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Cellectis SA (NASDAQ:CLLS)
Q2 2021 Earnings Call
Aug 6, 2021, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Greetings. Welcome to Cellectis' Second Quarter 2021 Earnings Call. [Operator Instructions] A question-and-answer session will follow the formal presentation. [Operator Instructions]

At this time, I'll now turn the conference over to Eric Dutang, Chief Financial Officer. Eric, you may now begin.

Eric Dutang -- Chief Financial Officer

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. Andre 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 second quarter and six months period ending June 30, 2021. The report and press release are available on our website at cellectis.com. As a reminder, we'll make forward-looking statements regarding Cellectis' financial outlook, in addition to its manufacturing, regulatory, and product development plan. 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 Andre.

Andre Choulika -- Chief Executive Officer and Board Director

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 the 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 1 dose escalation trial for our preclinical 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; 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 patients enrolled for the MELANI-01 of UCARTCS1 at the virtual American Society of Gene and Cell Therapy for the 23rd -- 24th Annual Meeting. Early preliminary data validates 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 dose level minus one, the first of the three planned doses 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 technologies, as well as our end-to-end state-of-the-art internal manufacturing capabilities. These new immuno-oncology 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 and UCART20x22 with the power of dual CAR-T can address all patients with B-cell malignancies, including the one not responding to numerous CD19 targeting treatment.

In addition, we also presented UCARTMESO, targeting mesothelin, expressing solid tumors and UCARTMUC1, targeting mucin-1, expressing epithelial cancers. Finally, we presented UCARTFAP, a fairly innovative mechanism to pursue solid tumor through 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 leverage 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 on the mutation at the sickle cell disease-causing hemoglobin subunit beta, HBB gene, and in AAV that will be providing a DNA repair matrix designed to correct the faulty HBB gene homologous recombination. Cellectis plan 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 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 discussions to execute a commercial supply of alemtuzumab under pre-agreed financial condition. In our Paris GMP manufacturing facility, manufacturing of plasmids, the starting material of 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 vialed drug product, and we have started mid-year 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 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 vialed final products 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 our financials for the quarter. Eric, please go ahead.

Eric Dutang -- Chief Financial Officer

Thank you, Andre. Before I provide a brief overview of our financial for the second quarter and the first six months of 2021, I'd 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 sales milestones, and we are eligible to receive single-digit royalty payment on the net sales of all partners' 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. With respect to our alliance with Allogene, in 2021, we received a $5 million milestone payment from the launch of its TRAVERSE Study of ALLO-316 in renal cell carcinoma. As a reminder, we are eligible to receive $4 billion [Phonetic] in disclosed development and sales milestones, plus royalty on sales from our partner, Allogene, Servier and Cytovia.

Regarding our financials, the cash, cash equivalents, current financial assets, and restricted cash position of Cellectis, excluding Calyxt, as of June 30, 2021 was $238 million compared to $244 million as of December 31, 2020. This difference mainly reflects $59 million of net cash flows used in operating, investing and lease financing activities, 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 the stock option exercise. This cash position is expected to be sufficient to fund Cellectis stand-alone operations into early 2023. This runway discounts any future milestone payment.

The 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 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 revenues and other income of $25 million or an increase in R&D expenses of $19 million.

The consolidated net sales 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 candidate in the clinic and operating our state-of-the-art manufacturing facilities in Paris and Raleigh. On the -- 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 Andre for concluding remarks. Andre, please go ahead.

Andre Choulika -- Chief Executive Officer and Board Director

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. And 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.

Questions and Answers:

Operator

Thank you. At this time, we will 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.

Gena Wang -- Barclays -- Analyst

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 ASH and what kind of a data package will you be presenting? And then second question is regarding your.HEAL, a new technology, which I think is very impressive, but so far most of the indication is focusing on the ex vivo system, just wondering if you have any thoughts to meet this technology to the in vivo system?

Andre Choulika -- Chief Executive Officer and Board Director

Hi, Gena. Thank you very much for these questions, that 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, for UCART22.

Carrie Brownstein -- Chief Medical Officer

Yeah, that's perfect, Andre. Yeah, hi, Gena. 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 arms, 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.

Andre Choulika -- Chief Executive Officer and Board Director

Thank you, Carrie for answering the first question. I'll take the second one. So concerning.HEAL, Gena, we are, of course, focusing on gene-editing to fix genes. So what is a real genuine gene repair as we've shown it for the sickle cell disease program called TALGlobin01. And the IDs that we have today is trying to move step-wise. 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 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 in autologous cells for long-term. So most of the products that are developing today are based on this ex vivo platform in hematopoietic stem cells at first. And then we are currently working on the second phase that we have not disclosed during these Innovation Days that I hope will be the new -- next-generation products that will be in vivo.

In vivo is 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 HSCs with all the control and the quality that can be applied on these type of platform because [Indecipherable] reinjection, then we'll move step-wise into in vivo. You've seen recently series of articles in Nature magazine, etc., that shows that there are some things to be checked with such as like the ex off-target cleavage, can we practice, etc., that can happen with a lot of alternative gene-editing 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 ribonucleo particle as most of the competing technology, it opens some gates that are very powerful for the Company and we're very excited and moving forward in this ex vivo platform that would definitely pave the way for the in vivo gene therapy that we have. But step-wise, this is definitely the way we would like to move forward. I hope that answers the question.

Gena Wang -- Barclays -- Analyst

Thanks. Yes, thank you.

Andre Choulika -- Chief Executive Officer and Board Director

Thank you, Gena.

Operator

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

Michael Schmidt -- Guggenheim -- Analyst

Hey, guys, good morning. Thanks for taking my questions. I had a big picture question first. So, obviously you have a lot going on pre-clinically with programs now spanning CAR-T, as well as genetic diseases, etc., just wondering how you think about 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?

Andre Choulika -- Chief Executive Officer and Board Director

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, so 2014 has been a very fruitful partner year as we signed two partner -- partnership. In February 2014, Servier partnership, we 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 the U.S. rights to Pfizer at this time.

And in '20 -- like in June 2015 -- in 2014, we signed this agreement with Pfizer licensing out 14 targets -- 15 targets to Pfizer, including BCMA or like CD70, etc. But Pfizer decided later to spin out into a company called Allogene, and that had also the CD19 rights in the U.S. And to-date, I have the feeling that there was more criticism toward Cellectis on the fact that we licensed our targets to third-parties. And potentially that I believe it represents in term 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 a huge potential for Cellectis, even if CD19 and BCMA that was considered as the more generalistic targets that had been licensed to them.

I don't think that it's only hit by BCMA and CD19, I think it's UCART22, UCARTCS1, UCART123, UCART20x22, mesothelin, UCARTFAP, UCARTMUC1, etc., represents a huge potential for Cellectis as wholly controlled targets for us, but also.HEAL. Nevertheless, Cellectis has signed since then two partnerships. First one was in tumor-infiltrating lymphocytes with Iovance Therapeutics, and we believe that this partnership brings a lot of potential for Cellectis and also for Iovance in term of the development of our gene-editing technology in tumor-infiltrating lymphocytes.

We're not the expert in this field and we teamed up with the best company in the world to develop tumor-infiltrating lymphocytes, and I believe that Iovance is about to solve the problem they have into like this quality stuff. 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-cell and KCAR -- CARs that are going to be developed by Cytovia. So we're also very excited about it.

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 has the potential in partnering, because there is some options 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 opened the gate to a bigger biopharma partnering in the future. And this is something we definitely consider, but we remain very opportunistic in the field.

And it depends on what can be considered in the future, and Cellectis is definitely poised to consider any type of partnership in the field. I'm not going to emphasize on this, because we have like series of discussion and questions on this -- in this field. And so we 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.

Michael Schmidt -- Guggenheim -- Analyst

Okay, great. Thanks, Andre. And then just one follow-up on TALGlobin, this is obviously a very elegant and perhaps differentiated mechanism to address sickle cell disease. So 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 program?

Andre Choulika -- Chief Executive Officer and Board Director

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 boosted by one of our competitors in this space. You leave the sickle hemoglobin inside the cells and just bring another gene that is going to start producing normal hemoglobin, but the sickle hemoglobin will remain in the cell. This is random insertion of the gene inside the cell that can insert sometimes in low-sided produces the hemoglobin gene like the beta, HBB gene correctly.

Sometimes it will be inserted in some places where they are silencing a wobbling, so their expression will not be consistent or sometimes insertion could induce some side effect into the metabolism of the cell that could be potentially harmful. So we considered that this option, even though of close to commercialization, will represent a window in this spectrum of approaches toward 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. Yet 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 everything in the text would go. So 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 the reflector that represses the expression of sickle hemoglobin. So same case as before, you keep the sickle hemoglobin inside the cell, so the problem remains the same, but you lift the expression of fetal hemoglobin that could compensate for the sickle hemoglobin inside the cell.

So I destroy a gene, I don't fix the problem, I just destroy a gene to try to imbalance the way like the cell behaves 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 Cellectis approach,.HEAL approach, which is a bona fide 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, whereas a patch that would fix the DNA. So 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.

And this is what we believe would represent in the 21st century the future of these type 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 with 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 normally with normal adult hemoglobin at the end. So Cellectis is pursuing this approach, will file probably in 2021 the first IND in the field -- 2022, sorry not 2021 in the field.

Of course, there is competition in this field, but not that much. It requires a lot of power. It means the ability to target very precisely the mutation in the hemoglobin B gene, fixing with a very high efficiency, the hemoglobin gene -- B gene at the very high level, without inducing some thalassemic mutation, which is beta zero hemoglobin, so destroying the hemoglobin itself. And at the end, Cellectis I think has the best by far technology in this field, and that's why we believe that this.HEAL platform would definitely change the game. It's a game changer in the field of gene therapy and gene editing.

Michael Schmidt -- Guggenheim -- Analyst

Great. Thanks, Andre.

Operator

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

Kelly Shi -- Jefferies -- Analyst

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 bodies to antigens, and also how widely they are expressed, are they complementary to each other? And also another question is about UCARTCS1 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 T-cells, dendritic cells and NK cells like autoimmune cells, and how do you address this issue moving forward? Thank you.

Andre Choulika -- Chief Executive Officer and Board Director

Thank you so much, Kelly. I think these two questions definitely fits Carrie's space. So Carrie, please, if you...

Carrie Brownstein -- Chief Medical Officer

Sure.

Andre Choulika -- Chief Executive Officer and Board Director

Okay.

Carrie Brownstein -- Chief Medical Officer

Absolutely, 25 -- both CD20 and CD22 are validated targets in B-cell malignancies, and they're just as frequently if not more commonly expressed as in 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 expressed in 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 UCART20x22 is an excellent target for NHL. And it can also be used in a broad B-cell malignancy space, because CD20 and CD22 are expressed 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 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.

Kelly Shi -- Jefferies -- Analyst

Thank you very much. Very helpful.

Operator

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

Yigal Nochomovitz -- Citi -- Analyst

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. And I'm curious about UCARTMUC1 specifically from an IP perspective, and the reason I'm asking is that there is 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 knockin to provide immune cloaking, which appears also very similar to what you are doing with UCARTMUC1. 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 UCARTMUC1? Thank you.

Andre Choulika -- Chief Executive Officer and Board Director

Thank you so much, Yigal for this question. It's very much appreciated. I tend not too much to comment the IP situation for obvious reasons, but 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 at the basis meganucleases. We've been also developing series of different type of approaches with TALEN.

But since 2013 --- even in 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 on the CRISPR side. So I strongly believe that Cellectis have 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 20 [Phonetic] years even if you want to take whole the history of the Company, 21 years, and all these IDs are flapping out, all these deals are developing, all these strategies in the product development, including MUC1 and all the attributes that are included in that makes this development of our portfolio -- patent portfolio strategy extremely strong. Nevertheless, we're still old companies in the clinical or pre-clinical development phase. And the thing will be solved at the time the first product will start to be commercialized. So I guess that all the space around alternative competing 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 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, as we're still in the Safe Harbor situation, the thing seems to be quite simple for our competitor. So I would keep it here, but I think that Cellectis have a very -- has one of the, like first company in the field of like developing gene-editing tools in the space and very strong, strong position in the space, and we're not going to compromise on this field.

Yigal Nochomovitz -- Citi -- Analyst

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 solid tumors you would tackle first, given your product candidates, are there certain solid tumors that would make more sense to start with?

Andre Choulika -- Chief Executive Officer and Board Director

The first target that will probably go into the clinic is something that seems to be quite already tackled with autologous CAR-T, which is our mesothelin CAR, which has series of attributes in there, including TGF beta 2, our receptor knockout. And for all mesothelin -- mesothelin expressing tumors that come from mesothelioma, pancreatic cancer, etc., so a series of different type of indications will be probably the first CAR-T to go into clinic.

Yigal Nochomovitz -- Citi -- Analyst

Got it, thank you.

Andre Choulika -- Chief Executive Officer and Board Director

In '21.

Operator

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

Jack Allen -- Baird -- Analyst

Hi, thank you so much for taking the questions. Congratulations on all the progress. I guess to start, we are wondering if you 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 minus one 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.

Andre Choulika -- Chief Executive Officer and Board Director

Carrie, do you want to take this question?

Carrie Brownstein -- Chief Medical Officer

I can take the question. We're progressing -- progressing well on 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 lymphodepleting chemotherapy and starting at dose level minus one. Those are the two big things.

One of the other requirements is also the FDA is requiring long safety watching period. So we are -- the dose escalation is slow, but we have our sights on board. We are very, very active investigators looking with patients and I don't foresee recruitment being an issue. What I see being a issue is that our -- the requirements to hold in between patients. What I'm very optimistic about is as we gather more data being able to discuss with FDA potentially in the future moving and go on faster if things are continuing to look safe, so to be continued.

Jack Allen -- Baird -- Analyst

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 a milestone from Allogene and Servier 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.

Andre Choulika -- Chief Executive Officer and Board Director

Eric, this is a question for you.

Eric Dutang -- Chief Financial Officer

Thank you very much for the question. Definitely, when you know Allogene will start the clinical 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, but the revenue will be recognized in 2021 if they start.

Andre Choulika -- Chief Executive Officer and Board Director

The size of the milestone has not been disclosed today and it's still a confidential information. Sorry about that.

Jack Allen -- Baird -- Analyst

No problem. Thank you so much for the answers.

Operator

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

Hartaj Singh -- Oppenheimer -- Analyst

Great, thank you for the question and the updates. I just have a question on UCART20x22 and UCARTMESO. And that is UCARTMESO is for solid tumors, UCART20x22 is all for biospecific dual CAR-T product. If you can just comment, Andre on what are the sort of the differences in your pre-clinical and manufacturing between these two as you get them into the clinic next year trying with the IND? What are the different steps or maybe additional steps you've had to take with addressing dual CAR-T and another one that targets solid tumors, are there any, and if so, what are those? And thanks for the question.

Andre Choulika -- Chief Executive Officer and Board Director

Thank you very much, Hartaj. Hi, by the way. Thank you very much for the question. So UCART22 and UCART123 and UCART20x22 are all based on the same type of platform. So they are 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-T. So UCART123 and UCART22 are built -- have the CAR that is embedded in the lentiviral vector, plus R2/RA [Phonetic] that is a suicide switch.

So UCART20x22, we removed the suicide switch and replaced it by another CAR, so we have UCART20 and UCART22 that are expressed in the same lenti, so it's pretty much the same. So you always add first lenti, then you have a double knockout that happens, which is CD52 TCR alpha, same platform. So UCART22, UCART20x22, UCART123, no difference. Any kind of operator would not see even the difference. It's essentially the quality control that makes the difference. So like the building the CAR is extremely similar and very much straightforward and we know very well how to do it.

Mesothelin, which is the first solid tumor CAR, is slightly different and requires maybe one level up in term of complexity, because it adds a third knockout. So it's mesothelin CAR, CD52, TCR alpha, plus TGF beta 2 are knockouts. So it's a third knockout that 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 Cellectis is mastering the electroporation technology because it's the only technology there allow us to develop these type of process in a very efficient way. And we're very excited to start the production of mesothelin to file the IND next year, not 2021, as I said it before, but probably in -- by 2022.

Hartaj Singh -- Oppenheimer -- Analyst

Yeah, great, Andre. This is all very, very cool stuff. Just a general question, which is that your facility in Raleigh 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? And again thanks for all the questions.

Andre Choulika -- Chief Executive Officer and Board Director

Thank you 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 that the 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 this year, and third or fourth quarter actually like probably in three months from now. And we'll definitely send a save the date for all the investor and analysts community and everyone that would like to visit the facility that we believe is setting the trend into what will be the modern way to do these type of therapies in the future.

Hartaj Singh -- Oppenheimer -- Analyst

Great. Thank you.

Operator

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

Sami Corwin -- William Blair -- Analyst

Hi, this is Sami 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? And then also for your solid tumor program, how are you guys thinking about lymphodepletion and dosing? Thank you.

Andre Choulika -- Chief Executive Officer and Board Director

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

Carrie Brownstein -- Chief Medical Officer

Sure. I'll start -- thanks so much. So I'll start with UCART123. So as we have 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. And so we're hoping to see some data -- some probably first half or early second half of next year.

In terms of the solid tumors, the lymphodepletion as our first program, as Andre pointed out, would be the UCARTMESO program, and that is utilizing the CD52 knockout. So we would be using similar lymphodepletion to what we're doing now for the hematologic malignancy program. But maybe not exactly the same, but we would be using the alemtuzumab route with this product. And in terms of dosing, we haven't disclosed what we're doing with the doses at this time.

Operator

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

Andre Choulika -- Chief Executive Officer and Board Director

Well, thank you very much. I would like to thank everyone for this -- for attending the session, like this Q&A session, those like 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 Raleigh manufacturing facility. We're super excited.

We're extremely excited by the programs we have in the clinic, but also by the pre-clinic 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. So thank you very much for all your attention and looking forward for the next steps.

Operator

[Operator Closing Remarks]

Duration: 52 minutes

Call participants:

Eric Dutang -- Chief Financial Officer

Andre Choulika -- Chief Executive Officer and Board Director

Carrie Brownstein -- Chief Medical Officer

Gena Wang -- Barclays -- Analyst

Michael Schmidt -- Guggenheim -- Analyst

Kelly Shi -- Jefferies -- Analyst

Yigal Nochomovitz -- Citi -- Analyst

Jack Allen -- Baird -- Analyst

Hartaj Singh -- Oppenheimer -- Analyst

Sami Corwin -- William Blair -- Analyst

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