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Earnings Call: Q2 2021

Aug 6, 2021

Speaker 1

Greetings. Welcome to the Selectus Second Quarter 2021 Earnings Call. At this time, all participants will be in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded.

At this time, I'll now turn the conference over to Eric Duthang, Chief Financial Officer. Eric, you may now begin.

Speaker 2

Thank you, and welcome, everyone, to Selectus' 2nd quarter 2021 corporate asset and financial results conference call. Joining me on the call today with prepared remarks is Doctor. Andres Schulikar, our Chief Executive Officer Doctor. Carrie Bernstein, our Chief Medical Officer and Steve Doris, our Senior Vice President of U. S.

Manufacturing, will be joining for the QNS. Yesterday evening, Selective filed its interim report and issued a press release reporting our financial results for the 2nd quarter 6 month period ending June 30, 2021. The reports and press release are available on our website at selective.com. As a reminder, we'll make forward looking statements regarding Selective's financial outlook in addition to its manufacturing, Regulatory and Product Development Plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasts.

A description of these risks can be found on our most recent Form 20 F filed with ATTC and the financial report for the year ending on December 31, 2020, and subsequent filings Selective makes with the SEC from time to time. Now I would like to turn the call over to Andre.

Speaker 3

Thank you, Eric. Good morning, and thank you, everyone, for joining us today. Despite challenges the world is facing, Selective set a series of key milestones and we are incredibly grateful I'm proud of all the hard work achieved by our team, our partners and our stakeholders. During the first half twenty twenty one, we have made significant progress on all fronts that we're thrilled to share with you Over the next half an hour, today, we believe that Selectus is reaching a turning point And it's entering into new phase of its development, demonstrating excellence in clinical execution And acceleration of our internal product manufacturing of both new products and also New stock of existing products for expansion phases of our clinical program. Selective has enrolled patients In parallel, in the 3 sponsored Phase I dose escalation trial for our preclinical stage Wholly owned product candidate, UCART22 and VAL-one for relapsed refractory B cell lymphoblastic leukemia.

You'll call 123 and AMOLED01 for relapse for refractory acute myeloid leukemia and UCARTS-one and Melanie-one for relapsed or refractory multiple myeloma. During the Q2, we presented preliminary Translational data for the 1st group of patient enrolled for the Melanie 1 of QCAR TS1 at the Virtual American Society of Gene and Cell Therapy for the 24th Annual Meeting. Early preliminary data validate CS1 as a target for allogeneic CAR T cells in multiple myeloma. UCART CS1 expansion and persistence was observed and correlated with the Change in relevant serum cytokines and anti myeloma activity. Melanie-one trial is currently enrolling patients At dose level minus 1, the first of the 3 planned doses level.

We organized a virtual event called Selective Innovation Day that took place in May 2021. The event provides an inside look at Selective And was a huge success with great attendance through the week. We presented a clear view into our pipeline of new product candidates, Our gene editing platform, our electroporation technologies as well as our end to end State of the art internal manufacturing capabilities. These new immuno oncology product candidates include UCART 20 by 22, the first allogeneic dual CAR T cell candidate product for B cell malignancies. The power of cue card 2522 is that it is not yet another CD19 product.

CD19 is a no more crowded target space, and UCART 20x22 with the power of DuoCard Can address all patients with B cell malignancies, including the one not responding to the numerous CD19 targeting treatment. In addition, we also presented UCART's mezzled targeting mesothelin expressing solid tumors And UCART MUC1 targeted MuSK1 expressing epithelial cancer finally represented UCART FAB, A fairly innovative mechanism to pursue solid tumor through targeting cancer associated fibroblast, CAP, In the tumor microenvironment, which has the potential to turn a cold tumor hot, We plan to file INDs of Nucor 20x22 and Nucor Mezopolin in 2022. During these Innovation Days, we also introduced the market to Heal, our genome surgery platform for genetic diseases. The platform leveraged the power and the precision of tailing gene editing to perform We announced programs in sickle cell disease With zonal storage disorders and primary immune deficiencies. Heal's lead product candidate is tau globin01 for the treatment of sickle cell disease.

Tau globin01 is developed using both tailing technology To induce a double stranded DNA break on the mutation at the sickle cell disease, causing hemoglobin subunit beta HBV gene and an AAV that will be providing a DNA with Care matrix designed to correct the faulty HBV gene, the amorphous recombination. Selective plans to file an IND for If you are interested in watching Selective's Innovation Day's on demand episodes, You can get more information on our website, selective.com. In May 2021, Selective and Sanofi entered into partnership agreement and supply agreement regarding alemtuzumab, And then tied CD52 monoclonal antibody to be used as part of the lymphodepleting regimen in certain Selective sponsored Your Heart Clinical trials. Sanofi will supply palantuzumab to support Selective clinical trials, And we agreed to enter into discussion to execute the commercial supply of alemtuzumab under pre agreed financial conditions. In our Paris GMP manufacturing facility, Manufacturing of plasmids, starting material containing matrixes is now fully operational.

One very critical element was the production of messenger RNA coding payments That we are that are at the center of our gene editing approach. We are proud To announce that messenger RNA are now in production at Selectus, We finally remain on track for the manufacturing of viral vectors in the second half of twenty twenty one. In our Rally GMP manufacturing facility, We successfully completed 2 UCAR training runs from starting cells to vial drug product, And the cell and gene therapy space is a key success factor for all companies operating in this We believe that Selective is a state of the art biotechnology company with a product development process Nate Baster, from A to Z, including the construction of our proprietary electrosion devices To the production of buffers up to the vial final product ready to be injected. With that, I would like to hand the call over to Eric Dutton, Selective's Chief Financial Officer, for an overview of our financials for the quarter. Eric, please go ahead.

Speaker 2

Thank you, Andre. Before I provide a brief overview of our financials for the Q2 and the 1st 6 months of 2021, I'd like to highlight some of our business development activities in 2021. In particular, At the beginning of 2021, we announced our alliance with Cytovia, which includes up to $760,000,000 of development, Regulatory and set milestones, and we are eligible to receive single digit royalty payments on the net sales of all partners' products product commercialized by Cytoguan. In addition, we expect to receive an equity stake of $15,000,000 in Cytogia's debt We are on a cash payment of $15,000,000 if certain conditions are not met by December 31, 2020, 1 as well as an option to invest in future financing rounds. With respect to our alliance with Allogene, in 2021, We received a $5,000,000 milestone payment from the launch of its prior study of ALLO360 in renal cell carcinoma.

As a reminder, we are eligible to receive $4,000,000,000 in disclosed development and sales milestones, plus royalty and sales from our partner Allogene, Servier and Criteria. Regarding our financials, the cash cash equivalents, current financial assets and restricted cash position of Selective, Excluding Calyxt, as of June 30, 2021 was $238,000,000 compared to $244,000,000 as of December 20 20.20. This difference mainly reflects $59,000,000 of net cash flows used in operating, investing and refinancing activities, which were partially offset by $46,000,000 of net equity proceeds raised from the company's ATM program in April 2021 and $11,000,000 proceeds from the stock option exercise. This cash position is expected to be sufficient to fund Selective's The consolidated cash, cash equivalents, current financial assets and electric cash position of Selective, including Talix, It was $257,000,000 as of June 30, 2021 compared to 2.70 $4,000,000 as of December 31, 2020. The net cash flow used in operating capital expenditures and leases We're at $59,000,000 at Selective and $12,000,000 at Telix in the 1st semester of 2021.

The net loss attributable to shareholders of Selective, excluding Selective, was $43,000,000 in the 2021 compared to a net income of $3,000,000 in 2020, this 46,000,000 Dollar decrease in the net result between 2021 2020 was primarily driven by a decrease in revenue and other income of 20 $5,000,000 or an increase in R and D expenses of $19,000,000 The consolidated Net sales attributable to shareholders of Selective, including Calyxt, was $52,000,000 or $1.17 per share The Q1 of 2021 compared to $12,000,000 or $0.29 per share in 2020. The consolidated adjusted net loss attributable to shareholders of Selective, excluding non cash stock based compensation expenses, It was $48,000,000 or $1.08 per share in the 1st semester of 2021 compared to $4,000,000 or $0.09 per share in 2020. We are laser focused to spend our cash On developing our deep pipeline of wholly owned product candidates in the Philippines and operating our state of the art manufacturing facilities in Paris and in On the other hand, our focus on maintaining an efficient profile infrastructure should enable more limited growth in G and A expense. With that, I would like to hand the call back over to Andre for concluding remarks.

Andre, please go ahead.

Speaker 3

Thank you, Eric. At Selective, we continue to leverage our groundbreaking gene editing platform to develop Novel proprietary medicines to transform the lives of patients with serious diseases. Our current proprietary clinical stage programs Our focus on patients with advanced hematologic malignancies, and we continue to advance our robust pipeline into the clinic To tackle additional oncology settings, including solid tumors and to address the unmet medical means of patients with severe genetic diseases. We look forward to entering the clinic with the novel

Speaker 1

Thank you. At this time, we'll now be conducting a question and answer session.

Speaker 4

Thank you.

Speaker 1

Our first question comes from the line of Gena Wang with Barclays. Please proceed with your question. Thank

Speaker 5

you. Thank you for the comprehensive update. I have two questions. The first one is regarding You will have data later this year. Just wondering, should we expect that data at ASH?

And then what kind of data package Good evening presenting. And then second question is regarding your Heal, a new technology that seems very impressive. But so far, most of the indications are focusing on the ex vivo system. Just wondering if you have any thoughts to resist technology to the in vivo system?

Speaker 3

Hi, Gina. Thank you very much for these questions. Those are excellent questions, by the way. So my suggestion is maybe to have Carrie answering the first question and I'll take the second one. Carrie, please.

Speaker 2

Thanks, Andre.

Speaker 6

Yes. Hi, Gina. So we're aiming to present the data at ASH. So we don't know obviously How that will work after submission. As we pointed out last year, we started enrolling patients into the alemtuzumab And ARM, so the length of depletion that includes LM2 demand since we thought that would be more appropriate going forward.

And we would hope to be presenting that data with some cohorts by the end of the year.

Speaker 3

Thank you, Carey, for answering this first question. I'll take the second one. So Concerning GEO, GINA, we are, of course, focusing on gene editing To fix genes, so what is real genuine gene repair as we've shown us for the sickle cell disease program called TAUDAV001. And the idea that we have Today, we're trying to move stepwise. We have our first platform for gene therapy product That we'll be focusing on hematopoietic stem cells at first, and that's the first focus we have Because it would give us a lot of insight on the way it's functioning and also on the way we can conduct The quality control and the safety of the products in general and how the tail end can behave in It's followed itself for a long time.

So most of the products that we're developing today are based on the ex vivo platform It's an activate extent sales at first. And then we are currently working on the second phase Yes, we have not disclosed during this innovation date that I hope will be the new next generation product That will be in vivo. In vivo is part of Selective's strategy, of course. But once we'll have some very good ID and clearance on the safety and the efficacy of our technology ex vivo with HFC All the control and the quality that can be applied on these type of platforms because Good morning, Paul. Forward injection.

Then we'll move stepwise into INDiGO. You've seen Recently, a series of articles in Nature Magazine, etcetera, that shows that there are some Things we checked with such as X off target cleavage, kind of practice, etcetera, that can happen with Luzdorf's alternative gene editing technology, and we believe KLM is an extremely safe and efficient Technology to conduct invisible gene therapy and as tailings are vectorized in messenger RNA And messenger RNA is not a ribonucleoparticle. Most of computing technology, it Open some dates that are very powerful for the company, and we're very excited on moving forward In the ex vivo platform, that would definitely pave the way for the in vivo gene therapy that we have. So stepwise, it's definitely the way we'd like to move forward. I hope that answers the question.

Speaker 5

Yes. Thank you.

Speaker 3

Thank you, Gina.

Speaker 1

Next question is from the line of Michael Schmidt with Guggenheim. Please proceed with your question.

Speaker 4

Hey, guys. Good morning. Thanks for taking my questions. I had a big picture question first. So obviously, you have a lot Going on preclimetry with programs now spanning CAR T as well as genetic disease, etcetera.

I'm just wondering how you think about longer term your partnering strategy. Historically, you obviously had the collaboration with Pfizer and Servier on the CAR T side. I'm just curious how you think about partnering with a larger company going forward to perhaps

Speaker 3

Thank you very much, Michael, for this question. That is not a simple question because When I take the picture of the company in the past, so 2014 has been a very fruitful partner year as we signed 2 partnerships. In February 2014, Survey Partnership was licensed UCART T19 to survey for all We sell malignancies and we also everything that we're CD19 targeting. And Servier in 20 1, like end of 2015 licensed out The U. S.

Strives to Pfizer at this time. In June 2015, in 2014, We signed this agreement with Pfizer licensing out 13 targets 15 targets to Pfizer, including the CMA or I see the 70, etcetera. Pfizer decided later to spin out into A company called Allogene, and I've had also the CD19 rights in the U. S. And to date, I had the feeling that there was no criticism in our Selective The fact that we licensed our targets to 3rd parties and the potential that I believe it represents In time of power and execution, more resources and more As potential in developing these products, so I always see the further partnership and the Pfizer slash how it's in fire partnership as a huge potential for Selective even if CB19 and BCMA that we have considered are the most near risk targets that have been likened to them.

I don't think that it's So only as by BCMA in 'nineteen, I think that TRICAR-twenty two, TSR-twenty 19, 20 by 'twenty two, and also in SAB, MACH1, etcetera, will present a huge potential for Selective as a wholly controlled target for us, But also here, nevertheless, Selective has signed since then 2 partnerships. First one was In 2 months, it's creating a link to size with Iovance Circulate, and we believe that this partnership brings a lot of potential for Selective and also for Hi, Avan. In terms of the development of our genome editing technology and internal infiltrating windsurfers were not accepted in this field, And we teamed up with the best company in the world to develop tumor infiltrating the lymphocytes, and I believe that iovant is About to solve the problem they have and to like this quality stuff that I'll leave it to the Iovant team to answer the Also recently in the NK cells that are derived from IPS cells Car team, so entry cards that are going to be developed by Cartovia. So we're also very excited about this. On our own portfolio, we've been very much Focusing on trying to push them forward in the clinic as much as we can with the resources we have.

Nevertheless, We believe that Selective has the potential in partnering because there is some Option to develop some of these products and the potential of Selective in producing them with the manufacturing For clinical supplies, but also for commercial supplies, open the gate to a bigger biopharma partner in the future. And this is something we definitely consider that we remain very opportunistic in the field. And it depends on what can be considered in the Future and Selectus is definitely poised to consider any type of partnership in the field. I'm not going to emphasize on this because we are like curious of discussion and questions on this in this field. And We expect to remain very open, very opportunistic, but we will definitely continue also to self develop our own portfolio because we think that this will Right.

Probably the best value and consideration for the company in the future.

Speaker 4

Okay, great. Thanks, Andre. And then just one follow-up On TAR Global, this is obviously a very elegant and perhaps differentiated mechanism to address So, based on that, I guess, how would you expect the product clinical profile perhaps To differentiate from some of the other programs out there, be it gene editing or the gene therapy program.

Speaker 3

Thank you, Michael, for this question. Well, we have a series of different types of approaches. The first approach The classical gene therapy approach that is pursuing one of our competitors in this space You leave the sickle snobulins inside the cells and start to bring another gene That is going to start producing normal hemoglobin, but the sickle hemoglobin will remain a bit tall. This is random insertion of the gene inside the cell that can insert sometimes in well side Producers, the model of gene like beta HBV gene correctly, sometimes it will be inserted in some places where they're Simultaneous wobbling, so the expression will not be consistent or sometimes insertion could induce some side effects Into the metabolism of the cell that could be potentially harmful. So we consider that this Option, even though it's close to commercialization, will represent a window in the spectrum of Approaching power to hemoglobinopathies in general.

So I don't think that despite Classical transgenesis approaches without fixing the modeling will prevail. So it will be an intermediate. Yes, the second approach, which represents more the use of DNA figures. I'm not speaking Here, we've noted about gene editing because gene editing means everything detects So people consider that gene editing is getting into itself and that is the mistake. Most of these approaches are fixed on destroying a gene, which is BCL11A, which is a web presser that web presses the expression of cyclical hemoglobin.

So same case as before, You keep the cyclical hemoglobin inside itself, the problem remains the same. But you lift the expression of people's hemoglobin That could compensate for the sickling modulin inside the cell. So I destroy gene. I don't fix the problem. I just destroy gene To try to imbalance the way like the cell behaves, and that obviously works also.

But I also consider that this is going to be a parenthesis in the field, therapies in the field. And then you have Selective's approach, key approach, which is a bonafide gene editing approach. You have a mutation in the mangled in region. You get inside the cell. You clean the mutation itself And repair limitation was attached that we fix the G and A.

So really do True editing, it means you remove the mutation and the mutation will be removed from the cell and the normal physiological hemoglobin will be Expressing at this time in a very high and very efficient way. And this is what we believe would represent in the 21st century The future of these types of gene editing approaches, which are a true editing of the mutation inside the cell, Not trying to, for example, if you have flat tire, add the 5th tire to the car, but a real Fixing the June, it means we removed the flat tire and put the rear tire to the 4 tires to the car to move forward. That's the kind of comparison that we have here. And that we believe that these cells will behave totally normal with normal Adults and modular in IDINA. So Selectus is pursuing this approach to all 5 problems in 20 21, the first IND in the field 2022, sorry, not 2021.

In the field, of course, our stabilization in the field doesn't run that much. It requires a lot of Power, it means the ability to target very precisely the mutation in the hemoglobin B gene, Fitsing with a very high efficiency, the molecule being gene at a very high level results inducing some Thalassemic mutation, which is beta 0 modulates, the stronger modulate in itself. And at the end, Selectus, I think, has The best by far technology in this field, and that's why we believe that the pure platform is definitely changed again. It's a game changer in the field of Gene therapy and gene editing.

Speaker 4

Great. Thanks, Andre.

Speaker 1

Our next question is from the line of Kelly Hsieh with Jefferies. Please proceed with your question.

Speaker 5

Thank you for taking my questions. My first is about your new program targeting CD20 and CD22 simultaneously. I'm curious, What is the rationale to pursue this new targeting strategy? What are the expression levels relative to CD19 for these 2 antigens? And also how widely they are expressed?

Are they complementary to each other? And also another question is about You called CX-one program. For a long, the lymphopenia was observed in this program. And I wonder if this is caused by a CS1's ubiquitous expression not only to B cells, but on T cells, dendritic Sales and MK sales like other new sales. And how do you address this issue moving forward?

Thank you.

Speaker 3

Thank you so much, Kelly. I think these two questions definitely fits Carrie in space or Carrie to market for you. Okay.

Speaker 6

Absolutely. Both CD20 and CD22 are validated targets and And they're just as frequently, if not more, commonly expressed as MCD19. So as you All know rituximab, which is the ubiquitous treatment for all B cell malignancies, particularly for NHL, Is this target CD20? CD22 is similarly expressed. So there are and NHL is expressed in more than 90% of patients.

And the idea obviously of having 2 targets is number 1, you can prevent the antigen escape if you lose 1 or the other. You also have had increased synapses between the CAR T and the tumor cell, which should End up with a better expansion and because of The Synapse. So we think 2020 by 'twenty two is an excellent target for NHL. And it Can also be used in a broad B cell malignancy space because 202022 are expressed from early the early B cells through more mature. So that's the rationale for that.

And then in terms of CS1, so yes, we did see some prolonged in one of the patients. And theoretically, it could be due to the CS1 expression because as you point out correctly, CS1 is expressed on multitude of immune cells. But at this point, we don't know yet what We don't know exactly why the lymphopenia was as long as it is. We also know from autologous CAR Ts that are not And BCMA, so non CS1 expressing CAR Ts that people and patients who receive them can have prolonged lymphopenia out for 6 months. So and 6 months or more.

So it's unclear 100% if that's the reason. But that said, we've Our protocol, we have lower doses of the lymphodepletion, chemotherapy and monitoring for infectious causes and we'll keep moving with the program and see how things pan out.

Speaker 5

Thank you very much. It's very helpful.

Speaker 1

Next question is from the line of Yigal Markowitz with Citi. Please proceed with your question.

Speaker 4

Hi, great. Thank you very much for taking the question. I'm curious about the UCART MUC1 product candidate with multiple lates, which is a fascinating Product. And I'm curious about UCART Mark 1 specifically from an IP perspective. And the reason I'm asking is that there's another company Cariboo that recently went public It also has a product with the PD-one knockout in their C-nineteen CAR T product as well as a beta-two microglobulin knockout With an HLE knock in to provide immune cloaking, which appears also very similar to what you were doing with UCART MUC1.

So based on that, I'm just wondering where do you stand from an IP protection perspective with respect to some of these edits in UCART BUCK 1? Thank you.

Speaker 3

Thank you so much, Yigal, for this question. It's very much appreciated. I tend not so much to To commence the IT situation for obvious reasons, the fact is that Selectus has been long term In the field of gene editing, the company has been founded in 1999 in gene editing, there was a series of different types of With gene editing using at the basis negative lasers, We've been also just dropping series of different type of approaches with tailwind. Since 2013, Even March 2013, before Caribou, any type of company even had the I view us being inceptive at this time. We were already filing IP on the Crystal side.

So I strongly believe that Selective has a very strong position in this field, And we have very strong merit in developing these type of approaches. We can see the history of the company since at least 10 years in this field or I mean, years even if you want to take hold of history and become the 21 years. And all these ideas are sucking out All these deals and developing all the strategies in the product development, including Laquan and All the attributes that are included in that makes these The development of our patent portfolio strategy, extremely strong. That is the rationale. We're still all confident In the clinical or preclinical, the blocking phase.

And the thing will be So by the time the Q1 will start to be commercialized. So I guess all the space around alternative So computing technology that seems very easy to approach intellectually. I don't think that it's easier to approach Technically, but it seems to be more approachable intellectually will start to resolve at the time the first part That's coming to commercialization, and I think it's going to be a more different, more complex approach at this time. But for the time being, as we talked in the safe harbor situation, this thing seems to be quite simple for our competitor. So I will keep it here, but I think that Selective has a very one of the You know, only pretty like first company in the field of like developing gene editing tools in this space and a very I've got position in this space and we're not going to compromise on this field.

Speaker 4

Great. Thanks. And just one follow-up on an unrelated topic. Regarding your solid tumor strategy, how much can you say at this point regarding Which solid tumors you would tackle first, given your product candidates, the certain solid tumors that would make more sense To start with?

Speaker 3

The first target that we're probably going to the clinic is something that seems to be quite Already tackled the call of this CAR T, which is nuzaparin CAR, which We have a series of attributes in there, including TGF beta to our sector knockout. We'll be probably the 1st CAR T to be in the clinic.

Speaker 4

Got it. Thank you.

Speaker 1

The next question is from the line of Jack Allen with Baird. Please proceed with your question. Hi. Thank you so much for taking the questions. Congratulations on all the progress.

I guess to start, we're wondering if you provide some more color with respect to the Progress you're making with UCART T CS1. It sounds like based on the press release, you're still in the dose level of minus 1 cohort. Any color you can provide with The number of patients enrolled since the reinitiation of the study and when might the dose be able to escalate there? Thank you.

Speaker 3

Carrie, do you want to take this question?

Speaker 6

I can take the question. We're Progressing well in the clinic. I don't want to disclose specific numbers of exactly where we are and what we're doing. But what I can say is that We reopened after the hold with the changes I mentioned earlier. Most importantly was the lower dose of the lymphodepleting And starting at the level minus 1.

So those are the 2 big things. One of the other Requirements is also the FDA is requiring long safety watching periods. So we are the dose escalation is slow, but we have our sites on board. We have very, very active I was looking with patients and I don't foresee recruitment being an issue. What I see being an issue is the requirements Hold in between patients.

What I'm very optimistic about is as we gather more data, I'm being able to discuss it with FDA potentially in the future, moving and going faster if things are continuing to look safe, They're on to be continued.

Speaker 1

Awesome. That sounds great. And then, sorry, I just

Speaker 4

have one quick follow-up question.

Speaker 1

On the financial side, it appears you're pretty well lined up to receive a milestone from the Allogene and Sevyres by the end of the year due to the Initiation of pivotal CD19 program. I was wondering if you could provide any more color with respect to the size of that milestone and how you're going to And how you're going to account for it? Is it going to be a one time benefit to probably the Q4 this year? Or it will be amortized across a number of quarters? Thank you so much.

Speaker 3

Eric, this is a question for you.

Speaker 2

Thank you very much for the question. Depending on when Allogene will start The people studied, if they start at the end of in the Q4 of 2021, we recognize The revenue in terms of payment could be between end of 2021 or beginning of 2022 Based on the payment terms, but the revenue will be recognized in 2021. The

Speaker 3

size of the milestone has not been disclosed today, and it's still with confidential information. Sorry about that.

Speaker 1

No problem. Thank you so much for the answers. Thank you. The next question comes from the line of Hartaj Singh with Oppenheimer. Please proceed with your question.

Speaker 3

Great. Thank you for the question and the update. I just have a question on UCART 2022 and UCART neuGo. And that is, your current new dose for solid tumors 2022 is a cell to bispecific dual CAR T product. If you can just comment, Andre, on what are the sort of the differences in your preclinical and manufacturing between these two As you get them into the clinic next year, you're training with the IND, what are the different steps or maybe additional steps you've had to take With addressing a dual CAR T, another one that targets solid tumors.

Are there any? And if so, what are those? Thanks for the question. Thank you very much, Hartaj. Hi, Madhu.

Well, thank you very much for the question. So UCAR22, UCAR 123 and UCAR 20x22 are all based on the same Type of platform, so they're very similar, all of them, because they are built the same way. We have the car that is added by lentiviral vector or the dual part. So 123 and 2022 are built have the car that is embedded in the lentivial vector, Plus also our AWD, the C side switch. For 20 by 'twenty two, we'll remove the C side switch and replace it by Another call.

So we have 2020 and 2022 that are expressed in the same length. So it's pretty much the same. So we always add 1st length. Then we have a double knockout that happened, which is CD52 TCR alpha, same platform. So 'twenty two, 'twenty by 'twenty two, 1Q3, no difference.

Any kind of operator would not see even the difference. It's essentially the quality control that makes a difference. So like the build in the car is extremely similar And very much straightforward, and you know very well how to do it. Mezzotony, which is the first solid term car, is slightly different and requires Maybe one level up in terms of complexity because it adds a third knockout. So it's the Gulf and CAR CD52 TCR alpha plus TGS beta2 are knockout.

So it's a 3rd knockout that is added To the next year, which makes the things slightly more complicated, and you have to make a thorough Knockout theory in order to prevent some transportation. And I think Selective is mastering the The proportion technology because we're owning technologies there allow us to develop these type of Process in a very efficient way, and we're very excited to start with production of Envato and to fire the IND next year, not 2020 1, as I said it And a great honor. This is all very, very cool stuff. Just a general question, which is that your facility, Huawei, looks like they're able to run-in the first half. Like other companies do manufacturing days, are you thinking of doing something like that also for investors?

And again, if so, Thank you, Artag, for this question. The answer is yes. We have the plan to organize a live visit of our manufacturing In Raleigh, I think definitely it's worth the visit because we believe that's a state of the art 17 therapy manufacturing plant that combines not only gene addition, but also Gene editing was a very powerful way to do it. We're very sophisticated and modern way to produce So I'm going to be helping you in the space. So that will be organized probably in the Q3 of this year and the 3rd or Q4 actually like Probably in 3 months from now.

And we'll definitely send the save the date for all the investor and the highest community and everyone that would like to visit this facility The Twilby is setting the trend into what will be the modern way To do this part of characters in the future.

Speaker 5

Great. Thank you.

Speaker 1

Next question is from the line of Raju Prasad with William Blair. Please proceed with your question.

Speaker 5

Hi, this is Sami on for Raj. Thank you for taking our questions. I was wondering if you could provide an update regarding where you're at in enrollment and dosing in the UCART-one hundred

Speaker 6

and twenty three trial and when

Speaker 5

we could expect updated data from that trial? And then also for your solid tumor program, how are you guys thinking about lymphodepletion and dosing? Thank you.

Speaker 3

Well, thank you so much for these questions. And Carrie, I guess these questions are addressed to you. Sure.

Speaker 6

I'll start thanks so much. So I'll start with UCART-one hundred and twenty three. So as we had previously discussed at Earlier meetings, we remain in the dose escalation phase for UCART123. We had switched over To open the cohorts that include alemtuzumab earlier late Last year, and so those are continuing to enroll, and we're hoping to see some data, probably first half or Early second half of next year. In terms of the solid tumors, so we have the depletion as our first program, as Andre Pointed out would be the UCART V Go program, and that is utilizing the CD52 knockout.

So we would be Using similar length of depletion to what we're doing now for the hematologic malignancy program, But meeting is not exactly the same, but we would be using the Allen, Susan, our route with this product. And in terms of dosing, we haven't disclosed what we're doing with the doses at this time.

Speaker 1

Thank you. We've reached the end of our question and answer session. I'll turn the floor back to management for closing remarks.

Speaker 3

Well, thank you very much. I would like to thank everyone for attending this Q and A session. There was like excellent question. One of the things I'd like to say is that the company has definitely hit a turning point In the start of our own manufacturing, going from like DNA to messenger RNA to CAR T, the Really excited by the programs we have in the clinic, but also by the pro form programs we have either on the CAR T side, but also on the gene therapy and the Heal side, that marks a new trend in the company. Second half of twenty twenty two will be a very sunny time.

And by the end of this year, the company will start releasing a series of data and very exciting runway in 2022. So thank you very much for all your attention and looking forward to the next steps.

Speaker 1

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

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