Allogene Therapeutics, Inc. (ALLO) Q4 2025 Earnings Report, Transcript and Summary

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. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer; and Geoffrey 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. You are cautioned not to place undue reliance on these forward-looking statements, and Allogene Therapeutics, Inc. disclaims any obligation to update these. I will now turn the call over to David.

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 Zach to walk through the clinical progress in more detail.

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, Zach. As we prepare for multiple clinical catalysts in 2026, our financial position is aligned with our strategic priorities. We have been deliberate in concentrating our resources behind ALPHA-3 and RESOLUTION while maintaining balance sheet strength and operational flexibility. As of 12/31/2025, we had $258.3 million in cash, cash equivalents, and investments. In February, we received an additional $23.7 million previously held in escrow related to Servier's favorable arbitration outcome with Selecta. We have also made prudent and opportunistic use of our ATM equity facility, and have raised an additional $20.7 million year to date. As a result of these actions, we have extended our cash runway into 2028, which we believe covers the time frame we currently estimate is needed to complete enrollment in the ALPHA-3 trial. R&D expenses for the fourth quarter were $28.6 million, including $2.5 million of non-cash stock-based compensation. For the full year 2025, research and development expenses were $150.2 million, which includes $12.9 million of non-cash stock-based compensation expense. G&A expenses for Q4 2025 were $13.8 million, including $5.6 million in non-cash stock-based compensation. For the full year 2025, G&A expenses were $56.8 million, which includes $24.7 million of non-cash stock-based compensation expense. Net loss for the fourth quarter was $38.8 million, or $0.17 per share, including non-cash stock-based compensation expense of $8.1 million. For the full year 2025, net loss was $190.9 million, or $0.87 per share, including non-cash stock-based compensation expense of $37.6 million and non-cash impairment of long-lived asset expense of $2.4 million. Guidance for operating cash expense in 2026 is expected to be approximately $150 million. GAAP operating expenses are expected to be approximately $210 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities. With pivotal data from ALPHA-3 approaching in April, proof-of-concept data for ALLO-329 expected in June, and cash runway now extended into 2028, we believe we are well capitalized to execute through these important inflection points. Our focus remains clear: advance high-impact programs, manage capital responsibly, and position Allogene Therapeutics, Inc. for long-term value creation. We will now open for questions.

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, Zach, to elaborate on the safety aspect.

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 ZUMA-7 MRD analysis that were published last month, where ExaCell observed a treatment difference of 20% on MRD negative, which translates to about an EFS benefit of around 27 months versus the control group. Given you are expecting a 25% to 30% difference on MRD conversion, what read-throughs do you have from the ZUMA-7 data and your confidence on stopping at your interim EFS analysis? And on the interim EFS analysis, if you could maybe just walk us through how many events you need and what are the assumptions on hazard ratio that could lead to an early stoppage. And lastly, when can we expect interim EFS data? Thank you.

Hey, Biren. Thanks for pointing out that recent MRD data analysis coming from a subgroup of patients who were involved in the ZUMA-7 study. We view this study to be very consistent with how we have been looking at the MRD clearance and its correlation to the clinical outcome. Besides the study, an earlier study that we have been talking about is INVIGO 11, where MRD clearance difference of 11% led to a very meaningful clinical difference. So what has been reported with ZUMA-7 is very consistent, and I believe it validates the guidance that we have been providing, which is 25% to 30% MRD clearance difference at the futility interim analysis that we project to share in April. This is highly consistent, and we do believe that 25% to 30% is going to translate to very meaningful clinical difference in the outcome. With respect to your second question—how much can we speculate or model out about how the MRD clearance may translate to the EFS interim analysis—I would say it involves too many assumptions and speculations, and it is a little bit too early to talk about it. But internally, we are constantly reviewing the data and our functions. So stay tuned.

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 Zach has covered in his prepared statement—this is a highly differentiated program that is endowed with a Dagger that may enable ALLO-329 to work at low or no lymphodepletion. So in the ongoing study, the baseline case that we are testing is low lymphodepletion, which is essentially using cyclophosphamide only. Standard lymphodepletion involves both cyclophosphamide and fludarabine. We took out the fludarabine altogether, and we lowered the cyclophosphamide dose to only one day infusion. That is the baseline case that we are testing. Also, we are testing, as part of the study, no lymphodepletion. The target product profile we are trying to get to is providing a meaningful B-cell depletion that is leading to reset of the immune system at cyclophosphamide alone. We think that will be the base case, and we will see if we can get to that without any lymphodepletion. That would be a great win—not just for the field, but for patients and everything that people are trying to do with B-cell depletion in the autoimmune space.

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 Zach. Great question. It has been an interesting few years as these bispecifics have been approved in late lines and now are moving into frontline. I think if the early Phase 1 data in untreated patients is consistent with the overall Phase 3 readouts, there is a likely outcome that a certain percentage of patients may be cured with these very intense upfront regimens. So there is a possibility that there will be fewer MRD-positive patients. However, I think we very much need to wait for those final data before we begin to consider how the market opportunity may evolve—and not just efficacy, but also safety and the pace at which these complex and expensive regimens are taken up in the community. Our initial feedback is that not everybody is going to be lining up to be giving these very, very complex regimens that often require hospitalization for step-up dosing and so forth. We are watching this space very carefully, but we believe that the MRD positivity rate is largely going to be unchanged for the next many years.

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 Zach again. Absolutely, there does appear to be differential MRD positivity rates according to the baseline risk, which is of course no surprise. MRD positivity at the end of treatment is an extremely high risk for disease progression, and it is precisely disease progression that was used to generate those risk stratification tools. So it is very consistent that if you have high-risk disease at the time of diagnosis, you are more likely to be MRD positive at the end of frontline treatment, and of course then you are more likely to experience a relapse. The beauty of ALPHA-3, however, is that there are lots of examples out there where patients who even have low-risk disease turn out to be MRD positive at the end of treatment. These are the patients that keep oncologists up at night because you think that the patients are going to do very well, and then they end up experiencing relapse. One of the things that we find so exciting about ALPHA-3 is that everybody gets a shot at upfront cure, and we do the risk stratification at the end of treatment and then escalate care accordingly with a consolidation dose of SemiCell. Looking back at our Phase 1 experience, we definitely saw good activity across the risk spectrum. So we do not anticipate there being gross disparities in the risk profile of these patients in the context of ALPHA-3.

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 Zach again. Great question. We get asked this one quite a lot. We have long assumed that the number of patients who are clearing MRD without further treatment will be a nonzero number. We have modeled it at about 20%. So in the 12-patient arm that we will be revealing next month, we are talking about two to three patients that we expect to potentially have an MRD conversion from positive to negative. This comes back to the fact that no test in medicine is perfect. There are false positives and false negatives with every single test that you can perform, including PET scan. In fact, one of the reasons that MRD is so exciting and we believe will transform care of these patients is because the false positive and false negative rates of the MRD test are significantly better than they are for PET scan. This is why when we are talking about the efficacy that we hope to see next month in April, it is relative to the spontaneous clearance rate. So when we talk about 25% to 30%, we expect that improvement over the baseline clearance rate because patients, of course, are eligible to spontaneously clear in both arms. So we should expect that 20% distributed in both arms.