Vir Biotechnology, Inc.

Hello, welcome to VEER Biotechnology's third quarter 2024 financial results and business 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 presentation, there will be a question and answer session. If you would like to ask a question during this time, simply press the star key followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press star 1 again. I will now turn the call over to Rich Lepke, Senior Director, Investor Relations. You may begin, Mr. Lepke.

Thank you, and good afternoon. With me today are Dr. Marianne DeBacher, our Chief Executive Officer, Dr. Mark Eisner, our Chief Medical Officer, and Jason O'Byrne, our Chief Financial 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 DeBacher.

Thank you, Rich. Good afternoon, everyone, and thank you for joining us today. I'm pleased to provide an update on the significant progress we've made this quarter, beginning with the successful closing of our exclusive worldwide licensing agreement with Sanofi. This landmark agreement includes three clinical stage masked T-cell engagers and the use of Sanofi's proprietary ProX10 protease cleavable masking platform for oncology and infectious diseases. This strategic move aligns seamlessly with our mission to use the power of the immune system to fight disease. We believe that the three dual-masked T-cell engagers, PURE5818 for HER2, PURE5500 for PSMA, and PURE5525 for EGFR, have the potential to be best-in-class therapies. These investigational treatments aim to minimize toxicity challenges typically associated with T-cell engagers, allowing for higher dosing and thereby enhancing efficacy. As part of this agreement, we have welcomed key employees from Sanofi, which bring extensive scientific and development expertise in oncology and the ProX10 masking platform technology. These talented individuals have quickly proven to be an excellent fit within our organization. We believe that their expertise, combined with our deep understanding of T-cell immunology, our robust infrastructure, and leading machine learning and antibody engineering capabilities will create significant synergies. Moving on to our mid-stage clinical pipeline, we are making strong progress across our hepatitis programs with important upcoming data readouts. I'll now highlight our recent progress in the ongoing Phase 2 SALSTIS trial in patients with chronic hepatitis delta. Hepatitis Delta represents a highly promising growth opportunity for Veer, marking the next significant inflection point in our journey toward becoming a fully integrated and sustainable commercial company. Much like other orphan disease markets, the HDV market is characterized by significant unmet medical needs and severe clinical outcomes for patients. This underscores an opportunity for innovative and impactful therapies that address critical health challenges and offer substantial value to both patients and the healthcare system. We estimate there are approximately 100,000 people living with hepatitis delta in the United States and approximately 200,000 in Europe alone. Despite the severe and often life-threatening impact of HTV, patients currently have very limited treatment options. There are no approved therapies in the U.S., and in Europe, the only available treatment requires daily, self-administered subcutaneous injections, presenting challenges for long-term patient compliance and quality of life. Based on the preliminary Phase II clinical data we have shared to date, we believe our combination regimen of dobevibart and elapseron is highly differentiated compared to the current standard of care and has the potential to be a transformative treatment option for these patients in need. As we continue to advance this promising treatment, we anticipate an increase in both diagnosis and treatment rates. Feedback from physicians and advocacy groups has highlighted a growing interest in reflex testing for hepatitis delta. Reflex testing involves automatically testing for hepatitis delta in patients who test positive for hepatitis B without requiring a separate order from the healthcare provider. This proactive approach ensures early identification of HDV infections, even in regions like the United States, where treatment options are currently limited. By identifying patients early, we can help ensure they receive timely treatment once a therapy is approved. While we are at the early stages of driving this awareness, we aim to improve early diagnosis and pave the way for effective treatment outcomes for patients with hepatitis delta as our HDV program advances closer towards a potential approval. We are committed to partnering with key stakeholders across the healthcare landscape to advocate for and adopt these testing practices. Looking ahead, we will present data from the SALSTIS trial at the AASLD conference taking place November 15th to 19th in San Diego. We are making excellent progress advancing this program in the clinic and have engaged with the FDA to discuss our planned registrational program in HDV, which is expected to begin next year. Next, I'd like to address our functional cure program for chronic hepatitis B, which represents another substantial opportunity for our combination regimen of tobevibar and elapseron with or without regulated interferon alpha. Our goal is a functional cure in this setting, defined as a sustained loss of detectable hepatitis B surface antigen and hepatitis B virus DNA after a finite course of treatment. There are an estimated 1.6 million hepatitis B patients in the United States alone and approximately 254 million globally. We are looking forward to reporting end-of-treatment data from the March Part B trial in a late-breaking presentation at the upcoming AASLD meeting in November. This end-of-treatment data will be followed by the functional cure data readout in the second quarter of 2025. Based on KOL feedback, our target for a functional cure is 30% for the interferon-containing regimen and 20% for the regimen excluding interferon. Before I close, I would like to provide an update on our upcoming events and reaffirm our commitment to keeping you informed about our progress. While we had initially planned to host an R&D day in the fourth quarter, we will instead conduct an in-depth investor event focused on our hepatitis franchise in November. Given the addition of the T-cell engagers to our portfolio and the subsequent reprioritization of our pipeline, we have adjusted our plans. We now intend to discuss our T-cell engager programs at a dedicated investor event in the first quarter of of 2025. This timing also allows us to present initial clinical results, ensuring we provide insights into our progress and the future prospects of these programs. As mentioned, we will host an exclusively hepatitis-focused investor event immediately following the AASLD conference in November. During this event, we will provide detailed updates on both the March and Solstice programs. This focused approach will allow us to delve deeply into these two critical development programs and their implications for patients and our broader clinical strategy. We understand the importance of clear and timely communication with our investors and we're committed to keeping you updated on all the significant developments. Finally, I'm thrilled to have welcomed Jason O'Byrne as our new Executive Vice President and Chief Financial Officer earlier this month. Jason is an accomplished executive with more than 20 years of experience in finance and operations and a proven track record in financial strategy across public companies. His exceptional leadership and focus on excellence in execution make him a perfect fit as we embark on the next chapter for our organization. Since joining VEER, one of Jason's key priorities has been to ensure continued disciplined capital deployment and financial stewardship. As we recently announced, we have implemented a strategic restructuring initiative to prioritize our clinical stage pipeline opportunities and streamline our operations. These efforts are allowing us to allocate our resources more efficiently and focus on our core programs. In closing, I couldn't be more optimistic about FEAR's future and the potential impact of our innovative therapies. We have a strong balance sheet, which allows us to fund operations through our next major inflection points. We are prudently managing our expenses with a focus on our most promising programs and maximizing shareholder value. I would like to thank our dedicated team, including our new colleagues, for their hard work and our investors for their continued support. And with that, I'll now turn the call over to our Executive Vice President and Chief Medical Officer, Mark Eisner, to provide an update on our clinical development programs and pipeline.