Cellectis - Q3 2022
November 4, 2022
Transcript
Operator (participant)
Greetings, and welcome to Cellectis' third quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. A brief 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. It is now my pleasure to introduce your host, Arthur Stril, Chief Business Officer. Thank you, sir. You may begin.
Arthur Stril (Chief Business Officer)
Good morning, and welcome everyone to Cellectis' third quarter 2022 corporate update and financial results conference call. Joining me on this call today with prepared remarks are Dr. André 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 30, 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 licensed 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 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.
André Choulika (CEO)
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 Hematology's annual meeting. We're excited to share preliminary data from our 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 a 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 Centers will present preclinical data at ASH on our product candidate, UCARTCS1, which reinforces the validation of CS1 as a relevant target for relapsed and refractory multiple myeloma patients. Cellectis continues to make progress enrolling patients in its fourth sponsored allogeneic CAR-T trial. We will soon initiate dosing patients with our product candidate, UCART22 and UCART20x22, that have been fully manufactured in-house. 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 are facing. Our goal is to provide consistency and safety in our production, ensure 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 now 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 2 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 products 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's first genetically modified TALEN-edited tumor-infiltrating lymphocytes 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 TALEN gene-edited induced pluripotent stem cells-derived natural killer cells at the Society for Immunotherapy of Cancer's annual meeting that will take place in November.
These achievements showcase once more that Cellectis, along with its gene editing technology such as TALEN, is the 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 two years. Previously, as a Senior Vice President of Clinical Science, Mark will give an overview of our sponsored clinical trials and preclinical product pipeline. Mark, please go ahead.
Mark Frattini (CMO)
Thank you, André, and good morning, everyone. 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 1 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 Centers 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 1 clinical trials evaluating its four 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 two TALEN-based gene therapy preclinical programs for patients with sickle cell disease and mucopolysaccharidosis type I at the European Society of Gene and Cell Therapy's annual congress. The preclinical data further demonstrated our ability to leverage TALEN gene editing technology to potentially address genetic diseases, namely sickle cell disease and lysosomal storage diseases. By correcting a mutation or 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 two 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 tenth. The first poster will be on TALEN-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.
Bing Wang (CFO)
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 equivalent, current financial assets, and restricted cash position of Cellectis, excluding Calyxt, 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 pre-financing and $3 million cash received from milestones and licenses. Based on the current operating plan and financial projections, this cash position is expected to be sufficient to fund Cellectis' standalone operations into early 2024.
The consolidated cash equivalent, current financial assets, and restricted cash position of Cellectis, including Calyxt, was EUR 103 million as of September thirtieth, 2022, compared to EUR 191 million as of December thirty-first, 2021. The net cash flow used in operating, capital expenditure, and leases were EUR 81 million at Cellectis and EUR 17 million at Calyxt in the first nine months of 2022, partially offset by EUR 10 million capital raised at Calyxt, EUR 6 million of cash received related to research tax credit pre-financing at Cellectis, and EUR 3 million cash received from milestones and licenses. The net attributable loss to shareholders of Cellectis, excluding Calyxt, was EUR 73 million in the first nine months of 2022, compared to a loss of EUR 75 million in the first nine months of 2021.
This EUR 2 million decrease in net loss between 2022 and 2021 was primarily driven by a decrease of R&D expense of EUR 12 million, an increase in net financial gain of EUR 7 million, partially offset by a decrease in revenues and other income of EUR 18 million. The consolidated net loss attributable to shareholders of Cellectis, including Calyxt, was EUR 79 million, or $1.74 per share in the first nine months of 2022, compared to a loss of EUR 89 million, or $2 per share in 2021. The consolidated adjusted net loss attributable to shareholders of Cellectis, excluding Calyxt, excluding non-cash stock-based compensation expenses, was EUR 67 million, or $1.48 per share in the first nine months of 2022, compared to a loss of EUR 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.
André Choulika (CEO)
Thank you, Bing. We're excited about all clinical and pre-clinical 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 four 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 questions and answers. Thank you.
Operator (participant)
Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would 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. One moment please while we poll for questions. Our first question comes from Gena Wang with Barclays. Please proceed with your question.
Gena Wang (Managing Director and Senior Equity Research Analyst)
Thank you for taking my questions, and congrats on all the progress, and we look forward to the data update in the next few weeks. We did see, you know, the abstract from the ASH abstract yesterday from the UCART123 program. Maybe just, you know, thoughts there. What is your goal regarding, say, the activity, like, do you see, you know, we saw 1 out of 8 in the FCA arm show the CR rate and very durable. What would be the actual goal that you wanted to achieve that you think it would be competitive? You know, giving this clear benefit with alemtuzumab, how would you apply this, broadly apply this to the other programs?
Bing Wang (CFO)
Hi, Gena. Thank you so much for the question. They're both great questions. I will hand it over to Mark.
Mark Frattini (CMO)
Hi, Gina. Thank you for the question. I think I'll answer the second one first. In regard to the alemtuzumab, you know, 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 gonna present for UCART123 echoes what we've seen for UCART22 and was presented at ASH last year. I think overall points out to the importance of alemtuzumab in our UCART programs for the products that have the CD52 gene knocked out using our TALEN technology. 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 you know, we've discussed before and everyone knows, these are really heavily pre-treated 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. For patients like this, there are really no other treatment options, and their life expectancy is very short. The fact that we are able to achieve a long-term MRD negative CR that's been durable in a patient is incredibly exciting in the dose escalation part of this 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. Again, a very encouraging response as we proceed forward with the dose escalation part of the study.
Gena Wang (Managing Director and Senior Equity Research Analyst)
Thank you very much.
Operator (participant)
Our next question comes from Jack Allen with Baird. Please proceed with your question.
Jack Allen (Senior Research Analyst)
Hi. Thank you so much for taking my questions, and 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 or potentially from Iovance and also Allogene for initiating the pivotal study. Given that those milestones have been hit at this point, I was hoping you could maybe provide some more color as to the size of those milestone payments. Additionally, any comments you can provide as it relates to the Servier relationship and your path forward there as well would be great.
Mark Frattini (CMO)
Thank you, Jack. A great question. Maybe, Bing on the milestone and then probably André on the Servier relationship.
Bing Wang (CFO)
Yeah. For the purpose of this call, we're gonna focus on Q3, which ended on September thirtieth. In terms of any progress that happened since then, we'll withhold comment for now.
André Choulika (CEO)
For the Servier Allogene situation, actually, we think that we've seen that there is definitely good possibilities that this should be resolved. As the situation is progressing and also we're expecting some milestones to be reached on the Allogene side in the development of ALLO-501A, as stated in their Q3 press release and their call, we are very optimistic that a great product like this should find a path forward.
Jack Allen (Senior Research Analyst)
Great. Thanks so much.
Operator (participant)
Our next question comes from Yigal Nochomovitz with Citigroup. Please proceed with your question.
Yigal Nochomovitz (Managing Director and Senior Healthcare Analyst)
Hi. 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 own facilities?
Mark Frattini (CMO)
Hi, Yigal. 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, plasmids, mRNA, viral vectors, all the way to the allogeneic CAR T. The plan is definitely, in the long run to transition all our programs to this internal platform. Absolutely.
Yigal Nochomovitz (Managing Director and Senior Healthcare Analyst)
Got it. Then you announced the dual targeted, dual antigen CD 20, CD 22. I'm just wondering, you know, should we be expecting more of these dual antigen type products coming forward, or is the CD 20, CD 22 a, you know, more of a, like a one-off for a dual antigen?
Mark Frattini (CMO)
Okay. Also great question. André, do you wanna take this one?
André Choulika (CEO)
Sure. Of course. 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 two 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 synapse, better killing. That's the hypothesis behind all of this development that we're doing. 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 not expressing CD22 or CD22 and not expressing CD20 cells, and of course, both expressing this. However, in patient, you see wobbling on both targets.
That means the expression or density of these like CD20 and CD22 can vary. Single targeting CAR T can sometimes have some escapes due to the lack of good formation of the synapse. If there is like the two targets that are expressed on the cell, the synapse is better formed and the killing is better done. That's a hypothesis. We're gonna test this at first, but there is definitely plans to move forward in this strategy. We will analyze the data from the NATHALI-01 trial that is about to start.
Arthur Stril (Chief Business Officer)
Thanks.
Operator (participant)
Our next question comes from Salveen Richter with Goldman Sachs. Please proceed with your question.
Mason Stevens (Analyst)
Hi, good morning, and thanks for the question. This is Mason on for Salveen. Could you please remind us of the status of the UCART22 program, and whether it's still on track for the second half of 2022? Could you also give us an overview of which key catalysts we should look to by mid-2023? Thanks.
Arthur Stril (Chief Business Officer)
Hi. Thanks for the question. I will hand it over to Mark.
Mark Frattini (CMO)
Thank you. For 2022, absolutely, we're on track. As you know, we received the safe to proceed from the FDA on August first, and we are in process of opening sites and plan to begin enrollment in Q4 of this year.
Arthur Stril (Chief Business Officer)
André, do you wanna take the broader question on the key catalyst?
André Choulika (CEO)
Sure. Actually, thank you very much for the question, and it's appreciated. We believe that Cellectis has four clinical trials that are ongoing with like CD22 targeting, CD123 targeting, CS1 targeting, and CD20 and CD22 will provide numerous data points. The first one is that we have already an oral presentation at ASH, as Mark has said, and that's where we give an update on the acute myeloid leukemia trial for UCART123. We're also accumulating data in the other trials, and we'll definitely start, as Mark just said, the dual targeting CAR T UCART20x22 enrollment this year, so before the end of the year.
That would make 2023 very much rich in events starting now, actually from, like, 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. Thank you.
Mason Stevens (Analyst)
Thank you.
Operator (participant)
Our next question comes from David Dai with SMBC. Please proceed with your question.
David Dai (VP and Senior Biotech Analyst)
Great. Thanks for taking my questions and also want congrats on the current progress. First of all, just on the IND clearance of the UCART20x22, I wonder if you can share some high-level thoughts on clinical trial design so far.
Arthur Stril (Chief Business Officer)
Thank you, David. Mark, I think this is for you.
Mark Frattini (CMO)
Thanks. As we begin, I can't really share a lot right now, in terms of what's happening. You know, as we discussed in the prior question from Gina, obviously the use of alemtuzumab will be important in the lymphodepletion regimen for this study.
David Dai (VP and Senior Biotech Analyst)
Got it. That's helpful. Just another question on the response from the UCART123 patients. It seems so far in both the FC and FCA arms, especially interested in the durable MRD negative patient who has durable response for about 8 months so far. Wondering if you can share some additional color on the characteristic of the patient. You know, this patient has high ELN risk or any kind of thoughts would be helpful here.
Mark Frattini (CMO)
Yeah. Thanks for that. What I can share with you right now is just what's in the abstract 'cause the rest is obviously embargoed until the presentation. This patient in particular was an older patient, as outlined in the abstract that had failed five prior lines of therapy, including an allogeneic stem cell transplant, you know, which as you know, in this case is, you know, as we discussed before, is really in this patient population, sort of the worst of the worst. A great response.
David Dai (VP and Senior Biotech Analyst)
All right. Thank you so much for taking my questions.
Operator (participant)
Our next question is from Hartaj Singh with Oppenheimer & Co. Please proceed with your question.
Hartaj Singh (Managing Director and Senior Analyst, Biotechnology)
Great. Thank you, and thanks for the updates. I just got a couple of questions. One is, you know, can you just talk a little bit about UCART123 and UCARTCS1? What dose levels are you at there? You might have mentioned before. I missed it. If I missed it, I apologize. And then what line of patients are you seeing there? I know AML and multiple myeloma have multiple lines of therapy. If you can just kinda remind us what line of patients you're seeing in your clinical trials there for UCART123 and UCARTCS1 specifically. And then secondly, you know, there seem to be other companies, you know, interested in this post CD19 treatment, CAR T treatment kind of area.
You know, aside from the clinical design, can you just talk about you know, how big this market is from a patient perspective? How large is it getting now, you know, with all the CD19 therapies out there? Thanks for the questions.
Arthur Stril (Chief Business Officer)
Hi, Hartaj. Thank you for both question. I think the first one would be for Mark, and then probably Bing can give some color on the market sizing question.
Mark Frattini (CMO)
Thanks, Hartaj, for the question. In terms of the lines of therapy for both of these studies, you know, obviously, these are very advanced and highly refractory patients. You know, for the UCART123 abstract, what's out there is these people have had an average of four prior lines of therapy up to nine prior lines of therapy for the UCART123 study. For UCART123, they failed everything, including allotransplant in over 50% of the patients. It's really last treatment option for the patients with UCART123.
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 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, it's in the abstract. So we're at dose level 2 and 2i for FCA will be reported.
Arthur Stril (Chief Business Officer)
Bing, you want to take the question on the market size?
Bing Wang (CFO)
Sure. Thank you for the question, Hartaj. I think that's a very actually critical question at this point. I think, you know, 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 centers in the entire United States. This is reported by CNN in August of this year. If you were to think of that number, and those are the institutions that have the capability to do autologous therapy, it actually caps the total capacity for autologous treatment in the entire United States.
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. I think if we were to focus on that fact, then we realize that the current, some of the current limitation with autologous is really not just capped by manufacturing, as even we thought at the beginning of the year, it's really capped by the hospital infrastructure in the United States. This is not something that big pharma can just throw a few hundred million dollars at a new vector plant to solve.
I think once, you know, both ourselves as well as our partners at Servier and Allogene launch, you know, commercially viable allogeneic cell therapy, we will significantly expand the market. 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. The potential market size with a product that both ourselves and our partner will plan to launch will significantly expand cell therapy well beyond what is available today.
Hartaj Singh (Managing Director and Senior Analyst, Biotechnology)
Great. Thank you, Bing. Thanks, Mark. I really appreciate the questions.
Operator (participant)
Our next question is from Yanan Zhu with Wells Fargo. Please proceed with your question.
Yanan Zhu (Equity Analyst)
Hi. Thanks for taking my questions. About the CR patient in ASH abstract 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. Does this suggest a depth of response for this indication could be important and persistence may not be as important in this indication? If you can talk about how are you thinking about the dose going forward for the FCA arm. Obviously, you have one DLT out of 8 patients at this arm and at dose level 2.
For the FC arm, you do have, I think, a higher frequency of DLTs at the higher level, those Dose Level 2i and DL 3. How should we think about your ability to increase the dose in the FCA arm? Thanks.
Arthur Stril (Chief Business Officer)
Hi, Yanan. Thank you for this good set of questions on UCART123. Mark, over to you.
Mark Frattini (CMO)
Hi, Yanan. Thanks for the questions. Let me see if I get them all right going through. In terms of your first question, yes, in terms of the data cutoff, the patient's response was over eight months, which was reported in the abstract. Unfortunately, as you know, the presentation's 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, you know, 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.
I think the fact that we see efficacy and we see a 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. The fact that we were able to, you know, the patient was able to achieve a response like this with the CAR T-cell is fantastic. 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.
Yanan Zhu (Equity Analyst)
Great. Thanks for all the color. Appreciate it. Appreciate it. Thanks.
Operator (participant)
Our next question comes from Raju Prasad with William Blair. Please proceed with your question.
Brooke Schuster (Biotech Equity Research Associate)
Hi. Thank you for taking our question. This is Brooke on for Raj. Regarding UCART123 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.
Arthur Stril (Chief Business Officer)
Hi. Thank you for the question. Mark, any thoughts on this?
Mark Frattini (CMO)
Hi, Brooke. Yes, thanks for the question. I think that, you know, one thing that's clear from, you know, the table that's included in the ASH abstract is that, you know, there's really these are really the patients that have failed everything. As you can tell also that they have extremely high risk disease with multiple cytogenetic and high risk molecular mutations, given that, you know, over 80% of them were adverse risk by the ELN criteria. I think there's, you know, there'll be more discussed during the presentation, but I think these high-risk patients have had, you know, that we've seen multiple, you know, several responses in, but, you know, we're talking about the MRD negative CR.
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. Anyway, yeah. Thanks.
Brooke Schuster (Biotech Equity Research Associate)
Thank you so much.
Operator (participant)
Our next question comes from Luisa Morgado with Kempen. Please proceed with your question.
Luísa Morgado (Equity Research Analyst)
Hi. Thank you for the update and for allowing me to take my questions. I wanted to ask a few things. 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 programs in terms of development?
Arthur Stril (Chief Business Officer)
Thanks, Luisa, for the question. This is an ongoing matter, so I don't think we will comment further as this is being resolved as André discussed. But we don't anticipate any issues on the development itself of the ALLO-501A program. We're particularly excited that Allogene announced a few weeks ago that this program was entering a phase 2 pivotal trials. I think this bodes well for the future of the program and our allogeneic CAR-T franchise as a whole.
Luísa Morgado (Equity Research Analyst)
Clear. Then on your manufacturing facility, I wanted to ask if you could give me a bit more details or whether it's up and running at which point, and also whether this will be used for products outside of Cellectis.
Arthur Stril (Chief Business Officer)
Yeah, both great questions. It's definitely up and running, and it has already manufactured and released product. It manufactured UCART20x22, for which we got the IND approved, and the so-called second version, P2 version of UCART22. We have been swapping UCART22 manufactured previously from our CDMO into product manufactured at Raleigh. UCART22 and UCART20x22 have been manufactured in our facilities, which are definitely up and running. As mentioned to a previous question, the plan is to cover our entire pipeline in the future. 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.
This is definitely a fantastic asset for Cellectis.
Luísa Morgado (Equity Research Analyst)
Okay. Thank you.
Operator (participant)
There are no further questions at this time. I would now like to turn the floor back over to Arthur Stril for closing comments.
Arthur Stril (Chief Business Officer)
Thank you very much, everyone. We're very excited about the progress moving forward. As André 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. The future is very exciting, and we are looking forward to the next update, including the ones on UCART123 and UCARTCS1 at ASH in December. Thank you very much, everyone, for connecting today.
Operator (participant)
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Arthur Stril (Chief Business Officer)
Yeah, good stuff, guys.