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.
spk08: Good morning, everyone, and welcome to Selective's fourth quarter and full year 2022 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. Please be aware that today's conference call is being recorded. I'd now like to introduce you to the first speaker, Arthur Strill, Chief Business Officer. You may begin.
spk06: Good morning and welcome everyone to select this fourth quarter and full year 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 Fratini, our Chief Medical Officer. Yesterday evening, Selectus issued a press release reporting its financial results for the fourth quarter and full year 2022, ended December 31st, 2022. The press release is available on our website at selectus.com. We expect to file the annual reports in the coming days. 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 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 Security Exchange Commission, SEC, and the financial report, including the management report, for the year ended on December 31st, 2021, and subsequent filing Selectus makes with the SEC from time to time. I would now like to turn the call over to Andre.
spk11: Thank you, Arthur. Good morning, and thank you everyone for joining us today. 2022 has been a milestone year for Selectus. We have reached key milestones for our clinical trials that we're thrilled to share with you today. In December 2022, selectives presented positive preliminary clinical data from five additional patients from our BALI-01 trial evaluating UCAR22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia, or ALL. In this Phase I-IIa study, the five additional patients received UCAR22 at dose level three after lymphodepletion with fludarabine, cyclophosphamide, and alentuzumab, or FCA pre-conditioning regimen. These results showed evidence of FucRT22 anti-tumor activity observed in three of the five, or 60% of the patients. Overall, these preliminary data support the continued administration of FucRT22 after SCA lymphodepletion in patients with relapsed or refractory B-cell ALL. We're excited by these preliminary clinical responses for ALL patients who have limited, if any, treatment options, especially for those who have failed prior CD19-directed CAR T-cell therapy and allogenic stem cell transplant. UCAR T22 is currently the most advanced allogenic CAR T cell product in development for B cell ALL. We believe that our off-the-shelf treatment approach coupled with our ability to manufacture our UCAR T22 product candidate completely in-house give us a main advantage on market. It potentially maximizes the chances for eligible patients to be treated without delay. In December 2022, we also presented encouraging preliminary clinical data from our AMLE01 study evaluating UCAR T123 in patients with relapsed or refractory acute myeloid leukemia, or AML. The normal session at the American Society of Hematology, the preliminary data showed that adding alimtuzumab to the fludarabine and cyclophosphamide lymphodepletion regimen was associated with sustained lymphodepletion and significantly higher URCAR-T123 cell expansion, which correlated with improved antitumor activity. 25% of patients at dose level 2 in the FCA arm achieved a meaningful response, Exemplary activity was seen in a 64-year-old female with AML who had relapsed after allergenic stem cell transplantation and had maintained a durable minimal residual disease negative complete responses for over one year without salvaged donor lymphocyte infusion. Or second allergenic stem cell transplantation. We're excited by these encouraging clinical data, which are a meaningful step forward for patients and support further enrollment into phase one study. On the business development front, Plectus gene editing system continued to provide the company with expanded opportunities. Plectus has announced a collaboration agreement with Primera Therapeutics to edit mutations in the mitochondrial DNA in vivo to treat the root cause of associated diseases. Primera, together with Selectis, will be co-developing a mitochondrial DNA engineering toolbox that could enable effective therapies for mitochondrial diseases. Our partnership with Primera further showcases and expands the application of our gene editing capabilities into a previously unexplored space. This partnership is very much in line with Selecta's mission to leverage its gene editing technologies to develop potentially life-saving prologue candidates to address unmet medical needs. In October 2022, our licensed partner, iOVAN, announced that the first patient was dosed and completed the safety observation period in the IOV-GM1-201 clinical trial of Iovance's first genetically modified tail-in-edited tumor infiltrating lymphocyte, or TIL therapy, for the treatment of previously treated metastatic non-small cell lung cancer and advanced melanoma. In December 2022, Selective signed a 40 million credit facility with the European Investment Bank and in the same month received a milestone payment from our licensed partners survey in connection with the phase two trial of Allo501A for patients with relapsed or refractory large B-cell lymphoma. Finally, in February 2023, we were proud to announce the closing of a $25 million equity offering. All the selectives team and I would like to warmly thank the European Investment Bank and our investors for the strong support, and we know now have cash runway into the third quarter 2024. This year, Selectus remains deeply focused on the patient recruitment on our four ongoing phase one clinical trials, Bally 01, Amelie 01, Melanie 01, and Nathalie 01, evaluating UCAR T22, UCAR T123, UCAR TCS1, and UCAR T20 by 22, respectively. With that, I would like to turn the call over to Dr. Mark Frattini, our Chief Medical Officer, who will give an overview of these clinical trials. Mark, please go ahead.
spk12: Thank you, Andre, and good morning, everyone. As Andre mentioned, 2022 has been a productive year for Selectus. With our proprietary clinical programs making progress, And we were specifically excited to share additional preliminary clinical data from our Bali 01 trial evaluating UCART22 in a live webcast last December. BALIO-1 is a phase 1-2A open-label dose escalation trial currently evaluating the safety and clinical activity of UCART-22 given an escalating dose levels after lymphodepletion with fludarabine, cyclophosphamide, and allantuzumab, or FCA regimen. In patients with relapse or refractory B-cell acute lymphoblastic leukemia. Alamtuzumab was added to the lymphodepletion regimen to sustain host T-cell and NK-cell depletion and to allow for UCAR22 cell expansion and clinical activity. Compared to the last clinical update on Bali at ASH 2021, The webcast presented after the ASH meeting in December revealed data from five additional patients who received UCART22 at dose level 3, 5 million cells per kilogram, after lymphodepletion with FCA. No dose-limiting toxicities, grade 2 or higher cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or adverse events of special interest were observed. Evidence of UCAR22 anti-leukemia activity was observed in 60%, or three of the five patients at dose level three. One patient experienced a durable, minimal residual disease negative complete response with incomplete count recovery that continued beyond six months as of December 2022. The second patient experienced a minimal residual disease negative complete response that continued beyond day 70 as of December 2022. And the third patient experienced a minimal residual disease negative morphologic leukemia-free state that continued beyond day 84 as of December 2022. As Andre mentioned, these preliminary data support the continued administration of UCAR22 after FCA lymphodepletion in patients with relapsed refractory B-cell ALL and are very encouraging for patients who have limited, if any, treatment options, especially for those who have failed prior CD19-directed CAR T-cell therapy and allogeneic stem cell transplant. We have also announced the first dosing of a patient with our completely in-house manufactured UCART22 product candidate. This patient completed the 28-day dose limiting toxicity observation period without complication. We believe that having this capability in-house is a great competitive advantage as it will give us the ability to swiftly version our product candidates as we monitor clinical responses, resulting in what we expect to be the best product possible. The BALIO-1 study is now enrolling patients with product candidate manufactured in-house at dose level 2, 1 million cells per kilogram, after FCA lymphodepletion. The next data set is expected to be released later this year. Last December, Selectus presented clinical data in an oral presentation at ASH 2022 on its Amelie 01 clinical trial, evaluating UCART123, a Phase I open-label dose escalation study in patients with relapsed or refractory acute myeloid leukemia. The presentation by Dr. David Salmon from Moffitt Cancer Center, one of the study investigators, included preliminary clinical data showing that adding alimtuzumab to the FC lymphodepletion regimen was associated with sustained host cell lymphodepletion that allowed for significantly higher UCART123 cell expansion and correlated with improved anti-leukemia activity. Evidence of UCAR123 antileukemia activity was observed in four patients out of 15 at dose level two or above with best overall responses in the FCA arm. 25% at dose level two with FCA achieved meaningful response. One patient who failed five prior lines of therapy including allogeneic stem cell transplant, experienced a durable, minimal residual disease negative complete response with full count recovery at day 56 that continues beyond one year. One patient with stable disease achieved greater than 90% bone marrow blast reduction from 60% to 5% at day 28. Overall, these encouraging clinical data are a meaningful step forward for patients and support further enrollment into the study. This trial addresses a patient population with severe unmet medical need, where a successful CAR T-cell product candidate could be a major breakthrough. Amelie 01 is now enrolling patients in the FCA two-dose regimen arm at dose level two, 6.25 times 10 to the fifth cells per kilogram. A dose that has already been administered and cleared for safety as a single dose by the study data safety monitoring board. Next, I'll move on to our MELANIE-01 clinical trial. our CS1-directed, tail-in-gene-edited allogeneic CAR T-cell product candidate being evaluated in patients with relapsed or refractory multiple myeloma. Selectus is currently enrolling patients at dose level 1, 1 million cells per kilogram, using an FC lymphodepletion regimen. Lastly, I will speak about our NATALI-01 study, evaluating UCART 20x22. UCART 20x22 is Selectus' first allogeneic dual CAR T-cell product candidate being developed for patients with relapsed or refractory non-Hodgkin lymphoma. UCART 20x22 is also the first product candidate Selectus has designed, developed, and manufactured completely in-house. In addition, the advantage of UCART 20 by 22 is that it goes beyond the highly competitive CD19 antigen directed therapy space by providing a dual antigen targeted allogeneic alternative. With that, I would like to hand the call over to Bing Long, Selectus' Chief Financial Officer for an overview of our financials for the fourth quarter and full year 2022.
spk16: Bing, please go ahead.
spk13: Thank you, Mark. I will provide a brief overview of our financials for the fourth quarter of 2022. I would like to highlight that our financials, the cash, cash equivalent, current financial asset, and restricted cash position selectives, excluding CALEX as of December 31st, 2022, was $95 million. compared to $177 million as of December 31, 2021. This difference mainly reflects $104 million of net cash flow used in operating, investing, and lease financing activities, and $6 million of negative foreign exchange impact, partially offset by $6 million of cash received related to research tax credit pre-financing, and $22 million 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 the third quarter of 2024. On January 13, 2023, Calix, CBUS, and certain other parties entered into a merger agreement pursuant to which Calix and CBUS will merge in an all-stock transaction. Following the closing of the proposed Calix merger, Selecta's SA is expected to own approximately 2.4% of the equity interest of the combined company. Accordingly, if the proposed Calix merger is consummated, it will result in a loss of control over Calix, and Calix should no longer be a consolidated subsidiary. The closing of the proposed Calix merger is expected in the second quarter of 2023. In this context, Calix is presented as a discontinued operations in the financial statements for the year ending December 31st. The net loss excluding CALEX was $99 million in the 12 months of 2022 compared to a $97 million in the 12 months of 2021. This $2 million increase in net loss between 2022 and 2021 was primarily driven by an increase of net financial loss of $16 million due to Cytovia's convertible note loss in fair value on December 31, 2022, and a decrease in revenue and other income of $13 million, partially offset by a decrease of R&D expense of $20 million and a decrease of SG&A expense of $5 million. attributable to shareholders of Selectus, including Calix, was $106 million, or $2.33 per share, in the 12-month of 2022, compared to a loss of $114 million, or $2.55 per share, in 2021. This $8 million decrease in net loss between 2022 and 2021 was primarily driven by a decrease of net loss from discontinued operations attributable to shareholders of Selectus of $10 million and partially offset by an increase of $2 million in net loss of Selectus standalone. The adjusted net loss attributable to shareholders of Selectus, including Calix, which excludes non-cash stock-based compensation expenses, was $98 million, or $2.15 per share. in the 12 months of 2022 compared to a loss of 102 million or $2.27 per share in 2021. As Andre mentioned earlier, we signed a 40 million euro credit facility with the European Investment Bank in December of 2022. We also received 15 million euros from Servier in connection with the phase two study for ALO 501A in December 2022. In February of 2023, we raised $25 million in an equity offering with a net proceeds of $23 million. Combined, this will allow our cash runway to extend into the third quarter of 2024. We are laser focused on spending our cash on developing our clinical candidates and operating our state-of-the-art manufacturing facilities in Paris and in Raleigh. In addition, Our focus on maintaining an efficient corporate infrastructure also enable more limited growth in G&A spend.
spk11: Thank you, Bing. To close out this call, I would like to reiterate how proud we are of what Selectus achieved thus far, and especially in 2022, and how excited we are as we move forward into 2023. Selectus will continue to reach key clinical milestones with our clinical stage pipeline of four allergenic CAR T in hematological malignancies this year. At Selectus, we strongly believe that our prologue candidates, our technologies, and our in-house manufacturing capabilities will lead us to a paradigm shift for patients with hard-to-treat cancers, positioning us at the forefront of this promising medical and scientific field.
spk15: With that, I would like to open the call for Q&A. Thank you.
spk08: Ladies and gentlemen, at this time, we will 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 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.
spk15: Ladies and gentlemen, we will wait for a moment while we poll for questions. Our first question comes from the line of Kelly Shee from Jefferies. Please go ahead. Hello, can you hear me? Yes, we can. Hello.
spk07: Hi, thank you for taking our question. This is Dave on for Kelly Shee at Jeffrey. So a couple of questions. For UCAR 22, could you share more color on enrollment, including a number of active sites and pace of patients in recruitment? And just one general question on expenses. If you could guide for expenses in 23 and 24. Should we expect lower R&D expenses since most of the manufacturing is in-house now? Thank you.
spk06: Hi, Deb. These are great. This is Arthur. Thanks for these two great questions. I think the first one would be best for Mark and the second one for Bing. So, Mark.
spk12: So, yeah. Thank you for the question. So, for 22 enrollment is proceeding very well. We have sites open in the U.S. and in France that we're currently enrolling in this study. And as we discussed, we're using the completely in-house manufactured P2 product candidate for these patients.
spk15: And Bing, maybe you have some questions?
spk13: Sure. Regarding R&D expenses in 23 and 24, You know, a very good point. Thank you for pointing that out. We, you know, we transferred the manufacturing to in-house, so that actually reduces some of our R&D expenses, as you can see from our financials from 2021 to 2022. So going forward, we can expect to see the 2022 R&D expense on the runway on a very similar level on 2023. We have not provided or will not provide guidance for 2024 R&D expense because, as you can imagine, if some of the data, that we're working on right now turns out to be very good, potentially we'll have to expand that in the future year. So those expense could go up. At least for 2023, we expect R&D expense to be in roughly the same area as we are for 2022.
spk15: Thank you. Thank you.
spk08: Our next question comes from the line of Gina Wang from Barclays. Please go ahead.
spk10: Thank you for taking my questions. I have two questions. First one is regarding the BALI-01 trial, the in-house manufacturing product at dose level two. Wondering how many patients will we see at the initial data report and will we see the data at the EHAR? What kind of a clinical profile can warrant a quick transition to pivotal study? And then quickly, second question for Bing, regarding the recent capital raise, can you give a little bit more color on rationale of the timing?
spk06: Thank you so much, Gina, for the two questions. Let's start with Mark and then Bing.
spk12: All right, Gina, thank you for the question. So, yes, we are currently enrolling with the P2 product, and right now we're currently at dose level two, as we discussed. We are planning to have a, you know, to discuss the results of the enrollment of the P2 product at a point later this year.
spk13: Thank you for the question, Gina. So, regarding the timing of the recent financing, so I'd like to highlight, In December of 2022, you know, there was two events from us that's worthy of note. The first is obviously we had a webcast on the last day of ASH regarding some of the data that were announced on UCAR 123 and UCAR 22. But on December 28th, we signed a credit facility agreement with the European Investment Bank as, you know, we mentioned on the call earlier. And, you know, there's three tranches in the European Investment Bank loan. The first is tranche A with 20 million euro, you know, to the extent that when we issue the warrants, we can draw on this loan. But the second tranche of that loan, tranche B, is 15 million euros, and it has two precedent conditions, one of which is we need to receive at least 15 million euros from any partnership or collaboration. And as we mentioned, we received that from Servier end of last year. The other precedent condition that we need to meet is to raise at least 20 million euros worth of capital, whether in the form of equity convert or anything that's junior to the European Investment Bank loan on the capital structure. So to satisfy the second precedent condition, you know, we timed the raise so that we can trigger and draw on the, satisfy the condition for the challenge B of the European Investment Bank Loan.
spk15: Thank you. Very helpful. Thank you.
spk08: Our next question comes from the line of Salveen Richter from Goldman Sachs. Please go ahead.
spk01: Hi, this is for Salveen. We had two questions on the AML program. First, what gives you confidence that there won't be any new safety issues or allogeneic rejection following the two-dose regimen? And then second, to evaluate if the two-dose regimen is effective, what are the initial signals that you're going to be looking at, and what would be the clinical bar for success here? Thank you.
spk06: Thank you for the focus on the 123, and I'll hand both to Mark.
spk12: Hi, thank you for the question. So as we've disclosed earlier, the two-dose regimen is being done such that we're giving the first dose on day zero as per usual, and we're giving a second dose 10 to 14 days after that. To address your question about allorejection, by giving that second dose between 10 and 14 days Later, we will, based on what we've seen, we'll see a peak of activity before day 28. And as we've shown with multiple patients at the ASH presentation, the use of alimtuzumab in these patients has allowed us to have host immune suppression past day 28. So from the standpoint of having host recovery that rejects the cells, we think this is We think this is going to be extremely minimized by the planning of when we're giving the second dose. And to answer your next question about, you know, clinical success will obviously be monitored by looking at, you know, disease activity with bone marrows during this process. You know, they will have a bone marrow 28 days after the second dose that will evaluate the that will evaluate the cumulative activity of the two doses against the disease, in addition to our translational studies, which will look at flow cytometry of CAR T cells in the peripheral blood, as well as the vector copy number analysis.
spk15: Thank you. Our next question comes from the line of Jack Allen from Baird.
spk08: Please go ahead.
spk04: Great. Thank you so much for taking my questions. The key question I had was I wanted to ask you about some of the recent data coming out of the CD22 CAR-T space and some of the auto programs at ASH. I was wondering if you could compare and contrast what some of those auto programs are seeing as compared to the UCAR22 data and just give an overview of how you think about allogeneic and opportunity in this space.
spk06: Hi, Jack. Thanks for the great question on 22. That would be for Mark.
spk12: Hi, Jack. Thank you for the question. So, as you're probably aware, there were two presentations at ASH on the autologous CD22 product, one from the Stanford group and one from the group at UPenn. And specifically to your question in terms of The response rates and specifically more the duration of response that was shown at the meeting. The, again, small numbers in all three settings, both autologous and ARS, but the trend is that the allogeneic, the allogeneic 22 appears to have a longer duration, a significantly longer duration of response. That's been seen to date, at least in the data that was discussed at the ASH meeting with the autologous product. Again, I think we think a lot of this is also due to the fact that the allogeneic product is from normal healthy donor T cells, and therefore this product could potentially be more potent and result in a longer duration of response than the autologous product.
spk15: Great, thank you.
spk08: Thank you. Our next question comes from the line of Haritaj Singh from Oppenheimer and Company. Please go ahead.
spk14: Great, thank you. And thanks for the question. Really nice update on the clinical programs. Can you just give an update on 20 by 22? You know, what dose, other dosing levels you're going to go through? I believe the product is in-house. If you can just update that. And then lastly, What line of patients in relapsed refractory NHL are you recruiting? Thanks for the question.
spk06: Hi, Hartaj. Thanks for the great question on 20 by 22. That would be for Mark.
spk12: Hi, Hartaj. Thank you. So, yes, the 20 by 22 product is completely in-house manufactured product that is in the clinic. Currently, we are currently enrolling in the study. And this study is like most of the other NHL studies is done via flat dosing of the UCAR 20 by 22. And so we're beginning with a dose level there. And I don't know, was there another part to the 20 by 22? I'm sorry, Kirtosh.
spk14: Yeah, no worries, no worries. I just, what line of patients are you recruiting in that relapsed refractory NHL? What, you know, what are you sort of going after post various lines of therapy? Just any color there. Thanks.
spk12: Yeah, so thanks. So particularly, as you know, given the approvals for the autologous 19 directed products, as well as the cell therapy products, as well as the antibodies, that it's likely that patients are going to be receiving these therapies, if possible, prior to receiving 20 by 22. So, I think in the setting of, you know, if they can't receive an autologous product for various reasons, either they can't be leukapherese successfully, they don't manufacture a successful product, or their disease is, you know, too... hyperproliferative that it can't be controlled during the waiting period for an autologous product, or if they have a CD19 escape via prior exposure to Blinitumumab, for example, those patients would all be eligible for our study. But we fully expect that the majority of them will have had some 19-directed therapy prior to enrolling in the study.
spk14: Great. Thanks, Mark. And sorry, one last question. Are you going to be using altuzumab or an FCA preconditioning regimen here or not?
spk12: Yes. We'll be getting FCA just like in the 22 study.
spk15: Great. Thank you for all the questions. Thank you.
spk08: Our next question comes from the line of David Dai from SMBC. Please go ahead.
spk05: Yeah, hey, thanks for taking my questions, and congrats on the progress here. I have a question on UCAR T22. I just want to follow up on Gina's prior question. Could you maybe just talk about the efficacy bar for UCAR T22 in BAL for the BALI-1 trial? We've seen a ZUMA-3 trial showed about 52% CR rate. Would this be the bar, or should we be expecting some sort of haircut since the patient has received a prior C19 therapy? Thank you.
spk16: Thank you, David, for the question, and I'll hand it over to Mark.
spk12: Thanks, David. So, yes, the short answer is that we, given the line of therapy that we would be in, we would expect the bar would be a little bit lower than that. But, however, what we've seen in the dose level three data that we've disclosed with a 60% response rate you know, two long-term, one CRI and an MRD negative MLFS. Those are significant responses, and I'll just remind you that those patients, all three of them, failed both prior CD19 autologous CAR therapy as well as prior allogeneic stem cell transplant. So, These are super refractory patients that we're seeing these responses in. So the investigators are super excited by this as well.
spk15: Thank you so much. Thank you.
spk08: Our next question comes from the line of Yanan Su from Wells Fargo Securities. Please go ahead.
spk02: Hi, thanks for taking our questions. On BALI-01 for UCARD-22, is there any update on the duration of response for the three patients who responded, as you just mentioned, at those level three? And also for 20 by 22, are we... Are we still expecting data, you know, this year? And at the time of data, do you expect to be at an effective dose at the dose escalation? Thanks.
spk06: Thank you, Yanan. These are great questions, and definitely for Mark.
spk12: Thank you. So for the 22 patients, we have not yet discuss an update on the durations, but later this year during data presentation, we will update the DORs for these patients at dose level three. In terms of your question for 20 by 22, we do expect data from the early first in human dose escalation later this year, by the end of this year. To answer the second part of your question, right now we don't know if it will be added, what we can say is an RPTD or not. We have to see where the data goes.
spk15: Great. Thanks for the cover. Thank you.
spk08: Our next question comes from the line of Brooke Schuster from William Blair. Please go ahead.
spk09: Hi, thank you guys for taking my question. So regarding UCAR-CS1, where do you see UCAR-CS1 fitting into the current CAR-T landscape in multiple myeloma? And I guess, what would you consider benchmarks for success in that future phase one data?
spk06: Hi, Brooke, and thank you for the focus on CS1, and I'll pass it to Mark.
spk12: Hi, thanks for the question. So, yeah, so CS1, obviously there's, as you know, there's a great number of BCMA-directed both cellular therapy and antibody-antibody drug conjugate trials and the recent approval of teclistamab. So, you know, we feel that, you know, CS1 is obviously going to be going to fit in currently after a BCMA-directed And the question would be, you know, if it's after one or two BCMA-directed therapies, but this is sort of in a patient-dependent investigator-specific question. But we do see it fitting in after BCMA.
spk15: Awesome. Thank you. Thank you.
spk08: Our next question comes from the line of Sylvan Turkan from JMP Securities. Please go ahead.
spk03: Good morning and thank you for the update and thank you for taking my question. First, on UCAR22, now that you've dosed a patient with the new in-house manufactured product, could you already comment on the potency and where you've seen it trending? And then secondly, could you just comment on the Primera Therapeutics collaboration? How did this come about? And how much expense and work does this collaboration mean for you? Or is it primarily driven by Primera?
spk06: Thank you very much. Thank you so much, Sylvain. I'll let Marc start with the first question, and then I can take the question Primera. Go ahead, Marc. Great. Thank you for the question.
spk12: You know, what we've discussed previously is one of the reasons why we did a dose de-escalation with the P2, the in-house manufactured product, is because our in vitro potency test showed that the Selectus in-house product was far superior to the CDMO product that was used prior. And so that's why we dropped down to 1 million cells per kilo, which is still a great dose. And, you know, we will disclose later this year on the effects in the patients as we begin the escalation there, whether that becomes the RP2D or whether we have to escalate further will be determined based on the responses.
spk06: Yeah, and so on Primera, we're very excited to be partnering with Hibiscus BioVentures and the Mayo Clinic on the mitochondrial disorders. I think what's very interesting is that this is a place where we can leverage our TALEN and TAL-based editor gene editing platform, and that this is indications of the mitochondria where other gene editing techniques like CRISPR have been extremely difficult to work. So this is where having a platform like the TAL-based platform, both doing nucleases and gene editors, is an extremely powerful advantage. So we're very excited to be working with them. This is obviously, there is a 19% equity ownership that Selectis is having on Primera. And we're eligible for up to 750 million of development and sales milestones that could stem from the potential partnership products if Primera exercise the option for up to five product candidates. And we do not expect this will materially impact our expenses. A lot of the work is going to be driven by Primera. We will contribute to the activities, but this is not going to be materially impacting our expenses.
spk15: Thank you. Thank you. Our next question comes from the line of Jack Allen from Baird.
spk08: Please go ahead.
spk04: Hi. Thanks so much for taking the follow-up. I just wanted to ask a little bit about your rationale for deciding to utilize both the CD20 and CD22 CAR T in this CD19 auto refractory patient population. Is there any external data that provides you confidence in the selection of those two kind of dual targets?
spk06: Thank you, Jack, and welcome back. We are, I'll hand it over to Mark for that question as well.
spk12: Yeah, Jack, thank you for the follow-up. So, yes, the reason for 20 and 22 in the NHL space is they are both antigens that are present and clearly expressed very well on essentially most all subtypes of B-cell NHL. So it does provide a very attractive alternative for those people that are obviously patients that have obviously failed a 19-directed product. And the dual antigen effect obviously we think will be beneficial into giving us a better response rate without a potential antigen escape that was seen with the single 19 product.
spk15: Great. Thanks so much for taking the questions again. Thank you.
spk08: Ladies and gentlemen, we have reached the end of the question and answer session. And I would like to turn the conference over to Andre Chilika, CEO, for closing comments.
spk11: Well, thank you very much. Thank you very much for joining the call. It's really appreciated all these list of questions to the team. It's pumping us because it gives us confidence in the coming near future for the development of the company and on the long term, too. There is a lot of excitement on our side and on also the network of PIs and hospital centers that we have, and we look forward for the next update on the company, and there's plenty of things that should happen in the coming year. Thank you very much.
spk15: Thank you. The conference of selectors has now concluded.
spk08: Thank you for your participation. You may now disconnect your lines.
Disclaimer