster medicines with biotech partners. The examples on this slide highlight Astellas' ability to work collaboratively and successfully to translate innovation into market-leading therapies. Third, Astellas brings strong internal global clinical development and lifecycle management capabilities operating across roughly 70 countries. Xtendi has benefited from robust lifecycle management, enabling multiple label expansions into earlier lines of prostate cancer. This ability to continually generate data, expand indications, and maximize long-term asset value is a key differentiator and an important capability as we think about the future development opportunities. Here is a snapshot of the deal terms that we announced with Astellas today, whereby PureBio and Astellas will co-develop and co-commercialize Pure5500 for the treatment of prostate cancer. The financial impact of these terms is substantial. The total potential in combined upfront and milestone payments is $1.7 billion. In addition, in the US, commercial profits will be split 50-50 between the parties, with Virbio having the option to co-promote alongside Astellas. And outside of the U.S., Astellas obtains exclusive commercial rights for VIR 5500, while VIR Bio is entitled to receive sales milestones and tiered double-digit royalties on ex-U.S. net sales. Global development costs will be shared between the parties, with VIR Bio contributing 40% and Astellas 60%. Overall, this deal provides immediate capital and significantly reduces our near-term development spend while preserving substantial long-term economic upside. The collaboration can maximize the potential of VIR5500 through accelerated clinical development and global reach, thereby creating value and benefiting more patients. I now turn to Mark to walk you through the compelling VIR5500 Phase 1 data, that forms the foundation of this collaboration.