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spk10: Good morning, everyone, and welcome to Selective's first quarter 2023 earnings 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 the first speaker, Arthur Strill, Chief Business Officer. Please go ahead, sir.
spk09: Good morning, and welcome, everyone, to Selectus' first quarter 2023 corporate update and financial results conference call. Joining me on the call today with prepared remarks are Dr. André Choulicat, our Chief Executive Officer, Dr. Bing Wang, our Chief Financial Officer, and Dr. Mark Trottini, our Chief Medical Officer. Yesterday evening, Selectus issued a press release reporting its financial results for the three-month period ended March 31, 2023. The report and press release are available on our website at selectives.com. As a reminder, we will make statements regarding Selectives Financial Outlook, in addition to its manufacturing, regulatory, and product development standards and plans, and product development of its licensed partners. These forward statements, which are based on our management's current expectations and assumptions, and the 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 Security Exchange Commission, SEC, and the financial report, including the management report, for the year ended on December 31st, 2022, and subsequent filing selected makes with the SEC from time to time. I would now like to turn the call over to André.
spk06: Thank you, Arthur. Good morning, and thank you, everyone, for joining us today. Lectus made significant progress with its pipeline this quarter. We took a notable step forward with the first patient being dosed in France with our in-house manufacturer product candidate, UCAR T22, evaluated in the Bally01 clinical study. This is an important advancement for the selective team who has worked tirelessly to expand the Bally01 clinical study to Europe. UCAR-T22 is currently the most advanced allogenic CAR-T cell product in development for relapsed or refractory B-cell acute lymphoblastic leukemia. We believe that our off-the-shelf treatment approach, coupled with our ability to manufacture UCAR-T product candidates, give us a competitive advantage on the market. It potentially maximizes the chances for eligible patients to be treated without delay. On the business development front, our partnerships proved to be an exciting highlight for Selective. Last month, we announced that we have implemented the use of Sanofi's Alentuzumab as the Selective's investigational medicine product. coded as ELLS-52 as part of the lymphodepletion regimen for UCAR-T22 in the Bally-01 clinical trial, for UCAR-T123 in the Amelie-01 clinical trial, and for UCAR-T20-by-22, the Natalie clinical trial. This follows the partnership and supplies agreement that we entered with Central Care regarding allanthuzanab. This quarter, we were proud to present encouraging preclinical data at the American Association for Cancer Research annual meeting on TALEN-edited MUC1 CAR T-cell to enhance efficacy in targeting triple-negative breast cancer. The data showed the capability of armored allogenic MUC1 CAR T-cell with sophisticated gene edits to excel in the immune-suppressive tumor microenvironment, suggesting that they could be an effective option in treating patients with limited therapeutic options. We're proud of these results that reinforces the performance of our technologies and our commitment to treat cancer patients. We also announced that two abstracts have been accepted at the upcoming American Society of Cell and Gene Therapy annual meeting. Selectives will present clinical data on the Amelie-01 clinical trial in evaluating UCAR-T123 that were already showcased in an oral presentation at the 2022 ASH annual meeting, as well as preclinical data on multiplex engineering for superior generation of CAR-T cells. Those presentations will take place on May 17th in Los Angeles. This quarter, Selectus announced the closing of the global offering of $25 million of its depository shares, launched in February. The net proceeds of the global offering is approximately $22.8 million. Finally, in April, we announced that the drawdown of the first tranche of the 20 million euros under the finance contract for up to 40 million euros credit facility made with the European Investment Bank in December 2022, selected this plan to use the net proceeds of the funds to focus on the development of its pipeline of allergenic CAR T cell prologue candidates, UCAR T22, UCAR T20x22, and UCAR T123, and decided to stop enrollment of treatment of patients with UCAR TCS1. To accelerate the speed of enrollment of patients in the MELANIE-01 study evaluating UCAR-PCS1, the company would have had to invest a meaningful amount of resources. Therefore, to optimize its resources, Selectus decided to focus its development efforts on the BALI-01, AMOE-01, and NATALI-01 studies and stop MELANIE-01. Lastly, based on our current plan, we anticipate our cash runway to take us into the third quarter of 2024. We are excited about the drive in our clinical trials, building on the momentum of our lead product candidates in our pipeline and the upcoming milestones for 2023. With that, I would like to turn the call over to Dr. Mark Frettini, our Chief Medical Officer, who will give us an overview of these clinical trials. Mark, please go ahead.
spk15: Thank you, Andre. As Andre mentioned, we have made progress in our BALI-01 clinical trial with the dosing of our first patient in Europe with our in-house manufactured product candidate, UCART22. UCART22 is an allogeneic CAR T-cell product candidate that targets CD22 and is evaluated in the BALI-01 clinical study, a Phase I-IIa open-label study designed to evaluate the safety and clinical activity of the product candidate in patients with relapsed refractory B-cell acute lymphoblastic leukemia. The last preliminary data presented in a live webcast last December 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. The BALI-01 study is actively enrolling patients after FCA lymphodepletion. Our AMELI-01 study evaluating UCART-123 in patients with relapsed refractory AML continues to progress and enroll patients in the FCA two-dose regimen arm. We look forward to sharing clinical data from this program when it becomes available. Next, I'll move on to our MELANEO-1 clinical trial, our CS1-directed, tail and gene-edited allogeneic CAR T-cell product candidate being evaluated in patients with relapse or refractory multiple myeloma. As Andre previously mentioned, in order to focus on the development of our pipeline of allogeneic CAR T-cell product candidates, UCART22, UCART20x22, and UCART123, we decided to stop enrollment and treatment of patients in the MELANIE-01 study evaluating UCART CS1. Lastly, I will speak about our NATALI-01 study evaluating UCART20x22. UCART20x22 is Selectus' first allogeneic dual CAR T-cell product candidate being developed for patients with relapsed or refractory B-cell 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 20x22 is that it goes beyond the highly competitive CD19 antigen-directed therapy space, by providing a dual antigen, CD20 and CD22, targeted allogeneic alternative. Selectus is now enrolling patients in the Nataleo 1 trial. Lastly, as Andre mentioned, Selectus announced that we have implemented the use of Sanofi's alamtuzumab as a Selectus investigational medicinal product coded as CLLS52. as part of the lymphodepletion regimen in the Bali-01, Amelie-01, and in the Natali-01 clinical trials. As previously reported, the importance of alamtuzumab in the lymphodepletion regimen was demonstrated in our Bali-01 and Amelie-01 studies, where the addition of this lymphodepletion agent to the fludarabine and cyclophosphamide regimen was associated with sustained lymphodepletion and significantly higher UCAR T-cell expansion, allowing for greater clinical activity. We believe these encouraging outcomes are a meaningful step forward to a safe, effective, and controllable therapeutic window for our allogeneic CAR T-cell product candidates. With that, I would like to hand the call over to Dr. Bing Wang, Selectus' Chief Financial Officer for an overview of our financials for the first quarter of 2023. Bing, please go ahead.
spk03: Thank you, Mark. I'll provide a brief overview of our financials for the first quarter of 2023. I would like to highlight that our financials, the cash, cash equivalent, and restricted cash position of selectives, excluding Calix, as of March 31st, 2023, was $88 million, compared to $95 million as of December 31, 2022. This difference mainly reflects $30 million of cash out, which includes $6 million of payments for R&D expenses, $4 million for SG&A suppliers, $15 million for staff costs, $4 million for rent and taxes, $1 million of reimbursement of the PGE loan, and a $23 million net cash inflow from the capital raise close in February. This cash position is expected to be sufficient to fund Selectus standalone operations into the third quarter of 2024. On January 13, 2023, Calix, CBIS, and certain other parties entered into a merger agreement pursuant to which Calix and CBIS will merge in an all-stock transaction. Following the closing of the proposed Calix merger, Selectus SA is expected to own approximately 2.4% of the equity interest of the combined company. Accordingly, if the proposed Calix merger is consumed, it will result in the loss of control over Calix and Calix 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 discontinued operations in the financial statement for the year three-month period ended March 31st. The net loss excluding Calix was $20 million in the three months of 2023 compared to a loss of $28 million in the three months of 2022. The $0.5 million decrease in net loss between 2023 and 2022 was primarily due to a decrease of $4 million in purchases and external expense as a result of quality and manufacturing internalization, a decrease of $3 million in personal expenses due to headcount rationalization, and almost fully offset by an increase of net financial loss of $5 million due to SITOVIA's convertible note loss in fair value and an increase of other operating expense of $1 million. The net loss attributable to shareholders of a selective including Calix, was $30 million, or $0.58 per share, in the three months of 2023, compared to a loss of $32 million, or $0.70 per share, in the three months of 2022. This $2 million decrease in net loss between 2023 and 2022 was primarily driven by a decrease of net income from discontinued operation attributable to shareholders or selectors of $1 million. The adjusted net loss attributable to shareholders of selectors, including Kalex, which excludes non-cash stock-based compensation expenses, was 28 million, or 55 cents per share, in the three months of 2023, compared to a loss of 29 million, or 64 cents per share, in 2022. The tranche of 20 million euro of the credit facility we got from the European Investment Bank was received in April. We are laser focused on spending our cash on developing our clinical candidates and operating our state-of-the-art manufacturing facility in Paris and in Raleigh. In addition, our focus on maintaining an efficient corporate infrastructure should also enable a more limited growth in G&A spend. Back to you, Andre.
spk06: Thank you, Ben. To close out this call, I would like to reiterate how excited we are about the continued progress of our clinical trials and the upcoming milestones for 2023. Pioneering this field, Selectis continuously leverages gene editing and its series of breakthrough innovation into clinical development in order to transform the lives of patients with cancer and rare genetic diseases. And we look forward to continuing this effort in the second quarter of 2023 and beyond.
spk05: With that, I would like to open the call for Q&A.
spk10: 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 key. One moment, please, while we poll for questions. Our first question comes from Gina Wang with Barclays. Please proceed with your question.
spk11: Thank you for taking my questions. I have three very quick ones. First one is UCAR123. You will present data at the ASGCT. The abstract looks similar. versus last ASH. So wondering what kind of a new data we will see at the ASGCT. And the second question is a UCAR-22 since you complete, you know, the first patient complete 28-day dose limiting tox period. Any additional waiting period for you in order to dose next patient and what would be the plan for next steps? And lastly, very quickly for being you know, according to the cash guidance, should we expect largely flat quarter over quarter burden?
spk09: Hi, Gina. Thank you so much for these great questions. So, we'll start with Mark for the first two on 123 and 22, and then Bing for the financial question.
spk15: Thanks. Thanks, Gina, for the question. So, in regards to your first question about 123, Yes, there is an oral presentation coming up in a couple of weeks, and it is an encore presentation of the, of the presentation in that in that forum. As, you know, we are, as we discussed in December, we are proceeding with enrollment in the 2 dose regimen arm and that data will be presented later when available in terms of your 2nd question about 22. Yes, there is a full DLT waiting period of 28 days between the first and second patient, but subsequent patients can be enrolled simultaneously. And we will be updating the 22 data later this year as well.
spk03: Hi, Gina. Regarding the cash burn question, yes, quarter over quarter burn should be flat for the rest of this year.
spk18: Thank you very much.
spk10: Our next question comes from Yanan Zhu with Wells Fargo. Please proceed with your question.
spk08: Hi. Thanks for taking our question. This is Kuan for Yanan. So back to UCAR 22. Can you comment on how your in-house product performs compared to the previous product so far?
spk09: Hi, Kuan. Great question. That would be for Mark as well.
spk15: Hi, thank you for the question. So, yeah, as you know, we are currently enrolling both in the EU and the U.S. with our completely in-house manufactured UCAR 22 product. And as I said from the previous question, we will be updating that data later this year.
spk08: Got it. And another question on elantuzumab. I wonder if you can comment on how adding elantuzumab may affect the overall safety Thank you.
spk15: Sure. So as we've already presented at ASH prior two times with the 22 product and last December with the 123 product, the omtizumab component of lymphodepletion is very important for allowing for sustained lymphodepletion and optimal UCART expansion and therefore clinical activity. And what we did show looking at the AEs that were presented for both products was that there was no significant difference in terms of safety with the use of either with or without the use of allantuzumab. Those were very equivalent.
spk08: And next question, very quick. For the two-dose regimen, given that some literature suggests patients' disease burden may affect the greater CRS, is it the company's plan that you would adjust the dose level based on patients' disease burden?
spk15: Thank you. Yeah, great question. So, with the two-dose regimen, as we discussed in December, We began enrollment with dose level 2, which was a dose that was cleared for safety as a single dose regimen by the Data Safety Monitoring Board for the study. And so the regimen is two doses of dose level 2 that are given during the study. You know, the hypothesis going in, obviously, is that with the second dose, that will be given in a state where there is a much lower disease burden, and therefore, as has been shown before, a much lower level of potential CRS in that situation.
spk02: Got it. Thank you so much.
spk10: Our next question comes from Yigal Nachumovitz with Citigroup. Please proceed with your question.
spk16: Hi, thanks. Just a few questions. Could you just comment on the level of enthusiasm for enrolling the UCART 20 by 22 program, please?
spk15: Mark? Sure. Thanks, Yigal, for the question. So there's an extreme... enthusiasm for this study from all the investigators that have this study open so far. They're very excited to proceed with this dual alginate CAR-T cell, and in particular because it does not involve CD19, so it's out of the 19 space.
spk16: Okay. And then you mentioned for UCAR22, you completed the 28-day Can you comment any further on the safety that was observed in that initial period?
spk15: Yeah, so for, as we said, for the 22, there'll be a data update later this year about the patients enrolled with the P2 that we will disclose at that time.
spk16: Okay. And then with regard to Melanie 01, is the reason for that because you just had difficulty competing with the BCMA by specifics? Is that why or is there a different reason?
spk09: Yeah. Thanks, Yigal. André, do you want to take this one first?
spk06: Hi, Yigal. Yes. It's definitely the competition between all the product that are currently in either approved or in clinical development makes our enrollment very difficult. And what we're getting currently in the trial are patients, as we've shown in the past, with multiple lines of treatment. And also, we need to remanufacture the product. And they show the current product that we're using was essentially manufactured at self-locure. And we think that it's essential to manufacture ourselves prolapse. We see it with 22 and 20 by 22. It makes a huge difference. And so the arbitration has, like either you open more sites and probably outside the United States or, and you can get the thing going or you try to focus and focus has been the choice in the current conditions.
spk02: I see. Thank you. Given the drive, we have for 22 and 20 by 22 and, of course, 123. Okay. Got it. Thanks.
spk10: Our next question comes from Salveen Richter with Goldman Sachs. Please proceed with your question.
spk13: Hi. This is for Salveen. Thank you for taking our question. Just another question on the CS1 program. Do you anticipate bringing it back at some point given the opportunity for a non-BCMA-targeted CAR T in the multiple myeloma space? And then are there any patients that have been dosed already from this program, and would we see data from those patients? And then just a quick follow-up on CD20x22. I guess, you know, are you targeting mostly the CD19-naive or CD19-relapsed patients? And then in that context, what clinical profile are you looking to achieve relative to, you know, the approved CD19 therapies or Allo's CD19 program? Thank you.
spk09: Hi, Numid. Thank you very much for the question. I'll leave the first question on CS1 to André, and then Marc for 20 by 22.
spk06: Yes, thank you very much for the question. we really like the target CS1, and we believe it's a very interesting alternative to BCMA. We've already presented data in the past, and we showed that UCAR TCS1 can provide, like, meaningful tumor reduction, and, like, had some patients that went into, it's not a CR because, like, the M-protein was still quite high, but in a VGPR, Mark will correct me concerning this, but we definitely think that it's a great target. And for us, it's something that has been an arbitration that we really needed to do. And I think that it's healthy for the company. But of course, if we have the potential to change the course of this, especially if we have the means to do it, We would definitely restart it as we believe that CS1 is a huge alternative to BCMA and all the multiple myeloma current products that are developed. It's a validated target with elotuzumab. And it's self-reliant to depleting, so it's great in its own space. So there's a lot of features that are extremely interesting, but you have to remanufacture the product internally. given the performance of our group currently, and this is something we would like to focus on the current driver in the company, which are 2220 by 22 and 122.
spk18: Mark?
spk02: Okay, thanks, Andre.
spk15: So, and I'll go to the 20 by 22 question. So, yes, so patients that have had prior CD19 directed therapy of any variety are eligible for this study. And in addition, patients that obviously could not receive CD19 directed therapy for one reason or another are also eligible for this study.
spk12: Thank you. And just a follow-up, what target profile are you hoping to achieve with this program? Thank you.
spk15: Right now, it would be considered as an additional line past CD19 directed therapy.
spk18: Our next question comes from Kelly Chee with Jefferies.
spk10: Please proceed with your question.
spk01: Hi, this is Dave on for Kelly Chee. I have a couple of questions. One is, you mentioned runway into third quarter of 24. I just wanted to make sure, does it include any milestone payments? Also, any thoughts on doing two-dose regimen for UCAR 22? Thank you.
spk09: Hi, thank you for the question. So Bing for the runway, and then Mark for the two-dose regimen on 22.
spk03: Yes, we've included some probability-adjusted, I would say pretty conservative on our part, on the milestone to provide the runway guidance to third quarter of 2024.
spk15: And then for the second question about 22, so right now the trial is structured obviously as a single-dose regimen, which we will, you know, continue to evaluate as we move forward.
spk10: Our next question comes from with Oppenheimer. Please proceed with your question.
spk04: Great. Thank you. Thanks for the question. Good to hear everybody's voice. I just want to ask a more holistic question, maybe just stepping back. you know, you had mentioned previously that, um, I, I believe is for value. One of the patients would be post, uh, autologous CAR T and stem cell therapy, uh, and, and, and correct me if I'm wrong. Um, can you give us an idea for Bali? And I think you mentioned this for, for Emily and then for Natalie, um, what line of patients generally are you recruiting, um, you know, for these, uh, for these studies right now? Um, and then secondly, I assume, you know, you have ongoing discussions with regulators. If you get to a recommended phase two dose, can you just kind of walk us through quickly what sort of dose expansion trials could we look forward to in these?
spk05: I know that could be, you know, there might be some hypotheticals there, but it'd be nice to get an idea. Thank you.
spk09: Thank you, Hartaj, for the questions, and I'll give them to Mark.
spk15: Thanks, Hartaj. Good to hear you. In terms of the first question, in terms of the studies, what we did, you know, these patients are all heavily, heavily pretreated. And so what, you know, what we've disclosed for 22 from the obvious prior two ashes where we presented are a lot of these patients fail 19 directed therapy. at least some Blinitumab, some Blinitumab CD19 autologous CAR T-cells, as well as inotuzumab, as well as allogeneic stem cell transplant. They really truly have no other treatment options for a lot of these patients due to all the lines of therapy that they failed. For 123, It's very similar because AML, as you know, very aggressive, very refractory in these patients once they relapse. And they fail multiple different chemotherapeutic regimens, you know, some small molecule targeted regimens, and almost, you know, greater than almost three quarters, two-thirds to three quarters have failed an allogeneic stem cell transplant. And those that haven't failed a transplant, have been such that they've been refractory and haven't had a significant response to even go on to transplant. So, again, this is the kind of, you know, heavily pretreated patients we're seeing for 123 as we presented before. And with 20 by 22, as we just discussed, again, these are going to be patients that are going to be heavily pretreated and they will be an additional line, at least one additional line beyond their first CD19 directed therapy. In terms of your second question, again, this is stuff that's currently being discussed with the regulators. You know, what we have, you know, what we have disclosed, obviously, the all study will be open to young adults and older adults and down to the age of 12 once we get into expansion from the pediatric perspective for 123 it's obviously right now it's adults 18 and 18 to 65 and for 20 by 22 it's also in the adult space but we are eight um with 18 to 80, and currently, as we've discussed, the logical first expansion cohort is in the large B-cell lymphoma space due to the, just due to the incidence, the high incidence.
spk05: Great. Thank you, Mark. Really appreciate all the color.
spk10: Our next question comes from Jack Allen with Baird. Please proceed with your question.
spk17: Great. Thank you for taking the questions, and congratulations on all the progress in the quarter. I guess the first question, I just wanted to confirm, you mentioned the ASGCT presentation of the AML data will be an encore presentation. Will there be any additional follow-up of patients in that presentation, or will it just be more of an encore as it relates to ASH? And then as it relates to 20 by 22, you've made a few comments that you're enrolling patients in the study, but I was wondering if you could provide some additional thoughts around the dose levels that you've reached and what we should think about as it relates to data readouts as we move through the year from the 2022 program. Thank you so much.
spk09: Hi, Jack. Thank you so much. And these are great questions for Mark.
spk15: Hi, Jack. Thanks for your question. So, yes, in terms of the ASGCT oral for 123, it will be an encore of the ASH presentation. with the data cutoff used for ASH. For 20 by 22, as we've discussed before, we expect to disclose first in human data for this study later this year. So we'll go through the first patients that have been treated.
spk02: Great. Thanks so much.
spk10: Our next question comes from Sylvain Turkin with JPM Securities, JMP Securities. Please proceed with your question.
spk07: Good morning and thanks for taking my question. I have a question about your manufacturing capabilities. So clearly you can manufacture fully in-house in the US and in Europe at this point. Are there any access capacities that you could potentially monetize in the short term or Will you just kind of fully use that for yourself? Thank you.
spk09: Hi, Sylvain. Great question. And I think that one would be for André.
spk06: Well, first of all, we're extremely proud of our manufacturing capacity. And I think that it was a blessing that the strategy that we took initially, it was like before COVID. to integrate all the chain of manufacturing, meaning like from buffers to DNA to RLVs to the final product, even for commercial that has been internalized. And the more it goes, the more internalizing things. And I don't know in which position we would be if we wouldn't have taken this decision previously. But the second thing that we're excited about is this year, as Mark is saying since the beginning of the cold, is uh present you the data with the data the product that has been manufactured internally in the performance of our manufacturing now if this manufacturing is essentially for internal use we're always open to manufacture for our partners but select this is not positioning itself as a potential cmo and this is not our business, and there is like an offer that is given by a series of CMOs outside. Now, if there's a potential to monetize this, there's always, this option is always open, but we don't think that it's something that must be discussed today because of the opportunity of this, but it's definitely an asset that Slate has, and it's a very strong asset that we would like to keep internal so far. I think that makes a big difference, and there is two categories of cell and gene therapy companies, the one that know how to manufacture the prologue and the others, and selectives is among the first category that I think would distinguish themselves.
spk02: Thank you. Thanks for the question.
spk10: Our next question comes from Ingrid Gassano with Garnier. Please proceed with your question.
spk14: Hi, thank you for taking my questions. Good morning, good afternoon. I have two questions, if I may. So the first one, you mentioned that you have to change the trade name of allantozumab in the context of your trials. Could you just remind us how the regulatory landscape might look like? Do you have to, you know, allantozumab is an approved product. Is that enough for the agencies? Or do you have to do something in parallel to get this approved? as liquid-depression regimen together with your cells. And my second question is regarding the next EIB change from the EIB loan. When do you roughly expect, time-wise, to have access to that one? Thanks.
spk09: Okay. Thank you, Ingrid. And maybe I can speak a little bit about the LM2Zoom app, given the partnership that we have with Sanofi, and then hand it over to Bing for the EIB. So, you're absolutely right, and in 2021, we signed a strong partnership with Sanofi on the supply of alimtuzumab, and as you know, alimtuzumab is already an approved product in other indications, so we definitely expect to leverage that and the agency's familiarity with that product. Of course, we'll have to demonstrate the importance of alimtuzumab in our CAR-T trials, which as Mark has highlighted, we have already done and disclosed data for UCAR-123 and UCAR-22. But we definitely expect that through our partnership with Sanofi and the agency's prior familiarity with alimtuzumab, the approach will be streamlined as opposed to a completely novel agent. And Bing for the EIB.
spk03: Great. Thank you, Ingrid, for the question. So first of all, I also want to highlight, and there was a question earlier on the cash runway, is the cash balance that we reported for Q1 does not include the 20 million euro tranche A of the EIB cash that came in, because that came in April. So that 20 million euro is not reflected in Q1 cash balance, and that's in tranche A. And your question regarding tranche B, You know, we have already satisfied the financial precedent conditions for tranche B, which is as a result of our equity raise in February and also as a result of the 50 million euro milestone payment that came in December of 2022. Now, when do we plan to draw on it? Depends on when we plan to issue the warrants for the necessary drawdown of the tranche B, which is 50 million euro. And that we have not made a decision at this point, but I just want to highlight that we have satisfied the present condition to draw on this 15 million euros.
spk14: Great. And if I may ask a follow-up thing. So your current cash guidance is somewhat risk-adjusting. Are you taking into account that you have access to the next trend, or is that not in your current plan?
spk03: So our cash guidance to the third quarter of 2024, assumes that we will draw down on tranche B of the European Investment Bank loan.
spk14: It's clear. Thank you very much.
spk03: Thank you for your question.
spk10: We have reached the end of our question and answer session. I would now like to turn the floor back over to Mr. Chulika for closing comments.
spk06: Well, thank you everyone for attending this earning call. We're extremely proud of what has been achieved so far. We think that 2023 and the next 12 to 18 months are going to be extremely rich, as has been described in this presentation, like event-rich for the company. And we're very excited by the product we're developing. We think that the company is focused more than ever. on its resources and great prologue that we're developing and we'll look forward for the next update. Thank you very much and wish you a great day.
spk10: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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