Cellectis S.A. (EPA:ALCLS)
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Earnings Call: Q1 2022

May 13, 2022

Operator

Greetings, and welcome to the Cellectis First Quarter 2022 Corporate Update and Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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, Cellectis

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. André 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 Form 6-K and issued a press release reporting its financial results for the first quarter and three-month 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 report, including the management report for the year ending on December 31, 2021, and subsequent filings Cellectis makes with the Securities and Exchange Commission from time to time. I would now like to turn the call over to André Choulika.

André Choulika
Chairman and CEO, Cellectis

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 allogeneic dual CAR T-cell product candidate being developed for patients with relapsed or refractory non-Hodgkin's lymphoma, or NHL. We are 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 Cellectis' first product candidate with fully integrated in-house development.

This showcases our transformation into an end-to-end cell and 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 two back-to-back publications in Nature Communications, 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 allogeneic UCART123 in the clinic. While the few CD123 T-cell therapies evaluated to date rely on autologous approaches with complex clinical and logistical challenges, this set of preclinical data strongly supports 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 patients, specifically in very hard to treat diseases like AML and our mission to address unmet medical needs. Our partnerships proved to be an exciting highlight with Cellectis. In January, Allogene announced that the U.S. Food and Drug Administration removed 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 cells of a single patient treated with ALLO-501A was unrelated to TALEN gene editing in these cells.

Allogene is now focused on initiating their pivotal trial of ALLO-501A in third line large B-cell lymphoma around middle of this year, pending FDA discussion, and continue to enroll in the phase I portion of the study to offer ALLO-501 to patients in need. Enrollment has previously resumed in trial targeting BCMA for patients with relapsed or refractory multiple myeloma and targeting CD70 for patients 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 lymphocyte, or TIL therapy, using Cellectis technology to develop next generation TIL therapy. This provides a significant opportunity to deliver the combination of TIL and a new checkpoint inhibitor 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 partner, 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 SPAC. Cellectis is developing custom TALENs for Cytovia to develop gene-edited induced pluripotent stem cells, or iPS-derived natural killer cells. These announcements reiterate once more that TALEN is a technology of choice for gene editing, which continue to provide the company with expanded business opportunities. As I stated in our last earnings call, Cellectis made a meaningful leap toward becoming one of the few end-to-end cell and gene therapy companies.

With our two manufacturing sites fully operational in Raleigh, North Carolina, and in Paris, Cellectis plans to initiate dosing of patients 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. The 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 three sponsored clinical trials and preclinical product pipeline. Carrie, please go ahead.

Carrie Brownstein
CMO, Cellectis

Thank you for that overview, André. UCART22, our CD22-directed, TALEN gene-edited, allogeneic, off-the-shelf CAR T-cell product candidate 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 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 post-lymphocyte suppression and promoted expansion of UCART22. Signs of anti-leukemic activity of UCART22 was observed.

BALLI-01 is currently enrolling patients at dose 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 myeloid 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's 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 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 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's Chief Financial Officer, for an overview of our financials. Bing, please go ahead.

Bing Wang
CFO, Cellectis

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 equivalents, current financial assets, and restricted cash position of Cellectis, excluding Calyxt, as of March 31st, 2022, was $ 142 million compared to $ 177 million as of December 31st, 2021. This difference mainly reflects $33 million of net cash flows used in operating, investing, and lease financing activities.

$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's standalone operation into early 2024. The consolidated cash equivalent, current financial assets, and restricted cash position of Cellectis's, including Calyxt, was $ 160 million as of March 31st, 2022, compared to $ 191 million as of December 31, 2021. The net cash flow used in operating capital expenditure and leases were $33 million at Cellectis and $7 million at Calyxt in the first three 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 three months of 2022, compared to a loss of $6 million in the first three months of 2021.

The $23 million increase in net loss between 2022 and 2021 was primarily driven by a decrease in revenues and other income of $ 19 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 $0.07 per share in the first three months of 2022, compared to a loss of $12 million or $0.28 per share in the first three 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 three months of 2022, compared to a loss of $11 million or $0.26 per share in the first three 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.

André Choulika
Chairman and CEO, Cellectis

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. We look forward to continuing this effort in the second quarter of 2022 and beyond. Cellectis's proficiency and command of gene editing technology has enabled the successful development of a robust pipeline of novel preclinical product candidates, which are designed to overcome the challenges of cell-based cancer treatments and gene therapy.

At Cellectis, we strongly believe that our product candidates, 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

Thank you. At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Gena Wang with Barclays. Please proceed with your question.

Gena Wang
Managing Director and Biotech Equity Research Analyst, Barclays

Thank you for taking my questions, and congrats on the progress. 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 different 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? You know, do you think, with and you have a slightly different approach. Do you think, what could be a better approach, or you think it's too early at this point?

Arthur Stril
Chief Business Officer, Cellectis

Hi, Gena. Thank you so much for the question. I think this one is probably one for André.

André Choulika
Chairman and CEO, Cellectis

Well, thank you, Gena. Thank you for the question also. It's appreciated. Of course, Cellectis has been investigated 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 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 the, preconditioning treatment with alemtuzumab, which has been today used, as the platform in Cellectis, but also with our partners Allogene and Servier.

Of course, one of the products does not get into this category, which is UCARTCS1 to treat multiple myeloma, where we knock out CS1, and CS1 is present a lot of different type of immune cells. Therefore, UCARTCS1.

That has the knockout of CS1 to prevent the fratricide killing, has a self lympho-depleting 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 months in the patient and can clear the tumor during this period. That's like a very interesting procedure of self lymph depleting and self engrafting CAR T such as CS1. Not all the targets have this property. 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 gonna be presented by one of our scientists at ASGCT, so we'll communicate very soon on this.

There are a series of approaches that we can do in the space. Of course, we are not bound to one way to do it, but several different ways. Of course, we are very often copied.

Gena Wang
Managing Director and Biotech Equity Research Analyst, Barclays

Okay. Well, thank you very much.

Operator

Thank you. Our next question comes from the line of Yigal Nochomovitz with Citigroup. Please proceed with your question.

Yigal Nochomovitz
Director and Biotechnology Analyst, Citigroup

Hi, André and Ben and team. Thanks for taking the questions. I just had two on UCART20x22. First, with regard to the manufacturing capacity in Raleigh for UCART20x22, can you just expand on what is the current manufacturing capacity down there? And what do you expect to be the peak manufacturing capacity? Then secondly, obviously, since you have two antigens in the one cell product, does this mean that you're gonna 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? Thank you.

Arthur Stril
Chief Business Officer, Cellectis

Hi, 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 Carrie for the clinical question. 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. 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. 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. That's definitely the plan.

I will hand it over to Carrie for the clinical question on UCART20x22.

Carrie Brownstein
CMO, Cellectis

Hi, Yigal. Nice to hear from you. Yeah, that's a really good question about the dosing. I think, though, the dual antigen targeting on UCART20x22 is really designed for a couple 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 antigen escape from relapse. I think there's different reasons for why the two antigens on our CARs for two antigens on our cells would be helpful in the clinic. That said, it's hard to determine upfront how that's gonna 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.

Yigal Nochomovitz
Director and Biotechnology Analyst, Citigroup

Understood. Thanks.

Operator

Thank you. Our next question comes from the line of Kelly Shi with Jefferies. Please proceed with your question.

Kelly Shi
Senior Equity Research Analyst, Jefferies

Thank you for taking my questions. My first question is on UCART22. Could you share progress so far in manufacturing in-house products, and how far are you in tech transfer and the process validation? The second question is, what are the anticipated milestone payments over the next 12 months to Cellectis? Thanks.

Arthur Stril
Chief Business Officer, Cellectis

Yeah. Great. Thank you so much, Kelly. On the first question, 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. 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, second half of this year. That's obviously gonna be a great milestone, and we'll definitely share that with you 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. Allogene has guided that they will enter pivotal trial with ALLO-501A in mid this year, which will trigger a milestone payment to Cellectis. We'll definitely have other milestones.

Kelly Shi
Senior Equity Research Analyst, Jefferies

Thank you.

Arthur Stril
Chief Business Officer, Cellectis

Yeah. Sorry, please go ahead.

Kelly Shi
Senior Equity Research Analyst, Jefferies

Sorry, go ahead.

Arthur Stril
Chief Business Officer, Cellectis

No, no. I was gonna say, we will also have other milestones coming from partnerships with Allogene, Iovance and Cytovia.

Kelly Shi
Senior Equity Research Analyst, Jefferies

Thank you very much.

Operator

Thank you. Our next question comes from the line of Salveen Richter with Goldman Sachs. Please proceed with your question.

Speaker 13

Hi, thanks. This is Matt on for Salveen Richter. Just a quick question on UCART123. When are we likely to see initial phase I data? I know you didn't guide anything specific on the call or the press release, but just wondering when that could be likely. Could you remind us of the registrational path, if those data are positive, when would we potentially move into a pivotal study? And then also for UCART123, 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, are there any assets or indications you're most excited about? Thank you very much. Bye.

Arthur Stril
Chief Business Officer, Cellectis

Great. I will hand over the UCART123 clinical questions to Carrie, and then I will take the question on partnerships at the end.

Carrie Brownstein
CMO, Cellectis

Yeah, hi, thanks so much for that. You know, we're still extremely excited about the UCART123 program. You know, as you are well aware, even 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 with AML. That said, we remain extremely excited about the program and moving it forward. We haven't guided yet as to when we're gonna share data. But what I can say is that we're moving the program forward.

We have extremely excited investigators who are 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, Cellectis

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 four shots on goal as soon as UCART20x22 is in the clinic this year, with in very different hematological malignancies with very different risk profiles. I think all these assets are definitely interesting. I think having the ability to have these different products all together in our pipeline is definitely a defining asset for Cellectis.

Operator

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

Jack Allen
Senior Research Analyst, Baird

Hey, team. Congrats on the progress, and thank you so much for taking the questions. 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. Thanks so much.

Arthur Stril
Chief Business Officer, Cellectis

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

André Choulika
Chairman and CEO, Cellectis

Well, of course, in the cell and gene therapy, the IP space is always changing. What is interesting for the Cellectis position is that we've been based in this space for a 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 meganucleases, but also CRISPR. 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, you know, knocking out certain genes to enhance engraftment, such as PD-1, CD52, beta-2 microglobulin, or replacement by HLA E, etc., with a very nice package of IP around.

None of these drugs have been commercialized, or therapies have been commercialized. Today the situation is that all the competition is still in clinical development. We hope that the first product to file a BLA will be the one from our partner, Allogene. ALLO-501A would be potentially the first one to file a BLA soon. 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 this more in detail, of course will be something that I would refrain to do.

I hope that clears the question.

Jack Allen
Senior Research Analyst, Baird

That's great context. Thank you so much.

Gena Wang
Managing Director and Biotech Equity Research Analyst, Barclays

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

Hartaj Singh
Managing Director and Senior Analyst, Oppenheimer

Great. Thank you for the two questions and all of the really nice updates. The first question's on UCART22, the product you're gonna file the IND on. You know, I'm sure you're getting close to getting the protocol finalized there for your phase I dose escalation, dose expansion. Can you just maybe give us some idea of what that, you know, could look like? You know, will it be on the CD19 refractory patients? Could it be all, you know, sort of all comers in that area, CD19, CD20? H ow do you envision the dose escalation happening and then going into dose expansion? That's number one. You know, number two is a financial question.

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 gonna get about $30 million-$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 12-24 months that sort of runway? Thank you.

Arthur Stril
Chief Business Officer, Cellectis

Hi, Hartaj, and thanks 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
CMO, Cellectis

Hi, Hartaj. How are you? Good to hear from you. Yeah, we're incredibly excited about the UCART22 program. As you are well aware, NHL remains a high unmet medical need, and what I think is great about our program is also in a space where there's a tremendous proof of concept, not only for autologous CAR T-cell therapy, but for allogeneic as well. You know, we haven't disclosed what our phase I design is going to look like. Suffice it to say it'll be on ClinicalTrials.gov when we open it, so you'll see it then. It'll 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.

Hartaj Singh
Managing Director and Senior Analyst, Oppenheimer

Great. Thanks, Carrie.

Carrie Brownstein
CMO, Cellectis

Sure.

Bing Wang
CFO, Cellectis

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

Hartaj Singh
Managing Director and Senior Analyst, Oppenheimer

Great. All right. Thank you, Bing.

Operator

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

Raju Prasad
Senior Biotechnology Analyst, William Blair

Thanks for taking the question. Just curious to know kind of as you're taking UCART20x22 into the clinic, you know, expectations for, you know, 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 UCART19 and UCART22 candidates that we've seen in the clinic thus far? I have a question after that.

Arthur Stril
Chief Business Officer, Cellectis

Hi, Raju. Very interesting question. I think Carrie's probably the best place.

Carrie Brownstein
CMO, Cellectis

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 CD22, those that only express CD20, 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 and killing, but we're not necessarily looking for long-term persistence.

I know in the autologous 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, is that long-term persistence is associated with longer-term durability. We want durability of our responses. We don't necessarily need durability of our cells more than enough to do the killing. I think, again, we're gonna 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, 'cause as you well know, outside of the B-cell space, there's really not that many antigens out there that you would wanna have persistence for a significant period of time.

We're really strongly believe in our current strategy and we think that we're gonna be able to see the persistence we need to see durable responses.

Raju Prasad
Senior Biotechnology Analyst, William Blair

Great. Thanks. 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 to know your thoughts on, you know, how that sets up kind of the UCART123 readout when the NK cell approach is, you know, showing some MRD negativity in their CRs. Is that something that we you think that we should anticipate with a UCART123 T-cell approach? Thanks.

Arthur Stril
Chief Business Officer, Cellectis

Yeah, Carrie, this one is for you as well.

Carrie Brownstein
CMO, Cellectis

Sure. I was extremely excited to see the encouraging data. You know, 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. 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. You know, we are looking forward to sharing data when we have it available. W e still, as I said, believe strongly in the program and have very engaged investigators.

I think w hen we have the data to share, we will share it.

Raju Prasad
Senior Biotechnology Analyst, William Blair

Thanks, Carrie.

Carrie Brownstein
CMO, Cellectis

Sure.

Operator

Thank you. Our next question comes from the line of Silvan Tuerkcan with Citizens JMP Securities. Please proceed with your question.

Silvan Tuerkcan
Senior Biotechnology Analyst, Citizens JMP Securities

Thank you. Thanks for taking my question, and congrats on the progress. I have two quick questions. The first one, about the EHA data that came out yesterday. The Caribou, 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 responsible as well for the greater expansion and it's not only the PD-1 KO here? Then my second question was around what are the learnings from your ongoing trials and also maybe from the Allogene trials that you can leverage directly to UCART20x22 to inform dosing lymphodepletion and kind of selection, patient selection? Thank you.

Arthur Stril
Chief Business Officer, Cellectis

Hi, Silvan. These are two great questions. I'll pass it over to Carrie.

Carrie Brownstein
CMO, Cellectis

Yeah. Thanks. Thanks so much, Silvan. Yeah, 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 as in addition to the doses. 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, you know, decimated by multiple rounds of chemotherapy. Higher doses 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 Precision BioSciences data in ALL and NHL where they gave much higher doses of Cy/Flu, and they saw significant toxicity actually, you know, leading to, you know, grade five events from infection and among other things. It's a very fine needle to thread, which is why, you know, 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 and NK cells and other lymphocytes as opposed to knocking out someone's marrow. That approach and, you know, 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 are, you know, been published by NCCN. 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 tweaking, so to speak, of what that lymphodepletion may look like for a specific patient population. You know, we're sold on what we're doing and, you know, we'll see how their data progresses as time goes on.

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.

André Choulika
Chairman and CEO, Cellectis

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

Now when we come up with another CD19 allogeneic data that comes out, like from a new conference with a new approach, etc., it doesn't make the thing where we see that with us, with our partners are getting into new phases, and probably the first products that are going to get to registration at the end will come up from labs that have been selected for a long period of time, and we're being excited about what we're doing. We are excited also by providing some data on our four assets, UCART22, which is differentiated, UCART123, which is differentiated, UCART20x22, which is differentiated in non-Hodgkin's lymphoma, and finally UCARTCS1 in multiple myeloma. Please watch a bit what's gonna happen in the company.

I think the next month is 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.

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