Allogene Therapeutics, Inc.

Hello, and thank you for standing by, and welcome to Allogene Therapeutics' second quarter 2025 conference call. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. At this time, all participants are in a listen-only mode. Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Cassiano. Chief Corporate Affairs and Brand Strategy Officer, Ms. Cassiano, please go ahead.

Thank you, Operator, and thank you for joining this call. After the market closed, Allogene issued a press release that provided a business update and financial results for the second quarter of 2025. This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q&A session. We recognize that historically questions have been multifaceted, but note that we will endeavor to keep this call to under an hour. I'm joined today by 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, commercial market forecasts, and 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. Your caution not to place undue reliance on these forward-looking statements, and Allergy disclaims any obligation to update these statements. I'll now turn the call over to David.

Thank you, Christine, and welcome, everyone. This past quarter marked a period of significant advancement across our portfolio, with progress that highlights how scientific excellence, rigorous decision-making, and thoughtful planning and execution can call us into transformative momentum. We are seeing the power of this approach across our pipeline, from semicell in first-line consolidation for large B-cell lymphoma to allo316 in fellow tumors, and now allo329 in autoimmune disease. Let me begin with semicell in the alpha-3 study. The Alpha-3 study has been streamlined into a two-arm randomized trial comparing treatment with semacell following a standard lymphodipollution regimen of fludarabine and cyclophosphamide in the active arm to observation in the control arm. This decisive move made in conjunction with the Data Safety Monitoring Board and steering committee reflects our unwavering commitment to patient safety. It also reflects our ability to act swiftly, balancing scientific judgment with agility to create and preserve the long-term value of our platform. I also would like to thank the review team at the FDA that provided prompt informal consultation and guidance. More than 50 sites are now activated across the US and Canada, and additional international expansion is underway. We remain on track for the planned futility analysis in the first half of 2026 and expect to share MRD conversion rates at that time. The changes to the protocol exemplify our vision to redefine CAR T therapy by prioritizing patient accessibility in every stage of development. Turning to ALO316, our CD70 targeted CAR T for renal cell carcinoma we presented compelling Phase I data at ASCO 2025. This trial serves as a significant proof point for our Dagger platform and how this technology may define the future of off-the-shelf cell therapy. The results seen to date from the TraVERSE trial underscore the potential for Dagger technology to support both robust expansion of CAR T cells and durable clinical responses in cell tumors. We have since aligned with FDA on a pivotal trial strategy and are actively exploring partnership opportunities with several third parties to advance this program. In autoimmune disease, we opened enrollment in the resolution study, one of the first allogeneic CAR T trials in this space and the first of such to contemplate a new approach to lymphodepletion. We have designed both our Allocarti product and the trial itself with patient accessibility, not as an afterthought, but as a priority from the outset. By simplifying or eliminating lymphodepletion altogether, we are testing both hypotheses grounded in strong science and clinical insight. This study reflects not only our ambition, but also our readiness to challenge paradigms with data. Each of these advances is rooted in the belief that the breakthroughs are not born by chance. They are built. They emerge from foundation of strong science, disciplined execution, cross-functional collaboration, and the agility to adapt and evolve when circumstances change. Nowhere is this more evident than in cell therapy, a field with a potential to transform how we treat disease, and in doing so, generate extraordinary value for those who invest in companies that have demonstrated the ability to navigate the train. While early optimism often feels bold ambition, reality is often far more complex, especially in the unforgiving terrain of clinical development. where transformative idea must be tested and refined. That's why many have studied on this path, yet only a few have advanced beyond the early promise. Allergen stands among the few that have successfully persevered in this field. From the beginning, we have committed to these principles, not just in theory, but in practice. Today, we are one of the last allergenic cell therapy companies standing. and the one with the most diverse and advanced clinical pipeline, and we take that position seriously. While the finish line in this field is neither fixed nor guaranteed, our continued progress reflects the depth of our platform, the strength of our team, and our unwavering commitment to doing the hard, necessary work that real innovation demands. As we look ahead, our near-term milestones are more than clinical achievements. We believe they are value-driving catalysts that reinforce our foundation and advance our vision of making allogeneic CAR T the standard of care. I want to thank the entire allogene team for their passion and commitment and give a special thanks to Zach for his steady leadership in R&D. The choices we made this quarter really reflects our responsibility to move boldly and thoughtfully always keeping patients at the center. With that, I'll hand it over to Zach.