Cellectis S.A. (CLLS) Q2 2021 Earnings Report, Transcript and Summary

Greetings. Welcome to the Cellectis Second Quarter 2021 Earnings Call. At this time, all participants will be in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is being recorded. At this time, I will now turn the conference over to Eric Dutang, Chief Financial Officer. Eric, you may now begin.

Thank you, and welcome, everyone to Cellectis second quarter 2021 corporate update and financial results conference call. Joining me on the call today with prepared remarks is Dr. André Choulika, our Chief Executive Officer; Dr. Carrie Brownstein, our Chief Medical Officer; and Steve Doares, our Senior Vice President of US Manufacturing will be joining for the Q&A. Yesterday evening, Cellectis filed its interim report and issued a press release reporting our financial results for the second quarter and six months period, ending June 30, 2021. The reports and press releases are available on our website at cellectis.com. As a reminder, we will make forward-looking statements regarding Cellectis financial outlook in addition to its manufacturing, regulatory and product development plans. These statements 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 SEC and the financial report for the year ending on December 31, 2020, and subsequent filings Cellectis makes with the SEC from time-to-time. Now, I would like to turn the call over to André. André Choulika: Thank you, Eric. Good morning, and thank you, everyone for joining us today. Despite challenges the world is facing, Cellectis has achieved a series of key milestones and we are incredibly grateful and proud of all the hard work achieved by our team, our partners and our stakeholders. During the first half 2021, we have made significant progress on all fronts that we're thrilled to share with you over the next half an hour. Today, we believe that Cellectis is reaching a turning point and is entering into a new phase of it’s development demonstrating excellence in clinical execution and acceleration of our internal product manufacturing of both new products and also new stock of existing products for expansion phases of our clinical program. Cellectis has enrolled patients in parallel in the three sponsored Phase 1 dose-escalation trial for our three clinical stage wholly-owned product candidate, UCART22 and BALLI-01 for relapsed or refractory B-cell lymphoblastic leukemia, you’ll recall 123 in AMELI-01 for relapsed or refractory acute myeloid leukaemia and UCARTCS1 in MELANI-01 for relapsed or refractory multiple myeloma. During the second quarter we presented preliminary translational data for the first group of patient enrolled for the MELANI-01, UCARTCS1 at the virtual American Society of Gene and Cell Therapy for the 24th Annual Meeting. Early preliminary data, validate CS1 as a target for allogeneic CAR T-cell in multiple myeloma. UCARTCS1 expansion and persistence was observed and correlated with the change in relevant serum cytokines and anti-myeloma activity. MELANI-01 trial is currently enrolling patients at the dose level minus one, the first of the three plan doses level. We organize a virtual event called Cellectis Innovation Days that took place in May 2021. The event provides an inside look at Cellectis and was a huge success with great attendance through the week. We're presented a clear view into our pipeline of new product candidates, our gene editing platform, our electroporation technologies, as well as our end-to-end state-of-the-art internal manufacturing capabilities. The new in oncology product candidate includes UCART20x22, the first allogeneic dual CAR T-cell candidate product for B-cell malignancies, the power of UCART20x22is that it is not yet another CD19 product. CD19 is a de novo crowded target space and UCART20x22 with the power of UCART can address all patients with B cell malignancies, including the one not responding to the numerous CD19 targeting treatment. In addition, we also present a UCARTMESO targeting mesothelin expressing solid tumors and UCARTMUC1 targeting mucin-1 expressing epithelial cancers. Finally, we're presented UCARTFAP, a very innovative mechanism to pursue solid tumor to targeting cancer associated fibroblasts CAFs in the tumor microenvironment, which has the potential to turn a cold tumor, hot. We plan to file INDs of UCART20x22 and UCART mesothelin in 2022. During these innovation days, we also introduced the market to heal our genome surgery platform for genetic diseases. The platform leveraged the power and the precision of TALEN gene editing to perform therapeutic genome surgery of hematopoietic stem cells. We announced programs in sickle cell disease, lysosomal storage disorders and primary immunodeficiencies. .HEAL’s lead product candidate is TALGlobin01 for the treatment of sickle cell disease. TALGlobin01 is developed using both TALEN technology to induce a double strand DNA break under mutation of the sickle cell disease causing hemoglobin subunit beta, HBB gene and AAV that will be providing a DNA repair matrix designed to correct the faulty HBB gene via homologous recombination. Cellectis plans to file an IND for TALGlobin01 in 2022. If you're interested in watching Cellectis Innovation Days on-demand episodes, you can get more information on our website cellectis.com. In May 2021, Cellectis and Sanofi entered into a partnership agreement and a supply agreement regarding alemtuzumab, an anti-CD52 monoclonal antibody, to be used as part of the lymphodepleting regimen in certain Cellectis’ sponsored UCART clinical trials. Sanofi will supply alemtuzumab to support Cellectis clinical trials and we agreed to enter into discussion to execute a commercial supply of alemtuzumab under pre-agreed financial condition. In our Paris GMP manufacturing facility, manufacturing of plasmids starting material its DNA matrixes is now fully operational. One very critical element was the production of messenger RNA coding TALEN that we are -- that are at the center of our gene editing approach. We are proud to announce that messenger RNA are now in production at Cellectis. We finally remain on track for the manufacturing of viral vectors in the second half of 2021. In our Raleigh GMP manufacturing facility, we successfully completed two UCART training runs from starting cells to vile drug product. And we have started major production of first batches. Manufacturing independent and execution in the cell and gene therapy space is a key success factor for all companies operating in this competitive arena. We believe that Cellectis a state-of-the-art biotechnology company with the product development process, master from A to Z, including the construction of our proprietary electroporation devices to the production of buffers up to the vile file product ready to be injected. With that, I would like to hand the call over to Eric Dutang, Cellectis, Chief Financial Officer for an overview of financials for the quarter. Eric, please go ahead.

Thank you, André. This slide provides a brief overview of our financials for the second quarter and the first six months of 2021. I like to highlight some of our business development activities in 2021. In particular, at the beginning of 2021, we announced our alliance with Cytovia, which includes up to $760 million of development, regulatory and set milestones and we are eligible to receive single digit royalty payment of the net sales of all partnered products commercialized by Cytovia. In addition, we expect to receive an equity stake of $15 million in Cytovia stock or an upfront cash payment of $15 million if certain conditions are not met by December 31, 2021, as well as an option to invest in future financing rounds. We expect Cytovia alliance with Allogene in 2021 will receive a $5 million license payment from this launch of its further study of ALLO-316 in renal cell carcinoma. As a reminder, we are eligible to receive $4 billion in disclose development and cell milestones plus royalty on cells from our partner Allogene, Servier and Cytovia. Now on to our financials. The cash, cash equivalents, current financial assets and restricted cash position of Cellectis, excluding Calyxt, as of 6 August, 2021 was $238 million compared to $244 million as of December 31, 2020. This difference mainly reflects $59 million of net sales proceeds in operation investing in a niche financing activity which were partially offset by $46 million of net equity proceeds raised from the Company’s ATM program in April 2021 and $11 million of proceeds from stock options exercises This cash position is expected to be positioned to fund Cellectis operations into early 2023. This kind way, discount any future milestone payments. We have consolidated cash, cash equivalents, current financial assets and restricted cash position of Cellectis including Calyxt was $257 million as of June 30, 2021 compared to $274 million as of December 31, 2020. The net cash flows used in operating, capital expenditures and leases were $59 million at Cellectis and $12 million at Calyxt in the first semester of 2021. The net loss attributable to shareholders of Cellectis, excluding Calyxt was $43 million in the first semester of 2021 compared to net income of $3 million in 2020. This $46 million decrease in the net result between 2021 and 2020 was primarily driven by a decrease in revenues and other income of $25 million or an increase in R&D expenses of $19 million dollars. The consolidated net loss attributable to shareholders of Cellectis including was Calyxt $52 million or $1.17 per share in the first semester of 2021 compared to $12 million or $0.29 per share in 2020. The consolidated adjusted net loss attributable to shareholders of Cellectis excluding non-cash compensation expenses was $48 million or $1.08 per share in the first semester of 2021 compared to $4 million or $0.09 per share in 2020. We are laser focused to spend our cash on developing our deep pipeline of fully owned product candidates in the key and operating our state-of-the-art manufacturing capabilities in Paris and in Raleigh. On the other end, our focus on making an efficient profile should enable [Indiscernible]. With that, I would like to hand the call back over to André for concluding remarks. André, please go ahead. André Choulika: Thank you, Eric. At Cellectis, we continue to leverage our groundbreaking gene editing platform to develop novel proprietary medicines to transform the lives of patient with serious diseases. Our current proprietary clinical stage programs are focused on patient with advanced hematologic malignancies, and we continue to advance a robust pipeline into the clinic to tackle additional oncology settings, including solid tumors, and to address the unmet medical needs of patients with severe genetic diseases. We look forward to entering the clinic with the novel IO and HEEL product candidate in 2022. With that, I'd like to open the call for Q&A.

Thank you. At this time, we'll now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question comes from the line of Gena Wang with Barclays. Please proceed with your question.

Thank you. Thank you for the comprehensive update. I have two questions. The first one is regarding the UCART22, you will have data later this year, just wondering should we expect that data at the ASH? And then what kind of data package will you be presenting? And then second question is regarding your HEAL, a new technology seems very impressive. But so far, most of the indications you are focusing on the ex-vivo system. Just wondering if you have any thoughts to move this technology to the in-vivo system? André Choulika: Hi, Gina. Thank you very much for these questions. Those are excellent questions, by the way. So, my suggestion is maybe to have Carrie answering the first question and I'll take the second one. Carrie please.

That’s perfect André. Hi Gina. So, we're aiming to present the data at ASH, though we don't know obviously how that will work after submission. As we pointed out last year, we started enrolling patients into the alemtuzumab arm, so the lymphodepletion includes alemtuzumab, since we thought that would be more appropriate going forward. And we would hope to be presenting that data with some cohorts by the end of the year. André Choulika: Thank you, Carrie for answering this first question. I'll take the second one. So, concerning HEAL, Gina, we are, of course, focusing on gene editing to fix genes. So, what is a real genuine gene repair as we've shown for the sickle cell disease program called TALGlobin01. And the ID that we have today is trying to move supplies. We have our first platform for the gene therapy product that will be focusing on hematopoietic stem cells at first. And that's the first focus we have, because it would give us a lot of insights on the way it's functioning and also on the way we can conduct all the quality control and the safety of the probe outs in general and how the TALEN can behave in a tolerate cells for a long time. So, most of the products are in developing today are based on the ex-vivo platform in hematopoietic stem cells at first. And then we are currently working on the second phase that we have loved the flow during this innovation days, that I hope will be the new next-generation product that will be in-vivo. In-vivo as part of Cellectis strategy, of course, but once we'll have some very good ID and clearance on the safety and efficacy of our technology ex-vivo with HFCs with all the control and the quality that can be applied on these type of platform because -- injection, then we'll move stepwise into in-vivo. You've seen recently series of articles and nature magazine, et cetera, that shows that there are some things to be checked such as like ex -- off-target leverage, practice, et cetera that can happen with lots of alternative genetics and technology. And we believe TALEN is an extremely safe and efficient technology to conduct in vivo gene therapy. And as TALEN are vectorized in messenger RNA and messenger RNA is not a liberal nuclear particle, most of competing technology, it opens some gates that are very powerful for the company. And we're very excited. And moving forward in this identical platform that would definitely pave the way for the in vivo gene therapy that we have. But stepwise is definitely the way we would like to move forward. I hope that answers the question.

Yes. Thank you. André Choulika: Thank you, Gina.

Next question is from the light of Michael Schmidt with Guggenheim. Please proceed with your questions.

Hey, guys. Good morning. Thanks for taking my questions. I had a big picture question first. So obviously, you have a lot going on pretty closely with programs now expanding CAR T as well as genetic diseases, et cetera. Just wondering how you think about the longer term your partnering strategy, historically, you obviously had the collaboration with Pfizer and Servier on the CAR T side. I'm just curious how you think about partnering with a larger company going forward to perhaps accelerate or extend especially on the clinical execution side? André Choulika: Thank you very much, Michael, for this question. It is not the simple question because when I take the history of the company in the past, so 2014 has been a very fruitful partner year as we find two partnerships. In February 2014, Servier partnership licensed UCART19 to Servier for all B-cell malignancies in general, so everything that was CD19 targeting and Servier in 20 -- like end of 2015 licensed out to US right to Pfizer at this time and like in June 2015 -- in 2014, we signed this agreement with Pfizer licensing out 14 targets, 15 targets to Pfizer, including the CMA or like CD70, et cetera. But Pfizer decided later to spin out into a company called Allogene, and that has also the CD19 right in the US. And to date, I have the feeling that there was more criticism in power Cellectic we decided to license our targets to third parties and potential that I believe it represents in terms of power, in execution, more resources and more of potential in developing these products. So I've always seen the Servier partnership and the Pfizer/Allogene partnership as huge potential for Cellectis even if CD19 and DCMA that was considered as the most generated targets that have been licensed to them. I don't think that it's only by BCMA19 I think that UCART22, CS1, 123, 20x22, FAP, MUC1 et cetera, represents a huge potential for Cellectis as a wholly controlled targets for us but also heal. Nevertheless, Cellectis has find since then two partnerships. First one was tumor infiltrating lymphocytes, Iovance TALEN, and we believe that this partnership brings a lot of potential for Cellectis and also for our Iovance. In terms of the development of our gene editing technology in tumor infiltrating lymphocytes, we're not experts in this field, and we teamed up with the best company in the world to the tumor infiltrating lymphocytes and I believe that Iovance is about to solve the problem they have into like this quality and also I’ll leave it to the Iovance team to answer this question, but also recently in NK cells that are derived from IPS cells, CAR-T, so NK CAR-T that are going to be developed by Cytovia. So we're also very excited by that. On our own portfolio, we've been very much focusing on trying to push that forward in the clinic as much as we can with the resources we have. Nevertheless, we believe that Cellectis have the potential imparting, because there is some options to develop some of these products, and the potential of Cellectis and producing them with the manufacturing, for clinical supplies, but also commercial supplies, opens the gate to bigger biopharma partnering in the future. And this is something we definitely consider to remain very opportunistic in the field. And it depends on what can be considered in the future. And Cellectis is definitely poised in consider any type of partnership in this field. I'm not going to emphasize on this because we're like series of discussion and questions on this – in the field. And we definitely remain very open, very opportunistic. But we will definitely continue also to sell the swap on portfolio because we're saying that this will provide probably the best value and consideration for the company in the future.

Okay, great. Thanks, Andre. And then just one follow-up on [indiscernible]. This is obviously a very elegant and perhaps differentiated mechanism to address Sickle Cell disease. Based on that, I guess, how would you expect the product, clinical profile perhaps to differentiate from some of the other programs out there beta gene editing or the gene therapy program? André Choulika: Well, thank you, Michael for this question. Well, you have a series of different type of approaches. The first approach is the classical gene therapy approach that is pursued by one of our competitors in the space, believe the Sickle Haemoglobin inside the cells and plus bring another gene that is going to start producing normal haemoglobin, the Sickle Haemoglobin will remain in the cell. This is random insertion of the gene inside the cell that can insert sometimes in low side produces the haemoglobin gene like beta HPV genes directly, sometimes it will be inserted in some places where there are silencing or wobbling, so the expression will not be consistent, or sometimes insertion could induce some side effects into the metabolism of the cell that could be potentially harmful. So we consider this option even though close to commercialization will represent a window in this spectrum of approaching power hemoglobinopathies in general. So I don't think that this type of classical transgenesis approaches without fixing hemoglobin will prevail. So it would be an intermediate. We have the second approach which represents more the use of DNA scissors. I'm not speaking here you would notice about gene editing because gene editing means editing the text. You go -- so people consider that gene editing is getting into the cell and edit the mistake. Most of these approaches are fixed on destroying the gene which is BCL11A, which is a reflector therefore presses the expression of peoples’ hemoglobin. So same case as before, you keep the sickled hemoglobin inside the cell, so the problem remains the same, but you lift the expression of T2 hemoglobin, that could compensate for the sickling hemoglobin inside the cell. So I destroy a gene. I don't fix the problem, I just destroy gene to try to imbalance the way -- the cell behave. And that obviously works also. But I also consider that this is going to be a parenthesis in the field of therapies in the field. And then you have selective approach, Q-approach, which is a bonafide gene editing approach. You have a mutation in the hemoglobin B-gene, you get inside the cell. You clean the mutation itself and repair the mutation with a patch that would fix the DNA. So really do true editing. Its means you remove the mutation, and the mutation will be removed from the cell. And the normal physiological hemoglobin will be expressing at this time in a very high and very efficient way. And this is what we believe would represent in the 21st century, the future of these types of gene editing approaches, which are a true editing of the mutation inside the cell. Not trying to, for example, if you have a flat tire, at the side tire to the car, but a real fixing the gene, it means you remove the flat tire and put a real tire to the fourth tire -- four tires to the car to move forward. That's the kind of comparison that we have here. And that's why we believe that these cells will behave totally normal with normal adult hemoglobin at the end. So selectors -- pursuing this approach, we'll find probably in 2021, the first IND in the field 2022 -- sorry, not 2021 in the field. Of course, our submission this field, but not that much it requires a lot of power. It means the ability to target will precisely -- the mutation and the hemoglobin B-gene, shifting with a very high efficiency, the hemoglobin gene -- B-gene at the very high level, without inducing some thalassemia mutation, which is beta-zero hemoglobin so destroying the hemoglobin itself. And at the end, like this, I think has the best by far technology in this field. And that's why we believe that the [indiscernible] platform would definitely change the game as a – the game changer in the field of gene therapy and gene editing. Q –: Great. Thanks, André.

Our next question is from the line of Kelly Shi with Jeffries. Please proceed with your question.

Thank you for taking my questions. My first question is about your new program targeting CD20 and the CD22 simultaneous. I'm curious, what is the rationale to pursue this dual targeting strategy? What are the expression levels relative to CD19 bodies to antigen? And also, how widely they are expressed? Are they complimentary to each other? And also, another question is about the UCARTCS1 program, for how long the lymphopenia was observed in this program? And I wonder if this is caused by CS1s ubiquitous expression, not only to B cells but on T cells, Dendritic cells and NK cells like autoimmune cells? And how do you address this issue moving forward? Thank you. André Choulika: Thank you so much, Kelly. I think these two questions definitely fits Carrie’s space, so Carrie, please if you – okay.

Absolutely. Both CD20 and CD22 are validated targets in B cell malignancies and they're just as frequently, if not more, commonly expressed than CD19. So as you all well know, rituximab, which is the ubiquitous treatment for all B cell malignancies, particularly for NHL is this -- target CD20. CD22 is similarly expressed, so they’re -- in NHL they’re expressed at more than 90% of patients. And the idea, obviously, of having two targets is, number one, you can prevent antigen escape, if you lose one or the other. You also have increased synapses between the CAR-T and the tumor cell, which should end up with a better expansion and because of the synapse. So we think 20 by 22 is an excellent target for NHL. And it can also be used in a broad T cell malignancies space, because 20 and 22 our Express from early -- the early B cells through more mature. So that's the rationale for that. And then in terms of CS1, so, yes, we did see some prolonged lymphopenia in one of the patients and theoretically it could be due to the CS1 expression, because as you point out correctly, CS1 is expressed on multitude of other immune cells. But at this point, we don't know yet what -- we don't know exactly why the lymphopenia was as long as it is, we also know from autologous CAR-Ts that are not in BCMA. So non-CS1 expressing CAR-Ts that people and patients who receive them can have prolonged lymphopenia out for six months. So -- and six months or more. So it's unclear 100% if that's the reason, but that said, we've updated our protocol, we have lower doses of the lymphodepletion chemotherapy and monitoring for infectious causes. And we'll keep moving with the program and see how things pan out.

Thank you very much. Very helpful.

The next question is from the line of Yigal Nochomovitz with Citi. Pleas proceed with your question.

Hi. Great. Thank you very much for taking the question. I'm curious about the UCART MK1 [ph] product candidate with multiple arrays, which is a fascinating product. And I'm curious about UCART MK1 specifically from an IP perspective. And the reason I'm asking is that there's another company Caribou, that recently went public, that also has a product with the PD-1 knockout in their CD19 CAR-T product as well as a beta-2 microglobulin knockout with an HLA-E knock in to provide in cloaking, which appears also very similar to what you were doing with UCART MK1 [ph]. So based on that, I'm just wondering, where do you stand from an IP protection perspective with respect to some of these edits in ECART MK1? Thank you. André Choulika: Thank you so much Yigal for this question. Its very much appreciated. I tend not so much to command the IP situation for obvious reasons. But the fact is that Cellectis has been long time in the field of gene-editing. And the company has been founded in 1999. In gene-editing in the lapping series of different types of approaches with gene editing using as the basis negative phases, we've been also developing a series of different types of approaches with PON [ph], since 2013, even March 2013, so before Caribou, or any type of company even had the ID of being incepted at this time, we were already filing IP and crystal side. So I strongly believe that Cellectis has a very strong position in the field. And we have very, like strong merit in developing these type of approaches. We can see the history of the company since at least 10 years in the field or 10 years, even if you want to take whole history of the company, 21 years, and all these ideas are flocking out, all these years and developing all these strategies. And in the product development including MK1 and all the attributes that are included in that makes these development of our patent portfolio strategy extremely strong. Nevertheless, you know, we're still old companies in the clinical or preclinical developing phase. And the thing will be solved at the time it will start to be commercialized. So, I guess, all this space around those tentative competing technologies that seems very easy to approach intellectually, I don't think that it's easier to approach technically but it seems to be more approachable, intellectually. We'll start to resolve at the time the first product will come to commercialization. And I think it's going to be a more different and more complex approach at this time. But for the time being, I just filled in the safe harbor situation, the thing seems to be quite simple for our competitor. So I will keep it here, but I think that it's like they have a very one off the – like the first company in the field of like developing gene editing tools in the space and very strong competition in this space, and we're not going to compromise on the skill.

Great, thanks. And just one follow-up on an unrelated topic, regarding your solid tumor strategy. How much can you say at this point regarding, which cell tumors you would tackle first given your product candidates have a certain solid tumors that would make more sense to start with. André Choulika: The first target that will probably go into the clinic is something that seems to be quite already tackled with mesothelin CAR-T which is our mesothelin CAR which have a series of attributes in there including TGFβ receptor knockout, and all mesothelin-expressing in tumor come from mesothelioma and pancreatic cancer et cetera for a series of different types of indications will be probably the first CAR-T to go into clinic.

Got it. Thank you. André Choulika: Thank you, Yigal.

The next question is from the line of Jack Allen with Baird. Please proceed with your questions.

Hi. Thank you so much for taking the questions. Congratulations all progress. I guess, the start we were wondering, if you provide some more color with respect to the progress you are making with UCARTCS1. It sounds like based on the press release you are still in the dose level minus one cohort, any color you can provide to reflect the number of patients enroll since the re-initiation of the study? And when might the dose level? Thank you. André Choulika: Carrie, do you want to take this question.

I can take the question on. We're progressing – progressing well in the clinic, I don't want to disclose specific numbers of exactly where we are and what we're doing. But what I can say is that, we reopened after the whole with those changes I mentioned earlier. Most importantly, with the lower dose of f lymphodepletion chemotherapy and starting at dose of those e MELANI-01. So those are the two big things. One of the other requirements is also the FDA is requiring long safety watching periods. So we are – the dose escalation is slow. But we have our sights on board. We're very, very active investigators looking with patients and I don't foresee recruitment being an issue, what I see being issues that are the requirements to hold in between patients. What I'm very optimistic about is as we gather more data, being able to discuss that with FDA potentially in the future moving into long faster things are continuing to look safe. So to be continued.

Awesome. That sounds great. And then sorry, I just have one quick follow-up question. On the financial side, it appears you're pretty well lined up to receive milestones from the allogeneic in February – by the end of the year due to the initiation of the pivotal CD19 program? I was wondering if you provide any more color with respect to the size of that milestone, and how you're going to account for it is going to be a one-time benefit to probably the fourth quarter this year, it will be amortized across a number of quarters? Thank you so much. André Choulika: Eric, this is a question for you.

Thank you very much for the question. Depending on when allogeneic will stop the study, if they stop at the end of – fourth quarter of 2021 will organize the overview in terms of payments could be between as of 2021 or beginning of 2022. Based on the payment terms, but the revenue will be recognized in 2021. The size of the milestone has not been disclosed today. And it's still a confidential information. Sorry about that.

No, problem. Thank you so much for the answers.

Thank you. The next question comes from the line of hearted Hartaj Singh with Oppenheimer. Please proceed with your question.

Great. Thank you for the and the updates. I just have a question on your UCART22 and UCARTMESO and that is, UCARTMESO is for solid tumors and 22 is a circled by specific dual CART products. If you can just comment, André, on what are the sort of the differences in your preclinical and manufacturing between these two, as you get them into the clinic next year, trying with the IND. What are difference steps or maybe additional steps you have to take with addressing dual CART and another one that targets solid tumors. Are there any, and if so, what are those? Thanks for the question. André Choulika: Thank you very much, Hartaj. Hi, it’s André. Thank you very much for the question. So UCART22 and UCART123 and UCART20x22 are all based on the same type of platform. So they're very similar, all of them, because they are built the same way. They have the CART that is added by lentiviral vector for the dual CART. So 123 and 22 built -- have the CAR that is embedded in the lentiviral vector plus [Indiscernible] A that is to suicide switch. For 20x22, we’ve made the suicide switch and replaced it by another CAR. So you have 20 and 22 that are expressed in the same lentis, so pretty much the same. So you always add first lenti. Then you have a double knockout that happens, which is CD52 TCRalpha, same platform. So 22 – 20x22, 123, no difference. Any kind of operator would not see even the difference. It’s essentially the quality control that makes a difference. So like the building the CAR is extremely similar, and very much straightforward, and you know very well how to do it. [Indiscernible] which is the first solid tumor CAR is slightly different and requires maybe one level up in term of complexity, because it's as a third knockout. So it is offline CAR, CD52 TCRalpha plus Beta2 to or knockout. So it's a third knockout is added to the mixture, which makes things slightly more complicated. And you have to make a serial knockout series in order to prevent some translocation. And I think selected in mastering the proportion technology because the only technologies there allow us to develop these types of process in a very efficient way. And we're very excited to start the production of the modeling to file IND next year not 2021, as I said before, probably in 2022.

Great André. This is all very, very cool stuff. Just -- there's just a general question, which is that your facility Raleigh, it looks like they were able to run the first time. Like other companies do manufacturing days, are you thinking of doing something like that also for investors? And again, if so, when could we see that? Thanks for all the questions. André Choulika: Thank you, Hartaj for this question. The answer is, yes. We have the plan to organize live visit of our manufacturing facility in Raleigh. I think definitely it's worth the visit, because we believe, it's a state-of-the-art, cell and gene therapy manufacturing plant that combines not only gene addition, but also gene editing with a very powerful way to do it, with very sophisticated and modern way to produce cell and gene therapy in the space. So that will be organized probably in the third quarter of this year and this third or fourth quarter actually you like probably in three months from now. And we'll definitely send a save the date for old investor and analyst community and everyone that you'd like to visit this facility. But we believe is setting the trend and to what will be the modern way to do this type of therapies in the future.

Great. Thank you.

Next question comes from the line of Raju Prasad with William Blair. Please proceed with your questions.

Hi, this is Sami on for Raj. Thanks for taking our questions. I was wondering, if you could provide an update regarding, where you're at in terms of enrollment and dosing in the UCART123 trial, and when we could expect updated data from that trial? And then also for your cell and gene programs, how are you guys thinking about lymphodepletion and dosing? Thank you.

Well. Thank you so much for these questions. And Carrie I guess these questions are addressed to you.

Sure. I'll start -- thanks so much. So I'll start with UCART123. So as we previously discussed at earlier meetings, we remain in the dose-escalation phase for UCART123. We had switched over to open the cohorts that include inotuzumab earlier -- late last year and so those are continuing to involve. And we're hoping to see some data, some probably first half or in early second half of next year. In terms of the solid tumor, lymphodepletion as our first program, as André pointed out would be the UCART T-cell and that is utilizing the CD52 knockout. So we would be using similar lymphodepletion to what we're doing now for the Hematologic alignancies Program, but maybe its not exactly the same. But we wouldn't be using choosing that route with this product. And in terms of dose, we haven't disclosed what we're doing with the doses at this time.

Thank you. We've reached the end of our question-and-answer session, I'll turn the floor over to management for closing remarks.

Well, thank you very much. I'd like to thank everyone for this -- for attending the session like this Q&A session. Those are excellent question. One of the things, I'd like to say is that, the company has definitely hit a turning point in the start of our own manufacturing, going from like DNA to Messenger RNA to CAR-T that started to produce in our Relay Manufacturing Facility. We're super excited. We're extremely excited by the program we have in the clinic, but also by the personal programs we have, either on the CAR-T side, but also on the gene therapy and the heal side, that marks a new term in the company. Second half of 2022 will be a very exciting time. And by the end of this year, the company will start producing series of data and a very exciting runway in 2022. So thank you very much for all your attention, and looking forward to the next step.

This will conclude today's conference. You may disconnect your lines at this time. And thank you for your participation.