Cellectis - Q1 2023

Transcript

Operator (participant)

Good morning, everyone, and welcome to Cellectis' Q1 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 Stril, Chief Business Officer. Please go ahead, sir.

Arthur Stril (Chief Business Officer)

Good morning. Welcome everyone to Cellectis' first Q1 2023 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 Frattini, our Chief Medical Officer. Yesterday evening, Cellectis issued a press release reporting its financial results for the 3-month period ended March 31, 2023. The report and press release are available on our website at cellectis.com. As a reminder, we will make statements regarding Cellectis' financial outlook, in addition to its manufacturing, regulatory, and product development status and plans and product development of its licensed partners.

These forward statements, which are based on our management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners, are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Form 20-F, filed with the Securities and Exchange Commission, SEC, and the financial report, including the management report for the year ended on December 31st, 2022, and subsequent filings Cellectis makes with the SEC from time to time. I would now like to turn the call over to André.

André Choulika (CEO)

Thank you, Arthur. Good morning, and thank you everyone for joining us today. Cellectis 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 manufactured product candidate, UCART22, evaluated in the BALLI-01 clinical study. This is an important advancement for the Cellectis team, who has worked tirelessly to expand the BALLI-01 clinical study to Europe. UCART22 is currently the most advanced allogeneic 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 UCART product candidates completely in-house, 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 Cellectis.

Last month, we announced that we have implemented the use of Sanofi's alemtuzumab as a Cellectis investigational medicine product, coded as CLLS52, as part of the lymphodepletion regimen for UCART22 in the BALLI-01 clinical trial for UCART123 in the AMELI-01 clinical trial and for UCART20x22, the NATHALI-01 clinical trial. This follows the partnership and supplies agreement that we entered with Sanofi regarding alemtuzumab. 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 the efficacy in targeting triple-negative breast cancer. The data showed the capability of armored allogeneic MUC1 CAR T-cell with sophisticated gene edits to excel in the immune-suppressive tumor and 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 2 abstracts have been accepted at the upcoming American Society of Gene & Cell Therapy annual meeting. Cellectis will present clinical data on the AMELI-01 clinical trial in evaluating UCART123 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-cell. Those presentations will take place on May 17th in Los Angeles. This quarter, Cellectis 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 EUR 20 million under the finance contract for up to EUR 40 million credit facility made with European Investment Bank in December 2022. Cellectis plan to use the net proceeds of the funds to focus on the development of its pipeline of allogeneic CAR T-cell product candidates, UCART22, UCART20x22, and UCART123, and decided to stop enrollment of treatment of patients with UCARTCS1. To accelerate the speed of enrollment of patients in the MELANI-01 study evaluating UCARTCS1. The company would have had to invest meaningful amount of resources. Therefore, to optimize its resources, Cellectis decided to focus its development efforts on the BALLI-01, AMELI-01, and NATHALI-01 studies and stop MELANI-01.

Lastly, based on our current plan, we anticipate our cash runway to take us into the Q3 of 2024. We're excited about the drive in our clinical trials, building on the momentum of our lead product candidate in our pipeline and upcoming milestones for 2023. With that, I would like to turn the call over to Dr. Mark Frattini, our chief medical officer, who will give us an overview of these clinical trials. Mark, please go ahead.

Mark Frattini (Chief Medical Officer)

Thank you, Andre. As Andre mentioned, we have made progress in our BALLI-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 BALLI-01 clinical study, a phase 1/2a open-label study designed to evaluate the safety and clinical activity of the product candidate in patients with relapse refractory B-cell acute lymphoblastic leukemia. The last preliminary data presented in a live webcast last December support the continued administration of UCART22 after FCA lymphodepletion in patients with relapse 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 BALLI-01 study is actively enrolling patients after FCA lymphodepletion. Our AMELI-01 study evaluating UCART123 in patients with relapsed/refractory AML continues to progress and enroll patients in the FCA 2-dose regimen arm. We look forward to sharing clinical data from this program when it becomes available. I'll move on to our MELANI-01 clinical trial, our CS1-directed TALEN gene-edited allogeneic CAR T-cell product candidate being evaluated in patients with relapsed or refractory multiple myeloma. As André 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 MELANI-01 study evaluating UCARTCS1. I will speak about our NATHALI-01 study evaluating UCART20x22.

UCART20x22 is Cellectis' first allogeneic dual CAR T-cell product candidate being developed for patients with relapsed or refractory B-cell non-Hodgkin lymphoma. UCART20x22 is also the first product candidate Cellectis has designed, developed, and manufactured completely in-house. The advantage of UCART20x22 is that it goes beyond the highly competitive CD19 antigen-directed therapy space by providing a dual antigen, CD20 and CD22, targeted allogeneic alternative. Cellectis is now enrolling patients in the NATHALI-01 trial. As André mentioned, Cellectis announced that we have implemented the use of Sanofi's alemtuzumab as a Cellectis investigational medicinal product coded as CLLS52 as part of the lymphodepletion regimen in the BALLI-01, AMELI-01, and in the NATHALI-01 clinical trials.

As previously reported, the importance of alemtuzumab in the lymphodepletion regimen was demonstrated in our BALLI-01 and AMELI-01 studies, where the addition of this lymphodepletion agent to the fludarabine and cyclophosphamide regimen was associated with sustained lymphodepletion and significantly higher CAR 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, Cellectis' Chief Financial Officer, for an overview of our financials for the Q1 of 2023. Bing, please go ahead.

Bing Wang (CFO)

Thank you, Mark Frattini. I will provide a brief overview of our financials for the Q1 of 2023. I would like to highlight that our financials, the cash equivalent, and restricted cash position of Cellectis, excluding Calyxt, as of March 31st, 2023, was $88 million, compared to $95 million as of December 31st, 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 closed in February. This cash position is expected to be sufficient to fund Cellectis standalone operations into the Q3 of 2024.

On January 13, 2023, Calyxt, CBIS, and certain other parties entered into a merger agreement pursuant to which Calyxt and CBIS will merge in an all-stock transaction. Following the closing of the proposed Calyxt merger, Cellectis S.A. is expected to own approximately 2.4% of the equity interest of the combined company. Accordingly, if the proposed Calyxt merger is consumed, it will result in the loss of control over Calyxt and Calyxt no longer be a consolidated subsidiary. The closing of the proposed Calyxt merger is expected in the Q2 of 2023. In this context, Calyxt is presented as discontinued operations in the financial statement for the year 3-month period ended March 31. The net loss excluding Calyxt was $20 million in the 3 months of 2023 compared to a loss of $28 million in the 3 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 Cytovia's convertible note loss in fair value and an increase of other operating expense of $1 million. The net loss attributable to shareholders of Cellectis, including Calyxt, was $30 million, or $0.58 per share in the 3 months of 2023, compared to a loss of $32 million or $0.70 per share in the 3 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 of Cellectis of $1 million. The adjusted net loss attributable to shareholders of Cellectis, including Calyxt, which excludes non-cash stock-based compensation expenses, was $28 million or $0.55 per share in the three months of 2023, compared to a loss of $29 million or $0.64 per share in 2022. The tranche A of EUR 20 million 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 facilities 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, André.

André Choulika (CEO)

Thank you, Bing. 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, Cellectis continuously leverages gene editing and a series of breakthrough innovation into clinical development in order to transform the lives of patients with cancer and rare genetic diseases, we look forward to continuing this effort in the Q2 of 2023 and beyond. With that, I would like to open the call for Q&A.

Operator (participant)

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from Gena Wang with Barclays. Please proceed with your question.

Gena Wang (Managing Director and Senior Equity Research Analyst)

Thank you for taking my questions. I have three very quick one. First one is UCART123. You will present data at the ASGCT. The abstract looks similar versus last ASH. Wondering what kind of a new data we will see at the ASGCT. The second question is the UCART22. 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? What will be the plan for next steps? Lastly, very quickly for Bing, you know, according to the cash guidance, should we expect largely flat quarter-over-quarter burn?

Bing Wang (CFO)

Hi, Gena. Thank you so much for these great questions. We'll start with Mark for the first two on UCART123 and UCART22 and then Bing for the financial question.

Mark Frattini (Chief Medical Officer)

Thanks. Thanks Gena, for the question. In regards to your first question about UCART123, yes, there is an oral presentation at ASGCT coming up in a couple of weeks, and it is an encore presentation of the ASH 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 second question about UCART22, yes, there is a full DLT waiting period of 28 days between the first and second patient, but subsequent patients can be enrolled simultaneously. We will be updating the UCART22 data later this year as well.

André Choulika (CEO)

Hi, Gena. Regarding the cash burn question, yes, quarter-over-quarter burn should be flat for the rest of this year.

Gena Wang (Managing Director and Senior Equity Research Analyst)

Thank you very much.

Operator (participant)

Our next question comes from Yanan Zhu with Wells Fargo. Please proceed with your question.

Derek Archila (Managing Director and Senior Equity Research Analyst)

Hi. Thanks for taking our question. This is Kwan for Yannan. Back to UCART22, can you comment on how your in-house product performs compared to the previous product so far?

Arthur Stril (Chief Business Officer)

Hi, Kwan. Great question. That would be for Mark as well.

Mark Frattini (Chief Medical Officer)

Hi. Thank you for the question. Yeah, as you know, we are currently enrolling both in the EU and the US with our completely in-house manufactured UCART22 product. As I said from the previous question, we will be updating that data later this year.

Derek Archila (Managing Director and Senior Equity Research Analyst)

Got it. Another question on alemtuzumab. I wonder if you can comment on how adding alemtuzumab may affect the overall safety. Thank you.

Mark Frattini (Chief Medical Officer)

Sure. So as we've already presented at ASH, prior, two times with the 22 product and last December with the 123 product, the alemtuzumab 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 alemtuzumab. Those were very equivalent.

Derek Archila (Managing Director and Senior Equity Research Analyst)

Got it. Last question, very quick. For the two-dose regimen, given that some literature suggest patient's disease burden may affect the grade of CRS, is it the company's plan that you would adjust the dose level based on patient's disease burden? Thank you.

Mark Frattini (Chief Medical Officer)

Yeah, great question. With the 2-dose regimen, as we discussed in December, We began enrollment with a dose level, 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. The regimen is 2 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.

Derek Archila (Managing Director and Senior Equity Research Analyst)

Got it. Thank you so much.

Operator (participant)

Our next question comes from Yigal Nochomovitz with Citigroup. Please proceed with your question.

Yigal Nochomovitz (Director)

Yeah. Hi. Thanks. Just a few questions. Could you just comment on the level of enthusiasm for enrolling the UCART20x22 program, please?

Arthur Stril (Chief Business Officer)

Mark?

Mark Frattini (Chief Medical Officer)

Sure. Thanks, Yigal, for the question. There's an extreme enthusiasm for this study from all the investigators that have the study open so far. They're very excited to proceed with this dual allogeneic CAR T-cell, and in particular because it does not involve CD19, so it's out of the 19 space.

Yigal Nochomovitz (Director)

You mentioned for UCART22 you completed the 28-day EOC period. Can you comment any further on the safety that was observed in that initial period?

Mark Frattini (Chief Medical Officer)

Yeah. 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.

Yigal Nochomovitz (Director)

Okay. Then with regard to MELANI-01, is the reason for that because you just had difficulty competing with the BCMA bispecifics? Is that why? Or is there a different reason?

Arthur Stril (Chief Business Officer)

Yeah. thanks, Yigal. Andre, do you wanna take this one first?

André Choulika (CEO)

Hi, Yigal. Yes. It's definitely the competition between all the products that are currently in either approved or in clinical development makes our enrollment very difficult. What we're getting currently in the trial are patients, as we've shown in the past, with multiple lines of treatment. Also we need to remanufacture the product. That initially the current product that we were using was essentially manufactured at CellforCure, and we think that it's essential to manufacture ourselves products. We see it with 22 and 20x22. It makes a huge difference. The arbitration has... Like, either you open more sites and probably outside the United States or you can get the thing going or you try to focus, and focus has been the choice in the current conditions.

Yigal Nochomovitz (Director)

I see. Thank you.

André Choulika (CEO)

Given the drive we have for UCART22 and UCART20x22 and of course UCART123.

Yigal Nochomovitz (Director)

Okay. Got it. Thanks.

Operator (participant)

Our next question comes from Salveen Richter with Goldman Sachs. Please proceed with your question.

Salveen Richter (Managing Director and lead equity research analyst)

Hi, this is Anupam Vaziri on for Salveen Richter. 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 and CAR-T in the multiple myeloma space? Are there any patients that have been dosed already from this program? Would we see data from those patients? Just a quick follow-up on CD 20 by 22. I guess, you know, are you targeting mostly the CD19 naive or CD19 relapse patients? In that context, what clinical profile are you looking to achieve relative to, you know, the approved CD19 thirty therapies or allo's CD19 program? Thank you.

Arthur Stril (Chief Business Officer)

Hi, Anoumid. Thank you very much for the question. I'll leave the first question on CS1 to André and then, Mark for Twenty by Twenty-Two.

André Choulika (CEO)

Thank you very much for the question. Well, 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 your CAR T CS1 can provide meaningful tumor reduction and had some patient that went into. It's not a CR because the M protein is still quite high, but in VGPR, or Mark will correct me concerning this, but we definitely think that it's a great target. 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.

Of course, if we have the potential to change the course of this, especially if we have, like, 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 product that are developed. It's a validated target with elotuzumab. It's self-limited depleting, so it's great its own space. There is a lot of features that are extremely interesting, but you have to remanufacture the product entirely given the performance of our group currently. This is something we would like to focus on the current driver in the company, which are 22, 20 by 22, and 123. Mark?

Mark Frattini (Chief Medical Officer)

Okay. Thanks, André. I'll go to the Twenty by Twenty-Two question. Yes. Patients that have had prior CD19-directed therapy of any variety, are eligible for this study. In addition, patients that obviously could not receive CD19-directed therapy for one reason or another are also eligible for this study.

Salveen Richter (Managing Director and lead equity research analyst)

Thank you. Just, a follow-up. What target profile are you hoping to achieve with this program? Thank you.

Mark Frattini (Chief Medical Officer)

you know, right now, it's, it would be considered as an additional line past CD19-directed therapy.

Operator (participant)

Our next question comes from Kelly Shi with Jefferies. Please proceed with your question.

David Windley (Managing Director & Healthcare Equity Research Analyst)

Hi. This is Dave for on for Kelly Shi. I have a couple of questions. One is, you mentioned runway into Q3 of 2024. I just wanted to make sure, does it include any milestone payments? Also, any thoughts on doing two-dose regimen for UCART22? Thank you.

Arthur Stril (Chief Business Officer)

Hi. Thank you for the question. So Bing for the runway, and then Mark, for the two-dose regimen on 22.

André Choulika (CEO)

Yes. We've included some probability adjusted, I would say a pretty conservative large part, on the milestone to provide that, runway guidance to Q3 of 2024.

Mark Frattini (Chief Medical Officer)

For the second question about 22. Right now the trial is structured obviously as a single-dose regimen, which we will, you know, continue to evaluate as we move forward.

David Windley (Managing Director & Healthcare Equity Research Analyst)

Thank you.

Operator (participant)

Our next question comes from Hartaj Singh with Oppenheimer. Please proceed with your question.

Hartaj Singh (Senior equity research analyst)

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, I believe it was for BALLI-01, the patients would be post autologous CAR T and stem cell therapy, and correct me if I'm wrong. Can you give us an idea for BALLI-01, and I think you mentioned this for AMELI-01 and then for NATHALI-01?

What line of patients generally are you recruiting, you know, for these, for these studies right now? Secondly, I assume, you know, you have ongoing discussions with regulators. If you get to a recommended phase 2 dose, can you just kind of walk us through quickly what sort of dose expansion trials could we look forward to in these? I know that could be, you know, there might be some hypotheticals there, but it'd be nice to get an idea. Thank you.

Arthur Stril (Chief Business Officer)

Thank you, Hartaj Singh, for the questions, and I'll give them to Mark.

Mark Frattini (Chief Medical Officer)

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 pre-treated. What, you know, what we've disclosed for UCART22 from the obvious prior to ASH where we presented are a lot of these patients fail CD19 directed therapy, at least, you know, some blended tumor maps, some blended tumor map CD19, autologous CAR T-cells, as well as inotuzumab, as well as allogeneic stem cell transplant. They really, truly, really have no other treatment options for a lot of these patients due to all the lines of therapy that they failed.

For UCART123, it's very similar because AML is, you know, very aggressive, very refractory in these patients once they relapse. They fail multiple different chemotherapeutic regimens, you know, some small molecule targeted regimens and almost, you know, greater than almost Q3, Q2-Q3 to Q3 have failed an allogeneic stem cell transplant. 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. Again, this is the kind of, you know, heavily pre-treated patients we're seeing for UCART123, as we presented before.

With 22, 20x22, as we just discussed, again, these are going to be patients that are going to be heavily pre-treated and they will be an additional line, at least 1 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 UCART123, it's obviously right now it's adults 18-65.

For UCART20x22, it's also in the adult space, but we are with 18 to 80. Currently, as we've discussed, the logical first expansion cohort is in the large B-cell lymphoma space just due to the incidents, the high incidents.

Hartaj Singh (Senior equity research analyst)

Great. Thank you, Mark. Really appreciate all the color.

Operator (participant)

Our next question comes from Jack Allen with Baird. Please proceed with your question.

Jack Allen (Senior Research Analyst)

Great. Thank you for taking the questions, 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, in that presentation, or will it just be a more of an encore as it relates to ASH? As it relates to 20x22, you've made a few comments that you're, you know, 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 20x22 program. Thank you so much.

Arthur Stril (Chief Business Officer)

Hi, Jack. Thank you so much. These are great questions for Mark.

Mark Frattini (Chief Medical Officer)

Hi, Jack. Thanks for your questions. Yes, in terms of the ASGCT oral for UCART123, it will be an encore of the ASH presentation with the data cutoff used for ASH. For UCART20x22, as we've discussed before, we expect to disclose first in human data for this study later this year. We'll go through the first patients that have been treated.

Jack Allen (Senior Research Analyst)

Great. Thanks so much.

Operator (participant)

Our next question comes from Silvan Tuerkcan with JMP Securities. Please proceed with your question.

Silvan Tuerkcan (Senior equity research analyst)

Good morning, thanks for taking my question. I have a question about your manufacturing capabilities. Clearly you can manufacture fully in-house in the U.S. and in Europe at this point. Are there any excess capacities that you could potentially monetize in the short term, or do you just plan to fully use that for yourself? Thank you.

Arthur Stril (Chief Business Officer)

Hi, Silvan. Great question, and I think that one would be for André.

André Choulika (CEO)

Well, first of all, we're extremely proud of our manufacturing capacities, and I think that.

Blessing that the strategy that we took initially, it was like before COVID, to integrate all the chain of manufacturing. It means like from buffers to DNA to RLVs to the final product, and even for commercial that has been internalized. The more it goes, the more internalizing things. I don't know in which position we would be if we wouldn't have taken this decision previously. The second thing that we're excited about is this year, as Mark is saying since the beginning of the call, is present you the data with the product that has been manufactured internally and the performance of our manufacturing. If this manufacturing is essentially for internal use, we're always open to manufacture for our partners.

Selecta is not positioning itself as a potential CMO, and this is not our business, and there is like an offer that is given by series of CMOs outside. If there is a potential to monetize 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. It's definitely an asset that Selecta 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 cellular and gene therapy companies, the one that know how to manufacture the product and the others. Selecta is among the first category that I think would distinguish themselves.

Silvan Tuerkcan (Senior equity research analyst)

Thank you.

André Choulika (CEO)

Thanks for the question.

Operator (participant)

Our next question comes from Ingrid Gafanhao with Kempen. Please proceed with your question.

Ingrid Gafanhao (healthcare equity research analyst)

Hi. Thank you for taking my questions. Good morning. Good afternoon. I have 2 questions, if I may. The first one, you mentioned that you have changed the trade name of alemtuzumab in the context of your trials. Could you just remind us how the regulatory landscape might look like? You know, alemtuzumab is an approved product. Is that enough for the agencies, or do you have to do something in parallel to get this approved as lymphodepletion regimen together with your cells? My second question is regarding the next EIB tranche from the EIB loan. When do you roughly expect time-wise to have access to that one? Thanks.

Arthur Stril (Chief Business Officer)

Okay. Thank you, Ingrid, maybe I can speak a little bit about the alemtuzumab given the partnership that we have with Sanofi and then hand it over to Bing for the EIB. You're absolutely right, in 2021, we signed a strong partnership with Sanofi on the supply of alemtuzumab. As you know, alemtuzumab is already an approved product in other indications, we definitely expect to leverage that and the agency's familiarity with that product. Of course, we'll have to demonstrate that the importance of alemtuzumab in our CAR-T trials, which as Mark has highlighted, we have already done and disclosed data for UCART123 and UCART22.

We definitely expect that through our partnership with Sanofi and the agency's prior familiarity with alemtuzumab, the approach will be streamlined as opposed to a completely novel agent. Bing for the EIB.

Bing Wang (CFO)

Great. Thank you, Ingrid, for the question. First of all, I also wanna highlight, there was a question earlier on the cash runway, is the cash balance that we reported for Q1 does not include the EUR 20 million tranche A of the EIB cash that came in, because that came in April. That EUR 20 million is not reflected in Q1 cash balance, that's in tranche A. 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 EUR 50 million milestone payment that came in December of 2022.

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 EUR 50 million. That we have not made a decision at this point, but I just wanna highlight that we have satisfied the precedent condition to draw on this EUR 50 million.

Ingrid Gafanhao (healthcare equity research analyst)

Great. If I may ask a follow-up, Bing. Your current cash guidance is somewhat risk adjusting or taking into account that you have access to the next tranche, or is that not in your current plans?

Bing Wang (CFO)

Our cash guidance through the Q3 of 2024 assumes that we will draw down on tranche B of the European Investment Bank loan.

Ingrid Gafanhao (healthcare equity research analyst)

It's clear. Thank you very much.

Bing Wang (CFO)

Thank you for your question.

Operator (participant)

We have reached the end of our question and answer session. I would now like to turn the floor back over to Mr. Choulika for closing comments.

André Choulika (CEO)

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 12-18 months are gonna be extremely rich, as being 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 product that we're developing, and we'll look forward for the next update. Thank you very much, and wish you a great day.

Operator (participant)

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.