Earnings call transcript: Allogene Therapeutics Q3 2025 beats EPS expectations

Allogene Therapeutics Inc. (ALLO) reported its third-quarter 2025 earnings, surpassing analysts' expectations with an EPS of -$0.19 against a forecast of -$0.22. This result represents a positive surprise of 13.64%. Despite the earnings beat, the company's stock declined by 5.41% to close at $1.11, although it saw a slight uptick of 0.9% in after-hours trading.

Key Takeaways

• Allogene's EPS of -$0.19 beat the forecast of -$0.22, surprising by 13.64%.
• Stock fell 5.41% post-earnings, closing at $1.11, with a minor after-hours recovery.
• Cash reserves stand at $277.1 million, extending the runway into late 2027.
• Key trials in lymphoma, autoimmune diseases, and kidney cancer are progressing.
• The company is expanding its clinical trials to Australia and South Korea.

Company Performance

Allogene Therapeutics demonstrated resilience in Q3 2025 by outperforming EPS expectations, a positive indicator amid challenging market conditions. The company continues to innovate with its Allogene XL Therapy platform, targeting both oncology and autoimmune diseases. This quarter, Allogene maintained a strong cash position, which is crucial for its ongoing and future clinical trials.

Financial Highlights

• Revenue: Not specified
• Earnings per share: -$0.19 (beat forecast of -$0.22)
• Cash position: $277.1 million as of September 30, 2025
• R&D expenses: $31.2 million
• G&A expenses: $13.7 million
• Net loss: $41.4 million

Earnings vs. Forecast

Allogene reported an EPS of -$0.19, exceeding the forecast of -$0.22, marking a 13.64% positive surprise. This performance contrasts with previous quarters where expectations were either met or slightly missed, indicating a potential turnaround in operational efficiency or cost management.

Market Reaction

Following the earnings announcement, Allogene's stock fell by 5.41% to $1.11. However, in aftermarket trading, the stock showed a slight recovery with a 0.9% increase to $1.12. This movement reflects mixed investor sentiment, possibly due to broader market conditions or sector-specific challenges.

Outlook & Guidance

Allogene anticipates significant milestones in the first half of 2026, including interim data for cema-cel in lymphoma and proof of concept for Allo329 in autoimmune diseases. The company projects a cash burn of approximately $150 million for 2025, with full-year operating expenses around $230 million.

Executive Commentary

CEO David Chang emphasized the company's commitment to innovation, stating, "True innovation is not about chasing what is next. It is about delivering what patients need now." Dr. Zachary Roberts, Chief Medical Officer, added, "Allogene XL CAR-T is not an iteration. We believe it is the foundation upon which the next generation of cell therapy will be built."

Risks and Challenges

• High R&D expenses: With $31.2 million spent, managing costs remains crucial.
• Market competition: Intense competition in cell therapy could impact market share.
• Regulatory hurdles: Approval processes for new therapies are lengthy and complex.
• Economic conditions: Broader economic pressures might affect funding and operations.

Q&A

During the earnings call, analysts inquired about the central MRD testing, which was confirmed to ensure consistency. Questions also focused on the potential of Allo329 across multiple autoimmune indications, highlighting the company's confidence in achieving a 30% MRD conversion rate in lymphoma trials.

Full transcript - Allogene Therapeutics Inc (ALLO) Q3 2025:

Conference Operator: Ladies and gentlemen, please stand by. Your conference will begin shortly. Please continue to stand by, and thank you for your patience. Hello, and thank you for standing by. Welcome to Allogene Therapeutics' third quarter, 2025, conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. 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.

Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer, Allogene Therapeutics: Thank you, Operator, and welcome everyone to Allogene's third quarter 2025 conference call. After the market closed, Allogene issued a press release that provided a business update and financial results for the third 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. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, and Jeff 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 the 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 David.

David Chang, President and Chief Executive Officer, Allogene Therapeutics: Thank you, Christine. This quarter has been about conviction. Conviction in our science, in the path we have chosen, and in the future we are building for patients. We are aware of the shifting conversation in the field. Every new modality brings excitement and speculation about what the future might hold. True innovation is not about chasing what is next. It is about delivering what patients need now. If a platform can safely, effectively, and at scale deliver curative therapies, it does not just shape the future, it redefines it. At Allogene, our focus has never wavered. We are advancing the platform we believe is not only essential to making cell therapies accessible and scalable, but one that could fundamentally upend the current paradigm, and even the one others are still imagining, by making the promise of curative one-time off-the-shelf cell therapy a reality today.

That is exactly what Allogene XL Therapy represents. It is not a bridge to something else. It is the foundation. Allogene XL Technology delivers the scalable backbone needed to democratize access, reduce the overall cost of care, and bring transformative and potentially curative treatment to far more patients than ever before. We expect Allogene XL Therapy to be central across oncology and autoimmune disease because it combines the precision and power of autologous with a flexible, efficient, and commercially viable model no other approach can. Its capacity for multiplex gene engineering allows the creation of future platform products within a single cell, an advance that we believe will be critical for addressing complex cancers, including solid tumors. This is not incremental progress. It is a leap forward that reshapes what is possible. We have done the hard work to make the future real.

Our leadership in manufacturing, translational science, and clinical development positions Allogene to endure and lead, setting the standard for how cell therapy can be delivered at scale and with impact. Each of our programs, cema-cel, Allo329, and Allo316, reflects that strategy to make cell therapy scalable, practical, accessible, and in some cases, curative. At Allogene, we are not waiting for the future of cell therapy. We are creating it with conviction, with data, and with a platform built for lasting impact. As we move into next year, we are preparing for what we expect to be a defining moment with pivotal interim data from cema-cel in the AlphaTru trial in first-line consolidation and proof of concept from Allo329 in autoimmune disease, both milestones that we believe will shape the next era of cell therapy. With that, I'll now turn it to Zach to share updates on our R&D progress.

Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, Allogene Therapeutics: Thanks, David. Our programs this quarter continue to demonstrate the conviction David spoke of, conviction in our science, in our execution, and in the discipline required to advance truly innovative medicines. Across AlphaTru, Resolution, and Traverse, we're driving forward a portfolio that spans earlier line lymphoma, autoimmune disease, and solid tumors. Each is a distinct challenge, but together, a unified demonstration of the strength and versatility of our Allogene platform. In AlphaTru, our pivotal trial of cema-cel has now been streamlined into a two-arm randomized study comparing treatment after standard FC lymphodepletion versus observation. This structure balances efficacy, safety, and scalability, which are critical for translating CAR-T therapy into earlier lines of treatment. We are now at more than 50 active sites across the U.S. and Canada, with expansion into Australia and South Korea expected early next year.

The planned futility analysis, focused on MRD conversion, remains on track for the first half of 2026. A positive outcome would not only demonstrate disease modification in earlier line lymphoma, it would also mark a key step toward a potential BLA submission. As we look ahead to the upcoming futility analysis and the questions we often get about what success looks like at this stage, there are two key benchmarks worth keeping in mind. The first is the pivotal POLARIX study, and the second is the recent InVIGOR-11 trial in bladder cancer, which is highly analogous to what we're doing with AlphaTru. The POLARIX study, which evaluated polatuzumab plus chemoimmunotherapy in front-line DLBCL, demonstrated a modest 7% improvement in progression-free survival over standard treatment. That result alone underscores how much opportunity remains for meaningful progress and the transformative potential of AlphaTru.

While AlphaTru is the first study of its kind in LBCL, the concept of consolidating remission in patients at high risk of relapse has guided adjuvant trials in solid tumors for decades. Highly sensitive MRD tests are emerging as powerful tools to identify patients at greatest risk of progression. The recent data from the InVIGOR-11 trial in bladder cancer is a powerful illustration of this approach. Patients with no evidence of disease after definitive front-line treatment, in this case surgery, underwent a ctDNA-based MRD test. Those who were ctDNA positive while in remission were randomized to immunotherapy or placebo. Notably, ctDNA clearance differed by only 11% between arms at cycles three or five, yet both the primary endpoint of disease-free survival and the key secondary endpoint of overall survival were statistically significant, representing a potentially practice-changing advance.

While every study is different, the new InVIGOR-11 data provides a valuable analog for illustrating the potential impact of this kind of approach. Achieving an approximately 30% delta between cema-cel and observation would represent the largest improvement in lymphoma outcomes since the approval of rituximab. Given these reference points, we believe our study is well-positioned to deliver a highly meaningful difference and the potential for a successful trial outcome. Together, these insights reinforce our confidence in the strength of the AlphaTru program and its potential to meaningfully advance lymphoma treatment. As we look beyond cema-cel, our Dagger technology continues to demonstrate its value across indications. In the Traverse trial, the Dagger technology enabled Allo316 produced durable responses in nearly one-third of patients with metastatic kidney cancer and high CD70 expression.

These responses, following standard flue cy and a single infusion of Allo316, highlight the built-in lymphodepletion advantage of the Dagger technology, enabling best-in-class CAR-T cell expansion in solid tumors. The Traverse trial provided important insights that helped shape the design of our dual CD19/CD70 construct in autoimmune disease. Rather than repurposing a construct from another indication, we set out to create something truly fit for purpose, designed from the start with long-term application in mind for autoimmune disease and the patients who would be treated. We were the first to engineer a CAR specifically for this setting, pairing dual targeting with our Dagger technology to achieve intrinsic built-in lymphodepletion through selective immune modulation. Allo329 is a first-in-class Allogene XL CD19/CD70 dual CAR-T product designed to target both CD19-positive B cells and CD70-positive activated T cells, which are key drivers of autoimmune disease.

This approach is intended to simplify administration, improve tolerability, and extend the reach of CAR-T therapy to a much broader patient population. If successful, it could represent a step change in the treatment of immune-mediated diseases. That is what we aim to achieve in the Resolution study, our phase one basket trial in autoimmune disease, which is now enrolling for lupus, myositis, and scleroderma. We expect to report translationally important biomarker and early proof of concept data in the first half of 2026. David and I spend a great deal of time in the field with investigators. Their enthusiasm remains strong because they see how these studies could fundamentally change the accessibility of cell therapy. By enabling treatment delivery within community networks where most patients receive care, we are aligning with how these institutions operate clinically and economically.

This model reduces referral barriers, simplifies logistics, and supports sustainable integration of advanced therapies into routine practice. Clinical development is complex. We compete for patients, particularly in autoimmune indications, and face both scientific and operational challenges. Each challenge strengthens our understanding and sharpens our execution. That is the nature of innovation: iterative, demanding, and grounded in data. Collectively, our programs underscore that Allogene XL CAR-T is not an iteration. We believe it is the foundation upon which the next generation of cell therapy will be built. The science continues to advance, the early signals remain strong, and our focus is on turning that progress into real-world impact for patients. With that, I'll hand the call over to Jeff.

David Chang, President and Chief Executive Officer, Allogene Therapeutics: Thank you, Zach.

Jeff Parker, Chief Financial Officer, Allogene Therapeutics: The operational and scientific progress that David and Zach described is backed by a strong financial foundation and disciplined capital management. Our focus remains on advancing our clinical priorities while maintaining flexibility to capture long-term value for shareholders. As of September 30, 2025, we had $277.1 million in cash, cash equivalents, and investments. Our disciplined approach to resource management continues to support a cash runway that extends into the second half of 2027. R&D expenses for the third quarter were $31.2 million, including $2.8 million of non-cash stock-based compensation. G&A expenses for Q3 2025 were $13.7 million, including $5.9 million in non-cash stock-based compensation. Net loss for the third quarter was $41.4 million, or $0.19 per share, including non-cash stock-based compensation expense of $8.7 million. We continue to expect a 2025 cash burn of approximately $150 million.

Full-year GAAP operating expenses of approximately $230 million, which includes an estimated non-cash stock-based compensation expense of approximately $45 million. This guidance excludes any impact from potential business development activities. The impact of our Allogene XL platform extends well beyond our disciplined cost structure. By manufacturing product in advance and at scale, we lay the groundwork for a more efficient and sustainable model for the broader healthcare system. Allogene XL therapies have the potential to meaningfully lower the overall cost of care for cell therapy, expand access beyond specialized centers, and make transformative cell therapies available to patients in a way that is both clinically practical and economically viable. With important clinical catalysts on the horizon and a solid financial foundation, we remain confident in our ability to execute and deliver on the opportunities ahead. We'll now open the call for questions.

Conference Operator: Thank you. Ladies and gentlemen, as a reminder to ask a question, please press star 11 on your telephone, then wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Salveen Richter with Goldman Sachs. Your line is open.

Good afternoon. Thanks for taking my question. For the futility analysis in the first half of next year, could you see any data beyond MRD conversion? Could you just expand on the 30% bar that you commented on, and then just remind us how enrollment is progressing for AlphaTru and whether you've seen any changes post-discontinuation of the FCA LD arm earlier in the year? Thank you.

Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, Allogene Therapeutics: Hi, Salveen. This is Zach. I'll go ahead and answer that one. For the first part of your question, will we be sharing anything additional besides the MRD conversion? At this time, we plan to really focus on the MRD conversion. This is not an interim analysis in which we intend to allocate alpha, so we really are looking at this MRD conversion and not any of the primary endpoints for efficacy. As far as the 30% bar that we mentioned in the prepared remarks, I think we went into some detail as to why we think that that would be a pretty significant win for cema-cel in that trial with the benchmarks of the POLARIX data showing a 7% improvement in PFS in front-line lymphoma, and then sort of looping in some recent data that was published for an analogous trial in bladder cancer showing an 11%.

MRD clearance in that clinical context, yet still having a significant primary endpoint win on disease-free survival as well as an overall survival win there. We think that 30% would be a pretty strong showing for cema-cel as it pertains to the MRD clearance rate. I think the third part of your question, Salveen, was around enrollment, and I'll reiterate here that we're on track for the interim analysis, the futility analysis, in the first half of next year. As far as impact of the study conduct change when we had the grade 5 event over the summer and went to a two-arm instead of a three-arm, I think the general view of the investigators is that they are pleased to be working with a regimen that they consider standard in CAR-T and not having to use an additional component with the CD52 antibody.

It appears as though that has had a slight uptick in terms of the pace of screening for this trial.

Conference Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Tyler Van Buren with TD Cowen. Your line is open.

Hello. This is Sam on for Tyler. Thanks for taking our question. Just for the over 50 U.S. and Canada active sites, what % of these have made it through that initial internal setup period and are now able to start actively enrolling patients? Thanks.

Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, Allogene Therapeutics: Hey, Sam. This is Zach again. We have gotten a lot better at forecasting how long that internal setup takes as well as sort of incorporating that into our timelines. I would say that of the over 50 that are active, it's going to be close to all of them that are open to enrollment. Only the most recently activated sites might still have a few remaining things that they need to do before they switch on, but for the most part, all 50 of those, 50-plus, are actively screening and enrolling patients.

Very helpful. Thank you.

Conference Operator: Thank you. Our next question comes from the line of Jack Allen with Baird. Your line is open.

Great. Thanks so much for taking the questions and congrats to the team on the progress made over the course of the quarter. I guess I'll ask one on the autoimmune program with 329. It seems like that's started to get off the ground here, and you're going to have an update in the first half of next year. I just wanted to hear any updated thoughts you have around the size and breadth of the data set we should expect next year from that program.

David Chang, President and Chief Executive Officer, Allogene Therapeutics: Hey, Jack. This is Dave Chang. Let me take that question, giving Zach a little bit of a break. In terms of the scope of that data communication, as we have previously said, it will be a handful of patients where we can show biomarker as well as the early clinical responses. That is the extent of it. Frankly, what we have seen with autologous programs is a handful of patients are sufficient to really understand what is going on with the CAR-T therapy. We are hoping that the initial communication early first half of next year will be very meaningful communication.

Great. Thank you so much.

Conference Operator: Thank you. Our next question comes from the line of Samantha Danielle Corwin with William Blair & Company. Your line is open.

Hey, guys. Congrats on the progress, and thanks for taking my questions. I'm just curious how many patients have consented for MRD testing now in AlphaTru, and if you're seeing the expected rate of MRD positivity that you initially theorized you'd see.

Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, Allogene Therapeutics: Hey, Sammy. Zach. I don't think we have, since we made that update earlier this year around the number of patients who had consented, we haven't really been providing kind of regular updates on that. I can say, generally speaking, that the pace of consenting has at least held steady since that early part of the year, so we're really growing in numbers. As far as the MRD positive rate goes, it is holding steady to our assumptions.

Conference Operator: Thank you. Our next question comes from the line of Asthika with Citizens. Your line is open.

Hi. This is Corina from Asthika. Thanks for taking my question. Caribou recently reported that their Allogene XL CAR-T product derived from younger donors demonstrated improved durability. Have you observed similar associations in your experience?

Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, Allogene Therapeutics: Hey, Corina. Let me take that question. Yeah, we follow Caribou, and in terms of their recent announcement of the result, it looks pretty encouraging. In terms of the studying materials, I mean, this is something that we have been following pretty closely, and we have a good way to identify the studying materials that will result in very important and consistent products.

Okay. Thank you.

Conference Operator: Thank you. Our next question comes from the line of Samantha Seiman with Citi. Your line is open.

Hi. Good afternoon. Thank you very much for taking the question. Another one on the autoimmune program. I'm wondering, there's some recent data in the autologous space in pemphigus where there was no lymphodepletion in that trial that showed some pretty encouraging results. I'm wondering if there's any read-through that you can take into your program. Obviously, you have the CD70 CAR as well, but I'm curious if this increases your optimism on showing pretty robust efficacy without lymphodepletion. Thanks very much.

David Chang, President and Chief Executive Officer, Allogene Therapeutics: Hi. Samantha, Dave Chang here. Thanks for that great question. I have to say that what we are seeing in the autologous CAR-T therapy, so obviously, autologous and the Allogene XL, there are different issues, but what we have seen just gives us even higher confidence that Allo329, this is CD70, CD19 dual CAR that has a built-in lymphatic bleeding capability, that Allo329 in the low-volume setting, such as in the autoimmune disease setting where it targets essentially the resident B cells and activated T cells, it will work well without the lymphatic depletion. Obviously, we have to show that. And just as a reminder, in the ongoing study, we will be testing two different cohorts, one with a reduced lymphatic depletion, so this is just with cyclophosphamide alone, and the second cohort will be without any lymphatic depletion.

Thanks very much.

Conference Operator: Thank you. Our next question comes from the line of John Newman with Cantor. Your line is open.

Hi there. Thanks for taking my question. So David, given that 329 is pretty unique in that it targets both B cells and activated T cells, I'm wondering, in the initial data readout, will you be able to get a look at the phenotype of the remaining T cells just to see if perhaps there's anything left after you hopefully wipe out all the CD70-positive T cells? Thanks.

David Chang, President and Chief Executive Officer, Allogene Therapeutics: John, I think that's definitely something that we will be looking at, but I think it will be. Now that it's also going into very nuanced questions about how the CD70 is working. I mean, we certainly have looked at the fraction of CD70-positive versus CD70-negative T cells. And keep in mind, most flaccid T cells are CD70-negative and are not affected by Allo329. There's a real benefit of just eliminating activated T cells, and activated T cells here are potentially those that are contributing to the autoimmune disease itself as well as our reactive T cells. In terms of how much data we will be sharing when we announce the proof of concept data in the first half of 2026, let me not go too much into that, but the question is really very relevant, and we will certainly be looking at CD70-positive and CD70-negative fractions.

Thank you.

Conference Operator: Thank you. Our next question comes from the line of Clara Dong with Jefferies. Your line is open. Please check to see if you're on mute. Clara, your line is open. Please stand by for our next question. Our next question comes from the line of Randy Benjamin with Citizens Bank. Your line is open.

Hey, guys. Thanks for taking the questions. Also for Allo329, when you talk about the biomarker data, David, are there any in particular that would alert you to achieving a B cell reset? And when we get those results, will the results be robust enough that it could help you, help us as analysts decide which indications you might move forward with?

David Chang, President and Chief Executive Officer, Allogene Therapeutics: Yeah. Great question. I mean, there are two parts to your question. One is whether the biomarker data will give us a lot of insight about how Allo329 is working. Having seen most of the data that's coming out in this space from those health CAR-T, I do believe that the biomarker data will be very meaningful. Also, we intend to show some early clinical responses depending on how long the patient has been followed up. When we communicate the proof of concept data in the first half of 2026, it will be more than just a biomarker. There will be early sort of clinical responses that may corroborate with what we are seeing in the biomarker data. The second question to me is probably the most fascinating one. If anything, I believe that we have probably very broad indications that we can potentially consider.

The fact that 329 targets both CD19 and CD70 really allows us to not just think about those autoimmune disorders that are heavily B cell-driven, but also autoimmune diseases that are very T cell-dependent or have a big T cell component. Essentially, from the rheumatology indications to neurology indications such as multiple sclerosis or even metabolic indications such as type 1 diabetes, it could be considered. Stay tuned.

Thanks, guys.

Conference Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Brian Chen with JPMorgan. Your line is open.

Hi, guys. Thanks for taking our questions. This is Ron for Brian. Can you talk about your level of confidence in MRD conversion to event-free survival? When you said around 30% MRD conversion as the bar, can you clarify a bit on the time point that is going to be meaningful for LBCL? How soon do you think we can reset level of conversion? Thanks.

Dr. Zachary Roberts, Executive Vice President of Research and Development and Chief Medical Officer, Allogene Therapeutics: Zach, you want to take that question?

Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer, Allogene Therapeutics: Yeah, I can take that question. Ron, I may need to have you repeat one or two of them, but I think the first question was, how confident are we in the prognostic value of MRD conversion as it relates to the study endpoints? I would say we're pretty confident, high confidence, actually, given everything that we know about the performance of this assay. After Frontline, which was recently published in JCO, as well as after CAR-T, which has been shown at ASH a couple of years in a row, the test seems to be pretty good at actually correlating with long-term outcomes. Can you repeat the next two questions? I heard the second one, but I didn't hear the third one.

Conference Operator: Yeah, of course. Sorry. When you said the bar, you said 30% MRD conversion, can you clarify a bit on the time point that's going to be meaningful for LBCL? And then how soon after dosing do you think we can reach that level?

Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer, Allogene Therapeutics: I see. Okay. Yeah, the 30% that we've been talking about, I think we provided some context already on this call on why we picked that number. I mean, another way to look at that is that's equivalent or maybe even slightly better than what rituximab brought when it was added to CHOP. If the MRD conversion is roughly predictive of clinical endpoints, as I just described, I think it is. That would be a pretty significant win. Some might even call a home run. As far as the time point goes, we haven't gone into detail around what exactly time we're drawing these MRD results. What I can say is that this is a pretty dynamic test, meaning that it goes up fast and it goes down fast. We are able to assess MRD relatively soon after the CAR-T is infused.

Again, we haven't specified exactly what that time point is. We are pretty confident that the time point that we selected is going to be predictive for the clinical outcomes.

Conference Operator: Great. Thank you so much.

Thank you. Our next question comes from the line of Luca Issi with RBC Capital Markets. Your line is open.

Hi, team. Thanks for taking our question. This is Cassian for Luca. Congrats on the progress this quarter. If I can push on the last question, the timing of analysis for MRD, is the futility study for stopping the trial if MRD is below your bar of 30%? I think you mentioned the last time the 30% MRD bar is partially based on other autologous CAR-T's objective response rate. Correct me here if I'm not understanding this correctly, but that is from a potentially much longer follow-up. Is there a chance that you see insufficient MRD at your futility analysis first half next year, but we probably just have to give it more time? Any color there much appreciated. Thanks.

David Chang, President and Chief Executive Officer, Allogene Therapeutics: Yeah. Let me take that question. I think there are some questions still around what would look good for the study. In terms of the MRD conversion, which is the primary reference point that we will be looking at at the fertility analysis, I think we are very well grounded with the assumptions that we are making. That assumption is supported from many different angles: the data that's coming from the autologous CAR-T therapy, as well as more newer data coming from other MRD-based studies. We feel very comfortable about how we will be conducting the fertility analysis in the first half of next year.

Conference Operator: Thank you. Our next question comes from the line of Robert Burns with HC Wainwright. Your line is open.

Hi. This is Katie on for Rob. My question is more about if you have any more recent interactions with the FDA and if you feel like they've kind of moved towards greater flexibility in CAR-T oversight, might give you some accelerated pathways or reduce some friction for you guys to get to market.

David Chang, President and Chief Executive Officer, Allogene Therapeutics: Yeah. We have a lot of ongoing communications with FDA. And so far, it has been very timely and very productive. The question that you are raising, it is a very interesting one. I mean, I think we will have to see when the time comes. All the indications that we can make from what FDA has said is that a single-time approach with the CAR-T therapy, that path is still wide open. FDA is carefully reviewing the other side of the BLA requirement, what is needed on the CMC side. We view this to be very positive for what we are doing.

Great. Thank you.

Conference Operator: Thank you. Our next question comes from the line of Clara Dong with Jefferies. Your line is open.

Jeff Parker, Chief Financial Officer, Allogene Therapeutics: Hi. Can you hear me okay now?

Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer, Allogene Therapeutics: Yes.

Jeff Parker, Chief Financial Officer, Allogene Therapeutics: Okay. I apologize for technical issues. And just one question from me. How are you controlling for variability in the MRD assay sensitivities, if any, across different sites? And what steps are you taking to ensure consistency in MRD conversion assessment for the fertility analysis? Thank you.

Christine Cassiano, Chief Corporate Affairs and Brand Strategy Officer, Allogene Therapeutics: Clara, that's an easy one. The MRD test is all being done centrally by Foresight Diagnostics. All the sites are doing is collecting the samples and then sending them into the central lab. We do not expect there to be any kind of technical variability in the test performance.

Jeff Parker, Chief Financial Officer, Allogene Therapeutics: Okay. That's good to hear. Thank you.

Conference Operator: Thank you. Ladies and gentlemen, that concludes our question and answer session. I would now like to turn the conference back over to David for any additional comments.

David Chang, President and Chief Executive Officer, Allogene Therapeutics: Thank you, operator. Let me close out by saying that everything we have built over the past seven and a half years has led to what's ahead in 2026. There are many ideas about where cell therapy is headed, but progress depends on staying focused on what is real and achievable. At Allogene, we kept our focus on building therapies that are scalable, reproducible, and ready for patients. In the first half of 2026, we expect two major milestones: interim fertility data for ALPHA3 with cema-cel first-line consolidation and proof of concept result from ALLO-329 in autoimmune disease. These will not be theoretical advances. If successful, they will mark true clinical validation of the Allogene XL platform, shaping our company's trajectory and building broader confidence in the potential of Allogene XL CAR-T therapy. The opportunity ahead is significant. We are entering 2026 with conviction.

Clarity, and momentum, and I'm excited for what the coming months may hold. Operator, you may now disconnect.

Conference Operator: Thank you. Ladies and gentlemen, thank you for your participation in today's conference. That does conclude the program, and you may now log off and disconnect.

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