11/4/2022

speaker
Operator

Greetings and welcome to Selecta's 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 Strill, Chief Business Officer. Thank you, sir. You may begin.

speaker
Selecta

Good morning, and welcome everyone to Selectus' third 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. Bing Wang, our Chief Financial Officer, and Dr. Mark Frittini, our Chief Medical Officer. Yesterday evening, Selectus filed a tintering report and issued a press release reporting its financial results for the third quarter and nine-month period ended September 30th, 2022. The report and press release are available on our website at Selectus.com. As a reminder, we will make statements regarding Selectus 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 our 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 20F filed with the SEC and the financial report, including the management report, for the year ending on December 31st, 2021, and subsequent filing Selectus makes with the Securities Exchange Commission from time to time. I would now like to turn the call over to André.

speaker
André Choulika

Thank you, Arthur. Good morning and thank you everyone for joining us today. 2022 has been a productive year thus far for Selectus. We have made progress on all fronts that we're thrilled to share with you today. Yesterday, We've announced that our UCART 1-2-3 abstract was accepted for an oral presentation at the American Society of Anthropology'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 UCAR T123 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 Center will present preclinical data at ASH on our product candidate, UCAR-T CS1, which reinforces the validation of CS1 as a relevant target for relapsed and refractory multiple myeloma patients. Selectus continues to make progress enrolling patients in its four sponsored allogenic CAR-T trials. We will soon initiate dosing patients with our product candidate, UCAR T22 and UCAR T20x22 that have been fully manufactured in-house. This will be a significant milestone for Selectis, 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 no filing. This quarter, our partnership continued to be a highlight for Selectis as several of our partners disclosed exciting milestones. Allogene announced that it was starting the first allogenic CAR-T potentially pivotal phase two trial for patients with large B-cell lymphoma. We share Allogene's excitement for this accomplishment as it paves the road for both Allo501A and our broader pipeline of allogenic 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 Iovansper genetically modified palin-edited tumor infiltrating lymphocytes, or TILT therapy, for the treatment of previously treated metastatic non-small cell lung cancer and advanced melanoma. Our partner, Cytovia, announced that it will present new preclinical data on tailing gene-edited induced pyropotent stem cells 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 selectives, along with this gene-editing technology such as tailings, 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 promises 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 Fratini, 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.

speaker
Arthur

Thank you, Andre, and good morning, everyone. As Andre mentioned, 2022 has been a busy and productive year for Selectus, with our proprietary clinical and preclinical programs making progress, and we are specifically excited to share additional preliminary clinical data from our Amelie 01 trial in an oral presentation at the ASH Annual Meeting next month. The abstract for Amelie 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 alumtuzumab 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 UCARTS CS1 presented by the Amsterdam University Medical Center includes preclinical data demonstrating anti-tumor activity in vitro and in vivo and supported the initiation of the first in-human study of UCARTS CS1, Selectus' Melanie 01 clinical study. Selectus continues to progress in its Phase I clinical trials, evaluating its four proprietary allogeneic CAR T-cell therapies in hematologic malignancies. Bali 01, evaluating UCAR22 in patients with relapse or refractory B-cell acute lymphoblastic leukemia. Amelie 01, evaluating UCAR123 in patients with relapse or refractory acute myeloid leukemia. Melanie 01, evaluating UCART CS1 in patients with relapsed or refractory multiple myeloma. Last quarter, we were pleased to announce the FDA IND clearance for our product candidate UCART 20x22. Selectus' first allogeneic dual CAR T-cell product candidate being developed for patients with relapsed or refractory non-Hodgkin lymphoma. UCAR 20 by 22 is Selectus' 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, Selectus presented data on two talon-based gene therapy preclinical programs for patients with sickle cell disease and mucopalysaccharidosis type 1 at the European Society for Gene and Cell Therapies Annual Congress. The preclinical data further demonstrated our ability to leverage tail and 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, Selectus aims to provide a lifelong supply of healthy cells from a single intervention. Lastly, Selectus 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 10th. The first poster will be on talon-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, Selectus' chief financial officer, for an overview of our financials for the third quarter of 2022.

speaker
Andre

Bing, please go ahead. Thank you, Mark.

speaker
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 equivalent, current financial assets, and restricted cash position of selectives, excluding Calix, as of September 30, 2022, was $95 million, compared to $177 million as of December 31, 2021. This difference mainly reflects $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 selected standalone operations into early 2024. The consolidated cash, cash equivalent, current financial assets, and restricted cash position of Selectus, 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 Selectus and $17 million at Calix in the first nine months of 2022, partially offset by a $10 million capital raise at Calix 6 million of cash received related to research tax credit pre-financing at Selectus, and 3 million cash received from milestones and licenses. The net attributable loss to shareholders of Selectus, excluding Calix, was 73 million in the first nine months of 2022, compared to a loss of 75 million in the first nine 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 selectives, including Calix, was $79 million, or $1.74 per share in the first nine 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 Selectus, excluding Calix, excluding non-cash stock-based compensation expenses was $67 million or $1.48 per share in the first nine months of 2022, compared to a loss of $66 million or $1 and 49 cents 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.

speaker
André Choulika

Thank you, Bing. We're excited about all clinical and preclinical data Selectus has generated and will continue to generate. We're also excited by the progress with our partners. Selectus 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 allogenic CAR T cell therapy. With that, I would like to open the call for question and answers. Thank you.

speaker
Operator

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 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 Gina Wang with Barclays. Please proceed with your question.

speaker
Gina Wang

Thank you for taking my questions, and a congrats on all the progress. And we look forward to the data update in the next few weeks. So we did see, you know, the abstract from the ASH abstract yesterday from the UCAR 123 program. So maybe just, you know, thoughts there. What is your goal regarding, say, the activity? Like, do you see, you know, we saw one out of eight in the FCA arm show the CR rate and very durable. And so what would be the... the actual goal that you wanted to achieve, that you think will be competitive? And then, you know, giving this clear benefit with LN2's map, how would you apply this, broadly apply this to the other programs?

speaker
Selecta

Hi, Gina. Thank you so much for the question. Both great questions. I will hand it over to Mark.

speaker
Arthur

Hi, Gina. Thank you for the question. I think I'll answer the second one first. So in regard to the allamtuzumab, you know, I think the data that we're presenting about the effect of allamtuzumab in terms of prolonging the lymphodepletion and allowing for UCARD expansion and clinical activity that we're going to present for 123 echoes what we've seen for UCARD 22 and was presented at ASH last year. And I think overall points out to the importance of allamtuzumab in our UCAR 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 allamtuzumab in the regimen. As far as the data for UCARP-123, we're incredibly excited by what we've seen. I think as we've discussed before and as 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 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. So again, a very encouraging response as we proceed forward with the dose escalation part of the study.

speaker
Gina

Thank you very much. Our next question comes from Jack Allen with Baird. Please proceed with your question.

speaker
Jack Allen

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 I guess essentially 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 could maybe provide some more color as to the size of those milestone payments, and then additionally, any comments you could provide as it relates to the Sevier relationship and I guess your path forward there as well would be great.

speaker
Selecta

Thank you, Jack. Great question.

speaker
Andre

Maybe Bing on the milestone and then probably Andre on the Servia relationship. Yeah.

speaker
Mark

So for the purpose of this call, we're going to focus on Q3, which ended on September 30th. So in terms of any progress that happened since then, we'll withhold comment for now.

speaker
André Choulika

And for the survey allergene situation, actually, we think that we've seen that there is definitely good possibilities that this should be resolved. And as the situation is progressing, and also we're expecting some milestones to be reached on the allergene side and the development of ALO501A, as stated in their under Q3 press release and their call, we are very optimistic that a great product like this should find a path forward.

speaker
spk00

Great. Thanks so much.

speaker
Gina

Our next question comes from Yigal Nakomovitz with Citigroup.

speaker
Operator

Please proceed with your question.

speaker
Yigal

Yeah, hi. I just had a quick question regarding your manufacturing. Is the long-term plan also to have the UCART 123 and UCART CS1 being manufactured in your own facilities?

speaker
Selecta

Hi, Yigal. Yeah, great question. I think on this, definitely the plan is to leverage the fully internal manufacturing capabilities of Selectis. We're extremely proud to now have the entire Calti value chain in-house. ranging from starting material, plasmids, 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.

speaker
Yigal

Got it. And then you announced the dual-targeted dual-antigen CB20, CB22. So I'm just wondering, you know, should we be expecting more of these dual-antigen-type coming forward, or is the CD20, CD22 more of a one-off for dual antigen?

speaker
Selecta

Okay, also a great question. André, do you want to take this one?

speaker
André Choulika

Sure, of course. Thank you, Igor, for the question. The dual targeting is extremely interesting for numerous reasons, and it's like the first allogenic 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, a 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... 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 both targets. It means the expression or density of these, like CD20 and CD22, can vary. So single-targeting CAR-T can sometimes have some escapes due to the lack of good formation of the synapse, and if there is like the two 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 Natalie trial that is about to start.

speaker
Andre

Thanks.

speaker
Gina

Our next question comes from Salveen Richter with Goldman Sachs.

speaker
Operator

Please proceed with your question.

speaker
spk12

Hi, good morning, and thanks for the question. This is Mason on for Salveen. Could you please remind us of the status of the UCAR 20 by 22 program and whether it's still on track for the second half of 22? And could you also give us an overview of which key catalysts we should look to by mid-23? Thanks.

speaker
Andre

Hi, thanks for the question. I will hand it over to Marc.

speaker
Arthur

So, thank you. So, for the 20 by 22, absolutely, we're on track. As you know, we received the safe to proceed from the FDA on August 1st, and so we are in process of opening sites and plan to begin enrollment in Q4 of this year.

speaker
Selecta

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

speaker
André Choulika

Sure. Actually, thank you very much for the question, and it's appreciated. We believe that Selectus was for 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's where we give an update on the acute myeloid leukemia trial for UCAR T123. But we're also accumulating data in the other trials, and we'll definitely start, as Mark just said, the dual targeting CART-T, your CART-T 20 by 22 enrollment this year, so before the end of the year. And that would make 2023 very much rich in event starting now, actually, from like the end of this year and through 2023. Of course, this is about all our CART-T, but we expect also some meaningful data points from our partners, iEvents, Cytovia and Allogene survey, of course. Thank you.

speaker
Andre

Thank you.

speaker
Gina

Our next question comes from David Dai with SMBC.

speaker
Operator

Please proceed with your question.

speaker
spk02

Great. Thanks for taking my questions, and I also want to congrats on the progress. First of all, just on the IMD clearance of the CAR T20 by 22, I'm wondering if you can share some high-level thoughts on clinical trial design so far.

speaker
Andre

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

speaker
Arthur

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

speaker
Gina

Got it. That's helpful.

speaker
spk02

And just another question on the response from the CAR T123 patients. So it seems so far in both the FC and FCA arms, especially interested in the doable MRD negative patient who has doable response for about eight months so far. So I'm wondering if you can share some of the characteristics of the patients.

speaker
Gina

This patient has high risk or any kind of thoughts would be helpful here.

speaker
Arthur

Yeah, 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 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. So, a great response.

speaker
Andre

All right. Thank you so much for taking my questions.

speaker
Gina

Our next question is from Hataj Singh with Oppenheimer and Company.

speaker
Operator

Please proceed with your question.

speaker
spk13

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 UCARP 1, 2, 3, and CS1? What dose levels are you there? You might have mentioned before, 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 therapies, you can just kind of remind us what line of patients you're seeing in your clinical trials there for 123 and CS1 specifically. And then secondly, there seem to be other companies interested in this post-CD19 treatment, CAR-T treatment kind of 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, you know, with all the C-19 therapies out there? Thanks for the questions.

speaker
Andre

Hi, Hartaj.

speaker
Selecta

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.

speaker
Arthur

Thanks, Hartaj, for the question. And 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 123 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 123 study. For 123, they failed everything, including allotransplant 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 had reopened after it had been on hold from the FDA, and we're continuing in the dose escalation process. part of that study. And again, these are, again, same way in terms of patients' eligibility criteria includes failing 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.

speaker
Selecta

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

speaker
Mark

Sure. Thank you for the question, Hartaj. I think that's 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 centers 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 that 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 six 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 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. And this is not something that big pharma can just throw a few hundred million dollars in a new vector plant to solve. So I think once, you know, both ourselves as well as our partners, is serving an allergen launch, commercially viable allergenic 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 treatments. So the potential market size with a product that both ourselves and a partner will plan to launch will significantly expand cell therapy well beyond what is available today.

speaker
Andre

Great. Thank you, Bing. Thanks, Mark. I really appreciate the questions.

speaker
Gina

Our next question is from Yanen Zhu with Wells Fargo.

speaker
Operator

Please proceed with your question.

speaker
spk01

Hi. Thanks for taking my questions. About the CR patient in ASH abstract, it was quite durable, eight months as of the cutoff date of July. just wondering if you can comment if that patient is still in response currently and also does this suggest 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 one DLT out of eight patients at this arm and at dose level two, but for the FCA arm, you do have, I think, a higher frequency of DLTs at the higher level, those DL2I and DL3. So how should we think about your ability to increase the dose in the FCA arm? Thanks.

speaker
Selecta

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

speaker
Arthur

Hi, Yanan. Thanks for the questions. Let me see if I get them all right going through. But 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, I think one of the things we know about this being an allergenic 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 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. And so 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. 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.

speaker
spk01

Great. Thanks for all the cover. Appreciate it.

speaker
Andre

Thanks.

speaker
Operator

Our next question comes from Raju Prasad with William Blair. Please proceed with your question.

speaker
Raju Prasad

Hi, thank you for taking our question. This is Brooke on for Raj. So regarding 1, 2, 3 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?

speaker
Andre

Hi, thank you for the question.

speaker
Selecta

Mark, any thoughts on this?

speaker
Arthur

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. And 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. So, 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-CR, but the other patients in the FC cohort that was somebody who had a 90% blast reduction by day 28 and achieving stable disease will also be discussed. So, anyway, yeah.

speaker
Andre

Thanks.

speaker
Gina

Thank you so much. Our next question comes from Louisa Morgado with Kempin. Please proceed with your question.

speaker
Kempin

Hi, 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 programs in terms of development?

speaker
Andre

So, thanks, Riza, for the question.

speaker
Selecta

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 501 program, and we're particularly excited that Allogene announced a few weeks ago that this program was entering phase two pivotal trials. So, I think this bodes well for the future of the program and our Allogene CAR-T franchise as a whole.

speaker
Gina

Clear.

speaker
Kempin

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 Selectus?

speaker
Selecta

Yeah, both great questions. So it's definitely up and running and it has already manufactured and released products. So it's manufactured UCAR 20x22 for which we got the IND approved and the so-called second version, P2 version of UCAR 22. So we have been swapping UCAR22 manufactured previously from our CDMO into product manufactured at Raleigh. So UCAR22 and UCAR20x22 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 Selectus.

speaker
Gina

Okay, thank you. There are no further questions at this time.

speaker
Operator

I would now like to turn the floor back over to Arthur Stultz for closing comments.

speaker
Selecta

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 available activities ranging from discovery manufacturing product development and all the way to clinical development so the future is is very exciting and we are looking forward to the next update including the ones on you got one two three and you got cs1 at ash in december thank you very much everyone for connecting today this concludes today's teleconference you may disconnect your lines at this time thank you for your participation

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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