CELLECTIS S.A.

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Transcript : Cellectis S.A., Q3 2022 Earnings Call, Nov 04, 2022

04/11/2022 | 13:00

Presentation Operator Message
Operator (Operator)

Greetings, and welcome to the Cellectis Third Quarter 2022 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Arthur Stril, Chief Business Officer. Thank you, sir. You may begin.

Presenter Speech
Arthur Stril (Executives)

Good morning, and welcome, everyone, to Cellectis' Third 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. Bing Wang, our Chief Financial Officer; and Dr. Mark Frattini, our Chief Medical Officer. Yesterday evening, Cellectis filed its interim report and issued a press release reporting its financial results for the third quarter and 9-month period ended September 30th, 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 status and plans and product development of its license partners. 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 31st, 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 Andre.

Presenter Speech
André Choulika (Executives)

Thank you, Arthur. Good morning, and thank you, everyone, for joining us today. 2022 has been a productive year thus far for Cellectis. We have made progress on all fronts that we're thrilled to share with you today. Yesterday, we've announced that our UCART123 abstract was accepted for an oral presentation at the American Society of Ontology's Annual Meeting. We're excited to share preliminary data from AMELI-01 trial, which is a dose escalation and dose expansion study evaluating the safety, expansion, persistence and clinical activity of UCART123 in patients with relapsed or refractory acute myeloid leukemia. Acute myeloid leukemia is a huge unmet medical need with lack of cell therapy options. And these encouraging clinical data are a great step forward for patients. We're also proud that the Amsterdam University Medical Center will present preclinical data at ASH on our product candidate, UCARTCS1, which reinforces the validation of CS1 as the relevant target for relapsed and refractory multiple myeloma patients. Cellectis continues to make progress enrolling patients in its 4 sponsored allogeneic CAR-T trial.

We will initiate dosing patients with our product candidate, UCART22 and new CAR-T 2022 that have been fully manufactured in health. This will be a significant milestone for Cellectis, highlighting how our investment in building our GMP manufacturing facilities has now provided the company with independence and control over our gene and cell therapy processes. We believe that bringing manufacturing fully in-house could contribute to eliminating some of the barriers competitors facing -- are facing. Our goal is to provide consistency and safety in our production and sure lead times are met and adaptability. Importantly, having our manufacturing in-house means that we can rapidly optimize promising therapeutic candidates as we monitor clinical responses, leading to the best possible product at registration, not filing. This quarter, our partnership continued to be a highlight for Cellectis, as several of our partners disclosed exciting milestones. Allogene announced that it was starting the first allogeneic CAR-T potentially pivotal Phase II trial for patients with large B cell lymphoma.

We share Allogene's excitement for this accomplishment as it paves the road for both ALLO-501A and our broader pipeline of allogeneic candidate product to greatly increase patient access to cell therapy. Our licensed partner, Iovance announced that the first patient was dosed and completed the safety observation period in the IOV-GM1-201 clinical trial for Iovance first genetically modified TALEN-edited tumor-infiltrating lymphocyte, or TIL therapy. For the treatment of previously treated metastatic non-small cell lung cancer and advanced melanoma.

Finally, our partner Cytovia announced that it will present new preclinical data on tailing gene-edited induced pluripotent stem cell-derived natural killer cells at the Society of Immunotherapy of Cancer's Annual Meeting that will take place in November. These achievements showcase once more that Cellectis, along with this gene editing technologies, such as TALEN is a partner of choice for cell and gene therapy applications across a wide range of cell types and that we're continuing to deliver on our promise of constant innovation in order to advance the efforts of both our and our partners' clinical trials.

With that, I'd like to turn the call over to Mark Frattini, our newly appointed Chief Medical Officer. Most of you know Mark as he has been serving as a core member of the senior clinical team over the past 2 years. Previously, as the Senior Vice President of Clinical Science, Mark will give an overview of our sponsor clinical trials and preclinical product pipeline. Mark, please go ahead.

Presenter Speech
Mark Frattini (Executives)

Thank you, Andre, and good morning, everyone. As Andre mentioned, 2022 has been a busy and productive year for Cellectis with our proprietary clinical and preclinical programs making progress, and we are specifically excited to share additional preliminary clinical data from our AMELI-01 trial in an oral presentation at the ASH Annual Meeting next month. The abstract for AMELI-01 includes preliminary clinical data from the Phase I open-label dose escalation study in patients with relapsed or refractory acute myeloid leukemia, showing that adding alemtuzumab to the fludarabine cyclophosphamide lymphodepletion regimen or FC regimen was associated with improved lymphodepletion and significantly higher UCART123 cell expansion, which correlated with improved clinical activity. These data are encouraging and support the continued enrollment into the study.

The abstract for UCARTCS1 presented by the Amsterdam University Medical Center includes preclinical data demonstrating antitumor activity in vitro and in vivo and supported the initiation of the first-in-human study of UCARTCS1, Cellectis' MELANI-01 clinical study. Cellectis continues to progress in its Phase I clinical trial evaluating its 4 proprietary allogeneic CAR T cell therapies in hematologic malignancies. BALLI-01 evaluating UCART22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. AMELI-01 evaluating UCART123 in patients with relapsed or refractory acute myeloid leukemia.

MELANI-01 evaluating UCARTCS1 in patients with relapsed or refractory multiple myeloma. Last quarter, we were pleased to announce the FDA IND clearance for our product candidate, UCART20x22, Cellectis' first allogeneic dual CAR T cell product candidate being developed for patients with relapsed or refractory non-Hodgkin lymphoma. UCART20x22 is Cellectis' first product candidate, fully designed, developed and manufactured in-house, showcasing the company transformation into a true end-to-end cell and gene therapy company. In addition to the exciting clinical updates, we have several additional preclinical updates.

In October, Cellectis presented data on 2 tailing-based gene therapy preclinical programs for patients with sickle cell disease and mucopolysaccharidosis type 1 at the European Society for Gene & Cell Therapies Annual Congress. The preclinical data further demonstrated our ability to leverage tailing gene editing technology to potentially address genetic diseases, namely sickle cell disease and lysosomal storage diseases. By correcting a mutation are inserting a corrected gene at the hematopoietic stem cell level, Cellectis aims to provide a lifelong supply of healthy cells from a single intervention.

Lastly, Cellectis announced that 2 posters showcasing preclinical data on TALEN-edited smart CAR T cells for solid tumors will be presented at the Society for Immunotherapy of Cancer's Annual Meeting on November 10. The first poster will be on tailing edited smart CAR T cells targeting MUC1-expressing solid tumors. MUC1 is a tumor-associated antigen that is overexpressed in triple-negative breast cancer and other solid tumor malignancies. The second poster will be on innovative T-cell engineering strategies designed to increase the activity of CAR T cells for solid tumors while mitigating toxicity risks.

With that, I would like to hand the call over to Bing Wang Cellectis' Chief Financial Officer, for an overview of our financials for the third quarter of 2022. Bing, please go ahead.

Presenter Speech
Bing Wang (Executives)

Thank you, Mark. I will provide a brief overview of our financials for the third quarter of 2022. I would like to highlight that our financials, the cash, cash equivalents, current financial assets and restricted cash position of Cellectis, excluding Calix, as of September 30, 2022, was $95 million compared to $177 million as of December 31, 2021. This difference mainly reflect $81 million of net cash flow used in operating, investing and lease financing activities and $10 million of negative foreign exchange impact, partially offset by $6 million of cash received related to research tax credit prefinancing and $3 million cash received from milestones and licensees. Based on the current operating plan and financial projections, this cash position is expected to be sufficient to fund Cellectis' stand-alone operations into early 2024.

The consolidated cash, cash equivalents, current financial assets and restricted cash position of Cellectis, including Calix, was $103 million as of September 30, 2022, compared to $191 million as of December 31, 2021. -- the net cash flow used in operating capital expenditure and leases were $81 million at Cellectis and $17 million at Calix in the first 9 months of 2022, partially offset by a $10 million capital raise at Calix, $6 million of cash received related to research tax credit prefinancing at Cellectis and $3 million cash received from milestones and licenses. The net attributable loss to shareholders of Cellectis, excluding Calix, was $73 million in the first 9 months of 2022 compared to a loss of $75 million in the first 9 months of 2021.

This $2 million decrease in net loss between 2022 and 2021 was primarily driven by a decrease of R&D expense of $12 million, an increase in net financial gain of $7 million, partially offset by a decrease in revenues and other income of $18 million. The consolidated net loss attributable to shareholders of Cellectis, including Calix was $79 million or $1.74 per share in the first 9 months of 2022 compared to a loss of $89 million or $2 per share in 2021.

The consolidated adjusted net loss attributable to shareholders of Cellectis, excluding Calix, excluding noncash stock-based compensation expenses, was $67 million or $1.48 per share in the first 9 months of 2022 compared to a loss of $66 million or $1.49 per share in 2021. We are laser-focused on spending 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 going forward.

Presenter Speech
Arthur Stril (Executives)

Thank you, Bing. We're excited about all clinical and preclinical data Cellectis has generated and will continue to generate. We're also excited by the progress with our partners. Cellectis continues to make progress with our pipeline, highlighting our forced ongoing for ongoing clinical trials in hematological malignancies this quarter as we make steps closer to becoming a true end-to-end cell and gene therapy company. These updates clearly show our potential and ability to advance the field of allogeneic CAR T cell therapy.

With that, I would like to open the call for question and answers. Thank you.

Question and Answer Operator Message
Operator (Operator)

[Operator Instructions]. Our first question comes from Gena Wang with Barclays.

Question
Huidong Wang (Analysts)

Congrats on all the progress, and we look forward to the data update in the next few weeks. So we did see the abstract from the ASH Aster yesterday from the UCART123 program. So maybe just thoughts there, what is your goal regarding, say, the activity, where -- do you see -- we saw 1 out of 8 in the FCA arm show the CRA and very durable. And so what would be the actual goal that you wanted to achieve that you think it will be competitive? And then giving this clear benefit with alemtuzumab, how would you apply this broadly applied this to the other programs?

Answer
Arthur Stril (Executives)

Gena, thank you so much for the question. Both great questions. I will hand it over to Mark.

Answer
Mark Frattini (Executives)

Gena, thank you for the question. So I think I'll answer the second one first. So in regard to the alemtuzumab, I think the data that we're presenting about the effect of alemtuzumab in terms of prolonging the lymphodepletion and allowing for UCART expansion and clinical activity that we're going to present for 123 echoes what we've seen for UCART22 and was presented at ASH last year. And I think overall, point out to the importance of alemtuzumab in our UCART programs for the products that have the CD52 gene knocked out using our tail-end technology. So I think as we move forward, it's definitely really important to proceed with the alemtuzumab in the regimen. As far as the data for UCART123, we're incredibly excited by what we've seen.

I think as we've discussed before and everyone knows, these are really heavily, heavily pretreated patients who have essentially failed everything. And as you can see from the abstract data, over 50% of the patients have also failed allogeneic transplant. And for people, for patients like this, there are really no other treatment options and their life expectancy is very, very short. So the fact that we are able to achieve a long-term MRD-negative CR that's been durable and a patient is incredibly exciting in the dose escalation part of the study. I think the other thing to point out is the other responder in the FCA regimen, albeit stable disease was a patient that had over 90% blast reduction on day 28. So again, a very encouraging response as we proceed forward with the dose escalation part of the study.

Question and Answer Operator Message
Operator (Operator)

Our next question comes from Jack Allen with Baird.

Question
Jack Allen (Analysts)

Congratulations to the team on the progress over the course of the quarter. I wanted to ask you about some of the milestone payments that you're expecting to receive from Iovance and -- I guess, potentially from Iovance and also Allogene for initiating the pivotal study. Given that those -- I guess, milestones have been hit at this point. I was hoping you can maybe provide some more color as to the size of those milestone payments. And then additionally, any comments you can provide as it relates to the Servier relationship? And I guess, your path forward there as well would be great.

Answer
Arthur Stril (Executives)

Thank you, Jack. Great question, maybe being on the milestone and then probably Andre on the Servier relationship.

Answer
André Choulika (Executives)

Yes. So for the purpose of this call, we're going to focus on Q3, which ended up September 30. So in terms of any progress that happens since then, we'll withhold comment for now. And for the Servier Allogene situation, actually, we think that -- we've seen that there is definitely good possibilities that this should be resolved. And the situation is progressing. And also we're expecting some milestones to be reached on the Allogene side and the development of ALLO-501A, as stated in their Q3 press release and their call. We are very optimistic that the great product like this should find a path forward.

Question and Answer Operator Message
Operator (Operator)

Our next question comes from Yigal Nochomovitz with Citigroup.

Question
Yigal Nochomovitz (Analysts)

I just had a quick question regarding your manufacturing. Is the long-term plan also to have the UCART123 and UCARTCS1 being manufactured in your facilities?

Answer
Arthur Stril (Executives)

Yes, great question. I think on this, definitely, the plan is to leverage the fully internal manufacturing capabilities of Cellectis. We're extremely proud to now have the entire CAR T value chain in-house, ranging from starting material, plasmid, mRNA, viral vectors, all the way to the allogeneic CAR-T. So the plan is definitely, in the long run, to transition all our programs to this internal platform Absolutely.

Question
Yigal Nochomovitz (Analysts)

Got it. And then you announced the deal a targeted fuel and on CD20, CD22. So I'm just wondering, should we be expecting more of these fuel antigen-type products coming forward? Or is the CD20, CD22 more of like a one-off for a dual antigen?

Answer
Arthur Stril (Executives)

Okay. Also a great question. Andre, do you want to take this one? Sure, of course.

Answer
André Choulika (Executives)

Thank you, Yigal, for the question. The dual targeting is extremely interesting for numerous reasons and it's like the first allogeneic CAR-T that will be tested for dual targeting, the big advantage of having cars expressed in the same T cell gives you more chances to be able to grab tumor-associated antigen on the surface of the cancer cell and form a better seat to better killing. And that's the hypothesis behind all of this development that we're doing.

So the killing that we see so far in preclinical settings is very encouraging, and the data that we have is very solid. So the cell can kill CD20 and non-expressing CD22 or CD22 and non-expressing CD20 cells and, of course, both expressing this. However, in patients, you see wobbling on the both targets, it means the expression or density of these like CD20 and CD22 can derive. So single targeting CAR-T can sometimes have some escapes due to the lack of good formation of synapse and if there is like the 2 targets that are expressed on the cell so the synapse is better formed and the killing is better done. That's a hypothesis. So we're going to test this at first, but there is definitely plans to move forward in this strategy as we will analyze the data from the NATALEE trial that is about to start.

Question and Answer Operator Message
Operator (Operator)

Our next question comes from Salveen Richter with Goldman Sachs.

Question
Unknown Analyst (Analysts)

This is [ Mason ] on for Salveen. Could you please remind us of the status of the UCART 2022 program and whether it's still on track for the second half of '22? And could you also give us a review of which key catalysts we should look to by mid-'23?

Answer
Arthur Stril (Executives)

Thanks for the question. I will hand it over to Mark.

Answer
Mark Frattini (Executives)

So thank you. So for the 2022, absolutely, we're on track. As you know, we received the same to proceed from the FDA on August 1. And so we are in process of opening sites and plan to begin enrollment in Q4 of this year.

Answer
Arthur Stril (Executives)

Andre, do you want to take the broader question on the key catalysts?

Answer
André Choulika (Executives)

Sure. Actually, thank you very much for the question, and it's appreciated. We believe that Cellectis was 4 clinical trials that are ongoing with like CD22 targeting CD123 targeting CS1 targeting and CD22 by CD20 is very -- will provide numerous data points. The first one is that we have already an oral presentation at ASH, as Mark has said, and that where we give an update on the acute myeloid leukemia trial for UCART123, but we're also accumulating data in the other trials and will definitely start, as Mark just said, for the dual targeting CAR -- UCART 2022 enrollment this year, so before the end of the year. And that would make a 2023 very much rich in event starting now actually from the end of this year and through 2023. Of course, this is about all our CAR-T, but we expect also some meaningful data points from our partners, Iovance, Cytovia and Allogene Servier, of course.

Question and Answer Operator Message
Operator (Operator)

Our next question comes from David Dai with SMBC.

Question
Xiaochuan Dai (Analysts)

Great. also on congrats on the from progress. First of all, just on the IND clearance of CD22. I'm wondering if you can share some high-level thoughts on clinical trial design so far.

Answer
Arthur Stril (Executives)

Thank you, David. Mark, I think this is for you.

Answer
Mark Frattini (Executives)

So thanks. So as we begin, I can't really share a lot right now in terms of what's happening. But as we discussed in the prior question from Gena, obviously, the use of alemtuzumab will be important in the lymphodepletion regimen for this study.

Question
Xiaochuan Dai (Analysts)

Got it. That's helpful. And just another question on the response from the UCART123 patients seen so far in both the FC and FCA arms, especially interested in the durable MRD-negative patient who has [ Dover ] response for about 8 months so far. So wondering if you can share some at color on the characteristics of the patient. Does this patient have high assumption net risk? Or any thoughts would be helpful here.

Answer
Mark Frattini (Executives)

Yes. Thanks for that. So what I can share with you right now is just what's in the abstract because the rest is obviously embargoed until the presentation. But this patient, in particular, was an older patient, as outlined in the abstract that it failed 5 prior lines of therapy, including an allogeneic stem cell transplant which, as you know, in this case, as we discussed before, is really in this patient population, the worst of the worst. So a great response.

Question and Answer Operator Message
Operator (Operator)

Our next question is from Hartaj Singh with Oppenheimer & Company.

Question
Hartaj Singh (Analysts)

I just got a couple of questions. One is -- can you just talk a little bit about UCART123 and CS1? What dose levels are you there? You might have mentioned before I missed if I missed it, I apologize. And then what line of patients are you seeing there? I know AML, multiple myeloma have multiple lines of therapy. If you can you just remind us what line of patients you're seeing in your clinical trials there for 13 and CS1 specifically? And then secondly, there seems to be other companies interested in this post-CD19 treatment, CAR-T treatment area. Aside from the clinical design, can you just talk about how big this market is from a patient perspective? How large is it getting now with all the C19 therapies out?

Answer
Arthur Stril (Executives)

Thank you for both questions. I think the first one would be for Mark and then probably Bing can give some color on the market sizing question.

Answer
Mark Frattini (Executives)

Thanks, Hartaj, for the question. And in terms of the lines of therapy for both of these studies, obviously, these are very advanced and highly refractory patients for the 123 abstract, what's out there is these people have had an average of 4 prior lines of therapy up to 9 prior lines of therapy for the 123 study. So for 123, they failed everything, including Allo transplant in over 50% of the patients. So it's really last treatment option for the patients. with 123. For CS1, what we can disclose is that, as you know, the trial has reopened after it had been on hold from the FDA, and we're continuing in the dose escalation part of that study. And again, these are, again, the same way in terms of patients' eligibility criteria includes failing a BCMA-directed therapy, both antibody as well as prior CAR-T therapy. So highly refractory patients for both studies. As far as the dose levels for 123 goes is in the abstract. So we're at dose level 2 and 2 [ I ] for FCA will be reported.

Answer
Arthur Stril (Executives)

And Bing, you want to take the question on the market side?

Answer
Bing Wang (Executives)

Sure. Thank you for the question, Hartaj. I think that was a very actually critical question at this point. I think a lot of the indication we go after, the primary cell therapy solutions are still autologous. I think one thing that we need to think about is that there's only about 150 transplant center in the entire United States. This is reported by CNN in August of this year. So if you were to think of that number, and those are the institutions have the capability to do autologous therapy, it actually caps the total capacity for autologous treatment in the entire United States. So at 150 centers and if you were to even put an optimistic estimate of 6 patients a month, that is only about a 10,000 capacity for the entire United States every year for all autologous therapy. That's BCMA-CD19 combined.

So I think if we were to focus on that fact, then we realize that the current -- some of the current limitation autologous is really not just capped by manufacturing as even we thought at the beginning of the year is really capped by the hospital infrastructure in the United States. And this is not something that big pharma can just throw a few hundred million dollars on a new vector plant to solve. So I think once both ourselves as well as our partners as Servier and Allogene launch commercially viable allogeneic cell therapy, we will significantly expand the market. So that means in my home state of California, for example, people don't have to go to UCSF or City of Hope or Stanford. They can potentially go to Kaiser for a lot of these similar treatment. So the potential market size with the product that both ourselves and our partner will plan to launch will significantly expand cell therapy well beyond what is available today.

Question and Answer Operator Message
Operator (Operator)

Our next question is from Yanan Zhu with Wells Fargo.

Question
Yanan Zhu (Analysts)

About the CR patient in ASH abstract, it was quite durable 8 months as of the cutoff date of July 2022. Just wondering if you can comment if that patient is still in response currently? And also, does this suggest a depth of response for this indication could be important and persistence may not be as important in this indication? And also, if you can talk about how are you thinking about the dose going forward for the FCA arm? Obviously, you have 1 DLT out of 8 patients at this arm and at dose level 2. But for the FC arm, you do have, I think, higher frequency of DLTs at the higher level, those DL2 and DL3. So how do you -- should we think about your ability to increase the dose in the FCA arm?

Answer
Arthur Stril (Executives)

Thank you for this good set of questions on 123. So Mark, over to you.

Answer
Mark Frattini (Executives)

Thanks for the questions. Let me see if I get them all right going through. But then in terms of your first question, yes, in terms of the data cutoff, the patient's response was over 8 months, which was reported in the abstract. Unfortunately, as you know, the presentation is embargoed until the time of presentation. So I really can't go into more detail than that right now. In terms of your second question in terms of depth of response, I think one of the things we know about this being an allogeneic CAR T product that we're not necessarily going to get long-term persistence. And I think the fact that we see efficacy and we see an MRD-negative CR at an early time point, as you point out, is important.

Again, I would point out that patients such as this are usually lifespan is measured in weeks. And so the fact that we were able to -- the patient was able to achieve a response like this with the CAR T cell is fantastic. And then to your last question, which is a great one and will be addressed in the presentation, but unfortunately, I can't go into any more details right now.

Question and Answer Operator Message
Operator (Operator)

Our next question comes from Raju Prasad with William Blair.

Question
Brooke Schuster Gray (Analysts)

This is Brooke on for Raj. So regarding 123 again, I was wondering if you've seen any correlation of patient baseline characteristics, even if it is like relatively small that correlate with better responses to the therapy.

Answer
Arthur Stril (Executives)

Thank you for the question. Mark, any thoughts on this?

Answer
Mark Frattini (Executives)

Brooke, yes, thanks for the question. I think that one thing that's clear from the table that's included in the ASH abstract is that there's really -- these are really the patients that have failed everything. And as you can tell also that they have extremely high-risk disease with multiple cytogenetic and high-risk molecular mutations given that over 80% of them were adverse risk by the ELN criteria. So I think there's -- there will be more discussed during the presentation, but I think these high-risk patients have had -- that we've seen multiple -- several responses in, but we're talking about the MRD-negative CR, but the other patient in the FC cohort that was somebody who had a 90% blast reduction by day 28 and achieving stable disease will also be discussed.

Question and Answer Operator Message
Operator (Operator)

Our next question comes from Luísa Morgado with Kempen.

Question
Luísa Morgado;Kempen & Co;Analyst (Analysts)

Thank you for the update and for allowing me to take my questions. I wanted to ask a few things. So first, on the issue with Allogene and the Servier agreement, what are the exact hurdles in this agreement? And what are the risks for the 501 program in terms of development?

Answer
Arthur Stril (Executives)

So thanks, Luísa, for the question. This is an ongoing matter. So I don't think we will comment further as this is being resolved as Andre discussed but we don't anticipate any issues on the development itself of the 501A program. And we're particularly excited that Allogene announced a few weeks ago that this program was entering a Phase II pivotal trials. So I think this is -- this bodes well for the future of the program and our allogeneic CAR-T franchise as a whole.

Question
Luísa Morgado;Kempen & Co;Analyst (Analysts)

Clear. And then on your manufacturing facility. I wanted to ask if you could give me a bit more details of whether it's up and running at which point and also whether this will be used for products outside of Cellectis.

Answer
Arthur Stril (Executives)

Yes, good, great question. So it's definitely up and running, and it has already manufactured and released product. So it manufactured UCART20x22, for which we got the IND approved and the so-called second version, P2 version of UCART22. So we have been swapping UCART22 manufactured previously from our CDMO into product manufactured at Raleigh. So UCART22 and UCART20x22 have been manufactured in our facilities, which are definitely up and running. And as mentioned to a previous question, the plan is to cover our entire pipeline in the future. And regarding partnerships, definitely, there is room for spare capacity for potential partnerships. We do not aim to become a CDMO, but we could definitely leverage the manufacturing facility in broader partnership deals around our CAR-T or around some of the starting materials. So this is definitely a fantastic asset for Cellectis.

Question and Answer Operator Message
Operator (Operator)

There are no further questions at this time. I would now like to turn the floor back over to Arthur Stril for closing comments.

Answer
Arthur Stril (Executives)

Thank you very much, everyone. We're very excited about the progress moving forward. As Andre mentioned, there will be a number of exciting catalysts on our clinical trials moving forward. We're also particularly excited to have the full end-to-end platform for allogeneic cell therapy activities ranging from discovery, manufacturing, product development and all the way to clinical development. So the future is very exciting, and we are looking forward to the next update, including the ones on UCART123 and CRS-1 at ASH in December. Thank you very much, everyone, for connecting today.

Question and Answer Operator Message
Operator (Operator)

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

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