Allogene Therapeutics (NASDAQ:ALLO) Q2 2026 Earnings Call

0:00 Hello, thank you for standing by and welcome to Allogene Therapeutics Second Quarter twenty twenty six Conference Call. After the speakers presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Casciano, Chief Corporate Affairs and Brand Strategy Officer. Ms. Casciano, 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 twenty twenty six. This press release and today's webcast are available on our website.

1:00 Following brief prepared remarks from Doctor. Zachary Roberts,

1:03 President and Chief Executive Officer, we will open the call for questions. Jeff Parker, Chief Financial Officer, will also join the Q and A. To help us conclude within forty five 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.

1:48 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'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.

2:33 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 an 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-three sixteen, and ALLO-three twenty nine is beginning to demonstrate those advantages in practice.

3:30 I will start with alpha-three because it is the clearest expression of this strategy. Alpha-three 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, lack sufficient specificity because many patients classified as high risk by those methods are still cured with our CHOP.

4:24 That new tool emerged just weeks before I joined Allogene, When I saw the foresight, now Natera, CLARITY data presented at ASH twenty twenty two, 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 INVIGORA 11 study is the first where patient selection was based solely on a ctDNA MRD test.

5:12 INVIGORA 11 closely parallels ALPHA3's design and this approval, as well as a new category one 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. 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-three's potential to change the lymphoma landscape by offering CAR T earlier with less logistical burden and greater access across more treatment settings.

6:07 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, Semi Cell 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.

7:02 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.

7:53 This expansion reflects growing investigator conviction in MRD and the Alpha-three strategy, supports enrollment momentum and gives more sites hands on experience with Semi Cell's ease of use ahead of a potential commercial launch. Turning to ALLO-three sixteen, the publication of the TRAVERSED results in the Journal of Clinical Oncology was an important milestone for the program and the DataVer platform. Solid tumors have been CAR T's hardest test. In patients with CD70 high renal cell carcinoma, ALLO-three sixteen produced a thirty one percent 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 eighteen months after a single dose of ALLO-three sixteen.

8:40 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-three 16. 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.

9:31 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 ALLO-three 29 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-three twenty nine 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.

10:28 Our objective is to both identify the optimal dose regimen for ALLO-three twenty nine and to understand how to 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 twelve months, we expect the value of that work to become increasingly visible beginning with an ALLO-three '29 update by year end and opportunities to update investors on ALPHA3 throughout 2027. Those milestones will help define our progress, the standard we are working toward is simpler. Innovation only matters if patients can actually access it.

11:17 We'll now open the call for questions. Thank you. As a reminder, to ask a question, please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star, 11 again. In the interest of time, we ask that you limit yourself to one question. Please stand by while we compile the Q and A roster.

11:42 And our first question comes from Michael Yee of UBS. Your line is open. Hey, good afternoon guys. This is Matt on for Mike. Thank you so much for taking our questions. I wanted to add, I saw you guys added an observational cohort to the ALPHA three study, and I just wanted to ask about kind of the design of this cohort, maybe what the goal of it is and kind of the questions you're hoping to answer. It looks like it's in MRD negative patients. So just to kind of expand on kind of what the goals are and what you're hoping to show with that observational cohort might be. Thank you so much. Hey, Matt, thanks for the question. So it's pretty straightforward. We added this cohort to help provide context for the overall results of alpha-three looking at the MRD positive patients. Of course, those are the ones that we randomized now into alpha-three. So having a paired, MRD negative cohort using essentially the same patient population as this is coming into alpha-three itself will give that ability to compare outcomes in the observational cohort of the MRD positive patients is alpha-three with the MRD negative patients as well. So really, it'll give us the ability to further characterize the test itself in a prospective manner.

13:03 Thank you. And our next question comes from Tyler Van Buren of TD Cowen. Your line is open. Hey, guys. Congratulations on your first call at CEO Zach and appreciate the efficient prepared remarks. I guess given the acceleration of site activation by six months, is it possible that the interim EFS analysis could occur earlier than the guided mid-twenty twenty seven timeline?

13:36 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, so we are currently maintaining guidance that the EFS should occur at roughly the same time as previously guided. We are just moving to try to accelerate the enrollments of the study and of course, working very hard to bring on as many sites for the reasons stated in the prepared remarks. But at this time, we're not making any adjustments to the expectation of data availability.

14:10 Thank you. And our next question comes from Salveen Richter of Goldman Sachs. Your line is open. 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 ALPHA-three 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 be one third community and two thirds academic? And what feedback are you hearing from the community physicians? Thanks, Mark.

14:48 Without getting too specific here, I would say that the interest continues be very high and growing in both the academic corners as well as the community corners. I would say that

15:00 surge of interest that we did see after the interim data really was pretty balanced between the two. We had some pretty big name centers, reach out to try to join. And then we've got quite a number of community practices that also asked to join. So as far as how the patients break down, in terms of where they come from, we actually I don't know if we've stated previously that it's about a third is expected. That's what we did see in the interim futility analysis, which was a very great outcome for us. I think that if we can maintain that or even bring it closer to parity in final analysis, that would be something that we would be interested in doing. And that really does, I think, capture the last part of your question, which I believe was around, you know, what we're hearing from the various docs about the program.

15:51 And I think everything that we heard early on when we launched the study, and even before that when we were just talking about it with sites is that the community practices

16:02 view this as really the best and first true opportunity to access CAR T for their patient populations. And the academicians on the other hand, you know, very excited about, you know, cutting edge technologies serving their patients in ways that improve the benefit risk profile, ideally preventing relapse, which everybody universally agrees is a bad outcome. So,

16:25 across the board, we continue to hear very strong conviction that this strategy is excellent for patients. And then from the community, practices specifically, enthusiasm around gaining access to CAR T, which has been out of their reach, from the beginning.

16:49 Comes from Samantha Semencal of Citi. Your line is open. Hi, good afternoon. Thanks very much for taking the question. Zach, let me add my congratulations on your first call as CEO. So just another one on ALPHA-three. We look forward to the interim EFS analysis mid next year. Just wondering how we should think about that analysis in terms of the potential for overwhelming benefit to be demonstrated. If the interim MRD assessment that we saw is repeatable for with more patients, how likely is that to translate into a stat seg benefit on EFS at the interim analysis? Thank you. Thanks Sam, and it's a great question. So as we went into some detail when we released the data in April, the strong MRD clearance data that we observed, we did think was quite positive and gave us some very

17:48 positive views on the potential outcome of the study either at the interim EFS or at the primary analysis. We also detailed that because of the way that we've allocated the alpha between those two EFS analyses, that it would require overwhelming efficacy to achieve statistical significance at the midway point there at the EFS, the inner BFS analysis. You know, We can't really go into further detail around whether about how we're thinking about the likelihood of that statistical significance, except I will reiterate that prior studies such as the TRANSFORM study of BRYANZI illustrated that a 24% MRD clearance differential between the CAR T and the transplant arm translated into a greater than 60% improvement in the EFS between those two arms. So a very, very positive outcome there on a comparatively lesser differential in the MRD clearance rate. So we remain very excited about the potential for a positive outcome here.

18:56 But going into any further detail around how that might play out at the EFS analysis that is currently planned for middle of next year, I don't want to get too far ahead myself on that one.

19:09 Thank you. And our next question comes from Matt Dibbs of William Blair. Your line is open. Hey team, this is Josh on for Matt. Thanks for taking my question. Congrats on such a good quarter. So I had a question on the resolution readout asset approaches. We were wondering what kind of data and the level of granularity that we should expect from the readout in this year? Thanks.

19:42 Thanks, Josh. So for the RESOLUTION trial, the data readout that we're currently planning for quarter four of this year, we expect to share clinical and translational data. I'll reiterate what was contained in the prepared remarks that we continue to be very pleased with the way enrollment is going. At the last call, last quarter, we announced that we had treated nine patients in both the LD and non LD containing arms. We have continued to see very robust demand to put patients into the study. So we should have a nice number of patients by the time we share that data in quarter four. And then that will feature, of course, safety and efficacy outcomes as well as the translational findings. Thank you.

20:32 And our next question comes from Yang of Jefferies. Your line is open. Hi, this is Chacha on for Roger. Thanks so much for taking my question and congrats on the quarter as well. Just a question on the three twenty nine trial with the data coming in fourth quarter. Just wondering if your guidance has changed in terms of the dose groups that you're going to announce. Are we still expecting the twenty million, forty million and eighty million doses or is there any change to that?

21:00 Thank you, ChaCha. So those are indeed the first three dose levels or the first two dose levels. We also will be dosing patients with eighty million and this there are additional doses above that that are contemplated within the protocol. So as far as we get in that dose escalation, that will be, the data that we share, but at least those three dose cohorts two thousand and forty and eighty will be included. Thank you. And our next question comes from Jack Allen of Baird. Your line is open. Great. Thanks for taking the questions and congrats on the progress over the quarter. So I want to extend my congratulations to Zach on the new role. Really great to see you on the quarterly call here.

21:46 My question is around the RMAT and Fast Track designations that you were able to secure over the course of the quarter. My understanding is that for RMAT specifically, there's a need to share clinical data when available with FDA. And I'm just curious if you could provide any more context around what data was shared with FDA? Was it really the April MRD data or were there additional clinical data that were shared with FDA? And then also kind of in the same vein, what aspects of the data set were most intriguing from the FDA's perspective? Was it the efficacy? Was it the safety? Or is it a combination of the two? Any context you can provide would be very helpful. Thanks so much.

22:23 Thanks, Jack. Yeah, we were thrilled to receive those designations. RMAT, as you point out, is it does in fact require clinical data. It's very similar to breakthrough therapy designation. And so the clinical data that we provided was derived from that interim analysis that we shared back in April. And of course, what we share with regulators generally speaking is quite a bit more extensive than what is shared publicly outside of the company. And so this was a complete briefing package that went into all the available detail that we had. Again, EFS at the time of the actual events were blinded and they remain blinded to us. So this was really focused on the MRD results. But additional detail around the MRD was provided to the FDA and of course, know, an exhausted safety package also.

23:14 In the FDA's decision, to award RMAT or not, they generally don't go into details about which aspect of the package was most enticing to them or most influential in their decision. But just generally that number one, the disease under study in our case MRD positive large B cell lymphoma represents an unmet medical need, which I really want to highlight is a pretty important thing for them to have pointed out that

23:46 this trial and this dataset was even eligible for RMAT designation was predicated on that very fact that MRD positivity is on that need. And then critically, of course, that based on the data that they reviewed, SEMAcel has the potential to meet that unmet medical need. So for those reasons, they decided to give us RMAT, but any further granularity they did not provide. Thank you.

24:11 And our next question comes from John Newman of Canaccord. Your line is open. Hi, guys. Thanks for taking the question, and congrats on the excellent progress. My question is, given the very impressive pace of enrollment for ALPHA-three and the increased target of enrollment sites to 100 by the end of the year. Are you open to the possibility of enrolling additional patients beyond the current target? Thank you. Thanks, John. The short answer is, we are going to try to find as many ways that we can, in the context of an ongoing study to offer enrollment to patients who meet the eligibility criteria for alpha-three.

24:57 Within the confines of alpha-three as written, the target is the target, two twenty patients randomized into the two arms. And, generally speaking, you don't want to go much above that, until data is available to suggest a benefit risk ratio that is permissive of over enrollment. However, if additional opportunities along the way present themselves, to add cohorts or explore other nuances within this, broader field, those things will be considered in due time. But as the time sits right now, our target is two twenty.

25:34 Thank you. And our next question comes from Luka Issy of RBCCM. Your line is open. Thanks so much for taking our question and adding our congrats to Zach and team on successful transition. This is Cassie for Luka. Quick question on 03/29. As Zach, you mentioned that dosing started for the lymphodepletion arm. Are you hearing any early anecdotes for CAR T expansion or persistence in patients treated with alcetosulfamide? And what positive signs are you looking for here at the 4Q update for this specific arm?

26:10 So we'd be thinking non inferior or any specific benchmark? Any color there, much appreciated. Thanks. Thanks, Cassie. So, we were as all phase one first in human studies are, they are primarily a safety trial. So this is why we started a low dose and go up. And really we're monitoring most closely the safety outcomes and then making decisions about whether to dose escalate, dose expand, add additional cohorts, what have you. So we are collecting all of the safety information and we meet as a team with outside advisors prior to dose escalation. So that is the most important and comprehensive data package review that in real time.

26:54 We obviously are in close contact with the investigators around the efficacy. And so, as in previous statements, we've talked about encouraging signs of activity in that program. And I'll reiterate that now here is that we continue to have very robust interest and demand from investigators and patients to come in, on what we're seeing so far. As far as the translational data goes, those data are developed sort of in parallel and typically in batches. But, so we do not we're not in a position to comment on the translational findings here today. Just that we will be including those findings in the upcoming fourth quarter data release. Thank you.

27:39 And our next question comes from Reni Benjamin of Citizens. Your line is open. Hey, good afternoon guys. Thanks for taking the questions. And Zach, congratulations on the new role. I guess, I jumped in late. I hope this hasn't already been asked, but I'm interested in the competitive landscape as it continues to evolve and how you guys are kind of thinking about things and managing it. In particular, you know, not just the frontline study for autologous CAR Ts that are being evaluated, but also the recent legend in vivo CAR T data. I would love to kind of get your thoughts as to how manage these things. Thanks. Thanks, Rene, for the question and for the congrats. So great question. Thanks for asking it. And it had not been asked prior to you joining.

28:25 So good opportunity for me to dive in a little bit on that. So obviously we monitor the competitive landscape across our portfolio very, very carefully. And one of the things that we've enjoyed and continue to enjoy, I believe is a pretty well protected place within this first line consolidation for ALPHA-three. Nobody else has entered this space explicitly in that way yet. And the upfront, the first line studies that are ongoing, you mentioned CAR T, but of course there's other, there's bispecific pivotal studies as well. We've looked at this very carefully both through conversations with PIs and investigators that are involved in the studies and those that are not. And then we've also performed some fairly extensive blinded market research.

29:17 Our conclusion from that, those ongoing, frontline studies is that they'll actually have a fairly minimal impact on the overall rate of MRD positivity, in the immediate post frontline setting. And that's primarily because both the CAR T cells and the bispecifics tend to carry a fairly significant toxicity profile. They're a bit cumbersome for patients and with some of them needing step up dosing and even at prospective hospitalization just to administer the therapy. So this is largely in my view, and in the view of the respondents to our study, will probably be reserved for select patients and select centers. So by and large, being that most patients eighty percent or more are treated in the community practices, the MRD rate is likely to stay pretty much where it is, primarily driven by outcomes following our CHOP and Pola R CHIP.

30:10 With respect to the question around in vivo, my view on this, and I think this has been validated through several conversations I've had is that obviously an extremely exciting platform for the field and for patients, but likely I believe that will primarily suffice to replace autologous CAR T in the relapsed refractory setting. Again, pointing primarily to the toxicity profile, at least in the early days here, unless that gets markedly better. Most community oncologists are not going to be enthusiastic about administering a large dose of active viral particles into patients during a busy clinic afternoon. So it feels like this is an opportunity for really an off the shelf CAR T being available, to community oncologists.

31:00 They can give it in their infusion clinics over five minutes and the patients can be reasonably assured to go home without having much toxicity. At least that's the intention of alpha-three. So clearly a lot of activity, both upstream from us, as well as downstream from us with the in vivo, but we think we're pretty well protected here right 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.