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Cellectis SA (NASDAQ:CLLS)
Q3 2020 Earnings Call
Nov 6, 2020, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Greetings, and welcome to the Cellectis Q3 2020 Earnings Call. [Operator Instructions] I would now like to turn the conference over to your host, Simon Harnest, Senior Vice President, Strategy and Finance.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Thank you, and welcome everyone to Cellectis third quarter 2020 corporate update and financial results conference call. Joining me on the call today with prepared remarks are Dr. Andre Choulika, our Chief Executive Officer, Dr. Carrie Brownstein, our Chief Medical Officer, and Eric Dutang, our Chief Financial Officer. Yesterday evening, Cellectis issued a press release reporting our financial results for the second quarter ended September 30, 2020. The press release is available on our website at cellectis.com.

As a reminder, we will make forward-looking statements regarding financial outlook, in addition to 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, including the management report for the year ended December 31, 2019, and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time.

I would now like to turn the call over to Andre. Andre, please go ahead.

Andre Choulika -- Chief Executive Officer

Thank you, Simon. Good morning, and thank you everyone for joining us today. Yesterday, Cellectis as well as our sub-licensee Allogene announced a series of clinical updates in the form of abstracts selected for oral presentations at the upcoming ASH Conference. These abstracts will be the main subject of today's call and our Chief Medical Officer, Dr. Carrie Brownstein will summarize these data in detail, followed by an update on our financials from our Chief Financial Officer, Eric Dutang.

As a quick overview, Cellectis yesterday announced an abstract on an early interim clinical data readout of BALLI-01 study investigating UCART22, one of our wholly controlled allogeneic CAR T-cell program. This data set has been selected for an oral presentation at the upcoming ASH Conference in December. This abstract provides interim data on the first two dose cohorts of the BALLI-01 dose escalation clinical trial of UCART22 in patient with relapsed or refractory B-cell Acute Lymphoblastic Leukemia. Already at the first dose level of 100,000 cell per kilogram with the standard fludarabine and cyclophosphamide lymphodepletion regime without alemtuzumab, two out of three patients achieved a best response of complete remission or CR and a second patient with a CR with incomplete hematologic recovery. We also announced the second abstract selected for trial in progress poster presentation of our AMELI-01 Phase 1 dose escalation study of UCART123 in relapsed-refractory AML patients. We have cleared the two -- the first two dose levels and are progressing to deal three and we are looking forward to presenting clinical update when available.

Our strategy moving forward is to give regular updates on clinical milestones for our lead allogeneic CAR T-cell programs, UCART22 in the BALLI-01 study in B-ALL and UCART123 in the AMELI-01 study in AML. We are about to start dose cohorts for both studies with the addition of alemtuzumab to the fludarabine plus cyclophosphamide lymphodepletion regimen, a packet of invention of Cellectis, utilizing our gene editing platform to knock out the CD52 gene in allogeneic CAR T-cells. Our third wholly controlled program, UCARTCS1 is in its first dose cohort in patients with relapsed/refractory Multiple Myeloma in the MELANI-01 study. While the study is currently on clinical hold, we have responded to the questions of the FDA and are waiting for an agreement on the proposed path forward. We believe we have a straightforward plan to get this promising candidate back on track in clinical development and we will share an update -- any update as soon as available.

Our sub-licensee Allogene Therapeutics, yesterday announced an abstract selected for oral presentation at ASH on the UNIVERSAL trial investigating ALLO-715 in relapsed/refractory Multiple Myeloma patients. ALLO-715 is an allogeneic CAR T-cell product, candidate targeting BCMA, which is exclusively licensed from Cellectis to Allogene. The virtual presentation will include data on approximately 20 patients evaluable for efficacy across ALLO-715 cell dose cohorts and lower dose at 39 milligrams of ALLO-647, as well as patient evaluable for efficacy who're treated with higher doses of ALLO-715 and higher doses of ALLO-647. We are impressed with the initial response rate in the first-in-class allogeneic CAR-T approach and are excited for the future of this program.

A quick word on our alliance regarding the CD19 targeted allogeneic CAR T-cell program. Allogene's continued enrollment in the Phase 1 ALPHA and ALPHA2 trials, expecting rich data set to emerge. Pending data, Allogene's current plan is to initiate the potential pivotal Phase 2 trial of ALLO-501A in 2021. Furthermore, Allogene announced its plan to submit three additional IND applications in the coming months, expanding clinical development of targets on our -- under our license agreement. This includes the first solid tumor target with ALLO-316, targeting CD70 by the end of 2020, as well as the expansion of the BCMA franchise with ALLO-715 in combination with nirogacestat by the end of 2020 and ALLO-605, a new BCMA TurboCAR T in Multiple Myeloma will be filed in 2021.

Although the year 2020 has created a challenging environment for virtually every aspect of professional and personal life, we had immediately adapted to this new environment. I'm excited to announce that our in-house manufacturing site in Europe and in the United States are on track to start production by year 2020 and year 2021, respectively. This is a major milestone for Cellectis in becoming an independent gene and cell therapy manufacturing powerhouse.

With that, I would like to hand the call over to Dr. Carrie Brownstein, our Chief Medical Officer, who will go into more details on the ASH abstract for our proprietary clinical program. Carrie, please go ahead.

Carrie Brownstein -- Chief Medical Officer

Thank you, Andre. I would first like to go into more detail on BALLI-01, which is a Phase 1 open-label dose-escalation study designed to assess the safety, the maximum tolerated dose and preliminary anti-leukemia activity for UCART22, our first proprietary programs in patients with relapsed/refractory B-cell Acute Lymphoblastic Leukemia, which will be presented in an oral presentation at the upcoming Virtual ASH Meeting in December. As of July 1, 2020, six patients were enrolled on the trial. One patient discontinued prior to UCART22 administration after developing hypoxia related to the lymphodepletion and five patients received UCART22 infusion. Three patients were administered Dose Level 1 of 100,000 cells per kilo and two patients were administered Dose Level 2 of 1 million cells per kilo. All five patients received the standard lymphodepletion regimen of cyclophosphamide and fludarabine, which we refer to as FC.

Patients were heavily pre-treated having received between two and four prior lines of therapy, including one patient with prior CD19 CAR-T and one patient with prior CD22 ADC therapy and all presented with high baseline bone marrow blast prior to lymphodepletion with a median of 35%. We are encouraged by the initial anti-leukemia activity observed. Two of three patients in Dose Level 1 achieved an objective response, one with the best response of complete remission or CR and a second patient with a CR with incomplete count recovery or CRi.

Of note, the patient with the CRi at Dose Level 1 had previously been unsuccessfully treated with inotuzumab, an antibody-drug conjugate targeting CD22. One of two patients at Dose Level 2 achieved a significant reduction in bone marrow blasts from 40% on day -1 to 13% at day 28 post UCART22 infusion. Notably, this patient was unsuccessfully previously treated with the CD19 targeted CAR-T cell therapy. We are excited about this data as this is the first time we could show there is an allogeneic CAR-T cell potential for patients who have previously failed a CD19 or CD22 targeted therapy, including prior CAR-T. These promising results were achieved in the lower two dose levels with standard FC lymphodepletion prior to the incorporation of alemtuzumab.

UCART22 was generally well tolerated and demonstrated no dose limiting toxicities, unexpected toxicities nor treatment-related patient death. No patients developed graft versus host disease, immune effector cell associated neurotoxicity syndrome nor grade 3 or higher cytokine release syndrome. With this safety profile and activity milestone, we believe we achieved our goal of validating CD22 as a new allogeneic CAR-T cell target. As a next step, the addition of alemtuzumab to the standard FC lymphodepletion regimen is now being explored in ongoing treatment cohorts to potentially achieve a deeper and more sustained T-cell depletion and to promote expansion and persistence of UCART22. Patient enrollment in these cohorts is ongoing and we are excited to share further updates on this trial next year.

Coming to UCART123, our allogeneic CART-cell program in acute myeloid leukemia. AMELI-01 is our Phase 1 dose escalation trial of our proprietary UCART123 product candidate in patients with relapsed and refractory acute myeloid leukemia and will be presented as a trials and progress poster, a new format for the ASH Annual Meeting. AML is an area of significant unmet medical need. It is the most common form of acute leukemia in adults and despite the number of products approved in the past few years, the prognosis remains poor. Novel therapeutic approaches are urgently needed that can be applied to a broad patient population. CD123 is a cell surface target expressed on the vast majority of AML blast in most patient segments.

AMELI-01 is a multi-center clinical trial designed to evaluate the safety, tolerability and preliminary anti-leukemia activity of UCART123 in patients with relapsed/refractory acute myeloid leukemia. In the initial cohort, patients receive lymphodepletion with fludarabine and cyclophosphamide followed by administration of UCART123. Patients may receive one or four potential dose levels are evaluated for the presence of dose limiting toxicities during a 28-day observation period and are evaluated for response at day 28. Dose level 1 and 2 have cleared safety review without dose limiting toxicities and enrollment as the next dose levels are proceeding.

In the third quarter, we have initiated simultaneous dose escalation cohorts evaluating the administration of UCART123 after lymphodepletion with fludarabine, cyclophosphamide plus alemtuzumab after Dose Level 1. Enrollment in these cohorts where alemtuzumab is added to the FC lymphodepletion has already started and we look -- we are looking forward to presenting updates on this program next year when available.

With that, I would like to hand the call over to our CFO, Eric Dutang, who will give an update on our financial position. Eric, please go ahead.

Eric Dutang -- Chief Financial Officer

Thank you, Carrie. Cellectis third quarter 2020 was driven by robust financials. The cash, cash equivalents, current financial assets and restricted cash position of Cellectis excluding Calyxt as of September 30, 2020 was at $278 million compared to $304 million as of December 31, 2019. That mainly reflects $28 million of proceeds received from Servier in the first quarter of 2020 and $21 million state-guaranteed loan received from a bank syndicate, which was offset by $79 million of other net cash flows used in operating, investing and lease financing activities. This cash position is expected to be sufficient to fund Cellectis stand-alone operations into 2022.

The consolidated cash, cash equivalents, current financial assets and restricted cash position of Cellectis including Calyxt was $308 million as of September 30, 2020 compared to $364 million as of December 31, 2019. The net cash flows used in operating capital expenditure, lease and debt financing activities were $29 million at Cellectis and $31 million at Calyxt of the same months of 2020.

The net loss attributable to shareholders of Cellectis excluding Calyxt was $21 million in first nine months of 2020 compared to a net loss of $46 million in 2019. This $25 million increase in the net result between 2020 and 2019 was primarily driven by a significant increase in revenues and other income of $44 million, which was partially offset by an increase in R&D expenses of $4 million and a decrease in financial gains of $15 million.

The consolidated net loss attributable to shareholders of Cellectis including Calyxt was $42 million or $0.98 per share in the first nine months of 2020 compared to $65 million or $1.52 per share in 2019. The consolidated adjusted net loss attributable to shareholders of Cellectis excluding non-cash stock-based compensation expenses was $30 million or $0.72 per share in the first nine months of 2020 compared to $48 million or $1.12 per share in 2019. We are laser focused to spend our cash on developing our deep pipeline of wholly owned product candidate in the clinic and entering into prediction with our state-of-the-art manufacturing facilities in Paris in 2020 and in Raleigh in 2021.

With that, I would like to hand the call over back to Andre.

Andre Choulika -- Chief Executive Officer

Thank you, Eric. I'm proud of the progress we have made in our journey over the last nine months. Even more, over the past eight years, Cellectis has been pioneering the allogeneic CAR T-cell space with its sub-licensees Allogene and Servier. We have delivered clinical results in already three different targets CD19, BCMA and CD22. This is just the beginning with more clinical results on these targets as well as our other proprietary and partnered targets to come next year.

We are the first company that grow gene editing to create allogeneic CAR T-cells. UCART19 the first ever gene edited allogeneic CAR T-cell program entered the clinic back in 2015. Furthermore, Cellectis was the first company in the world to bring gene editing as a life saving therapy to patients with unmet medical needs. Along the way, we have amassed strong intellectual property in the field of gene editing since the early '90s using different technologies, including meganucleases, zinc-finger nucleases, TALEN, MegaTAL and CRISPR. One illustration of our innovation is the early Cellectis invention that has led to the patent covering the CD52 knock out in T-cells with concurrent administration of an anti-CD52 antibody to prolonged the window of persistence of our CAR T-cells.

In 2013, Cellectis filed patent applications in the use of CRISPR in T-cells, such as the removal of the TCR to suppress ALL activity, an essential step to create allogeneic CAR T-cells with CRISPR. This pattern has been granted in Europe in 2017 and upheld in 2019 following an opposition procedure and it was granted in the U.S. in March 2020. Furthermore, our R&D team has constantly published cutting edge innovation in the CAR T-cell space with the first beta-2-microglobulin knockout in CAR T-cells presented in 2016. We have been granted on January 2020 a patent covering the knockout of beta-2-microglobulin together with the knockout of TCR alpha using CRISPR in CAR T-cells, such as the one targeting CD19 antigen. All these elements are essential tools for the successful allogeneic CAR T-cell programs and we intend to make full use of our technological arsenal to drive the success of our development program.

We have a strong cash position to lead us through a series of clinical milestone into 2022. This cash runway projection is conservative in its assumption regarding our expected milestone revenue from our partner program and we believe the progress of our sub-license program increases the likelihood of success of our expected milestone revenue.

As a reminder, we could potentially receive up to $410 million in milestone payment from the CD19 targeted under our alliance with Servier and up to $185 million for each of the 15 targets directly licensed to Allogene, including the BCMA and the CD70, as well as additional undisclosed milestone to come from our partnership with Iovance Biotherapeutics along with high single-digit or low double-digit percent royalty and further worldwide sales. We strongly believe the combination of our proprietary and partnered clinical programs and our in-house manufacturing capacity as well as our strong intellectual property position in the cell therapy and genetic engineering will lead to major value creation and transformation of Cellectis over the next months.

With that, I would like to hand the call over to the operator to open the Q&A. Operator?

Questions and Answers:

Operator

Thank you, sir. [Operator Instructions] Our first question today is from Gena Wang of Barclays. Please proceed with your question.

Gena Wang -- Barclays -- Analyst

Thank you for taking my questions. I have a few regarding the UCART22. Just wondering it seems Dose Level 1, Dose Level 2, I understand the small number of patient, but we didn't see very clear dose response in terms of CR rate. And the related question is why the Dose Level 1 seems to achieve pretty high CR rate? So what is the reason to adding alemtuzumab? Is that because that durability from the Dose Level 1 was not very good and at the ASH full presentation, just wondering how many more patients we will see for the full presentation?

Simon Harnest -- Vice President, Corporate Strategy and Finance

Thank you, Gena. That is a very, very good question and thank you first of all for taking the time to be on our call today. We're very excited to give you the first updates on our first proprietary program, although it being very early. The question I'd like to delegate it to Carrie who can best answer the questions on alemtuzumab etc. in doses.

Carrie Brownstein -- Chief Medical Officer

Yeah. Hi, Gena. Thanks so much for the question. You're absolutely right. I mean, I think it was interesting that we saw more response in Dose Level 1 than Dose Level 2. Again, these are very early dose levels and again without the incorporation of alemtuzumab, and therefore, it's really hard to say whether you would necessarily see a dose response at this time given the low dose levels. Now, we're looking forward to continuing to enroll to see these cohorts with alemtuzumab as well as higher dose levels and see where that takes us. We've decided that we think the alemtuzumab is important, particularly given the data we've seen with B-cell NHL as well as from Allogene and from our other partners from Servier in allo and we think that's an important part of the puzzle to ensure that we're giving each of the patients the best chance for success.

Gena Wang -- Barclays -- Analyst

Okay. And how many more patients should we expect at ASH?

Carrie Brownstein -- Chief Medical Officer

Yeah. I mean, we're not -- we can't disclose what the data is going to be at ASH until ASH, because the abstract is the only thing that's been out yet. So we'll see where that is.

Gena Wang -- Barclays -- Analyst

Okay, that's fair. And my last question is regarding the partner Allogene's BCMA allo-CAR-T and just wondering like from there data so far seems seems like safety look a little bit worse than the CD19 allo-CAR-T we will get to see more interaction either have a long Grade 5 infection, just any thoughts there why the safety profile could be so different between these two programs?

Carrie Brownstein -- Chief Medical Officer

I'm sorry, between which two programs, you're saying Allogene's and which one?

Gena Wang -- Barclays -- Analyst

The Allogene's BCMA CAR-T versus Allogene's CD19 CAR-T program.

Carrie Brownstein -- Chief Medical Officer

Yeah. I mean I don't know to speak to their programs and I think there are better people to ask that, but I would say that they are two very different indications. So I think it's hard to compare. It's how I would answer, but they would know better than I given its their program.

Gena Wang -- Barclays -- Analyst

Okay, great. Thank you.

Operator

[Operator Instructions] Our next question is from Yigal Nochomovitz of Citigroup. Please proceed with your question.

Yigal Nochomovitz -- Citigroup Inc. -- Analyst

Hi, great. Thank you very much for taking the question. For the patient in the BALLI-01 trial at Dose Level 2 there has been bone marrow blast reduction from 40% to 13%. I'm just wondering is there still an opportunity for this patient to show a CR or CRi with more time on study or is that bone marrow blast reduction, the best response that we can expect from this patient?

Carrie Brownstein -- Chief Medical Officer

Thanks, Yigal. That's a very good question. So, I mean, given its leukemia and its not NHL where patients can just sit and wait and get rescanned and things like that, which is what you would do in lymphoma and leukemia, because it's a much more proliferative and progressive disease, they need to move on to other therapy. I think that this is the kind of patient where additional doses would make sense and that's something we're going to continue to look at as we move forward in the development plan, because clearly the patient had some -- had a response, had some activity and therefore would have been a good patient for something like that. And we're looking forward to getting that data together.

Yigal Nochomovitz -- Citigroup Inc. -- Analyst

Okay, great. And then for the patient that had the CRi after failing the CD22 targeted ADC, could you just talk a bit about whether this patient remained CD22 positive at enrollment and what was your expectation for targeting patients that failed prior CD22 targeted therapies with the expectation for success with UCART22 prior to seeing the CRi in this particular patient?

Carrie Brownstein -- Chief Medical Officer

Yeah. So in order to get enrolled in this part of the trial, the patients do require to have a significant CD22 expression. So that wasn't an issue in terms of having previous CD22. Though I do you think it's very promising and encouraging that after having a prior CD22 that didn't work out so well for the patients that we were able to show some activity. What was the second part of the question again. I feel like there was a second part.

Yigal Nochomovitz -- Citigroup Inc. -- Analyst

I was just wondering what your expectations were....

Carrie Brownstein -- Chief Medical Officer

Yeah.

Yigal Nochomovitz -- Citigroup Inc. -- Analyst

For our success with UCART22 in patients that have failed prior CD22 prior to...

Carrie Brownstein -- Chief Medical Officer

Yeah. I mean, I think one that are expressing the CD22, we expect that there is a good chance of activity.

Yigal Nochomovitz -- Citigroup Inc. -- Analyst

Okay. And then just the last...

Andre Choulika -- Chief Executive Officer

Yigal, one thing I'd like to say it's like very often some failure with T-cell engagers is sometimes due to the fact that the T-cell of the patient are not super fit at the time of the injection. And therefore the response of the engager needs to have T-cells of the patient, like a target T-cells that are fit. It's the same thing like in the target T-cell products. So when they fail doesn't mean and when you inject allogeneic T-cell that don't have the same fitness would not respond differently and that's why we continue to kind of...

Yigal Nochomovitz -- Citigroup Inc. -- Analyst

Okay. Thank you. And then just one technical question. Is there any particular reason why in the BALLI-01 trial you're exploring three dose levels, whereas in AMELI-01 you're testing four dose levels, is there some reason for that?

Simon Harnest -- Vice President, Corporate Strategy and Finance

Yes. That's a good question. The reason is that in the UCART123 program we are actually -- we were based on dose escalation of three doses, but there is one split dose, so to speak, between the second and the third dose built into the study that's why there is four dose levels.

Yigal Nochomovitz -- Citigroup Inc. -- Analyst

Got it, OK. Thanks, Simon.

Operator

The next question is from Jim Birchenough of Wells Fargo. Please proceed with your question.

Jim Birchenough -- Wells Fargo -- Analyst

Yeah. Hi, guys. Congrats on the data. I guess just following up on the theme of durability of response and what we might expect at ASH, will you have data on CAR persistence, antigen expression? And just in terms of durability overall, do you think it's more a function of depth of initial response or persistence of the CAR? And then I have got a follow-up.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Good question for Carrie.

Carrie Brownstein -- Chief Medical Officer

Yeah. Thanks Jim for the question. And I think it's a little bit -- well part one is in terms of what we're going to present in terms of additional data, I'm not going to speak to today. That said, I think that the answer to a lot of the questions you're asking now are going to hold with the alemtuzumab cohorts and we're looking forward to collecting that data and showing that when we have it. I don't -- so it's really where we are with the -- with that data.

Simon Harnest -- Vice President, Corporate Strategy and Finance

And maybe I can add to that Carrie, and Jim thank you so much for the question. Just to clarify, we are in the middle of enrollment for UCAR22 in BALLI and for AMELI with 123 without the alemtuzumab addition and we're now starting enrollment with the alemtuzumab addition. For the UCART123 program, this will probably be two cohorts, one with alemtuzumab and one without and for the 22 program because it's very similar to the 19 program that's driven by Allogene, ALLO-501, we're probably switching over to the usage in the lymphodepletion with alemtuzumab. And that's why right now the number of patients that we're announcing is limited and we are the next -- the real big data update for us will be the addition with alemtuzumab and we are waiting to have a cohort completed to then show that different in the durability of response.

Jim Birchenough -- Wells Fargo -- Analyst

And maybe just one, sorry, go ahead.

Andre Choulika -- Chief Executive Officer

Okay. So one thing that has to be kept in mind here like the data, for example, for DL 1 is like two patients out of three that test like CRs. Like the dose is 100,000 cells per k, which is cell for an adult approximately. When you compare this to, for example, 19 data without alemtuzumab without anything, without beta 2-micro level knockout etc. this is the kind of response you have to this type our product, which is quite interesting to assess in the condition. When you compare for example with other data where you go for example of 30 million cells per kg with no responses, different type of preconditioning, it's a total different type of set. So that's why I think it's also interesting to analyse it through this angle and that's why we've made with or without cohorts -- with or without alemtuzumab cohort.

Jim Birchenough -- Wells Fargo -- Analyst

And maybe just, yeah, just maybe it is a follow-up on the beta-2-microglobulin knockout and congrats on the IP. When does that -- when would you move into the clinic a B2M knock out sort of a follow-on effort hitting both the TCR and the B2M?

Andre Choulika -- Chief Executive Officer

Well, today I'm not sure that I'm like fully convinced with the data we've seen with this. I think that definitely a combo between knockout of B2M and replace them with HLA-E blocking NK and T might be really interesting and might be interesting for repeat dosing strategy for example in the solid tumor setting. But now like the strategy with alemtuzumab is way more flexibility the -- in the way we're going for this. So it's something that has been in the papers of the company for more than 10 years now and like this would come probably after we are entering the solid tumor space, which is something we are envisaging.

Jim Birchenough -- Wells Fargo -- Analyst

And just maybe finally on CS1, any sense of when -- what the time might -- timeline might be to hear back from FDA and how you communicate that to the street?

Andre Choulika -- Chief Executive Officer

Carrie, do you want to answer this one?

Carrie Brownstein -- Chief Medical Officer

Sure. So I mean the second part Simon can answer about how you want to communicate, but at this point we've submitted everything we can. And we hopefully have a very straightforward path forward with FDA to have it reopened. I think the FDA's a lot on the plate right now. So we're just waiting to hear back. And once we have a path forward, that's final. We're happy to share how we're reopening and more information on that.

Simon Harnest -- Vice President, Corporate Strategy and Finance

And maybe I can add to that. So CS1 is an excellent product and we are very excited by the early start of the trial as we've seen patient enrollments in the beginning of this year and there is a lot of patients that need for this product and we think the this will be a fantastic alternative to a BCMA target. And as Carrie said, we've submitted everything to the FDA already weeks ago and we're just waiting to hear back. We think the questions from the FDA were pretty straightforward and we answered in a very clear way and we have a plan that we think is acceptable and as soon as we hear back, obviously we will let the street known does this exciting for us to get this product back on track.

Jim Birchenough -- Wells Fargo -- Analyst

Great. Thanks for taking the questions guys.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Thanks, Jim.

Carrie Brownstein -- Chief Medical Officer

Thank you, Jim.

Operator

The next question is from Michael Schmidt of Guggenheim. Please proceed with your question.

Kelsey Goodwin -- Guggenheim Partners -- Analyst

Hey, this is Kelsey on for Michael. Thanks for taking our question. I guess maybe just to start off with UCART22, maybe just could you maybe help us guide to what the efficacy bar is that you're thinking about as we kind of assess this initial look at ASH? And then bigger picture, did you say you would be pursuing repeat dosing for your programs? And if so, I guess what patients would get retreatment? Thank you.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Yes. Thanks, Kelsey.

Carrie Brownstein -- Chief Medical Officer

Yeah, hi.

Simon Harnest -- Vice President, Corporate Strategy and Finance

That's a good question for Carrie, sorry.

Carrie Brownstein -- Chief Medical Officer

Yeah, hi. I can take it. No problem. Thanks, Simon. So, I'm sorry, so the first part of the question about the efficacy bar. So what we're looking at, in particular, and why we love our target of CD22 is that it gives us multiple shots on goal for a regulatory strategy. And so you can foresee that going forward a very fast to market. Lower bar for an approval would be in patients who have already failed the CD19 directed treatment, whether it'd be A, any of the options, whether it'd be a CAR-T or otherwise. And so looking at prior approvals for very refractory relapse patient populations in All the bar is not terribly high. So FDA has President for approving on single-arm trials, CR rates that are reasonably durable with MRD negativity in the 30% to 35% range. So that's not -- so in that group, that would be where we were looking. Obviously a upside for this program would be if the activity is better than that, we could easily move it up in the treatment paradigm to get earlier patients. So that's one of the important factors are for this program.

And then as far as redosing, I think we have said before, one of the mean improvements in allo-CAR-Ts over auto is the fact that it can be treated like a pharmaceutical product and can be dosed more than once. And we are actively pursuing how and in which patients we would potentially be redosing. In All in particular, we know that in the normal treatment, when we treat with chemo in these patients, they typically get an induction type of therapy where you try to get them into remission and then they get another slug of high dose therapy to consolidate that remission. So we can envision a treatment strategy similar to that that we could use with our products. So that's the kind of things that we're going to be looking at as we move forward in the development.

Kelsey Goodwin -- Guggenheim Partners -- Analyst

Okay, great. Thank you so much.

Operator

The next question is from Salveen Richter of Goldman Sachs. Please proceed with your question.

Salveen Richter -- Goldman Sachs Group, Inc. -- Analyst

Good morning. And I'm just curious here, as you look at the other allogeneic CAR-T players like Allogene, CRISPR and Precision, provide data and really layout their thesis right on the purchase, whether it's B2M knockout or knock down or adding alemtuzumab and playing with multi-doses or refractory to CAR- T. How are you adopting that in addition to the other leverage? You're playing with into your trial design just so you can optimize one aspect before kind of moving to the next. And I'm just curious if you have any takeaways from what we're seeing from the landscape to date?

Simon Harnest -- Vice President, Corporate Strategy and Finance

Hey, Salveen, it's Simon. Thank you for the question. Really appreciate it. So as you see the landscape come together to us it's very rewarding because honestly and you can see this in the publications, we were the first with all these approaches. We were the first with the B2M knockout. We presented that at the Keystone Conference in the spring of 2016. We were the first to file patents in the gene editing space on these approaches. We're actually the first to use the alemtuzumab approach that's the patent that Cellectis owns with the CD52 knockout and the concurrent administration of alemtuzumab. So now it's interesting that a lot of people are echoing what we pioneered and implementing that in their programs.

So far the CD19 and BCMA targets are the most advanced ones. And what we're trying to show with our proprietary pipeline is that we are actually giving alternatives to these very crowded targets like CD19 or BCMA. We think from our strategy from that point of view, we have the best partner in the space with Allogene and the most advanced partner to bring forward an allogeneic first CD19 off the shelf CAR as as well as the first BCMA CAR that's off the shelf. And we think with alemtuzumab, you have a great way of actually dialing in window of persistence, because you have modality that you can dose in different levels, which is alemtuzumab. And with the B2M knockout, you just have to knockout on the cells as if without any modality there, but it's a very interesting alternative for sure.

For our trial, we have learned from what we've done over the last five years in the clinic and we are optimizing the lymphodepletion and we will give all those details with completed cohort, because we think it's more important to show full completed cohorts then make too many forward-looking statements, while not having the clinical data yet. So the alemtuzumab trials are ongoing with UCART22 and 123. CS1 is a different mechanism of action, because the knockout of CS1 in the CAR T-cell and targeting CS1 actually help these T-cells lymphodeplete on their own, which is very interesting as well in the setting, but we're excited that we show already responses in patients with 22 for example without alemtuzumab at the lowest dose of 100,000 cells per kilogram, which is pretty comparable to the early CD19 approaches and we're seeing responses in patients that have been treated with a CAR-T targeting CD19 before. So that's kind of showing two proofs of concepts that we wanted to confirm and with this data set we have it, although being very early. But Carrie, sorry, that was a long answer already, but if you want to add anything, please go ahead.

Carrie Brownstein -- Chief Medical Officer

No, I think you got it all their, Simon. Thank you. And I think Andre had something to say.

Andre Choulika -- Chief Executive Officer

Yeah. Like the thing is -- thank you very much for these great questions, Salveen. I really appreciate it. Like the position of the company is quite simple. Like we have two of our very important assets, like a series of our important assets in the hands of our partners, particularly the CD19 target that I think is going to be the first one to be -- to file a BLA as an allogeneic CAR-T. When you compare, for example, an allogeneic within autologous, you see real interest in bringing allogeneic CAR-T because there are a lot of patients that are excluded as part of the therapy for a number of reasons, sometimes lack or the poor quality of the T-cells, etc.

So, the proof of superiority or the expansion of the market access on these type of product makes it approvable. When you come with another CD19 CAR, you have allogeneic CD19 CAR, then you have to prove something different that it shows better. And I'm not sure that it's going to be that much easy when you look for example at the data from Legend on the BCMA and the toxicity induced by BCMA or the 19 data of competitors that induce -- that has also induced toxicity that the alternative CAR-T on 19 and BCMA shows a better index. With this, we have a very strong IP that comes behind this and that can protect our assets for their commercialized -- during their commercialization step within the hands of our partner, and that's why IP is for. If you have a protection during, for example, all the clinical trials that is called the safe harbor, once you go out into commercialization, then this safe harbor disappears and the IP comes full-fledged.

Now, on our side, we have alternatives to these two overloaded targets 19 and BCMA, which is 22, CS1 or an unencumbered targets such as 123. And that's where the company has a very clear path to the registration with a strong IP behind it and also you see that the quality of the product that we produce, even a 100,000 cell per kg finally, 6 time less than others we have better results even without any kind of to precautioning angle B2M knockout etc. and give a clear path to where the company is heading at in the coming months.

Salveen Richter -- Goldman Sachs Group, Inc. -- Analyst

Thank you.

Operator

The next question is from Hartaj Singh of Oppenheimer & Company. Please proceed with your question.

Hartaj Singh -- Oppenheimer & Co. Inc. -- Analyst

Great. Really nice update all. Thank you. Just a couple of questions. One is with the addition of alemtuzumab as a lymphodepleting regimen to 22 and 123, from your modeling and just experience with your partner programs also, how much of a boost could you get from that? I mean, trying to understand, what additional sort of efficacy would be able to offset any safety and how are you thinking about that? If you can give us some color there. Secondly, on manufacturing, the way you're integrating your clinical and commercial manufacturing, I think actually is something that here competitors are doing. So if you could just give us an update there and help and you will move to your programs into mid and late stage. And then lastly, could you actually detail for us what are some of the specific milestones as much as possible that you could receive based on the milestones that your partners have disclosed over the next 12 to 24 months? Thank you.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Hey, Hartaj. Thank you so much. And I can take the second part of the question first and then I'll hand it over to Carrie for the clinical part. So in terms of milestones, this is becoming very relevant for us because our partners are making a lot of progress in our collaborative targets. So, for the CD19 alliance, that's an alliance, just as a reminder, between Cellectis and Servier for the U.S. and European rights, and Servier sub-license the U.S. rights to Allogene, so -- just to know that framework. And all of those CD19 CARs, if it's ALLO-501, 501A, UCART19 etc. are basically bundled in one alliance. And for this alliance, we are entitled to receive up to $410 million in outstanding milestone payments, plus a low double-digit royalty on worldwide sales. And these milestone payments are obviously tied to whichever product makes it into the market first and in whichever indication. And then any further indication would apply as well. That is the CD19 alliance.

For the other targets, there are 15 targets that are directly licensed to Allogene. So essentially Allogene's pipeline is built up on Cellectis license targets and Cellectis is entitled to receive up to $185 million per target in development and commercial milestones, plus a low -- plus a high single-digit royalty on worldwide sales of any product out of this alliance. So in those targets are BCMA etc. what Allogene has already disclosed. And Carrie, sorry, to the clinical part of that question.

Carrie Brownstein -- Chief Medical Officer

So back to the, yeah, so the alemtuzumab question. I mean I think the key here there is not too much to say is that, I can't quantify per se how much more efficacy we should see, but the key is that the alemtuzumab should allow for a deeper and more prolonged lymphodepletion, which would only benefit the cells to have more time to expand. And I don't -- the point of our trials are really want to see how much additional expansion, and therefore -- and how that then correlates or translates into improved and more prolonged efficacy in these patients. So we're like you are looking forward to seeing what that data looks like.

Hartaj Singh -- Oppenheimer & Co. Inc. -- Analyst

And just any updates on the manufacturing, just on the clinical and commercial and how that could help with the -- as you move your trials from early to mid and then to late stage in the next 12 to 24 months? Thank you.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Andre, do you want to take the commercial -- the manufacturing question?

Andre Choulika -- Chief Executive Officer

Yeah. The -- hi, Hartaj. Actually the manufacturing is currently on track. So like the Paris site construction finished, the production started and that's like producing older raw material. We think we're on track also on the construction for the Raleigh site and we're still probably start producing next year for all the clinical supplies, but also the commercial supply for the allo version is currently on track to be produced for the three plus stem cells and we have the backups with the CMOs with MolMed and Lonza. I think the company has a tremendous amount of experience in the field of production of CAR-Ts. I think the quality of the product we produce and that's why low doses gives interesting results because of the quality of the product we're producing at the end.

And also probably the gene editing technology itself gives you more fit cells to expand in the patient at the end and all daily proportion technologies that we master. So I think that this -- that is fully mastered by the company and is on track to move on. What I think was the key decision inside the company is the ability to in-house manufacture from clinical supplies up to commercial supplies and we have good view on this. And I think that next year is going to be a big year with the kickoff of the production of the first batches at Raleigh, at our Raleigh facility and I hope that we'll be able if you get out from all the situation to organize within and fewer like the high standard of the company where we are at now.

Hartaj Singh -- Oppenheimer & Co. Inc. -- Analyst

Great. Thank you, Andre. Thank you, everyone.

Andre Choulika -- Chief Executive Officer

Sure. Thank you.

Operator

The next question is from Wangzhi Li of Ladenburg Thalmann. Please proceed with your question.

Wangzhi Li -- Ladenburg Thalmann & Co. -- Analyst

Hi. Thanks for taking my question. I noticed the difference between the UCART22 and the UCART19 trials. So UCART19 trial when you have to know alemtuzumab basically there is no much CAR T-cell expansion and no response, but in your current ASH abstract out of the three, those one patients, you have two CRi responses. I think -- and you may already mentioned this, but I want to see if any further color on the potential reason for the difference. Do you think that the manufacturer -- the later manufacturer of the UCART22 has some see improvements over the issue UCAR19 that may enable more potent expansion or efficacy even without alemtuzumab or any color on the improvement in manufacturing maybe related to that difference.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Hey, Wangzhi, its Simon. Thank you so much for the question. Really appreciate that you're dialing in. So the -- it's a little too early to tell exactly obviously and the patients set up just three, but we have certainly always made improvements at our manufacturing. Its something that we quietly make. We don't make too much of a big deal about it for competitive purposes, but we continuously improve our manufacturing and we have a lot of know-how in terms of selecting the best cells and specific cells for these trials.

What we do know and Carrie can elaborate a little more on this is the alemtuzumab addition certainly increases the window of persistence for these CARs. So it is something that we think important for the durability of response. That's also why we're adding that to our trials right now. And therefore, while we're super excited about these early CRs and these are in patients that have been extremely difficult to treat and they have failed basically all other therapies. We're also very excited about the significant reduction in blasts in the patient on DL 2, because that was a patient that was previously treated with a CD19 CAR. And so we do show that we have a very powerful product already at low doses and it may be the only option for these patients. But Carrie, maybe talk a little bit about our vision with alemtuzumab going forward.

Carrie Brownstein -- Chief Medical Officer

Yeah, sure. Thanks. So, yeah. So to that question, I mean I can't speak to why there is a difference. And again, as Simon clearly pointed out, with only treating five patients at this point, it's very hard to draw any conclusions. That said, we're obviously incredibly encouraged that without the alemtuzumab in that dose cohort we were able to see some response. So we're very excited about that. And we think that when we add in the alemtuzumab, it should only improve the responses that we see, because it will give significantly more time for cell expansion and room for them to expand and do their thing in the patient. So we are looking forward to continuing to enroll those cohorts and gathering that data and presenting that in the future. But I can't speak necessarily to why it wasn't seen in that -- in those CD19 early cohorts about alemtuzumab.

Andre Choulika -- Chief Executive Officer

Yeah.

Simon Harnest -- Vice President, Corporate Strategy and Finance

That's fair.

Andre Choulika -- Chief Executive Officer

Yeah. Like the manufacturing -- like Wangzhi -- hi, Wangzhi, how are you. Like maybe one thing I would like to add is like the manufacturing process has evolved, of course, over the time in every version of the process development that is becoming a real trade secret among all companies around us like. So difficult to elaborate on this and we will not. However, I think I will -- and seriously I was surprised that like without alemtuzumab it didn't work with 19 because like when you look at our data, for example, other companies that don't use alemtuzumab of preconditioning such as like Precision Biosciences data, I think it's interesting to see that they're -- they do have also expansion and responses with their CAR-T. So it's -- there is the ability to do this and this is not extraordinary.

After this what is important is to see on the cell per kg or like the flag dose that you give and the type of response that you get with the amount of cell that are injected gives you a hint on the quality of the product at the end. Why that because in the viral inject, there is a need to have the right cell there that will get you the expansion and the right type of expansion CD4, CD8, gamma, delta etc. all the secret sauce around like the number of like the T-cell memory, like the central memory cells etc. everything that is inside the viral should be fit and great in there. And that's why I think also, not only the -- when you culture the cell, but the gene editing technology that don't share the DNA into pieces is important, but also the portion technology and the way you deplete the cells at the end comes and owe to give you the secret sauce to give you a product that can expand very powerfully even with super low doses.

Wangzhi Li -- Ladenburg Thalmann & Co. -- Analyst

Got it. That's helpful. Maybe if I may ask the last question is for the alemtuzumab optimization. I think of that could imply the fixed dose, but do you think -- do you see a feasibility to maybe personalize the dose based on the patient conditions, the baseline immunity or to any other potential predictive biomarkers?

Carrie Brownstein -- Chief Medical Officer

Yeah. I can speak to that. I think that's a really good point and it is something that we're going to be looking at. I think the complication obviously is when we're doing the development in the way the regulators look at it, if they look at them for depletion regimen plus a dose as the treatment, so we would have to -- it becomes a little bit more challenging to what you're saying. Though I do think there is a place for that not only for the alemtuzumab, but really for the entire regimen, because there will be patients who have much more banged up bone marrows and other things where they can't tolerate as high doses, let's say, a cyclophosphamide or what have you versus patients that can and that could be partially contributing to some of the differences we see from the study to study as well and from patient to patient. So I do you think that is something that needs to be looked into and explored as we move forward. But again the straightforward plan is to have it be a standard -- some sort of standard dosing, because that's just the way the agency editors look at it as a treatment paradigm, as a regimen, not just as the dose of cells. But that is something that needs to be moved, not just for us, but for the whole field in my opinion.

Wangzhi Li -- Ladenburg Thalmann & Co. -- Analyst

Got it. Thanks a lot.

Operator

The next question is from Raju Prasad...

Carrie Brownstein -- Chief Medical Officer

Thank you.

Operator

Of William Blair. Please proceed with your question.

Raju Prasad -- William Blair & Company -- Analyst

Hey, thanks for taking the question. Just a couple of clarifying questions. One, it seems that Allogene may alluded to potentially taking over the manufacturing of the CD19 allo product. Can you just maybe with regards to UCART22 versus UCART19, maybe just describe a little bit more color on some of the differences in manufacturing there? And then, it says that -- in the press release, it says that there is a dose cohort level 2 with alemtuzumab that's being enrolled right now. Can you describe the dose and how the dose level will change over time? Thanks.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Hey, Raj. Thank you so much for the question. And it's very important to clarify that. On the manufacturing part, so UCART19 or the CD19 CARs have been manufactured since 2016 by our partners. First, that was Servier and Pfizer and Pfizer hand it over to Allogene and now because Allogene is doing fantastic work here in the U.S., it seems like, I think, I don't know all the details about it, but it seems that Servier and Allogene are consolidating their manufacturing efforts. So that's really great to see. But what I was saying earlier on another question is that, we don't talk often about manufacturing, but I think we can proudly say that we have one of the best manufacturing of CAR T-cells in the space. This is sometimes not public information. So we don't share this in detail. But we get some of the highest yields with the most potent cells per manufacturing one.

So, again, what we said previously is we can technically treat well over 100 patients out of one manufacturing run. We have a very high cell yield. Our electroporation systems are giving close to 100% fidelity of cells. Our gene knockouts are over 95% to 99% efficient and this is in GMP scale. This is already in basically commercial scale manufacturing. This is not in your lab. So I think the manufacturing at Cellectis is top-notch. And that's why we're so excited to really fully make our CAR-Ts in-house because that is starting next year with the completion of our manufacturing facility. And I think Allogene is somewhat on the same track of finishing the build out of their own manufacturing facility as well. But it's great that the partner targets are being manufactured by our partners, our proprietary targets are manufactured by Cellectis, because that obviously gives us the freedom to fully focus on our proprietary programs.

And then, the second question, I think is some work for Carrie. Sorry, Raj. Maybe if you can just repeat the second part of the question.

Carrie Brownstein -- Chief Medical Officer

Can you repeat the question?

Raju Prasad -- William Blair & Company -- Analyst

Yeah. Yeah, sorry. In the first part...

Carrie Brownstein -- Chief Medical Officer

It thought like it was 10 minutes ago.

Raju Prasad -- William Blair & Company -- Analyst

That's fair. In -- firstly, because Dose Level 2, talk on alemtuzumab enrollment is ongoing, can you disclose that dose and kind of the strategy around dose finding with the alemtuzumab dose moving forward?

Carrie Brownstein -- Chief Medical Officer

Yeah, absolutely. So the dose we have disclosed before the dose level, so the 100,000 cells per kg for Dose Level 1, Dose Level 2 is a 1 million cells per kg. The way we design the trial was that we were starting at Dose Level 1 without alemtuzumab after we clear Dose Level 2 without we would then split the trial into cohorts with and without that would enroll independently. So we now have able to dose escalate if we chose to without alemtuzumab or repeat Dose Level 2 with alemtuzumab and that's where we are now and we're starting to this forward on that side of the trial.

Raju Prasad -- William Blair & Company -- Analyst

And the dose with alemtuzumab that you are using?

Carrie Brownstein -- Chief Medical Officer

Sure. I mean we haven't disclosed what we're using, but we're starting at somewhere in between where Allogene has been. So we're doing for this trial 60 milligrams. So...

Raju Prasad -- William Blair & Company -- Analyst

Got it. And would you anticipate given what you've seen with them potentially moving up or what's in the protocol there?

Carrie Brownstein -- Chief Medical Officer

Yeah. I mean I think we'd have to see what we came up with our dose based on scouring of the literature, not just their literature, but the transplant literature and from my review and speaking with KLOs and others, that do you transplant and I've done transplant myself. We know you need a dose probably higher than 30 milligrams, but you run at less than 100 milligrams, typically you start to see a significant infectious problems around 100 milligram. So we kind of wanted to start somewhere that seemed in the range of what you really need to get the depletion you need without overstepping with potential risk of infection, and obviously, if we don't see what we want to see, we could always change. But I think from a prudent perspective given the patient population, I think we're starting in the right place.

Raju Prasad -- William Blair & Company -- Analyst

Got it. And is at 60 milligrams given all split dosing overall?

Carrie Brownstein -- Chief Medical Officer

It split up over a couple of days.

Raju Prasad -- William Blair & Company -- Analyst

Okay.

Carrie Brownstein -- Chief Medical Officer

And we left that open, because as you know alemtuzumab comes in different formulations and things, so we wanted to make it easy for the physicians to give it that's because -- it's not and also some patients have issues with infusion-related reactions and things, so some physicians like to titrate up and things like that. So to us it's really the total dose that matters not so much on how it split up.

Raju Prasad -- William Blair & Company -- Analyst

Great. That's very helpful. Thank you.

Carrie Brownstein -- Chief Medical Officer

Sure. Thank you so much for the question.

Operator

The next question is from Madhu Kumar of Baird. Please proceed with your question.

Madhu Kumar -- Robert W. Baird & Co. -- Analyst

Hey, thanks. And I apologize I might have missed some of these questions little bit early. But just what are your thoughts on employing CD22 CAR-Ts in DLBCL given what you've seen so far in B-ALL? And then given some of the kind of noise around latent virus reactivation, how does that impact your thinking about either screening protocols for patients or monitoring of latent virus reactivation in kind of the lymphodepletion CAR-T regimens you're implying now?

Simon Harnest -- Vice President, Corporate Strategy and Finance

That's two great questions. Thank you so much, Madhu. I'll hand it directly over to Carrie.

Carrie Brownstein -- Chief Medical Officer

I expected that. So really good questions. So, yes. So B-cell lymphoma, particularly DLBCL, makes sense for CD22. It's something we will think about in our clinical development plans as we move forward. I think there is no reason. It's a highly expressed in B-cell NHL as well as in ALL. That said, -- and it's the same story as you would expect with -- as we talked about earlier that its a target that there is not quite as much on going on as much competition right now. So it does give a opportunity for patients who have failed other things and could provide potential fast track for approval. So it's a very good question and it's something that we are thinking about.

In terms of latent virus, absolutely right. So almost everybody at some point in their life has been exposed to and has living in them all these viruses particularly, its HHV-6 and 7, which is is an issue and it's something that we're paying attention to. Unfortunately, unlike some of these other viruses, where there are medications that you can get for prophylaxis, there really isn't anything for HHV-6 and 7 and it is an area of current study in the field. There's really only one medication right now that really works well for it, which is CAR which isn't something we want to give patients as on prophylaxis, because it has all of these issues with your kidney and other problems.

So it is something we have to pay attention to, something we need to watch and we have to make sure the patients as they are screened and monitored closely for reactivation of these viruses and that when something does happen, where you start to see some reactivation that it turns on quickly. So it is something to pay attention to absolutely and we have incorporated into our trial monitoring and management of all these different latent virus infections as well as other opportunistic infections that you can see in these patients with or without alemtuzumab quite frankly to ensure that we're getting the best monitoring and management of these potential problems, so we does not get in the way of developing our products.

Madhu Kumar -- Robert W. Baird & Co. -- Analyst

Okay, great. And if anyone hasn't seen it, they call Pennsylvania for Joe Biden and so he has been called as President of United States by decision desk...

Carrie Brownstein -- Chief Medical Officer

What?

Madhu Kumar -- Robert W. Baird & Co. -- Analyst

One has not, they get. Yeah.

Carrie Brownstein -- Chief Medical Officer

Sorry.

Operator

The next question is from Kelly Shi of Jefferies. Please proceed with your question.

Kelly Shi -- Jefferies -- Analyst

Hi. Thank you guys for taking my questions and congrats on the progress. And this is Kelly for wherein Jefferies. I wonder if you have the information on CD22 expression level of treated patients? I know it's probably early. And also, I'm curious if you see the response actually correlates with the CD22 expression level. And another question is, do you have any like early tranche or probably from the biology perspective, such as the CD22 expression level versus CD19 expression level that suggest CD22 targeting strategy could be better than CD19 targeting strategy as a single agent therapy? Thank you.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Thanks, Kelly. Very, very important question and I'll hand it over to Carrie, but obviously we picked CD22 for a reason because we think it's very, very well expressed. Carrie, go ahead.

Carrie Brownstein -- Chief Medical Officer

Yeah. I'm sorry, I'm still like reeling from the last call.

Kelly Shi -- Jefferies -- Analyst

If you want repeat, I can.

Carrie Brownstein -- Chief Medical Officer

Yeah. Just do the first part again, and I heard the second part.

Kelly Shi -- Jefferies -- Analyst

Okay. So the first question is, do you see correlation between CD22 progression level and resources, yeah.

Carrie Brownstein -- Chief Medical Officer

Yeah. We haven't looked at that yet. I mean we do have a requirement of a certain level or higher to get on the first part of the study because we want to make sure that we're not throwing the baby out with the bathwater so to speak. So we haven't done a correlation, because we are requiring a significant expression of CD22 at this point in the trial. But it is something we will be looking at as we go into later stages of the program. And then as far as the second part of the question, I think as Simon said, CD22 we believe in it and we think it's an important target in ALL and B-cell malignancies in general. I think that part of the reason I think CD19 ended up kind of being the number one target for B-cell malignancies is just kind of -- because it just was similar to how rituximab happen to adjust in CD20 and that's why CD20 became so important. But also back many years ago there was antibody epratuzumab to CD22 that didn't really do very much. So I think CD22 fell out of favor a little bit. But we feel really strongly that it's an important target, it's ubiquitously expressed and it really does provide a really exciting opportunity for patients who fail CD19 because as of right now given the CD19s are way ahead in development, they will be something that is given first and we know they relapse without a CD19 often expression. So I think that -- we think it's a really important place to be and does provide multiple shots on goal for an approval.

Kelly Shi -- Jefferies -- Analyst

Okay, thank you. That's very helpful.

Carrie Brownstein -- Chief Medical Officer

Thank you so much.

Operator

There are no additional questions at this time. I would now like to turn the call back over to Simon Harnest for closing remarks.

Simon Harnest -- Vice President, Corporate Strategy and Finance

Yes. Thank you so much again to everyone on the call. We really appreciate your interest in Cellectis and we think we're really at a very unique moment for the company to start showing a lot of data on our proprietary programs. So, we'll keep you posted. And feel free to contact us if you have any further questions or would like follow-up calls. Thank you so much.

Operator

[Operator Closing Remarks]

Duration: 71 minutes

Call participants:

Simon Harnest -- Vice President, Corporate Strategy and Finance

Andre Choulika -- Chief Executive Officer

Carrie Brownstein -- Chief Medical Officer

Eric Dutang -- Chief Financial Officer

Gena Wang -- Barclays -- Analyst

Yigal Nochomovitz -- Citigroup Inc. -- Analyst

Jim Birchenough -- Wells Fargo -- Analyst

Kelsey Goodwin -- Guggenheim Partners -- Analyst

Salveen Richter -- Goldman Sachs Group, Inc. -- Analyst

Hartaj Singh -- Oppenheimer & Co. Inc. -- Analyst

Wangzhi Li -- Ladenburg Thalmann & Co. -- Analyst

Raju Prasad -- William Blair & Company -- Analyst

Madhu Kumar -- Robert W. Baird & Co. -- Analyst

Kelly Shi -- Jefferies -- Analyst

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