Cellectis — Call Transcript 2026

Hello and welcome everyone to today's Cellectis full-year 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. To register to ask a question at any time, please press star one on your telephone keypad. Please note this call is being recorded and that we are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Arthur Stril, Chief Financial Officer and Chief Business Officer. Please go ahead. Good morning and welcome everyone to Cellectis fourth quarter and full-year 2025 business update and financial results conference call. Joining me on the call today are Dr. André Choulika, our Chief Executive Officer, and Dr. Adrian Kilcoyne, our Chief Medical Officer. Yesterday evening, Cellectis issued a 20-F and press release reporting our financial statements for the 12-month period ended December 31st, 2025, and a business update. The report and press release are available on our website at cellectis.com. As a reminder, we'll make statements regarding Cellectis financial outlook, including the sufficiency of cash to fund operations in addition to its manufacturing, regulatory and product development status, as well as product development status of its licensed partners. These forward statements, which are based on our management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners, are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Form 20-F filed with the Securities and Exchange Commission, SEC, and the financial report, including the management report for the year ended on December 31st, 2025, and subsequent filings Cellectis makes with the SEC from time to time. I would now like to turn the call over to André Choulika. Thank you, Arthur. Good morning and thank you everyone for joining us today. Cellectis was founded with the conviction that gene editing could fundamentally transform how we treat patients in the 21st century. On that foundation and idea, we pioneered the allogeneic CAR-T approach, ready on day one, built for all patients regardless of their condition. Today, I'm proud to say that Cellectis is one of the only companies running a pivotal phase II allogeneic CAR-T trial, specifically in B-cell acute lymphoblastic leukemia. The past several years have been among the most challenging in recent memory of biotechnology companies. Many programs were shelved and many companies were forced to retreat. While others stepped back, Cellectis stepped forward. We held the line. We managed our cash with rigor. We invested where it matters, and we kept our team focused entirely on one thing, delivering clinical results for patients who are running out of time with no therapeutic solution. In 2025, that discipline paid off. In October, at our R&D day, we presented the full phase I data set for Lasme-cel, our allogeneic CAR-T candidate targeting CD22 in relapsed or refractory B-cell acute lymphoblastic leukemia. Lasme-cel achieved 100% overall response rate in the target phase II population. Critically, Lasme-cel converted all patients in the target population to transplant-eligible candidates. These results were achieved in patients in third line and beyond. Most of them have already failed CD19 CAR-T, blinatumomab, and inotuzumab. Their options were exhausted. This is clinical proof that an allogeneic CAR-T can deliver deep, durable responses in one of the most difficult cancer to treat. Let me take a moment to explain why our bridge to transplant strategy is medically powerful. For patients with relapse or refractory B-ALL, only known path to long-term cure is a bone marrow stem cell transplant. To be eligible for transplant in a patient, a patient must first achieve deep remission, ideally minimal residual disease negative or MRD negative. The challenge is that heavily pre-treated patients, often too burdened with disease or too time-constrained to wait for an autologous therapy to be manufactured. Window is narrow. This is precisely where our allogeneic CAR-T product, Lasme-cel, becomes a game changer. Off the shelf, immediately available. Lasme-cel has the potential to reach a patient in days, not weeks, rapidly eliminate residual disease and open the door to transplant. For the patients, it is the difference between a chance to a cure and no chance at all. With that, our pivotal phase II trial now initiated, we will continue site openings in North America and Europe and enroll expansion in 2026. The first interim analysis of the pivotal phase II trial is expected Q4 2026. Turning to our second product candidate, Eti-cel, for patients with relapsed or refractory non-Hodgkin lymphoma. Eti-cel is a best-in-class allogeneic dual CAR-T targeting CD20 and CD22 simultaneously. Two differentiated antigens validated in oncology. This dual targeting is a deliberate answer to one of the most stubborn clinical problem in lymphoma, antigen escape. When cancer cells lose one surface marker to evade a single target therapy, they cannot hide from both. Eti-cel was built for that challenge. At the ASH 2025 annual meeting in December 2025, Cellectis presented phase I interim results, which demonstrated an encouraging overall response rate of 88% and a complete response of 63% in heavily pre-treated patients. These preliminary data underscore the potential of this innovative approach to transform outcomes for relapsed or refractory non-Hodgkin lymphoma patients. Trial is now investigating any potential impact of low-dose Interleukin-2 support to significantly enhance the expansion and the persistence of CAR-T cells to boost CAR-T efficacy without exacerbating toxicity. Cellectis expects to present the full phase I data set of Eti-cel this year. Now, a few words on our partners. Cellectis is not operating in isolation. Our gene editing platform has become the technological backbone of a broader allogeneic CAR-T ecosystem. Two of our key partners are approaching a pivotal moment. Servier, through Allogene's Cema-cel program, is currently in a pivotal phase II study evaluating it as a consolidation therapy in first-line large B-cell lymphoma patients. Allogene anticipates that the interim futility analysis is on track for Q2 2026. Our partnership with Iovance is another powerful testament to the versatility of our platform. Iovance is advancing IOV-4001 in PD-1-inactivated tumor-infiltrating lymphocytes or TIL cell therapy. In previously treated advanced melanoma patients leveraging our gene editing capacity, clinical results of IOV-4001 in melanoma are anticipated this year. R&D activities continue to advance under our research and collaboration agreement with AstraZeneca, which leverages Cellectis' gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology, and rare genetic disorders. Partnership is a further testament to the industrial credibility of our gene editing platform and our manufacturing capabilities. 2026 will be a year of data, of milestones, and of momentum for Cellectis. We are grateful for your continued trust and support. We look forward to updating you through the year as we execute against each of these milestones. With that, I would like to turn the call over to Dr. Adrian Kilcoyne, our Chief Medical Officer, who will provide further details on our clinical programs. Adrian, please go ahead. Thank you, André. I will provide a focused clinical perspective on our Lasme-cel and Eti-cel programs. The phase I BALLI-01 study of Lasme-cel in third line and beyond acute lymphoblastic leukemia enrolled 40 patients with confirmed at least 70% CD22 expression. These patients were heavily pre-treated with a median of four prior lines of therapy. The median number of prior lines of therapy at the recommended phase II dose was higher at five. These heavily pre-treated patients have already relapsed following multiple targeted therapies. Most patients have been previously treated with blinatumomab and relapsed. Approximately 50% have also relapsed following CD19 CAR-T and inotuzumab, a CD22-directed antibody-drug conjugate. Therefore, there remains very few, if any, therapeutic options for these patients. At the recommended phase II dose, Lasme-cel achieved an overall response rate of 83% and a CR/CRI rate of 42%. In the target phase II population, with an upper age cutoff of 50 years old, response rates were even higher, with 100% overall response and a CR/CRI rate of 56%. Importantly, of those subjects who achieved a CR/CRI, 80% achieved MRD negative status. Additionally, of the nine patients in the target phase II population, all became transplant eligible, with seven of nine receiving stem cell transplant at the time of data cut off. This is a very positive outcome for these patients. In patients who achieved MRD negative CR/CRI, median overall survival was 14.8 months, a meaningful survival benefit in this heavily pretreated population. The safety profile of Lasme-cel was favorable and similar or lower than observed with other autologous CAR-T therapies. Greater than or equal to grade three cytokine release syndrome occurred in 2.5% of patients, and greater than or equal to grade three ICANS occurred in 5% of patients at the recommended phase II dose. The full phase I data has been submitted for presentation at the 2026 European Hematology Association Congress to be held in Stockholm in June. The phase I program also addressed two important additional questions. The first is whether our internally manufactured product could result in similar or indeed improved efficacy compared to product manufactured by an external CDMO. The second is whether alemtuzumab, as part of the preconditioning lymphodepletion regimen, results in superior Lasme-cel expansion, and therefore efficacy compared to the standard lymphodepletion regimen. Validating our decision to internalize our manufacturing capabilities, Cellectis manufactured product demonstrated meaningfully higher response rates than external CDMO manufactured product, with overall response rates of 68% and 28% respectively. Secondly, the data demonstrated that increased alemtuzumab exposure correlates with improved response. These data were outlined at the American Society of Hematology annual conference in December 2025. Additional data have also been submitted for presentation at the 2026 European Hematology Association Congress. We are now enrolling in the pivotal phase II program focused on the target phase II population of patients aged between 12 and 50 years of age. We are accelerating site openings and are on track to reach our goal of approximately 75 recruiting centers across Europe and North America. As André highlighted, we expect to complete the first interim analysis of 40 patients in Q4 2026. These data will be shared publicly in a forum to be determined. I will remind you that, as previously disclosed, the anticipated BLA submission is planned for the second half of 2028. Our second ongoing program, investigating our dual CAR-T, Eti-cel, targets CD20 and CD22 expressing tumors in third line and beyond non-Hodgkin lymphoma. This highly differentiated product offering important and much needed alternative targets to CD19 continues in phase one. The preliminary phase one data presented at ASH 2025 showed an 88% overall response rate and a 63% complete response rate at the current dose level in the six evaluable patients. Cellectis believes we can further enhance these already high response rates through the addition of low dose IL-2 support. The addition of low dose IL-2 offers the potential to further enhance CAR-T expansion, tumor killing and persistence without negatively impacting toxicities. We expect to present the phase I data set, including the IL-2 cohort results later this year. We plan to progress this program to pivotal phase II in 2027 and anticipate a BLA submission in H2 2029. As you can see, 2026 promises to be an exciting year for Cellectis with a number of critical milestones and catalysts as we transform into a late-stage development organization. I look forward to sharing our progress later this year. With that, I would like to hand the call over to Arthur Stril, Cellectis's Chief Financial Officer and Chief Business Officer, for an overview of our financials for the fourth quarter and full-year 2025. Arthur, over to you. Thank you, Adrian. Let me now walk you through our financial position. As André mentioned, we have managed our cash with discipline over the past year, focusing our spend on what matters most, the development of Lasme-cel and Eti-cel, and the operation of our end-to-end manufacturing facilities in Paris and Raleigh. We believe our current cash position gives us the financial runway to execute on our pivotal phase II program for Lasme-cel and our phase I for Eti-cel, and deliver two key readouts in Q4 2026, the first interim analysis with 40 patients for Lasme-cel and the full phase I data set for Eti-cel. We are well positioned financially to execute on these two trials as our cash equivalents and fixed term deposits as of December 31st, 2025 remain sufficient to fund our operations into H2 2027. We are also looking forward to the upcoming data readouts for our partnered programs, in particular Servier and Allogene Cema-cel in April 2026 and Iovance's IOV-4001 this year as well. Finally, we are excited that activities are progressing under our strategic collaboration with AstraZeneca, which has positively impacted our 2025 revenue. As of December 31st, 2025, our cash equivalents, restricted cash and fixed term deposits classified as current financial assets amount to $211 million compared to $264 million as of December 31st, 2024. This $53 million decrease is mainly due to $36.9 million cash in from revenue. $8.4 million of interest received from our financial and cash equivalent investments, partially offset by cash payments from Cellectis to suppliers of $50.5 million. Cellectis wages, bonuses, and social expenses paid of $40 million. The payments of lease debts of $11 million and the repayment of the PGE loan of $5.4 million. You are invited to refer to our press release for figures related to consolidated net loss attributable to shareholders of Cellectis for the 12 months ended December 31st, 2025. We very much look forward to a rich 2026, especially with Servier and Allogene's readouts for Cema-cel next month and our two readouts for Lasme-cel and Eti-cel later this year. We'll now turn the call over to the operator for questions. Thank you. If you would like to ask a question, please press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. Our first question will come from Amin Makarem with Jefferies. Please go ahead. Hey, team, thank you for taking our questions. Two from us. First, on the Lasme-cel and the BALLI-01 enrollment. How's recruitment tracking in the pivotal study, and when do you expect to complete enrollment for that dose selection portion? I have a follow-up. Yeah. Thanks, Amin. I can take that. Currently we're doing very well. We're engaging many sites. The site opening is on track. We're certainly on track to complete our data analysis by the end of the year. That's just for the other people on the call. That's the first 40 patients interim analysis, and that's part of the dose optimization phase of the study, looking at two alternative doses of alemtuzumab, which is required by CDER. Yes, it's going well, Amin, and we're on track for a Q4 data sharing. Thanks. For this dose optimization portion, as you evaluate the two alemtuzumab dose levels, what are the expectations there? What differences should we expect between the two arms in terms of efficacy signal, or are you expecting a meaningful difference in the safety, or you think the two arms are gonna be generally in the same ballpark? We don't. It's very difficult to say, and I, you know, almost require a crystal ball to decide will there be a big difference in terms of both. We anticipate, however, that we have designed a very strong analysis plan to allow us to differentiate between the two components. That will be based on efficacy, safety, but also significantly important translational markers in terms of our CAR-T expansion, host T cell reconstitution, et cetera. We do believe, excuse me, that we will be able to define an optimized dose by the end of the year. We don't think that will be a significant challenge. However, we know that both of these doses of alemtuzumab, very importantly, they work. It's all about dose optimization now. It's not about finding an effective dose. Okay. Helpful. Thanks. Thank you. Our next question will come from Salveen Richter with Goldman Sachs. Please go ahead. Taking my questions. Two questions from us. One is, could you provide more details on the Servier arbitration, given the ruling that you have to engage in discussions with Allo regarding the direct licensing of 501, and help us understand how this impacts your eligibility for the EUR 340 million in milestones into this interim data? Then secondly, could you talk about your decision to include CD52 preconditioning in both the studies in the context of safety, as we see some of the competitors moving away from CD52? Thank you. Hi, Salveen. This is Arthur. Thanks for the question. I'll take the question on the arbitration and then hand it over to Adrian for the clinical question. As a reminder, the arbitral decision of December 2025 ruled on a partial termination of the license agreement with respect to one product, which is UCART19 v1, also named ALLO-501 by Allogene. This product has been brought back to Cellectis, and we are free to develop it or moving forward. The tribunal did not affect ALLO-501A or Cema-cel, so we remain fully eligible for up to EUR 340 million in development and sales milestones. That is obviously under the Servier agreement, which has been then sub-licensed to Allogene. This does not impact any eligibility to upcoming developments, and sales milestone as well as royalties down the line, on Cema-cel, but it gave us back UCART19 v1 or ALLO-501, and we're free to do whatever we would like to do with it. I will hand it over to Adrian for the clinical question. One thing I'd like to add, like, during our thinking is that once the pivotal trial is effective, then the milestone should be triggered. Like, we're definitely expecting to have this $20 million milestone paid one day. Okay. I'll answer the alemtuzumab question. It's a great question. There's a few things. Just a few observations from our studies. One is that alemtuzumab is really important to optimize lymphodepletion. As I said earlier, the more optimal the lymphodepletion, the better the outcomes in terms of responses. You get a much deeper response. As part of our phase I program, we did test a lymphodepletion regimen without alemtuzumab, and we failed to get any MRD-negative responses. So we know that alemtuzumab is very effective. The second part is you were saying some people are moving away from it. Now, we believe, as I've said already, alemtuzumab is important, but we also believe that it's critically important that you get the right dose. It's like everything, too much is always too much. We have, compared to other companies that are using alemtuzumab or alemtuzumab similars, we're using a much lower dose. We spent a lot of time in already optimizing our doses. We believe we've got the right balance between optimal efficacy, mitigating the risks that may be associated with that more enhanced lymphodepletion regimen. Also, let's not forget that alemtuzumab has been widely used in other clinical contexts, so it's got a very well-characterized safety profile, and we've been able to build into all our protocols very extensive risk mitigation. We believe we've got the right strategy with our alemtuzumab. I cannot answer why others may have transitioned away from it. Thank you. Our next question will come from Jack Allen with Baird. Great. Thanks for taking the questions, and congrats to the team on all the progress. I guess the first one I wanted to ask was on Eti-cel, and how we should think about the update in the fourth quarter this year. Any additional color you're willing to provide as it relates to the breadth of update and number of patients and the durability of follow-up there would be great. I have a quick follow-up as well. I can give you a top-line update on top of the data we already have. As we've shared already, at our current dose level, we're seeing 63% complete remission rates, 88% overall response rates. By the end of the year, you will see data in cohorts with and without IL-2. Now, we would acknowledge that 63% complete remission rate is actually a very strong result, and theoretically, we do not need to enhance that further, but we want to. We believe we can with the addition of low-dose IL-2. By the end of the year, you will see, you know, we're currently expanded at our recruiting sites rather significantly. We've doubled them. We anticipate we will be able to get a reasonable. I cannot give you a number because I don't know what the recruitment rates are going to be. We will be towards the latter part of the year also not in the staggering phase, so we would anticipate a significant increase in recruitment. You will see some durability data, is what you asked about. For the patients in the later phase, there will hopefully be good durability signals. We have in our mind the durability levels we want to achieve, and it's around the six-month mark. Hopefully by the end of the year you'll be able to see a very clear picture. I think the efficacy question's already been answered. The question is can we enhance it even further into the seventies rather than in the mid-sixties. Also it'll give us a very good signal. Is IL-2 really a potential game changer for allogeneic therapy? We obviously, based on our preclinical data, which is going to be presented at AACR and again some at EHA, that we believe it could offer a really a fundamental improvement for allogeneic cell therapies. Great. Thanks for all that color. Then, we might be getting ahead of ourselves a little bit here, but on Lasme-cel and the commercial opportunity, I was wondering if you've been looking at Obe-cel from Autolus and if you have any thoughts around the initial commercial launch of that CD19 allo therapy in ALL. I can give it from a medical perspective, and Arthur, maybe you want to talk a bit more broadly on the commercial opportunity. Let's not forget our patients are generally post CD19 failures, so we are not seeing this as a competition. We have a very differentiated target, CD22. We believe the market is pretty saturated with CD19s. It's not to say Obe-cel isn't a very good product. It is. Their data is very strong. These patients are very difficult to treat. Many of them will relapse, and they need to have an alternative target. We believe that this is not a competing product, but actually a very differentiated one. In terms of the market size, you may be aware we're starting to look at earlier lines of therapy. We will have data starting to be generated next year on that frontline consolidation, very much aligned with what Allogene has done, which we think is a fantastic idea in the non-Hodgkin lymphoma space. We will be looking at that in the ALL space, so we believe that's a really important part for those incredibly difficult to treat patients frontline. I can add, I think from a commercial launch perspective, you absolutely cannot compare an autologous launch to an allogeneic launch. I think the two primary differences is, one, you need to have leukapheresis access for the patients, and this is slow, this is very competitive, and this is controlled by hospitals, not by the pharma companies. Whereas obviously with off-the-shelf, we will have had manufactured a huge number of doses in advance so that at the time of launch, we can address all our clinical centers immediately without having to set up these cumbersome logistics aspect. The second thing, obviously, is because of our off-the-shelf nature, we have very significant economies of scale, and we see it even at the pivotal stage, which will allow us to get extremely competitive gross margins, which was much more the types of what pharma is now used to with small molecules and antibodies. Whereas, pricing of autologous has been difficult, because of the significant cost of goods that make a very important impact on the margin. I think the fact that we're off the shelf will allow us for a much smoother launch in terms of pure access due to the off-the-shelf nature, and also in a much more economically competitive aspect, due to the economies of scale and the very favorable gross margins. I don't think Obe-cel will be a very good competitor there. Great. One thing I'd like to add, Jack, like one thing that was interesting, I was like recently visiting a clinical center we're working with for acute lymphoblastic leukemia with Adrian. There was one ALL patient that was sitting in the backlog waiting for an available apheresis slot for a long time, along with, you know, non-Hodgkin lymphoma, DLBCL patient, multiple myeloma patient, autoimmune patient, etc. This patient, like ALL, is very aggressive disease. Still this patient, I'm not going to say which type of product was about to be given to him because I don't know. The fact is that this patient was, like, in real distress waiting for this, like, apheresis spot. This is what you would consider as an autologous launch of yet another CD19 CAR-T, autologous CAR-T. Got it. Thanks so much. That's very helpful, André Choulika. Thank you. Our next question will come from Silvan Tuerkcan with Citizens. Please go ahead. Yeah, good morning, and thank you for taking my questions. I just wanted to ask if you could just give us a brief recap of what you're expecting at EHA from these two programs that you have ongoing. Is it mainly longer follow-up? Thank you so much. You will be aware that we shared our data at our R&D day back in October. We after that actually added some more patients in because we wanted to do some level of dose optimization in advance of our phase II program. We wanted to ensure that lower dose is an acceptable dose to give to patients. There was going to be an updated dataset, the whole dataset, including those additional patients. It is. I would consider it a level of progression from the original phase I package that we presented. The data are not remarkably different, let me tell you, but it's an important addition to the data. The second thing that we hope, we're assuming that it will be accepted, is really to try and understand what makes a product successful. Again, to build on the question from our Goldman Sachs colleagues, where they were talking about alemtuzumab, is the importance of that preconditioning and that day zero, not only from a level of lymphodepletion, but actually the environment in which you infuse your cells is critically important and in many ways predicts the outcome. The fact that we have now identified a really clear picture of optimal lymphodepletion, optimal environment in which you infuse your cells, we are now able to predict very early on are patients going to respond. All these data will be shared. I think we're excited by it so far. Thank you. Thank you. Our next question will come from Sebastiaan van der Schoot with VLK. Please go ahead. Hi, guys. Good morning, and thanks for taking our question. I wanted to ask you how you're looking at the possibility of applying your lymphodepletion procedure in the outpatient setting as well as the allogeneic CAR-T. Maybe can you provide some insight on how the partnership with AstraZeneca is going? Can we expect any updates in the next 24 months? Thank you. I can take the first part of that, Arthur, in terms of outpatient setting. Right now, the regulatory authorities require inpatient delivery of product. I think that's consistent with most autologous therapies as well in the CAR-T space. Once there becomes some clinical confidence in how to use, will that transition into the outpatient setting? I think that may be a natural transition, but for that you need a body of evidence. Hopefully that will be provided not only by the phase II program but also by clinical usage from that. Again, I think it's a very different offering in that, to Arthur's point, we do not need that leukapheresis, etc. I do think it'll take some time for this to be in the outpatient setting you know, assuming that we continue to have a fairly reassuring safety profile, there's no real reason why this cannot in time transition to the outpatient setting. I will take the question on AstraZeneca. So first of all, we're extremely pleased to count AstraZeneca as a strategic partner. As you have seen, they have continued to invest very heavily in the cell and gene therapy space, and they're one of the few companies that are betting very hard, not only on cell and gene therapy, but also on off-the-shelf treatments. I think we're very fortunate to have them as a key shareholder, but also a strategic R&D partner. The activities are going very well under the collaboration. There's a number of activities ongoing across a range of therapeutic areas. Do not expect updates in the short term. This is at the request of AstraZeneca. They are essentially asking us for now to stay reasonably quiet, especially given the competitive nature of certain aspects that we are working on. Definitely, as we continue the dialogue with them around disclosure as and when the time is right, we will be providing update, and I think you will be interested in seeing what has been brewing with them. Great. Thank you, guys. Thank you. Once again, to ask a question, press star one on your telephone keypad. Our next question will come from Yanan Zhu with Wells Fargo. Oh, great. Thanks for taking our questions. So first, regarding the Lasme-cel pivotal study. Was wondering for the Q4 readout, is the focus there, the three-month CR/CRi from the two arms in that first 40-patient cohort? And then how do you manage the transition from completing that cohort to the start of the enrollment of the 80-patient portion for the optimal alemtuzumab dose, i.e., the final pivotal cohort? Will you be able to start enrolling before you have the data for the comparison of the two alemtuzumab cohorts? I have a follow-up. Thanks. Great. This is some great questions there. First and foremost, no. The decision for dose optimization is not based on the three-month CR/CRI. It's actually based at an earlier time cutoff of eight weeks. That's important. We will still be looking at efficacy, safety, but all the important translational markers predictive of not only short-term, but long-term outcomes, we have those answers by that first eight weeks. It's a composite of many of those that we will be presenting. In terms of that transition from that to the longer phase of the study, we have built a lot of flexibility into the protocol to allow us to continue recruiting. Importantly, this does not mean our study has to stop while we're engaging with the regulatory authorities. The recruitment will continue for the remaining aging patients. Great. Thanks for those very, very helpful color. The follow-up is mainly on the competitive landscape in terms of additional modalities, in vivo CAR-T, specifically. Can you talk about the advantages or limitations for that modality or whether you have any interest in moving in that direction, at earliest stage efforts? Thanks. I can have an initial thoughts on this. I think I know that André and Arthur also have views on the positioning of vivo CAR. You know, we're looking at incredibly sick patients with incredibly aggressive disease that need a lot of therapy. We don't believe these very difficult to treat tumors will be the destination for vivo CAR. We think in vivo CAR-T certainly have a place, but will it be the right therapy for incredibly difficult to treat tumors and incredibly difficult to manage patients? We don't believe so. Yes, there will be in vivo CAR-T in some, maybe autoimmune may be a better destination. Any therapy that requires extensive gene editing and extensive patient management will probably, maybe it will be a bridge too far for in vivo CAR. I know, André, you have a view on this as well. I think their process, like in vivo CAR, is similar to autologous CAR-T. The only thing it allows is essentially try to, you know, leapfrog apheresis, which is a great thing. It's like it's a huge market access option that is given here. Nevertheless, it will still be totally linked in to the fitness of the cells of the patient or their presence. If it doesn't respond to blinatumomab, if you can't do an autologous, then you go for an in vivo. Well, if the cells are not really very well functional, it's not gonna work anymore because you need the T cells to be fit. That's one point. The second point is, it will also be very much related to the current malignancies that are treated, which is essentially liquid tumors, B-cell malignancies, or multiple myeloma. The spread of this into solid tumor is going to be different. Finally, like, there's a lot of papers that are coming out, like a lot of cells are transduced by these vectors that are not T cells. Like, you need to restrict at the time. I think these technologies are going to come in the coming future, to try to restrict the cells to what needs to be transduced by the in vivo CAR-T and not to go and deliver. For example, I've seen a paper recently that shows more vector inside, for example, hepatic cells expressing CAR and then in T cells. If you do this worldwide, like really broadly, then big questions at a time. Like, the genome is only 6.4 billion base pairs, like 23, 2x chromosomes. If you inject trillions and trillions of vectors in hundreds of patients, like thousands of patients, it's like, I hope that this will be safely integrated. If you go, for example, with an autologous CAR-T, you can master exactly when the cells are transduced. If you go for an allogeneic CAR, you have all the QC that lasts a long period of time to ensure that everything is totally square. If you make the product in vivo, which is the case here, then you have to master how the product is made and not to have a lot of byproducts all around the place. That's like the initial concern. I'm sure that this will be solved in coming decades. Great. Thanks for all the insights and congrats on the quarter. Thank you. Thank you. At this time, there are no further questions in the queue, so I'll turn the meeting back over to our speakers for any additional or closing remarks. Thank you very much, everyone. Really appreciate all the questions here. As you can see, this will be a very exciting year, 2026, with a number of updates from our partners and from ourselves. I think we are poised for a new dawn of allogeneic CAR-T-cell therapy. Stay tuned for more updates, and looking forward to further discussions as our progress unfolds this year. Thank you very much. Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

Speaker 6: Hello and welcome everyone to today's Cellectis full-year 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. To register to ask a question at any time, please press star one on your telephone keypad. Please note this call is being recorded and that we are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Arthur Stril, Chief Financial Officer and Chief Business Officer. Please go ahead. Hello and welcome everyone to today's Cellectis full-year 2025 Earnings Conference Call. hello and welcome everyone to today's cellectis full-year 2025 earnings conference call At this time, all participants are in a listen-only mode. at this time all participants are in a listen-only mode Later, you will have the opportunity to ask questions during the question and answer session. later you will have the opportunity to ask questions during the question and answer session To register to ask a question at any time, please press star one on your telephone keypad. to register to ask a question at any time please press star one on your telephone keypad Please note this call is being recorded and that we are standing by if you should need any assistance. please note this call is being recorded and that we are standing by if you should need any assistance It is now my pleasure to turn the meeting over to Arthur Stril, Chief Financial Officer and Chief Business Officer. it is now my pleasure to turn the meeting over to arthur stril chief financial officer and chief business officer Please go ahead. please go ahead

Speaker 4: Good morning and welcome everyone to Cellectis fourth quarter and full-year 2025 business update and financial results conference call. Joining me on the call today are Dr. André Choulika, our Chief Executive Officer, and Dr. Adrian Kilcoyne, our Chief Medical Officer. Yesterday evening, Cellectis issued a 20-F and press release reporting our financial statements for the 12-month period ended December 31st, 2025, and a business update. The report and press release are available on our website at cellectis.com. As a reminder, we'll make statements regarding Cellectis financial outlook, including the sufficiency of cash to fund operations in addition to its manufacturing, regulatory and product development status, as well as product development status of its licensed partners. Good morning and welcome everyone to Cellectis fourth quarter and full- year 2025 business update and financial results conference call. good morning and welcome everyone to cellectis fourth quarter and full- year 2025 business update and financial results conference call Joining me on the call today are Dr. André Choulika, our Chief Executive Officer, and Dr. Adrian Kilcoyne, our Chief Medical Officer. joining me on the call today are dr andré choulika our chief executive officer and dr adrian kilcoyne our chief medical officer Yesterday evening, Cellectis issued a 20-F and press release reporting our financial statements for the 12-month period ended December 31st, 2025, and a business update. yesterday evening cellectis issued a 20-f and press release reporting our financial statements for the 12-month period ended december 31st 2025 and a business update The report and press release are available on our website at cellectis.com. the report and press release are available on our website at cellectis.com As a reminder, we'll make statements regarding Cellectis financial outlook, including the sufficiency of cash to fund operations in addition to its manufacturing, regulatory and product development status, as well as product development status of its licensed partners. as a reminder we'll make statements regarding cellectis financial outlook including the sufficiency of cash to fund operations in addition to its manufacturing regulatory and product development status as well as product development status of its licensed partners These forward statements, which are based on our management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners, are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Form 20-F filed with the Securities and Exchange Commission, SEC, and the financial report, including the management report for the year ended on December 31st, 2025, and subsequent filings Cellectis makes with the SEC from time to time. I would now like to turn the call over to André Choulika. These forward statements, which are based on our management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners, are subject to risks and uncertainties that may cause actual results to differ from those forecasted. these forward statements which are based on our management's current expectations and assumptions and on information currently available to management including information provided or otherwise publicly reported by our licensed partners are subject to risks and uncertainties that may cause actual results to differ from those forecasted A description of these risks can be found in our most recent Form 20-F filed with the Securities and Exchange Commission, SEC, and the financial report, including the management report for the year ended on December 31st, 2025, and subsequent filings Cellectis makes with the SEC from time to time. a description of these risks can be found in our most recent form 20-f filed with the securities and exchange commission sec and the financial report including the management report for the year ended on december 31st 2025 and subsequent filings cellectis makes with the sec from time to time I would now like to turn the call over to André Choulika. i would now like to turn the call over to andré choulika

Speaker 3: Thank you, Arthur. Good morning and thank you everyone for joining us today. Cellectis was founded with the conviction that gene editing could fundamentally transform how we treat patients in the 21st century. On that foundation and idea, we pioneered the allogeneic CAR-T approach, ready on day one, built for all patients regardless of their condition. Today, I'm proud to say that Cellectis is one of the only companies running a pivotal phase II allogeneic CAR-T trial, specifically in B-cell acute lymphoblastic leukemia. The past several years have been among the most challenging in recent memory of biotechnology companies. Many programs were shelved and many companies were forced to retreat. While others stepped back, Cellectis stepped forward. We held the line. We managed our cash with rigor. Thank you, Arthur. thank you arthur Good morning and thank you everyone for joining us today. good morning and thank you everyone for joining us today Cellectis was founded with the conviction that gene editing could fundamentally transform how we treat patients in the 21st century. cellectis was founded with the conviction that gene editing could fundamentally transform how we treat patients in the 21st century On that foundation and idea, we pioneered the allogeneic CAR-T approach, ready on day one, built for all patients regardless of their condition. on that foundation and idea we pioneered the allogeneic car-t approach ready on day one built for all patients regardless of their condition Today, I'm proud to say that Cellectis is one of the only companies running a pivotal phase II allogeneic CAR-T trial, specifically in B-cell acute lymphoblastic leukemia. today i'm proud to say that cellectis is one of the only companies running a pivotal phase ii allogeneic car-t trial specifically in b-cell acute lymphoblastic leukemia The past several years have been among the most challenging in recent memory of biotechnology companies. the past several years have been among the most challenging in recent memory of biotechnology companies Many programs were shelved and many companies were forced to retreat. many programs were shelved and many companies were forced to retreat While others stepped back, Cellectis stepped forward. while others stepped back cellectis stepped forward We held the line. we held the line We managed our cash with rigor. we managed our cash with rigor We invested where it matters, and we kept our team focused entirely on one thing, delivering clinical results for patients who are running out of time with no therapeutic solution. In 2025, that discipline paid off. In October, at our R&D day, we presented the full phase I data set for Lasme-cel, our allogeneic CAR-T candidate targeting CD22 in relapsed or refractory B-cell acute lymphoblastic leukemia. Lasme-cel achieved 100% overall response rate in the target phase II population. Critically, Lasme-cel converted all patients in the target population to transplant-eligible candidates. These results were achieved in patients in third line and beyond. Most of them have already failed CD19 CAR-T, blinatumomab, and inotuzumab. Their options were exhausted. This is clinical proof that an allogeneic CAR-T can deliver deep, durable responses in one of the most difficult cancer to treat. We invested where it matters, and we kept our team focused entirely on one thing, delivering clinical results for patients who are running out of time with no therapeutic solution. we invested where it matters and we kept our team focused entirely on one thing delivering clinical results for patients who are running out of time with no therapeutic solution In 2025, that discipline paid off. in 2025 that discipline paid off In October, at our R&D day, we presented the full phase I data set for Lasme-cel, our allogeneic CAR-T candidate targeting CD22 in relapsed or refractory B-cell acute lymphoblastic leukemia. in october at our r&d day we presented the full phase i data set for lasme-cel our allogeneic car-t candidate targeting cd22 in relapsed or refractory b-cell acute lymphoblastic leukemia Lasme-cel achieved 100% overall response rate in the target phase II population. lasme-cel achieved 100% overall response rate in the target phase ii population Critically, Lasme-cel converted all patients in the target population to transplant-eligible candidates. critically lasme-cel converted all patients in the target population to transplant-eligible candidates These results were achieved in patients in third line and beyond. these results were achieved in patients in third line and beyond Most of them have already failed CD19 CAR-T, blinatumomab, and inotuzumab. most of them have already failed cd19 car-t blinatumomab and inotuzumab Their options were exhausted. their options were exhausted This is clinical proof that an allogeneic CAR-T can deliver deep, durable responses in one of the most difficult cancer to treat. this is clinical proof that an allogeneic car-t can deliver deep durable responses in one of the most difficult cancer to treat Let me take a moment to explain why our bridge to transplant strategy is medically powerful. For patients with relapse or refractory B-ALL, only known path to long-term cure is a bone marrow stem cell transplant. To be eligible for transplant in a patient, a patient must first achieve deep remission, ideally minimal residual disease negative or MRD negative. The challenge is that heavily pre-treated patients, often too burdened with disease or too time-constrained to wait for an autologous therapy to be manufactured. Window is narrow. This is precisely where our allogeneic CAR-T product, Lasme-cel, becomes a game changer. Off the shelf, immediately available. Lasme-cel has the potential to reach a patient in days, not weeks, rapidly eliminate residual disease and open the door to transplant. For the patients, it is the difference between a chance to a cure and no chance at all. Let me take a moment to explain why our bridge to transplant strategy is medically powerful. let me take a moment to explain why our bridge to transplant strategy is medically powerful For patients with relapse or refractory B-ALL, only known path to long-term cure is a bone marrow stem cell transplant. for patients with relapse or refractory b-all only known path to long-term cure is a bone marrow stem cell transplant To be eligible for transplant in a patient, a patient must first achieve deep remission, ideally minimal residual disease negative or MRD negative. to be eligible for transplant in a patient a patient must first achieve deep remission ideally minimal residual disease negative or mrd negative The challenge is that heavily pre-treated patients, often too burdened with disease or too time-constrained to wait for an autologous therapy to be manufactured. the challenge is that heavily pre-treated patients often too burdened with disease or too time-constrained to wait for an autologous therapy to be manufactured Window is narrow. window is narrow This is precisely where our allogeneic CAR-T product, Lasme-cel, becomes a game changer. this is precisely where our allogeneic car-t product lasme-cel becomes a game changer Off the shelf, immediately available. off the shelf immediately available Lasme-cel has the potential to reach a patient in days, not weeks, rapidly eliminate residual disease and open the door to transplant. lasme-cel has the potential to reach a patient in days not weeks rapidly eliminate residual disease and open the door to transplant For the patients, it is the difference between a chance to a cure and no chance at all. for the patients it is the difference between a chance to a cure and no chance at all With that, our pivotal phase II trial now initiated, we will continue site openings in North America and Europe and enroll expansion in 2026. The first interim analysis of the pivotal phase II trial is expected Q4 2026. Turning to our second product candidate, Eti-cel, for patients with relapsed or refractory non-Hodgkin lymphoma. Eti-cel is a best-in-class allogeneic dual CAR-T targeting CD20 and CD22 simultaneously. Two differentiated antigens validated in oncology. This dual targeting is a deliberate answer to one of the most stubborn clinical problem in lymphoma, antigen escape. When cancer cells lose one surface marker to evade a single target therapy, they cannot hide from both. Eti-cel was built for that challenge. With that, our pivotal phase II trial now initiated, we will continue site openings in North America and Europe and enroll expansion in 2026. with that our pivotal phase ii trial now initiated we will continue site openings in north america and europe and enroll expansion in 2026 The first interim analysis of the pivotal phase II trial is expected Q4 2026. the first interim analysis of the pivotal phase ii trial is expected q4 2026 Turning to our second product candidate, Eti-cel, for patients with relapsed or refractory non-Hodgkin lymphoma. turning to our second product candidate eti-cel for patients with relapsed or refractory non-hodgkin lymphoma Eti-cel is a best-in-class allogeneic dual CAR-T targeting CD20 and CD22 simultaneously. eti-cel is a best-in-class allogeneic dual car-t targeting cd20 and cd22 simultaneously Two differentiated antigens validated in oncology. two differentiated antigens validated in oncology This dual targeting is a deliberate answer to one of the most stubborn clinical problem in lymphoma, antigen escape. this dual targeting is a deliberate answer to one of the most stubborn clinical problem in lymphoma antigen escape When cancer cells lose one surface marker to evade a single target therapy, they cannot hide from both. when cancer cells lose one surface marker to evade a single target therapy they cannot hide from both Eti-cel was built for that challenge. eti-cel was built for that challenge At the ASH 2025 annual meeting in December 2025, Cellectis presented phase I interim results, which demonstrated an encouraging overall response rate of 88% and a complete response of 63% in heavily pre-treated patients. These preliminary data underscore the potential of this innovative approach to transform outcomes for relapsed or refractory non-Hodgkin lymphoma patients. Trial is now investigating any potential impact of low-dose Interleukin-2 support to significantly enhance the expansion and the persistence of CAR-T cells to boost CAR-T efficacy without exacerbating toxicity. Cellectis expects to present the full phase I data set of Eti-cel this year. Now, a few words on our partners. Cellectis is not operating in isolation. Our gene editing platform has become the technological backbone of a broader allogeneic CAR-T ecosystem. Two of our key partners are approaching a pivotal moment. At the ASH 2025 annual meeting in December 2025, Cellectis presented phase I interim results, which demonstrated an encouraging overall response rate of 88% and a complete response of 63% in heavily pre-treated patients. at the ash 2025 annual meeting in december 2025 cellectis presented phase i interim results which demonstrated an encouraging overall response rate of 88% and a complete response of 63% in heavily pre-treated patients These preliminary data underscore the potential of this innovative approach to transform outcomes for relapsed or refractory non-Hodgkin lymphoma patients. these preliminary data underscore the potential of this innovative approach to transform outcomes for relapsed or refractory non-hodgkin lymphoma patients Trial is now investigating any potential impact of low-dose Interleukin-2 support to significantly enhance the expansion and the persistence of CAR-T cells to boost CAR-T efficacy without exacerbating toxicity. trial is now investigating any potential impact of low-dose interleukin-2 support to significantly enhance the expansion and the persistence of car-t cells to boost car-t efficacy without exacerbating toxicity Cellectis expects to present the full phase I data set of Eti-cel this year. cellectis expects to present the full phase i data set of eti-cel this year Now, a few words on our partners. now, a few words on our partners Cellectis is not operating in isolation. cellectis is not operating in isolation Our gene editing platform has become the technological backbone of a broader allogeneic CAR-T ecosystem. our gene editing platform has become the technological backbone of a broader allogeneic car-t ecosystem Two of our key partners are approaching a pivotal moment. two of our key partners are approaching a pivotal moment Servier, through Allogene's Cema-cel program, is currently in a pivotal phase II study evaluating it as a consolidation therapy in first-line large B-cell lymphoma patients. Allogene anticipates that the interim futility analysis is on track for Q2 2026. Our partnership with Iovance is another powerful testament to the versatility of our platform. Iovance is advancing IOV-4001 in PD-1-inactivated tumor-infiltrating lymphocytes or TIL cell therapy. In previously treated advanced melanoma patients leveraging our gene editing capacity, clinical results of IOV-4001 in melanoma are anticipated this year. R&D activities continue to advance under our research and collaboration agreement with AstraZeneca, which leverages Cellectis' gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology, and rare genetic disorders. Servier, through Allogene's Cema-cel program, is currently in a pivotal phase II study evaluating it as a consolidation therapy in first-line large B-cell lymphoma patients. servier through allogene's cema-cel program is currently in a pivotal phase ii study evaluating it as a consolidation therapy in first-line large b-cell lymphoma patients Allogene anticipates that the interim futility analysis is on track for Q2 2026. allogene anticipates that the interim futility analysis is on track for q2 2026 Our partnership with Iovance is another powerful testament to the versatility of our platform. our partnership with iovance is another powerful testament to the versatility of our platform Iovance is advancing IOV-4001 in PD-1-inactivated tumor-infiltrating lymphocytes or TIL cell therapy. iovance is advancing iov-4001 in pd-1-inactivated tumor-infiltrating lymphocytes or til cell therapy In previously treated advanced melanoma patients leveraging our gene editing capacity, clinical results of IOV-4001 in melanoma are anticipated this year. in previously treated advanced melanoma patients leveraging our gene editing capacity clinical results of iov-4001 in melanoma are anticipated this year R&D activities continue to advance under our research and collaboration agreement with AstraZeneca, which leverages Cellectis' gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology, and rare genetic disorders. r&d activities continue to advance under our research and collaboration agreement with astrazeneca which leverages cellectis' gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need including oncology immunology and rare genetic disorders Partnership is a further testament to the industrial credibility of our gene editing platform and our manufacturing capabilities. 2026 will be a year of data, of milestones, and of momentum for Cellectis. We are grateful for your continued trust and support. We look forward to updating you through the year as we execute against each of these milestones. With that, I would like to turn the call over to Dr. Adrian Kilcoyne, our Chief Medical Officer, who will provide further details on our clinical programs. Adrian, please go ahead. Partnership is a further testament to the industrial credibility of our gene editing platform and our manufacturing capabilities. 2026 will be a year of data, of milestones, and of momentum for Cellectis. partnership is a further testament to the industrial credibility of our gene editing platform and our manufacturing capabilities 2026 will be a year of data of milestones and of momentum for cellectis We are grateful for your continued trust and support. we are grateful for your continued trust and support We look forward to updating you through the year as we execute against each of these milestones. we look forward to updating you through the year as we execute against each of these milestones With that, I would like to turn the call over to Dr. Adrian Kilcoyne, our Chief Medical Officer, who will provide further details on our clinical programs. with that i would like to turn the call over to dr adrian kilcoyne our chief medical officer who will provide further details on our clinical programs Adrian, please go ahead. adrian please go ahead

Speaker 1: Thank you, André. I will provide a focused clinical perspective on our Lasme-cel and Eti-cel programs. The phase I BALLI-01 study of Lasme-cel in third line and beyond acute lymphoblastic leukemia enrolled 40 patients with confirmed at least 70% CD22 expression. These patients were heavily pre-treated with a median of four prior lines of therapy. The median number of prior lines of therapy at the recommended phase II dose was higher at five. These heavily pre-treated patients have already relapsed following multiple targeted therapies. Most patients have been previously treated with blinatumomab and relapsed. Approximately 50% have also relapsed following CD19 CAR-T and inotuzumab, a CD22-directed antibody-drug conjugate. Therefore, there remains very few, if any, therapeutic options for these patients. Thank you, André. thank you andré I will provide a focused clinical perspective on our Lasme-cel and Eti-cel programs. i will provide a focused clinical perspective on our lasme-cel and eti-cel programs The phase I BALLI-01 study of Lasme-cel in third line and beyond acute lymphoblastic leukemia enrolled 40 patients with confirmed at least 70% CD22 expression. the phase i balli-01 study of lasme-cel in third line and beyond acute lymphoblastic leukemia enrolled 40 patients with confirmed at least 70% cd22 expression These patients were heavily pre-treated with a median of four prior lines of therapy. these patients were heavily pre-treated with a median of four prior lines of therapy The median number of prior lines of therapy at the recommended phase II dose was higher at five. the median number of prior lines of therapy at the recommended phase ii dose was higher at five These heavily pre-treated patients have already relapsed following multiple targeted therapies. these heavily pre-treated patients have already relapsed following multiple targeted therapies Most patients have been previously treated with blinatumomab and relapsed. most patients have been previously treated with blinatumomab and relapsed Approximately 50% have also relapsed following CD19 CAR-T and inotuzumab, a CD22-directed antibody-drug conjugate. approximately 50% have also relapsed following cd19 car-t and inotuzumab a cd22-directed antibody-drug conjugate Therefore, there remains very few, if any, therapeutic options for these patients. therefore there remains very few if any therapeutic options for these patients At the recommended phase II dose, Lasme-cel achieved an overall response rate of 83% and a CR/CRI rate of 42%. In the target phase II population, with an upper age cutoff of 50 years old, response rates were even higher, with 100% overall response and a CR/CRI rate of 56%. Importantly, of those subjects who achieved a CR/CRI, 80% achieved MRD negative status. Additionally, of the nine patients in the target phase II population, all became transplant eligible, with seven of nine receiving stem cell transplant at the time of data cut off. This is a very positive outcome for these patients. In patients who achieved MRD negative CR/CRI, median overall survival was 14.8 months, a meaningful survival benefit in this heavily pretreated population. At the recommended phase II dose, Lasme-cel achieved an overall response rate of 83% and a CR/CRI rate of 42%. at the recommended phase ii dose lasme-cel achieved an overall response rate of 83% and a cr/cri rate of 42% In the target phase II population, with an upper age cutoff of 50 years old, response rates were even higher, with 100% overall response and a CR/CRI rate of 56%. in the target phase ii population with an upper age cutoff of 50 years old response rates were even higher with 100% overall response and a cr/cri rate of 56% Importantly, of those subjects who achieved a CR/CRI, 80% achieved MRD negative status. importantly of those subjects who achieved a cr/cri 80% achieved mrd negative status Additionally, of the nine patients in the target phase II population, all became transplant eligible, with seven of nine receiving stem cell transplant at the time of data cut off. additionally of the nine patients in the target phase ii population all became transplant eligible with seven of nine receiving stem cell transplant at the time of data cut off This is a very positive outcome for these patients. In patients who achieved MRD negative CR/CRI, median overall survival was 14.8 months, a meaningful survival benefit in this heavily pretreated population. this is a very positive outcome for these patients. in patients who achieved mrd negative cr/cri median overall survival was 14.8 months a meaningful survival benefit in this heavily pretreated population The safety profile of Lasme-cel was favorable and similar or lower than observed with other autologous CAR-T therapies. Greater than or equal to grade three cytokine release syndrome occurred in 2.5% of patients, and greater than or equal to grade three ICANS occurred in 5% of patients at the recommended phase II dose. The full phase I data has been submitted for presentation at the 2026 European Hematology Association Congress to be held in Stockholm in June. The phase I program also addressed two important additional questions. The first is whether our internally manufactured product could result in similar or indeed improved efficacy compared to product manufactured by an external CDMO. The second is whether alemtuzumab, as part of the preconditioning lymphodepletion regimen, results in superior Lasme-cel expansion, and therefore efficacy compared to the standard lymphodepletion regimen. The safety profile of Lasme-cel was favorable and similar or lower than observed with other autologous CAR-T therapies. the safety profile of lasme-cel was favorable and similar or lower than observed with other autologous car-t therapies Greater than or equal to grade three cytokine release syndrome occurred in 2.5% of patients, and greater than or equal to grade three ICANS occurred in 5% of patients at the recommended phase II dose. greater than or equal to grade three cytokine release syndrome occurred in 2.5% of patients and greater than or equal to grade three icans occurred in 5% of patients at the recommended phase ii dose The full phase I data has been submitted for presentation at the 2026 European Hematology Association Congress to be held in Stockholm in June. the full phase i data has been submitted for presentation at the 2026 european hematology association congress to be held in stockholm in june The phase I program also addressed two important additional questions. the phase i program also addressed two important additional questions The first is whether our internally manufactured product could result in similar or indeed improved efficacy compared to product manufactured by an external CDMO. the first is whether our internally manufactured product could result in similar or indeed improved efficacy compared to product manufactured by an external cdmo The second is whether alemtuzumab, as part of the preconditioning lymphodepletion regimen, results in superior Lasme-cel expansion, and therefore efficacy compared to the standard lymphodepletion regimen. the second is whether alemtuzumab as part of the preconditioning lymphodepletion regimen results in superior lasme-cel expansion and therefore efficacy compared to the standard lymphodepletion regimen Validating our decision to internalize our manufacturing capabilities, Cellectis manufactured product demonstrated meaningfully higher response rates than external CDMO manufactured product, with overall response rates of 68% and 28% respectively. Secondly, the data demonstrated that increased alemtuzumab exposure correlates with improved response. These data were outlined at the American Society of Hematology annual conference in December 2025. Additional data have also been submitted for presentation at the 2026 European Hematology Association Congress. We are now enrolling in the pivotal phase II program focused on the target phase II population of patients aged between 12 and 50 years of age. We are accelerating site openings and are on track to reach our goal of approximately 75 recruiting centers across Europe and North America. As André highlighted, we expect to complete the first interim analysis of 40 patients in Q4 2026. Validating our decision to internalize our manufacturing capabilities, Cellectis manufactured product demonstrated meaningfully higher response rates than external CDMO manufactured product, with overall response rates of 68% and 28% respectively. validating our decision to internalize our manufacturing capabilities cellectis manufactured product demonstrated meaningfully higher response rates than external cdmo manufactured product with overall response rates of 68% and 28% respectively Secondly, the data demonstrated that increased alemtuzumab exposure correlates with improved response. secondly the data demonstrated that increased alemtuzumab exposure correlates with improved response These data were outlined at the American Society of Hematology annual conference in December 2025. these data were outlined at the american society of hematology annual conference in december 2025 Additional data have also been submitted for presentation at the 2026 European Hematology Association Congress. additional data have also been submitted for presentation at the 2026 european hematology association congress We are now enrolling in the pivotal phase II program focused on the target phase II population of patients aged between 12 and 50 years of age. we are now enrolling in the pivotal phase ii program focused on the target phase ii population of patients aged between 12 and 50 years of age We are accelerating site openings and are on track to reach our goal of approximately 75 recruiting centers across Europe and North America. we are accelerating site openings and are on track to reach our goal of approximately 75 recruiting centers across europe and north america As André highlighted, we expect to complete the first interim analysis of 40 patients in Q4 2026. as andré highlighted we expect to complete the first interim analysis of 40 patients in q4 2026 These data will be shared publicly in a forum to be determined. I will remind you that, as previously disclosed, the anticipated BLA submission is planned for the second half of 2028. Our second ongoing program, investigating our dual CAR-T, Eti-cel, targets CD20 and CD22 expressing tumors in third line and beyond non-Hodgkin lymphoma. This highly differentiated product offering important and much needed alternative targets to CD19 continues in phase one. The preliminary phase one data presented at ASH 2025 showed an 88% overall response rate and a 63% complete response rate at the current dose level in the six evaluable patients. Cellectis believes we can further enhance these already high response rates through the addition of low dose IL-2 support. The addition of low dose IL-2 offers the potential to further enhance CAR-T expansion, tumor killing and persistence without negatively impacting toxicities. These data will be shared publicly in a forum to be determined. these data will be shared publicly in a forum to be determined I will remind you that, as previously disclosed, the anticipated BLA submission is planned for the second half of 2028. i will remind you that as previously disclosed the anticipated bla submission is planned for the second half of 2028 Our second ongoing program, investigating our dual CAR- T, Eti-cel, targets CD20 and CD22 expressing tumors in third line and beyond non-Hodgkin lymphoma. our second ongoing program investigating our dual car- t eti-cel targets cd20 and cd22 expressing tumors in third line and beyond non-hodgkin lymphoma This highly differentiated product offering important and much needed alternative targets to CD19 continues in phase one. this highly differentiated product offering important and much needed alternative targets to cd19 continues in phase one The preliminary phase one data presented at ASH 2025 showed an 88% overall response rate and a 63% complete response rate at the current dose level in the six evaluable patients. the preliminary phase one data presented at ash 2025 showed an 88% overall response rate and a 63% complete response rate at the current dose level in the six evaluable patients Cellectis believes we can further enhance these already high response rates through the addition of low dose IL-2 support. cellectis believes we can further enhance these already high response rates through the addition of low dose il-2 support The addition of low dose IL-2 offers the potential to further enhance CAR- T expansion, tumor killing and persistence without negatively impacting toxicities. the addition of low dose il-2 offers the potential to further enhance car- t expansion tumor killing and persistence without negatively impacting toxicities We expect to present the phase I data set, including the IL-2 cohort results later this year. We plan to progress this program to pivotal phase II in 2027 and anticipate a BLA submission in H2 2029. As you can see, 2026 promises to be an exciting year for Cellectis with a number of critical milestones and catalysts as we transform into a late-stage development organization. I look forward to sharing our progress later this year. With that, I would like to hand the call over to Arthur Stril, Cellectis's Chief Financial Officer and Chief Business Officer, for an overview of our financials for the fourth quarter and full-year 2025. Arthur, over to you. We expect to present the phase I data set, including the IL-2 cohort results later this year. we expect to present the phase i data set including the il-2 cohort results later this year We plan to progress this program to pivotal phase II in 2027 and anticipate a BLA submission in H2 2029. we plan to progress this program to pivotal phase ii in 2027 and anticipate a bla submission in h2 2029 As you can see, 2026 promises to be an exciting year for Cellectis with a number of critical milestones and catalysts as we transform into a late-stage development organization. as you can see 2026 promises to be an exciting year for cellectis with a number of critical milestones and catalysts as we transform into a late-stage development organization I look forward to sharing our progress later this year. i look forward to sharing our progress later this year With that, I would like to hand the call over to Arthur Stril, Cellectis's Chief Financial Officer and Chief Business Officer, for an overview of our financials for the fourth quarter and full- year 2025. with that i would like to hand the call over to arthur stril cellectis's chief financial officer and chief business officer for an overview of our financials for the fourth quarter and full- year 2025 Arthur, over to you. arthur over to you

Speaker 4: Thank you, Adrian. Let me now walk you through our financial position. As André mentioned, we have managed our cash with discipline over the past year, focusing our spend on what matters most, the development of Lasme-cel and Eti-cel, and the operation of our end-to-end manufacturing facilities in Paris and Raleigh. We believe our current cash position gives us the financial runway to execute on our pivotal phase II program for Lasme-cel and our phase I for Eti-cel, and deliver two key readouts in Q4 2026, the first interim analysis with 40 patients for Lasme-cel and the full phase I data set for Eti-cel. We are well positioned financially to execute on these two trials as our cash equivalents and fixed term deposits as of December 31st, 2025 remain sufficient to fund our operations into H2 2027. Thank you, Adrian. thank you adrian Let me now walk you through our financial position. let me now walk you through our financial position As André mentioned, we have managed our cash with discipline over the past year, focusing our spend on what matters most, the development of Lasme-cel and Eti-cel, and the operation of our end-to-end manufacturing facilities in Paris and Raleigh. as andré mentioned we have managed our cash with discipline over the past year focusing our spend on what matters most the development of lasme-cel and eti-cel and the operation of our end-to-end manufacturing facilities in paris and raleigh We believe our current cash position gives us the financial runway to execute on our pivotal phase II program for Lasme-cel and our phase I for Eti-cel, and deliver two key readouts in Q4 2026, the first interim analysis with 40 patients for Lasme-cel and the full phase I data set for Eti-cel. we believe our current cash position gives us the financial runway to execute on our pivotal phase ii program for lasme-cel and our phase i for eti-cel and deliver two key readouts in q4 2026 the first interim analysis with 40 patients for lasme-cel and the full phase i data set for eti-cel We are well positioned financially to execute on these two trials as our cash equivalents and fixed term deposits as of December 31st, 2025 remain sufficient to fund our operations into H2 2027. we are well positioned financially to execute on these two trials as our cash equivalents and fixed term deposits as of december 31st 2025 remain sufficient to fund our operations into h2 2027 We are also looking forward to the upcoming data readouts for our partnered programs, in particular Servier and Allogene Cema-cel in April 2026 and Iovance's IOV-4001 this year as well. Finally, we are excited that activities are progressing under our strategic collaboration with AstraZeneca, which has positively impacted our 2025 revenue. As of December 31st, 2025, our cash equivalents, restricted cash and fixed term deposits classified as current financial assets amount to $211 million compared to $264 million as of December 31st, 2024. This $53 million decrease is mainly due to $36.9 million cash in from revenue. We are also looking forward to the upcoming data readouts for our partnered programs, in particular Servier and Allogene Cema-cel in April 2026 and Iovance's IOV-4001 this year as well. we are also looking forward to the upcoming data readouts for our partnered programs in particular servier and allogene cema-cel in april 2026 and iovance's iov-4001 this year as well Finally, we are excited that activities are progressing under our strategic collaboration with AstraZeneca, which has positively impacted our 2025 revenue. finally we are excited that activities are progressing under our strategic collaboration with astrazeneca which has positively impacted our 2025 revenue As of December 31st, 2025, our cash equivalents, restricted cash and fixed term deposits classified as current financial assets amount to $211 million compared to $264 million as of December 31st, 2024. as of december 31st 2025 our cash equivalents restricted cash and fixed term deposits classified as current financial assets amount to $211 million compared to $264 million as of december 31st 2024 This $53 million decrease is mainly due to $36.9 million cash in from revenue. this $53 million decrease is mainly due to $36.9 million cash in from revenue $8.4 million of interest received from our financial and cash equivalent investments, partially offset by cash payments from Cellectis to suppliers of $50.5 million. Cellectis wages, bonuses, and social expenses paid of $40 million. The payments of lease debts of $11 million and the repayment of the PGE loan of $5.4 million. You are invited to refer to our press release for figures related to consolidated net loss attributable to shareholders of Cellectis for the 12 months ended December 31st, 2025. We very much look forward to a rich 2026, especially with Servier and Allogene's readouts for Cema-cel next month and our two readouts for Lasme-cel and Eti-cel later this year. We'll now turn the call over to the operator for questions. $8.4 million of interest received from our financial and cash equivalent investments, partially offset by cash payments from Cellectis to suppliers of $50.5 million. $8.4 million of interest received from our financial and cash equivalent investments partially offset by cash payments from cellectis to suppliers of $50.5 million Cellectis wages, bonuses, and social expenses paid of $40 million. cellectis wages bonuses and social expenses paid of $40 million The payments of lease debts of $11 million and the repayment of the PGE loan of $5.4 million. the payments of lease debts of $11 million and the repayment of the pge loan of $5.4 million You are invited to refer to our press release for figures related to consolidated net loss attributable to shareholders of Cellectis for the 12 months ended December 31st, 2025. you are invited to refer to our press release for figures related to consolidated net loss attributable to shareholders of cellectis for the 12 months ended december 31st 2025 We very much look forward to a rich 2026, especially with Servier and Allogene's readouts for Cema-cel next month and our two readouts for Lasme-cel and Eti-cel later this year. we very much look forward to a rich 2026 especially with servier and allogene's readouts for cema-cel next month and our two readouts for lasme-cel and eti-cel later this year We'll now turn the call over to the operator for questions. we'll now turn the call over to the operator for questions

Speaker 6: Thank you. If you would like to ask a question, please press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. Our first question will come from Amin Makarem with Jefferies. Please go ahead. Thank you. thank you If you would like to ask a question, please press star one on your keypad. if you would like to ask a question please press star one on your keypad To leave the queue at any time, press star two. to leave the queue at any time press star two Once again, that is star one to ask a question. once again that is star one to ask a question Our first question will come from Amin Makarem with Jefferies. our first question will come from amin makarem with jefferies Please go ahead. please go ahead

Speaker 2: Hey, team, thank you for taking our questions. Two from us. First, on the Lasme-cel and the BALLI-01 enrollment. How's recruitment tracking in the pivotal study, and when do you expect to complete enrollment for that dose selection portion? I have a follow-up. Hey, team, thank you for taking our questions. hey team thank you for taking our questions Two from us. two from us First, on the Lasme-cel and the BALLI-01 enrollment. first on the lasme-cel and the balli-01 enrollment How's recruitment tracking in the pivotal study, and when do you expect to complete enrollment for that dose selection portion? how's recruitment tracking in the pivotal study and when do you expect to complete enrollment for that dose selection portion I have a follow-up. i have a follow-up

Speaker 1: Yeah. Thanks, Amin. I can take that. Currently we're doing very well. We're engaging many sites. The site opening is on track. We're certainly on track to complete our data analysis by the end of the year. That's just for the other people on the call. That's the first 40 patients interim analysis, and that's part of the dose optimization phase of the study, looking at two alternative doses of alemtuzumab, which is required by CDER. Yes, it's going well, Amin, and we're on track for a Q4 data sharing. Yeah. yeah Thanks, Amin. thanks amin I can take that. i can take that Currently we're doing very well. currently we're doing very well We're engaging many sites. we're engaging many sites The site opening is on track. the site opening is on track We're certainly on track to complete our data analysis by the end of the year. we're certainly on track to complete our data analysis by the end of the year That's just for the other people on the call. that's just for the other people on the call That's the first 40 patients interim analysis, and that's part of the dose optimization phase of the study, looking at two alternative doses of alemtuzumab, which is required by CDER. that's the first 40 patients interim analysis and that's part of the dose optimization phase of the study looking at two alternative doses of alemtuzumab which is required by cder Yes, it's going well, Amin, and we're on track for a Q4 data sharing. yes it's going well amin and we're on track for a q4 data sharing

Speaker 2: Thanks. For this dose optimization portion, as you evaluate the two alemtuzumab dose levels, what are the expectations there? What differences should we expect between the two arms in terms of efficacy signal, or are you expecting a meaningful difference in the safety, or you think the two arms are gonna be generally in the same ballpark? Thanks. thanks For this dose optimization portion, as you evaluate the two alemtuzumab dose levels, what are the expectations there? for this dose optimization portion as you evaluate the two alemtuzumab dose levels what are the expectations there What differences should we expect between the two arms in terms of efficacy signal, or are you expecting a meaningful difference in the safety, or you think the two arms are gonna be generally in the same ballpark? what differences should we expect between the two arms in terms of efficacy signal or are you expecting a meaningful difference in the safety or you think the two arms are gonna be generally in the same ballpark

Speaker 1: We don't. It's very difficult to say, and I, you know, almost require a crystal ball to decide will there be a big difference in terms of both. We anticipate, however, that we have designed a very strong analysis plan to allow us to differentiate between the two components. That will be based on efficacy, safety, but also significantly important translational markers in terms of our CAR-T expansion, host T cell reconstitution, et cetera. We do believe, excuse me, that we will be able to define an optimized dose by the end of the year. We don't think that will be a significant challenge. However, we know that both of these doses of alemtuzumab, very importantly, they work. It's all about dose optimization now. It's not about finding an effective dose. We don't. we don't It's very difficult to say, and I, you know, almost require a crystal ball to decide will there be a big difference in terms of both. it's very difficult to say and i you know almost require a crystal ball to decide will there be a big difference in terms of both We anticipate, however, that we have designed a very strong analysis plan to allow us to differentiate between the two components. we anticipate however that we have designed a very strong analysis plan to allow us to differentiate between the two components That will be based on efficacy, safety, but also significantly important translational markers in terms of our CAR-T expansion, host T cell reconstitution, et cetera. that will be based on efficacy safety but also significantly important translational markers in terms of our car-t expansion host t cell reconstitution et cetera We do believe, excuse me, that we will be able to define an optimized dose by the end of the year. we do believe excuse me that we will be able to define an optimized dose by the end of the year We don't think that will be a significant challenge. we don't think that will be a significant challenge However, we know that both of these doses of alemtuzumab, very importantly, they work. however we know that both of these doses of alemtuzumab very importantly they work It's all about dose optimization now. it's all about dose optimization now It's not about finding an effective dose. it's not about finding an effective dose

Speaker 2: Okay. Helpful. Thanks. Okay. okay Helpful. helpful Thanks. thanks

Speaker 6: Thank you. Our next question will come from Salveen Richter with Goldman Sachs. Please go ahead. Thank you. thank you Our next question will come from Salveen Richter with Goldman Sachs. our next question will come from salveen richter with goldman sachs Please go ahead. please go ahead

Speaker 7: Taking my questions. Two questions from us. One is, could you provide more details on the Servier arbitration, given the ruling that you have to engage in discussions with Allo regarding the direct licensing of 501, and help us understand how this impacts your eligibility for the EUR 340 million in milestones into this interim data? Then secondly, could you talk about your decision to include CD52 preconditioning in both the studies in the context of safety, as we see some of the competitors moving away from CD52? Thank you. Taking my questions. taking my questions Two questions from us. two questions from us One is, could you provide more details on the Servier arbitration, given the ruling that you have to engage in discussions with Allo regarding the direct licensing of 501, and help us understand how this impacts your eligibility for the EUR 340 million in milestones into this interim data? one is could you provide more details on the servier arbitration given the ruling that you have to engage in discussions with allo regarding the direct licensing of 501 and help us understand how this impacts your eligibility for the eur 340 million in milestones into this interim data Then secondly, could you talk about your decision to include CD52 preconditioning in both the studies in the context of safety, as we see some of the competitors moving away from CD52? then secondly could you talk about your decision to include cd52 preconditioning in both the studies in the context of safety as we see some of the competitors moving away from cd52 Thank you. thank you

Speaker 4: Hi, Salveen. This is Arthur. Thanks for the question. I'll take the question on the arbitration and then hand it over to Adrian for the clinical question. As a reminder, the arbitral decision of December 2025 ruled on a partial termination of the license agreement with respect to one product, which is UCART19 v1, also named ALLO-501 by Allogene. This product has been brought back to Cellectis, and we are free to develop it or moving forward. The tribunal did not affect ALLO-501A or Cema-cel, so we remain fully eligible for up to EUR 340 million in development and sales milestones. Hi, Salveen. hi salveen This is Arthur. this is arthur Thanks for the question. thanks for the question I'll take the question on the arbitration and then hand it over to Adrian for the clinical question. i'll take the question on the arbitration and then hand it over to adrian for the clinical question As a reminder, the arbitral decision of December 2025 ruled on a partial termination of the license agreement with respect to one product, which is UCART19 v1, also named ALLO-501 by Allogene. as a reminder the arbitral decision of december 2025 ruled on a partial termination of the license agreement with respect to one product which is ucart19 v1 also named allo-501 by allogene This product has been brought back to Cellectis, and we are free to develop it or moving forward. this product has been brought back to cellectis and we are free to develop it or moving forward The tribunal did not affect ALLO-501A or Cema-cel, so we remain fully eligible for up to EUR 340 million in development and sales milestones. the tribunal did not affect allo-501a or cema-cel so we remain fully eligible for up to eur 340 million in development and sales milestones That is obviously under the Servier agreement, which has been then sub-licensed to Allogene. This does not impact any eligibility to upcoming developments, and sales milestone as well as royalties down the line, on Cema-cel, but it gave us back UCART19 v1 or ALLO-501, and we're free to do whatever we would like to do with it. I will hand it over to Adrian for the clinical question. That is obviously under the Servier agreement, which has been then sub-licensed to Allogene. that is obviously under the servier agreement which has been then sub-licensed to allogene This does not impact any eligibility to upcoming developments, and sales milestone as well as royalties down the line, on Cema-cel, but it gave us back UCART19 v1 or ALLO-501, and we're free to do whatever we would like to do with it. this does not impact any eligibility to upcoming developments and sales milestone as well as royalties down the line on cema-cel but it gave us back ucart19 v1 or allo-501 and we're free to do whatever we would like to do with it I will hand it over to Adrian for the clinical question. i will hand it over to adrian for the clinical question

Speaker 3: One thing I'd like to add, like, during our thinking is that once the pivotal trial is effective, then the milestone should be triggered. Like, we're definitely expecting to have this $20 million milestone paid one day. One thing I'd like to add, like, during our thinking is that once the pivotal trial is effective, then the milestone should be triggered. one thing i'd like to add like during our thinking is that once the pivotal trial is effective then the milestone should be triggered Like, we're definitely expecting to have this $20 million milestone paid one day. like we're definitely expecting to have this $20 million milestone paid one day

Speaker 1: Okay. I'll answer the alemtuzumab question. It's a great question. There's a few things. Just a few observations from our studies. One is that alemtuzumab is really important to optimize lymphodepletion. As I said earlier, the more optimal the lymphodepletion, the better the outcomes in terms of responses. You get a much deeper response. As part of our phase I program, we did test a lymphodepletion regimen without alemtuzumab, and we failed to get any MRD-negative responses. So we know that alemtuzumab is very effective. The second part is you were saying some people are moving away from it. Now, we believe, as I've said already, alemtuzumab is important, but we also believe that it's critically important that you get the right dose. It's like everything, too much is always too much. Okay. okay I'll answer the alemtuzumab question. i'll answer the alemtuzumab question It's a great question. it's a great question There's a few things. there's a few things Just a few observations from our studies. just a few observations from our studies One is that alemtuzumab is really important to optimize lymphodepletion. one is that alemtuzumab is really important to optimize lymphodepletion As I said earlier, the more optimal the lymphodepletion, the better the outcomes in terms of responses. as i said earlier the more optimal the lymphodepletion the better the outcomes in terms of responses You get a much deeper response. you get a much deeper response As part of our phase I program, we did test a lymphodepletion regimen without alemtuzumab, and we failed to get any MRD-negative responses. as part of our phase i program we did test a lymphodepletion regimen without alemtuzumab and we failed to get any mrd-negative responses So we know that alemtuzumab is very effective. so we know that alemtuzumab is very effective The second part is you were saying some people are moving away from it. the second part is you were saying some people are moving away from it Now, we believe, as I've said already, alemtuzumab is important, but we also believe that it's critically important that you get the right dose. now we believe as i've said already alemtuzumab is important but we also believe that it's critically important that you get the right dose It's like everything, too much is always too much. it's like everything too much is always too much We have, compared to other companies that are using alemtuzumab or alemtuzumab similars, we're using a much lower dose. We spent a lot of time in already optimizing our doses. We believe we've got the right balance between optimal efficacy, mitigating the risks that may be associated with that more enhanced lymphodepletion regimen. Also, let's not forget that alemtuzumab has been widely used in other clinical contexts, so it's got a very well-characterized safety profile, and we've been able to build into all our protocols very extensive risk mitigation. We believe we've got the right strategy with our alemtuzumab. I cannot answer why others may have transitioned away from it. We have, compared to other companies that are using alemtuzumab or alemtuzumab similars, we're using a much lower dose. we have compared to other companies that are using alemtuzumab or alemtuzumab similars we're using a much lower dose We spent a lot of time in already optimizing our doses. we spent a lot of time in already optimizing our doses We believe we've got the right balance between optimal efficacy, mitigating the risks that may be associated with that more enhanced lymphodepletion regimen. we believe we've got the right balance between optimal efficacy mitigating the risks that may be associated with that more enhanced lymphodepletion regimen Also, let's not forget that alemtuzumab has been widely used in other clinical contexts, so it's got a very well-characterized safety profile, and we've been able to build into all our protocols very extensive risk mitigation. also let's not forget that alemtuzumab has been widely used in other clinical contexts so it's got a very well-characterized safety profile and we've been able to build into all our protocols very extensive risk mitigation We believe we've got the right strategy with our alemtuzumab. we believe we've got the right strategy with our alemtuzumab I cannot answer why others may have transitioned away from it. i cannot answer why others may have transitioned away from it

Speaker 6: Thank you. Our next question will come from Jack Allen with Baird. Thank you. thank you Our next question will come from Jack Allen with Baird. our next question will come from jack allen with baird

Speaker 5: Great. Thanks for taking the questions, and congrats to the team on all the progress. I guess the first one I wanted to ask was on Eti-cel, and how we should think about the update in the fourth quarter this year. Any additional color you're willing to provide as it relates to the breadth of update and number of patients and the durability of follow-up there would be great. I have a quick follow-up as well. Great. great Thanks for taking the questions, and congrats to the team on all the progress. thanks for taking the questions and congrats to the team on all the progress I guess the first one I wanted to ask was on Eti-cel, and how we should think about the update in the fourth quarter this year. i guess the first one i wanted to ask was on eti-cel and how we should think about the update in the fourth quarter this year Any additional color you're willing to provide as it relates to the breadth of update and number of patients and the durability of follow-up there would be great. any additional color you're willing to provide as it relates to the breadth of update and number of patients and the durability of follow-up there would be great I have a quick follow-up as well. i have a quick follow-up as well

Speaker 1: I can give you a top-line update on top of the data we already have. As we've shared already, at our current dose level, we're seeing 63% complete remission rates, 88% overall response rates. By the end of the year, you will see data in cohorts with and without IL-2. Now, we would acknowledge that 63% complete remission rate is actually a very strong result, and theoretically, we do not need to enhance that further, but we want to. We believe we can with the addition of low-dose IL-2. By the end of the year, you will see, you know, we're currently expanded at our recruiting sites rather significantly. We've doubled them. We anticipate we will be able to get a reasonable. I can give you a top-line update on top of the data we already have. i can give you a top-line update on top of the data we already have As we've shared already, at our current dose level, we're seeing 63% complete remission rates, 88% overall response rates. as we've shared already at our current dose level we're seeing 63% complete remission rates 88% overall response rates By the end of the year, you will see data in cohorts with and without IL-2. by the end of the year you will see data in cohorts with and without il-2 Now, we would acknowledge that 63% complete remission rate is actually a very strong result, and theoretically, we do not need to enhance that further, but we want to. now we would acknowledge that 63% complete remission rate is actually a very strong result and theoretically we do not need to enhance that further but we want to We believe we can with the addition of low-dose IL-2. we believe we can with the addition of low-dose il-2 By the end of the year, you will see, you know, we're currently expanded at our recruiting sites rather significantly. by the end of the year you will see you know we're currently expanded at our recruiting sites rather significantly We've doubled them. we've doubled them We anticipate we will be able to get a reasonable. we anticipate we will be able to get a reasonable I cannot give you a number because I don't know what the recruitment rates are going to be. We will be towards the latter part of the year also not in the staggering phase, so we would anticipate a significant increase in recruitment. You will see some durability data, is what you asked about. For the patients in the later phase, there will hopefully be good durability signals. We have in our mind the durability levels we want to achieve, and it's around the six-month mark. Hopefully by the end of the year you'll be able to see a very clear picture. I think the efficacy question's already been answered. The question is can we enhance it even further into the seventies rather than in the mid-sixties. I cannot give you a number because I don't know what the recruitment rates are going to be. i cannot give you a number because i don't know what the recruitment rates are going to be We will be towards the latter part of the year also not in the staggering phase, so we would anticipate a significant increase in recruitment. we will be towards the latter part of the year also not in the staggering phase so we would anticipate a significant increase in recruitment You will see some durability data, is what you asked about. you will see some durability data is what you asked about For the patients in the later phase, there will hopefully be good durability signals. for the patients in the later phase there will hopefully be good durability signals We have in our mind the durability levels we want to achieve, and it's around the six-month mark. we have in our mind the durability levels we want to achieve and it's around the six-month mark Hopefully by the end of the year you'll be able to see a very clear picture. hopefully by the end of the year you'll be able to see a very clear picture I think the efficacy question's already been answered. i think the efficacy question's already been answered The question is can we enhance it even further into the seventies rather than in the mid-sixties. the question is can we enhance it even further into the seventies rather than in the mid-sixties Also it'll give us a very good signal. Is IL-2 really a potential game changer for allogeneic therapy? We obviously, based on our preclinical data, which is going to be presented at AACR and again some at EHA, that we believe it could offer a really a fundamental improvement for allogeneic cell therapies. Also it'll give us a very good signal. also it'll give us a very good signal Is IL-2 really a potential game changer for allogeneic therapy? is il-2 really a potential game changer for allogeneic therapy We obviously, based on our preclinical data, which is going to be presented at AACR and again some at EHA, that we believe it could offer a really a fundamental improvement for allogeneic cell therapies. we obviously based on our preclinical data which is going to be presented at aacr and again some at eha that we believe it could offer a really a fundamental improvement for allogeneic cell therapies

Speaker 5: Great. Thanks for all that color. Then, we might be getting ahead of ourselves a little bit here, but on Lasme-cel and the commercial opportunity, I was wondering if you've been looking at Obe-cel from Autolus and if you have any thoughts around the initial commercial launch of that CD19 allo therapy in ALL. Great. great Thanks for all that color. thanks for all that color Then, we might be getting ahead of ourselves a little bit here, but on Lasme-cel and the commercial opportunity, I was wondering if you've been looking at Obe-cel from Autolus and if you have any thoughts around the initial commercial launch of that CD19 allo therapy in ALL. then we might be getting ahead of ourselves a little bit here but on lasme-cel and the commercial opportunity i was wondering if you've been looking at obe-cel from autolus and if you have any thoughts around the initial commercial launch of that cd19 allo therapy in all

Speaker 1: I can give it from a medical perspective, and Arthur, maybe you want to talk a bit more broadly on the commercial opportunity. Let's not forget our patients are generally post CD19 failures, so we are not seeing this as a competition. We have a very differentiated target, CD22. We believe the market is pretty saturated with CD19s. It's not to say Obe-cel isn't a very good product. It is. Their data is very strong. These patients are very difficult to treat. Many of them will relapse, and they need to have an alternative target. We believe that this is not a competing product, but actually a very differentiated one. In terms of the market size, you may be aware we're starting to look at earlier lines of therapy. I can give it from a medical perspective, and Arthur, maybe you want to talk a bit more broadly on the commercial opportunity. i can give it from a medical perspective and arthur maybe you want to talk a bit more broadly on the commercial opportunity Let's not forget our patients are generally post CD19 failures, so we are not seeing this as a competition. let's not forget our patients are generally post cd19 failures so we are not seeing this as a competition We have a very differentiated target, CD22. we have a very differentiated target cd22 We believe the market is pretty saturated with CD19s. we believe the market is pretty saturated with cd19s It's not to say Obe-cel isn't a very good product. it's not to say obe-cel isn't a very good product It is. it is Their data is very strong. their data is very strong These patients are very difficult to treat. these patients are very difficult to treat Many of them will relapse, and they need to have an alternative target. many of them will relapse and they need to have an alternative target We believe that this is not a competing product, but actually a very differentiated one. we believe that this is not a competing product but actually a very differentiated one In terms of the market size, you may be aware we're starting to look at earlier lines of therapy. in terms of the market size you may be aware we're starting to look at earlier lines of therapy We will have data starting to be generated next year on that frontline consolidation, very much aligned with what Allogene has done, which we think is a fantastic idea in the non-Hodgkin lymphoma space. We will be looking at that in the ALL space, so we believe that's a really important part for those incredibly difficult to treat patients frontline. We will have data starting to be generated next year on that frontline consolidation, very much aligned with what Allogene has done, which we think is a fantastic idea in the non-Hodgkin lymphoma space. we will have data starting to be generated next year on that frontline consolidation very much aligned with what allogene has done which we think is a fantastic idea in the non-hodgkin lymphoma space We will be looking at that in the ALL space, so we believe that's a really important part for those incredibly difficult to treat patients frontline. we will be looking at that in the all space so we believe that's a really important part for those incredibly difficult to treat patients frontline

Speaker 4: I can add, I think from a commercial launch perspective, you absolutely cannot compare an autologous launch to an allogeneic launch. I think the two primary differences is, one, you need to have leukapheresis access for the patients, and this is slow, this is very competitive, and this is controlled by hospitals, not by the pharma companies. Whereas obviously with off-the-shelf, we will have had manufactured a huge number of doses in advance so that at the time of launch, we can address all our clinical centers immediately without having to set up these cumbersome logistics aspect. I can add, I think from a commercial launch perspective, you absolutely cannot compare an autologous launch to an allogeneic launch. i can add i think from a commercial launch perspective you absolutely cannot compare an autologous launch to an allogeneic launch I think the two primary differences is, one, you need to have leukapheresis access for the patients, and this is slow, this is very competitive, and this is controlled by hospitals, not by the pharma companies. Whereas obviously with off-the-shelf, we will have had manufactured a huge number of doses in advance so that at the time of launch, we can address all our clinical centers immediately without having to set up these cumbersome logistics aspect. i think the two primary differences is one you need to have leukapheresis access for the patients and this is slow this is very competitive and this is controlled by hospitals not by the pharma companies. whereas obviously with off-the-shelf we will have had manufactured a huge number of doses in advance so that at the time of launch we can address all our clinical centers immediately without having to set up these cumbersome logistics aspect The second thing, obviously, is because of our off-the-shelf nature, we have very significant economies of scale, and we see it even at the pivotal stage, which will allow us to get extremely competitive gross margins, which was much more the types of what pharma is now used to with small molecules and antibodies. Whereas, pricing of autologous has been difficult, because of the significant cost of goods that make a very important impact on the margin. I think the fact that we're off the shelf will allow us for a much smoother launch in terms of pure access due to the off-the-shelf nature, and also in a much more economically competitive aspect, due to the economies of scale and the very favorable gross margins. The second thing, obviously, is because of our off-the-shelf nature, we have very significant economies of scale, and we see it even at the pivotal stage, which will allow us to get extremely competitive gross margins, which was much more the types of what pharma is now used to with small molecules and antibodies. the second thing obviously is because of our off-the-shelf nature we have very significant economies of scale and we see it even at the pivotal stage which will allow us to get extremely competitive gross margins which was much more the types of what pharma is now used to with small molecules and antibodies Whereas, pricing of autologous has been difficult, because of the significant cost of goods that make a very important impact on the margin. whereas pricing of autologous has been difficult because of the significant cost of goods that make a very important impact on the margin I think the fact that we're off the shelf will allow us for a much smoother launch in terms of pure access due to the off-the-shelf nature, and also in a much more economically competitive aspect, due to the economies of scale and the very favorable gross margins. i think the fact that we're off the shelf will allow us for a much smoother launch in terms of pure access due to the off-the-shelf nature and also in a much more economically competitive aspect due to the economies of scale and the very favorable gross margins I don't think Obe-cel will be a very good competitor there. I don't think Obe-cel will be a very good competitor there. i don't think obe-cel will be a very good competitor there

Speaker 5: Great. Great. great

Speaker 3: One thing I'd like to add, Jack, like one thing that was interesting, I was like recently visiting a clinical center we're working with for acute lymphoblastic leukemia with Adrian. There was one ALL patient that was sitting in the backlog waiting for an available apheresis slot for a long time, along with, you know, non-Hodgkin lymphoma, DLBCL patient, multiple myeloma patient, autoimmune patient, etc. This patient, like ALL, is very aggressive disease. Still this patient, I'm not going to say which type of product was about to be given to him because I don't know. The fact is that this patient was, like, in real distress waiting for this, like, apheresis spot. This is what you would consider as an autologous launch of yet another CD19 CAR-T, autologous CAR-T. One thing I'd like to add, Jack, like one thing that was interesting, I was like recently visiting a clinical center we're working with for acute lymphoblastic leukemia with Adrian. one thing i'd like to add jack like one thing that was interesting i was like recently visiting a clinical center we're working with for acute lymphoblastic leukemia with adrian There was one ALL patient that was sitting in the backlog waiting for an available apheresis slot for a long time, along with, you know, non-Hodgkin lymphoma, DLBCL patient, multiple myeloma patient, autoimmune patient, etc. This patient, like ALL, is very aggressive disease. there was one all patient that was sitting in the backlog waiting for an available apheresis slot for a long time along with you know non-hodgkin lymphoma dlbcl patient multiple myeloma patient autoimmune patient etc this patient like all is very aggressive disease Still this patient, I'm not going to say which type of product was about to be given to him because I don't know. still this patient i'm not going to say which type of product was about to be given to him because i don't know The fact is that this patient was, like, in real distress waiting for this, like, apheresis spot. the fact is that this patient was like in real distress waiting for this like apheresis spot This is what you would consider as an autologous launch of yet another CD19 CAR-T, autologous CAR-T. this is what you would consider as an autologous launch of yet another cd19 car-t autologous car-t

Speaker 5: Got it. Thanks so much. That's very helpful, André Choulika. Got it. got it Thanks so much. thanks so much That's very helpful, André Choulika. that's very helpful andré choulika

Speaker 6: Thank you. Our next question will come from Silvan Tuerkcan with Citizens. Please go ahead. Thank you. thank you Our next question will come from Silvan Tuerkcan with Citizens. our next question will come from silvan tuerkcan with citizens Please go ahead. please go ahead

Speaker 9: Yeah, good morning, and thank you for taking my questions. I just wanted to ask if you could just give us a brief recap of what you're expecting at EHA from these two programs that you have ongoing. Is it mainly longer follow-up? Thank you so much. Yeah, good morning, and thank you for taking my questions. yeah good morning and thank you for taking my questions I just wanted to ask if you could just give us a brief recap of what you're expecting at EHA from these two programs that you have ongoing. i just wanted to ask if you could just give us a brief recap of what you're expecting at eha from these two programs that you have ongoing Is it mainly longer follow-up? is it mainly longer follow-up Thank you so much. thank you so much

Speaker 1: You will be aware that we shared our data at our R&D day back in October. We after that actually added some more patients in because we wanted to do some level of dose optimization in advance of our phase II program. We wanted to ensure that lower dose is an acceptable dose to give to patients. There was going to be an updated dataset, the whole dataset, including those additional patients. It is. I would consider it a level of progression from the original phase I package that we presented. The data are not remarkably different, let me tell you, but it's an important addition to the data. You will be aware that we shared our data at our R&D day back in October. you will be aware that we shared our data at our r&d day back in october We after that actually added some more patients in because we wanted to do some level of dose optimization in advance of our phase II program. we after that actually added some more patients in because we wanted to do some level of dose optimization in advance of our phase ii program We wanted to ensure that lower dose is an acceptable dose to give to patients. we wanted to ensure that lower dose is an acceptable dose to give to patients There was going to be an updated dataset, the whole dataset, including those additional patients. there was going to be an updated dataset the whole dataset including those additional patients It is. it is I would consider it a level of progression from the original phase I package that we presented. i would consider it a level of progression from the original phase i package that we presented The data are not remarkably different, let me tell you, but it's an important addition to the data. the data are not remarkably different let me tell you but it's an important addition to the data The second thing that we hope, we're assuming that it will be accepted, is really to try and understand what makes a product successful. Again, to build on the question from our Goldman Sachs colleagues, where they were talking about alemtuzumab, is the importance of that preconditioning and that day zero, not only from a level of lymphodepletion, but actually the environment in which you infuse your cells is critically important and in many ways predicts the outcome. The fact that we have now identified a really clear picture of optimal lymphodepletion, optimal environment in which you infuse your cells, we are now able to predict very early on are patients going to respond. All these data will be shared. I think we're excited by it so far. The second thing that we hope, we're assuming that it will be accepted, is really to try and understand what makes a product successful. the second thing that we hope we're assuming that it will be accepted is really to try and understand what makes a product successful Again, to build on the question from our Goldman Sachs colleagues, where they were talking about alemtuzumab, is the importance of that preconditioning and that day zero, not only from a level of lymphodepletion, but actually the environment in which you infuse your cells is critically important and in many ways predicts the outcome. again to build on the question from our goldman sachs colleagues where they were talking about alemtuzumab is the importance of that preconditioning and that day zero not only from a level of lymphodepletion but actually the environment in which you infuse your cells is critically important and in many ways predicts the outcome The fact that we have now identified a really clear picture of optimal lymphodepletion, optimal environment in which you infuse your cells, we are now able to predict very early on are patients going to respond. the fact that we have now identified a really clear picture of optimal lymphodepletion optimal environment in which you infuse your cells we are now able to predict very early on are patients going to respond All these data will be shared. all these data will be shared I think we're excited by it so far. i think we're excited by it so far

Speaker 9: Thank you. Thank you. thank you

Speaker 6: Thank you. Our next question will come from Sebastiaan van der Schoot with VLK. Please go ahead. Thank you. thank you Our next question will come from Sebastiaan van der Schoot with VLK. our next question will come from sebastiaan van der schoot with vlk Please go ahead. please go ahead

Speaker 8: Hi, guys. Good morning, and thanks for taking our question. I wanted to ask you how you're looking at the possibility of applying your lymphodepletion procedure in the outpatient setting as well as the allogeneic CAR-T. Maybe can you provide some insight on how the partnership with AstraZeneca is going? Can we expect any updates in the next 24 months? Thank you. Hi, guys. hi guys Good morning, and thanks for taking our question. good morning and thanks for taking our question I wanted to ask you how you're looking at the possibility of applying your lymphodepletion procedure in the outpatient setting as well as the allogeneic CAR-T. i wanted to ask you how you're looking at the possibility of applying your lymphodepletion procedure in the outpatient setting as well as the allogeneic car-t Maybe can you provide some insight on how the partnership with AstraZeneca is going? maybe can you provide some insight on how the partnership with astrazeneca is going Can we expect any updates in the next 24 months? can we expect any updates in the next 24 months Thank you. thank you

Speaker 1: I can take the first part of that, Arthur, in terms of outpatient setting. Right now, the regulatory authorities require inpatient delivery of product. I think that's consistent with most autologous therapies as well in the CAR-T space. Once there becomes some clinical confidence in how to use, will that transition into the outpatient setting? I think that may be a natural transition, but for that you need a body of evidence. I can take the first part of that, Arthur, in terms of outpatient setting. i can take the first part of that arthur in terms of outpatient setting Right now, the regulatory authorities require inpatient delivery of product. right now the regulatory authorities require inpatient delivery of product I think that's consistent with most autologous therapies as well in the CAR-T space. i think that's consistent with most autologous therapies as well in the car-t space Once there becomes some clinical confidence in how to use, will that transition into the outpatient setting? once there becomes some clinical confidence in how to use will that transition into the outpatient setting I think that may be a natural transition, but for that you need a body of evidence. i think that may be a natural transition but for that you need a body of evidence Hopefully that will be provided not only by the phase II program but also by clinical usage from that. Again, I think it's a very different offering in that, to Arthur's point, we do not need that leukapheresis, etc. I do think it'll take some time for this to be in the outpatient setting you know, assuming that we continue to have a fairly reassuring safety profile, there's no real reason why this cannot in time transition to the outpatient setting. Hopefully that will be provided not only by the phase II program but also by clinical usage from that. hopefully that will be provided not only by the phase ii program but also by clinical usage from that Again, I think it's a very different offering in that, to Arthur's point, we do not need that leukapheresis, etc. I do think it'll take some time for this to be in the outpatient setting you know, assuming that we continue to have a fairly reassuring safety profile, there's no real reason why this cannot in time transition to the outpatient setting. again i think it's a very different offering in that to arthur's point we do not need that leukapheresis etc i do think it'll take some time for this to be in the outpatient setting you know assuming that we continue to have a fairly reassuring safety profile there's no real reason why this cannot in time transition to the outpatient setting

Speaker 4: I will take the question on AstraZeneca. So first of all, we're extremely pleased to count AstraZeneca as a strategic partner. As you have seen, they have continued to invest very heavily in the cell and gene therapy space, and they're one of the few companies that are betting very hard, not only on cell and gene therapy, but also on off-the-shelf treatments. I think we're very fortunate to have them as a key shareholder, but also a strategic R&D partner. The activities are going very well under the collaboration. There's a number of activities ongoing across a range of therapeutic areas. Do not expect updates in the short term. This is at the request of AstraZeneca. I will take the question on AstraZeneca. i will take the question on astrazeneca So first of all, we're extremely pleased to count AstraZeneca as a strategic partner. so first of all we're extremely pleased to count astrazeneca as a strategic partner As you have seen, they have continued to invest very heavily in the cell and gene therapy space, and they're one of the few companies that are betting very hard, not only on cell and gene therapy, but also on off-the-shelf treatments. as you have seen they have continued to invest very heavily in the cell and gene therapy space and they're one of the few companies that are betting very hard not only on cell and gene therapy but also on off-the-shelf treatments I think we're very fortunate to have them as a key shareholder, but also a strategic R&D partner. i think we're very fortunate to have them as a key shareholder but also a strategic r&d partner The activities are going very well under the collaboration. the activities are going very well under the collaboration There's a number of activities ongoing across a range of therapeutic areas. there's a number of activities ongoing across a range of therapeutic areas Do not expect updates in the short term. do not expect updates in the short term This is at the request of AstraZeneca. this is at the request of astrazeneca They are essentially asking us for now to stay reasonably quiet, especially given the competitive nature of certain aspects that we are working on. Definitely, as we continue the dialogue with them around disclosure as and when the time is right, we will be providing update, and I think you will be interested in seeing what has been brewing with them. They are essentially asking us for now to stay reasonably quiet, especially given the competitive nature of certain aspects that we are working on. they are essentially asking us for now to stay reasonably quiet especially given the competitive nature of certain aspects that we are working on Definitely, as we continue the dialogue with them around disclosure as and when the time is right, we will be providing update, and I think you will be interested in seeing what has been brewing with them. definitely as we continue the dialogue with them around disclosure as and when the time is right we will be providing update and i think you will be interested in seeing what has been brewing with them

Speaker 8: Great. Thank you, guys. Great. great Thank you, guys. thank you guys

Speaker 6: Thank you. Once again, to ask a question, press star one on your telephone keypad. Our next question will come from Yanan Zhu with Wells Fargo. Thank you. thank you Once again, to ask a question, press star one on your telephone keypad. once again to ask a question press star one on your telephone keypad Our next question will come from Yanan Zhu with Wells Fargo. our next question will come from yanan zhu with wells fargo

Speaker 10: Oh, great. Thanks for taking our questions. So first, regarding the Lasme-cel pivotal study. Was wondering for the Q4 readout, is the focus there, the three-month CR/CRi from the two arms in that first 40-patient cohort? And then how do you manage the transition from completing that cohort to the start of the enrollment of the 80-patient portion for the optimal alemtuzumab dose, i.e., the final pivotal cohort? Will you be able to start enrolling before you have the data for the comparison of the two alemtuzumab cohorts? I have a follow-up. Thanks. Oh, great. oh great Thanks for taking our questions. thanks for taking our questions So first, regarding the Lasme-cel pivotal study. so first regarding the lasme-cel pivotal study Was wondering for the Q4 readout, is the focus there, the three-month CR/CRi from the two arms in that first 40-patient cohort? was wondering for the q4 readout is the focus there the three-month cr/cri from the two arms in that first 40-patient cohort And then how do you manage the transition from completing that cohort to the start of the enrollment of the 80-patient portion for the optimal alemtuzumab dose, i.e., the final pivotal cohort? and then how do you manage the transition from completing that cohort to the start of the enrollment of the 80-patient portion for the optimal alemtuzumab dose i.e the final pivotal cohort Will you be able to start enrolling before you have the data for the comparison of the two alemtuzumab cohorts? will you be able to start enrolling before you have the data for the comparison of the two alemtuzumab cohorts I have a follow-up. i have a follow-up Thanks. thanks

Speaker 1: Great. This is some great questions there. First and foremost, no. The decision for dose optimization is not based on the three-month CR/CRI. It's actually based at an earlier time cutoff of eight weeks. That's important. We will still be looking at efficacy, safety, but all the important translational markers predictive of not only short-term, but long-term outcomes, we have those answers by that first eight weeks. It's a composite of many of those that we will be presenting. In terms of that transition from that to the longer phase of the study, we have built a lot of flexibility into the protocol to allow us to continue recruiting. Importantly, this does not mean our study has to stop while we're engaging with the regulatory authorities. Great. great This is some great questions there. this is some great questions there First and foremost, no. first and foremost no The decision for dose optimization is not based on the three-month CR/CRI. the decision for dose optimization is not based on the three-month cr/cri It's actually based at an earlier time cutoff of eight weeks. it's actually based at an earlier time cutoff of eight weeks That's important. that's important We will still be looking at efficacy, safety, but all the important translational markers predictive of not only short-term, but long-term outcomes, we have those answers by that first eight weeks. we will still be looking at efficacy safety but all the important translational markers predictive of not only short-term but long-term outcomes we have those answers by that first eight weeks It's a composite of many of those that we will be presenting. it's a composite of many of those that we will be presenting In terms of that transition from that to the longer phase of the study, we have built a lot of flexibility into the protocol to allow us to continue recruiting. in terms of that transition from that to the longer phase of the study we have built a lot of flexibility into the protocol to allow us to continue recruiting Importantly, this does not mean our study has to stop while we're engaging with the regulatory authorities. importantly this does not mean our study has to stop while we're engaging with the regulatory authorities The recruitment will continue for the remaining aging patients. The recruitment will continue for the remaining aging patients. the recruitment will continue for the remaining aging patients

Speaker 10: Great. Thanks for those very, very helpful color. The follow-up is mainly on the competitive landscape in terms of additional modalities, in vivo CAR-T, specifically. Can you talk about the advantages or limitations for that modality or whether you have any interest in moving in that direction, at earliest stage efforts? Thanks. Great. great Thanks for those very, very helpful color. thanks for those very very helpful color The follow-up is mainly on the competitive landscape in terms of additional modalities, in vivo CAR- T, specifically. the follow-up is mainly on the competitive landscape in terms of additional modalities in vivo car- t specifically Can you talk about the advantages or limitations for that modality or whether you have any interest in moving in that direction, at earliest stage efforts? can you talk about the advantages or limitations for that modality or whether you have any interest in moving in that direction at earliest stage efforts Thanks. thanks

Speaker 1: I can have an initial thoughts on this. I think I know that André and Arthur also have views on the positioning of vivo CAR. You know, we're looking at incredibly sick patients with incredibly aggressive disease that need a lot of therapy. We don't believe these very difficult to treat tumors will be the destination for vivo CAR. We think in vivo CAR-T certainly have a place, but will it be the right therapy for incredibly difficult to treat tumors and incredibly difficult to manage patients? We don't believe so. Yes, there will be in vivo CAR-T in some, maybe autoimmune may be a better destination. Any therapy that requires extensive gene editing and extensive patient management will probably, maybe it will be a bridge too far for in vivo CAR. I can have an initial thoughts on this. i can have an initial thoughts on this I think I know that André and Arthur also have views on the positioning of vivo CAR. i think i know that andré and arthur also have views on the positioning of vivo car You know, we're looking at incredibly sick patients with incredibly aggressive disease that need a lot of therapy. you know we're looking at incredibly sick patients with incredibly aggressive disease that need a lot of therapy We don't believe these very difficult to treat tumors will be the destination for vivo CAR. we don't believe these very difficult to treat tumors will be the destination for vivo car We think in vivo CAR-T certainly have a place, but will it be the right therapy for incredibly difficult to treat tumors and incredibly difficult to manage patients? we think in vivo car-t certainly have a place but will it be the right therapy for incredibly difficult to treat tumors and incredibly difficult to manage patients We don't believe so. we don't believe so Yes, there will be in vivo CAR-T in some, maybe autoimmune may be a better destination. yes there will be in vivo car-t in some maybe autoimmune may be a better destination Any therapy that requires extensive gene editing and extensive patient management will probably, maybe it will be a bridge too far for in vivo CAR. any therapy that requires extensive gene editing and extensive patient management will probably maybe it will be a bridge too far for in vivo car I know, André, you have a view on this as well. I know, André, you have a view on this as well. i know andré you have a view on this as well

Speaker 3: I think their process, like in vivo CAR, is similar to autologous CAR-T. The only thing it allows is essentially try to, you know, leapfrog apheresis, which is a great thing. It's like it's a huge market access option that is given here. Nevertheless, it will still be totally linked in to the fitness of the cells of the patient or their presence. If it doesn't respond to blinatumomab, if you can't do an autologous, then you go for an in vivo. Well, if the cells are not really very well functional, it's not gonna work anymore because you need the T cells to be fit. That's one point. I think their process, like in vivo CAR, is similar to autologous CAR- T. i think their process like in vivo car is similar to autologous car- t The only thing it allows is essentially try to, you know, leapfrog apheresis, which is a great thing. the only thing it allows is essentially try to you know leapfrog apheresis which is a great thing It's like it's a huge market access option that is given here. it's like it's a huge market access option that is given here Nevertheless, it will still be totally linked in to the fitness of the cells of the patient or their presence. nevertheless it will still be totally linked in to the fitness of the cells of the patient or their presence If it doesn't respond to blinatumomab, if you can't do an autologous, then you go for an in vivo. if it doesn't respond to blinatumomab if you can't do an autologous then you go for an in vivo Well, if the cells are not really very well functional, it's not gonna work anymore because you need the T cells to be fit. well if the cells are not really very well functional it's not gonna work anymore because you need the t cells to be fit That's one point. that's one point The second point is, it will also be very much related to the current malignancies that are treated, which is essentially liquid tumors, B-cell malignancies, or multiple myeloma. The spread of this into solid tumor is going to be different. Finally, like, there's a lot of papers that are coming out, like a lot of cells are transduced by these vectors that are not T cells. Like, you need to restrict at the time. I think these technologies are going to come in the coming future, to try to restrict the cells to what needs to be transduced by the in vivo CAR-T and not to go and deliver. For example, I've seen a paper recently that shows more vector inside, for example, hepatic cells expressing CAR and then in T cells. The second point is, it will also be very much related to the current malignancies that are treated, which is essentially liquid tumors, B-cell malignancies, or multiple myeloma. the second point is it will also be very much related to the current malignancies that are treated which is essentially liquid tumors b-cell malignancies or multiple myeloma The spread of this into solid tumor is going to be different. the spread of this into solid tumor is going to be different Finally, like, there's a lot of papers that are coming out, like a lot of cells are transduced by these vectors that are not T cells. finally like there's a lot of papers that are coming out like a lot of cells are transduced by these vectors that are not t cells Like, you need to restrict at the time. like you need to restrict at the time I think these technologies are going to come in the coming future, to try to restrict the cells to what needs to be transduced by the in vivo CAR-T and not to go and deliver. i think these technologies are going to come in the coming future to try to restrict the cells to what needs to be transduced by the in vivo car-t and not to go and deliver For example, I've seen a paper recently that shows more vector inside, for example, hepatic cells expressing CAR and then in T cells. for example i've seen a paper recently that shows more vector inside for example hepatic cells expressing car and then in t cells If you do this worldwide, like really broadly, then big questions at a time. Like, the genome is only 6.4 billion base pairs, like 23, 2x chromosomes. If you inject trillions and trillions of vectors in hundreds of patients, like thousands of patients, it's like, I hope that this will be safely integrated. If you go, for example, with an autologous CAR-T, you can master exactly when the cells are transduced. If you go for an allogeneic CAR, you have all the QC that lasts a long period of time to ensure that everything is totally square. If you make the product in vivo, which is the case here, then you have to master how the product is made and not to have a lot of byproducts all around the place. That's like the initial concern. If you do this worldwide, like really broadly, then big questions at a time. if you do this worldwide like really broadly then big questions at a time Like, the genome is only 6.4 billion base pairs, like 23, 2 x chromosomes. like the genome is only 6.4 billion base pairs like 23 2 x chromosomes If you inject trillions and trillions of vectors in hundreds of patients, like thousands of patients, it's like, I hope that this will be safely integrated. if you inject trillions and trillions of vectors in hundreds of patients like thousands of patients it's like i hope that this will be safely integrated If you go, for example, with an autologous CAR- T, you can master exactly when the cells are transduced. if you go for example with an autologous car- t you can master exactly when the cells are transduced If you go for an allogeneic CAR, you have all the QC that lasts a long period of time to ensure that everything is totally square. if you go for an allogeneic car you have all the qc that lasts a long period of time to ensure that everything is totally square If you make the product in vivo, which is the case here, then you have to master how the product is made and not to have a lot of byproducts all around the place. if you make the product in vivo which is the case here then you have to master how the product is made and not to have a lot of byproducts all around the place That's like the initial concern. that's like the initial concern I'm sure that this will be solved in coming decades. I'm sure that this will be solved in coming decades. i'm sure that this will be solved in coming decades

Speaker 10: Great. Thanks for all the insights and congrats on the quarter. Great. great Thanks for all the insights and congrats on the quarter. thanks for all the insights and congrats on the quarter

Speaker 3: Thank you. Thank you. thank you

Speaker 6: Thank you. At this time, there are no further questions in the queue, so I'll turn the meeting back over to our speakers for any additional or closing remarks. Thank you. thank you At this time, there are no further questions in the queue, so I'll turn the meeting back over to our speakers for any additional or closing remarks. at this time there are no further questions in the queue so i'll turn the meeting back over to our speakers for any additional or closing remarks

Speaker 4: Thank you very much, everyone. Really appreciate all the questions here. As you can see, this will be a very exciting year, 2026, with a number of updates from our partners and from ourselves. I think we are poised for a new dawn of allogeneic CAR-T-cell therapy. Stay tuned for more updates, and looking forward to further discussions as our progress unfolds this year. Thank you very much. Thank you very much, everyone. thank you very much everyone Really appreciate all the questions here. really appreciate all the questions here As you can see, this will be a very exciting year, 2026, with a number of updates from our partners and from ourselves. as you can see this will be a very exciting year 2026 with a number of updates from our partners and from ourselves I think we are poised for a new dawn of allogeneic CAR- T-cell therapy. i think we are poised for a new dawn of allogeneic car- t-cell therapy Stay tuned for more updates, and looking forward to further discussions as our progress unfolds this year. stay tuned for more updates and looking forward to further discussions as our progress unfolds this year Thank you very much. thank you very much

Speaker 6: Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect. Thank you. thank you This brings us to the end of today's meeting. this brings us to the end of today's meeting We appreciate your time and participation. we appreciate your time and participation You may now disconnect. you may now disconnect