Allogene Therapeutics, Inc.

Hello, thank you for standing by and welcome to Allogene Therapeutics second quarter 2026 conference call. After the speaker's presentation, there will be a question and answer session. To ask a question during the 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 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 welcome everyone to Allogene's conference call. After the market closed, Allogene issued a press release that provided a business update and financial results for the second quarter of 2026. This press release and today's webcast are available on our website. Following brief prepared remarks from Dr. Zachary Roberts, President and Chief Executive Officer, we will open the call for questions. Geoff Parker, Chief Financial Officer, will also join the Q&A. To help us conclude within 45 minutes, we ask that each analyst limit themselves to one question. 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, the potential treatment setting, 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 Allogene disclaims any obligation to update these statements. I'll now turn the call over to Zach.

Thanks, Christine, and good afternoon, everyone. This is my first quarterly call as CEO, and it marks the beginning of a new chapter for Allogene, one made possible by the foundation David Chang helped build. David has been my mentor and one of the people who has most shaped how I think about cell therapy and drug development. More than that, he co-founded and built this company, led the field in the generation of clinical data in patients with relapsed cancer, and created the framework we needed to take Allogene into its next chapter. When I joined Allogene, my mandate was clear, challenge the conventional thinking about how allogeneic CAR T should be developed. That meant starting with the patient and working backward, understand what patients and their care teams need, then design products and clinical programs that meet those needs. That work led to a deliberate strategic shift announced in 2024, designing programs and products that leverages features of allogeneic cell therapy into a clinical advantage. We focused on settings that demand the unique attributes of off-the-shelf CAR T, ready availability, consistent product quality that is independent of the patient's immune status, and crucially, the ability to treat patients locally. Allogeneic CAR T is not a stepping stone between autologous therapy and whatever may come next. It is a distinct platform capable of filling gaps existing modalities cannot and progress across Alpha 3, Allo 316, and Allo 329 is beginning to demonstrate those advantages in practice. I will start with Alpha 3 because it is the clearest expression of this strategy. Alpha 3 arose from a simple premise. Can we identify patients at high risk of relapse after first-line treatment and intervene with CAR T before the disease returns clinically? By treating earlier, the study aims to prevent relapse while avoiding much of the toxicity associated with standard second-line therapies, including autologous CAR-T. The trial is also designed to prove that we can overcome long-standing access barriers by enabling patients to receive CAR-T where they already received their first-line care, in the community, with the same doctors who gave them their first-line treatment. Testing this required a more precise way to identify patients at high risk of relapse. Standard methods used at diagnosis, such as disease stage and IPI, lacked sufficient specificity because many patients classified as high risk by those methods are still cured with RCHOP. That new tool emerged just weeks before I joined Allergy. When I saw the Foresight, now Natera, clarity data presented at ASH 2022, the design of Alpha-3 came into focus. When Alpha-3 began, MRD and large B-cell lymphoma was viewed largely as an academic research tool. We believed it could become far more, a standard marker of a patient's prognosis and, if properly validated, a new treatment decision point. That view is gaining traction not only in LBCL but across oncology. In May, the FDA approved Ticentric as adjuvant therapy for patients with bladder cancer who are in radiographic remission but remain MRD positive by circulating tumor DNA. The approval, based on the INVIGOR-11 study, is the first where patient selection was based solely on a ctDNA MRD test. INVIGOR-11 closely parallels Alpha-3's design, and this approval, as well as a new Category 1 NCCN recommendation, signals a broader shift toward using MRD as a treatment decision trigger rather than waiting for clinical relapse. Fast forward to our first look at data from the Alpha-3 trial in April, the interim futility analysis, which provided an important early test of Alpha-3's hypothesis. Semicell drove rapid MRD clearance in a majority of patients and did so with no treatment-related hospitalizations. Most patients were treated and followed entirely in the outpatient setting. And importantly, Semicell was successfully delivered in community practices with no prior CAR T experience. Together, those findings support Alpha-3's potential to change the lymphoma landscape by offering CAR-T earlier with less logistical burden and greater access across more treatment settings. At the end of July, the FDA granted both RMAT and Fast-Track designations for semicell in first-line consolidation. These designations are based on two critical points. First, FDA acknowledges that MRD positivity at the end of first-line treatment is an unmet medical need, and second, Semicella has the potential to meet that need. We interpret this action by FDA as validation for the Alpha-3 program. Additionally, RMAT creates an important opportunity for more frequent and focused engagement as we advance the trial. That engagement will be central to how we move forward. Our objective is clear. Execute the study well, protect its integrity, and work with the FDA toward the most efficient development and regulatory path. As enrollment continues, we expect opportunities in 2027 to update investors on the program, including enrollment progress and potential data such as the planned interim EFS analysis. The timing and scope of these updates will of course be guided by our regulatory discussions and the Independent Data Monitoring Committee. In the meantime, we will communicate meaningful operational and regulatory progress. Today, we are proud to provide one such operational update. We entered the year with a goal of activating over 80 clinical sites by year-end. With strong execution by the team and increased investigator interest following the interim futility analysis, we reached that goal in July. New academic and community-based investigators have asked to join the trial, citing enthusiasm for the initial MRD clearance data and safety profile and growing momentum of MRD testing in lymphoma. As a result, we now expect to have approximately 100 sites active by year end with the significant majority in the United States and additional sites in Canada, Australia and South Korea. This expansion reflects growing investigator conviction in MRD and the Alpha-3 strategy, supports enrollment momentum and gives more sites hands-on experience with SemaCell's ease of use ahead of a potential commercial launch. Turning to Allo 316, the publication of the Traverse results in the Journal of Clinical Oncology was an important milestone for the program and the Dagger platform. Solid tumors have been CAR T's hardest test. In patients with CD70 high renal cell carcinoma, Allo 316 produced a 31% confirmed overall response rate using the optimized regimen. At the data cutoff, none of the five confirmed responders had experienced disease progression, with follow-up ranging from eight months to more than 18 months after a single dose of Allo 316. The data set is small, and the program has faced real safety challenges. We've been direct about both. But confirmed responses with this degree of durability in a solid tumor are notable. Just as important, the translational work gives us a much clearer view of the underlying biology of these responses using CAR T-cell expansion, persistence, tumor infiltration, and the contribution of Dagger. Traverse also demonstrates how we operate. There were moments when the conventional decision would have been to stop development of Allo 316. When toxicity emerged, our team brought in outside experts, engaged with the FDA, developed a management algorithm, and continued learning. That work gave us a pathway to manage the most serious events while advancing understanding of an increasingly recognized immunotherapy toxicity and allowed us to generate the foundational clinical evidence for our Dagger technology pipeline. We are still far from declaring victory in solid tumors, but these results provide encouragement to keep pushing. They move the field forward and reinforce the principle that is central to allergy. When the biology is sound, we stay focused, learn from the data, and continue advancing the science. That same focus on thoughtful program design brings me to ALLO329 and the Resolution Trial in Autoimmune Disease, where the core message is execution. Enrollment has moved quickly across cohorts, dose levels, and lymphodepletion strategies, even in a highly competitive field. We believe that momentum reflects a program designed with patients as the focus rather than one that asks them to adapt to the technology. Allo329 was designed with Dagger from the outset. Rather than designing another CAR-T product that requires chemotherapy-based lymphodepletion to work, the product is designed to function better when confronted by the biology of allorejection by targeting the activated host T cells that contribute to it. Our objective is to both identify the optimal dose regimen for Allo329 and to understand how its cell dose, lymphodepletion, and Dagger work together. Strong enrollment and execution are keeping us on track to report a clinical and translational update by year end. Across all three programs, the through line is clear. We embrace the features of allogeneic CAR T as unique strengths and have designed programs to allow us to meet the demands of patients when and where they arise. Over the next 12 months, we expect the value of that work to become increasingly visible, beginning with an Allo 329 update by year end and opportunities to update investors on Alpha 3 throughout 2027. Those milestones will help define our progress, but the standard we are working toward is simpler. Innovation only matters if patients can actually access it. We'll now open the call for questions.