Allogene Therapeutics, Inc.

Hello, and welcome to the Allergy and Therapeutics first quarter 2024 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be aware that today's conference is being recorded. We ask that you limit yourself to one question only. I would now like to turn the conference over to Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer. You may begin.

Thank you, Operator, and welcome to all who have joined this call. After the market closed today, Allogene issued a press release that provides a business update and financial results for the first quarter of 2024. This press release and today's webcast are both available on our website. Following our prepared remarks, we will host a Q&A session. We ask you to limit your questions to one per person as we will keep this call to an hour and do our best to get to as many questions as possible. Joining me today are Dr. David Chang, President and Chief Executive Officer, Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, and Jeff Parker, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, the safety and efficacy of our product candidates, expanded semacell development, and 2024 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and Allogene disclaims any obligation to update these statements. I'll now turn the call over to David.

Thank you, Christine, and welcome to those on the call today. We are excited to speak with you today to discuss how we have continued to strengthen our Allogeneic Cartier leadership position on every front. In January, we announced our Pivot to Focus development, on differentiated and competitive programs that are importantly designed to address unmet needs. In doing so, our future market opportunity dramatically increased. In large B-cell lymphoma alone, moving from the later line into the frontline consolidation meant that the U.S. market opportunity grew from approximately $500 million to more than $6 billion. That change meant something significant. It was time to extend our territory rights to include all of the European Union and the UK from Serbia. We are excited to have executed that vision, and Jeff will provide more details on that agreement on this call. Our team is making great progress in four core programs we outlined in January. We are very proud of the transformative potential of our Pivotal Alpha-3 trial with Semicel which is expected to read out in 2026, leading to potential BLA submission in 2027. This trial is designed to embed semacell as a part of curative first-line regimen and has the potential to change the standard care for patients with large B-cell lymphoma. The last point being something I want to emphasize as that is very rare in oncology. Our Semicell program could also set a new standard for what a CAR T can achieve in relapse, refractory chronic lymphocytic leukemia, or CLL. Differentiation is critical across our core programs. We declared a move into autoimmune space with the goal of resetting the immune system with a single infusion. Allo329, our next generation CD19-CD70 dual CAR, which incorporates our Dagger technology and CRISPR-based gene editing for site-specific integration, is designed to meet the unique needs of patients with autoimmune disease. Our Dagger technology provides a potential path to reducing or eliminating lymphodepletion which we believe may create more development and commercial opportunities for Allo329 in autoimmune indications. Our Allo316 program could be the first to demonstrate the unique potential of a CAR-T and solid tumor. We believe our $15 million California Institute for Regenerative Medicine grant awarded last month validates the remarkable inroads made in our Traverse trial and the therapeutic potential ALO316 has for patients with advanced renal cell carcinoma. This grant funds the completion of the phase one trial. We are grateful for the recognition from the CIRM reviewers of the potential for ALO316 to make a difference for patients. Lastly, we are pleased to have strengthened our cash runway to extend into third quarter 2026. I am very excited by the caliber of investors who participated in this financing and their demonstrated commitment to our mission. In addition, members of our board and executive management, including our executive chair, Ari Veldegrand, Jeff, our CFO, and I have further demonstrated our commitment to AlloGen by participating in this offering. Understandably, many investors are focused on milestones related to our Pivotal Alpha-3 trial, but it is essential to appreciate the multitude of inflection points across all our programs. Later in the call, Zach will review the development milestones across all four core programs. We will continue to focus all our resources on advancing these core programs and believe we are well positioned to change the CAR-Q treatment landscape to benefit patients. I'd like to turn the call over to Jeff to review our announcements today.