Prepared remarks
Hello. Thank you for standing by and welcome to Allogene Therapeutics second quarter 2026 conference call. At this time, all participants are in listen-only mode. To ask a question, press *1. 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. You are cautioned not to place undue reliance on these forward-looking statements, and Allogene disclaims any obligation to update these statements. I'm going to 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 leverage 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 ALPHA3, ALLO-316 and ALLO-329 is beginning to demonstrate those advantages in practice. I will start with ALPHA3 because it is the clearest expression of this strategy. ALPHA3 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 longstanding 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, lack sufficient specificity because many patients classified as high risk by those methods are still cured with R-CHOP. That new tool emerged just weeks before I joined Allogene. When I saw the Foresight now Natera CLARITY data presented at ASH 2022, the design of ALPHA3 came into focus. When ALPHA3 began, MRD in 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 Tecentriq 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 IMvigor011 study, is the first where patient selection was based solely on a ctDNA MRD test. IMvigor011 closely parallels ALPHA3'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 ALPHA3 trial in April, the interim futility analysis, which provided an important early test of ALPHA3's hypothesis. Cema-Cel 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, Cema-Cel was successfully delivered in community practices with no prior CAR-T experience. Together, those findings support ALPHA3'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 Cema-Cel 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, Cema-Cel has the potential to meet that need. We interpret this action by FDA as validation for the ALPHA3 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 ALPHA3 strategy, supports enrollment momentum, and gives more sites hands-on experience with Cema-Cel'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 with 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 consistently, 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 the 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 Allogene: 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 ALLO-329 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. ALLO-329 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 allo-rejection by targeting the activated host T cells that contribute to it. Our objective is to both identify the optimal dose regimen for ALLO-329 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 ALPHA3 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.
Questions and answers
At this time we'll open the floor for questions. Please limit yourself to one question. Our first question comes from Michael Yee of UBS.
Hey, good afternoon, guys. This is Matt on for Mike. Thank you so much for taking our questions. I wanted to ask about the observational cohort added to the ALPHA3 study. Can you discuss the design of this cohort, its goals, and the questions you're trying to answer? It looks like it's an MRD-negative cohort, so could you expand on the goals and how we should think about what that observational cohort might show?
Thank you so much, Matt, thanks for the question. It's pretty straightforward. We added this cohort to help provide context for the overall results of ALPHA3 looking at the MRD-positive patients. Of course, those are the ones that we randomized in ALPHA3, so having a paired MRD-negative cohort using essentially the same patient population as those coming into ALPHA3 itself will give us the ability to compare outcomes in the observational MRD-negative cohort with the MRD-positive patients in ALPHA3. So really it will give us the ability to further characterize the test itself in a prospective manner.
Our next question comes from Tyler Van Buren of TD Cowen.
Congratulations on your first call as CEO, Zach, and I appreciate the efficient prepared remarks. Given the acceleration of site activation by six months, is it possible that the interim EFS analysis could occur earlier than the guided mid-2027 timeline?
Thanks for the question, Tyler, and thanks for the congratulations. It's a thrill to be CEO and it's an honor. So getting to your question, we are currently maintaining guidance that the EFS should occur roughly at the same time as previously guided. We are working to accelerate enrollment of the study and are working very hard to bring on as many sites as possible for the reasons stated in the prepared remarks. But at this time we're not making any adjustments to the expectation of data availability.
Our next question comes from Salveen Richter of Goldman Sachs.
Hey, this is Mark on for Salveen. Thanks so much for taking our question and congrats on the progress. It was good to see the enrollment for ALPHA3 post the interim data. Could you give us a breakdown of enrollment cadence across academic versus community sites? Is the expectation still that it's going to be one-third community and two-thirds academic, and what feedback are you hearing from community physicians?
Without getting too specific, interest continues to be very high and growing in both the academic and community settings. The surge of interest after the interim data was pretty balanced between the two. We had some prominent academic centers reach out to join, and quite a number of community practices also asked to join. In terms of patient origin, we did see about a third coming from community settings in the interim futility analysis, which was a very positive outcome for us. If we can maintain that or bring it closer to parity in the final analysis, that would be desirable. From community practices specifically, we've heard enthusiasm about gaining access to CAR-T, which has been out of their reach historically. Academicians are excited about cutting-edge technologies and serving patients in ways that improve the benefit-risk profile, ideally preventing relapse. Across the board, we continue to hear strong conviction that this strategy is excellent for patients.
Our next question comes from Samantha Semenkow of Citi.
Zach, let me add my congratulations on your first call as CEO. Another question on ALPHA3: as we look forward to the interim EFS analysis mid-next year, how should we think about the potential for an overwhelming benefit to be demonstrated? If the interim MRD assessment we saw is repeatable with more patients, how likely is that to translate into a statistically significant benefit on EFS at the interim analysis?
Thanks, Samantha. Great question. As we detailed when we released the data in April, the strong MRD clearance we observed was quite positive and gives a favorable view of potential outcomes either at the interim EFS or at the primary analysis. However, because of the way we've allocated alpha between the two EFS analyses, it would require overwhelming efficacy to achieve statistical significance at the interim EFS analysis. We can't go into further detail about the likelihood of achieving statistical significance at the interim, but I will reiterate that prior studies, such as the TRANSFORM study of Breyanzi, illustrated that a 24% MRD clearance differential between CAR T and the transplant arm translated into a greater than 60% improvement in EFS between those two arms. So that was a very positive precedent given a comparatively smaller MRD differential. We remain excited about the potential for a positive outcome, but we won't speculate further on statistical probabilities for the interim analysis planned for mid-next year.
Thank you. Our next question comes from Matt Phipps of William Blair.
Hey team, this is Josh on for Matt. Thanks for taking my question and congrats on a good quarter. Regarding the RESOLUTION readout approaching, what kind of data and level of granularity should we expect from the readout later this year?
Thanks, Josh. For the RESOLUTION trial, the readout we're planning for Q4 will include clinical and translational data. As noted in the prepared remarks, we're pleased with enrollment. At the last call, we announced that we had treated nine patients in both the lymphodepletion and non-lymphodepletion arms. We've continued to see robust demand, so we should have a meaningful number of patients by the time we share that data in Q4. The update will feature safety and efficacy outcomes as well as translational findings.
Our next question comes from Cha Cha Yang of Jefferies.
This is Cha Cha on for Roger. Congrats on the quarter. Regarding the 329 trial with data coming in Q4, has your guidance changed in terms of the dose groups you'll announce? Are we still expecting the 20 million, 40 million and 80 million doses or is there any change?
Thank you, Cha Cha. Those are indeed the first three dose levels: 20 million, 40 million, and 80 million. We will be dosing patients with 80 million and additional doses above that are contemplated within the protocol. As we progress through dose escalation, we'll report on what we've achieved, but at minimum those three dose cohorts will be included in the data we share.
Our next question comes from Jack Allen of Baird. Your line is open.
Congrats on the progress over the quarter, and Zach, congratulations on the new role. My question is around the RMAT and Fast Track designations you secured. For RMAT specifically, there's a need to share clinical data with the FDA. Could you provide context around what data was shared with the FDA? Was it mainly the April MRD data or were there additional clinical data shared? And what aspects of the data were most intriguing from the FDA's perspective—efficacy, safety, or a combination?
Thanks, Jack. We were thrilled to receive those designations. RMAT does require clinical data and is similar to breakthrough therapy designation. The clinical data we provided was derived from the interim analysis we shared in April. When we brief regulators, the package is more extensive than public disclosures. This was a complete briefing package with available detail. EFS events were blinded at the time, so this was focused on the MRD results, but we provided additional detail around MRD and an exhaustive safety package. The FDA generally doesn't specify which part of the package was most influential, but their decision reflects two things: that MRD-positive large B-cell lymphoma represents an unmet medical need and that, based on the data they reviewed, Cema-Cel has the potential to meet that unmet need. For those reasons, they awarded RMAT, but they did not provide further granularity.
And our next question comes from John Newman of Canaccord. Your line is open.
Congrats on the excellent progress. Given the impressive pace of enrollment for ALPHA3 and the increased target of roughly 100 active sites by year end, are you open to the possibility of enrolling additional patients beyond the current target?
Thanks, John. Short answer: we will try to find as many ways as possible within the context of an ongoing study to offer enrollment to patients who meet ALPHA3 eligibility criteria. The current target in the protocol is 220 randomized patients, and generally you don't exceed that target until data suggests a benefit-risk profile that permits over-enrollment. If additional opportunities arise to add cohorts or explore other questions, those will be considered in due time. But as of now, our target remains 220.
Our next question comes from Luca Issi of RBC Capital Markets.
Adding our congrats to Zach and the team on the successful transition. This is Cassie for Luca. Quick question on ALLO-329. As you mentioned, dosing started for the lymphodepletion arm. Are you hearing any early anecdotes for CAR T expansion or persistence in patients treated with cyclophosphamide? What positive signs are you looking for at the Q4 update for this arm? Should we be thinking non-inferior or any specific benchmark? Any color would be appreciated.
Thanks, Cassie. As with all first-in-human phase 1 studies, the primary focus is safety. We start low and escalate, monitoring safety outcomes closely to inform dose escalation and expansion decisions. We collect safety information comprehensively and meet with outside advisors prior to dose escalation; that safety package is the primary dataset we review in real time. We're in close contact with investigators regarding efficacy signals, and as we've said previously, we've seen encouraging signs of activity in the program. Translational data are developed in parallel and typically in batches, so we are not in a position to comment on translational findings today, but we will include those findings in the Q4 data release.
Our next question comes from Reni Benjamin of Citizens.
Zach, congratulations on the new role. I hope this hasn't already been asked, but I'm interested in the competitive landscape as it evolves and how you are thinking about and managing it—particularly not just frontline autologous CAR-T studies but also recent in vivo CAR-T data. How do you manage these developments?
Thanks, Reni. Great question. We monitor the competitive landscape across our portfolio carefully. One advantage we believe we have is a well-protected position within the first-line consolidation setting for ALPHA3; no one else has entered this space in exactly this way. Regarding ongoing frontline studies, we've spoken with PIs and investigators and conducted blinded market research. Our view is these studies may have a minimal near-term impact on the overall rate of MRD positivity in the immediate post-frontline setting because CAR-Ts and bispecifics tend to carry significant toxicity profiles and can be cumbersome, with some needing step-up dosing or prospective hospitalization. Those factors mean such therapies are likely to be reserved for select patients and centers. Most patients—80% or more—are treated in community practices, so MRD rates are likely to remain driven by outcomes following R-CHOP and R-Pola-CHP. On in vivo approaches, they are extremely exciting, but early on they will likely replace autologous CAR-T in the relapsed/refractory setting. Given toxicity considerations and administration logistics, many community oncologists are unlikely to adopt them broadly in the near term. This creates an opportunity for an off-the-shelf CAR-T that community oncologists can administer quickly in an infusion clinic with a low toxicity profile. Clearly, there's considerable activity both upstream and downstream, but we believe we're well positioned in the middle.
Thank you. That concludes our question-and-answer session. Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program and you may now log off and disconnect.