Q4 2022 Cellectis SA Earnings Call
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Speaker 2: Good morning everyone and welcome to Selectis 4th 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.
Speaker 2: Please be aware that today's conference call is being recorded. I would now like to introduce you the first speaker, Arthur Strill, Chief Business Officer.
Speaker 2: You may begin.
Speaker 3: Good morning and welcome everyone to select this fourth quarter and full year 2022 corporate update and financial results conference call.
Speaker 3: Joining me on the call today with prepared remarks are Dr. Andre Choulikar, our Chief Executive Officer, Dr. Bing Wang, our Chief Financial Officer, and Dr. Mark Fruttini, our Chief Medical Officer. Yesterday evening, Selectis issued a press release reporting its financial results for the fourth quarter and full year 2022.
Speaker 3: ended December 31st, 2022.
Speaker 3: The press release is available on our website at selectis.com. We expect to file the annual reports in the coming days. As a reminder, we will make statements regarding Selectis Financial Outlook in addition to its manufacturing, regulatory and product development status and plans and product development of its licensed partners.
Speaker 3: These forward statements, which are based on our management's current expectations and assumptions, and are 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.
Speaker 3: A description of these risks can be found in our most recent Form 20F filed with the Security Exchange Commission, SEC, and the financial report, including the management report, for the year ended on December 31, 2021, and subsequent filings selected makes with the SEC from time to time.
Speaker 3: A description of these risks can be found in our most recent Form 20F filed with the Security Exchange Commission, SEC, and the financial report, including the management report, for the year ended on December 31, 2021, and subsequent filings selected makes with the SEC from time to time. I would now like to turn the call over to Andre.
Speaker 4: Thank you, Arthur. Good morning, and thank you everyone for joining us today.
Speaker 4: 2022 has been a milestone year for Selectives.
Speaker 4: We have reached key milestones for our clinical trials that we're thrilled to share with you today.
Speaker 4: In December 2022.
Speaker 4: Selective presented positive preliminary clinical data from five additional patients from our BALI 01 trial evaluating UCAR-22.
Speaker 4: In patients with relapsed or refractory B-cell acute lymphoblastic leukemia or ALL.
Speaker 4: In this Phase 1-2a study, the five additional patients received UCRT22 at dose level 3 after lympho depletion with fludarabine, cyclophosphamide, and alentuzumab, or FCA, pre-gonitioning regimen.
Speaker 4: These results showed evidence of FuCART T22 anti-tumor activity observed in 3 of the 5, or 60% of the patients.
Speaker 4: Overall, these preliminary data support the continued administration of PUCAR T22.
Speaker 4: after FCA lympho depletion in patients with relapsed or refractory B cell ALL.
Speaker 4: We're excited by these preliminary clinical responses.
Speaker 4: 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.
Speaker 4: U-CART T22 is currently the most advanced allogenic CAR T cell product in development for B-cell ALL.
Speaker 4: We believe that our off-the-shelf treatment approach coupled with our ability to manufacture our U-Car T22 product candidates
Speaker 4: completely in-house give us a main advantage on market.
Speaker 4: It potentially maximizes the chances for eligible patients to be treated without delay.
Speaker 4: In December 2022, we also presented encouraging preliminary clinical data from our AMELIE 01 study evaluating UCAR-T123 in patients with relapsed or refractory acute malleable leukemia, or AML. The latest data shows patients with rel camp in
Speaker 4: The Norweld session at the American Society of Hematology, the preliminary data showed that adding alantuzumab to the fludarabine and cyclophosphamide lympho-depletion regimen was associated with sustained lympho-depletion and significantly higher URCR T123.
Speaker 4: cell expansion, which correlated with improved anti-tumor activity.
Speaker 4: 25% of patients at dose level 2 in the FCA arm achieved a meaningful response.
Speaker 4: Exemplary activity was seen in a 64 year old female with who had relapsed after allergenic stem cell transplantation. And had maintained a durable, minimal, residual disease negative complete responses for over 1 year without salvage donor lympho.
Speaker 4: As a development fund, FLEXUS gene editing system continues to provide the company with expanded opportunities.
Speaker 4: Like this is announced a collaboration agreement with Primera Therapeutics to edit mutations in the mitochondrial DNA in vivo to treat the root cause of associated diseases.
Speaker 4: Mera, together with Selective, will be co-developing a mitochondrial DNA engineering toolbox that could enable effective therapies for mitochondrial diseases.
Speaker 4: Our partnership with Primera further showcases and expands the application of our gene editing capabilities into a previously unexplored space.
Speaker 4: This partnership is very much in line with selective mission to leverage is gene editing technologies to develop potentially life saving product candidates address unmet medical needs.
Speaker 4: in October 2022.
Speaker 4: A licensed partner, IOVAN, announced that the first patient was dosed and completed the safety observation period in the IOV-GM1 201 clinical trial of IOVAN's first genetically modified, talent-edited, tumor-infiltrating lymphocytes, or TILs therapy.
Speaker 4: for the treatment of previously treated metastatic non-small cell lung cancer and advanced melanoma.
Speaker 4: In December 2022.
Speaker 4: Like this time of 40 million credit facility. With European investment bank, and in the same month received the milestone payment from our license partners, Serbia in connection with the phase 2 trial. Our 501 a for patient was last or refractory large B cell informa. Finally, in February , 2023.
Speaker 4: We're proud to announce the closing of a $25 million equity offering.
Speaker 4: All the Selective Team and I would like to warmly thank the European Investment Bank and our investors for their strong support and we now have cash runway into the third quarter 2024.
Speaker 4: This year, selectus remains deeply focused on the patient recruitment on our four ongoing phase one clinical trials Valle01, Amalee01, Melanie01, and Nathalie01 evaluating UCRT22, UCRT123, and UCRT22.
Speaker 4: your car TCS1 and your car T20x22 respectively.
Speaker 4: With that, I would like to turn the call over to Dr. Mark Fertini, our Chief Medical Officer, who will give an overview of these clinical trials.
Speaker 5: Mark, please go ahead. Thank you, Andre, and good morning, everyone. As Andre mentioned, 2022 has been a productive year for Selectus.
Speaker 5: with our proprietary clinical programs making progress, and we were specifically excited to share additional preliminary clinical data from our BALI 01 trial evaluating UCART 22 in a live webcast last December .
Speaker 5: FALEO-1 is a Phase 1, 2a open-label dose escalation trial currently evaluating the safety and clinical activity of UCART22 given an escalating dose levels after lympho depletion with fludarabine, cyclophosphamide, and alantuzumab.
Speaker 5: or FCA regimen in patients with relapse or refractory B cell acute lymphoblastic leukemia.
Speaker 5: Alumtuzumab was added to the lympho depletion regimen to sustain host T-cell and NK-cell expansion and to allow for UCAR-22 cell expansion and clinical activity.
Speaker 5: 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.
Speaker 5: After lymphoid depletion with FCA.
Speaker 5: 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.
Speaker 5: Evidence of UCAR-22 antilucemia activity was observed in 60%, or three of the five patients at dose level three.
Speaker 5: One patient experienced a durable, minimal residual disease negative complete response with incomplete count recovery that continued beyond six months as of December 2022.
Speaker 5: The second patient experienced a minimal residual disease negative complete response that continued beyond day 70 as of December 2022.
Speaker 5: And the third patient experienced a minimal residual disease negative morphologic leukemia free state that continued beyond day 84 as of December 2022.
Speaker 5: As Andre mentioned, these preliminary data support the continued administration of UCAR-22 after FCA lymphodepletion in patients with relapsed refractory B-cell ALL and are very encouraging for patients who have limited, if any, to the
Speaker 5: treatment options.
Speaker 5: especially for those who have failed prior CD19-directed CAR T-cell therapy and allogeneic stem cell transplant.
Speaker 5: We have also announced the first dosing of a patient with our completely in-house manufactured UCart 22 product candidate.
Speaker 5: This patient completed the 28-day dose-limiting toxicity observation period without complications.
Speaker 5: 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..
Speaker 5: The BALEO-1 study is now enrolling patients with product candidate manufactured in-house at dose level 2, 1 million cells per kilogram, after FCA lymphoid depletion.
Speaker 5: The next dataset is expected to be released later this year.
Speaker 5: Last December , Selectus presented clinical data in an oral presentation at ASH 2022 on its OMLI-01 clinical trial evaluating UCART-123, a Phase I open-label dose escalation study in? Released Route negotiating Chart with Eon Ab Luigi
Speaker 5: in patients with relapsed or refractory acute myeloid leukemia. The presentation by Dr. David Solomon from Moffitt Cancer Center, one of the study investigators, included preliminary clinical data showing that adding alamtuzumab to the FC lymphodepletion...
Speaker 5: Evidence of UCAR-123 anti-leukemia activity was observed in four patients out of 15 at dose level 2 or above with best overall responses in the FCAR.
Speaker 5: 25% at dose level 2 with FCA achieved meaningful response.
Speaker 5: 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. For more information, visit www.ottobock.com
Speaker 5: One patient with stable disease achieved greater than 90% bone marrow blast reduction from 60% to 5%.
Speaker 5: Overall, these encouraging clinical data are a meaningful step forward for patients and support further enrollment into the study.
Speaker 5: This trial addresses a patient population with severe unmet medical need, where a successful CAR T-cell product candidate could be a major breakthrough.
Speaker 5: AMALY 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
Speaker 5: A dose that has already been administered and cleared for safety as a single dose by the Study Data Safety Monitoring Board.
Speaker 5: Next, I'll move on to our MELONY-01 clinical trial, our CS1-directed, tail-and-gene-edited, allogeneic CAR T cell product candidate being evaluated in patients with relapsed or refractory multiple myeloma.
Speaker 5: Selectus is currently enrolling patients at dose level 1, 1 million cells per kilogram, using an FC lymphodepletion regimen.
Speaker 5: Lastly, I will speak about our NAH-TULI 01 study evaluating UCAR 20 by 22.
Speaker 5: U-CARB 20x22 is Selectus' first allogeneic dual CAR T cell product candidate being developed for patients with relapsed or refractory non-Hodgkin lymphoma.
Speaker 5: UCART 20x22 is also the first product candidate Selectus has designed, developed, and manufactured completely in-house. For more information visit www.ucart.com
Speaker 5: In addition, the advantage of UCAR-20x22 is that it goes beyond the highly competitive CD19 antigen-directed therapy space by providing a dual-antigen targeted allogeneic alternative.
Speaker 5: With that, I would like to hand the call over to Bing Long, Selectis' Chief Financial Officer, for an overview of our financials for the fourth quarter and full year 2022.
Speaker 5: With that, I would like to hand the call over to Bing Long, Selectis' Chief Financial Officer, for an overview of our financials for the fourth quarter and full year 2022. Bing, please go ahead.
Speaker 6: Thank you, Mark. I will provide a brief overview of our financials for the fourth quarter of 2022.
Speaker 6: I would like to highlight that our financials, the cash, cash equivalents, current financial assets, and restricted cash position selectives, excluding CalEx as of December 31st, 2020, are not available.
Speaker 6: 2022 was 95 million compared to 177 million as of December 31st, 2021.
Speaker 6: 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.
Speaker 6: On the current operating plan and financial projections, this cash position is expected.
Speaker 6: be sufficient to fund selective standalone operations into the third quarter of 2024.
Speaker 6: On January 13, 2023, Talyx Sebas
Speaker 6: and certain other parties entered into a merger agreement pursuant to which Calix and Cebas will merge in an all-stock transaction. Following the closing of the proposed Calix merger,
Speaker 6: Selecta's SA is expected to own approximately 2.4% of the equity interest of the combined company.
Speaker 6: Accordingly, if the proposed Calix merger is consummated, it will result in a loss of control over Calix.
Speaker 6: and Calix should no longer be a consolidated subsidiary.
Speaker 6: The closing of the proposed CalX merger is expected in the second quarter of 2023. In this context, CalX is presented as a discontinued operations in the financial statements for the year ending December 31.
Speaker 6: 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 the increase in net loss between 2022 and 2021.
Speaker 6: by an increase of net financial loss of $60 million due to Cytovia's convertible loss in fair value of 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.
Speaker 6: and a decrease of SGN expense of 5 million.
Speaker 6: decrease of SG&A expense of $5 million. Scott grips on small trade line.
Speaker 6: 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 $2.33 per share in the 12 month of 2022, or $2.34 per share in the 12 month of 2022.
Speaker 6: $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 selectors. U Molly Jr is self-service available to orange
Speaker 6: of $10 million and partially offset by an increase of $2 million in net loss of selectives stand alone. The adjusted net loss attributable to shareholders of selectives, including Calix, which excludes non-cash, stock-based compensation expenses.
Speaker 6: 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.
Speaker 6: As Andre mentioned earlier, we signed a 40 million euro credit facility with the European Investment Bank in December of 2022.
Speaker 6: We also received 15 million euros from Servier in connection with a phase two study for ALLO 501A in December 2022. In February of 2023, we raised 25 million in an equity offering with a net proceeds of 23 million.
Speaker 6: Combined, this will allow our cash runway to extend into the third quarter of 2024.
Speaker 6: 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.
Speaker 6: In addition, our focus on maintaining an efficient corporate infrastructure
Speaker 6: In addition, our focus on maintaining an efficient corporate infrastructure also enable more limited growth in G&A spend.
Speaker 4: Thank you, Bing. To close out this call, I would like to reiterate how proud we are of exams.
Speaker 4: 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 allogenic CAR T in hematological malignancies this year.
Speaker 4: and select this.
Speaker 4: We strongly believe that our proleth candidate, our technologies and our enhanced manufacturing capabilities, will lead us to a paradigm shift for patient with heart to treat cancer.
Speaker 4: positioning us at the forefront of this promising medical and scientific field.
Speaker 4: With that, I would like to open the call for Q&A. Thank you.
Speaker 2: Ladies and Gentlemen, at this time we will be conducting a question and answer session.
Speaker 2: If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.
Speaker 2: You may press star 2 if you would like to remove your question from the queue.
Speaker 2: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key.
Speaker 2: Ladies and Gentlemen, we will wait for a moment while we poll for questions.
Speaker 2: Our first question comes from the line of Kelly She from Jeffries.
Speaker 7: Hello can you hear me?
Speaker 8: Yes, we can.
Speaker 7: Hi, thank you for taking our question. This is Dave on for Kelly. She had Jeffrey. So a couple of questions for you. For you got 22, could you share more color on enrollment, including a number of active sites and pace of patient patients in recruitment and.
Speaker 7: 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.
Speaker 3: Hi there, this is Arthur. Thanks for these two great questions. I think the first one would be best for Mark and the second one for Bena. So, Mark.
Speaker 5: Thank you for the question. 22 enrollment is proceeding very well. We have sites open in the U.S. and France that we are currently enrolling in this study. As we discussed, we are using the completely in-house manufactured pieces.
Speaker 6: for, 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...
Speaker 6: expect to see the 2022 R&D expense on the runway on a very similar level in 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.
Speaker 2: line of Gina Wang from Barclays. Please go ahead.
Speaker 9: Thank you for taking my questions. I have two questions. First one is regarding the Bali 01 trial, the in-house manufacturing product at those level two. Wondering how many patients will we see at the initial data report and will we
Speaker 9: at the ER, what kind of a clinical profile can warrant a quick transition to pivotal study? And then quickly, second question for Bing, regarding the reason capital raise, can you give a little bit more color on rationale of the timing?
Speaker 3: Thank you so much, Gina, for the two questions. Let's start with Mark and then Bing.
Speaker 5: Hi, Gina, thank you for the question. So so, yes, we are currently enrolling with the with the P2 product and right now we're currently at those level 2 as we discussed. We will we are planning to. Have a, you know, to discuss the results of the of the role.
Speaker 6: 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 a credit facility agreement with the European Investment Bank as
Speaker 6: We mentioned on a call earlier. And there's three tranches in the European Investment Bank loan. The first is Tranche A with 20 million Euro. 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 50 million Euros.
Speaker 6: 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 in the last year. The other precedent condition that we need to meet is to raise at least
Speaker 6: 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.
Speaker 6: So to satisfy the second precedent condition, you know we time the race so that we can trigger and draw on the satisfy the condition for the Tron to be of the European Investment Bank loan.
Speaker 2: Thank you. Our next question comes from the line of Salveen Richter from Goldman Sachs. Please go ahead. Our next question comes from the line of Salveen Richter from Goldman Sachs.
Speaker 10: Hi, this is Anomied Anfor-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. Thank you for the focus on the 123.
Speaker 5: 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 alamtuzumab in these patients has allowed us to have host immune suppression past day 28. So...
Speaker 5: From the standpoint of having host recovery that rejects the cells, we think this is going to be extremely minimized by the planning of when we're giving the second dose.
Speaker 5: 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...
Speaker 2: Our next question comes from the line of Jack Allen from Baird. Please go ahead. Our next question comes from the line of Jack Allen from Baird. Please go ahead.
Speaker 11: 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.
Speaker 5: and one from the group at UPenn. And specifically to your question, in terms of the response rates and duration, specifically more the duration of response that was shown at the meeting, the, again, small numbers in all three settings, both autologous and...
Speaker 5: at the ASH meeting with the autologous product. Again, 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.
Speaker 2: Our next question comes from the line of Haritaj Singh from Oppenheimer & Company. Please go ahead.
Speaker 4: Great. Thank you, and thanks for the question. Really nice update on the clinical programs. Can you just give an update on 20x22? What other dosing levels are you 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?
Speaker 4: Thanks for the question.
Speaker 5: Hi, Hartaj. Thanks for the great question on 20x22. That would be for Mark. Hi, Hartaj. Thank you. Yes, the 20x22 product is a completely in-house manufactured product that is in the clinic. Currently, we are currently enrolling in this study.
Speaker 5: This study, like most of the other NHL studies, is done via flat dosing of the U-part 20x22. We're beginning with a dose level there. Was there another part to the 20x22?
Speaker 5: 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.
Speaker 5: I think in the setting of, you know, if they cannot receive an autologous product for various reasons, either they cannot be Luca-free successfully, they do not manufacture a successful product, or their disease is, you know, too, um, you know, too much.
Speaker 5: hyper-proliferative 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 blended Tumamab, 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.
Speaker 2: Our next question comes from the line of David Dye from SMBC. Please go ahead. Thanks for taking my questions and congrats on the progress here. I have a question on UCAR-T92. I just want to follow up on Gina's prior question. Could you maybe just talk about the efficacy bar for UCAR-T92 in the AAL for the BALI-1 trial? We have seen a Zuma-3 trial show about 52...
Speaker 2: 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. Thank you, David, for the question. And I'll hand it over to Mark. Thanks, David. So yes, the short answer is that we given the line of therapy.
Speaker 5: term C1CR1CRI and an MRD negative MLFS.
Speaker 5: Those are significant responses. 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.
Speaker 5: These are super refractory patients that we are seeing these responses in. The investigators are super excited by this as well.
Speaker 5: These are super-refractory patients that we're seeing these responses in. So, you know, the investigators are super excited by this, as well. Thank you so much.
Speaker 2: Thank you. Next question comes from the line of Yan Su from wel Fargo Securities. Please go ahead.
Speaker 2: Hi, thanks for taking our questions. On Bally 01 for UCard22, is there any update on the duration of response for the three patients who responded, as you just mentioned, at dose level 3?
Speaker 2: And also for 20 by 22, are we still expecting data this year? And at the time of data, do you expect to be at an effective dose at the dose escalation? Yes.
Speaker 5: Thank you, Yannan. These are great questions and definitely for Mark. Thank you. So, for the 22 patients, we have not yet discussed an update on the durations, but later this year during data presentation, we will update the DORs for the next two weeks.
Speaker 5: part of your question. Right now we don't know if it will be added, what we can say as an RP2D or not. We have to see where the data goes.
Speaker 2: Great. Thanks for the cover. Thank you. Our next question comes from the line of Brooke Schuster from William Blair. Please go ahead.
Speaker 12: 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?
Speaker 12: in that future Phase 1 data.
Speaker 5: Hi, Brooke, and thank you for the focus on CS1. And I'll pass it to Mark. Hi. Thanks for the question. So, yeah, so CS1, obviously, as you know, there's a great number of BCMA-directed, both cellular therapy and antibody-antibody drug conjugate trials. And we're Cool.
Speaker 5: the recent approval of tclistimab. So, you know, we feel that, you know, CS1 is obviously going to be... We're going to fit in currently after a BCMA-directed therapy. 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...
Speaker 5: dependent investigator specific question, but we do see it fitting in after BCMA. Awesome, thank you.
Speaker 2: Thank you. Our next question comes from the line of Sylvan Turkhan from JMP Securities. Please go ahead.
Speaker 2: Hey, good morning, and thank you for the update, and thank you for taking my question. First, on UCAR-22, now that you've dosed a patient with the new in-house manufactured product, could you really comment on the potency and where you've seen it trending? And then secondly, could you just comment on the primary therapeutics?
Speaker 5: How does this come about and how much expense and work does this collaboration mean for you or is it primarily driven by Primera? 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 from Primera. Go ahead, Marc. Great. Thank you for the question. So, you know, what we've discussed previously is one of the reasons why…
Speaker 5: million cells per kilo, which is still a great dose. 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. On Primera, we're very excited.
Speaker 3: have been extremely difficult to work. So this is where having a platform like a tile-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 model.
Speaker 13: Thank you.
Speaker 13: Thank you.
Speaker 14: Our next question comes from the line of Jack Allen from Baird. Please go ahead.
Speaker 11: 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 dual targets? Thank you, Jack, and welcome back. We are at...
Speaker 5: 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 will...
Speaker 5: 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.
Speaker 5: think will be beneficial into giving us a better response rate without a potential antigen escape that was seen with the single 19 product. Great. Thanks so much for taking the questions again.
Speaker 14: Thank you. 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 Chulika, CEO for Closing Comments.
Speaker 4: Thank you very much for joining the call. It's really appreciated all these list of questions to the team. It's something to 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 also the network of CIs and
Speaker 4: like the hostel 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 Thank you the conference of selectors has now concluded. Thank you for your participation. You may now disconnect your lines
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