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 a listen-only mode. After the speakers’ 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 30, 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.

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. You are cautioned 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 quarter conference call during a very busy weekend new cycle. Given that this promises to be an eventful morning, we are going to keep today's prepared remarks short and focused on few key areas.

I will start with CD19, specifically our plans with ALLO-501 and ALLO-501A and I'll pass to investigating AlloCAR T therapy in solid 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 1 data from our first BCMA product candidate ALLO-715 in an upcoming scientific meeting later this year. Let's start with our CD19 program in relapsed 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 AlloCAR T therapy 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 that ALLO-647, our anti-CD52 monoclonal antibody in concert with a standard fludarabine and cyclophosphamide while Flu/Cy regimen to create the ideal depth and duration of lymphodepletion to allow robust expansion and persistence of AlloCAR T cells.

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 continued to believe that this approach of utilizing ALLO-647 as a differentiated component will help us to achieve our goal of providing a meaningful clinical benefit with allogeneic CAR-T therapy.

The initial read out from the ALPHA Phase 1 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 read those patients.

In the case study presented at ASCO, one patient dosed with 120 million cells of ALLO-501 following the lymphodepletion with a standard Flu/Cy and that 39 milligram dose of ALLO-647 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 the Flu/Cy and the 90 milligram dose of ALLO-647, which led to a complete response.

In the autologous setting, CAR-T dosing regiments 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 therapist 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 AlloCAR T therapy with a second dose of AlloCAR T approximately five to six weeks later.

Our hope is that this back to that dosing or consolidation might enable more patients to achieve deeper responses and maintain a durable remission. As enrollment continues in our ALPHA and ALPHA2 Phase 1 trials, we expect which data set to emerge, pending data. Our current plan is to initiate a potential pivotal Phase 2 trial of ALLO-501A in 2021.

We look forward to showcasing this holistic view on the CD19 programs progress, including additional data from ALLO-501 ALPHA trial and the dose escalation phase of ALLO-501A ALPHA2 study in the first half of 2021. The next update I would like to provide is on ALLO-316, our anti-CD70 AlloCAR 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 ALLO-316 in solid tumors.

We look forward to presenting additional preclinical data this year and believe RCC maybe 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 about teams at Allogene and the progress made not just across 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.

Our unwavering focus on bringing AlloCAR T therapy to patients has allowed us to quickly advance multiple AlloCAR T 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 Turbo CAR-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 ALLO-715 and our BCMA program. Thank you..

Thank you, David. I noticed seeing considerable interest in our upcoming ALLO-715 presentation in patients with relapsed/refractory in multiple myeloma, and I am excited to provide an update on our BCMA platform more broadly. Our prior Phase 1 data presentation of ALLO-501 at ASCO was an important step towards validating our platform.

I see it address key questions, including the successful manufacturer of an allogeneic CAR-T therapy, the ability to administer therapy without causing clinically relevant graft versus host disease.

The use of ALLO-647 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 1 dose escalation trial might confirm 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, lymphodepletion and potential repeat administration of ALLO-715.

Initial data sets from UNIVERSAL may also allow us to apply insights across our BCMA platform. Prize to our efforts is the recognition that an allogeneic CAR-T 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 a UNIVERSAL trial, rapid treatment timelines obviate the need for bridging therapy. For the initial Phase 1 data we will present later this quarter, we'll be focused on the initial dose escalation portion of the trial.

Our ultimate goal is to be comparable to the results seen in an autologous anti-BCMA CAR-T therapies in later stage trials.

The UNIVERSAL study of ALLO-715 was initially designed to explore optimal dosing of all components of the lymphodepletion regimen, including ALLO-647, fludarabine and cyclophosphamide with patients receiving ALLO-715 at one of three doses, 40 million, 160 million and 320 million cells in a three plus three dose escalation design.

As we noted last quarter, we have completed the initial dose escalation portion of the UNIVERSAL trial using 39 milligrams of ALLO-647 and began enrolling other lymphodepletion cohorts, one of which omitted fludarabine, and one in which we increased the dose of ALLO-647.

The end points being assessed our safety, tolerability, depth and duration of lymphodepletion, cell expansion and the signs of anti-tumor 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.

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, a lower dose 39 milligrams of ALLO-647, as well as a few patients treated with higher doses of ALLO-647.

While we may explore the consolidated cell dosing strategy as discussed in the ALPHA trial, we have not yet treat those patients in the ongoing UNIVERSAL trial.

As we keep an eye towards what might be possible in the future with AlloCAR T therapy in a disease such as multiple myeloma, we are progressing our BCMA program to include the study of ALLO-715 in combination with a gamma secretase inhibitor.

An IND to support the combination of ALLO-715 on nirogacestat from our partners at SpringWorks Therapeutics is on track to be filed this year, and we're excited to initiate the trial next year. We also look forward to evaluation our TurboCAR technology in the setting of myeloma.

We continue to believe that the innovation behind TurboCARs could be a breakthrough as this technology has the potential to overcome T-cell exhaustion and expand AlloCAR 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 proves to be an important opportunity to raise the bar in multiple myeloma treatment.

We look forward to soon sharing additional preclinical data of ALLO-605, our first TurboCAR clinical candidate and next generation AlloCAR T 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 AlloCAR T platform and what its potential may mean for patients. We look forward to continuing to provide updates, scientific congresses, to share our progress in the near term for ALLO-715 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 were likely to be very busy this morning. So let me be brief in my remarks. As noted in our SEC filings and third quarter press release issued earlier today, our financial position remained strong with cash, cash equivalents and investments totaling $1 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 $0.52 per share, including non-cash stock-based compensation expense of $17.8 million. 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 a strategic five-year collaboration aimed at accelerating the development of a broad AlloCAR T 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 advanced this collaboration.

Lastly, two Servier’s sponsored trials with UCART19 and ALL had 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, ALLO-501A.

As we near the end of the year, we continue to guide to 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..

[Operator Instructions] Our first question comes from Marc Frahm with Cowen. Your line is open..

Hi, yes. Thanks for taking my questions. Maybe 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 us to as the attribution kind of given to within the various agents of the preconditioning and kind of what makes you confident that whether ALLO-647 is contributing or not?.

Good morning, Marc. 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 phase of Grade 5 events, which occurred in patients who are 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 in ahead of pretty rapidly progressing disease and the initial symptoms of what was considered was as pneumonia was diagnosed on the day of solid fusion. And it remained somewhat refractory to treatment.

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 incidents, but I should remind you that, both in the autologous cell therapy, the both serious adverse events and death has been observed.

And we have to realize that we are dealing with very sick patient population. I mean, this particular patient, unlike most patients with multiple myeloma had remained refractory to all previous lines of therapy and was progressing pretty rapidly.

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 Grade 5 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 including removing flu/cy and how this might help with regard to the safety profile.

And then secondly, just given the ASH abstract today, how do you view the dose response seem to-date and just the overall profile in the context of the autologous data at this point?.

Okay, Salveen. Thanks for the question. And I'm going to refer the question to Rafael Amado.

Rafael?.

Yes. Thanks for the question. So we designed the trial to test flu/cy ALLO-647, and also to sequentially be able to remove cyclophosphamide – first fludarabine 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 are –we still have a little bit of a way to go.

We did drop fludarabine such as in the case I was just described. And we observed slightly lower outcomes and we decided to go back to FCA. We completed FCA to 39 milligrams and we continued to explore other doses of ALLO-647.

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 Ayman 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 ALLO-647, whether you foresee a potential increase risk of Grade 3 or greater infections with the higher 90 milligram dose?.

So Biren, let me take that question. In terms of serious adverse events or infections, let me just emphasize, these are not an infrequent events in a chimeric 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. It's not really raising, not to say it's a Phase 1 study, we're looking at the safety very carefully, but it's not raising in a heightened concerns.

And frankly at this point, we are continuing on with the clinical study and the study conduct has never been changed. And as Rafael has remarked during the prepared statement, we are exploring higher lymphodepletion conditioning, using higher dose ALLO-647.

And 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 Buren with Piper Sandler. Your line is open..

Hey, guys. Good morning. In the abstract dimensions, four out of five responders were still in response at the time of data cutoff. So I want to ask the 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?.

Okay. Yes. 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 comment..

Yes. I mean, it's the durability of response of that particular patient, and you have to understand it was a relatively short follow up. So what's a matter of a few months. And then, the other patients, I think, look up to see when we present the totality of the data. .

Thank you. Our next question comes from John Newman with Canaccord. Your line is open..

Hi, guys. Good morning. And thanks for taking my question. Different question on ALLO-501. And the question is, David, so we're all anxiously waiting for durability results in the first half.

And 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..

Yes, John great question. That question we used to get a lot of those questions and it sort of died out that our manufacturing process, I mean, the technical operations team had been continuously improving the yield. And improvement in yield comes from many different ways because at the end, what we give the patients CAR+ cells.

So the transduction efficiency, cell viability, all these things lead to what we can consider as a dose that we can use from a single manufacturing run. And all along we've been saying that even from the beginning that each manufacturing run can potentially treat up to about a 100 patients.

And I think, we feel pretty comfortable maintaining that statement. So, the yield is quite good, if anything, the manufacturing processes improved while we are continuing to 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 Cory Kasimov with JPMorgan. Your line is open..

Hey, good morning guys. Thank you for taking my question. I wanted to ask about the potential for re-dosing ALLO-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,.

Hey Corey, great question. I would say that it's really the potential of re-dosing that we really want to explore.

We get asked or talked about a single patient, when the first treatment in a patient only achieved a partial response and with a second treatment with essentially same cell dose, but with somewhat enhanced lymphodepletion patient achieved a complete remission.

That's a pretty unusual situation where the initial response was improved with the retreatment. So, when we think about it, I think, that really creates an opportunity in the context of what we know about CAR T dropped 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, patient who has 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 for essentially consolidate the tumor response with a second cell infusion.

And we think – we believe that we can do that within first five to six weeks of the treatment which essentially, from our perspective, will complete the plan dosing of ALLO-501 in those patients. So what we are really hoping is that with a second dose, we'll put small patient to complete remission.

And if you look at all the existing data patients who achieve 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 a single infusion which some of them whom we've presented at ASCO presentation. And those we plan to update the data in the first half of 2021..

Thank you. Our next question comes from Michael Schmidt 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 guess David, you mentioned already, but how does the grade three or higher infection rate compare to those that seen in autologous CAR T programs? And if the risk may be higher or different, you think, in diseases like multiple myeloma, as opposed to a non-Hodgkin's lymphoma?.

Yes, the underlying medical conditions that make a lot of difference. Certainly patients with multiple myeloma with essentially refractory disease they are at much higher risk infection. In concept the rates, I don't have the details about what has been recorded in the palliative setting.

Maybe Rafael, do you know that answer?.

No, but there's a fair number of infections as well, but we can’t give the exact number. I’ll send it later. But multiple myeloma patients are very prone to infections, they are hypogammaglobulinemia and they develop infections spontaneously as well. So there are probably 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 any of the responders in UNIVERSAL achieved MRD-negative status?.

Mark sorry, can you repeat the question?.

Sure, sure. I'm just wondering if any of the responses that you saw in the UNIVERSAL trial dose escalated study were MRD-negative..

Yes, great question. I know that we've been fielding a lot of questions about the Grade 5 events and infection, but I'm glad that you are talking about the efficacy side of the equation. Certainly, we are seeing ALLO-715 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 what we are seeing as the highest cell dose, the response occurs relatively quickly within first 28 days.

And the response tends to be pretty deep to begin with in a stringent complete remission and a very good partial responses are what we saw at cell dose of 320 million. And both of those patients had a MRD-negativity by the local MRD testing..

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 [indiscernible] coming out this morning. So I'll ask this since you 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, cyto cell, and the J&J program that will probably be approved sometime within the near future.

And from speaking with the multiple myeloma community and the docs treating these patients in the later lines, the consistent response has been Blenrep does seem like a good option for these patients you might think about, but probably reach for some of extra last AutoCAR T in the late line is great if you can do it for the patients 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 Leone I mean, that's a great question. I mean, I think, some of the questions that you are asking also relates to the question that we did not respond to [indiscernible] initial question about comparison of our data to what it has been reported for the autologous cell therapy.

One thing that I'll 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 image has been develop.

One thing that we constantly hear from the physicians, that yes, that are certain options, but none of these treatments really provide what will be a cure. And also, all these patients will eventually progress.

So, the existing therapy perspective, I mean, there are three major categories of drugs that have been used, proteasome inhibitor [indiscernible] immune-modulating 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 target therapy, whether it be chimeric antigen receptor, or ADC, it's 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 physician and patients can use. 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 it's pretty still premature in many ways, but I think, we're beginning to see some cells maybe there are some differences in the response rate, however, so-called the progression-free survival this 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 ALLO-715, I mean as an off-the-shelf therapy that can potentially give a deep response that’s durable, I think, we can position our product well in this space, once we complete the pivotal study.

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 in this space..

Thank you. Our next question comes from Reni Benjamin with JMP Securities. Your line is open..

Hey good morning guys. Thanks for taking the questions.

Just with ALLO-501A can you just remind us the doses that are being evaluated about how many patients’ worth of data we might see in the dose escalation phase of the study? Just wondering if we had to kind of go back to the drawing board, or did we hone in on particular doses? And just related to that, I guess, ALLO-501 is supposed to be the test kitchen.

I just wanted to know if there anything new being cooked up that would be of interest. Thanks..

We really are taking advantage of having two studies, ALLO-501, which is really the proof-of-concept construct candidate that we have generated data. We already showed some data. And then there’s a ALLO-501A, which we are positioning for the pivotal study.

So, to the first part of the question, we are really following what we have done in the ALLO-501 – with the ALLO-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 there will be, of course, we have no reason to think that they – 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 ALLO-501 in a very accelerated way. While that's going on, ALLO-501, it really gives us an opportunity to test things in many different ways.

And obviously the main thing that we're going after, as we explore different things, is trying to increase the depth of response, trying to improve the complete remission rate. And as we talk 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, we'll 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. Your line is open..

Thanks for taking the question.

I just wanted a little bit of color on the ALLO-715 Nirogacestat trial, particularly in how the trial design kind of will build on our kind of learnings from the UNIVERSAL with regards to cell dose and lymphodepletion regimen, is where you have to kind of restart a three plus three design trial, or will you be able to kind of take some of the learnings from the UNIVERSAL trial and just add it to – and add an arm with the GSI? Thanks..

Okay.

Rafael do you want to take that question?.

Yes, sure. I mean we will learn – sorry – I will just very briefly tell you what we plan to do. The Nirogacestat dose we will leave constant and we may start – we're not going to start with lower doses as we started in ALLO-715. We are planning to start with need doses, and then dose escalade, so most likely 120.

And then depending on what we've seen with the higher doses of ALLO-647, then we'll decide which ALLO-647 dose we will use. And we're going to use FCA. So it will be – there will be some dose-finding, but it will be pretty expedited..

Thank you. And our next question comes from Asthika Goonewardene from Truist Securities. Your line is open. Sorry about that..

Hi, good morning guys. Thanks for taking my question. And there was an interesting interpretation of my name there. David, I just wanted to touch back on a previous stance that you had on the MRD-negative status on ALLO-715.

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 are thinking about dosing Cy/Flu and that consolidation approach? And if you – and what are the things you’re thinking about in terms of managing toxicities and kind of develop your protocol around that textbook?.

Yes, great questions. Let me take on the consolidation and I'm going to ask Rafael about the MRD data set coming from the ALLO-715 study. I mean, I'd say that we are very impressed with the kind of MRD negativity you're seen in the responders, where the responses are acting very early in the BCMH trial.

On the question about the consolidation, I mean, we will detail in terms of how we lymphodeplete first time and the second time. But I would say that because of the ALLO-647, 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 being able to – not needing to use chemotherapy all the time for lymphodepletion, which is really another advantage that comes with the ALLO-647 that we are trying to incorporate in the design of the consolidation.

So, sorry that I'm not providing the exact details, but some of these competitive information are much may be deferred till the trial opens..

Thank you..

Yes we feel….

Yes, very briefly. This we're done by the site. We have a central lab that will do MRD stringent level ten to minus six and we will supply whatever data we have on that from the central lab, but this pushed on ten to the minus five at local lab..

At the hospital..

Thank you. And our next question comes from Luca Issi with RBC Capital. Your line is open..

Terrific, thank you for taking my questions. Two quick questions here. The first is, it is my understanding the state therapeutics actually will show data for their CK CD19 CAR at ASH.

What are your expectations around that data? And may be at higher level, what are some of the potential advantages and disadvantages of using T cells versus NK cells here? And then the second question obviously on the abstract, I think, just I want to confirm it, no patients received the high dose of ALLO-647 in 90 milligrams in the abstract.

Are we going to assume that data at ASH or will it be in 2021? Thank you..

So in terms of the first question, which is really, NK versus the T-cells, I mean the biology, as well as existing clinical data are very clear. I mean, all the cell therapy data where strong responses have been seen, whether – so you are talking about pills and chimeric antigen receptor. And that's all coming from the T cell based therapy.

And this is discussion that we have taken to our internal Scientific Advisory Board several times, and we consistently get the same feedback, which is, until you see something that is different or you’ll learn something more at this point, the existing evidence would point to that in a unique to focus on the T-cell based therapy.

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 else. We'll have to see. We haven't had chance to review the abstract that came up 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 ASH presentation of our UNIVERSAL data, we just sent out another press release, I mean, with a little bit science catch up game after ASH surprised us by releasing the assay little bit ahead of schedule. And it will detail what will be presented.

I mean certainly at this point, as Rafael has commented, we are testing the higher lymphodepletion using the higher ALLO-647. Some of those data will be included. But in terms of the exact details, I’ll just give another six weeks till you find out..

Thank you. And our next question comes from Ben Burnett with Stifel, your line is open..

Hi, good morning. Thank you. Question on ALLO-715, so the ASH abstract talks about going to higher doses of ALLO-715 beyond the third dose level. I think 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 a 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 the split dose? Thank you..

A split dose is something that we are not implicating. So when we talk about a cell dose, I mean, we are sort of planning to – that will be given as a single infusion..

Thank you. [Operator Instructions] 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. Thank you for joining us. I know that today is very busy time. And thank you for your ongoing support for Allogene 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 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. This does conclude the program, you may now log off and disconnect..