Greetings. Welcome to Cellectis' Second Quarter 2021 Earnings Call. At this time, all participants will be in listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. At this time, I'll now turn the conference over to Eric Dutang, Chief Financial Officer. Eric, you may now begin.
Thank you. 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 U.S. 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 2nd quarter and six-month period ending June 30th, 2021. The report and press release are available on our website at cellectis.com. As a reminder, we 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 forecasts.
A description of these risks can be found on our most recent Form 20-F filed with the SEC and the financial report for the year ending on December 31st, 2020, and subsequent filings Cellectis makes with the SEC from time to time. I would like to turn the call over to André.
Thank you, Eric. Good morning, and thank you everyone for joining us today. Despite challenges the world is facing, Cellectis has achieved 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 this first half 2021, we have made significant progress on all fronts that we're thrilled to share with you over this next half an hour. Today, we believe that Cellectis is reaching a turning point and is entering into a new phase of its 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 I dose-escalation trial for our three clinical stage wholly owned product candidate.
UCART22 in BALLI-01 for relapsed or refractory B-cell lymphoblastic leukemia. UCART123 in AMELI-01 for relapsed or refractory acute myeloid leukemia. 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 of UCARTCS1 at the virtual American Society of Gene & Cell Therapy, for the 24th annual meeting. Early preliminary data validates CS1 as a target for allogeneic CAR T-cells 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 dose level minus one, the first of the three planned dosage level. We organized 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 presented a clear view into our pipeline of new product candidates, our gene editing platform, our electroporation technology, as well as our end-to-end state-of-the-art internal manufacturing capabilities. These new immunology product candidates include UCART20x22, the first allogeneic dual CAR T-cell candidate product for B-cell malignancy. The power of UCART20x22 is that it is not yet another CD19 product. CD19 is an overcrowded target space, UCART20x22, with the power of dual CAR, can address all patients with B-cell malignancies, including the one not responding to the numerous CD19 targeting treatment. In addition, we also presented UCARTMESO targeting mesothelin expressing solid tumors, and UCARTMUC1 targeting mucin 1, expressing epithelial cancer.
We presented UCARTFAP, a fairly innovative mechanism to pursue solid tumor through targeting cancer-associated fibroblasts, CAF, in the tumor microenvironment, which has the potential to turn a cold tumor hot. We plan to file INDs of UCART20x22 and UCARTMESO 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 with 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 on the mutation at the sickle cell disease coding hemoglobin subunit beta HBB gene, and an 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 are 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 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. We agreed to enter into discussions to execute the commercial supply of alemtuzumab under pre-agreed financial conditions.
In our Paris GMP manufacturing facility, manufacturing of plasmids, the starting material with DNA matrices, is now fully operational. One very critical element was the production of messenger RNA coding TALE 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 vial drug product, and we have started midyear production of first batches. Manufacturing independence 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 is a state-of-the-art biotechnology company with the product development process mastered from A to Z, including the construction of our proprietary electroporation devices to the production of buffers up to the vial final 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 the financials for the quarter. Eric, please go ahead.
Thank you, Andre. Before I provide a brief overview of our financials for the second quarter on the first six months of 2021, I'd like to highlight some of our business development activities in 2021. At the beginning of 2021, we announced our alliance with Cytovia, which includes up to $760 million of development, regulatory, and sales milestones, and we are eligible to receive single-digit royalty payments on the net sales of all partners' products commercialized by Cytovia. 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 31st, 2021, as well as an option to invest in future financing rounds.
With respect to our alliance with Allogene, in 2021, we received a $5 million milestone payment from the launch of its HARPER study of ALLO-316 in renal cell carcinoma. As a reminder, we are eligible to receive $4 billion in disclosed development and sales milestones, plus royalty on sales from our partner Allogene, Servier, and Cytovia. Regarding our financials, the cash equivalents, current financial assets, and restricted cash position of Cellectis, excluding Calyxt, as of June 30th, 2021, was $238 million compared to $244 million as of December 31st, 2020.
This difference mainly reflects EUR 59 million of net cash flows due to operating, investing, and net financing activities, which were partially offset by EUR 46 million of net equity proceeds raised from the company's ATM program in April 2021 and EUR 11 million proceeds from the stock option exercise. This cash position is expected to be sufficient to fund selected standalone operations into early 2022. This runway discounts any future milestone payments. The consolidated cash equivalents, current financial assets, and restricted cash position of Cellectis, including Calyxt, was EUR 257 million as of June 30th, 2021, compared to EUR 274 million as of December 31st, 2020. The net cash flow used in operating capital expenditures and leases were EUR 59 million at Cellectis and EUR 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 a net income of $3 million in 2020. This $46 million decrease in the net results between 2021 and 2020 was primarily driven by a decrease in revenue and other income of $25 million, or an increase in R&D expenses of $19 million. The consolidated net loss attributable to shareholders of Cellectis, including Calyxt, was $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 stock-based 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 wholly-owned product candidates in the clinic and operating our state-of-the-art manufacturing facilities in Paris and in Raleigh. On the other hand, our focus on maintaining an efficient corporate infrastructure should enable more limited growth in G&A spend. With that, I would like to hand the call back over to André for concluding remarks. André, please go ahead.
Thank you, Eric. At Cellectis, we continue to leverage our groundbreaking gene editing platform to develop novel proprietary medicines to transform the lives of patients with serious diseases. Our current proprietary clinical stage programs are focused on patients with advanced hematologic malignancies. We continue to advance our 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 HEAL product candidates in 2022. With that, I would like to open the call for Q&A.
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? What kind of a data package will you be presenting? Second question is regarding your .HEAL, a new technology that seems very impressive. So far, most of the indications are focusing on the ex vivo system. Just wondering if you have any thoughts to move this technology to the in vivo system.
Hi, Gena. Thank you very much for these questions. Those are excellent questions, by the way. My suggestion is maybe to have Carrie answering the first question, and I'll take the second one. Carrie, please, for your question.
Sure. That's perfect, André. Yep. Hi, Gena. We're aiming to present the data at ASH. 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. The lymphodepletion, that 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.
Thank you, Carrie, for answering the first question. I'll take the second one. Concerning .HEAL, Gena, we are, of course, focusing on gene editing to fix genes. What is a real, genuine gene repair, as we've shown it for the sickle cell disease program called TALGlobin01. The idea that we have today is trying to move stepwise. We have our first platform for the gene therapy product that will be focusing on hematopoietic stem cells at first. That's the first focus we have, because it will give us a lot of insight on the way it's functioning and also on the way we can conduct all the quality control and the safety of the products in general, and how the TALEN can behave and tolerate itself for a long time.
Most of the products we are developing today are based on this ex vivo platform in hematopoietic stem cells at first. We are currently working on the phase II, that we have not disclosed during this Innovation Date, that I hope will be the new next generation product that will be in vivo. In vivo is part of Cellectis strategy, of course. Once we'll have some very good in vivo and clearance on the safety and the efficacy of our technology ex vivo with HSC, with all the control and the quality that can be applied on this type of platform because for injection, then we'll move stepwise into in vivo.
You've seen recently series of articles in Nature magazine, et cetera, that show that there are some things to be checked with such as off-target cleavage, genotoxicity, et cetera, that can happen with lot of alternative gene editing technology. We believe TALEN is an extremely safe and efficient technology to conduct in vivo gene therapy. As TALEN are vectorized in messenger RNA, and messenger RNA is not a ribonucleoprotein particle, as most of competing technology, it opens some gates that are very powerful for the company, and we're very excited on moving forward in this ex vivo platform that will definitely pave the way for the in vivo gene therapy that we have. Stepwise is definitely the way we would like to move forward. I hope that answered the question.
Yes. Thank you.
Thank you, Gena.
Next question is from the line of Michael Schmidt with Guggenheim. Please proceed with your question.
Hey, guys. Good morning. Thanks for taking my questions. I had a big picture question first. Obviously you have a lot going on pre-clinically with programs now spanning CAR T as well as genetic diseases, et cetera. I'm just wondering how you think about, longer term, your partnering strategy. Historically, obviously you 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.
Thank you very much, Michael, for this question that is not a simple question because when I take the history of the company in the past, 2014 has been a very fruitful partnering year as we signed two partnerships. In February 2014, Servier partnership where we licensed UCART19 to Servier for all B-cell malignancies, in general, everything but the CD19 targeting. Servier in end of 2015 licensed out the U.S. rights to Pfizer at this time. In June 2015, in 2014, we signed this agreement with Pfizer licensing out 14 targets or 15 targets to Pfizer, including BCMA or like CD72, et cetera. Pfizer decided later to spin out into a company called Allogene, and that had also the CD19 right in the U.S.
To date, I have the feeling that there was more credit in our Cellectis on the fact that we licensed our targets to third parties than the potential that I believe it represents in term of power, in execution, more resources, and more potential in developing these products. I always seen the Servier partnership and the Pfizer/Allogene partnership as a huge potential for Cellectis, even if CD19 and BCMA that were considered as the most realistic targets that had been licensed to them. I don't think that it's only led by BCMA 19. I think that UCART22, CS1, 123, 20x22, Votolimod, SAB, MUC1, et cetera, represent a huge potential for Cellectis as a wholly controlled target for us, but also here. Nevertheless, Cellectis has signed since then two partnerships.
First one was in tumor-infiltrating lymphocytes with Iovance Therapeutics. We believe that this partnership brings a lot of potential for Cellectis and also for Iovance in terms of the development of our gene editing technology in tumor-infiltrating lymphocytes. We're not experts in this field. We teamed up with the best company in the world to develop tumor-infiltrating lymphocytes. I believe that Iovance is about to solve the problem they have and to this quality stuff that I leave it to the Iovance team to answer the question, also recently in NK cells that are derived from iPSC, CAR-T, so NK CAR that are going to be developed by Cytovia. We're also very excited about this. On our own portfolio, we've been very much focusing on trying to push them forward in the clinic as much as we can with the resources we have.
Nevertheless, we believe that Cellectis have the potential in partnering because there is some option to develop some of these products and the potential of Cellectis in producing them with the manufacturing for clinical supplies, but also for commercial supplies, open the gate to a bigger biopharma partner in the future. This is something we definitely consider, but we remain very opportunistic in this field. It depends of what can be considered in the future, and Cellectis is definitely poised to consider any type of partnership in this field. I'm not going to emphasize on this because you have a series of discussion and questions in this field. We'll definitely remain very open, very opportunistic, but we will definitely continue also to self-develop our own portfolio because we think that this will provide probably the best value and consideration for the company in the future.
Okay, great. Thanks, André. Just one follow-up on TALGlobin01, 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's clinical profile perhaps to differentiate from some of the other programs out there, be it gene editing or the gene therapy programs?
Thank you, Michael, for this question. 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 this space. You leave the sickled hemoglobin inside the cells and just bring another gene that is going to start producing normal hemoglobin, but the sickled hemoglobin will remain in the cell. This is random insertion of the gene inside the cell that can insert sometimes in one side produces the hemoglobin gene, like HBB gene correctly. Sometimes it will be inserted in some places where there are silencing or wobbling, so the expression will not be consistent. Sometimes insertion could induce some side effects into the metabolism of the cell that could be potentially harmful.
We consider that this option, even though it's close to commercialization, will represent a window in the spectrum of approaches toward hemoglobinopathies in general. I don't think that this type of classical transgenesis approaches without fixing hemoglobin will prevail. It will be an intermediate. You 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. People consider that gene editing is getting into the cell and edit the mistake. Most of these approaches are fixed on destroying a gene, which is BCL11A, which is a repressor that represses the expression of fetal hemoglobin.
Same case as before, you keep the sickled hemoglobin inside the cell, so the problem remains the same, but you lift the expression of fetal hemoglobin that could compensate for the sickling hemoglobin inside the cell. I destroy gene, I don't fix the problem. I just destroy gene to try to imbalance the way the cell behaves, and that obviously works also. I also consider that this is going to be a parenthesis in the field of therapies in the field. Then you have Cellectis approach, gene approach, which is a bonafide gene editing approach. You have a mutation in the hemoglobin B gene. You get inside the cell. You cleave the mutation itself and repair the mutation with a patch that will fix the DNA. Really do true editing.
It 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. 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, add the fifth tire to the car, but really fixing the gene. It means you remove the flat tire and put a real tire to the four tires, so the car can move forward. That's the kind of comparison that we have here. That we believe that these cells will behave totally normally with normal adult hemoglobin again. Cellectis is pursuing this approach.
We will file probably in 2021, the first IND in the field. 2022, sorry, not 2021, in the field. There's competition in the field, but not that much. It requires a lot of power. It means in the ability to target very precisely the mutation in the hemoglobin B gene, fixing with a very high efficiency, the hemoglobin B gene at a very high level, without inducing some thalassemic mutation, which is beta-zero hemoglobin, so destroying the hemoglobin itself. At the end, Cellectis, I think, has the best by far technology in the field, and that's why we believe that the .HEAL platform will definitely change the game. It's a game changer in the field of gene therapy and gene editing.
Great. Thanks, André.
Our next question is from the line of Kelly Shi with Jefferies. Please proceed with your question.
Thank you for taking my questions. My first question is about your new program targeting CD20 and CD22 simultaneously. I'm curious, what is the rationale to pursue this dual targeting strategy? What are the expression levels relative to CD19 for these two antigens, and also how widely they are expressed? Are they complementary to each other? Another question is about your CAR CS1 program. Prolonged lymphopenia was observed in this program, and I wonder if this is caused by CS1's ubiquitous expression not only to B cells, but on T cells, dendritic cells, and NK cells, like other immune cells. How do you address this issue moving forward? Thank you.
Thank you so much, Kelly. I think these two questions definitely fit Carrie, in space. Carrie, please, 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. As you all well know, rituximab, which is the ubiquitous treatment for all B cell malignancies, particularly for NHL, is targeting CD20. CD22 is similarly expressed. They're, in NHLs, expressed in more than 90% of patients. 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. We think 20 by 22 is an excellent target for NHL. It can also be used in a broad B cell malignancy space because 20 and 22 are expressed from the early B cells through more mature.
That's the rationale for that. In terms of CS1, 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 a multitude of immune cells. At this point, we don't know exactly why the lymphopenia was as long as it is. We also know from autologous CAR Ts that are not anti-BCMA, so non-CS1 expressing CAR Ts, that people and patients who receive them can have prolonged lymphopenia out for 6 months or more. It's unclear 100% if that's the reason. That said, we've updated our protocol. We have lower doses of the lympho-depletion 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. Please proceed with your question.
Hi. Great. Thank you very much for taking the question. I'm curious about the UCARTMUC1 product candidate with multiple edits, which is a fascinating product. I'm curious about UCARTMUC1 specifically from an IP perspective. The reason I'm asking is that there's another company, Caribou, that recently went public that also has a product with a PD1 knockout in their CD19 CAR T product, as well as a beta-2 microglobulin knockout with an HLA knock-in to provide immune cloaking, which appears also very similar to what you are doing with UCARTMUC1. Based on that, I'm just wondering, where do you stand from an IP protection perspective with respect to some of these edits in UCARTMUC1? Thank you.
Thank you so much, Yigal, for this question. It's very much appreciated. I tend not so much to comment the IP situation for obvious reasons. The fact is that Cellectis has been long-term in the field of gene editing, and the company has been founded in 1999 in gene editing and developing series of different type of approaches with gene editing using as the basis meganucleases. We've been also developing series of different type of approaches with TALEN. Since 2013, even March 2013, before Caribou or any type of company even had the idea of being incepted at this time, we were already filing IP on the CRISPR side. I strongly believe that Cellectis have a very strong position in the field, and we have very 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 20 years even, if you want to take whole history of the company, 21 years. All these ideas of knocking out all these genes and developing all the strategies and the products development, including MUC1 and all the attributes that are included in, that makes this development of our patent portfolio strategy extremely strong. Nevertheless, we're still early company in the clinical or preclinical development phase. The thing will be solved at the time the first product will start to be commercialized. I guess, all the space around kind of this computing technology 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, will start to resolve at the time the first product that come to commercialization, and I think it's going to be a more different, more complex approach at this time. For the time being, as we talked in the safe harbor situation, this thing seems to be quite simple for our competitor. I will keep it here, but I think that Cellectis has a very, as one of the only first company in the field of developing gene editing tools in the space, and very strong position in this space, and we're not going to compromise on this field.
Great. Thanks. Just one follow-up on an unrelated topic. Regarding your solid tumor strategy, how much can you say at this point regarding which solid tumors you would tackle first, given your product candidates? Are there certain solid tumors that would make more sense to start with?
The first target that will probably go into the clinic is something that seems to be quite already tackled, where the target is CAR T, which is a mono-offering CAR, which have series of attributes in there, including TGF-β receptor II knockout, and for all mesothelin and metastatic tumor that comes from mesothelioma and pancreatic cancer, etcetera. A series of different types of indications will be probably the first CAR T to go in the clinic.
Got it. Thank you.
No problem.
The next question is from the line of Jack Allen with Baird. Please issue your questions.
Hi. Thank you so much for taking the question, and congratulations on all progress. I guess to start, we were wondering if you could provide some more color with respect to the progress you're making with UCARTCS1. It sounds like based on the press release, you're still in the dose level -1 cohort. Any color you could provide with respect to the number of patients enrolled since the reinitiation of the study, and when might the dose be able to escalate there? Thank you.
Carrie, do you want to take this question?
I can take the question. We're 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 hold with the changes I mentioned earlier. Most importantly, with the lower dose of the lymphodepleting chemotherapy and starting at dose level - 1. Those are the two big things. One of the other requirements is also the FDA is requiring long safety watching periods. The dose escalation is slow, but we have our sites on board. We're very active investigators with patients, and I don't foresee recruitment being an issue. What I see being the issue is about the requirements to hold in between patients.
What I'm very optimistic about is as we gather more data, being able to discuss it with FDA potentially in the future, moving things along faster if things are continuing to look safe. To be continued.
Awesome. That sounds great. Sorry, just have one quick follow-up question.
On the financial side, it appears you're pretty well lined up to receive a milestone from Allogene in February, by the end of the year, due to the initiation of the pivotal CD19 program. I was wondering if you could provide any more color with respect to the size of that milestone and how you're going to account for it. Is it going to be a one-time benefit to probably the fourth quarter this year, or it will be amortized across a number of quarters? Thank you so much.
Eric, this is a question for you.
Thank you very much for the question. Depending when Allogene will start the pivotal studies, if they start at the end of fourth quarter of 2021, we'll recognize the revenue in term of payments could be between end of 2021 or beginning of 2022, based on the payment terms. The revenue will be recognized in 2021, if they start.
The size of the milestone has not been disclosed today. 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 Hartaj Singh with Oppenheimer. Please share your question.
Great. Thank you for the question and the updates. I just have a question on UCART22 and UCARTMESO. That is, UCARTMESO for solid tumors 22 is a sort of a bispecific dual CAR T product. 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 in 2020 with the IND, what are the different steps or maybe additional steps you've had to take with addressing a dual CAR T, and another one that targets solid tumors? Are there any? If so, what are they? Thanks for the question.
Thank you very much, Hartaj. Hi, André. Thank you very much for the question. UCART22, UCART123, and UCART 20 by 22 are all based on the same type of platform. They're very similar, all of them, because they are built the same way. They have the CAR that is added by lentiviral vector or the dual CAR. 123 and 22 have the CAR that is embedded in the lentiviral vector, plus also our RQR8 suicide switch. For 20 by 22, we removed the suicide switch and replaced it by another CAR. You have 20 and 22 that are expressed in the same lenti. It's pretty much the same. You always add first lenti, then you have a double knockout that happens, which is CD52 TCR alpha, same platform. 22, 20 by 22, 123, no difference.
Any kind of operator would not see even the difference. It's essentially the quality control that makes a difference. Like the building the CAR is extremely similar and very much straightforward, and we know very well how to do it. The docking, which is the first solid tumor CAR, is slightly different and requires maybe one level up in terms of complexity because it adds a third knockout. It's the resulting CAR CD52 TCR alpha plus TGFBR2 knockout. It's a third knockout that is added to the mixture, which makes the things slightly more complicated, and you have to make a serial knockout series in order to prevent some translocation.
I think Cellectis has been mastering the electroporation technology because we own these technologies that allow us to develop these type of process in a very efficient way, and we're very excited to start the production of the docking to file the IND next year. Not 2021, as I said it before, but probably by 2022.
Yep. A great honor. This is all very cool stuff. Just a general question, which is that your facility in Raleigh looks like they're able to run the first time. Like other companies do manufacturing days, are you thinking of doing something like that also for investors? Again, if so, when could we see that? Again, thanks for all the questions.
Thank you, Hartaj, for this question. The answer is yes. We have the plan to organize a live visit of our manufacturing facility in Raleigh. I think that will be towards the visit because really, that'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. That will be organized probably in the third quarter this year. The third or fourth quarter, actually, like probably in 3 months from now. We'll definitely send a save the date for all the investor and analyst community and everyone that would like to visit this facility that we believe is setting the trend into what will be the modern way to do these type of therapies in the future.
Great. Thank you.
Next question is from the line of Raju Prasad with William Blair. Please proceed with your question.
Hi, this is Sammy on for Raj. Thank you for taking our question. 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. Also for your solid tumor program, how are you guys thinking about lymphodepletion and dosing? Thank you.
Well, thank you so much for these questions. Carrie, I guess these questions are addressed to you.
Sure. Thanks so much. I'll start with UCART123. As we had previously discussed at earlier meetings, we remain in the dose escalation phase for UCART123. We had switched over to open the cohorts that include alemtuzumab earlier or late last year. Those are continuing to enroll, and we're hoping to see some data from probably first half or early second half of next year. In terms of the solid tumors, the lymphodepletion as our first program, as André pointed out, would be the UCARTMESO program, and that is utilizing the CD52 knockout. We would be using similar lymphodepletion to what we're doing now for the hematologic malignancy program. Maybe not exactly the same, but we would be using the alemtuzumab route with this product. In terms of dosing, 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 back to management for closing remarks.
Thank you very much. I'd like to thank everyone for attending this Q&A session. There was excellent questions. 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 DNA to messenger RNA to CAR T that started to produce in our Raleigh manufacturing facility. We're super excited. We're extremely excited by the programs we have in the clinic, but also by the pipeline programs we have, either on the CAR T side, but also on the gene therapy and the .HEAL side. That marks a new trend 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.
Thank you very much for all your attention and looking forward to the next steps.
This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.