Vir Biotechnology, Inc.

Hello and welcome to Veer Biotechnology's third quarter 2025 financial results and corporate update call. As a reminder, this conference call is being recorded. At this time, all participants are in a listen-only mode. After the speaker's remarks, there will be a question and answer session. I will now turn the call over to Jason O'Byrne, Chief Financial Officer. Please go ahead.

Thank you and good afternoon. With me today are Dr. Marianne DeBacker, our Chief Executive Officer, and Dr. Mark Eisner, our Chief Medical Officer. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. 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. I will now turn the call over to our CEO, Marianne DeBacker. Please go ahead.

Good afternoon, everyone, and thank you for joining us for Vier Biotechnology's third quarter 2025 earnings call. Today's call will highlight the significant progress we've made and our clear path forward as an organization. We'll provide guidance on our VR5500 program timeline, discuss the upcoming Solstice data presentation, and highlight how our clinical execution this quarter positions us for the significant value-creating opportunities ahead. The third quarter has been marked by important achievements across both our hepatitis delta and T-cell engager programs that demonstrate our ability to execute on critical milestones. Our team remains committed to powering the immune system to transform patients' lives, and today we'll outline how our recent accomplishments set the stage for what we believe will be a pivotal period for Veerbio. I will now highlight the key accomplishments from this quarter that demonstrate this accelerating momentum. First, we completed enrollment in ECLIPSE-1, our first registrational Phase III study for hepatitis Delta. Second, we're excited to provide guidance that we plan to share a comprehensive data update for V5500, a ProX10-masked PSMA-targeted T-cell engager, in the first quarter of 2026. And third, we dose the first patient in our first-line metastatic gastration-resistant prostate cancer combination study with androgen receptor pathway inhibitors. Collectively, these achievements represent an acceleration in our development trajectory and provide clear line of sight to multiple value-creating catalysts ahead. We're executing with precision while advancing towards multiple important data readouts and regulatory milestones. I will now provide more detail on our hepatitis delta program, where we've made exceptional progress this quarter. The completion of Eclipse I enrollment represents a pivotal step towards bringing our differentiated combination regimen to patients with hepatitis delta in the United States and beyond. This achievement, accomplished ahead of our internal projections, reflects both strong investigator confidence and the substantial unmet medical need in this devastating disease. With Eclipse 1 enrollment complete, we now expect primary completion in the fourth quarter of 2026, with top-line data for all three Eclipse studies expected by the first quarter of 2027. This accelerated timeline positions us well for regulatory submissions and demonstrates our operational excellence in executing registrational studies. Eclipse 2 continues to enroll well across European sites and remains on track. Together, Eclipse 1 and Eclipse 2 are designed to form the backbone of our regulatory filing package. Eclipse 3, our Phase 2b head-to-head comparison against lever-type, is progressing ahead of schedule with strong enrollment momentum and will provide valuable comparative data to support access and reimbursement discussions, particularly in European markets. The hepatitis delta market represents a compelling commercial opportunity with approximately 61,000 RNA-positive patients in the United States and 113,000 in EU markets. The patient population's geographic concentration, particularly in major U.S. urban centers, supports an efficient commercial approach with a target specialty sales organization focused on hepatologists and infectious disease specialists. Looking ahead to this month, we're preparing to present the complete 48-week solstice data set at ASLD on November 9th. This presentation will provide important insights into the safety and efficacy profile of our combination regimen and is expected to provide supportive data that reinforces confidence in our registration program. Turning to our oncology portfolio, we are excited to provide guidance that we plan to share a data update for VIIRS 5500, our PSMA-targeted T-cell engager, in the first quarter of 2026. We've made substantial progress in our dose escalation across both weekly and every three-week schedules, and this dataset is expected to provide important insights into the program's potential. We are enthusiastic about this program and the differentiated PRO-X10 dual masking approach. As I mentioned, we recently dosed the first patient in our first-line metastatic, castration-resistant prostate cancer combination study with ARPIs, a third step towards addressing a significant unmet need for patients in earlier treatment lines. For VIIR-5818, our ProExtend-MOSC HER2-targeted T cell engager, we are continuing dose escalation in combination with pembrolizumab, which is actively enrolling. For VIIR-5525, our ProExtend-MOSC EGFR-targeted T cell engager, our program continues to advance with enrollment in our phase one study progressing as expected. We are leveraging the extensive learnings from both VEO 5818 and VEO 5500 to enable efficient development and accelerate decision-making. The clinical experience we're gaining across three distinct targets, PSMA, HER2, and EGFR, is building evidence for the versatility of the ProX10 universal masking platform. This emerging clinical validation gives us confidence as we advance our preclinical pipeline of additional T-cell engager candidates targeting various tumor-associated antigens, whether through internal development or strategic partnerships that leverage our platform technology. Finally, we ended the third quarter with approximately $810.7 million in cash, cash equivalents, and investments. Based on our current operating plan, we continue to project our cash runway extending into mid-2027. This strong financial foundation enables us to advance our registrational hepatitis delta program and our oncology pipeline with confidence. With that, I'll now turn the call over to Mark to provide a more detailed update on our clinical development program.