Vir Biotechnology, Inc.

Hello, welcome to VEER Biotechnology second 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 star followed by the number one on your telephone keypad to raise your hand. I would now like to turn the call over to Richard Lepke, Senior Director of Investor Relations. You may begin, Mr. Lepke.

Thank you, operator, and hello, everyone. I am Richard Lepke, Senior Director of Investor Relations at Beard & Byers Technologies. Joining me on the call are Dr. Marianne DeBacher, our Chief Executive Officer, Dr. Jennifer Towne, our Chief Scientific Officer, Dr. Mark Eisner, our Chief Medical Officer, and Brent Sabatini, our Chief Accounting Officer. Before we begin, I'd 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, 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 today's press releases and the company's reports files of the Securities and Exchange Commission, including Forms 10-K, 10-Q, and 8-K. With that, I'll turn the call over to Marianne. Please go ahead.

Good afternoon, everyone, and thank you for joining us today. At VEER, our mission is powering the immune system to transform lives. During today's earnings call, we will discuss two significant announcements that mark critical milestones on our journey to realize this mission. Before we dive into these announcements, let me quickly highlight some key achievements from the second quarter. We presented promising Phase II solstice data in chronic hepatitis delta at the ESL Congress, which generated significant interest from both the scientific as well as the medical community. These preliminary data underscore the potential of our combination therapy to bevipart in the lab strength to revolutionize the treatment landscape for people living with hepatitis delta. We are now preparing to engage with regulatory authorities to discuss the registrational path forward. We also recently received FDA IND clearance and fast track designation for this combination therapy. In parallel, we remain focused on advancing our functional cure program for chronic hepatitis B, and we eagerly anticipate reporting 48-week end of treatment data from the phase two March Part B study at the major medical congress in the fourth quarter. Now, let me turn to the two significant announcements that will be the main focus of today's call. First, I'm excited to announce that FEAR has entered into an exclusive worldwide license agreement with Sanofi for three clinical stage mask T-cell engagers and the exclusive use of the ProX10 protease-cleavable masking platform for oncology and infectious diseases. This license agreement is subject to HSR review and clearance, which we expect will take about 30 days from signing. Second, we will be providing a corporate update on our strategic restructuring. To provide you with a comprehensive overview of these announcements and their impact on our company, we have structured today's call as follows. First, I will summarize the strategic rationale behind the Sanofi license agreement and the corporate restructuring. Then, Jen will provide details on the masking platform and its potential applications. Mark will discuss the clinical stage assets we have licensed. Brent will provide a financial overview, including the terms of the agreement and our capital allocation priorities in light of the restructuring. And finally, I will offer some closing remarks before we open the call for questions. Let me now provide more details on our exclusive worldwide license agreement at Sanofi and the strategic measures we have announced today. First, the agreement adds three potentially best-in-class clinical stage assets, SAR446309 or AMX818, a dual-MOSC HER2-targeted T-cell engager in Phase I development. SAR446329 or EMX500, a dual-MOSC PSMA-targeted T-cell engager in Phase I clinical development. And SAR446368 or EMX525, a dual-MOSC EGFR-targeted T-cell engager with a cleared IND scheduled to begin phase one in early 2025. For the duration of the call, we will refer to these assets by the last four digits of their drug candidate code, 6309, 6329, and 6368, respectively. Looking ahead, these assets have multiple near-term key catalysts expected in the next nine to 18 months. Second, we obtained the exclusive license to Sanofi's ProX10 Protease Cleavable Masking Platform for Oncology and Infectious Diseases. T-cell engagers are, in essence, engineered by specific monoclonal antibodies, and given our deep antibody protein engineering and T-cell biology expertise, we believe that we can unlock meaningful synergies and create new best-in-class therapies. Upon closing, we are also excited to strengthen VIIRS capabilities by welcoming a team of key Sanofi employees with extensive scientific and oncology development expertise. Finally, we are strategically reprioritizing our pipeline, which has led to a restructuring of our organization. To better understand the potential impact of the licensed assets, let's first discuss the current landscape of cancer therapeutics and the unmet needs that still exist. Despite advances in cancer research, the global burden of cancer remains high, with 10 million deaths annually and a five-year survival rate of just 5% for some cancers. T-cell engagers have shown promise as a potent therapeutic modality, but they often have low durability because of off-tumor, on-target toxicity in healthy tissue, systemic toxicity such as cytokine release syndrome, and the inability to achieve therapeutically active doses in the tumor microenvironment. These limitations have hindered the widespread adoption of T-cell engagers to date. Our solution to addressing these challenges is a potential best-in-class ProX10 protease activating masking technology. This proprietary platform allows T-cell engagers cytokines, and other molecules to be selectively activated in the tumor microenvironment. By masking the T-cell engagers, this technology aims to minimize off-tumor toxicities and systemic side effects while enabling the achievement of therapeutically active doses directly in the tumor tissue. This technology has the potential to significantly improve the safety and efficacy profile of future treatments. Now, this strategic transaction not only enhances our clinical pipeline, but also augments our core R&D capabilities, and upon closing, will bring a complementary platform to the company. At Veer, we have always prided ourselves on our world-class immunology and biology expertise, which has enabled us to uniquely discover and engineer monoclonal antibodies to address serious infectious diseases. With the anticipated addition of the ProX10 masking platform, we will be even better positioned to develop innovative therapies that selectively target disease-causing cells while sparing healthy tissue. Our leading data science capabilities, including machine learning and AI, will further support our efforts to bring transformative therapies to patients faster. An important component of the agreement is that we are adding a team of key employees who offer extensive expertise in oncology clinical development, in-depth knowledge of the proprietary masking platform, and valuable expertise in manufacturing dual mask molecules. By combining our existing strengths with this new expertise, we will create a powerful synergy to drive innovation. And we look forward to working together to advance our mission following closing of the transaction. As we anticipate integrating the licensed assets into our pipeline, we are taking decisive steps to focus on the highest value near-term opportunities. First, we are focusing our resources on our core programs in hepatitis delta, hepatitis B, and upon closing, the newly licensed MOSC C-cell engager clinical portfolio. Second, we are phasing out programs in influenza and COVID-19, as well as our T-cell based viral vector platform and programs. Where appropriate, these programs will be made available for partnering. Third, we are implementing a workforce restructuring that will result in a reduction of approximately 25% of our employees. These actions are expected to yield significant cost savings while allowing us to effectively utilize our strong balance sheet to advance our strategic priorities. By streamlining our operations and allocating our capital efficiently, we are positioning VEER for long-term success and sustainable growth. In addition, we are revising our 2024 expense guidance lower. Brent will summarize the details later on the call. I do want to take a moment to express my deepest gratitude to all our employees, including those who will be leaving the company, for their dedication and their significant contributions to our mission. These decisions, while difficult, are necessary to ensure that we are allocating our capital and our talent in the most effective way possible to bring transformative therapies to patients. We believe that this strategic restructuring will enable us to deliver on that promise more effectively than ever before. With that, I would now like to turn the call over to Jen, who will provide more details on the masking platform and its potential applications in oncology and in infectious diseases.