ALLO - NASDAQ

Hello, and thank you for standing by. Welcome to Allogene Therapeutics, Inc. Fourth Quarter 2025 Conference Call. After the speakers' presentation, there will be a question-and-answer session. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. 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 Therapeutics, Inc.'s conference call. After the market closed, Allogene Therapeutics, Inc. issued a press release that provided a business update and financial results for the fourth quarter and year-end 2025. This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q&A session and will aim to keep the call under an hour. I am joined today by Dr. David Chang, President and Chief Executive Officer; Dr.

As we close 2025 and enter what we expect to be a defining year for Allogene Therapeutics, Inc., the environment around us is shifting. Cell therapy has entered a phase defined by evidence, where progress will be measured not by speculation and promises, but by data and disciplined execution. That shift plays to our strength. Our focus in 2026 is straightforward: delivering meaningful clinical milestones with rigor and speed. This is a year of critical proof points—proof points that could validate our allogeneic platform not merely as an alternative but as the imperative path to making cell therapy scalable, accessible, and deliverable at biologic-like scale. First, with SemiCell and ALPHA-3, we are asking a bold but important question that could redefine the management of large B-cell lymphoma. Can we intervene earlier, making CAR T truly accessible in the community setting, meaningfully improve outcomes, and alter the course of disease without disrupting the physician's practice? The goals of this study are not about incremental improvement in a late-line setting. It is about shifting the paradigm in the first-line treatment and demonstrating that SemiCell can reduce the risk of relapse and improve the cure rate. Importantly, it is about expanding access to community cancer centers that historically have been excluded from offering CAR T—bringing advanced cell therapy to where most patients are treated, off-the-shelf, at biologic-like scale. Second, with ALLO-329, we are extending the promise of allogeneic cell therapy to autoimmune disease. ALLO-329 is a purpose-built, dual CD19/CD70 CAR designed specifically for immune-mediated conditions, incorporating our Dagger technology to potentially reduce or maybe eliminate traditional lymphodepletion. We expect to report proof-of-concept data in June 2026, and assuming continued progress, another clinical update by the end of the year. We are entering this execution-focused period from a position of financial strength, having extended our runway into 2028. That gives us the ability to advance ALPHA-3 and RESOLUTION with focus and discipline. We have built a broad and innovative clinical pipeline, but we recognize we cannot advance everything at once. Discipline requires prioritization. Today, we are concentrating our resources on the programs where allogeneic CAR T has the greatest potential to demonstrate what this modality can achieve when developed around its inherent advantages: scalability, accessibility, and ultimately, the potential for durable cure. At the same time, we believe that as the field recognizes that allogeneic CAR T can deliver at scale with rigor and practicality, it will unlock new opportunities to expand the platform into additional settings and indications. With that, I will turn it over to

Thanks, David. As David outlined, the second quarter is defined by two key programs: SemiCell and ALPHA-3, and ALLO-329 in RESOLUTION. I will concentrate on the clinical execution behind these studies, and what we expect to learn in the months ahead beginning with ALPHA-3. ALPHA-3 is the first randomized study in lymphoma designed to test whether early MRD-guided consolidation with an allogeneic CAR T can prevent relapse. Patients who achieve remission after standard first-line therapy undergo highly sensitive ctDNA testing. Those who are MRD positive and therefore at high risk of relapse are randomized to observation or treatment with SemiCell. In April, we plan to report results from the interim futility evaluating MRD clearance in 24 patients—12 each in the SemiCell-treated arm and the control observation arm—along with early safety data. We will also outline the anticipated timeline and key inflection points as the study progresses. We have anchored expectations around what we and many clinicians believe would be a meaningful threshold at 25% to 30% absolute delta in MRD clearance between arms. Achieving that outcome would have the potential to alter disease and meaningfully improve the rate of cure of large B-cell lymphoma in the first-line setting. At the upcoming analysis, we also intend to provide preliminary safety data and additional perspective on how the use of SemiCell is being implemented in community settings. We now have over 60 active sites across the U.S. and Canada, with engagement with health authorities and clinical site start-up activities underway in Australia and South Korea. The level of real-world integration of SemiCell as consolidation into routine practice across both academic and community centers underscores what we believe is a core advantage of the off-the-shelf model and its potential to expand access beyond traditional CAR T delivery hubs. I will now spend a few minutes on ALLO-329, our first-in-class, dual CD19/CD70 allogeneic CAR T therapy designed specifically for autoimmune disease. ALLO-329 was engineered for this setting from the outset. It targets CD19-positive B cells and CD70-positive activated T cells, both of which contribute to autoimmune disease. Our Dagger technology is designed to endow the cells with a kind of built-in lymphodepletion to enable optimal cell expansion and persistence while potentially reducing or eliminating the need for conventional cytotoxic lymphodepletion. The Phase 1 RESOLUTION trial is a 3+3 dose-escalation study enrolling patients across multiple rheumatology indications, including systemic lupus erythematosus, lupus nephritis, scleroderma, and inflammatory myositis. The study is evaluating several dose levels beginning at 20,000,000 CAR T cells in two parallel dose-escalation cohorts—one that includes cyclophosphamide only and one without any traditional lymphodepletion. Twenty million cells is a small number, but one that we selected based on our conviction that the Dagger technology in ALLO-329 could drive meaningful in vivo expansion. For context, competitive programs in autoimmune disease are evaluating doses of autologous CAR T cells that are up to five to 10 times higher than our starting dose, and other allogeneic cell therapy programs are exploring cell doses nearly 50 times higher. In June, we expect to report initial proof-of-concept translational data as well as early clinical signals from the first dosing cohort with and without lymphodepletion. As an off-the-shelf allogeneic CAR T product that does not require any degree of patient HLA matching, ALLO-329 persistence in patients treated with minimal or no lymphodepletion at this low starting cell dose would be a strong validation of the Dagger effect in autoimmune patients. Assuming continued enrollment and follow-up, we anticipate providing an additional clinical update later this year. The opportunity in autoimmune disease could be significant. But success in this space requires tolerability, outpatient feasibility, and scalability, particularly as treatment moves into rheumatology practices. ALLO-329 was engineered with those requirements in mind. Across both programs, our focus remains on disciplined execution, with the goal of generating data that clearly define the role of allogeneic CAR T in earlier-line oncology and in autoimmune disease. With that, I will turn the call over to Jeff.

Thank you,

At this time, please press 11 on your telephone. If your question has been answered and you wish to remove yourself from the queue, please press 11 again. Our first question comes from Tyler Van Buren with TD Cowen. Your line is open.

Hey, guys. Thanks for taking the question and looking forward to both data updates next quarter. Could you elaborate on the safety parameters you will be looking at with the data update next month and what the bar is to support broad uptake in the community setting, and perhaps more importantly, how investigators in the community setting have already responded to incorporating SemiCell as a seventh cycle of treatment in the frontline?

Okay, thank you very much. I will ask our CMO,

Hey, Tyler. Thanks for the question. We plan to provide some high-level safety information—enough for everybody to understand how well this is being tolerated. It is unlikely we will go into very, very minute detail, but certainly serious adverse events in both arms, the sorts of adverse events that would lead to hospitalization—those sorts of things—which absolutely feeds into your second and third questions. What is the bar that we need to hit for safety? We believe that this is best delivered as an outpatient. Therefore, this needs to be a therapy that can be delivered as an outpatient and does not lead to rehospitalization due to adverse events. And finally, can this be done in the community? Absolutely, it is being done in the community currently, and we look forward to sharing all of the safety aspects that are allowing this to be taken up in the community by physicians.

Next question comes from Biren N. Amin with Piper Sandler. Your line is open.

Yes. Hi, guys. Thanks for taking my questions. I wanted to focus on the recent

Hey, Biren. Thanks for pointing out that recent MRD data analysis coming from a subgroup of patients who were involved in the

Great. Thank you.

Our next question comes from Michael Yee with UBS. Your line is open.

Yes, guys. We have two questions. One was your thinking—first question is your thinking around the interim analysis and what would define whether you took that interim analysis on EFS. In other words, if the MRD conversion is super high, is that what would drive your thinking to take the EFS? So that is the question number one. And then question number two is on autoimmune. We wanted to understand target product. When you get your data coming up, is this to be a low lymphodepletion, a no-lymphodepletion type program? What are you trying to envision with the profile of that product? Thank you.

Yes, two great questions. In terms of this being somewhat similar to what Biren was trying to get at, one thing is that there is not enough data out there to see how MRD clearance relates to clinical outcomes such as event-free survival—whether this is a linear relationship, meaning that if there is a greater difference in the MRD clearance, there will be a greater difference in the clinical outcome. That kind of data, while plausible, is—there is such paucity of the data—so we cannot really establish that other than saying it is possible that if we see greater MRD clearance difference, that may translate to greater clinical benefit. To the point about how that may put us in the timing of interim EFS analysis: interim EFS analysis is an alpha-spending analysis. It is the primary endpoint analysis at a smaller event rate, and there is always the possibility that interim may cross the statistical boundary. That is part of the reason that we do the interim analysis—not just us; everybody who does interim analyses faces this. But let us stay tuned. Our focus right now is the MRD clearance that we promised to communicate in April. With the second question on the target product profile with the autoimmune program, our CD19/CD70—as

Thank you. One moment for our next question. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open.

Good afternoon. Thanks for taking my question. On the overall SemiCell market opportunity and commercial positioning, CD3 bispecifics move to the frontline. This could influence MRD positivity rates or directly exclude patients from SemiCell eligibility. Just curious to get your thoughts on the evolving LBCL landscape and how you see SemiCell positioned long term? Thank you.

Hey, Salveen, this is

Thank you. One moment for our next question. Our next question comes from Matt Phipps with William Blair. Your line is open.

And the update on timeline staying on track. When you look at that Foresight CLARITY data that looks at rates of MRD positivity post R-CHOP, are there any patterns around high-risk baseline characteristics such as double-hit, triple-hit genetics or, you know, IPI in the 4s, or something that you see in those patients that do not reach MRD clearance? And maybe you can remind us how SemiCell performed in those types of subgroups in your previous last-refractory trial? Thank you.

Great question. This is

Thank you. One moment for our next question. Our next question comes from Samantha Semenkow with Citi. Your line is open.

Hello? Hi. This is Ben on for Sam. Thanks so much for taking our question. Can you talk about expectations for the observation arm in the ALPHA-3 study? What is the expected rate of spontaneous MRD conversion, and if there is any data you could help us to triangulate this? Thank you.

Hey, Ben. This is