Greetings. Welcome to the Selectus 4th Quarter and Full Year 2020 Earnings Call. At this time, all participants are 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 turn the conference over to Simon Harnas, Chief Investment Officer. Simon, you may begin.
Thank you, and welcome everyone to Selecta's 4th Quarter and Full Year Corporate Update and Financial Results Conference Call for the 2020 Fiscal Year. Joining me on the call today with prepared remarks are Doctor. Andrey Schulika, our Chief Executive Officer Doctor. Carrie Brownstein, our Chief Medical Sir, and Eric Douton, our Chief Financial Officer. Yesterday evening, Selectus filed its annual report and issued a press reporting our financial results for the Q4 and year ending December 31, 2020.
These reports and press releases are available on our website at selectus.com. As a reminder, we will make forward looking Statements regarding Selective's financial outlook in addition to its regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to A description of these risks can be found in our most recent Form 20 F filed with the SEC And the financial report, including the management report for the year ending on December 31, 2020, and subsequent filings Selectus makes with I would now like to turn the call over to Andre. Andre, please go ahead.
Thank you, Simon. Good morning and thank you everyone for joining us today. 2020 has been focused on advancing our company objectives. Despite the challenges the world is facing, Selective has achieved key milestones and we are Incredibly grateful and proud for all the hard work achieved by our team, our partners And our stakeholders during this challenging year. Strong of the progress we've made in 20, we are moving into 2021 determined on our commitment to a cure.
We are thrilled to share with you over the next half an hour this progress and our vision on an Citing future for CELLECTUS. In 2020, we fully entered into clinical development of our first 3 wholly controlled clinical programs. With our pioneering allogeneic UCAR T cell programs in ALL, AML and multiple myeloma, we are developing alternative targets through the overcrowded CD19 and BCMA landscape. We have already shared early data on our ALL program BALLY01 at ASH this past December. All three programs are currently enrolling patient in Phase 1 dose escalation trials And we are investigating differently for the depletion regimens.
While 2020 was an extremely challenging year with a significant impact on logistics, Selectus successfully completed The construction of our in house manufacturing facilities on time in Raleigh, North Carolina and in Paris, France. Both facilities are now up and running with a tech transfer between Paris and Raleigh happening in the first half of this year In order for Rally to start manufacturing GMP U CAR T cell batches in the second half of this year, Successful product development is highly dependent upon manufacturing from stable clinical supplies Drive the execution of our clinical plans to ensuring consistent quality and meeting regulatory expectations. Our facilities in Raleigh and Paris will allow us to achieve a large degree of manufacturing independence, Which is one of the most important value driver for any cell and gene therapy company. We expect to achieve this by year end and believe this step will propel Selective further And as we continue to lead this class of self therapy companies, our clinical execution Strongly accelerated during 2020 as we established a world class team of clinical experts From the CAR T cell and the hematology oncology space around our Chief Medical Officer, Doctor. Carrie Brown's team, who joined us from Celgene.
Carrie and her team have been instrumental in establishing a broad clinical presence For selectives within 7 of the top U. S. Hospitals, giving us an unprecedented access to large patient population from which to enroll into our clinical trials. In addition to expanding our general management And global manufacturing team with top talent, we appointed Mr. Jean Pierre Garnier I'd be the Chairman of the Board of Directors in November 2020.
Jean Pierre is a seasoned leader with decades of experience Within the global biopharma industry, most notably as the previous CEO of Blackstone SmithKline. From gene editing to CAR T cells, Flextis has always been a strong scientific leader in this space. As an example, Nature Magazine recently ranked top organizations in term of number of patent filed and owned in the CAR T cell space. In this ranking, Selectus became at the 4th institution worldwide just behind UPenn, BMS and Novartis, in the same publication among the top 20 CAR T cell inventors, 6th, so close to 1 third are from CELLECTUS. This is a great achievement overall.
We're also listed as the number one biotech company in the study. And this is just for CAR T and I'm not talking about gene editing. Yes. We are a leader in this field and we have plenty of followers. On the business development front, we're pleased about our recent agreement with Cytovia Therapeutics, which we announced last month.
This partnership leads us to expand our Talend gene editing platform into iPSC derived natural CAR cells and chimeric antigen receptor, so CAR NK cells for series of different tumor type will be responsible to develop custom tailwind, which will be used by Cytovia To edit iPSCs to be differentiated into NK cells addressing multiple gene target For therapeutic use in several cancer indications, Itopia will conduct the development of the mutually agreed upon therapeutic candidates and we will be eligible for up to $716,000,000 of development, regulatory and sales milestones as well as a single digit royalty payment on net sales. We will also receive an equity stake of $15,000,000 in Cytovia stock as well as an option to invest in future financing round, which will allow us to be part of Cytovia as a growing value driver. Together, With the research collaboration and exclusive worldwide license agreement with iOVense on gene edited tumor infiltrating lymphocytes, We announced last year this partnership shows the growing attraction and relevance of our Tailwind platform As the gene editing solution of choice for cell therapy, we're looking forward to see these next generation gene edited cell therapy programs Our partnerships with Allogene and SurVe are also gaining momentum and further At least establishing our growing allogeneic CAR T platform value.
Allogene presented initial data from the ALLO 715 program in relapsedrefractorymultiple myeloma at ASH in December 2020, The first data set ever presented on the allogeneic cell therapy targeting BCMA. In this initial data readout, 31 patients treated with ALLO-seven fifteen were available for safety and twenty Allogene is now moving into the next steps in the study, namely optimizing cell doses and lymphodepletion and plan to provide an update on ALLO-seven fifteen later this year. Allogene also initiated a cohort exploring ALLO-seven fifteen in combination with the gamma secretase inhibitor Neurogastate with their partner SpringWorks Therapeutics and is on track to submit an IND for ALLO 605, the first turbo cart targeting BCMA for multiple myeloma in the first half of this year. Regarding CD19, Allogene presented initial data on 22 NHL patients treated with ALLO-five zero one, of which 19 were available for efficacy. At ASCO 2020, in parallel to ALFA, Allogene ALLO-five zero one(eight) ALPHA-two trial is designed to enroll a homogeneous patient population focused on relapsed refractory LBCL and was recently granted fast track designation for the treatment of this population.
The ALPHA-two trial is designed to potentially move into pivotal Phase 2 trial Should the data support it, which would make us eligible for milestone payment, Allo will be Assessing the best course of action for pivotal trial in second half of this year, setting this product into a trajectory to potentially to become The first ever approved allogeneic CAR T cell candidate in the world. Finally, We're excited about the 3rd target license to allergy, CD70 entering the clinic this year with the TRAVERSE trial Evaluating ALLO-three sixteen in clear cell renal cell carcinoma. This is our 1st licensed allogeneic CAR T targeting solid tumors and were eligible for milestone payment for the first patient dosed. Inhibition to further de risking our allogeneic CAR T platform, our alliance with Servia and Allogene, our major value driver to select this. The agreement on CD19 was amended last year now makes us eligible And the licensing agreement with Allogene on 15 additional allogeneic CAR T targets makes us eligible to over $2,800,000,000 in potential future milestone per month, plus royalty and sales.
With that, I would like to hand the call over to Doctor. Carrie Brownstein, our Chief Medical Officer, for an overview of our proprietary clinical programs.
Thank you, Andre. I would like to start with our first proprietary product, UCART 22 are CD22 directed, Talend gene edited, allogeneic, off the shelf CAR T cell product candidate Currently being evaluated in patients with relapsed and refractory B cell acute lymphoblastic leukemia or B ALL. We presented preliminary data from patients enrolled in the first two dose levels of our Phase 1 dose escalation trial, BOLI01 at the American Society of Hematology Annual Meeting in December. This is the first publicly released data from CELLECTUS' BOLI-one clinical trial. As of the November 2, 2020 data cutoff, 7 patients were enrolled And 5 patients received UCART22 following lymphodepletion with fludarabine and cyclophosphamide or FC preconditioning.
One patient failed screening and one patient was discontinued prior to the administration of UCART22 due to an adverse event related to the lymphodepletion regimen. Importantly, no patient experienced dose limiting toxicity, Immune cell associated neurotoxicity syndrome, graft versus host disease, adverse events of special interest, nor grade 3 or higher adverse events or serious adverse events related to UCART22. No patient discontinued treatment due to a UCART22 related treatment emergent adverse event. 2 patients in dose level 1 achieved an objective response of complete remission with incomplete count recovery or CRI at day 28, One of which attained a complete remission or CR at day 42 and proceeded to hematopoietic stem cell transplant after subsequent therapy with enotuzumab. One patient in dose level 2 achieved a noteworthy reduction in bone marrow blast of 60% at screening to 13% at day 28 after treatment with UCART22 and subsequently progressed.
Host lymphocyte reconstitution was observed in all patients In the DLT period and correlative analysis of UCAR T cell expansion and persistence remains ongoing. We are encouraged that UCAR 22 demonstrated preliminary signs of activity at low dose levels with Fc lymphodepletion without unexpected nor significant treatment related toxicity. Our next step is to evaluate and optimize the cell dose and lymphodepletion in order to augment these early responses. We have added an arm to the trial in which we explore the addition of alemtuzumab, an anti CD52 antibody added to the Fc lymphodepletion regimen, which we call FCA, which is expected to result in a deeper and more sustained T cell depletion and thereby promote expansion and persistence of UCAR-twenty two cells. We are currently enrolling patients in dose level 2 with FCA And we plan to give an interim clinical data update on this cohort in the second half of this year.
Coming to UCART CS1, our CS1 1 directed, Helen gene edited, allogeneic CAR T cell product candidate being evaluated in patients with relapsed or refractory multiple myeloma. We collected preliminary translational data from the first group of patients enrolled last year and we plan to share an early look at this data in the first half of this year. Similar to BCMA, CS1 is a widely and consistently expressed target on the plasma cells of multiple myeloma. Interestingly, CS1 is also expressed on other immune cells, including T cells and NK cells. CELLECTUS is uniquely positioned to leverage this myeloma target because through the use of our gene editing technology, we are able to knock out CS1 from the T cells prior to inserting the CS1 directed CAR, which avoids T cell fratricide during manufacturing.
An additional differentiating factor is that our UCART CS1 cells self generate lymphodepletion through targeting CS1 expressing lymphocytes and thus do not require additional preconditioning with a CD52 directed antibody. While the FDA had placed a clinical hold on this program last year following a patient death in this level 2, which occurred towards the end of the Next is UCART-one hundred and twenty three, our CD123 directed, talent gene edited, allogeneic CAR T cell product candidate Being evaluated in patients with relapsed and refractory acute myelogenous leukemia. This program is addressing one of the highest unmet medical need population and the successful CAR T cell program in relapsed and refractory AML could be a significant paradigm shift for patients. Our current clinical product is an enhanced version of UCART-one hundred and twenty three, which includes updates to the manufacturing process and incorporates the CD52 knockout to allow the use of an FCA lymphodepletion regimen. We are currently enrolling in our Phase 1 dose escalation trial 2 study arms, 1 with Fc and 1 with FCA lymphodepletion.
Enrollment in both arms is ongoing and the data obtained will give us great insights Into the CAR T cell kinetics and host lymphocyte recovery using both strategies. We are looking forward to sharing this data from the program when available. Building on the technology platform of our current proprietary clinical program, I would like to add that we plan to submit INDs and initiate new clinical trials this year For novel proprietary product candidates targeting additional oncology indications as well as genetic disease setting. We look forward to sharing additional information in the near future. Our licensed allogeneic CAR T cell development programs are making great progress as well.
As Andre mentioned before, This year, we are expecting rich clinical data flow from Allogene and Servier from our licensed CD19 programs in relapsedrefractory NHL And from Allogene for the BCMA program in multiple myeloma at various medical meetings, further validating the allogeneic CAR T cell approach, which we invented and pioneered. With that, I would like to hand the call over to Eric, our Chief Financial Officer, for a more detailed overview of our business development activity. Eric, please go ahead.
Thank you, Carrie, and good morning. Before I provide a brief overview of Financials for the quarter year end, I'd like to spend a few minutes on some of our business development activities in 2020 and in early 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 sales milestones and we will also receive single digit royalty payments on the net sales of all partnered products Commercialized by Cytos.
We will
also receive an equity stake of $15,000,000 In Cytovia stock for an upfront cash payment of $15,000,000 if certain conditions are not met By December 31, 2021, as well as an option to invest in future financing rounds. In 2020, we announced our collaboration with Iovance and gene edited TILs With significant undisclosed development and sales milestones, plus royalties on sales, along with an amendment Of our partnership agreement with Sergier with up to $410,000,000 In development and sales milestones, plus low double digit royalties on sales. Further later, We will potentially receive in 2021 a milestone payment from the first pivotal trial Finally, as a reminder, We are also eligible to receive up to $2,800,000,000 in development and sales milestones, plus High single digit royalties and sales from Allogene related to 15 targets. We will potentially receive in 2021 a milestone payment from the launch of the TRAVERS trial of ALKELO 16 in renal cell carcinoma. Now on to our financials.
The cash, cash equivalents, current financial assets Enlisted cash position of Selective, excluding Calyxt, as of December 31, 2020, was $244,000,000 compared to $304,000,000 as of December 31, 2019. This difference mainly reflects $28,000,000 of proceeds Received from Sergier in the Q1 of 2020 and the receipt of $21,000,000 Debt guaranteed loans, which were offset by $102,000,000 of other net cash flows Used in operating, investing and lease financing activities. This cash position is expected to be sufficient To fund selected standalone operations into late 2022, this runway discounts any future milestone payments. The consolidated cash, cash equivalents, current financial assets and restricted cash position of Selective, Including Calyxt was $274,000,000 as of December 31, 2020 compared to $364,000,000 as of December 31, 2019. The net cash flow used in operating capital Expenditure and leases were $86,000,000 at Selective $44,000,000 at Calix in the full year of 2020.
The net loss attributable to shareholders of Selective, excluding Catalyst, was $54,000,000 in the full year of 2020 compared to a net loss of $75,000,000 in 2019. This $21,000,000 increase in the net results between 2020 2019 Was primarily driven by a significant increase in revenues and other income of $44,000,000 which was partially offset by an increase in SG and A expenses of $5,000,000 and a decrease in financial gains of $19,000,000 The consolidated net loss attributable to shareholders of Selective, including Calyxt, Was $81,000,000 or $1.91 per share in the full year of 2020 compared to 102 or $2.41 per share in 2019. The consolidated adjusted net loss Attributable to shareholders of Selective, excluding non cash stock based compensation expenses was $67,000,000 Or $1.77 per share in the full year of 2020 Compared to $79,000,000 or $1.86 per share in 2019. We are laser focused to spend our cash on developing our deep pipeline of polyolone product candidates In the clinic and operating our state of the art manufacturing facilities in Paris and in Wales. On the other hand, Our focus on maintaining an efficient corporate infrastructure should enable more limited growth in G and A spend.
With that, I would like to hand the call back over to Andre for concluding remarks. Andre, please go ahead.
Thank you, Eric. Again, we're very proud of the organization and team that we have built over the past years. We started treating the 1st patient pediatric ALL in 2015 under compassionate use protocol With the first ever gene edited allogeneic CAR T cell therapy, those babies Are now young kids in school and continue to be tumor free. This is what motivates us, Our entire team to get to work every day with the mission to save the lives and offer a treatment option To those cancer patients that have exhausted all other treatment options. Fast forward from 2015 to today, we now are fully integrated gene editing biotech company With 7 therapeutic development program in clinical trials, including 3 wholly controlled targets Based on our proprietary tail end gene editing technology.
To further expand our current clinical pipeline, We are in the middle of finalizing preclinical work on a series of new allogeneic CAR T cell targets and other product candidates. We strongly believe that our proprietary cell and gene therapy platform combined with our in house manufacturing facility Our broad clinical pipeline will lead to paradigm shift in the cancer therapeutics and cell therapies in general, With that, I would like to open the call for Q and A.
Thank you. At this time, we'll now be conducting a question and answer session. To allow as many as possible to ask questions today, please limit yourself to one question and one follow-up. Thank you. And our first question is from the line of Michael Amit with Guggenheim, please
proceed with your question.
Hi, guys. Good morning. Thanks for taking my question. I actually had a question Around your investment into the Car and K space as part of the Cytovia collaboration, I was just curious if you could share maybe how the Cytovia technology and approach Together with your talent approach, how that might differ or compare to what others are doing in the CAR NK space? And Longer term, how you think CAR NK cell products might be positioned relative to CAR T products within oncology indications?
Thank you so much.
Thanks, Michael. I appreciate the question and thanks for joining us this morning. This is Simon. Very good question. We make very selective business development deals with very high quality technology partners.
We want to be very selective, as I said, because there is just such a wealth of new technologies coming into the market, and we Cytovia is one of the best partners in the iPSC derived NK cell space. So that's obviously a space that catches a lot of momentum currently, And we can make a significant difference here by adding our Talend GeneEdit. And this collaboration is also Positioned more as an investment for Selective due to the fact that we actually have an equity stake in the company rather than an upfront cash payment. So we are very encouraged by the progress of the company so far, and we're continuing to be very excited about the growth that can come out of this collaboration. As we said, we have obviously over $700,000,000 in development milestones, regulatory milestones, some sales But for us, it's much more interesting to actually make a significant change to improve with gene editing What is a very wonderful scientific platform on the iPSC derived NK cell front.
So for us, it's a foray into this This will include some solid tumor targets as well, but without taking the focus and resources away from us to focus Our off the shelf CAR T cell treatments, which we think have the best shots on goal for the targets that we're pursuing. And Andre, feel free to add anything.
Well, it's in fact something that is important for us because there is a lot of selection among all the gene editing technologies and we see more and more people that are focusing on tailwind interest Because of the performance of the technology and the quality of the cells comes out plus Selectus is a one stop shop in the field of gene editing. It means we have the proliferation technologies, we have The tailwind technologies, we have other gene editing technologies and we have a huge amount of experience in handling cells and editing them. On the fact between NK, T cells, etcetera, Selectus is focusing on T cells, Cytovia is focusing on NK. We cannot be on all fronts and we believe very strongly that the focus that we have on primary T cells It is very promising and very straightforward currently because of the successes that we are starting to see In the field, Dan K, we believe in them. We think Cytoga is the best partner to do it, but we don't think that selective should spread itself into all directions.
Why in the T cell space we like primary cells for the simple reason that T cells are more Of cocktail than NK cells, there is of course like different type of NK cells, but in the space of T cells, it's CD8, CD4s, So it's a cocktail that is part of the know how of Cellectis and how to extract this From a leukotak of healthy donor and that's also not within the reach of immediate reach of Filing product on something that would be a sophisticated product in there. Now, we believe in the iPSC T and the stem cell differentiation and something that we are very excited about the technology of Cytovia Yes, that comes out from very prestigious labs on the West Coast and we think that it's going to deliver very strong results at the end.
Okay. Thank you.
Our next question comes from the line of Gena Wang with Barclays. Please proceed with your questions.
Thank you. I also have one question regarding Cytovia partnership. Just wondering if any color you can share with the initial targets? And also will SEKOVIA All selectors be responsible for manufacturing? And second question is regarding the CS1, UCAR CS1.
I know your Clinical hold lift was much faster or earlier than expected. Can you give a little bit more color what FDA Worth looking for and then what was the modification of the protocol going forward for the program?
Yes. Hey, Zena. Thank you so much for the wonderful questions. Maybe I can take the first part of the question and then I'll direct it over to Carrie, who is our Chief Medical Officer, who can answer a little bit of the background on the CS1 program. So for Cytovia, they will be Responsible for the manufacturing of their NK cell programs, we provide the technology for them needed to make the gene editing part, which is a pretty straightforward System that we have perfected in house and which we have already provided for example, Iovance's Till programs Gene editing approaches there, so it's a similar setup.
We haven't given too much color around the targets. Obviously, the Company is still a private company and has the benefit to move forward without disclosing those targets too early, but the mix of solid and liquid tumor targets. And Carrie, maybe you will talk a little bit about PS1. Thank you so much.
Yes. Hi, Gina. Nice to hear you. So yes, we were really pleased with the lifting of the hold back in the fall. And as we had previously disclosed To everyone, the hold initially was due to a patient death at dose level 2 during the dose limiting toxicity window.
We are planning on sharing data, hopefully very soon, from these first group of patients from last year prior to the hold. And with that, we will be providing additional details on what we were what we've done to reopen the study.
Our next question is from the line of Salveen Richter with Goldman Sachs. Please proceed with your questions.
Good morning. Thanks for taking my questions. I was just wondering if you could provide us with some timelines for The program the new programs moving into the clinic, be it genetic diseases, as you mentioned, or you're Looking to file INDs or these natural killer iPSC cell programs?
Yes. Hi, Salveen. Thank you so much. So first of all, the timelines for our new INDs That Carrie mentioned briefly on the call, this is something we will talk much more about this year as we're progressing towards IND filings. What we do want to show is that we have been quiet for the last couple of years on our preclinical development and our gene editing platform, while at the same time actually making a lot of progress on that front.
And we would really like to show The Street What is under the surface at Selectus? Because we are a world leading gene editing company with a platform in T cells internally. We have partnerships with leading companies in NK Cells, in TILT, and we have a gene therapy program that we would like So really put front and center as a new pillar of value for the company. But for us, the biggest focus and time lines this year is it's getting very Starting with our clinical development of our current proprietary CAR T program, we are advancing this through the dose escalation phases that we mentioned. So We expect some very interesting data flow out of our current clinical programs and then we expect new IND filings within 12 months.
So bear with us just a little longer. I think we'll give more Information in the segment Q3 of this year as we're getting really close to these IND filings.
Thank you.
Our next question is from the line of Hartaj Singh with Oppenheimer. Please proceed with your question.
Great. Thank you for the question and all the progress. Just one question, you know, some of the new companies and out in the field of problems locating things as simple as pipettes, also plasmids, mRNA etcetera, a lot of it seems to be vacuuming up into the COVID-nineteen space. Andre, how are you positioned with your Paris and your Raleigh facility in this regards also being autonomous by the end of this year? And then I just have a
quick follow-up after that. Thank you. Thank you very much Hartaj for the question. I think it's an important question. And We took the decision in 2018 to start constructing our manufacturing plant and we take it took a decision Was to split in order to go fast on the first phase and because the second phase would be longer.
So So the first phase was essentially to build up the manufacturing plant fully GMP to manufacture DNA, plasmids, mRNA for the tailing and vectors to bring the CARs inside the cells. And that's operational since 2020 and start producing. Imagine in 2020 With the COVID crisis, trying to order an mRNA with what's happening in there, even a plasmid, etcetera, It's becoming a real complication and when I'm saying that Selectus is full integration kind of one stop shop, it goes like from the idea at the bench And so we can manufacture everything, all the raw materials to make a CAR T Like plasmids and Synterna, you can immediately have them. We have all the quality system around this. We have all the vectors, all the mRNA, everything is shipped to Raleigh.
Riley is going to go operational this year and the cell and gene therapy is becoming a more and more tense market. And the fact that we can build everything internally, including sometimes the buffer, but the preparation technologies are ours, so we can tune up All the little details around this, I believe today in 2021, it's one of the biggest strengths And it differentiated the company very strongly.
Great, great. Thank you, Andre. And then just a quick question on UCART-1 hundred and twenty three. I think last year with the new IND, you had mentioned You'd be looking at patients with maybe a better performance status, maybe a slightly younger group of patients, And there might be a little bit more of a window between the core between doses. Has that changed?
Are you still sort of going through those initial Phases of that escalation protocol. Thank you for all the questions.
Hey, Hartaj. Maybe I can take it and I can hand it over to Carrie. So we're currently dosing patients at dose level 2 at the arm of addition of alemtuzumab to the preconditioning cycle. So we actually do 2 arms of the study in parallel, 1 with sluSI and one with sluSI Plus alemtuzumab. And Teri, maybe you'd take over here for the patient population we're treating and the dose escalation plan forward.
Yes. So thanks for the question. So as Simon points out, we have 2 arms now open in Trial and we're evaluating using alemtuzumab or not using alemtuzumab in this patient population. And I think it's important Point out and you make that clear, patients with AML are somewhat, I don't know if unstable is the right word, but it's a tough group of patients to crack. They tend to be older.
They tend to have poor performance status, etcetera. So it's really critically important to look at preconditioning using alemtuzumab or not because alemtuzumab Can sometimes add its own issues, so we want to be sure. That said, in terms of their performance status, the protocol, if any, allows People with relapsed refractory disease, we have some eligibility built in to ensure that patients We're enrolling patients that should be able to tolerate any side effects that we would expect like cytokine release, etcetera. But that said, as I said, patients with AML tend to be Unpredictable. What I'm very comfortable with and proud of is we have a really strong medical team, particularly in the a space that I've been building since I joined early last year, and we're very close with our investigators.
We're very close and Speak with them regularly and discuss the patients and go over all of their criteria to ensure that we all think that this is the appropriate study for those patients. So I feel confident that we're enrolling patients that can tolerate our product, so we can get some answers in this very difficult to treat patient
Great. Thank you. Our next question is from the line of Yigal Nochomovitz with Citigroup. Please proceed with your question.
Hi, great. Hi, Andre, Simon and Carey. Thank you very much for taking the questions. I just had one on UCART22. Could you clarify what you mean by the correlative analysis of cell expansion and persistence?
Do you mean correlation of cell expansion persistence with response? And will this analysis determine whether you need to adjust the lymphodepletion regimen? And then a separate financial question. Could you just comment where you stand with respect to your stake in Calix? Is that something you would consider selling To further finance the company.
Thank you. Yes.
Thank you, Gal. Maybe first question for Carey, and I can start with the second question really quick. So for Calyxt, we're over 50% shareholder in the company. We love what the company is doing. They actually have what we believe is a very strong period of growth ahead of them.
So Please monitor their earnings call as well that just happened last night or yesterday. It's a wonderful company with scarcity value because It's the only publicly traded gene editing company in the agriculture space currently, with a full focus on sustainability and improving Crops in the ag space for consumer consumption, it's again something that we don't expect to divest Anytime soon. Carrie, if you want to answer the question on 2022. Thank you.
Yes, sure. Thanks so much. So, correlative analysis are basically all of our translational work where we're going to be looking at the lymphocyte recovery, the subsets T, NK, B cell subsets as they come back and correlating that with our expansion data on the cells, on the UCAR cells as well as efficacy. And we're looking at that very closely to help us understand what our best foot forward will be, whether or not we need to make any additional adjustments to the preconditioning, etcetera, so we can give these UCART cells the best chance of success.
Okay. Thank you very much.
You're welcome. Thank you.
Our next question is from the line of Wang Chi Lee with Ladenburg. Please proceed with your questions.
Hi, thanks for taking my question. I have two questions, 2. The first one is regarding the new Programs you expect to file R and D this year. And Carrie mentioned also there's a new direction for genetic disease. So my question is, can you provide more color in terms of the number of New IND this year, is this one program, multiple programs?
And for the genetic disease, can you provide any more color on What kind of direction or space in terms of assuming the ex vivo approach for genetic disease? Any color would be helpful. And then the last question is on the KAR NK partnership. Can you provide us some high level color on The target is going to will it be not overlapping with your current CAR T targets or is it allowed to For some same targets?
Thanks, Wangzhi. Very good questions. I will have to say short answer for the Question, we will provide more color on our programs that are previously undisclosed in the Q2 of this year. So We will give you all the details then. And just rest assured, it's a very exciting program where we think we have a huge differentiating Technology 4, so it's something that currently cannot be done with any other technology.
Before this, I want to give a little more color on the targets. I don't believe we have given that color.
Well, disclose the targets because it's more on the Cytovia side to say this. And like we're we everyone's copying on everyone in this space And more especially everyone is coughing on select in this space. So So if you want to hear about what we're doing, then like it's like a fuel, you know, the market and new IDs and we'll definitely do this, but like to prepare ourselves as much as possible Try to like move forward very rapidly. But on the Cytovia side, I think that nothing of this was disclosed. We're super excited by the IDs We've been growing together and it's no there is no information we can unfortunately on this Outside the fact of maybe waiting for the second half, like second quarter We'll start to get an update on the pipeline, the preclinical pipeline we have.
Okay. Thank you very much.
Our next question is from the line of Biren Amin with Jefferies. Please proceed with your question.
Yes. Hi, guys. Thanks for taking my questions. Maybe on the myeloma program, given the clinical hold Was lifted in mid November. When do you expect to start redosing patients in that trial?
Yes. Carrie, would you like to take that one? Thank you, Karen. Good question.
Sure. Absolutely. So once the hold was lifted, we started all of the Downstream activities that would allow us to start redosing and we have Already begun opening our sites and should be planning on first patients with revosing hopefully very soon.
Okay. And then I guess, with any of these 3 programs, do you anticipate that you'll have sufficient clinical data By end of this year, where you can make a decision to go into a pivotal cohort next year?
So our plans as of now are as we have the data available to Give a good package of data, as I've said before, that is meaningful. As I think we previously stated, I think UCART22 is moving forward the most quickly, and that could be something that potentially We could consider, but we will have to depend on what we see with our data and how things move forward.
Great. Thank you. Sure.
Our next question is from the line of Nick Abbott with Wells Fargo.
Please proceed with your questions.
Good morning and thanks for taking our questions. Just one
is on
UCART22. Have you demonstrated direct evidence of host immunity targeting UCART22? There's the correlation Between T cell reconstitution and disappearance of UCART22, but have you actually identified Which host cells are targeting the UCART22 cells?
Yes. No. At this point, we haven't go ahead. Sorry.
No, no, I want to direct this to your question. Yes, sure.
I'm
sorry, I should have waited. Yes, so we're doing all of that work. We're really looking to see, to me, more important well, both things are very important. Any of the cell recovery as well as which We're actually targeting the allogeneic CAR Ts to be rejected. So we are looking at all that data.
We don't have that data available Share. That said, I do think the key is really ensuring that we are able to keep the account recovery Long enough for the UCART sales to expand and do their business. And I think that the addition of alemtuzumab and Ensuring that we find the best way of including it for both safety and efficacy is really key for this year in terms of our goals. And
we will
be looking at all that data to help inform the best plan for moving forward, whether it be in a Pivotal situation or otherwise.
Thanks. And that's a great segue to my second question, which is on alemtuzumab. Currently, you're 20 milligrams consecutively for 3 days. So how long do you expect That to be effective at dampening down this host immune recovery, how much variability do you expect to see and how long do you want to keep that Hostamine recovery down.
Yes, that's a great question. Again, I think this all goes to the data. So we know from earlier data with allogeneic transplant that The use of alemtuzumab can is used in preconditioning for transplant and typically You would expect the lymphodepletion to be 6 weeks or so. It can be for quite a long time because it's a monoclonal antibody obviously with a very long half So finding that balance where we're keeping the host immune system at bay Long enough for the cells to ablate the leukemia, but not too long that You end up with other issues is a critically important piece of this puzzle. And as we gather data, I want to be making data driven decisions on how we do that.
So to answer the question, I can't exactly answer how long because it's going to depend on what we see with the data.
Great. Thanks for the questions.
Sure. Thank you.
The next question is from the line of Raju Prasad with William Blair.
Please proceed with your questions.
Hi, there. This is Sami on for Raj. Thanks for taking our questions and congrats on the progress. Based on your data and the data from Allogene today, how are you guys thinking about redosing across your trials? And then also could you remind us if you plan on enrolling patients Refractory to BCMA therapies in your CS1 trial for multiple myeloma?
Thanks.
Absolutely. Carrie, you go ahead.
So the second part is the second part of the question is faster, so I'll start with that. So In all of our trials, whether it's BCMA or CD19 or other auto or allo CAR Ts for that matter, we don't exclude them. So our programs, which I think makes them unique and exciting, is that we're able to enroll patients and potentially see a signal And a patient who's already failed one of these therapies and would not be able to go on to, let's say, if they had an auto BCMA, they may not Go on to an allo BCMA, for example. So it does give us more shots on goal because there are alternative targets and we're really the only people pursuing them in the allo space In a large way. So I think that's a really important unique Property of our program.
So the short answer is, yes, they can come on the study. In regards to re dosing, absolutely, one of the The most important and exciting pieces of allogeneic CAR Ts is the fact that we can redose. And so we are exploring that in these studies. And we will be when we have data to share, we'll be exciting to share that with you all.
Thanks.
Thank you.
Our next question is from the line of Ingrid Vansenga with Kempen, please proceed with your question.
Hi, all. Good morning. Thank you for taking my question. I acknowledge that it may be difficult for you to speak for your partners. But to the best of your knowledge, when would you be expecting to hear something more from Servier and About their plans for UKERTY19 AORL.
Yes. Hey, Ingrid. Thank you so much for the questions. It's a very important point because it's obviously a strong value driver for us, not just from an economics perspective and milestone revenue, but also From a platform validation perspective, so UCART19 was the first product that Selective brought into the in 2015, and that has since been renamed ALLO-five zero one. And ALLO-five zero one is equal to UCART19.
However, there has been a new version of UCART19 that omits a built in off switch, which is activated by rituximab and that program is called ALLO-five 1a. So in short, it's just an easier to produce product that allows to use UCART19 or ALLO-five zero one with Patients that have been treated with rituximab, which is part of the standard of care approach in NHL patients. So Allogene and Servier are now moving forward in a unified fashion, the ALLO-five 1A And that ALLO-five 1A program, as Allogene has recently mentioned, is slated for an update in the Q2 of here at a medical meeting. So this is just a few months down the line now, where we will have an update on patients treated with ALLO-five zero one and And both companies have said that they would like to join forces to initiate a Phase 2 study by the end of this year for this program, which Could be potentially the pivotal registration trial for this program. So it's a very exciting time for us at Selectus because we think the 1st program that we brought into the clinic as a trailblazer of the allogeneic gene edited off the shelf CAR T cell space It's now actually on track towards potentially a first product approval over the next 18 months or 24 months.
So Look out for news on that front from Servia and Allogene. There will be data on this program mid this year and potentially initiation of a Phase 2 trial by the end of this year.
All right. Thank you, Simon. That was clear.
Our next question is from the line of Jack Allen with Baird. Please proceed with your questions.
Hi. Thank you so much for taking our questions. I wanted to ask about your thoughts with regards to timing of getting the Talend based product In the clinic in solid tumors, I know you mentioned that ALLO-three sixteen is expected to enter the clinic in the coming months. But I was also wondering if you could touch on the timing with respect to Advancing clinical products with respect to the Iovance and Zycovia partnerships as well.
Thank you so much. Thanks, Jack. Yes, it's a wonderful question. We think solid tumor approaches are really the next frontier for cell therapies as this pertains to partnership as well as to our proprietary programs that we're aiming to move into the clinic. So we mentioned this in the past that New INDs will also address solid tumor targets from Selectus.
So proprietary targets to Selectus, I think, will make An interesting development case here, but as you said, also on the TILs and NK cell platforms. We wanted to derisk our technology first in liquid tumors where we've seen really great responses with our CAR T cell approaches. Awesome. Thanks so much.
Thank you. The next question is from the line of Sameet Roy with Jones Trading. Please
Hi, thank you for taking the question. Sticking with the in line with the prior question, Could you give us some broad stroke thought process on tackling polytumor, like especially looking through the lens of Cytovia deal? Are you Picking winning strategies here with iPSC and Kissele line or how do you pick between gamma delta or alpha beta? Are you looking into tissue penetration of cell type or T cell modification? What do you think will crack the solid tumor or not?
Carrie, maybe you want to provide some comment on that first. And thank you so much for that question. Carrie, go ahead.
Yes, sorry. I was on mute. I'm not 100% clear on the question, to be honest with you. So just in terms of which targets or I'm not
No. Like The cell type like, are you still thinking alpha beta T cell is the right cell type to Tactile solid tumor or with Cytovia deal you are indicating maybe iPSC NK sales are a better candidate for Tissue penetration in the solid tumor versus liquid tumors?
Yes. So I think that's a good question that we just don't all know that we don't know the answer And I also would turn to Andre for more color on that, but I do think what What I think is critical here for us as Selectus is that we have the gene editing platform, so we can do all of these different Approaches to whether it be a liquid tumor, solid tumor or other diseases. And I think that applying this platform to different So all these different platforms, whether it be iPSCs or gamma, delta, alpha, beta, what have you, are important Clinical and research questions that need to be answered because I don't think there's an answer. And so I think it's what's important that we're doing here at Selectus is where we have our Feet or toes or fingers in all these different potential options that will help patients in need. And that's why I think being here is so exciting because we can make a difference And we will figure out what is actually the best strategy, whether it be for liquid tumor, solid tumor or other diseases.
Yes, I cannot agree more with Carige. The limitation that Selectus has is not Technical. We can do everything technically. Our gene editing technology is Extremely powerful and there is more and more papers that are coming showing that the access of tailing to any kind of DNA And the precision of this technology and its accuracy and its specificity and the ability to promote DNA recombination, replacement, correction, etcetera is unprecedented in this arena. And plus we have like the legislation, etcetera.
The limitation are not technical for Selective. The problem is more a focus of the company and also was for the past years on the manufacturing, but we just Unplug this blockage that we have. The manufacturing is internalized bit by bit and this year 2021 We'll have no limit in terms of what we can manufacture for clinical supplies, but also for commercial supplies. And also Carrie is building a huge and awesome clinical team around her From clean up to translational, etcetera. And that like the limit is more people and what we can do and of course the finances of the company that have to follow on this.
But we cannot spread ourselves on the thin layer. The problem is certainly not technology wise because we own it all. The problem is on the focus of the company and I think we're really laser focused on what we're doing currently.
Thank you and good luck with the upcoming catalysts.
Thanks.
Thank you. At this time, we've reached the end of our question and answer session. And I'll hand the floor back over to Simon Harnest for closing remarks.
Thank you so much. And again, thank you all for joining us. We'll have a couple of follow-up calls after this. Feel free to always reach out to me. And again, I'm very excited about this year because I think there's going to be a lot of clinical data Coming, that we're all very much eagerly waiting.
So thank you again for joining us, and we'll speak to you soon.
Thank you. This will conclude today's conference. You may disconnect your lines at this time. We thank you for your participation.