Allogene Therapeutics (NASDAQ:ALLO) Q3 2020 Earnings Call

0:00 Good morning, ladies and gentlemen. Thank you for standing by, and welcome to Allogene Therapeutics' third quarter 2020 conference call. At this time, all participants are in the listen-only mode. After the speaker presentation, there will be a question-and-answer session. Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Communications Officer. Ms. Cassiano, please go ahead. Thank you, Operator, and good morning. Before market opened today, Allogene issued a press release that provides a corporate update and financial results for the third quarter ended September 30th, 2020. This press release is available on our website at www.allogene.com. Today's call is being webcast on our website and will be available for replay.

0:48 Joining me on the call today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amado, Executive Vice President of Research and Development, and Chief Medical Officer, and Dr. Eric Schmidt, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities and 2020 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. These statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our Form 10-Q, for the quarter ended September 30, 2020.

1:47 Your caution not to place undue reliance on these forward-looking statements, and Allogene disclaims any obligation to update these statements. I'll now turn the call over to Dr. David Chang. Thank you, Christine, and my thanks to all of you for joining us on our third floor conference call during a very busy week and news cycle. Given that this promises to be an eventful morning, we are going to keep today's prepared remarks short and focus on a few key areas. I will start with CD19, specifically our plans with allo501 and allo501A and our path to investigating allocardial therapy in follow tumors. Later in the call, Rafael will speak to the work we are doing to advance our BCMA-directed therapies, including our plans to present our initial Phase I data from our first BCMA product candidate, Alloc715, in an upcoming scientific meeting later this year.

2:48 Let's start with our CD19 program in relapse and refractory non-Hodgkin lymphoma. We believe the proof of concept data we presented at ASCO provides a strong foundation of support of our efforts to make allocardial therapy a reality. However, one outstanding question for the allogeneic field is durability of response. Durability is critical to the value proposition of any CAR-T therapy, and we firmly believe that the answer to durability lies in how we utilize lymphodepletion, optimize cell dose, and embrace dosing flexibility that is viable and scalable with an off-the-shelf cell therapy. We have spoken at length about lymphodepletion and how we are optimizing the dose of allo-647, our anti-CD52 monoclonal antibody, in concert with a standard clodarabine and cyclophosphamide, while flucide regimen to create the ideal depth and duration of lymphodepletion to allow robust expansion and persistence of alopecia cells.

3:54 In our view, such a controlled immune suppression is necessary to maximize the tumor cell killing while minimizing the risk of cytopenia and opportunistic infection. We continue to believe that this approach of utilizing allo647 as a differentiated component will help us to achieve our goal of providing a meaningful clinical benefit with allogeneic cardiac therapy. The initial readout from the alpha phase one trial also gave us a glimpse at What may be one of the more exciting benefits of our potential off-the-shelf therapy? The ability to re-dose patients. In the case study presented at ASCO, one patient dosed with 120 million cells of Allo501 following the lymphodepletion with a standard full-size and the 39-milligram dose of Allo647 achieved a partial response but subsequently progressed in month two. Shortly after progression, the patient was retreated with 120 million cells of Allo 501, and this time with a fluci and a 90 milligram dose of Allo 647, which led to a complete response.

5:10 In the autologous setting, CAR-T dosing regimens are shaped by the inherent limitations in cell supply. Rather than applying autologous thinking to the design of an allogeneic trial, we want to exploit the benefit of allogeneic therapies to better understand the potential for repeat dosing. In particular, we plan to explore the risk-benefit profile of a scheduled repeat dosing, which we will refer to as consolidation therapy in the alpha trial. Practically speaking, the consolidation therapy entails treating patients without disease progression after the first Allocard T therapy with a second dose of Allocard T approximately five to six weeks later.

5:58 Our hope is that this back-to-back dosing or consolidation might enable more patients to achieve deeper responses and maintain a durable remission. As enrollment continues in our Alpha and Alpha-2 Phase I trials, we expect a rich data set to emerge Pending data, our current plan is to initiate a potential pivotal Phase 2 trial of Allo501A in 2021. We look forward to showcasing this holistic view on the CD19 program's progress, including additional data from Allo501 Alpha trial and the dose escalation phase of Allo501A Alpha 2 study in the first half of 2021.

6:45 The next update I would like to provide is on Allo316, our anti-CD70 Allocard T candidate. As we prepare to file our IND in renal cell carcinoma, or RCC, this quarter, our enthusiasm increases for the start of our clinical trial in 2021 and the potential to explore Allo316 in solid tumors. We look forward to presenting additional preclinical data this year and believe RCC may be just the beginning of what can be addressed by Allo 316 given the expression of CD70 in lung cancer, glioblastoma and hematologic malignancies. We could not be prouder of our teams at Allogene and the progress made not just to close our development pipeline but also the work being done to complete our state-of-the-art manufacturing facility which we expect will begin producing clinical GMP labs in 2021.

7:47 Our unwavering focus on bringing Allocardia therapy to patients has allowed us to quickly advance multiple Allocardia candidates. In 2021, just our third full year as a company, we expect to have five clinical trials underway, including one pivotal trial, our initial endeavor into solid tumors, and our first study using our TurboCAR-T technology. I will now turn the call over to Rafael for further updates on our research and development activities with a specific focus on allo715 and our BCMA program. Thank you, David. I know there's been considerable interest in our upcoming allo715 presentation in patients with relapsed refractory multiple myeloma.

8:37 and I am excited to provide an update on our BCMA platform more broadly. Our prior phase one data presentation of ALLO501 at ASCO was an important step towards validating our platform as it addressed key questions including the successful manufacture of an allogeneic CAR T therapy, the ability to administer therapy without causing clinically relevant graft versus host disease, the use of ALLO647 to enable deep and selective lymphodepletion required for cell expansion, and the finding that allogeneic cell therapy can generate meaningful anti-tumor activity. We hope the initial look at our universal Phase I dose escalation trial might reconfirm these foundational observations in a different disease setting, thereby positioning us to move on to the next steps in this study, namely optimizing cell dose, info depletion, and potential repeat administration of allo715.

9:33 Initial data sets from Universal may also allow us to apply insights across our BCMA platform. Central to our efforts is the recognition that an allogeneic RT option may be critical for patients with multiple myeloma, many of whom are not in a position to wait for the availability of an autologous option. Investigators have told us that there are significant wait times associated with the delivery of autologous cells and that the use of bridging chemotherapy during this treatment interval is quite common. As we execute on our trials, we aim to exploit the fundamental advantages of an allogeneic CAR-T therapy with regards to its on-demand availability. For example, in our universal trial, rapid treatment timelines obviate the need for bridging therapy.

10:22 While the initial phase one data we will present later this quarter will be focused on the initial dose escalation portion of the trial, Our ultimate goal is to be comparable to the results seen in autologous anti-DCMA CAR-T therapies in later stage trials. The universal study of allo715 was initially designed to explore optimal dosing of all components of the lymphodepletion regimen, including allo647, fludarabine, and cyclophosphamide, with patients receiving allo715 at one of three doses. 40 million, 160 million, and 320 million cells in a 3 plus 3 dose escalation design. As we noted last quarter, we had completed the initial dose escalation portion of the universal trial using 39 milligrams of allo647 and began enrolling other lymphodepletion cohorts, one of which omitted fludarabine and one in which we increased the dose of allo647.

11:20 The endpoints being assessed are safety, tolerability, Debson Duration of Lymphodepletion, Cell Expansion, and Science of Antitumor Activity. The multiple variables in the trial design and our ability to fully optimize each component of the therapy will be critical to creating the best product profile for the myeloma setting. Much like the abstract for Allo 501 at ASCO, the first look at Allo 715 data will occur prior to formal presentation and will include high-level data on the first 15 evaluable patients treated with escalating doses of allo 715 and 39 milligrams of allo 647. Cell activity will be based primarily on day 28 tumor assessment.

12:07 We expect to present detailed results at a virtual medical meeting later this year. That presentation will include data on approximately 20 patients across the initial three allo 715 cell dose cohorts and lower dose, 39 milligrams, of allo647, as well as a few patients treated with higher doses of allo647. While we may explore the consolidated cell dosing strategy as discussed in the alpha trial, we have not yet predosed patients in the ongoing universal trial. As we keep an eye towards what might be possible in the future with allocard T therapy in a disease such as multiple myeloma, we are progressing our BCMA program to include the study of allo715 in combination with a gamma secretase inhibitor.

12:55 An IND to support the combination of allo715 and Neogastastat from our partners at SpringWorks Therapeutics is on track to be filed this year, and we are excited to initiate the trial next year. We also look forward to evaluating our TurboCard technology in the setting of myeloma. We continue to believe that the innovation behind TurboCards could be a breakthrough as this technology has the potential to overcome T cell exhaustion and expand allocard T cell viability and efficacy while reducing CAR T cell dose requirements. These properties may enable CAR T success in harder to treat hematologic malignancies and solid tumors and proved to be an important opportunity to raise the bar in multiple myeloma treatment.

13:42 We look forward to soon sharing additional preclinical data of Allo 605, our first TurboCard clinical candidate and next generation AlloCard therapy in multiple myeloma and have accelerated work necessary to now submit an IND for Allo 605 in the first half of next year. We remain enthusiastic about our AllocardT platform and what its potential may mean for patients. We look forward to continuing to provide updates to scientific congresses to share our progress in the near term for Allo 715 and in the first half of next year for Allo 501 and Allo 501A. I'd like to now turn the call over to Eric to review financials. Thank you, Rafael, and good morning. We appreciate that you are likely to be very busy this morning, so let me be brief in my remarks.

14:31 As noted in our SEC filings and third quarter press release issued earlier today, our financial position remains strong, with cash, cash equivalents, and investments totaling $1.0 billion as of September 30, 2020. In the third quarter, our research and development expenses were $51.4 million, which includes $8.8 million of non-cash stock-based compensation expense. General and administrative expenses were $16.6 million for the third quarter of 2020, which includes $9 million of non-cash stock-based compensation expense. Our net loss for the third quarter of 2020 was $66.2 million, or 52 cents per share, including non-cash stock-based compensation expense of $17.8 million.

15:20 A few quick corporate updates include that we are nearing completion of construction for our cell manufacturing facility in Newark, California, as mentioned by David, and as we prepare for a pivotal trial and beyond with CGMP manufacturing from this facility expected in 2021. On the business development front, we were very pleased to expand our relationship with the University of Texas MD Anderson Cancer Center with their strategic five-year collaboration aimed at accelerating the development of a broad Allocarty portfolio across hematologic and solid tumors. Under the agreement, we plan to collaborate with MD Anderson on the design and conduct of preclinical and clinical studies. Dr. Christopher Flowers, Interim Division Head of Cancer Medicine and Chair of Lymphoma and Myeloma at MD Anderson and a key opinion leader in the field of cell therapy, will play a key role as we advance this collaboration.

16:15 Lastly, two Servier-sponsored trials with UCART19 and ALL have been completed or nearing completion with no additional patients planned for enrollment. We in Servier are now reviewing the development strategy for ALL, which may include the possibility of consolidating our programs around a single manufactured cell product, Allo501A. As we near the end of the year, we continue to guide the full year 2020 net losses of between $260 million and $280 million, which includes estimated non-cash stock-based compensation expense of $70 million to $75 million and excludes any impact from potential business development activities. With that, we will now open the call to your questions.

17:05 As a reminder, to ask a question, you'll need to press star one on your telephone. To withdraw your question, please press the pound key. We ask that you please limit yourself to one question only. Please stand by while we compile the Q&A roster. Our first question comes from Mark Fromm with Cowan. Your line is open. Hi, thanks for taking my questions. With the BCMA abstract having come out this morning, there's a patient death reported in there that was associated with the conditioning regimen. Is there any further details you can provide as to, you know, was the attribution kind of given to within the various agents of the preconditioning? And kind of what makes you confident that, you know, whether ALO647 is contributing or not?

17:54 Good morning, Mark. This is Dave Chang. Let me take your question. I think we were a little bit surprised about the abstract coming out today because the scheduled release of abstract was supposed to be tomorrow. And I think you're pointing out around the fact that we report one case of Grade 5 events. which occurred in patients who were lymphodepleted with cyclophosphamide and allo 647. So, if anything, this is a patient who received lesser lymphodepletion in other patients in studies in the trial. The patient had a pretty rapidly progressing disease and, you know, The initial symptoms of what was considered as pneumonia was diagnosed on the day of solid fusion and it remained somewhat refractory to treatment.

19:01 And as the patient's course deteriorated, the family simply wanted a comfort care, which was pursued, and the patient expired. on day eight. It is an unfortunate incident, but I should remind you that both in the autologous cell therapy, both serious adverse events and death has been observed, and we have to realize that we are dealing with very sick patient population. This particular patient, unlike most patients with multiple myeloma, remained refractory to all previous lines of therapy and was progressing pretty rapidly.

19:48 So as a physician, having dealt with patients who had a rapidly progress, this is a very difficult situation. And in this case, unfortunately, the patient died from a grade five event. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Good morning. Could you talk about the various lymphodepletion regimens you're looking at in the multiple myeloma study and, you know, including removing Flucide and how this might help with regard to the safety profile? And then secondly, you know, just given the ASH abstract today, how do you view the dose response seen to date and just the overall profile in the context of the autologous data at this point?

20:36 Okay, Salvin, thanks for the question. And I'm going to refer the question to Rafael Amado. Rafael? Yes, thanks for the question. So we designed a trial to test Flucide Allo647 and also to sequentially be able to remove cyclophosphamide, first Flutavine and then cyclophosphamide. and then subsequently explore higher doses of allo-647. And we're really in the midst of doing this. I mean, we still have a little bit of a way to go. We did drop flu darabine, such as in the case that was just described.

21:24 And we observed slightly lower outcomes and We decided to go back to FCA. We completed FCA at 39 milligrams, and we continue to explore other doses of allo647. So I don't want to get ahead of the presentation, but most likely our conditioning will include all three agents at this point. Thank you. Our next question comes from Brian Amon with Jefferies. Your line is open. Hi, guys. Thanks for taking my questions. Just on the ASH abstracts, I think you talked a little bit about the Grade 5 event, but you also had three other Grade 3 or greater infections. Can you just talk about that relative to the higher dose of Allo647, whether you foresee You know, a potential increased risk of grade three or greater infections with the higher 90 milligram dose?

22:37 So, Darren, let me take that question. You know, in terms of, you know, serious adverse events or, you know, infections, let me just emphasize, and these are not an infrequent event in a kinetic antigen receptor cell therapy. So yes, I know that there is a sort of heightened attention given to our trials about opportunistic infection, but at this point, the degree of infection that we are seeing in my opinion, and I think many clinicians would agree, especially in the refractory multiple myeloma, You know, it's not really raising, you know, obviously it's a phase one study, you know, we're looking at the safety, you know, very carefully, but, you know, it's not raising, you know, you know, you know, heightened concerns. And frankly, at this point, we are continuing on with a clinical study and the study conduct has never been changed.

23:48 and as Rafael had remarked during the prepared statement, you know, we are exploring, you know, higher lymphodepletion conditioning, you know, using higher dose ILO647. And, you know, the questions about how that looks like and those details, you will have to wait for the ASH presentation. Thank you. Our next question comes from Tyler Van Verde with Piper Sandler. Your line is open. Hey guys, good morning. In the abstract, it mentions four out of five responders were still in response at the time of data cutoff. So I wanted to ask a question related to that. Can you provide us maybe details on when that one responder progressed, at what time point, and then also where the four responders are in terms of duration of response?

24:42 Okay, yeah. Yeah, Tyler, I think some of these questions are better to be waited for the actual data presentation at ASH. But let me ask Rafael to provide some additional comments. Yeah, I mean, the durability of response of that particular patient You have to understand it was a relatively short follow-up. So it was a matter of a few months. And then the other patients, I think, we'll have to see when we present the totality of the data.

25:32 Thank you. Our next question comes from John Newman with Canaccord. Your line is open. Hi, guys. Good morning. Thanks for taking my question. Different question on Aloe 501. And the question is, David, so we're all anxiously waiting for durability results in the first half. But I'm just curious, from a manufacturing standpoint, if the durability for this product turns out to be better than we expect, do you feel confident that when the product is approved, you'll be able to meet potentially increased demand? Thanks. Yeah, John, great question. That question, you know, we used to get a lot of those questions and, you know, sort of died out. But, you know, our manufacturing process, I mean, you know, the technical operations team have been continuously improving the yield, you know, and, you know, improvement in yield comes from, you know, many different ways because at the end, what we give to the patients are positive cells. So the transduction efficiency, cell viability, you know, all these things lead to, you know, what we can consider as a dose that we can use from a single manufacturing one.

26:55 And, you know, all along we've been saying that, you know, even from the beginning that each manufacturing one can potentially treat up to about 100 patients. and I think, you know, we feel pretty comfortable, you know, maintaining that statement. So, you know, the yield is, you know, quite good. If anything, the manufacturing process is improved, you know, while we are continuing the study and we feel very confident that as we move forward, the manufacturing of the product will not be a major issue for us. Thank you. Our next question comes from Corey Kazimoff with J.P.

27:40 Morgan. Your line is open. Hey, good morning, guys. Thank you for taking my question. I wanted to ask about the potential for redosing 501 or any of your allocars, for that matter. I'm just wondering, is there any read-through from the alpha study on that front in terms of durability or possibly need to increase durability that's driving this desire, this approach, or is it just another way to potentially differentiate the product in your platform? Thank you. Corey, great question. I would say that it's really the potential of redosing that we really want to explore. You know, we at ASCO talked about a single patient, you know, when the first treatment, you know, a patient only achieved a partial response.

28:28 and with a second treatment with essentially same cell dose but with somewhat enhanced lymphodepletion in a patient achieved a complete remission. That's a pretty unusual situation where the initial response was improved with a retreatment. So when we think about it, I think that really creates an opportunity in the context of what we know about in a CAR-T therapy in non-Hodgkin's lymphoma. The response rate is high, but some of the responses are not complete responses, are partial responses, and partial responses tend to progress relatively quickly. So that's the setting. And here, what we're trying to achieve is let's treat the patient with a first cell therapy, and at month one, which is when we do the first tumor assessment, Patients who have evidence of disease progression, unfortunately, they will come off the study. However, anybody who has an evidence of response or a stable disease, we are planning to retreat or essentially consolidate the tumor response with a second cell infusion.

29:50 And we believe that we can do that within the first five to six weeks of the treatment, which essentially, from our perspective, would complete the planned dosing of the 501 in those patients. So what we're really hoping is that with a second dose, we'll push more patients to complete remission. And if you look at all the existing data, patients which complete remission tend to have a more durable response. So that is sort of what we are looking for. and obviously the durability will take a little bit longer for us to get a sense about how the durability will last. Frankly, we're still following the durability of patients who responded after single infusion, which some of them we presented at the ASCO presentation, and those we plan to update the data in the first half of 2021.

30:52 Thank you. Our next question comes from Michael Smith with Guggenheim. Your line is open. Hey, guys. Thanks for taking my questions. I just wanted to follow up on Allo 715 and the infection rate. I mean, I guess, David, you mentioned already, but how does the Grade 3 or higher infection rate compare to those that are seen with autologous CAR T? programs, and is the risk maybe higher or different, you think, in diseases like multiple myeloma as opposed to non-Hodgkin lymphoma? Yeah, you know, the underlying medical conditions, you know, that makes a lot of difference. Certainly, you know, patients with multiple myeloma with, you know, essentially refractory disease, they are at much higher risk of infection In terms of the rates, I don't have the details about what has been reported in the pilot setting. Maybe, you know, Rafael, do you know that answer?

31:58 No, but there's a fair number of infections as well, but we can get the exact number, you know, and send it later. But, I mean, multiple myeloma patients are very are prone to infections. They're hypogammaglucanemic, and they develop infections spontaneously as well. So they're fairly common, especially in late-stage disease like the ones that we treat. Thank you. Our next question comes from Mark Breidenbach with Oppenheimer. Your line is open. Hey, good morning, guys, and thanks for taking the question. David, I'm wondering if you can tell us if any of the responders in universal achieved MRD-negative status.

32:50 Mark, sorry. Can you repeat the question? Sure. I'm just wondering if any of the responses that you saw in the universal trial dose escalating study were MRD-negative. Sure. Yeah, great question. I know that we've been fielding a lot of questions about the grade five events and infection, but I'm glad that you are talking about the efficacy side of the equation. Certainly, we are seeing allo795 as an active compound. I mean, there is a cell dose response relationship, but we are seeing very good evidence of response as we go to the higher cell doses. And to the question, you know what we are seeing at the highest cell dose the response occurs relatively quickly within first 28 days and you know the response tends to be pretty deep to begin with you know in a stringent complete remission and the very good partial response is what we saw at cell dose of 320 million and you know both of those patients had a MRD negativity by the local MRD testing.

34:08 Thank you. Our next question comes from Dane Leone with Raymond James. Your line is open. Hi. Thanks for taking the questions. And it's just kind of classic 2020 at this point for the ASH abstracts to randomly come out this morning. So I'll ask this, since you've had a lot of questions on the abstract data itself. From a drug development strategy in myeloma, how are you thinking about patient disposition? And what I mean by that is you have Blenrep, which is now being used as a late-line BCMA-targeted agent. You do have the auto CAR-T programs, Idacel, and the J&J program that will probably be approved sometime within the near future. And from speaking with the and multiple myeloma community in the docs treating these patients in the later lines.

35:07 You know, the consistent response has been blend rep does seem like a good option for these patients. You might think about, but probably reach first, sell next or last. Auto CAR T in the late line is great if you can do it for the patients, you know, and they don't have rapid progression. So where are you thinking about what type of patients you really want to start focusing on as you get into the later stages of the Allo 715 program and how you would think about this drug product fitting into the continuum of treatment as it's evolving? So Leon, I'm sorry, I think that's a great question. I mean, I think some of the questions that you're asking also relates to the question that we did not respond to Sabine in her initial question about comparison of our data to what has been reported for the autologous cell therapy.

36:08 One thing that I will say is in multiple myeloma, as we all know, there is a lot of treatment options that are available. and frankly patients remain on treatment for a long period of time because that's how some of the proteasome inhibitors as well as IMiDS has been developed. One thing that we constantly hear from the physicians are that yes there are treatment options but none of these treatments really provide what will be a cure and also all these patients will eventually progress. So from the existing therapy perspective, there are three major categories of drugs that are being used.

36:57 Proteasome inhibitor, IMIDs, immunomodulating drugs such as Revlimid, and then the third one, CD38, monoclonal antibody therapy. essentially the patient population that we are targeting are the ones who have already gone through those existing therapies. And this is where now BCMA targeted therapy, whether it be chimeric antigen receptor or ADC, it really fits in. I think the good thing about all the efforts that different companies are making is that at the end there will be more treatment options. that physicians and patients can use.

37:43 And to some extent, it will depend on the physician's comfort level as well as preference. However, we definitely see a situation where different BCMA-targeted therapy can potentially be sequenced. The data is still premature in many ways, but I think we're beginning to see some sense of maybe there are some differences in the response rate. However, so-called progression-free survival, they all seem to give a similar number. I think that's the current early read of the data, which obviously we'll have to know more. So that's the setting. And what we are coming with Our BCMA-targeted programs in 715, as an off-the-shelf therapy that can potentially give a deep response that's doable, I think we can position our product well in this space once we complete the pivotal study.

38:46 Hope this is sort of answering your question, but the nature of your question, until all the dust settles, is somewhat speculative at this point, but we have a clear position on how we want to put our product into space. Thank you. Our next question comes from Ren Benjamin with JMP Securities. Your line is open. Hey, good morning, guys. Thanks for taking the questions. With Allo 501A, can you just remind us the doses that are being evaluated about how many patients' worth of data we might see and many more. Thank you. You know, we are really, you know, taking advantage of, you know, having two studies, you know, 501, you know, which is really, you know, the proof of concept construct, you know, candidate that we have generated data.

40:02 We already short some data. And then there's a 501A, which we are positioning for the pivotal study. So, you know, to the, you know, the first part of the question, you know, we are really following what we have done with the 501A in a very accelerated way. I mean, in many ways, we are just testing to make sure that there aren't any surprises unexpected. Of course, we have no reason to think that these two will behave in any different ways, but I think it's very important to confirm that in the clinical setting. So we are sort of following what was done in the 501 in a very accelerated way. While that's going on, 501, it really gives us an opportunity to test things in many different ways.

40:54 Obviously, the main thing that we are going after as we explore different things is trying to increase the depth of response, trying to improve the complete remission rate. As we talked about, consolidation is one strategy. while we wait for the durability of the response from patients who have responded. So that's more or less the underlying theme of how we are positioning these two studies. And in terms of the details of the data, number of patients and all those things, that will sort of provide additional color to it when we present the data in the first half of 2021. Thank you. Our next question comes from Raju Prasad with William Blair.

41:43 Your line is open. Thanks for taking the question. I just wanted a little bit of color on the 715 and NeuroGaslit trial, particularly in how the trial design kind of will build on kind of learning from the universal with regards to cell dose and lymphodepletion regimen. Will you have to kind of restart a 3 plus 3 design in the trial, or will you be able to kind of take some of the learnings from the universal trial and just add an arm with the GSI. Thanks. Okay. Rafael, do you want to take on the question? Yeah, sure. I mean, we will...

42:30 We will... Sorry. I'm on mute now. I will just very briefly tell you what we plan to do. The Neurogastastat dose we will leave constant and we may start, we're not going to start with lower doses as we started in 715. We are planning to start with mid doses and then dose escalate so most likely 120 and then depending on what we've seen with the higher doses of allo647, then we'll decide which 6 or 7 dose we will use and we're going to use FCA.

43:17 So it will be, there will be some dose finding but it will be pretty expedited. Thank you. And our next question comes from Ashita Gunawada from Truist Securities. Your line is open. Sorry about that. Hi. Good morning, guys. Thanks for taking my question, and that was an interesting interpretation of my name there. David, I just wanted to touch back on a previous answer that you had on the MRD negative status on seminar five.

44:04 Those two patients, were you able to get any color on if they are MRD negative five or MRD negative six? And then just maybe bigger picture here thinking about the consolidation strategy Could you maybe tell us about how you think about dosing side flu and that consolidation approach and what are the things you're thinking about in terms of managing toxicities and kind of develop your protocol around that? Thanks a lot. Great questions. Let me take on the consolidation and I'm going to ask Rafael about the MRD dataset coming from the 715 study. I have to say that we are very encouraged with the kind of MRD negativity we're seeing in the responders, where the responses are happening very early in the BCMA trial.

44:58 Back on the question about the consolidation, we will detail in terms of how we live for the first time and the second time. But I would say that because of the ALO647, we do have a lot of flexibility in terms of how we can maintain the lymphodepletion through both first and the second treatment. So without going too much into the clinical trial details, let me just end by saying that the question is great. Not needing to use chemotherapy all the time for lymphodepletion, which is really another advantage that comes with the LO647 that we are trying to incorporate in the design of the consolidation.

45:58 Sorry that I'm not providing the exact details, but some of these are competitive information, so I much rather defer to the trial of themselves. With regards to MRD, very briefly, we're done by the site. We have a central lab that will do MRD at a stringent level, 10 to the minus 6, and we will supply whatever data we have on that from the central lab, but this was done at 10 to the minus 5 at a local lab. of the hospital.

46:44 Thank you. And our next question comes from Luca Essie with RBC Capital. Your line is open. Oh, terrific. Thank you for taking my question. Two quick questions here. The first is, it is my understanding that state therapeutics actually will show data for their NKCD19 CAR at ASH. What are your expectations around that data? And that may be a higher level. What are some of the potential advantages and disadvantages of using T cells versus NK cell here? and the second question obviously on the abstract. I think just I want to confirm it. No patients received the high dose of alloxicin for 7 and 90 milligrams in the abstract. Are we going to see that data at ASH or will it be in 2021? Thank you.

47:33 So in terms of the first question, which is really NK versus the T-cells, I mean, you know, the biology as well as existing, you know, clinical data are very clear. I mean, all the cell therapy data where, you know, strong responses have been seen, whether, you know, so you're talking about pills and chimeric antigen receptor. And, you know, that's all coming from the T cell-based therapy. And, you know, this is discussion that we have taken to our internal scientific advisory board several times. and we consistently get the same feedback, which is, you know what, until you see something that is different or you learn something more, at this point, the existing evidence would point you that you need to focus on the T cell-based therapy.

48:31 That's what we are doing. I know that there are a number of companies moving into the NK cells and we are waiting for the data. Hopefully at ASH, maybe we'll find something out. We'll have to see it. We haven't had a chance to review the abstract that came out today. But that's more or less our view of the NK cells versus the T cells. And the second question, what you will see at the ASH presentation of our universal data, You know, we just sent out another press release. I mean, we're a little bit trying to do a catch-up game after Ash surprised us by, you know, releasing the abstract a little bit ahead of schedule.

49:21 And it will detail what will be presented. I mean, certainly at this point, as Rafael had commented, you know, we are testing, you know, the higher lymphodepletion using the higher LO647. Some of those data will be included, but in terms of the exact details, you know, just give another six weeks until you find out. Thank you. And our next question comes from Ben Burnett with Stiefel. Your line is open. Hi, good morning. Thank you. Question on 715. So the ASH abstract talks about going to higher doses of allo 715 beyond the third dose level.

50:06 I think 480,480 million cells was mentioned. I wanted to ask, is that planned on being given all at once as a single bolus? Are you going to implement some type of like split dosing strategy? And if that's the case, could you just give a little color around kind of the timing and logistics of a split dose? Thank you. You know, in a split dose, it's something that we are not entertaining. So when we talk about a cell dose, I mean, we are, you know, sort of planning to, you know, that will be given as a single infusion. Thank you. Again, ladies and gentlemen, to ask a question, please press star and then 1.

50:54 And that concludes our Q&A session. I would like to turn the conference back over to management for any additional comments. All right. Thank you very much. You know, thank you for joining us. I know that today is a very busy time. And, you know, thank you for your ongoing support for Allergen as we look ahead, not just an exciting fourth quarter, but a busy first half of 2021. We anticipate that you may have additional questions in the days and weeks ahead, so please don't hesitate to reach us to our team if you want to have any additional questions. And with that, operator, you may now disconnect. Thank you. Ladies and gentlemen, thank you for your participation in today's conference.

51:40 This does conclude the program. You may now log off and disconnect.