Cellectis SA (CLLS) 2022 Q1 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

  • Greetings and welcome to the Cellectis' first quarter 2022 corporate update and earnings call. (Operator Instructions) As a reminder, this conference is being recorded.

  • I would now like to turn the conference over to your host, Mr. Arthur Stril, Chief Business Officer for Cellectis. Please go ahead, sir.

  • Arthur Stril - Chief Business Officer

  • Good morning, and welcome, everyone, to Cellectis' first quarter 2022 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 Dr. Bing Wang, our Chief Financial Officer.

  • Yesterday evening Cellectis' filed its interim reports and issued a press release reporting its financial results for the first quarter and 3 months' period ended March 31, 2022. The report and press release are available on our website at cellectis.com. As a reminder, we will make statements regarding Cellectis' financial outlook, in addition to its manufacturing, regulatory and product development plan.

  • These forward statements which are based on our management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners 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 reports including the management report for the year ending on December 31, 2021, 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 Choulika - Co-Founder, CEO & Director

  • Thank you, Arthur. Good morning, and thank you, everyone, for joining us today. Cellectis made progress with our pipeline this quarter. We took a notable step forward with the first preclinical data on UCART20x22, the allogenic dual CAR T-cell product candidate being developed for patients with relapsed or refractory non-Hodgkin's lymphoma or NHL.

  • We're proud to see that the data demonstrated a robust preclinical proof of concept with strong activity against tumor cell lines expressing either a single antigen CD20 or CD22 Or both simultaneously. We remain on track to file an investigational new drug for UCART20x22 this year. UCART20x22 is expected to be selective first product candidate with fully integrated in-house development. This showcases our transformation into an end-to-end cell line gene therapy company from discovery and preclinical development to product development and transfer into GMP manufacturing and to clinical development.

  • We were proud to announce 2 back-to-back publications in Nature Communication, providing strong validation of UCART123 to treat acute myeloid leukemia or AML and blastic plasmacytoid dendritic cell neoplasm or BPDCN. This is the first preclinical data published on UCART123 that supports our rationale for evaluating these allogenic UCART123 in the clinic. While the few CD123 T-cell therapy evaluated to date rely on autologous approaches with complex clinical and logistical challenges, this set of preclinical data strongly support the potential benefits of the allogeneic CAR-T approach in AML and BPDCN. We are proud of these results that reinforce our commitment to cancer patient specifically in very hard-to-treat diseases like AML and our mission to address unmet medical needs. Our partnerships provide to be an exciting highlight reflected.

  • In January, Allogene announced that the U.S. Food and Drug Administration remove the clinical hold on their clinical trials, which was announced on October 2021. Allogene reported that after investigation, it was determined that the chromosomal abnormality detected in some CAR-T cell of the single patient treated with ALLO-501A was unrelated to TALEN gene editing in B-cells.

  • Allogene is now focused on initiating their pivotal trial of ALLO-501A in third line large B-cell lymphoma around the middle of this year, pending FDA discussion and continue to enroll in the Phase 1 portion of the study to offer ALLO-501 to patient in need. Enrollment has previously resumed in trial targeting BCMA for patients with relapsed or refractory multiple myeloma and targeting CD70 for patient with advanced or metastatic clear cell renal carcinoma.

  • This quarter, our partner, Iovance announced that the U.S. FDA allowed an IND to proceed for its first TALEN-edited tumor infiltrating lymphocytes or TIL therapy using Cellectis technology to develop next generation TIL therapy. This provides a significant opportunity to deliver the combination of TIL and immune checkpoint inhibition within single genome edited TIL therapy in multiple solid tumor types. We look forward to continuing our collaboration with Iovance.

  • In April, we also received $20 million of convertible note in payment of the upfront collaboration consideration for our partners Cytovia Therapeutics. The note will be converted into common stock upon completion of the announced business combination between Cytovia and Isleworth Healthcare Acquisition Corp., a Special Purpose Acquisition Company or SPEC. Cellectis is developing custom TALEN for Cytovia to develop gene-edited introduced through potent stem cells or IPS derived natural killer cell.

  • These announcement reiterate once more that TALEN is a technology of choice for gene editing, which continue to provide the company with expanded business opportunity. As I stated in our last earnings call, Cellectis made a meaningful lead power to becoming one of the few end-to-end cell and gene therapy company with our 2 manufacturing sites fully operational in Raleigh, North Carolina and in Paris.

  • Cellectis plan to initiate dosing a patient in the BALLI-01 trial with clinical supplies of UCART22 manufactured in-house in Raleigh and UCART20x22 in non-Hodgkin lymphoma trial during the second half of 2022. A milestone our entire company has been working towards this year.

  • Lastly, based on our current plan, we anticipate our cash runway takes us into early 2024.

  • Now I would like to turn the call over to Dr. Carrie Brownstein, our Chief Medical Officer to give an overview of our 3 sponsored clinical trials and preclinical product pipeline. Carrie, please go ahead.

  • Carrie Brownstein - Chief Medical Officer

  • Thank you for that overview, Andre. UCART22 are CD22 directed TALEN gene-edited allogeneic off-the-shelf CAR T-cell product candidates currently being evaluated in patients with relapsed or refractory B-cell acute lymphoblastic leukemia continues to make progress in the clinic. At the annual meeting of the American Society of Hematology in December 2021, we released encouraging early data from the first set of patients who received the UCART22 after lymphodepletion with fludarabine, cyclophosphamide and alemtuzumab in the BALLI-01 trial.

  • These preliminary data shows that adding alemtuzumab to the fludarabine and cyclophosphamide lymphodepletion regimen did not adversely affect the overall safety profile. Further the addition of alemtuzumab sustained host lymphocyte suppression and promoted expansion of UCART22, signs of antileukemic activity of UCART22 was observed. BALLI-01 is currently enrolling patients at those level 3 and we plan to initiate the administration of UCART22 batches manufactured in-house from our Raleigh facility in the second half of this year.

  • This month, we announced our first publication on UCART123 in Nature Communications providing strong preclinical validation of UCART123 to treat acute myeloid leukemia. Our AMELI-01 study evaluating UCART123 in patients with relapsed and refractory acute myeloblastic leukemia continues to progress and enroll patients with fludarabine, cyclophosphamide and alemtuzumab preconditioning regimen. We look forward to sharing clinical data from this program when it becomes available.

  • I will now speak to UCARTCS1 our CS1 directed TALEN gene-edited allogeneic CAR T-cell product candidate being evaluated in patients with relapsed or refractory multiple myeloma. Cellectis' MELANI-01 evaluating UCARTCS1 is currently enrolling patients at dose level 1 with fludarabine and cyclophosphamide preconditioning.

  • Lastly, I'm excited to announce that we anticipate filing an IND this year for UCART20x22, Cellectis' first allogeneic dual CAR T-cell product candidate being developed for patients with relapsed or refractory non-Hodgkin's lymphoma. UCART20x22 features TALEN mediated disruptions of both the TRAC gene to reduce the risk of graft versus host disease and the CD52 gene to permit use of CD52 directed monoclonal antibody in the preconditioning to enhance CAR-T engraftment, expansion and persistence.

  • Dual targeting of CD20 and CD22, both validated targets in B-cell malignancies is designed to enhance tumor cell killing and to prevent immune escape due to single antigen targeting. UCART20x22 has the potential to offer an alternative to CD19 directed therapies and CD19 negative relapses. This April Cellectis released preclinical data on UCART20x22 at the American Association for Cancer Research Annual Meeting.

  • These data established robust preclinical proof-of-concept and demonstrated with the potential to overcome common mechanisms of resistance to CAR-T cell therapies such as single antigen escape and tumor heterogeneity. As we previously stated, an investigational new drug application for UCART20x22 is expected to be filed this year.

  • With that I would like to hand the call over to Dr. Bing Wang, Cellectis' Chief Financial Officer for an overview of our financial. Bing, please go.

  • Bing C. Wang - CFO

  • Thank you, Carrie. I will provide a brief overview of our financials for the first quarter 2022. I would like to highlight that our financials, the cash, cash equivalents, current financial assets, a restricted cash position of Cellectis excluding Calyxt, as of March 31, 2022, was a $142 million compared to $177 million as of December 31, 2021.

  • This difference mainly reflects $33 million of net cash flows using operating, investing and lease financing activities and $2 million in negative foreign exchange impact. Based on the current operating plan and financial projections, this cash position is expected to be sufficient to fund Cellectis' standalone operation into early 2024. The consolidated cash, cash equivalents, current financial assets and restricted cash position of Cellectis including Calyxt was $160 million as of March 31, 2022, compared to $191 million as of December 31, 2021.

  • The net cash flow using operating capital expenditure and leases were $33 million at Cellectis and $7 million at Calyxt in the first 3 months of 2022 partially offset by a $10 million capital raise at Calyxt. The net attributable loss to shareholders of Cellectis excluding Calyxt was $20 million in the first 3 months of 2022 compared to a loss of $6 million in the first 3 months of 2021. This $23 million increase in net loss between 2022 and 2021 was primarily driven by a decrease in revenues, and other income of $90 million and a decrease in net financial gain of $4 million.

  • The consolidated net loss attributable to shareholders of Cellectis, including Calyxt, was $32 million or $0.70 per share in the first 3 months of 2022 compared to a loss of $12 million or $0.28 per share in the first 3 months of 2021. The consolidated adjusted net loss attributable to shareholders of Cellectis excluding non-cash stock-based compensation expenses was $29 million or $0.64 per share in the first 3 months of 2022 compared to a loss of $11 million or $0.26 per share in the first 3 months of 2021.

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

  • Arthur Stril - Chief Business Officer

  • Thank you, Bing. To close out this call, I would like to reiterate how excited we are about the continued progress of our clinical trials, and the upcoming milestones for 2022 pioneering this field, Cellectis continually leverages gene editing and a series of breakthrough innovation into clinical development in order to transform lives of patients with cancer and rare genetic diseases. And we look forward to continuing this effort in the second quarter of 2022 and beyond.

  • Cellectis' proficiency and command of gene editing technology has enabled the successful development of the robust pipeline of novel preclinical product candidates, which are designed to overcome the challenges of cell-based cancer treatment and gene therapy. At Cellectis, we strongly believe that our product candidate, our technology, and our in-house manufacturing capabilities will lead us to a paradigm shift for patients with hard-to-treat cancer, positioning us at the forefront of this promising medical and scientific field.

  • With that, I would like to open the call for Q&A.

  • Operator

  • (Operator Instructions) Our first question comes from the line of Gena Wang with Barclays.

  • Huidong Wang - Research Analyst

  • Congrats on the progress. So maybe I would just start with a big picture question. I'm pretty sure you also saw yesterday the [EHA's abstract] release. We first saw the differing approach, try to improve the persistence or like a host versus graft regarding the allogeneic CAR-T using PD-1 knockout approach. Any thoughts there? Do you think with -- I mean, you have a slightly different approach, do you think what could be a better approach or you think it's still too early at this point?

  • Arthur Stril - Chief Business Officer

  • Hello, Gena, thank you so much for the question. And I think this one is probably one for Andre.

  • Andre Choulika - Co-Founder, CEO & Director

  • Thank you, Gena. Thank you for the question also. It's appreciated. Of course, like this has been investigated, a series of different type of approaches to tackle the host versus graft as well as the graft versus host, and we've been very much advanced in a series of different type of ways to do this. Of course, the first one that has been always used in the company since 2015 is the CD52 knockout plus TCR alpha knockout. TCR alpha for GVHD and CD52 to resist preconditioning treatment with alemtuzumab, which has been today used as the platform in Cellectis, but also with our partner Allogene -- partners, Allogene and Servier.

  • Of course, one of the products does not get into this category, which is CS1 to treat multiple myeloma, where we knock out CS1 and CS1 is present in a lot of different type of immune cells. Therefore, UCARTCS1 has the knockout of CS1 to prevent the fratricide killing has a self-lymphodepleting activity itself and self-engraft. We've shown this last year at ASGCT, and we see that the CAR does provoke self-engraftment in the patient and can stay for several weeks or N months in the patient and can clear the tumor during this period. So that's like a very interesting procedure of self-lymphodepleting and self-engrafting CAR-T such as CS1, but not all the targets have this property. And I think that it's going to be interesting for the next ASGCT, there will be probably some approaches that Cellectis has been using and developing for many years that are going to be presented by one of our scientists at GCT. So we'll communicate very soon on this. So there are a series of things that can be -- that approaches that we can do in this space. And of course, we are not bound to one way to do it, but several different ways. And of course, very often copied.

  • Operator

  • Our next question comes from the line of Yigal Nochomovitz with Citigroup.

  • Yigal Dov Nochomovitz - Director

  • I just had 2 on 20x22. So first, with regard to the manufacturing capacity in Raleigh for 20x22, can you just expand on what is the current manufacturing capacity down there? And what do you expect to be the peak manufacturing capacity? And then secondly, obviously, since you have 2 antigens in the 1 cell product, does this mean that you're going to be able to get away with a lower dose or will you still be expecting to dose in the same range as with your other products?

  • Arthur Stril - Chief Business Officer

  • Hello, Yigal thank you so much for both questions. They're great. I will take the first one on manufacturing and then hand it over to Carrier for the clinical question.

  • So on manufacturing, I mean, we're extremely excited that both our Paris and Raleigh manufacturing are now up and running, which really allows us to manufacture the entirety of our product from A to Z, so including buffers, plasmid DNA, mRNA, which is delivered with our proprietary electroporation device, viral vectors, all the way to the allogeneic CAR T candidate product in Raleigh. So that's truly a big milestone for the company, and we've definitely designed Raleigh to be supporting the entirety of our allogeneic CAR T clinical trials and then moving forward, the ability to be geared up for commercial supply. So that's definitely the plan. And I will hand it over to Carrie for the clinical question on 20x22.

  • Carrie Brownstein - Chief Medical Officer

  • Yigal, nice to hear from you. So yes, that's a really good question about the dosing. I think though the dual antigen targeting on 20x22 is really designed for a couple of things. One is to enhance the synapse between the tumor cell and the allogeneic CAR T to promote the expansion as well as potentially help with managing escape from relapse.

  • So I think there's different reasons for why the 20 -- the 2 antigens on our CARTs for 2 antigens on our cells would be helpful in the clinic. That said, it's hard to determine upfront how that's going to translate to dose. And that's why, like anything else, we have to go through our dose escalation trial, and we'll see where we land.

  • Operator

  • Our next question comes from the line of Kelly Shi with Jefferies.

  • Dingding Shi - Equity Analyst

  • My first question is on UCART22. Could you share progress so far in the manufacturing in-house products and how far are you in tech transfer and process validation. And the second question is what are the anticipated milestone payments over the next 12 months to Cellectis?

  • Arthur Stril - Chief Business Officer

  • Yes. Great. Thank you so much, Kelly. So on the first question, so UCART22 has been manufactured at Raleigh. Just by way of reminder, this year, we've announced that we will be replacing the current version of UCART22 manufactured at our CMO with UCART22 manufactured in-house. So manufacturing has happened at Raleigh. We're finalizing the release, and then we'll be filing the data with FDA in order to be using the product in the clinic by the end of the year and second half of this year. So that's obviously going to be a great milestone and we'll definitely share that with you in second half of this year. Now, regarding the milestone payments, I think the main significant milestone that we're expecting this year is the entry of pivotal trial of ALLO-501A, so the anti-CD19 allogeneic CAR T product candidate, we licensed to Allogene. So Allogene has guided that they will enter pivotal trial with ALLO-501A in mid this year, which will trigger a milestone payment to select us. And we'll definitely have other milestone -- yes, sorry, please go ahead.

  • Dingding Shi - Equity Analyst

  • Sorry, go ahead.

  • Arthur Stril - Chief Business Officer

  • No, no, I was going to say we will also have other milestones that are coming from Allogene, our partnerships with Allogene, Iovance and Cytovia.

  • Operator

  • Our next question comes from the line of Salveen Richter with Goldman Sachs.

  • Unidentified Analyst

  • This is [Ned] on for Salveen. Just a quick question on 123. When are we likely to see initial Phase 1 data? I know you didn't guide anything specific on the call or the press release. But just wondering when that could be likely. And then could you remind us of the registrational path, if those data are positive, when would you potentially move into a pivotal study? And then also for 123, are you thinking about the market opportunity with regard to fit versus unfit? Is there anything we should consider there in AML and then separately on the partnerships, is there -- are there any assets or indications you're most excited about?

  • Arthur Stril - Chief Business Officer

  • Great. So I will hand over the 123 clinical questions to Carrie, and then I will take the question on partnerships at the end.

  • Carrie Brownstein - Chief Medical Officer

  • Yes, hello, thanks so much for that. So we're still extremely excited about the UCART123 program. As you are well aware, and just based on your questions, AML, particularly relapsed/refractory AML is an extremely challenging disease to treat. The patients are extremely fragile and it's difficult to move through, given some of the difficulties of AML. That said, we remain extremely excited about the program and moving it forward. We haven't guided yet as to when we're going to share data. But what I can say is that we're moving the program forward. We have extremely excited investigators. We're very engaged in the program and we're moving through to ensure that we have the right clinical development plan and the right path forward.

  • Arthur Stril - Chief Business Officer

  • Yes. And so on the partnership, I mean, I think what's very interesting with the current pipeline is we have several shots on goal. We will have 4 shots on goal as soon as UCART20x22 is in the clinic this year with -- in very different hematological malignancies with very different risk profiles. So I think all these assets are definitely interesting and I think having the ability to have these different products altogether in our pipeline is definitely a defining asset for Cellectis.

  • Operator

  • Our next question comes from the line of Jack Allen with Baird.

  • Jack Kilgannon Allen - Senior Research Analyst

  • Congrats on the progress. I just have one right now, and it's with regards to the IP, we saw some interesting data from a competitor, [Caribou] yesterday with their CD19 targeted allogeneic CAR T. They use a unique gene editing sequence, but I believe you have IP on the TCR knockout with a variety of gene editing modalities. I was hoping you could just touch on that a little bit more and how you plan to leverage your unique IP position as it relates to that aspect of creating these allogeneic cell therapies.

  • Arthur Stril - Chief Business Officer

  • Thanks, Jack. Excellent question. I'll hand it over to Andre for this one.

  • Andre Choulika - Co-Founder, CEO & Director

  • Well, of course, in the cell and gene therapy, the IP space is always changing. And what is interesting for the selective position is that we've been based in this space for very long period of time, and we've been amassing series of different type of IP going from like gene editing, patents that are umbrella patents covering also TALEN (inaudible) but also CRISPR. And we've been using also a lot of our IP in covering all the innovation that the company has been doing from lymphodepletion regimen to the engraftment of the cells and going through, for example, like the questions we had before, such as the knocking out certain genes to enhance engraftment such as CD52, Beta-2 microglobulin or replacing by HLA et cetera, with a very nice package of IP around.

  • Well, now none of these drugs have been for now commercialized or therapies have been commercialized. And so today, the situation is that all the competition is still in clinical development, and we hope that the first product to be -- to file a BLA will be the one from our partner Allogene, ALLO-501A, would be potentially the one -- first one to file a BLA soon. And then once the other competition will start hitting the market, that would totally change the position and I think then the IP will become an interesting asset for the company that holds a very large amount of IP.

  • Now, commenting all of this more in detail, of course, will be something that we're refraining to do. I hope that answers the question.

  • Operator

  • Our next question comes from the line of Hartaj Singh with Oppenheimer.

  • Hartaj Singh - Research Analyst

  • Thank you for the 2 questions and of the really nice updates. The first question is on 20x22, the product you're going to file the IND on. I'm sure you're getting close to getting the protocol finalized there for your Phase 1 dose escalation dose expansion. Can you just maybe give us some idea of what that could look like? Will it be on CD19 refractory patients? Could it be of -- sort of all comers in that area, CD19, CD20? How do you envision the dose expansion -- dose escalation happening, then going into dose expansion? That's number 1.

  • Number 2 is the financial question. So if I just do kind of rough back of the envelope math, it looks like your cash runway to 2024 means we have to kind of make an assumption that you're going to get about $30 million to $60 million from potentially your partners coming in through milestone payments. And we're not looking for guidance there, but that's a pretty good chunk of change coming in. Can you just maybe give us some color around that over the next essentially 12 to 24 months, that sort of that runway?

  • Arthur Stril - Chief Business Officer

  • Hello, Hartaj and thank you so much for the questions. The first one is definitely for Carrie, and I'll hand it over to Bing for the second one.

  • Carrie Brownstein - Chief Medical Officer

  • Hello, Hartaj, how are you? Good to hear from you. Yes. So we're incredibly excited about the UCART20x22 program. As you are well aware, NHL remains a high unmet medical need and what I think is great about our program is in also in a space where there is a tremendous proof of concept, not only for autologous CAR T-cell therapy, but for allogeneic as well.

  • We haven't disclosed what our Phase 1 design is going to look like. Suffice it to say, it will be on clinicaltrials.gov, when we open it, you will see it then. But it's -- it will look like your -- it will be interesting and I think we are in a good place to move this through very quickly given the proof of concept that's already there. Thank you for asking.

  • Bing C. Wang - CFO

  • And Hartaj, on your cash pressure, we are comfortable with our cash position right now. And you're right, this is based on some assumptions on milestone payment, and we have already provided those guidance, and that is all we can answer on that question for now.

  • Operator

  • Our next question comes from the line of Raju Prasad with William Blair.

  • Raju Yashaswi Prasad - Senior Research Analyst

  • Just curious to know kind of as you're taking 20x22 into the clinic, expectations for -- could we see this approach extend durability? I mean I think ALLO rejection has still been kind of the big question here. And I was wondering kind of is it antigen specificity that you think is the reason why we're seeing it in some of the 19 and 20 candidates that we've seen in the clinic thus far? And then I have a question after that.

  • Arthur Stril - Chief Business Officer

  • Hello, Raju, very interesting question. I think Carrie is probably the best, please.

  • Carrie Brownstein - Chief Medical Officer

  • Sure. I mean I think as I mentioned earlier, I think the dual antigen approach is more about having increased contact with the tumor cells for potential improved expansion, improved killing, et cetera, as well as for patients who are multiply relapsed who may have had loss of antigen, you have the opportunity to kill both or actually cells that are only expressing 22, those that only express 20 and those that express both. So it really provides a much broader killing mechanism than with a single antigen.

  • In terms of persistence, again, I think that in the allogeneic space, we are looking for a certain amount of persistence in order to have the appropriate engraftment and expansion in killing, but we're not necessarily looking for long-term persistence. And I know in the auto space, mainly because there's not an easy ability to redose as well as at least the data from ALL, which is really the only data that's shown this that long-term persistence is associated with longer-term durability. We want durability of our responses. We don't necessarily need durability of ourselves more than enough to do the killing.

  • So I think, again, we're going to continue with our approach that we think is a really terrific approach, which is the CD52 knockout using alemtuzumab. It allows us to kind of dial in and dial out the persistence as needed because as you well know, outside of the B-cell space, there's really not that many antigens out there that you would want to have persistent for a significant period of time. So we really strongly believe in our current strategy. And we think that we're going to be able to see the precisions we need to sustain durable responses.

  • Raju Yashaswi Prasad - Senior Research Analyst

  • And then I just wanted to get some comments on some of the NK cell AML data that was announced earlier this year. Just kind of curious on your thoughts on how that sets up kind of the 123 readout when the NK cell approach is showing some MRD negativity in their CRs. Is that something that you think that we should anticipate with a 123 T-cell approach?

  • Arthur Stril - Chief Business Officer

  • Yes. Carrie, this one is for you as well.

  • Carrie Brownstein - Chief Medical Officer

  • Sure. I was extremely excited to see the (inaudible) data. Again, I think that -- and as I said earlier in the call, AML is such a horrible aggressive disease and as many shots on goal to improve the lives and the outcome of patients with AML is an incredibly positive thing. So we were really happy to see that data, and I think it actually bodes well for our programs as well and shows that an allogeneic approach can work in the context of AML. So we are looking forward to sharing data when we have it available. And we still, as I said, believe strongly in the program and have very engaged investigators. So I think when we have the data share, we will share it.

  • Operator

  • Our next question comes from the line of Silvan Tuerkcan with JMP Securities.

  • Silvan Can Tuerkcan - Director and Equity Research Analyst

  • Congrats on the progress. I have 2 quick questions. The first one about the [EHA] data that came out yesterday. The (inaudible) they use a more enhanced lymphodepletion regimen. So is that something that you may be looking at, seeing that they kind of thread the needle and that may be a response as well for the greater expansion and it's not only the PD-1 KL here? And then my second question was around, what can -- what are the learnings from the ongoing trials and also maybe from the Allogene trials that you can leverage directly to UCART20x22 to inform dosing, lymphodepletion and kind of patient selection.

  • Arthur Stril - Chief Business Officer

  • Hello, Silvan, these are 2 great questions, and I'll pass it over to Carrie.

  • Carrie Brownstein - Chief Medical Officer

  • Yes. Thanks so much, Silvan. So yes, I mean, I think their data is interesting. But I do think that the enhanced lymphodepletion, particularly higher doses of Cy/Flu, you have to be super careful, right? It's very dependent on the disease that you're treating and in addition to the doses. So for example, in the context of lymphoma, those patients are a little more sturdy. They're healthier. They're less fragile. Their marrow hasn't been completely desecrated by multiple rounds of chemotherapy. And so higher dose of cyclophosphamide, fludarabine may be okay in those patients and not lead to higher issues from toxicity.

  • I'm sure you saw, for example, the -- I think it was the precision data in ALL and NHL, where they gave much higher doses of Cy/Flu and they saw a significant toxicity actually leading to grade 5 events from infection and among other things. So it's a very fine needle to thread, which is why, again, our approach is also an enhanced lymphodepletion, but not with giving more chemo, but with the fludarabine -- I'm sorry with the alemtuzumab and the CD52 knockout because it gives a selective lymphodepletion and selective to T-cells, NK cells and other lymphocytes as opposed to knocking out someone's marrow. And that approach, and we know the drug well, it has a profile that we understand well. We have very strong guidelines in terms of toxicity management for infections, which have been published by NCCN. So this is something that's been around for a long time, and we're very comfortable with and allows us to have much more manageable -- and manageable and tweaking, so to speak, of what that lymphodepletion may look like for a specific patient population. So we're sold on what we're doing, and we'll see how their data progresses as time goes.

  • Operator

  • Thank you. Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Mr. Choulika for any final comments.

  • Andre Choulika - Co-Founder, CEO & Director

  • Thank you very much, everyone, for your time. I know we're in a very special period for cell and gene therapy. There's a lot of trials ongoing, lot of different methods that are ongoing using different approaches for lymphodepletion, for CAR expansion, different type of CAVs, et cetera. But we see also that Cellectis has been very interestingly positioned us with our partners; Allogene, Servier, but also Cytovia and Iovance into a fantastic space where we've been leading into this space.

  • Now when we come up with another CD19 allogeneic data that comes out, like from a new conference or a new approach, et cetera, it doesn't make the thing where we see that, well, us with our partners getting into new phases and probably the first [promos] that are going to get to registration at the end will come up from lab that have been selected for a long period of time, and we've been excited about what we're doing. And we are excited also by providing some data on our 4 assets, 22 which is differentiated, 123 which is differentiated, 20x22 which is differentiated in Non-Hodgkin's lymphoma and finally CS1 in multiple myeloma.

  • So please watch a bit what's going to happen in the company. And I think the next month in this whole cell and gene therapy space is going to be very interesting and Cellectis is here to contribute to the space.

  • Thank you very much for your time, and have a good day.

  • Operator

  • Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.