Cellectis SA (CLLS) Q3 2021 Earnings Call Transcript

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Cellectis SA (CLLS -0.40%)
Q3 2021 Earnings Call
Nov 5, 2021, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Greetings. Welcome to the Cellectis Q3 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.

[Operator Instructions]

Please note this conference is being recorded. I will now turn the conference over to your host, Eric Dutang, Chief Financial Officer. Thank you. You may begin.

Eric Dutang -- Chief Financial Office

Thank you. And welcome everyone, to Cellectis Third 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, and Dr. Carrie Brownstein, our Chief Medical Officer. Yesterday evening, Cellectis filed its interim report and press release, reporting our financial results products third quarter and nine-month period, ending September 30th, 2021. These people and press release 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. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

A description of these risk can be found in our most recent Form 20-F filed with the SEC, for the year ending on December 31st, 2020, and subsequent filings Cellectis makes with the SEC from time to time. I would like now hand the call over to Andre.

Andre Choulika -- Chief Executive Officer

Thank you, Eric. And good morning, and thank you everyone for joining us today. Over the course of the third quarter, and the last 9 months of 2021, 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. 2021 has been a productive year thus far for Cellectis, we have made significant progress on all fronts that we're thrilled to share with you over the next half hour. Notably, yesterday Cellectis announced that the release of two abstracts accepted for presentation at the 63rd American Society of Hematology Annual Meeting. Cellectis will present additional preliminary clinical data from its BALLI-01 trial of UCAR-T22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. And presentation of our first preclinical data of TALGlobin-01 for the treatment of sickle cell disease.

Additionally, with regard to our preclinical UCAR T pipeline focusing on solid tumors. We have made notable progress with UCART metal, our allogeneic CAR T-cell product candidate targeting [indecipherable] expressing solid tumors. We are excited to share that the first preclinical data demonstrating In Vitro and In Vivo antitumor activity will be presented at the Society for Immunotherapy of Cancer Annual Meeting later this month. In 2018, Cellectis made transformative decision to internalize the manufacturing of its therapeutic products. This decision revealed the crucial competitive advantage in today's world, this investment in our GMP many factoring facility provide Cellectis with independence and control over its gene and cell therapy processes, from buffers to DNA, messenger RNA, vectors, and of course, our cell therapies such as our UCAR-Ts. We create and own our processes, our development, and our production.

In the cell and gene therapy space whoever owns the process, owns the product. Due to the success of completion of both of our GMP manufacturing facilities, we can move swiftly into an innovative ID at the R&D stage to clinical trials with potentials to produce commercial level supplies in the future. We are proud to be one of the only companies of our size that are capable of moving into innovative new IDs from R&D, to clinical trial, to manufacturing and delivery directly to the patient, all-in-house. We believe that bringing manufacturing in-house could contribute to eliminating some of the barriers competitor are facing. Our goal this to provide consistency and safety in our production, ensure lead time are met, and adaptability. As each disease target by our advanced therapies may require cutting edge innovation at the level of our manufacturing capabilities, we need to fully master the process.

Importantly, having our manufacturing in-house means that we can rapidly version promising therapeutic candidates as we monitor clinical responses, leading to the best possible product at registrational filing. Our parent GMP manufacturing facility is now fully operational for the production of starting [Phonetic] material. On the other side of the plant, our rally GMP manufacturing facility, qualification of the facility, equipment, and systems was completed successfully in Q3. Qualification of the second UCART production suite equipment remains on track to enable start of engineering runs of this third UCART product in early 2022. Now, I would like to turn the call over to Dr. Carrie Brownstein, our Chief Medical Officer to give an update of our three-sponsored clinical trials, and preclinical product pipeline. Carrie, please go ahead.

Carrie Brownstein -- Chief Medical Officer.

Thank you, Andre. Cellectis continues to progress our Phase one clinical trials, evaluating our three proprietary allogeneic CAR T-cell therapies in hematologic malignancies. BALLI-01, evaluating UCART-22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. AMELI-01 evaluating UCART-123 in patients with relapsed or refractory acute myeloid leukemia, and MELANI-01 evaluating UCART-CS1 in patients with relapsed or refractory multiple myeloma. As Andre mentioned,2021 has been a busy and productive year for Cellectis, with our proprietary clinical and preclinical program making substantial progress, and we are excited to share additional preliminary clinical data from our BALLI-01 trial at the American Society of Hematology 63rd Annual Meeting next month.

The abstract includes updated preliminary results from the Phase 1 open-label dose-escalation BALLI-01 study in patients with relapsed-refractory BALL, from the first cohort of patients who received UCART-22 after fludarabine cyclophosphamide and alemtuzumab lymphodepletion. The addition of alemtuzumab to FC was well tolerated deep in host T-cell depletion, and promoted CAR T-cell expansion and persistence. The data presented support the safety and activity of UCART-22 after FDA lymphodepletion, and patients with relapsed-refractory BALL and the additional data will be presented at the Congress, enrollment in the study is ongoing. Additionally, preclinical data from the TALGlobin-01, an autologous gene therapy product candidate designed to repair the mutated beta-globin gene, and subsequently restore production of hemoglobin A in patients with sickle cell disease was awarded a poster presentation at ASH. The data that will be presented are the first demonstration that TALEN-based engineering could be used to correct the mutation in the beta-globin gene of homozygous sickle cell anemia patients derived hematopoietic stem and progenitor cells. The data showed high level of hemoglobin-A expression, reversion of phenotype, the capacity of TALGlobin-01, edited cells to engraft In Vivo and a low level of off-target cleavage. Collectively, the data demonstrate high efficiency and safety of TALEN treatment in HSPCs, and positioned it as the best in class gene-editing technology for gene therapy product development.

We are also pleased to share that our partner Allogene will present data from our licensed allogeneic CAR T-programs at ASH, data from both the Phase 1 ALPHA II study evaluating ALLO-501A and patients with relapsed-refractory non-Hodgkin's lymphoma, and the Phase I Universal study evaluating ALLO-715 in patients with relapsed-refractory multiple myeloma, will be shared in oral presentations. Allogene will also present a poster on data from their Phase 1 ALPHA study, evaluating ALLO-501 in patients with relapsed-refractory non-Hodgkin's lymphoma. During the second quarter of 2021, we presented preliminary translational data from the first group of patients enrolled in the MELANI-01 trial of UCART-CS1 at the virtual 24th Annual Meeting of the American Society of Gene and Cell Therapy. The early preliminary data presented validate CS1 as a target for allogeneic CAR T-cells in multiple myeloma.

UCART-CS1 expansion and persistence was observed and correlated with changes and relevant serum cytokines and anti-myeloma activity. Cellectis is advancing one of the most robust allogeneic CAR T-pipelines, and we anticipate filing two additional new drug applications for two novel UCAR T-product candidates in 2022, UCART-20x22 and UCART MESO. UCART-20x22 is the first allogeneic dual CAR T-cell product candidate, which is being developed for patients with B-cell non-Hodgkin's lymphoma. UCART MESO is an allogeneic CAR T-cell product candidate targeting mesothelin. A tumor-associated antigen that is highly consistently expressed in mesothelioma and pancreatic cancer, and is also over-expressed in a subset of other solid tumors. In addition to expressing meso-[Indecipherable] CAR, UCART MESO also leverages TALEN gene editing to overcome immune suppression, mediated by TGF-beta. UCART MESO is being developed for patients with mesotheline expressing solid tumors.

Cellectis will present initial preclinical data that support antitumor activity of UCART MESO in a poster presentation at the Society for Immunotherapy of cancer's 36th Annual Meeting in Washington DC, and virtually on November 10th, to 14th, 2021. With that, I'd like to hand the call back 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 Office

Thank you. I will provide a brief overview of our financials for the third quarter and first 9 months of 2021. I would like to highlight that the cash equivalents, current financial assets, and restricted cash position of Cellectis, excluding Calyxt as of September 30th, 2021, was $201 million compared to $244 million as of December 31st, 2020. This difference mainly reflects $92 million of net cash flows used in operating, investing, and lease financing activities, which were partially offset by $45 million of net equity proceeds, raised from the company's ATM Program in April 2021, and $10 million proceeds from the stock option exercise. This cash position is expected to be sufficient to fund Cellectis stand-alone operations into early 2023. The consolidated cash equivalents, current financial assets, and restricted cash position of Cellectis including credit was $216 million as of September 30, 202,1 compared to $274 million as of December 31st, 2020.

The net cash flows used in operating capital expenditure and these financing activities were $92 million at Cellectis and $15 million at Calyxt in the first 9 months of 2021. The net loss attributable to shareholders of Cellectis, excluding Calyxt was $75 million in first 9 months of 2021, compared to $21 million in 2020. This $54 million decrease in the net loss between 2021 and 2020 was primarily driven by a decrease in revenues and other income of $30 million, and an increase in R&D expenses of $32 million which was partially offset by an increase in net financial gains by $8 million. The consolidated net loss attributable to shareholders of Cellectis including Calyxt what $89 million or $2 per share in the first 9 months of 2021, compared to $42 million or $0.98 per share in 2020. The consolidated adjusted net loss attributable to shareholders of Cellectis excluding non-cash stock-based compensation expenses was $80 million or $1.09 per share in the first 9 months of 2021, compared to $30 million or $0.72 per share in 2020.

We are laser-focused to spend our cash on developing our deep [Indecipherable] product candidates in the clinic and operating our state-of-the-art manufacturing facilities in Paris, in New Island [Phonetic]. On the other hand, our focus on maintaining an efficient corporate infrastructure should enable more limited growth in G&A. 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

Thank you, Eric. [Foreign Speech]. Our allogeneic CAR T-platform position us at the forefront of developing Navarro CAR T-therapeutics that usher in the next generation of cancer therapies. We continue to leverage our expertise in gene editing and clinical development to transform the lives of patients with cancer and rare genetic diseases. And we look forward to continuing this effort in Q4 2021, into 2022, and beyond. 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 hematological malignancies.

And we continue to expect 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 disease. With that, I would like to open the call for question and answers.

Questions and Answers:

Operator

Thank you. At this time, we'll be conducting a question-and-answer session.

[Operator Instructions]

Our first question comes from the line of [Indecipherable] with Citigroup. Please proceed with your question.

Unidentified Participant

Yeah. Hi, Andrew, and thank you very much for taking the question. I had a question on UCART-22 on the ASH data. Could you provide a bit more detail with respect to the types of data that we'll see in the presentation? And what is your internal bar that would qualify as industry successful datasets?

Andre Choulika -- Chief Executive Officer

Thank you so much for this question. I think the most appropriate person to answer the question is probably Carrie. Carrie would like to take this question?

Carrie Brownstein -- Chief Medical Officer.

Sure, absolutely. Hi Miguel, nice to hear from you. So what we're planning on showing is the first handful of patients that were treated with fludarabine cyclophosphamide and alemtuzumab. The lymphodepletion regimen-- so in the abstract is the first group that we had ready to prepare for the abstract. But we will have additional data at the meeting, and just know we're-- as you know, we're still in the dose-escalation phase of the study. So we're not quite where we need to be from what we consider a bar for an approval so to speak. And as you know, we are in a very relapsed refractory group of patients, we will have patients who have previous CD-19 directed therapy. So for acute leukemia, I'm not expecting as we move through our clinical development plan for our first shot on goal so to speak with this product, I would not expect the bar to be tremendously high.

Unidentified Participant

Got it. Okay, thanks. And then I just had a question on the UCART MESO, for the data to be presented at 50, to the extent that you can comment, can you give us a preview of that dataset? And what are the key features of that preclinical data sets that are supporting the clinical development?

Andre Choulika -- Chief Executive Officer

Carrie, do you want to also describe MESO well, as you want? Okay. [Speech Overlap]

Carrie Brownstein -- Chief Medical Officer.

So Andre, I think we are in a better position to do that. Yeah, thanks.

Andre Choulika -- Chief Executive Officer

Yes. So like MESO has been developed, it's-- I think it's like the first off the shelf CAR T out there, like all the complication that you've seen in other types of sourcing for allogeneic CAR T targeting MESO. And one of the features is extremely interesting that would be showed at ASH on this, is like the knock out of the TGF-beta receptor on the cell. TGF-beta receptor is always-- is the potential down regulator for a T-cells in the tumor microenvironment, and one of the big challenges Cellectis is tackling through all the CAR T we are developing for solid tumors, is trying to tackle the tumor in like microenvironment; "the TME", such as TAP for example, that is something that is supposed to blow the like an article. But definitely, TAP is the product that will poke holes into the solid tumor protection.

And MESO is essentially a CAR that's not going to be shut down by the negative feedback loop that you have with TJ [Phonetic] beta-2, that is present in the macro environment, and this is part of data that we have. We show also that this type of CAR will probably work in combo, and that would probably give a very interesting feature, not only for mesothelioma but potentially for a lot of different types of cancers. The FDA view was selected also with all the attributes that this CAR has, which is like a CD--, it's the same platform as all the other CAR we developed, which is the CD-52 knockout. So it will work on that alemtuzumab and TCR-alpha, plus it's a triple knock out, I think it's the first of its kind triple knock out CAR T. We're currently preparing this CAR to go into clinic, and I think the data are compelling and definitely encourages us In Vitro, as well as In Vivo, frequent [Phonetic] data gives like the compelling results for the tackling series of solid tumors.

Unidentified Participant

Thank you.

Operator

Thank you. Our next question comes from the line of Gena Wang with Barclays. Please proceed with your question.

Gena Wang -- Barclays -- CFA- Manager Director

Thank you for taking my questions. I have a few regarding a modern big picture question. So the first one, maybe for Andre, wondering the-- your partner Allogene had the clinical hold, and I think that the earnings call, they comment-- they did not disclose too much, but they comment there is some concern about translocation. So just wondering, how is the read-through to your programs? And then also, regarding your drug product, how much do you test regarding each step with the chromosome translocation events, and how do you detect that? And then my second question is regarding the allogeneic CAR T-approach in general, we did see several companies, and also your partner, Allogene will share some data on consolidation approach. And we did see improved the Complete Response Rate, and we don't know about the durability, any thoughts from this approach like apply to your programs?

Andre Choulika -- Chief Executive Officer

Well, thank you, Gena, so much for the questions. First of all, I think I'm going to let the Allogene management team comment on the clinical hold because I think it's like-- we're definitely very supportive, very confident on the handling of the situation by the Allogene team that's making fantastic work on their side. We're extremely excited by the data they're showing on UCAR T-19 or ALLO-501A actually. And I think this is definitely transformative, the data on the allergenic CAR special with the consolidation, I will come back to this. But to speak about the impact on Cellectis there is like-- of course, we're monitoring the situation very closely. We're helping as much as we can do, whatever we can, we will definitely help to go through this period and we have like a strong confidence in the product and the outcome. And we believe that this is-- like this trial is going to resume, and definitely.

Nevertheless, chromosomal aberrations are quite frequent among human population. And would it be certain chromosomes have more aberration because there are subject to DNA recombination due to the state where they are. So like a lot of our immune cells B and T-cells undergo again DNA recombination at a certain stage and sometimes these DNA recombinations can lead to some normal changes in there. However, a few things that should be said. First, the prologue does not endanger, like there is like series of patients that have been-- those are the same platform. So we're confident on Cellectis global platform in our-- not only gene-editing but also the global platform where we develop our genic CAR T to be very stable. The second thing is that adult T-cells-- there is no cell line of adult T-cells in general. And then finally, the cancer is like an allogeneic cell term cancerous. This is all the beauty about an allogeneic approach. You don't catch cancer, especially T-cell cancer from like an allogeneic donor.

This is not going to happen, actually never happened in history, and it's something that could be quite fair. So we're quite confident with this, and we believe that the platform on the contrary, will come stronger from the space. And also with a lot of confidence about what do we have. So we have no concerns today on the potential risk on what Cellectis and our partners are doing. And we believe that this is like an intermediate phase in there. On the contrary, we're very focused and very positive on the outcome of the data, that not only our partners are having but also Cellectis' producing. And these all are ideas and products and targets that Cellectis has been accepting, and I think for the size of the company and joining so many lifesaving products is something that's definitely transformative, and will remain with the same type of technologies that we have.

Now, on the consolidation study is something I've been always a very strong advocate, but I think it could be interesting to have Carrie's view because I've been speaking about like the consolidation studies since years, and we discussed this together. Gena-- but Carrie have like a fresher eye than myself, and a more medical doctor eye. So Carrie, if you want to say a few words about this.

Carrie Brownstein -- Chief Medical Officer.

Sure. Hi, Gena. Nice to here from you as well. So I'm really excited about the presentation that includes all of the consolidation treatment. I think I've been saying this since I joined Cellectis now a year and a half ago. I mean, it's one of the main beauties and key points that I think is going to make allogeneic CAR T-cell therapies successful is the fact that you can give additional doses, and that's one of the huge drawbacks of the autologous setting. We all know that these additional treatments, whether we're using chemotherapy, whether using anabolic therapies, whether using small molecules, whatever it is-- in the history of treating any of these diseases has to do with being able to get the cancer cells to a state that not only you don't see that anymore, but that you can't measure them anymore.

And the deeper the remission that you couldn't bring a patient to, the longer their duration, as well as the longer their survival and potential for cure. So giving additional treatment is always the right way to go when you can. And therefore, it really exciting to finally being able to see larger dataset for the patients who receive more than one therapy in the allogeneic setting, and showing that it's able to really make a difference in treatment for these patients.

Gena Wang -- Barclays -- CFA- Manager Director

Thank you very much.

Operator

Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Please proceed with your question.

Kelsey Goodwin -- Guggenheim -- Senior Associate

Hey. This is Kelsey on for Michael, thanks for taking our questions. I have two quick ones. First, could you just provide some color on where you're at with the other ongoing CAR T-programs, so UCART-123 and CS1? And then, with respect to the TALGlobin program, could you just remind us kind of the key areas of differentiation versus existing competitors in the field and how you kind of think about that? Thanks so much.

Andre Choulika -- Chief Executive Officer

Carrie, do you want to give an update on 123 and CS1, I can give an update TALGlobin.

Carrie Brownstein -- Chief Medical Officer.

Yes, sure. That's perfect. Sorry I was on mute for a second. Yeah, so for UCART-123, for relapsed refractory AML, and for the-- I'll start with that one first. So that study as we've said, has been moving through dose escalation. I think as you know AML is a tough space with patients who are quite sick and tend to be a little more fragile than you would see with acute lymphoblastic leukemia, or with lymphoma. So it is taking a bit longer, but we're moving through dose escalations and we're hoping to have additional data at some point next year to share with everyone. As far as the myeloma study for UCART-CS1, that too as you know we had been on clinical hold. We reopened after changing the protocol, adding some additional safety pieces for guidance for treatment of adverse events, as well as some other rules that the FDA was requiring to ensure safety as we move forward.

So we've been moving through dose escalation, and that too has been moving along nicely. There's a lot of interest from all of our investigators. And again, this is another program that we hope to be able to show additional data later next year. As you know, earlier this year, we did present the original translational data from that first data set before the hold, which did show some interesting translational data that included the expansion of the cells, it showed all the cytokines that we expect to see, and we did see some response. So we're super excited about this program continuing to move forward and are looking forward to share data when the time is right.

Andre Choulika -- Chief Executive Officer

Thank you, Carrie. On the TALGlobin side, the big differentiation that we have is most of the current trials that you see for tackling beta-globin or beta-thalassemia or sickle cell disease is based on the knock-out of one repressor to reactivate different type of hemoglobin, which is people hemoglobin. So you keep the model the sickle hemoglobin in the cells, you destroy another gene. So, there is one gene that is disrupted with the mutation in there sickling the cells. You destroy another gene that is a repressor and finally reactivate a gene that is not supposed to be expressed, that can restore kind of the phenotype, which works. Actually, which is like the results that have been produced so far. What people imagine that could be the gene-editing if there is a point mutation that induces sickling in the hemoglobin gene, people imagine-- figure out that editing the mutation would be fixing back the mutation, which is not happening in most of these trials.

So the approach Cellectis is taking is repairing the mutation in the hemoglobin B-gene and fixing this mutation and restoring the adult hemoglobin in the cells without leaving any scars or new scars in the DNA. So you put back the gene to the sequence it was supposed to be. This is an approach, we're not-- of course, there is competition in this field, but we believe that Cellectis approach with the technologies we're developing, such a TALEN, and the approach we have with our electric portion technology which is the gene engine, and the sizable technology brings it to a very high level of repaired adult hemoglobin. So like cells that are totally fixed, with a very reduced side effects around, and a very high on target, with very accurate repair of this hemoglobin at the end. So that's what differentiates us from most of the approach that you see currently in the clinic, and we believe that this is what patients want, their hemoglobin to be fixed.

Kelsey Goodwin -- Guggenheim -- Senior Associate

Great. Okay, thank you so much. Thank you. Our next question comes from the line of Kelly Shi with Jefferies. Please proceed with your question.

Dave Windley -- Jefferies LLC -- Senior Equity Research Analyst

Hi. Hi, this is Dave on for Kelly. Thank you for taking the question. Just a quick question on [Indecipherable], is it possible that other things like CD-52 lymphodepletion regimen could be the reason for this expected outcome? And another question is the for ASH data, can you provide some detail whether it will include patient who had prior CD-19 CAR T-treatment?

Andre Choulika -- Chief Executive Officer

Thank you. Well, thank you very much for the question. Well, you mean like just to ask precision, like you mean that like the CD-52 monoclonal antibody could induce inversion or like a chromosomal aberration somewhere?

Dave Windley -- Jefferies LLC -- Senior Equity Research Analyst

Yeah.

Andre Choulika -- Chief Executive Officer

That was the question. Well, personally I might not have all the information about this, but it seems to me-- complex, especially for a non-internalizing antibody such as like alemtuzumab or like bi-generic of alemtuzumab to induce such type of course migration [Phonetic] that are quite classical in general, it's not something that has not been observed and is observed quite often in a lot of patient but potentially the global population. It's not that is not susceptible to chromosomal changes in there. So it's extreme, it's part of whole but extremely unlikely on the mechanistic side. Excuse me, like the second part of the question, I just stepped out?

Dave Windley -- Jefferies LLC -- Senior Equity Research Analyst

The second part of the question is if you can provide any color on ASH update, do you have-- will you have any data on patient with prior CD-19 CAR T-treatment?

Carrie Brownstein -- Chief Medical Officer.

I can answer that. So sure. I mean to make the long story short, ASH abstract will include the next group of patients treated on the study. All of your prior therapies, whether it was CD-19 or otherwise will be included in their past medical history, past prior treatment dataset. So that data will be included, but I'm not going to speak to today what proportion of those patients. We do allow patients in the trial, who have had prior CD-19 directed therapy. And I think we have already disclosed in terms of our study design for the expansion we're going to focus on those group of patients, but for the dose escalation we're not limiting to only those types of patients.

Dave Windley -- Jefferies LLC -- Senior Equity Research Analyst

Okay, better. Thank you.

Carrie Brownstein -- Chief Medical Officer.

Sure.

Operator

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

Hartaj Singh -- Oppenheimer -- Stock Analyst

Great, thank you. And thanks for the update. I just got a couple of quick questions, one is a follow-up on the CD-19 project. Some of those patients that are on CD-19 directed therapies also have an antigen loss, I don't know if that is all of the patients that relapse of CD-19 directed therapies, it's about the subset, and if it is a subset, could that be a biomarker for example in those expansion for an accelerated sort of like approval, assuming you see good responses? So that's number one. And the number two, in terms of your solid tumors with mesothelioma, it's really interesting. We are looking forward to this data among the first, and I believe that's solid tumors with that preclinically [Technical Issues] allogeneic CAR T. But Andre you've spoken of this earlier, but can you talk specifically how a clinical development plan in Phase one and Phase two can work? I mean the PD-1 and PD-L-- initial PD-1 are approved in three to four years as immunotherapy in various cancers solid tumor seem to be, you can move faster. Any thoughts there, just in terms of what a development program could look like, assuming you see success early on with the [Technical Issues] product? Thank you.

Andre Choulika -- Chief Executive Officer

Thanks Hartaj, for the great questions. And I'm going to split it to two, like so the first part of the question-- your question, maybe Carrie can answer this because she knows a lot of it. The second part of the question, she can also answer it.

Carrie Brownstein -- Chief Medical Officer.

Yeah.

Andre Choulika -- Chief Executive Officer

I guess she can answer all the questions.

Carrie Brownstein -- Chief Medical Officer.

Yeah, sure. Or maybe I won't answer but I will give you some idea. [Speech Overlap].

Andre Choulika -- Chief Executive Officer

So go ahead, please Carrie.

Carrie Brownstein -- Chief Medical Officer.

Yes, sure. So the first part of the question but CD-19. So I think that's a good point. But, no, not everyone who relapses, and, or doesn't respond to a CD-19 directed therapy has the antigen loss. I think the numbers if I'm not mistaken at somewhere between 20% and 30%. That said, I wouldn't necessarily call that a biomarker, but I'll get to that in a second. So there's not a tremendous amount of data in leukemia obviously after the CD-19 directed therapy and when we have the blinatumomab data, and there is some of the UCART-19 data from survey, but there is no- it's not as vast of a dataset as you would-- as we've seen for lymphoma. So it's hard to compare what we know from one data to another. But that said, in terms of the development plan, and we've been very open about this from the get-go. My plan for this program is to try to get it into patients as quickly as possible and have the therapy that can go to a BLA.

And as you know, that is exactly the group of patients that while it's a super small niche indication, it is a place where the bar would be extremely low for the amount of data, as well as the was the response rate to see something. And so, absolutely, that is a group of patients that we're focused on. It's in our clinical trial design for our expansion to focus on that group because we know that group really needs therapy, and needs it quickly, and could help us bring a product to market quick. That said, the reason it's such an interesting piece is that it gives-- depending on how good the data is. So even if it works in patients who have failed, and maybe they have CD-19 loss, it also may show dramatic activity even in patients who haven't failed. So it gives us an opportunity to kind of move into multiple in the treatment paradigm for these patients. And I think it's super important. So, yes, and it's yes, and yes, but also no. If that make sense?

Hartaj Singh -- Oppenheimer -- Stock Analyst

Yeah, thanks. And just on the solid tumor question just broadly, what are your thoughts [indecipherable] once you get into the clinic, any potential for accelerated approval in this if you had user filling [Phonetic] overexpressing cancers?

Carrie Brownstein -- Chief Medical Officer.

Yeah, I mean I think that the Mesothelin program is really interesting and exciting. I do think however, it really will be the first program targeting user filling from an allogeneic setting and while yes, can we have a chance for an accelerated approval? It's all going to depend on the data we see, and until we get into the clinic and see what we see, it's going to be hard to make that calculation. But obviously in my plans, and when I look into how do we do clinical development, I'm always looking for multiple different avenues to take. So we can have staggered approaches and whether there is an accelerated approval path for a specific like mesothelioma, for example, highly specific cancer where there is clear consistent overexpression, where you would likely see your proof of concept and where there isn't a ton of options. I would be looking for one option to go quickly and fast, and that could be one. I would also be looking for broader ways of getting larger indications and a bigger market share and things like that.

So all of that will be looked into. And we would be putting together a comprehensive program, so we can find ways of doing that quickly and efficiently.

Hartaj Singh -- Oppenheimer -- Stock Analyst

Great.

Andre Choulika -- Chief Executive Officer

Hartaj, what is interesting is that like the monoclonal antibody like PD-1 enters-- or PDL-1 blockers enter into the solid tumors, so they can get into there. The problem is that immune cells are protected by the cancer accentuated thermal blast, in 70% of solid tumors they do not respond because of the difficulty of the immune system to access the tumor itself, that can continue to grow protected by the CAR. So the concept of blowing up the CAR with the fat CAR can be transformative in doing these types of combos. And approach to this is, I think which Carrie is describing is a very wise type of approach that can definitely expand a potential that today we cannot really have a graph on it, it could be transformative.

Hartaj Singh -- Oppenheimer -- Stock Analyst

Great, thank you, Andre. Thank you Brownstein.

Andre Choulika -- Chief Executive Officer

Thanks.

Carrie Brownstein -- Chief Medical Officer.

Thank you.

Operator

Thank you. Our next question comes from the line of Jack Allen with Baird. Please proceed with your question.

Jack Allen -- Baird -- Senior Research Analyst

Thank you guys so much for taking the questions. I just had one brief one and I know we're going to avoid commenting on Allogene's specific instances here, but I was wondering if you could provide any update with regard to ongoing regulatory interactions you have with the FDA? And have regulators had any request for additional product specifications or anything about nature as we move past this hold with Allogene? Thank you so much for taking the question.

Andre Choulika -- Chief Executive Officer

Hi, Jack. like-- thank you so much for the question. It's a hard question to answer fully, for the simple reason it's a lot of these interactions we have on a regular basis with the FDA are confidential and under-- I don't want to share, particularly because it's also a competitive advantage that Cellectis has on its side. But so far, we haven't seen any significant change into this, I guess that things are going to-- so these exchanges are very fluid today, and it doesn't change anything. So I think that it's important to monitor the situation on daily basis but Cellectis is so far on a very good track with our own trials. Excuse me, but like it's difficult to share more than this.

Jack Allen -- Baird -- Senior Research Analyst

I totally understand, thank you so much.

Andre Choulika -- Chief Executive Officer

Sure.

Operator

Thank you. Our next question comes from the line of Raju Prasad with William Blair. Please proceed with your question.

Raju Prasad -- William Blair -- Research Associate

Thanks for taking the question. In the ASH abstract for BALLI, it's said that the three patients in the FCA DL-2 discontinue, I'm just wondering why? And as we think about the 20x22 next gene candidate, can you maybe put that in the context of UCART 22 development. Thanks.

Carrie Brownstein -- Chief Medical Officer.

Sure. Yeah, Andre, I can take this one. So our abstract concludes the first three patients. We will have the other additional patients in the abstract presentation at the meeting and all of that data will be in there. So I don't want to get into reasons for discontinuation and all that because it will be in the data set, and I don't think I can share that due to embargo rules because that's part of the dataset. Again, just suffice it to say that we're still in dose escalation and we haven't reached our recommended Phase two dose yet. So there'll be different reasons for why patients came up in study. And as far as 20x22, I mean I think the big differences and why this is important as you well know the UCART-22 which was one of our first programs, has their RQRE CD20 on it. So it would be potentially be activated and killed with rituximab on board. And as you know in lymphoma, we can't really use got as well, since most patients will have rituximab on board, and rituximab has been shown to be floating around in-patient bodies for up to 6 months or longer.

And therefore, it would potentially diminish the activity of our cells, so we wouldn't want to do that for lymphoma. So we're positioning UCART-22 for AML for leukemia because of that, and rituximab is rarely used in AML but 20x22, which not only is fantastic because it has the dual CAR, and really has an opportunity to really differentiate itself from what's out there. But, therefore would not cause an issue with rituximab.

Operator

Thank you. Our next question comes from the line of David Dai with SNBC. Please proceed with your question.

David Dai -- SNBC -- Vice President-Senior VBotech Analyst

Hey, thank you so much for taking my questions. I have 2 questions. First, I just wanted to get some clarification on the UCART-22 ASH abstract data where you said one patient had blast reduction consistent with CRI, could you provide some additional color on this reduction? Is that a confirmed our CRI? And then second question is you were also presenting really encouraging preclinical data for TALglobin at ASH, and your approach is a very differentiating from competitors, but could you comment on how frequently do data compare to the competitor programs from CRISPR and BLUEs and also is the INDs still on track for next year?

Carrie Brownstein -- Chief Medical Officer.

So I can start with the first part of the question about UCART-22. And now I'm trying to remember exactly what the question was, there were just so many questions. So the question is the reduction consistent with CRI. [Speech overlap] So confirm CRI

David Dai -- SNBC -- Vice President-Senior VBotech Analyst

Yeah, well, so the thing is with leukemia, it all depends on-- it's not the same as--- there is no such thing as confirmed or not confirmed in terms of the response criteria. So it's sort of depends on which response criteria being used, whether you can count it as an actual CRI or not. So you'll see in the data set when we present the data, what the patient had and what their blast reduction was, it was quite impressive I will say, But however, depending on which response criteria you use in leukemia, and there's a few. So the one is the NCCN which is what we were using, there is also the modified chesting which is what we've used for inotuzumab. And then just each one of them has different depending on how long you can measure them for. But unfortunately, unlike with other-- with [Indecipherable] for example, we're not checking that leukemia in the bone marrow every day. So it's really hard to know exactly whether or not it needs certain criteria.

So that's why we were kind of careful engaging with our answer there, but I think it's extremely interestng, and then it's extremely encouraging data at a very lower dose level in our first group of patients treated with SDA, which is pretty amazing in my opinion. And then I don't know, Andre, if you want to speak to TALGlobin?

Andre Choulika -- Chief Executive Officer

Yes. The TALGlobin is currently being manufactured, but once we finish manufacturing, we have to go through all the requirements with the GMP material to start preparing the IND package, and this is something that will start probably next year once the product will be released, and it is all done internally. So it's something that's quite exciting. And I'm not giving any guidance for the IND filing today, but it is definitely a problem that will go into clinic.

Operator

Thank you. Our next question comes from the line of Nick Abbott with Wells Fargo. Please proceed with your question.

Nick Abbott -- Wells Fargo -- Analyst Vice President, Biotech Equity Research

Thank you. First question, just going back to the ASH abstract in what data will be presented. So have you cleared 2.5 mil per kg dose if not, when do you think you'll do that? And is the next step 5 million per mill-- per kilo, and I have a follow-on. Thanks.

Carrie Brownstein -- Chief Medical Officer.

Sure. I mean again, I really given the embargo rules for ASH, I don't want to get into exactly what we're going to be presenting in which cohorts, which data sets unless it was already in the abstract that has been released. But as you pointed out, the dose level two is the 1 million, and the two is the 2.5, and the next stage would be 5.

Nick Abbott -- Wells Fargo -- Analyst Vice President, Biotech Equity Research

Yes, thanks. And then just on the lymph count profile, there are no range bars on the data that's in the abstract. But it shows only a 50% reduction 9 days after infusion of the CAR, bottoms out of 11. Is that the profile you want? I would have expected ALC to bottomed out really before infusion or at the time of infusion?

Carrie Brownstein -- Chief Medical Officer.

I have to pull up exactly what you're looking at, because maybe it's not accurate the way it's being interpreted. But what I can tell you is the patients all went to zero with the lymphodepletion and the alemtuzumab. So you may be looking at the other line, which is the UCART expansion. I think [Speech Overlap]

Nick Abbott -- Wells Fargo -- Analyst Vice President, Biotech Equity Research

I'm looking at the blue line that's lymphocyte counts. So.

Carrie Brownstein -- Chief Medical Officer.

I have to fill it up, I know in one of the patients, the data was shown-- yeah, I have to look at it, I don't have it open in front of me, but what I do know is that we can get back to you in email to explain it, but what I can tell you is, it depends on where it was being measured from. So in some cases, we're measuring the actual UCART cells in the absolute lymphocyte counts, that could be what you're looking at, but I'll look at it and we can send you an email with the clarification.

Nick Abbott -- Wells Fargo -- Analyst Vice President, Biotech Equity Research

Thanks. And then maybe last one, obviously it is a very heavily pretreated population as you've said.

Andre Choulika -- Chief Executive Officer

Yeah.

Nick Abbott -- Wells Fargo -- Analyst Vice President, Biotech Equity Research

I think median is five, and the abstract versus 3 at ASH last year. So as you think about expansion, is this the kind of population five median price with CAR T-failure? And if so, is that a population, you think you can successfully complete the trial? I mean we already have a patient here who has apparently no benefit from the CAR T, but it still has no lymphocyte because they had the alemtuzumab and lymphodepletion. So it's that patients obviously is in a very challenging place.

Carrie Brownstein -- Chief Medical Officer.

Yeah, that's a really good question. I think the answer though is yes. I mean I think it's in our-- if you go to clinical trial.gov, it has the information on our expansion cohort I believe. But I think that this goes to what I said before, it's really important to have a comprehensive multiple shot on goal plan for development of any product. Then I think particularly given our size, and wanting to be able to bring a product to BLA and approval. This is definitely something that we can do, and I think that while in leukemia, even which you've had multiple therapies, it is a disease that typically is of younger healthier people, so it's not like acute myeloid leukemia where most people-- the vast majority of patients are over 65 or even over 75 for that matter, and are super frail, had multiple therapies, that their organs don't work well. Generally speaking, leukemia patients are younger, it's the most common cancer in children, it is the most common cancer for young adults. And we're going to be-- as one of our arms so to speak of development for this program is to really focus on these patients who were otherwise in super good shape.

Maybe they've had multiple therapies, but they're in super good shape and can keep taking more, and bring them to hopefully to a cure, somewhere where they can continue to have a long life. And I think it's super important. So I think in AML in particular, it's a little bit of a different story than when you're talking about myeloid leukemia or some of these other diseases that you see in older people. So I think in our expansion and where we would want to potentially have a fast-to-market strategy would be in these younger CD-19 directed failures. So it still need the therapy, and are still-- otherwise, with the exception of their leukemia really well, and to need to be treated and need something they can make them move forward and potentially have a life. So that said, though there are-- it's a small niche indication, and therefore other strategies and other development plans are in place for us in terms of where else we can go, and how we go about doing that so we can bring it to a larger group. And to your point, potentially, not necessarily people who failed five therapies and failed CAR T already. That will ulter [Speech Overlap] obviously.

Yeah, thanks.

Nick Abbott -- Wells Fargo -- Analyst Vice President, Biotech Equity Research

Thank you very much.

Operator

Thank you. Our final question comes from the line of Ingrid Gafanhao with Kempen. Please proceed with your question.

Ingrid Gafanhao -- Kempen -- Equity Research Analyst

Hi, team. Thank you for taking my questions. I'll keep it a bit brief then, just checking-- I just wanted to check with you once again what are your plans Calyxt and your shareholdership? I think you mentioned you are planning to maintain it. But would you be keen to monetize this, let's say in the short to mid-term?

Andre Choulika -- Chief Executive Officer

Hi, Ingrid. Excuse me. Like the I missed the beginning of your question, actually was not super clear. It's about what?

Ingrid Gafanhao -- Kempen -- Equity Research Analyst

Yeah, sure. I just wanted to check with you what is your current thinking on Calyxt and your shareholdership?

Andre Choulika -- Chief Executive Officer

Yeah, actually currently we think Kelly just announced leadership change with the arrival of Michael Carr, and also the change in strategy that has been introduced, not only by the new leadership but also by the Board of Directors under the chairmanship of Eva Bay, and we believe that this change is about to transform the company in a very meaningful manner. And as Cellectis has a significant stake into account Calyxt, I think that we are positive on the fact that this is going to bring a lot of value, and you see that since then it has been quite well received by the market. As I said like Cellectis is definitely have a invested interest in the success of Calyxt, and waiting up to this and it's something that we believe is going to be very valuable in the future for us as shareholders of Calyxt. So we have to wait up to the time the change in strategy is implemented, and we believe that the current company have all the pieces to be extremely successful in the implementation of this new strategy, very rapidly and very swiftly which we should be to our advantage.

Nick Abbott -- Wells Fargo -- Analyst Vice President, Biotech Equity Research

Right, Andre, thank you. That's clear. And if I may, I have just one more question for Eric. Just looking ahead into next year, considering that you're planning to move some programs IND forward, are you providing any guidance on your cash run?

Eric Dutang -- Chief Financial Office

We don't provide any guidance on our cash run, what we say the cash runway is in 2023 on Cellectis. And we don't disclose milestone payments, we have a partnership with [Indecipherable] where we can get up to-- from $10 million from 19 programs, and also the partnership with the Allogene where we can get up to 3 billion on 15 target.

Andre Choulika -- Chief Executive Officer

And also with Iovance. And with [Technical Issues] series of milestone to be paid, but currently the cash run into 2023 is unchanged.

Ingrid Gafanhao -- Kempen -- Equity Research Analyst

Alright, thank you very much.

Andre Choulika -- Chief Executive Officer

Thank you.

Operator

Thank you. Ladies and gentlemen, we have reached the end of the question and answer session. I will now turn the call over to Andre Choulika for closing remarks.

Andre Choulika -- Chief Executive Officer

Well, thank you very much everyone for this Q&A. We're extremely excited to have all these questions and excited of our trials and our partners trials. There is a lot of things ongoing at Cellectis. I think that Cellectis have seriously leaped in point, a turning point for the company was internalizing mold of manufacturing. And what comes next in the coming months and years is the transformative Cellectis that is becoming a true like modified biopharmaceutical company, making things from A to Z and like one-stop-shop with gene-edited, CAR T, and oncology, gene therapy, and of course with the powerful strategy in the clinic. As we've been sharing with Carrie, and I think that this is going to change. So please watch closely and come to our meetings, and posters at ASH, we're waiting for you.

Operator

Thank you.

Andre Choulika -- Chief Executive Officer

Thank you very much.

Operator

[Operator Closing Remarks]

Duration: 61 minutes

Call participants:

Eric Dutang -- Chief Financial Office

Andre Choulika -- Chief Executive Officer

Carrie Brownstein -- Chief Medical Officer.

Unidentified Participant

Gena Wang -- Barclays -- CFA- Manager Director

Kelsey Goodwin -- Guggenheim -- Senior Associate

Dave Windley -- Jefferies LLC -- Senior Equity Research Analyst

Hartaj Singh -- Oppenheimer -- Stock Analyst

Jack Allen -- Baird -- Senior Research Analyst

Raju Prasad -- William Blair -- Research Associate

David Dai -- SNBC -- Vice President-Senior VBotech Analyst

Nick Abbott -- Wells Fargo -- Analyst Vice President, Biotech Equity Research

Ingrid Gafanhao -- Kempen -- Equity Research Analyst

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