Annual General Meeting Transcript - CLLS 2026-06-25

Operator

Hello, and welcome everyone to today's Selectus 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 1 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 Strill, Chief Financial Officer and Chief Business Officer. Please go ahead.

Arthur Stril, CFO

Good morning, and welcome everyone to Selectus 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, Selectus issued a 20th and press release reporting our financial statements for the 12-month period ended December 31, 2025, and a business update. The report and press release are available on our website at Selectus.com. As a reminder, we'll make statements regarding Selectus' 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 20F filed with the Security Exchange Commission, SEC, and the financial report, including the management report, for the year ended on December 31, 2025, and subsequent filings Selectus makes with the SEC from time to time. I would now like to turn the call over to Andrei.

Andre Choulika, CEO

Thank you, Arthur. Good morning, and thank you, everyone, for joining us today. Selectus was founded with the conviction that gene editing could fundamentally transform how we treat patients in the 21st century. From that foundation and ID, we pioneered the allogenic CAR-T approach, ready on day one, built for all patients regardless of their condition. Today, I'm proud to say that Selectus is the one of the only company running a pivotal phase 2 allogenic 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 were stepped back, selectors 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 one data set for Lasmus cell, our allogenic CAR-T candidate, targeting CD22 in relapsed or refractory B-cell acute lymphoblastic leukemia. Lasmus cell achieved 100% overall response rate in the target phase II population. Critically, LASMICEL 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, lenatomumab, and inotuzumab. Their options were exhausted. This is clinical proof that an allogenic 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 breacher transplant strategy is medically powerful. For patients with relapse or refractory BLL, only known path to long-term cure is a bone marrow stem cell transplant. But 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 allogenic CAR-T product, LASMICELL, becomes a game changer. Off the shelf, immediately available. LASMICELL 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 cure and no chance at all. Without our pivotal phase 2 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 2 trial is expected Q4-2026. Turning to our second product candidate, Etiselle, for patients with relapsed or refractory non-Hodgkin lymphoma, ET cell is a best-in-class allogenic 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 problems in a lymphoma, antigen escape. When cancer cells lose one surface marker to evade a single-target therapy, They cannot hide from both. Edicel was built for that challenge. At the ASH 2025 annual meeting in December 2025, Slytus presented Phase I interim results, which demonstrated an encouraging overall response rate of 88% and a complete response of 63% in heavily pretreated patients. These preliminary data underscore the potential of this innovative approach to transform outcomes for relapsed or refractory, not Hodgkin lymphoma patients. The file is now investigating any potential impact of low-dose interleukin-2 support, who significantly enhance expansion and the persistence of CAR-T cells to boost CAR-T efficacy without exacerbating toxicity. Selectus expect to present the full Phase I data set of EtiCell this year. Now, a few words on our partners. Flectis is not operating in isolation. Our gene editing platform has become technological backbone of a broader allogenic CAR-T ecosystem. Two of our key partners are approaching pivotal moment. Survey through Allogene's semicell program is currently in a pivotal phase 2 study, evaluating it as a consolidation therapy in first-line large B-cell lymphoma patients. Allogene anticipates that an interim fertility analysis is on track for Q2-2026. Our partnership with IOVance is another powerful signal to reach any versatility of our platform. IOVance is advancing IOV4001 in PD-1 inactivated tumor infiltrating lymphocytes of TILS cell therapy. In previously treated advanced melanoma patients leveraging our gene editing capacity, clinical results of IOV4001 in melanoma are anticipated this year. R&D activities continue to advance under our research and collaboration agreement with AstraZeneca, which leverages selective gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high 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. Please, 2026 will be a year of data, of milestones, and of momentum for selectives. 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'd 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 Kilcoyne, Other

Thank you, Andre.

Adrian Kilcoyne, Other

I will provide a focused clinical perspective on our Lashmi cell and EtiCell programs. The Phase I-BALIO-1 study of Lashmicelle in third line and beyond acute lymphoblastic leukemia enrolled 40 patients with confirmed at least 70% CD22 expression. These patients were heavily pretreated 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 pretreated patients have already relapsed following multiple targeted therapies. Most patients have been previously treated with linatumumab and relapsed. Approximately 50% have also relapsed following CD19 CAR-T and dinatuzumab, a CD22-directed antibody drug conjugate. Therefore, there remains very few, if any, therapeutic options for these patients. At the recommended Phase II dose, Lashvicelle achieved an overall response rate of 83% and and a CR-CRI rate of 42%. In the target phase two 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 cutoff. This is a very positive outcome for these patients. In patients who achieved MRD-negative CRCRI, median overall survival was 14.8 months, a meaningful survival benefit in this heavily pretreated population. The safety profile of Lashmi cell 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 2 does. The full Phase 1 data has been submitted for presentation at the 2026 European Hematology Association Congress to be held in Stockholm in June. The Phase 1 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 alentuzumab, as part of the preconditioning lymphodepletion regimen, results in superior Lashmicell expansion and therefore efficacy compared to the standard lymphodepletion regimen. Validating our decision to internalize our manufacturing capabilities, Selectus manufactured product demonstrated meaningfully higher response rates than an external CDMO manufactured product, with overall response rates of 68% and 28% respectively. Secondly, the data demonstrated that increased amtuzumab 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 2 program focused on the target Phase 2 population of patients aged between 12 and 50 years of age. We are accelerating site opening 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 asset, EntiCell, targets CD20 and CD22, expressing tumors in third line and beyond non-Hodgkin's lymphoma. This highly differentiated product offering important and much-needed alternative targets of 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 eight evaluable patients. Selectus 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 1 dataset, including the IL-2 cohort results, later this year. We plan to progress this program to Pivotal Phase 2 in 2027 and anticipate a BLA submission in H2 2029. As you can see, 2026 promises to be an exciting year for Selectus 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 Strill, to select us as Chief Financial Officer and Chief Business Officer for an overview of our financials for the fourth quarter and full year 2025.

Arthur Stril, CFO

Arthur, over to you. Let me now walk you through our financial position. As Henri mentioned, we have managed our cash with discipline over the past year, focusing our spend on what matters most, the development of LASMICEL and ETESEL, 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 2 program for LASMICEL and our phase 1 for ETASEL and deliver two key readouts in Q4 2026, the first interim analysis with 40 patients for LASMICEL and the full phase 1 data set for ETASEL. We are well positioned financially to execute on these two trials as our cash, cash equivalents and fixed-term deposits as of December 31, 2025, remain sufficient to fund our operations into H2 2027. We are also looking forward to the upcoming data readout for our partnered programs, in particular Servian Allogene Semicel in April 2026 and 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, 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 selectives to suppliers of $50.5 million, selectives 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 Selectis for the 12 months ended December 31, 2025. We very much look forward to a rich 2026, especially with Servian Allogene's readout for Semicel next month and our two readouts for Lasmus Semicel and Eticel later this year. We'll now turn the call over to the operator for questions.

Operator

Thank you. If you would like to ask a question, please press star 1 on your keypad. To leave the queue at any time, press star 2. Once again, that is star 1 to ask a question. And our first question will come from Amin Makaram with Jeffries. Please go ahead.

Amin Makaram, Analyst — Jefferies

Thank you for taking our questions. questions, two from us. First on the LASM cell and the Valley 1 enrollment, how's recruitment tracking in the Pivotal study, and when do you expect complete enrollment for that dose selection portion? And I have a follow-up.

Adrian Kilcoyne, Other

Yeah, thanks, Eman. 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. So 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 valumtizumab, which is required by CEDAR. So yes, it's going well, and we're on track for Q4 data sharing.

Amin Makaram, Analyst — Jefferies

Thanks. And for this dose optimization portion, as you evaluate the two alentizumab, those levels, what are the expectations or 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 do you think the two arms are going to be generally in the same ballpark?

Adrian Kilcoyne, Other

It's very difficult to say, and I almost required 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 and translational markers in terms of our CAR T expansion, host T cell reconstitution, et cetera. So 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 allumtuzumab, very importantly, they work. It's all about dose optimization now. It's not about finding an effective dose.

Adrian Kilcoyne, Other

Helpful. Thanks.

Operator

Thank you. Our next question will come from Salveen Richter with Goldman Sachs. Please go ahead.

Salveen Richter, Analyst — Goldman Sachs

My questions. Two questions from us. One is, could you provide more details on the survey arbitration given the ruling that you have to engage in discussions with ALO regarding the direct licensing of 501 and help us understand how this impacts your eligibility for the $340 million in milestones into this interim data? And 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.

Arthur Stril, CFO

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. So just as a reminder, so the arbitral decision of December 2025 ruled on a partial termination of the license agreement with respect to one product, which is UCART-19V1, also named Aloe 501 by Allogene. So this product has been brought back to Selective, and we are free to develop it moving forward. The tribunal did not affect Aloe 501A or Semucel, So we remain fully eligible for up to $340 million in development and sales milestones. That is obviously under the survey agreement, which has been then sub-licensed to allergens. So this does not impact any eligibility to upcoming development and sales milestones, as well as royalties down the line on Semicel, but it gave us back UCART-19 or Aloe 501, and we're free to do whatever we would like to do with it. And I will hand it over to Adrian for the clinical question.

Andre Choulika, CEO

One thing I'd like to add during our thinking is that once the PIVOLU trial is effective, then the milestone should be triggered. So we're definitely expecting to have

Adrian Kilcoyne, Other

this $20 million milestone paid one day.

Adrian Kilcoyne, Other

Okay, and I'll answer the antizumab question. It's a great question. There's a few things, just a few observations from our studies. One is that allumtuzumab is really important to optimize lymphodepletion. And 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 one program, we did test a lymphodepletion regimen without allumtuzumab. And we failed to get any MRD negative responses. So we know that alimtuzumab 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, alimtuzumab 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. So we have, compared to other companies that are using alimtuzumab or alimtuzumab similars, we're using a much lower dose. We've spent a lot of time in already optimizing our doses. So we believe we've got the right balance between optimal efficacy, mitigating the risks that may be associated with that more enhanced lymphodepletion regimen. But also, let's not forget that alumtuzumab 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. So we believe we've got the right strategy with our alabintuzumab. I cannot answer why others may have transitioned away from it.

Operator

Thank you. Our next question will come from Jack Allen with Baird. Great.

Jack Allen, Analyst — Baird

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 SEPO and how we should think about the update in the fourth quarter of this year, any additional color you're willing to provide as it relates to the breadth of the update a number of patients and the durability of follow-up there would be great. And then I have a quick follow-up as well.

Adrian Kilcoyne, Other

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. So 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. So we anticipate we will be able to get a reasonable, and I cannot give you a number because I don't know what the recruitment rates are going to be, but 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. But of course, for the patients in the later phase, there will hopefully be good durability signals. We have in our minds the durability levels we want to achieve, and it's around the six-month mark. But hopefully by the end of the year, you'll be able to see a very clear picture. I think the efficacy question has already been answered. The question is, can we enhance it even further into the 70s rather than in the mid-60s? But also it'll give us a very good signal is, 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, really fundamental improvement for allergenic cell therapies.

Jack Allen, Analyst — Baird

please. Great. Great. Thanks for all that color. And then we might be getting ahead of ourselves a little bit here, but on Lasmosel and the commercial opportunity, I was wondering if you've been looking at Alcatazole from Onilus, and if you have any thoughts around the initial commercial launch

Adrian Kilcoyne, Other

of that CD19 auto therapy in AOL. 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 Capsule isn't a very good product. It is. Their data is very strong. But these patients are very difficult to treat. Many of them will relapse and they need to have an alternative target. So 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 allergen has done, which we think is a fantastic idea in the non-Hodgkin's lymphoma place, 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

Arthur Stril, CFO

I can add, I think from a commercial launch perspective, you absolutely cannot compare an autologous launch to an allogeneic launch. And 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 aspects. And 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 and gross margin 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. So 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. So I don't think Ocadville will be a very good comparator there. Great.

Andre Choulika, CEO

One thing I'd like to add, Jack, one thing that was interesting, I was recently visiting a clinical center we're working with for acute lymphoblastic leukemia with Adrian, And there was one ALL patient that was sitting in the backlog waiting for an available apheresis spot since a long time. Meeting with, you know, not-hushkin lymphoma, DLBCL patient, multiple myeloma patient, autoimmune patient, etc. and this patient it's like all is very aggressive disease and 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 but the fact is that this patient was like in real distress waiting for this like aphrasis spot and this is what you would consider as a the autologous launch of yet another CD19 autologous

Adrian Kilcoyne, Other

car team. Thanks so much that's very helpful colleague

Operator

Thank you Our next question will come from Sylvain Turkin with Citizens. Please go ahead.

Sylvain Turkan, Analyst — Citizens

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 are ongoing. Is it mainly longer follow-up? Thank you so much.

Adrian Kilcoyne, Other

So 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 two program. We wanted to ensure that that lower dose is an acceptable dose to give to patients. So there are going to be an updated data set, the whole data set, including those additional patients. So it is, I would consider it a level of progression from the original phase one 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. successful. And again, to build on the question from our Goldman Sachs colleagues, whether we're talking about alimtuzumab, 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. And 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 our patient's going to respond. So all these data will be shared. So I think we're excited by it so far.

Operator

Thank you. Our next question will come from Sebastian Vanderschut with VLK. Please go ahead.

Adrian Kilcoyne, Other

Hi, guys. Good morning. Thanks for taking our question. So I wanted to ask you how you're

Yanan Zhu, Analyst — Wells Fargo

looking at the possibility of applying your lean flow depletion procedure in the outpatient setting as well as the allergenic CAR-T. And then maybe can you provide some insight on how the partnership with Ostervenica is going? Can we expect any updates in the next 24 months? Thank you.

Adrian Kilcoyne, Other

I can take the first part of that, Arthur, in terms of outpatient setting. Right now, the regulatory authorities require inpatient delivery of products. And I think that's consistent with most autologous therapies as well in the CAR-T space. And 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. So hopefully that will be provided not only by the phase two program, but also by clinical usage from that. But again, I think it's a very different offering in that to this point, we do not leave that leukophoresis, et cetera. So I do think it'll take some time for this to be in the outpatient setting. But, 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.

Arthur Stril, CFO

And 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. And 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 area. 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. But definitely, as we continue the dialogue with them around disclosure and as and when the time is right, we will be providing updates and I think you will be interested in seeing what has been brewing with them.

Adrian Kilcoyne, Other

Great. Thank you, guys.

Operator

Thank you. Once again, to ask a question, that is star one on your telephone keypad. Our next question will come from Yan and Zhu with Wells Fargo.

Yanan Zhu, Analyst — Wells Fargo

Oh, great. Thanks for taking our questions. So first, regarding the last missile pivotal study, I was wondering, for the 4Q readout, is the focus there, the three-month 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 alantuzumab 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 alantuzumab cohorts? Yeah, and then I have a follow-up. Thanks.

Adrian Kilcoyne, Other

Great. There's some great questions there. First and foremost, no. The decision for dose optimization is not based on the three-month CRI. It's actually based at an earlier time cut off of eight weeks. And 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. So it's a composite of many of those that we will representing. 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. So importantly, this does not mean our study has to stop while we're engaging with the regulatory authorities. Recruitment will continue for the remaining AGI patients.

Yanan Zhu, Analyst — Wells Fargo

Great. Thanks for those very helpful color. The follow-up is mainly on the competitive landscape in terms of additional modalities in VivoCart 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 early stage efforts?

Adrian Kilcoyne, Other

I can have an initial thought on this. And I think I know that Andre and Arthur also have views on the positioning of VivoCar. 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 VivaCar. We think VivaCar 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. So, yes, there will be in vivo CAR in some, maybe autoimmune, maybe a better destination, but 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, Andre, you have a view on this as well.

Andre Choulika, CEO

I think the approach of In Vivo Car is similar to Autologa's Car Key. The only thing it allows is essentially try to leapfrog aphorases, which is a great thing. It's like it's a huge market access option that is given here.

Adrian Kilcoyne, Other

nevertheless

Andre Choulika, CEO

it will still be totally linked to the fitness of the cells of the patient or their presence so if it doesn't respond to blena if you can't do an autologous then you go an in vivo if the cells are not really very well functional, it's not going to 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. But the spread of this into solid tumor is going to be different. And finally, there's a lot of papers are coming out. Like a lot of cells are transduced by these vectors that are not these cells. So like you need to restrict at the time. But 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. So if you do this worldwide, like really broadband, then be questions at a time. And also like the genome is only 6.4 billion base pairs, like 23, two times chromosomes. If you inject trillions and trillions of vectors in hundreds of patients or 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 what the cells are transduced. If you go for an allergenic 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. So that's like the initial concern, but I'm sure that this will be solved in coming decades.

Adrian Kilcoyne, Other

Thanks for all the insights, and congrats on the quarter. Thank you.

Operator

Thank you. And 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.

Adrian Kilcoyne, Other

Thank you very much, everyone.

Arthur Stril, CFO

I 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. And I think we are poised for a new dawn of allogeneic CAR T-cell therapy. So stay tuned for more updates and looking forward to further discussions as our progress unfolds this year. Thank you very much.

Operator

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