CLLS

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.

Good day, everyone, and welcome to today's Cellectis' Second Quarter 2025 Earnings Call. [Operator Instructions] Please note this call may be recorded. And I will be standing by, if you should need any assistance. It is now my pleasure to turn the conference over to Arthur Stril, Interim Chief Financial Officer. Please go ahead.

Good morning. and welcome, everyone, to Cellectis' Second Quarter 2025 Business Update and Financial Results Conference Call. Joining me on the call today are Dr. Andre Choulika, our Chief Executive Officer; and Dr. Adrian Kilcoyne, our Chief Medical Officer. Yesterday evening, Cellectis issued a 6-K and press release reporting our financial statements for the 6 months period ended June 30, 2025, and a business update. The report and press release are available on our website at cellectis.com. As a reminder, we will make statements regarding Cellectis' financial outlook, including the presentation of our BALLI-01 and NatHaLi-01 clinical trials, the timing and ability to progress our clinical trial into a later phase, the progress of our R&D activities under the AstraZeneca partnership, the timing and outcome of our arbitration with Servier and sufficiency of cash to fund operations. 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 31, 2024, and subsequent filings Cellectis makes with the SEC from time to time. I would now like to turn the call over to Andre.

Thank you, Arthur. Good morning, and thank you, everyone, for joining us today. I would like to begin this call with an important announcement. On October 16, 2025, Cellectis will be hosting an Investors R&D Day in New York City. Our leadership team, along with key opinion leaders will present the Phase I data set and late-stage development strategy for lasme-cel, UCART22, in relapsed or refractory acute lymphoblastic leukemia, and will share insights on the Company's vision and differentiated capabilities. Cellectis' Investors R&D Day is scheduled as an in-person only event. However the recording of the event will be made available in the following days after the event. Despite the challenges of the biotech market, our teams have remained focused on advancing research and developing solutions for patients with unmet medical needs. In July 2025, Cellectis completed end of Phase I discussion with both the United States Food and Drug Administration and European Medicines Agency. We are excited to prepare for the initiation of the pivotal Phase II trial for lasme-cel, UCART22, in relapsed or refractory acute lymphoblastic leukemia in the second half of this year. Regarding the NatHaLi-01 study, which is assessing eti-cel program, UCART20x22, in relapsed or refractory non-Hodgkin lymphoma. Cellectis anticipates presenting data from Phase I and outlining its late-stage development strategy late 2025. On the partnership front, Research and development activities are ongoing under the three cell and gene therapy programs under our Joint Research and Collaboration Agreement with AstraZeneca: one allogeneic CAR-T for hematological malignancies, one allogeneic CAR-T for solid tumors, and one in vivo gene therapy for a genetic disorder. Regarding our licensing agreement involving Servier and sublicensee, Allogene, and following Servier's decision in September 2022 to seize the development of the licensed CD19 Products. We've initiated an arbitration before the Paris Mediation and Arbitration Center to protect our interests. We're asking the tribunal to terminate the agreement with Servier and to award fair compensation for the losses incurred due to the lack of development of the licensed products and the payment of the milestone which we consider due under the agreement. The arbitral decision is expected to be rendered on December 15, 2025 or before. Earlier this quarter, Cellectis announced that during its Annual Shareholders Meeting, Mr. André Muller has been appointed as a member of the company's Board of Directors. I'm pleased to welcome André at Cellectis Board. His extensive experience will be an invaluable asset to the company. We would also like to express our gratitude to Mr. Pierre Bastid and Mr. Axel-Sven Malkomes, who have terminated the directorship for their esteem commitment to Cellectis. It has been a huge honor and a pleasure for us all to work with them during their term. Their contribution over the past years has been exceptional and their precious support has greatly contributed to the advancement of the company's strategy. With that, I would like to turn the call over to Dr. Adrian Kilcoyne, our Chief Medical Officer, who will give an overview of our clinical trials. Adrian, please go ahead.

Thank you, Andre. As Andre mentioned, Cellectis continues to focus its development efforts on the BALLI-01 and NatHaLi-01 studies. Recruitment to the dose escalation component of the Phase I BALLI-01 study which is evaluating UCART22 in relapsed or refractory B-cell acute lymphoblastic leukemia has been completed. This study addresses an important unmet need for patients who have relapsed following multiple prior lines of therapy, including a CD19 bispecific or autologous CAR-T and a few, if any, other treatment options. The Phase I data set has been shared with both FDA and EMA as part of the end of Phase I and scientific advice meetings. Following productive interactions with both agencies, we now have a clear path to commence our pivotal Phase II study later this year. We have set up additional trial sites in order to accelerate accrual into the Phase II study, and we'll continue to focus on expanding sites in the United States and Europe, including the United Kingdom. We anticipate having sites open for recruitment into our Phase II study by the end of the year. We are also planning to publicly share the full Phase I dose escalation data set during our R&D Day, as highlighted by Andre earlier. Additional data from the Phase I study has also been submitted for consideration of presentation at the ASH Annual Conference in the fourth quarter. We also continue to enroll in the NatHaLi-01 study of our dual CAR-T asset, UCART20x22 in relapsed or refractory non-Hodgkin's lymphoma. This study is addressing an important unmet needs for patients who have relapsed following previous lines of therapy, including when available, an autologous CD19 CAR-T. Data from this program has also been submitted for presentation at the ASH Annual Conference in the fourth quarter. We are expanding our clinical trial sites to accelerate recruitment and we hope to transition to Phase II preparation in 2026. With that, I would like to hand the call over to Arthur Stril, Cellectis' Chief Financial Officer and Chief Business Officer, for an overview of our financials for the second quarter 2025. Arthur, please go ahead.

Thank you, Adrian. We are pleased about the progress of our wholly owned product candidates, lasme-cel and eti-cel, as well as over the three cell and gene therapy programs in partnership with AstraZeneca. In this context, we are excited to be hosting an R&D Day on October 16 to focus on the Phase I data set and late-stage development strategy of lasme-cel as we prepare to launch a pivotal Phase II in H2 2025. We also expect to provide an update on eti-cel by the end of the year. Finally, the arbitral decision in our arbitration with Servier is expected to be rendered on or before December 15, 2025. Importantly, we are well positioned financially to execute on our pipeline as our cash, cash equivalents and fixed-term deposits as of June 30, 2025, remain sufficient to fund our operations into H2 2027. Our cash. Cash equivalents, restricted cash and fixed-term deposits classified as current and non-current financial assets as of June 30, 2025, amounts to $230 million compared to $264 million as of December 31, 2024. This $33.2 million decrease is mainly due to $13.4 million of cash in from our revenue and $5.1 million of interest income, offset by cash payments from Cellectis to suppliers of $23.2 million. Cellectis' wages, bonuses and social expenses paid of $23.6 million. The payments of lease debt of $5.4 million and the repayment of the PGE loan of $2.6 million. You are invited to refer to our press release for figures related to consolidated net loss attributable to shareholders of Cellectis for the 6 months ended June 30, 2025. We're very much looking forward to welcoming you at our Investor R&D Day as well as to providing further updates later this year. And now I would like to turn the call over to Andre for closing remarks.

Thank you, Arthur. To close out this call, I would like to reiterate how excited we are to have one of our first product moving into Phase II pivotal trial powered registration. I'm confident about the continued progress of our ongoing clinical trials in hematological malignancies as well as how excited we are about our strategic collaboration with AstraZeneca. At Cellectis, we strongly believe that our product candidates, our technologies and our in-house manufacturing capabilities will lead us and our partners to a paradigm shift for patients with hard-to-treat cancer and genetic disorders, positioning us the forefront of this promising medical and scientific field. With that, I would like to open the call for Q&A.

[Operator Instructions] Our first question will come from Gena Wang with Barclays.

Congrats on the progress. So I have two questions. One is regarding the Servier arbitration decision by December 15. Could you contextualize the different scenarios and your likely actions? The second question is regarding the lasme-cel. You already met with both FDA and EMA regarding the pivotal Phase II trial design. Could you share a bit high-level thoughts with us? What could be the path forward there?

Gena, this is Andre speaking. I'd like to answer the first question. It's complicated to answer your question for the simple reason that, I guess that probably there is still thinking on the way the things are going to go. And I don't want to draw here any kind of scenario, knowing that any kind of scenario can happen from one side or another. And I personally hope that we're going to prevail in this arbitration, it means that we're going to get back our CD19 products and that we're going to have the compensation for like the loss incurred by the non-development by Servier. However, it's very difficult to forecast exactly what could be the decision at the end in these type of arbitration. So I'd like to keep the door open as much as possible for any kind of scenarios. But we believe that we're totally right in our position knowing that there is nothing has been happening so far. A question mark on, -- if I start like putting some scenario, it means, I already thought about the fact that we can have some back position, but we don't have any back position. And for the question for, like the interaction with the FDA and the EMA, I'd like to defer this to Adrian. Adrian?

Yes. Thanks, Andre. Great question. Yes, we've interacted with both EMA and FDA. And just in the spirit of transparency, the EMA, it was a written feedback. They felt the, our submission was clear, and therefore, they could give us very clear guidance on that and a very productive feedback that was. The FDA was a face-to-face meeting. And while I can't go into the details, but certainly at the R&D Day on October 16, we will share a lot more detail around the study design, et cetera. But a few top-level take homes is, we got clear agreement on end points. We had -- there was no concerns raised around our statistical plan. There was no issues raised about the size of the database we would have as we go to BLA with -- based on what we had submitted. So overall, in our view, there is a very clear path forward for our Phase II program. So again, I'd reiterate very productive meetings with both regulatory authorities, who are generally aligned in their feedback, which is always a bonus, I feel.

Our next question comes from Kelly Shi with Jefferies.

This is Anqi Yu on behalf of Kelly Shi from Jefferies. I have two questions. For the R&D Day, what data points should we expect? And supposing we don't have the trial design at this point, you will disclose on the R&D Day. Then how do you consider the dynamic in the FDA that could potentially have any impacts on the pivotal trials?

This is Arthur. I will start on the R&D Day and then let Adrian add any points and also on the FDA question. So the purpose of the R&D Day is really twofold. We want to be presenting the full Phase I data set for lasme-cel that will include all patients that have been dosed so far and a particular focus on the patients at the recommended Phase II dose, and that will be safety, efficacy and durability data set. And the second point is, we want to present what we call the late-stage development strategy, which indeed will include the Phase II design, the patient population and then provide some color on the path to BLA. So it will be both a look into the path that all the Phase I set, but also look into the future as to the plans for the product all the way to commercialization. And then, I'll hand it over to Adrian, if you want to add any color and address the FDA question.

I mean, I think, if I can answer with a question. Are there any barriers that became evident in our interactions with either regulatory authorities to progressing to Phase II and pivotal? Absolutely not. I think the regulatory authorities, both of them acknowledged the high unmet need that is -- that exists within the space, we're going -- positioning that product. But also, I think it was very clear from the tone of these meetings that they're broadly supportive of what we're doing. So again, to get alignment on endpoints, to get alignment broadly on the study design as we had presented it to them and patient numbers, overall, we don't see any significant roadblocks. So again, alignment between ourselves and the regulatory authorities, we -- and again, as Arthur said, we will be presenting the study design in detail, discussing through those endpoints. But I think, again, I would restate that the registration path for this product seems relatively clear. And of course, everything is dependent on ultimately Phase II data.

Our next question will come from Jack Allen with Baird.

Great. Congratulations on the progress. I guess maybe I'll start with one on UCART22 and the upcoming R&D Day. I wanted to ask what -- how the team is thinking about the bar for success in relapsed or refractory. I know, there's some data about best response out there and also some autologous CD19 CAR-Ts. But as you move toward the pivotal study, what are you looking at as the bar for success? And what kind of expectations do you have for durability of response from UCART22? And how much follow-up should we expect on Phase I patients when we get that data update in the back half of this year and then, I guess, in mid-October? And then I have a quick follow-up as well.

Thanks, Jack, for the great questions. Adrian, do you want to take this?

Sure. So there's many questions in there. Suffice to say, again, more detail on the endpoints, the timing of those endpoints will be shared in detail during the October 16, R&D Day. But durability of response in the allogeneic setting is really important. And on sharing the data with both regulatory authorities, they are very clear on the approach we're taking will give you the adequate data in order to support a registration, assuming the data is positive based on our -- what we're showing. Of course, this is also, there will be a longer-term follow-up in all these. You know we're committed to a 15-year follow-up with these patients. But also within the trial, we have -- we will have a longer survival. It's a long overall survival follow-up for a number of years. So -- but that is not part of the primary analysis. So the primary analysis, as we will share is a much more short-term surrogate endpoint, which, again, has been agreed with the regulatory authorities.

Got it. That's very helpful. And then maybe for Adrian, again, with ALLO, correct it, as he sees fit. I'd love to hear any high-level thoughts you have on the recent decision by Allogene to move away from the CD52 lymphodepletion. How are you thinking about that as it relates to your programs moving forward? And would you anticipate including alemtuzumab in a potential pivotal study of UCART22?

Well, I can start on that, Arthur and Andre. Yes, we've been following the Allogene story very closely. We believe that alemtuzumab is really important as part of the lymphodepletion regimen. And we want to be really cautious in how we interpret our approach in the context of Allogene's approach. I want to stress that these are very different positionings of the products. We're talking very late-stage ALL, and we're talking very late stage NHL compared to the Allogene approach is much earlier. While we -- and we also don't know very much around the pharmacokinetics of the ALLO product. But it appears to be at a much higher dose than we gave within our clinical trials. And of course, the third thing, which is really, really important is that everything we do is based on risk benefits. So the risk-benefit assessment within the Allogene program is very different to the risk-benefit assessment we see in our programs. So all in all, very difficult. I think it would be unfair to draw any comparisons between these programs. We are fairly confident about our risk-benefit assessment across our programs with alemtuzumab. And we believe that adds a critical improvement in responses, which we're fairly confident in our approach moving forward.

Yes. And if I can add something, I think, Adrian, you're spot on, obviously, on the dose, but it's also important to -- remember that these are different products. And I think our strategy has always been from the get-go to secure direct access to alemtuzumab, which is something that we've done with Sanofi a few years back. So we know we have access to actual alemtuzumab. ALLO-647 is a different product. And honestly, we're not exactly aware as to how it compares, what are the glycosylation patterns, what are the -- what is the structure of the antibody. And so it's very difficult to compare apples to oranges. And we're very pleased to be moving forward with actual alemtuzumab.

Great. I guess just maybe one last one on the topic. Any high-level thoughts on ways you could mitigate potential infection risk in your study? I know the CD52 lymphodepletion can lead to a longer depletion of T cells. Have you given any further thought on the protocols you can put in place to mitigate infection risk?

Yes. I mean, it's part of all our trials. We have a mandatory prophylaxis. So that's already built in. We have significant risk mitigation strategies already built into our trials. So yes, I think we've already addressed much of that. But of course, we remain vigilant.

Our next question comes from Yanan Zhu with Wells Fargo Securities.

Great. Just maybe a follow-up on the FDA discussion for the BALL program. Wondering -- I know you will provide more details at the R&D Day. Wondering if the population for the pivotal trial, is that specific population like post CD19 CAR-T? Or is that a more broader population? And also in terms of the patient number, could we look to the most recent CD19 autologous CAR-T programs for BALL for the rough range? Or could the trial be smaller than that?

Yes. Good questions. So as you're probably aware, we're looking at a very late stage treatment. So -- but we're going for a fairly broad patient population in terms of age cutoff. And again, we'll share the details with that, we would anticipate there will be a significant number of lines of therapy for most patients in our clinical trial. And that will include, obviously, CD19, CARs, et cetera. So you'll see detailed breakdown of this at the R&D Day. So I would encourage you to come along. In terms of the number of patients, I think the number of patients in our trial is driven by two things. One is the powering of our trials. And the two is the requirement of the safety database, which often takes precedence. So I think, your suggestion that, looking at other autologous CD19, CARs in this space will give you, while not entirely accurate, it will give you a ballpark as to what kind of numbers we need to have in these kind of trials. And it's driven by the size of the safety database rather than the assumed statistical powering.

Great. That's super helpful. And then as a follow-up for the Servier program arbitration discussion. I was just wondering, could you give us a sense of the size of the milestone payments that potentially could be awarded at that point?

Yes. Thanks, Yanan. Unfortunately, as this is an ongoing legal matter, we're not going to be able to give more details on this. Sorry.

No problem. Congrats on the progress.

Our next question will come from Sebastiaan van der Schoot with Kempen.

Just two from my side. The first one is a follow-up on Allogene decision to not move forward with the anti-CD2 or CD52 antibody. Can you maybe give some insight whether there's been any feedback from the regulators from inclusion of the anti-CD52 in your treatment regimen? And do you expect that there might be another conversation with the FDA after these filings from Allogene? And then, I have a follow-up.

Thanks, Sebastiaan. Adrian, do you want to take this one?

Sebastiaan, I just want to make sure I've understood the question. Could you just repeat it?

Sure. So it comes down to whether you expect that this decision from Allogene that came after your conversation with the regulator, but that can still influence the design of the pivotal study with the use of the anti-CD52 antibody.

No. We -- honestly, we don't believe so. Again, we have an established safety profile and an established risk-benefit assessment. As Arthur already stated, this is -- the Allogene product is different. And if we assume they may be even similar, our dosing levels are significantly lower than we see with the Allogene product. And again, the regulatory authorities have reviewed our full in the Phase I package including detailed look at the safety profile. So I don't see that there will be -- we don't foresee any changes, based on what we've seen with Allogene.

Got it. Very clear. And then, maybe regarding the cash runway and cash position. Could you indicate whether that incorporates the entire completion of the pivotal study for lasme-cel?

Yes. Great question. So the cash runway into H2 2027 does include pivotal studies. Actually, we've made assumptions both for lasme- cel and for eti-cel. So all the costs are fully loaded in that front. We've also been very prudent, as we've always done on cash in from milestones and non-dilutive funding. So this one have been probabilized, so there is potential for upside there if they do materialize. And we will provide the full detailed time lines of the Phase II at the R&D Day. But to answer your question, yes, the runway does include the pivotal studies.

Great. And then maybe a last one, it's on the data set for eti-cel by year-end. Can you just give some color on the size of that data set? Will it be similar in patient size? I understand that there will not be enough follow-up, but in terms of patient size, will be similar to the lasme-cel disclosure back in October.

Yes, I'll take that, Arthur. So obviously, lasme-cel is a much more -- it's early candidate with much more patients within the Phase I program than eti-cel. So you will be anticipating smaller patient numbers. And again, we will -- you'll see based on our submissions to ASH, you'll see much more of that data then.

Our next question will come from Salveen Richter with Goldman Sachs.

This is Mark on for Salveen. I have, I guess, a follow-up on eti-cel. There's been a lot of news from autologous dual-targeting CAR- Ts recently. And -- what are your thoughts? How do you view that data? Is there any read-through to eti-cel? And sort of beyond the allogeneic autologous, sort of, difference? How do you think eti-cel is differentiated in the dual targeting space?

Yes, it's a great question. We believe we've got a very well differentiated product with eti-cel. We believe our positioning is very clear. It's a later line diffuse large B-cell lymphoma, most likely, certainly within the non-Hodgkin lymphoma space. We think our -- and again, when you see what's presented at ASH, it will be assuming it's accepted. You'll see a clear strategy, which I think differentiates the product significantly from the current batch of autologous products. So I can't really say much more until we -- you see what we will be hopefully presenting at ASH.

If I can add -- and thanks, Mark, for the great question. I think the -- I'm sorry, I'm going to state the obvious, but the big important piece about eti-cel is, it does not target 19. A lot of the dual targeting data we've seen is like 19, 20, 19, 22. So I think it's great, but it's yet again hitting 19. So the primary competitors to 19, 20 or 19, 22 are going to be the approved autologous 19 and potentially some of the ALLO-19. I think where eti-cel is pretty unique to our knowledge at this stage is that it is a 20 and 22. And so it will be particularly relevant to physicians who have hit 19 once and will then want to -- or twice. And we want to alternate the targets. I think, the other important thing to remember is, right now, 19 is firmly entrenched in the second line. This is primarily YESCARTA and BREYANZI. If Allogene is successful with this first-line consolidation approach, to which, by the way, we have a vested interest in. There is a potential for 19 to come already up to the first-line consolidation. And then there will be a very, very strong need to hit orthogonal targets. So coming at it with an off-the-shelf alternative that does not require an additional round of leukapheresis, harvesting of the patient, slots, et cetera. So pure off-the-shelf alternative that does not target 19, I think in our universe of NHL and LBCL is pretty differentiated and unique.

It appears we have no further questions at this time. I would now like to turn the program back over to our presenters for any additional or closing remarks.

Well, we would like to thank you all. And we definitely -- there is a very rich second half this year for Cellectis. So please stay tuned and we hope that you will be all at our R&D Day event on October 16 and probably wait to what's going to happen for Cellectis by the end of the year. So a lot of like rich event things that will come up. Thank you very much for your attention, and have a good day.

Thank you, ladies and gentlemen. This concludes today's event. You may now disconnect.