ALLO - NASDAQ

Hello. Thank you for standing by, and welcome to Allogene Therapeutics First Quarter and 2025 Conference Call. [Operator Instructions] Please be aware that, today's conference call is being recorded. I would 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 thanks to all of you for joining this call. After the market closed, Allogene issued a press release that provided a business update and financial results for the first quarter of 2025. This press release and today's webcast are available on our website. Following our prepared remarks, we will host a Q&A session. We recognize that historically, questions have been multifaceted, but note that we will endeavor to keep this call to under an hour. I'm joined today by Dr. David Chang, President and Chief Executive Officer; Dr.

Thank you, Christine, and welcome everyone. Today we come together at a defining moment for Allogene. A moment that potentially validates the bold forward-looking strategy we launched in January 2024. At the time, we committed to doing what no CAR T had done before. That strategy wasn't about being autologous or allogeneic. It was about breaking boundaries. One year later, that decision looks not just bold, but prescient. I believe we have built something extraordinary, especially for a small biotechnology company. In the current market environment. We have a trio of highly differentiated clinical assets, each with a potential to be transformative. Combined, they demonstrate that Allogene is potentially changing the trajectory of cell therapy. At the center of that vision is ALPHA3, a pivotal first line consolidation trial with cema-cel which we believe will transform care in large B cell lymphoma and open the door for community cancer centers. The use of MRD paired with first line treatment consolidation is a radical departure from traditional approaches, and it's gaining powerful traction. What once seemed ambitious is now being embraced across nearly 50 activated U.S. sites. Investigators recognize that ALPHA3 is not just another CAR T study. It seeks to redefine how to identify and when we treat high-risk patients. That recognition is reflected in the collaboration we are seeing across sites, many of which are proactively developing and sharing patient identification strategies. Launching this groundbreaking trial has come with important lessons. We've had to adapt quickly to unexpected hurdles from site level staffing shortages to educating patients who believe their treatment journey was complete when they received the news of a clean PET/CT scan. These insights are now guiding smarter enrollment tactics, more effective communication with patients, and more precise forecasting. The result has been tangible. To date, over 250 patients have consented for MRD Screening, with nearly half in the last three months. With improved site engagement and more patients introduced to the trial earlier, we are seeing the early returns of a system that is working. In light of these operational dynamics, we have shifted the lymphodepletion regimen selection and futility analysis milestone into the first half of 2026. While that's two quarters later than planned, it reflects a strategic decision to prioritize precision, insight and a stronger foundation for a future commercial launch. During this time we are also actively evaluating what data will be most meaningful to share at the time of the lymphodepletion selection and futility analysis in response to feedback from stakeholders. ALLO-316 in the TRAVERSE trial continues to break new ground, showing signs of efficacy in patients with heavily pretreated advanced renal cell carcinoma. These patients are highly refractory to treatment and often only have months to live. For these patients, ALLO-316 may offer something they never thought possible, “Hope”. With our CD70 Targeted Dagger technology, ALLO-316 is providing a clear demonstration of potential that CAR T holds in solid tumors, something the field long viewed as aspirational.

Thank you David. As David shared, this is a pivotal time for Allogene, not just in terms of vision, but execution. The progress we are making across all three of our clinical stage programs is the result of years of scientific rigor, operational learning and close partnership with the clinical community. Let's begin with ALPHA3, where the enthusiasm we're seeing from nearly 50 activated sites across the U.S. is not only sustained, it is growing here and internationally. This trial represents a true paradigm shift. Sites, including those new to CAR T, have embraced this concept and we're seeing a level of collaboration that is rare in oncology trials. But as first movers, we've also encountered realities that no modeling could fully anticipate. Site level operational constraints, including staffing shortages and administrative hurdles, led to slower than expected transitions from site activation to patient screening. Bifurcation of care between frontline lymphoma doctors and second line cell therapy providers, even sometimes within institutions, required us to build bridges that had never been built before. Well-worn monologues given to patients at the time of their diagnosis, honed over decades telling them that a clean PET scan at the end of therapy means they are cured needed to be updated to reflect the increased power of prognosis coming from MRD results. We've responded by doubling down on engagement, embedding, trial education earlier in the patient journey, and supporting sites in identifying patients who are most likely to be MRD positive after frontline therapy. Those investments are working, as David noted, with improved site and patient engagement and education we have now consented over 250 patients for MRD testing since the start of the trial. With robust month-over-month improvement in the screening rate, especially since the earliest sites to activate began hitting their stride early in 2025. Nearly half of these patients have been consented in the last three months and many of them are still undergoing frontline treatment. Furthermore, many sites are sharing best practices with one another and encouraging signs that this trial is building momentum. The central value proposition of this trial that a patient's MRD status, positive or negative, is a critically valuable piece of information and that a single dose of an off the shelf CAR T can eradicate residual disease to cure patients of their lymphoma, has only gained traction with doctors and patients. We are looking to further feed that momentum and embrace the enthusiasm we have experienced from potential investigators outside the U.S. with international expansion of ALPHA3. The first ex-U.S. sites we will launch are in Canada, which are on track to activate in the next several weeks. Turning to ALLO-316, this program continues to challenge expectations for CAR T in solid tumors. We are excited that the updated results from the Phase 1b expansion cohort will be featured at an oral presentation of ASCO on June 1. This data will be presented in the main Kidney and Bladder Cancer session at ASCO alongside updates of pivotal data sets and cutting edge combination trials presented by respected leaders in RCC. That alone signals how important this data could be to the field. What makes ALLO-316 so compelling is that it is one of a very small handful of CAR T therapies and the first allogeneic to demonstrate meaningful activity in solid tumors with just a single infusion. To have achieved this, especially with a standard lymphodepletion regimen, puts ALLO-316 in a class of its own. That ALLO-316 achieved this in a patient population as sick and heavily pre-treated as these Phase 1b patients, which may be some of the most treatment refractory patients ever studied in RCC, is truly groundbreaking. Individuals with metastatic renal cell carcinoma who have failed every approved therapy face a prognosis measured in mere months. For them, ALLO-316 may offer not just treatment but a potential lifeline. In our data cut presented at SITC last November, eight patients were treated in the Phase 1b expansion cohort. In the six of these heavily pretreated patients whose tumors expressed high levels of CD70, we observed a 50% best overall response rate and a 33% confirmed response rate, results that we believe underscore the promising potential of this therapy. The upcoming ASCO presentation will build on those results with additional patients treated and longer term follow ups of the results presented at SITC. Key translational findings, including the role of our CD70 targeted Dagger technology in promoting CAR T cell expansion and persistence, reveal a mechanistic basis for the clinical results and give us confidence that ALLO-316 could be a blueprint for CAR T and solid tumors more broadly. We've completed enrollment in the Phase 1b expansion and are actively evaluating strategic options for the path forward, including potential partnerships. We look forward to sharing this data with the community next month. Finally, I want to briefly touch on ALLO-329 and our progress in autoimmune disease. This is a new frontier for cell therapy and ALLO-329 is engineered for it. The Phase 1 RESOLUTION Trial launching mid-year is a first of its kind basket study across multiple rheumatologic indications and it features a truly innovative design including one arm without any lymph foot depletion at all. Thanks to the inherent advantages of our Dagger Technology as demonstrated by ALLO-316. We expect proof-of-concept data first half 2026 as we apply our experience with ALPHA3 and the potential for delays to patient screening activity site activation. But the most important takeaway is our continued belief that this trial could unlock significant potential across a broad spectrum of immune mediated diseases. In summary, the Allogene story today isn't just about bold ideas. It's about a growing body of evidence that allogeneic CAR T is no longer a theoretical promise, but a transformational reality on the verge of reshaping the field. Each of our programs is moving forward with increasing clarity and confidence, and I believe the data we are generating will shape how this field evolves in hematologic malignancies in solid tumors and in autoimmune disease. With that, I'll hand the call over to Geoff.

Thank you,

Thank you. [Operator Instructions] Our first question will come from the line of Michael Yee from Jefferies. Your line is open.

Thank you. Good afternoon. Obviously our first question is on the understanding the progress of the enrollment of the first line study. And you had commented about some logistical issues in terms of operational handoff at the sites. Could you explain what the issue is and how you think that's resolved? And as part two of that same question, when you talk about 250 people that have been consented to screening, that means they are consenting to be tested. That doesn't necessarily mean that they're actually going to get into the study. So as your timing of in the interim, based on a whole bunch of assumptions, including how many people would be positive and then actually have to enroll into the study. Thank you.

Hey Michael thanks for your question. Let me take the first one and I'll ask

And Mike, I'll add to that really speaking to what David just outlined, the fact that we've seen such a very nice pickup in the amount of patients that are signing up to undergo screening really since the beginning of the year, as we indicated in the press release. That really has been quite validating of that observation that we are making that that was a little bit of a slow start but the sites and the enthusiasm that they've had from the beginning is now translating directly into screening activity. As far as the question around the 250, you are correct. That doesn't mean that there are 250 patients that are ready to undergo randomization. That is the number of patients that are undergoing consented to screen for the MRD test. Now of course we need that number to those patients to undergo screening and then test positive for them to be randomized. So we think of this as a funnel and that is the top of the funnel. So we're seeing lots of terrific activity at the site level that will translate as it is currently translating into enrollment.

Thank you.

Thank you. One moment for our next question. Our next question will come from the line of Tyler Van Buren with TD Cowen. Your line is open.

Hey guys, thanks very much for the questions. The first one related to ALPHA3, of course. So are you seeing a significant difference in the occurrence of these site related factors at community versus the more academic sites? And what do you believe is the probability that we still get an interim EFS readout from ALPHA3 by the end of next year? And then the second one, just to follow up on your Dr. Prasad comments given his appointment at CBER been critical in MRD. So it'd be helpful if you could elaborate on why those don't necessarily apply to the ALPHA3 clinical trial program.

Hi Tyler, great question. Let me take the second one since I made some comments about new director of the CBER in my preparation statement and I'll ask

And Tyler, I'll address the first question which I think was about the startup times and the screening activity in community versus academic centers. I would say that there's not a clear delineation between the two. Generally speaking, it has taken quite a bit longer for all sites to come online than I think many of us have experienced in our prior lives. So I don't think that there is much of a difference between those two. But it is clear that once they get up and running they are screening patients very aggressively.

And then let me just finish up here a question about [Indiscernible] free survival towards the year-end in 2026. At this point [Indiscernible] remain silent beyond what we have said, which is communicating the lymphodepletion and security analysis data in the first half. At that time, we will definitely have a lot more clarity on the pace of the study and we plan to provide additional guidance and overall study together with the lymphodepletion. And as we have said in the prepared statement, we are looking into ways to make the lymphodepletion selection announcement more meaningful. Previously we have stayed away from potentially sharing any kind of data, but we are reviewing that decision and we will update you accordingly.

Very interesting. Thank you.

Thank you. One moment for our next question. Our next question will come from line. Biren Amin from Piper Sandler. Your line is open.

Yes, hi guys. Thanks for taking my questions. Just on the ALPHA3, do you believe all sites have sufficient site staffing currently compared to, I guess when you first initiated a study and then I guess a couple of other questions around the trial. What's the conversion rate from consent to randomization and what's the average time that it takes a patient to go from consent to randomization? Thanks.

Hey Biren, so with respect to your first question, are sites adequately staffed? I would say generally yes. I think part of what we saw was them having to get kind of internal regulatory sign off and operational pieces in place, get the study staffed and then critically sort of understanding the workflow of how they're going to identify these patients and then get them consented and screened. So that took some doing. But in all cases, more or less it is up and running very nicely now across the sites. Of course, the ones that are coming on most recently, they are going through that process now, but we now know all of the pitfalls and how to support them so that we are trying to shrink that three to four months down to as little time as possible in these more recently activated sites. As far as the other two questions, around conversion rate and time from screening to randomization. I am going to defer clear answers on those questions until we are at a point where we can share more data about the trial. We generally don't get that kind of granularity. But I'll say, David, if there's anything else you want to add to that.

Yes, I mean, in terms of site staffing. Yes, sites staff up. But another thing that is helping us greatly is during the course of trying to troubleshoot what was going on, we have had multiple discussions with investigators and investigators themselves, coming up with ideas about how to identify patients who could be eligible from the study. This entails looking at not just patients who are coming into the clinic, but looking at their own database, appointment books and others. And I would say that is also helping greatly. And these are the kind of the learnings that sites volunteer. This works really well and you should really share with other clinical sites, which we have done. Exactly. And conversion rate. I mean, as

Perfect. Thank you.

Thank you. One moment for our next question. Our next question comes line of Brian Chang from JPMorgan. Your line is open.

Hey guys, thanks for taking a question today. Just two from us. It seems that you still have a bit of a gap to enroll the first 36 patients. First is that is the lag in screening that attributed to the three to four months of delay more concentrated in the community based sites. And then second related to the expansion to the international sites, how might that impact the ultimate patient mix? And also powering of your initial assumptions and more importantly, is there any regulatory implication in this expansion? Have you received the FDA's feedback on this?

Hey, Brian, this is

Yes, that's correct.

Yes. So, no, we're actually seeing quite encouraging activity from both large academic practices, but also community practices, and again, including community practices with no prior code CAR T experience. So all of the things that we found attractive about ALPHA3 are playing out very, very nicely in this study. As far as our expansion into the ex-U.S. territories, will that introduce heterogeneity into the patients? The short answer to that question is no. And the reason is quite simple. R-CHOP is the global standard for frontline DLBCL treatment. Very few regions even have a second alternative like polar chip. So if anything, it will increase the homogeneity in terms of what that prior therapy is in those ex U.S. territories.

All right, thank you. One moment for our next question. Our next question will come flying to Matthew Biegler from Oppenheimer. Your line is open.

Hey, guys, thanks for the question. I wanted to maybe shift things and ask about the INI strategy. David, it sounded like, at least from the prepared remarks, you're being pretty cautious on the burn. And obviously, INI is a big component of that burn. So my question is, would you guys be open to partnering that program away or are you still 100% committed to it? Or maybe the answer involves waiting for some early data first to make that decision. Thanks.

On the different market environment, my answer would be different. But in the current market, in a situation, really protecting the cash runway is the key. So if there is any kind of reasonable deal to be had, we will. We have indicated previously that, we are very willing to partner and the risk, the autoimmune program, especially given that this is not our core therapeutic area of expertise. And in terms of pushing the timeline from the year end to the first half, I think this is just a little bit more providing a little more caution, but also it's factoring in the feedback that we've been getting from the investors. Previously, we were focused on just using the biomarker data as a proof-of-concept, but some consistent feedback that we have gotten from the investigators. Well, yes, but you want to see a little bit more data, You got to have some clinical responses as well. So, just to do both, having a little more cautious and a little bit of buffer, as well as giving the clinical team opportunity to include a clinical update on the patients who are treated. And that's the reason that we are pushing out the timeline for the proof-of-concept data from 3 to 9 to the first half. I would just add, I mean, we are in the midst of site identification and activating the clinical trial sites for the ALLO-329 study. And that process is going exceedingly well. And we feel very optimistic as well as we are very enthusiastic about this program.

Appreciate it.

One moment for our next question. Our next question will come from line. Samantha Semenkow with Citi. Your line is open.

Hi, good afternoon. Thanks very much for taking the question. Just following up on ALLO-329. I'm wondering in the initial readout, what is the speed, general size of the data set that you think would be sufficient for you to be comfortable making a decision on which lymphodepletion regimen to move forward with? And just related to that, do you believe you'll see any of similar challenges in the resolution study as you are seeing in ALPHA3 as it comes to staffing issues? Thanks very much.

Well, in terms of the second question, based on our experience, it will be foolish for us not to at least be paying a lot of attention to the site staffing issue which we are doing as part of the site activation process. But, based on our experience, it is a real issue, especially in autoimmune disease studies, not only is a site staffing issue, we have to bring together cell therapists as well as rheumatologists on the same room to be able to conduct the study. So there is the added logistical challenges of doing the autoimmune studies with a CAR T. And in terms of the expected data, this is a dose escalation as well as testing two lymphodepletion regimen. In terms of the number of patients that we can reasonably treat, it will be a handful of patients because there is a wait period between first and subsequent patients at each dose level and as well as wait time between escalating from one dose level to another. And your other question about are we going to make any lymphodepletion selection regimen? Well, we are testing both cyclophosphamide alone as well as testing no lymphodepletion at all. Those two cohorts will continue and we will make a decision on whether to continue both or select one based on the data. So the study is really not designed to select one, but it's really to test both different lymphodepletion and use that information as we expand the clinical study into other indications.

Thanks very much.

One moment for our next question. Our next question comes from Reni [ph] Benjamin from Citizens. Your line is open.

Great. Thanks for taking the questions, guys. Maybe just a couple. About how many sites total are you now expecting in the U.S. and worldwide for this study. Related to that, how many patients do you feel you'll ultimately need to screen to Enroll the full 240 patients? And I guess as you kind of think about the workflow right now between a patient getting diagnosed and ultimately getting dosed with cema-cel. Can you just talk us through kind of how are investigators having this discussion? How long does it take for a patient to kind of agree and maybe what are the main reasons for patients not agreeing to move forward with ALPHA3? Thanks.

Hey, Rani, this is

Great. Thank you.

One moment for our next question. Our next question will come from the line of Jack Allen from Baird. Your line is open.

Hey everyone, this is Nick [ph] on for Jack. Thanks for taking our question. So with recent turnover FDA and CBER, CBER Director Vinay Prasad impacting clinical trial designs going forward. I know one of my peers asked about any potential impacts to ALPHA3, but what are your expectations surrounding how these changes could impact the autoimmune opportunity cell therapies? Thanks.

Yes, so, here I think, there are so many speculations out there about how new director at CBER may influence what goes on in the cell therapy and rare diseases. But all my experience, you know, FDA is an institution, there is a director, there are medical reviewers that abide by the guidance document that exists that dictates, how they should be reviewing the clinical data and programs. So, when I sort of think about the institutional, the knowledge within the FDA, plus the fact that in autoimmune diseases the clinical endpoints always has been never been survival. It's a symptom improvement. I know there's a lot of discussions about the emphasis that Dr. Prasad has put on overall survival in the hematology oncology trials, but that's not the case in the lower immune disease indications. To me, if anything, provided that the safety and efficacy meets the criteria, I do not see any problems of advancing CAR T products or for that matter, any other new modalities such as T cell engagers or even in vivo CAR T treatment into the autoimmune indications.

Thank you. One moment for our next question. Our next question will come from the line of Salvine Richter from Goldman Sachs. Your line is open.

Hey everyone, this is Mark [ph] on first Salvine. Thanks so much for taking our question. So back to the autoimmune data set. Given the push to first half of 2026, how much additional follow up would this provide? Could we see like six months to follow up for example? And also what additional clinical information are you hoping to show? Could we see like fleet eye score and will you show a side-by-side comparison of data from the cyclophosphamide versus no lymphodepletion regimen? And finally, what is the bar for success here in your view? Kind of noting that some of your competitor allogeneic CAR T players will likely have some first autoimmune data by then.

Mark, great question. That's very loaded question. Give us the time, enroll the patients and as we always have said in a dose escalation study, it takes time to enroll the patients. There will be a handful of patients based on which we believe that we can provide both clinical as well as the biomarker driven data. And obviously when we push out the data communication from the year end to the first half, the follow up on these patients will be lengthened accordingly.

Thank you.

One moment for our next question. Our next question comes to the line of Sami Corwin from William Blair. Your line is open.

Hi, this is Caleb [ph] on for Sami Corwin. Thanks for taking our question. So just a couple from us. Do you think there'll be any overlap in the site related challenges you saw for ALPHA3 in the ex-U.S. sites or do you think they're a little bit more or less equipped at these centers? And then for three to nine, can you remind us if you plan to also activate ex-U.S. sites for the resolution study? Thanks.

Hey Caleb [ph], this is

Ex-U.S. site, yes.

Okay, so stay tuned on that one. I think we're still defining our regulatory and operational strategy. We're focused in the near term on U.S. sites for 329. But given the competitive intensity, we are certainly open to considering expanding ex-U.S.

Thank you. One moment for our next question. Our next question will come from line of Asthika Goonewardene with Truist. Your line is open.

Hi, this is Karina [ph] for Asthika. Thanks for taking the question. It seems like you guys are prioritizing cema-cell and ALLO-329. How should we think about ALLO-316? Has it been prioritized?

Great question. I mean, the fact is we have to prioritize. We will be presenting ALLO-316 data as an oral presentation at ASCO. So, let's see, let's wait for that oral presentation and we'll provide additional guidance.

All right, thank you.

Thank you. One moment for our next question. Our next question will come from the line of John Newman from Canaccord Genuity. The line is open.

Hi, guys. Thanks for taking my question. So, we've seen some really interesting and in some cases strong data from the autologous CAR Ts autoimmune disease. But one of the challenges we’ve heard is, there's obviously a period where patients need to be basically off immunosuppressants when the CAR T is being made. And to that point, I'm just curious as to the approach that you're taking to taper immunosuppressants. And also if you could just talk about the potential advantages that you have since maybe that period off immunosuppressants is going to be a lot shorter.

Hey, John. So the answer to your question, I think I'll be able to tackle both with a single response. And that is, I think one of the great advantages of an off the shelf therapy like 329 is that we can deliver it with minimal disruption to the standard care that the patients are receiving. So with autologous, you're absolutely right, they need to taper. But what many don't appreciate is actually need to taper not once but twice. They have to taper off immunosuppressants for collection and then again for infusion. For us, we can keep those immunosuppressants on right up until the last minute and then stop them and infuse ALLO-329. And in fact, that has turned out to be one of the several key differentiating advantages. As we are approaching clinical trial sites proposing that they open this trial, it just feels like to them that this is going to fit much more naturally into the routine care of their patients.

Great, thank you.

One moment for our next question. Our next question will come from William Pickering from Bernstein. Your line is open.

Hi, good afternoon. Thank you for taking my question. I understand you're not ready to share expectations on the conversion rate from consent to randomization, but it does sound like your assumptions are fairly conservative, just given the 250% of patients and your estimates for the positivity rate. So I'm just wondering if you could describe how you see this conversion rate comping against other trials you've previously been part of and what may be some of the factors that might lead patients to not convert. Thank you so much.

So I think we're seeing very good uptake at the site, both by doctors and by patients. So when this study is pitched appropriately at the right time, as we discussed previously on the call, we're finding that most of these patients are signing up for treatment. It's a pretty clear, straightforward decision for them to make. Once they're found to be MRD positive again, the vast majority of those patients are agreeing to undergo screening for the main study. Now, there are a handful of screening tests. We actually consider them to be fairly straightforward. This is a frontline study. Most of these patients are pretty healthy, so we're not seeing many patients screen fail. Again, it's still relatively early days in the trial and we'll have a lot more information later on. And of course, when we share the overall results of the study, all that will be detailed out.

Thank you. One moment for our next question. And our next question from line are. Robert Burns from H.C. Wainwright. Your line is open.

Good afternoon, this is Dan [ph] on for Rob. Thanks for taking our question. So, in discussing your large inventory stock and the manufacturing rollback in relation to the capital allocation strategy, have you done any frozen cell stability testing on the products? And what's the approximate freezer shelf life of the cell? Thank you.

Hey Dan, this is David Cheng. I'll take that question in terms of the cell product, frozen stability tends to be pretty, pretty long, several years. What is being done is we carry out the stability test as time goes on and, the stability is established by how long that we have done the stability. So there will be an ongoing process. And our expectation is that the inventory that we have under current stability testing strategy will be sufficient to cover all the clinical studies that we are planning to do.

Thank you. And that concludes our question and answer session. I would now like to turn the conference back over to management for any additional comments.

Well, thank you operator. And thank you everybody who participated in this call. I want to say that Allogene was built to challenge convention. And today that ambition is becoming reality. With ALPHA3, we are changing the playbook in large B cell lymphoma. With ALLO-316, we are proving solid tumors that are within reach of cell therapy. And with ALLO-329, we are opening a bold new chapter in autoimmune disease. These aren't just ideas. These programs are backed by data and real potential to transform care. The path forward won't be easy. But we've never aimed for easy. We've aimed for impact. And with focus, discipline and world class science, we intend to deliver. Thanks for joining us, operator. You may now disconnect.