Cellectis Q1 2023 Earnings Call Transcript

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May 5, 2023

There are 13 speakers on the call.

Operator

Good morning, everyone, and welcome to Selecta'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 Strel, Chief Business Officer.

Operator

Please go ahead, sir.

Speaker 1

Good morning, and welcome everyone to Selective's Q1 2023 corporate update and financial results conference call. Joining me on the call today with prepared remarks are Doctor. Andre Schulichap, our Chief Executive Officer Doctor. Bing Wang, our Chief Financial Officer And Doctor. Marc Fratini, our Chief Medical Officer.

Speaker 1

Yesterday evening, Selectus issued a press release reporting its financial results The 3 months period ended March 31, 2023. The report and press release are available on our website at selectus.com. As a reminder, we will make statements regarding Selecta's 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 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 20 F filed with the Securities and Exchange Commission, SEC and the financial reports, including the management reports For the year ended on December 31, 2022, and subsequent filings selected makes with the SEC from time to time.

Speaker 1

I would now like to turn the call over to Andre.

Speaker 2

Thank you, Arthur. Good morning and thank you everyone for joining us today. Leclis 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, UCART T22, evaluated in the BALA-one clinical study. This is an important advancement for the selected team who has worked tirelessly to expand the BALI-one clinical study to Europe.

Speaker 2

UCART T22 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 T product candidate 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 Selective. Last month, We announced that we have implemented the use of Sanofi's onintuzumab as a selective investigational medicine product Coded as ELLS-fifty 2 as part of the lymphodepletion regimen for UCART-twenty 2 in the BALI-one clinical trial For UCART T123 in the AML1 clinical trial and for UCART T20x22, the NAFLD clinical trial. This follows the partnership and supplies agreement that we entered with regulatory regarding elantuzumab.

Speaker 2

This quarter, we were proud to present encouraging preclinical data at the American Association For Cancer Research Annual Meeting on tailing edited MUC1 CAR T cell to enhance efficacy in targeting triple negative breast cancer. The data showed the capability of armored allogeneic Mucorn 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 2 abstracts have been accepted At the upcoming American Society of Cell and Gene Therapy Annual Meeting, select us will present clinical data on the AMLA-one clinical trial Eligarwait and 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 17 in Los Angeles.

Speaker 2

This quarter, I'd like to announce the closing of the global offering of $25,000,000 profit depository shares Launched in February, the net proceeds of the global offering is approximately $22,800,000 Finally, in April, we announced that the drawdown of the first tranche of the EUR 20,000,000 under the finance contract For up to EUR 40,000,000 credit facility made with European Investment Bank in December 2022, Select is planned to use the net proceeds of the funds to focus on the development of its pipeline of allogeneic CAR T cell product candidate, UCART T22, UCART T20x22 and UCART T123 and decided to stop enrollment of Treatment of patient with UCART TCS1. To accelerate the speed of enrollment of patients In the MELANIE-one study evaluating UCART TCS1, the company would have had to invest meaningful amount of resources. Therefore, to optimize its resources, Glactose decided to focus its development efforts on the VAL-one, AMOLED01 and NAFLED01 studies and stop Melanin-one. Lastly, based on your current plan, we anticipate Our cash runway to take us into the Q3 of 2024. We are excited about the drive in our clinical trials, Building on the momentum of our lead PRINT robot candidate in our pipeline and the upcoming milestones for 2023.

Speaker 2

With that, I would like to turn the call over to Doctor. Marc Fretic, our Chief Medical Officer, who will give us an overview of these clinical trials. Mark, please go ahead.

Speaker 3

Thank you, Andre. As Andre mentioned, we have made progress in our BALLY-one 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 BALLY-one clinical study, A Phase IIIa open label study designed to evaluate the safety and clinical activity of the product candidate in patients with relapsedrefractory 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 relapsedrefractory 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 VAL-one study is actively enrolling patients after FCA lymphodepletion.

Speaker 3

Our AMALY-one study evaluating UCART123 in patients with relapsedrefractory 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 Next, I'll move on to our melanio-one clinical trial, our CS1 directed Talend gene edited allogeneic CAR T cell product candidate being evaluated in patients with relapsed 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 treatment of patients in the MELANIE-one study evaluating UCART CS1. Lastly, I will speak about our NATALI-one study evaluating UCART 20x22. UCART 20x22 is Selectus' 1st allogeneic dual CAR T cell product candidate Being developed for patients with relapsed or refractory B cell non Hodgkin lymphoma.

Speaker 3

UCART 20x22 is also the 1st 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 NATALI-one trial. Lastly, as Andre mentioned, CELLECTUS announced that we have implemented the use of Sanofi's alemtuzumab as a CELLECTUS investigational medicinal product Coded as CLLS52 as part of the lymphodepletion regimen in the BOLI-one, AMALI-one And in the NACELI-one clinical trials. As previously reported, the importance of alemtuzumab in the lymphodepletion regimen was in our BOLI-one and AMALI-one 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.

Speaker 3

With that, I would like to hand the call over to Doctor. Bing Huang, Selectus' Chief Financial Officer, for an overview of our financials for the Q1 of 2023. Bing, please go ahead.

Speaker 4

Thank you, Mark. I will provide a brief overview of our financials for the Q1 of 2023. I would like to highlight that our financials, the cash, cash equivalents and restricted cash position of Selectus, excluding Calyxt, As of March 31, 2023 was $88,000,000 compared to $95,000,000 as of December 31, 2022. This difference mainly reflects $30,000,000 of cash out, which includes $6,000,000 of payments for R and D expenses, $4,000,000 for SG and A Suppliers, dollars 15,000,000 for staff costs, dollars 4,000,000 for rent and taxes, $1,000,000 of reimbursement of the PGE loan and a $23,000,000 net cash inflow from the capital raise closed in February. This cash position is expected to be sufficient to fund selected standalone operations into the Q3 of 2024.

Speaker 4

On January 13, 2023, Calyxt, CBIZ and certain other parties Entered into a merger agreement, pursuant to which, Calyxt and CBIZ will merge in an all stock transaction. Following the closing of the proposed Calyxt merger, Selectus S. A. Is expected to own approximately 2.4 percent of the equity interest of the combined company. Accordingly, if the proposed Calyxt merger is consumed, It will result in a loss of control over Calyxt and Calyxt no longer be a consolidated subsidiary.

Speaker 4

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 $20,000,000 in the 3 months of 2023 compared to a loss of 28,000,000 The $500,000 decrease in net loss between 20232022 Was primarily due to a decrease of $4,000,000 in purchases and external expense as a result of quality and manufacturing internalization, A decrease of $3,000,000 in personnel expenses due to headcount rationalization and almost fully offset an increase of net financial loss of $5,000,000 due to Cytovia's convertible note loss in fair value And an increase of other operating expense of $1,000,000 The net loss attributable to shareholders of Selective, including Calyxt was $30,000,000 or $0.58 per share in the 3 months of 2023 compared to a loss of 32,000,000 or $0.70 per share in the 3 months of 2022. This $2,000,000 decrease in net loss between 2023 And 2022 was primarily driven by a decrease of net income from discontinued operation Attributable to shareholders of Selectus of $1,000,000 The adjusted net loss attributable to shareholders of Selectus, including Calyxt, which excludes non cash stock based compensation expenses was $28,000,000 or $0.55 per share In the 3 months of 2023 compared to a loss of $29,000,000 or $0.64 per share in 2022.

Speaker 4

The tranche A of €20,000,000 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 and A spend. Back to you, Andre.

Speaker 2

Thank you, Ben. To close out this call, I would like to reiterate how excited we are about the continued progress of our clinical trial And the upcoming milestones for 2023. Pioneering this field, Selective 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 Q2 of 2023 beyond. With that, I would like to open the call for Q and A.

Operator

Thank you. We will now be conducting a question and answer session. Our first question comes from Gena Wang with Barclays. Please proceed with your question.

Speaker 5

Thank you for taking my questions. I have 3 very quick ones. First one Is UCAR-one hundred and twenty three, 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?

Speaker 5

And the second question is the UCAR-twenty two, since you complete the first patient complete 28 day Dose limiting talks period, any additional waiting period for you in order to dose next patient and what will be the plan for next steps? And lastly, very quickly for Bing. According to the cash guidance, should we expect largely flat Quarter over quarter, Boon?

Speaker 1

Hi, Gina. Thank you so much for these great questions. So will start with Mark for the first two on 123 and 22 and then Bing for the financial question.

Speaker 3

Thanks. Thanks, Gina, for the question. So in regards to your first question about 123, yes, there is an oral presentation at ASGCT GCT coming up in a couple of weeks, and it is an encore presentation of the ASH presentation 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 2022, Yes.

Speaker 3

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 2022 data later this year as well.

Speaker 4

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

Speaker 5

Thank you very much.

Operator

Our next question comes from Yan Xu with Wells Fargo. Please proceed with your question.

Speaker 6

Hi, thanks for taking our question. This is Quan on for Yanan. So back to UCART 22, can you comment on how your in house product performs compared to the previous product so far?

Speaker 1

Hi, Juan. Great question. That will be for Mark as well.

Speaker 3

Hi. Thank you for the question. So, Yes. As you know, we are currently enrolling both in the EU and the U. S.

Speaker 3

With our completely in house manufactured UCART22 product. And as I said from the previous question, we will be updating that data later this year.

Speaker 6

Got it. And another question on alemtuzumab. I wonder if you can comment on how Adding alemtuzumab may affect the overall safety? Thank you.

Speaker 3

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 It's 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 Whereas 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.

Speaker 6

And last question, very quick. For the 2 dose regimen, given that some literature such as Patients' disease burden may affect the grade of CRS. Is it The company's plan that you would adjust the dose level based on patients' disease burden? Thank you.

Speaker 3

Yes, great question. So with the 2 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 this study. And so the regimen is 2 doses of dose level 2 that are given during the study. And the hypothesis going in obviously is that with the second dose They 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.

Speaker 6

Got it. Thank you so much.

Operator

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

Speaker 7

Hi, thanks. Just a few questions. Could you just comment on the level of enthusiasm for enrolling That's the UCART 20 by 22 program, please.

Speaker 3

Mark? Sure. Thanks, Yigal, for the question. So There is an extreme enthusiasm for this study from all The gators 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.

Speaker 6

Okay. And

Speaker 7

then you mentioned for UCART 22, you completed the 28 day ELC period. Can you comment any further on the safety that was observed in that initial period?

Speaker 3

Yes. So for, as we said, for the 'twenty two, there'll be a data update later this year about the patients enrolled with the P2 That we will disclose at that time.

Speaker 7

Okay. And then with regard to Melanie-one, Is the reason for that because you just had difficulty competing with the BCMA bispecifics? Is that right or is there a different reason?

Speaker 1

Yes. Thanks, Yigal. Andrey, do you want to take this one first?

Speaker 2

Hi, Gal. 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 We manufactured the product that initially the current product that we were using was essentially manufactured by self secure And we think that it's essential to manufacture ourselves Prolox. We see it with 22 and 20 by 22. It makes a huge difference.

Speaker 2

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.

Speaker 7

I see. Thank you.

Speaker 2

Given the drive we have for 2022 and 20 by 22 and of course 1, 2, 3.

Speaker 6

Okay. Got it. Thanks.

Operator

Our next question comes from Salveen Richter

Speaker 8

Jen, 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 of the 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, 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 the approved CD19 therapies or Allo's CD19 program.

Speaker 8

Thank you.

Speaker 1

Hi, Numeet. Thank you very much for the question. I'll leave the first question on CS1 Andre and then Mark for 20 by 20 2.

Speaker 2

Yes. 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 TCS1 can provide like meaningful tumor reduction And like had some patient that went into it's not a CR because like the M protein was still quite high, but in 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.

Speaker 2

And I think that is healthy for the company. But 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 and So it's self limiting to depleting, so it's great to own space. So there's a lot of features that are extremely interesting, but you have to remain factor 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 2022 by 2021, 2023. Mark?

Speaker 3

Okay. Thanks, Andre. So and I'll go to the 20 by-twenty 2 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

Speaker 8

Thank you. And just, a follow-up, what Target profile are you hoping to achieve with this program? Thank you.

Speaker 3

Right now, it would be considered as an additional line past CD19 directed therapy.

Operator

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

Speaker 9

Hi, this is Dave on for Kelly Shee. 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 2 dose regimen for UCART22?

Speaker 6

Thank you.

Speaker 1

Hi. Thank you for the question. So Bing

Speaker 4

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

Speaker 3

And then for the second question about 22, so right now the trial is structured obviously as a single dose

Operator

Our next question comes from Hartaj

Speaker 10

Good to hear everybody's voice. I just want to ask a more holistic question, maybe just stepping back. You had mentioned previously that, I believe is for VALU-one, 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 Bali, and I think you mentioned this for Emily and then for Nathalie, what line of patients generally are you recruiting for these studies right now? And then secondly, I assume you have ongoing discussions with regulators.

Speaker 10

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 There might be some hypotheticals there, but it'd be nice to get an idea. Thank you.

Speaker 1

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

Speaker 3

Thanks, Hartaj. Good to hear you. In terms of the first Question in terms of the studies, what we did these patients are all heavily, heavily pretreated. And so what we've disclosed for 'twenty two from the obvious prior to ASH's where we presented are A lot of these patients fail 19 directed therapy, at least some blinatumomab, some blinatumomab CD19 Autologous CAR T cells, as well as inatumomab, as well as allogeneic stem cell transplant. So 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.

Speaker 3

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, Some small molecule targeted regimens and almost greater than almost 3 quarters 2 thirds of 3 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 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 Discuss with the regulators, what we have 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 to 65. And for 20 by 22, it's also in the adult space, but we are 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.

Speaker 10

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

Operator

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

Speaker 11

Great. Thank you for taking the questions and congratulations on the whole 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 And that presentation will just be more of an encore as it relates to ASH. And then as it relates to 20 by-twenty 2, you've made a few

Speaker 7

comments that you're enrolling patients in the study, but I was wondering if you could provide

Speaker 11

some additional thoughts around 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

Speaker 2

so much.

Speaker 1

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

Speaker 3

Hi, Jack. Thanks for your questions. So, yes, in terms of the ASGCT oral for 123, it will be an on of the ASH presentation with the data cutoff used for ASH. For 20 by 'twenty 2, as we've discussed before, we expect to disclose 1st in human data for this study later this year. So we'll go through the first patients that have been treated.

Speaker 2

Great. Thanks so much.

Operator

Our next question comes from Silvan Turkan with JMP Securities, please proceed with your question.

Speaker 11

Yes, 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 U. S. And in Europe at this point, are there any access capacities that you could potentially Tyson, in the short term or will you did you just plan to fully use that for yourself?

Speaker 11

Thank you.

Speaker 1

Hi, Sylvain. Great question. And I think that one would be for Andre.

Speaker 2

Well, First of all, we're extremely proud of our manufacturing capacities. And I think that it was 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 RVs 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 Same since the beginning of the call is present you the data with the product that has been manufactured Currently in the performance of our manufacturing.

Speaker 2

Now if this manufacturing is essentially for internal use, We're always open to manufacture for our partners, but Selectus 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 there is 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's latest 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 2 categories of cellular and gene therapy companies. The one that know how to manufacture the Prolog And the others and select this is among the first category that I think would distinguish themselves.

Speaker 2

Thank you. Thanks for the question.

Operator

Our next question comes from Ingrid Gassana with Garnier. Please proceed with your question.

Speaker 12

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 changed the trade name of alintuzumab in the context of your trials. Can you just remind us how the regulatory landscape might look like?

Speaker 12

Do you have to no, alantizumab 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 depletion regimen together with yourselves? And my second question is regarding the next EIB, a change from the EIB loan. When do you roughly expect time wise You have access to that one.

Speaker 12

Thanks.

Speaker 1

Okay. Thank you, Ingrid. And maybe I can speak a little bit about the Tuzumab, given the partnership that we have with Sanofi and then hand it over to Bing for the EIB. So you're absolutely right. In 2021, we signed up a strong partnership with Sanofi on the supply of alemtuzumab.

Speaker 1

And as you know, alemtuzumab 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 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, but 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. And Bing for the EIB?

Speaker 4

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 €20,000,000 Tranche A of the EIB cash that came in because that came in April. So that €20,000,000 is not reflected in Q1 Cash balance, and that's in tranche A. And your question regarding tranche B, 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 €50,000,000 Milestone payment that came in December of 2022.

Speaker 4

Now when do we plan to draw on it? It depends on when we plan to Issue the warrants for the necessary drawdown of the tranche B, which is €15,000,000 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 €15,000,000

Speaker 12

Great. And if I may ask a follow-up. So your current cash guidance is Somewhat risk adjusted, you're taking into account that you have exited next tranche or is that not in your current plans?

Speaker 4

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

Speaker 12

It's clear. Thank you very much.

Speaker 4

Thank you for your question.

Operator

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.

Speaker 2

Well, thank you everyone for attending this earnings call. We're Really proud of what has been achieved so far. We think that 2023 and the next 12 to 18 months are going to be 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

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

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