Hello. Thank you for standing by, and welcome to Allogene Therapeutics Third Quarter 2021 Conference Call. At this time, all participant lines are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone keypad. Please be aware that today's conference is being recorded. I would now like to hand the conference over to Christine Cassiano, Chief Communications Officer. Ms. Cassiano, you may begin. Thank you, operator, and welcome to all who have joined the call. After the market closed today, Allogene issued a press release that provides a corporate update and financial results for Q3 2021. This press release and today's webcast are both available on our website. 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 timing and ability to advance our clinical trials and regulatory matters, our clinical data, and 2021 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and the expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. 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 David. Thank you, Christine, and good afternoon. In October, we communicated that the FDA had placed a clinical hold on our AlloCAR T clinical programs based on a chromosomal abnormality observed in one patient in ALPHA2 trial. Although we have been unable to treat patients while the hold is in place, multiple other work streams at Allogene continue, including preparation for a phase II pivotal trial on ALLO-501A, advancement of our CellForge 1 manufacturing facility, and all our preclinical work on solid tumor targets and next-generation technologies. On today's call, we will share a brief update on the clinical hold and perhaps even more importantly, the ultimate reason that we remain committed to advancing our platform, our data, and the potential impact to patients in need. Let me first start with what's top of mind. Since we announced the clinical hold on October seventh, we have been actively engaged with the FDA in discussions that we hope will lead to a timely resolution. We are extremely appreciative of the time and attention that the FDA has devoted to this matter, which we believe has implications not only for the field of allogeneic cell therapy, but also the broader field of cell therapy. I'm also grateful to our team at Allogene, which are making great progress in generating information for us and the field to understand and properly address the chromosomal abnormalities observed in our patients. The FDA's stated mission is to ensure the safety and efficacy of medical products, but the agency has also been mandated by Congress to expedite product development. As FDA leadership has shared at recent public forums, they have identified the development of allogeneic CAR T derived from healthy donor cells as a potential way to increase access to the therapy and decrease manufacturing time and cost. We recognize the FDA's responsibility to ensure patient safety while supporting innovation. The FDA has continued its review of our end-of-phase I material submitted in anticipation for a potential ALLO-501A pivotal phase II trial. From Allogene's perspective, we understand our own responsibility that comes with being a pioneer in the field of cell therapy and look forward to doing everything necessary to facilitate a safe and timely resumption of our clinical studies. During our interaction with the FDA, we have remained in close contact with our investigators, including the clinician who is caring for a patient who subsequently received an allogeneic stem cell transplant. We have heard from many of these investigators. They look forward to reinitiation of our trials and view our AlloCAR T product as an important therapeutic options for patients, calling out how many of their patients cannot wait for the delivery of autologous CAR T cells or don't want to risk manufacturing failure. Most importantly, we believe in the potential of our AlloCAR T products and have treated now more than 130 patients with lymphoma, multiple myeloma, and renal cell carcinoma across five phase I studies. In the ALPHA trial alone, we have treated over 60 lymphoma patients, and we are excited to share updated data at the ASH Conference in December. I will now turn the call over to Rafael to preview our upcoming data presentations. Thank you. As David has noted, I will focus my comments today on data updates from both our anti-CD19 and BCMA programs, which will be presented at next month's ASH Conference. We believe the data disclosed in the ASH abstracts for ALLO-501 and ALLO-501A continue to validate our consolidation strategy. ASH will feature an oral presentation on our phase I ALPHA2 trial with ALLO-501A and a poster presentation on an ALPHA study with ALLO-501. Consistent with the data presented at ASCO earlier this year, the updates in the ASH abstract continue to support a favorable clinical profile for AlloCAR T in non-Hodgkin's lymphoma and demonstrate that consolidation dosing is well-tolerated with the potential for enhanced efficacy compared to a single dose of cell. We chose the term consolidation to describe our unique approach to redosing, which goes beyond simple retreatment. Our proprietary lymphodepletion strategy enables us to provide a second dose of cells without re-administration of chemotherapy, allowing cells that persist from an initial dose to remain active while newly administered cells can work to consolidate a response to therapy. While the data are early, we believe this strategy holds advantages over other retreatment paradigms that are being studied. As you may recall, data presented from the ALPHA2 study at ASCO earlier this year included six evaluable large B-cell lymphoma patients treated with a single dose of ALLO-501A and five evaluable large B-cell lymphoma patients from the consolidation cohort in this study. As of the ASH abstract data cut-off date in July, 15 patients had received ALLO-501A, six in the single dose cohort and nine in the consolidation cohort, with 12 patients or six each evaluable for response at day 28. In the consolidation cohort, both the overall response rate and complete response rate were at 67%, with all three partial responses converting to CRs following consolidation. We look forward to presenting data on additional patients from the consolidation cohort at ASH, recognizing that a few in this group were not able to receive a second dose following the clinical hold. The safety profile of ALLO-501A continues to be manageable in both the single dose and consolidation cohorts. Events of interest in the single dose cohort were previously reported at the 2021 ASCO annual meeting. In the consolidation cohort, there was no cytokine release syndrome, no graft-versus-host disease, no ICANS, no dose-limiting toxicities, no dose reductions or grade 3+ infections, and infusion reactions were grade two. Among all treated patients, cytopenias were the most common adverse event that occurred in 72% of patients. The patient with aplastic anemia and the chromosomal abnormality treated in the ALPHA2 trial was not referenced in the ASH abstract due to the timing of the data cut-off. Meanwhile, we continue to prepare for the advancement of the ALLO-501A program into a pivotal phase II study with the understanding that certain work streams are being delayed by the hold and subject to ongoing discussions with the FDA. In the ASH abstract for the poster presentation of the ALLO-501 ALPHA trial, the updated data continues to highlight that allogeneic CAR T therapy can be effectively and conveniently delivered to patients with relapsed/refractory non-Hodgkin's lymphoma, with responses observed across all cell doses and tumor histologies. In data presented across 36 CAR T naive patients, response rates continue to be similar to those seen in autologous CAR T therapy trials, and the modified intent-to-treat population remained nearly identical to the intent-to-treat population, with 46 of 47 enrolled patients receiving therapy and an average time from enrollment to start of therapy of five days. As of the July ASH abstract data cut-off, five additional patients were treated relative to the data previously reported at ASCO earlier this year. Overall response rate and CR rates remain at 75% and 50% respectively. In the 13 CAR T naive patients with large B-cell lymphoma, the overall response rate was 62% and the CR rate was 46%. In the 23 CAR T naive patients with follicular lymphoma, the overall response rate was 83% and the CR rate was 52%. Four of the seven follicular lymphoma patients enrolled in the consolidation cohort were evaluable for assessment after consolidation dosing at the time of the data cut-off, with an overall response rate and CR rate of 100% and 75% respectively. As with ALPHA2, we will report on additional patients treated in the consolidation cohort of alpha at the ASH meeting, with a few not able to receive a second dose following the clinical hold. The percent of patients remaining in CR at six months following a single infusion of ALLO-501 was 36% in large B-cell lymphoma, which is similar to six-month CR rates reported in the pivotal trials of autologous CAR T-cell therapies, with the longest ongoing CR at 15+ months as of the data cut-off. The six-month CR rate from follicular lymphoma was 28%. There were no cases of GvHD or DLTs observed. As noted previously, one case of grade three ICANS was reported. Grade 1/2 CRS occurred in 22% of patients with one case of grade three CRS. All were managed with standard protocol. Cytopenias were the most common adverse events and occurred in 83% of patients. Infection rates remained similar to those observed in autologous CAR T trial. There were no new treatment-emerging deaths reported in this abstract. The oral presentation at ASH from our multiple myeloma program will focus on a single administration of ALLO-715 at higher cell dose cohort. Overall, we continue to target 2022 for data from the combination of ALLO-715 with nirogacestat, consolidation dosing with ALLO-715, and our ALLO-605 TurboCAR study. Findings from UNIVERSAL abstract indicate that an allogeneic CAR T cell therapy can be delivered rapidly and without the need for bridging therapy to patients with refractory multiple myeloma, with a single dose of therapy capable of inducing deep responses. The ASH abstract contains data as of June, with 42 patients treated at escalating doses of ALLO-715 and doses of ALLO-647 ranging from 39 mg-90 mg. As with the ALPHA trials, the median time from enrollment to lymphodepletion was five days. Patients were in advanced stage of disease with a median of 5 prior lines of therapy, and 43% of patients were penta-refractory. The trial did not permit bridging therapy. When the initial UNIVERSAL data set was presented at ASH 2020, we reported on 26 evaluable patients across all doses. The efficacy analysis for this ASH presentation, however, will focus on those patients treated at the highest two dose levels of 320 million and 480 million CAR-positive cells. At the time of the abstract, 26 patients were treated at the highest two cell dose levels, along with fludarabine, cyclophosphamide, and ALLO-647 lymphodepletion. The overall response rate was 62%, with a Very Good Partial Response or better, or VGPR+ rate of 38.5%. Median follow-up for these patients was 7.4 months, with a median duration of response of 8.3 months. Of the 10 patients with the best response of VGPR+, 8 were found to be MRD-negative. No GvHD was observed. The most common grade 3+ adverse events included cytopenias. CRS was reported in 52% of patients. In all cases, grade one and two, except for one patient with grade three. One patient with grade two CRS experienced grade one neurotoxicity that resolved. Grade three blast phase infections occurred in 13% of patients, including two previously reported grade five events. We are pleased that the data from UNIVERSAL show that multiple myeloma patients treated with ALLO-715 can achieve and maintain meaningful response rates. We look forward to providing updated data across our lead product candidates at ASH in December. We remain enthusiastic about our differentiated AlloCAR T platform and what its potential may mean for patients. I'd like now to turn over the call to Eric for an update on our financials. Thank you, Rafael, and good afternoon. We ended the quarter in a strong financial position with $861.7 million in cash equivalents, and investments. In the third quarter of 2021, our research and development expenses were $58.7 million, which includes $10.1 million of non-cash stock-based compensation expense. General and administrative expenses were $19 million for the third quarter of 2021, which includes $10.8 million in non-cash stock-based compensation expense. Our net loss for the third quarter of 2021 was $78.2 million or $0.57 per share, including non-cash stock-based compensation expense of $20.9 million. While the clinical hold has detracted from our ability to enroll patients into our five clinical studies, we continue to support multiple research and operational initiatives, including preparation for a potential pivotal phase II study on ALLO-501A and deployment of cGMP production at our CellForge 1 manufacturing facility. As a result, we continue to expect our full-year 2021 operational expenses to be between $300 million and $330 million. This includes estimated non-cash stock-based compensation expense of $80 million-$90 million and excludes any impact from development activities. With that, we will now open the call for your questions. Thank you. At this time, to ask a question, you will need to press star one on your telephone. Again, that is star one to ask a question. To withdraw your question, just press the pound key. Please stand by while we compile your Q&A roster. The first question comes from the line of Tyler Van Buren from Cowen. Your line is now open. Hey, guys. Good afternoon. Thanks very much for taking the question. In the release, you state that there's ongoing discussions with the FDA. I have to ask, is there anything more you could say with respect to these discussions or the nature of them? If the FDA has formally requested any data, what that might look like. If not, perhaps you could talk about your ongoing internal investigation to generate the data that would make the FDA comfortable, whether that's testing samples from the manufacturing batch that produced the patient sample or other things that you might be doing. Hi, Tyler. Good afternoon. This is Dave Chang. Let me take that question. In terms of, you know, whether we have received a communication related to the clinical hold, yes, we have received the clinical hold letter that details FDA's concerns as well as the data requirements. We have met informally with FDA to discuss some of the details. To that extent, we can talk about it, but in terms of the details, other than what we have previously communicated, which is that, you know, the agency's concern around the single case of A chromosomal abnormality is whether this has any clinical relevance, also whether there is any evidence of clonal expansion, and also whether there is a relation between the chromosomal abnormalities and gene editing. In each of these areas, our team has made a you know tremendous progress in terms of making a path towards addressing each areas of the concern. You know, that's about you know at this point you know what we are willing to share. While the investigations are ongoing and you know this matter is still under FDA review you know we cannot really talk too much into the details. Thank you. Your next question comes to the line of Michael Yee from Jefferies. Your line is now open. Hi, this is Ben Asson for Mike. Thanks for taking the questions. You outlined a few possible hypotheses on the last call regarding the chromosomal abnormality, whether it's from TALEN or just from T-cell expansion. Has any of those changed given the additional work that you've done? Number two, can you please lay out some of the timelines over the next few months in terms of your interactions with the FDA? How much back and forth do you expect? You know, just give investors a sense of the timelines on when this could be resolved. Thank you. Yeah. In terms of FDA interaction, and I would say that this is a very active and collaborative interaction, we have had, you know, sort of informal, you know, discussion as well as ongoing dialogue as we are preparing to respond to the clinical hold letter. To that extent, you know, I think, you know, this is very positive. You know, with respect to, you know, how this may happen, yes, in the previous conference call, you know, we laid down couple of different, you know, hypothesis. Obviously with, you know, given all the published literature about the potential of gene editing nuclease to cause chromosomal structural deletions or abnormalities, we have to take that into a possibility. We also highlighted that the kind of chromosomal abnormality that we have detected in this patient is also known to happen in healthy T-cells as they go under expansion. Those two, you know, possible explanation, you know, still is the basis of our ongoing investigation. Your next question comes to the line of Michael Schmidt from Guggenheim. Your line is now open. Hey, guys. I have two questions. Just another regulatory question. This one is around the end of phase I, you know, materials that have been submitted to the FDA. I just wanted to understand, I guess what you know what needs to be checked off here, in order to get the go ahead for the phase II study, which you said I think is a parallel process, you know, side by side to the clinical hold investigation. Yeah. Mike, Rafael has been leading the end of phase I discussions with FDA, and I'll ask him to respond to your question. Yeah. I mean, obviously our main focus has been you know on the hold activities, and we obviously are fully dedicated to that. As David said, you know, interacting productively with FDA. In spite of that, FDA has remained engaged with us on the phase II pivotal trial for 501A. Those discussions have also been very productive. We don't get into the details of regulatory discussions just as a matter of policy, but I can tell you that you know all the discussions which included not just clinical discussions on the nature of the clinical trial, but also extensive discussions on manufacturing, which as you know in this field are quite important. They all have taken place both for the cell product as well as 647, which is, as you know, this is a co-development type sort of development. You know, further than that, I think it would be premature to comment. We're being doubly busy, I would say, with the hold as well as the registration program. Okay, great. A question on ALLO-715. I may have missed it, but I'm curious how much additional data you'll be able to share at ASH on the multiple myeloma study and whether that will or will not include patients that have received the consolidation. In multiple myeloma, we will not include consolidation that started later and then that will report next year. We will share data with you know, about a few additional patients or some more patients that have been accumulated since the cutoff that was in June, as well as longer follow-up both in terms of responses, durability and MRD type of data. Okay. Thank you. Your next question comes from the line of John Newman from Canaccord. Your line is now open. Hi guys, thanks for taking the question. Also had a question about the pivotal study, the phase II pivotal study for 501. Just curious, generally speaking, if you would say that, given the additional data that we'll be seeing at ASH, do you believe that the optimal way forward would be consolidation dosing, and whether that consolidation dosing would apply to both patients with stable disease after the initial dose as well as a response? Thank you. Yeah, hi, this is Rafael. I think what I would say to that is that we are encouraged about the consolidation data. It's still early for us to say that, you know, this is gonna be a definitive dosing. You know, as you've heard in the prepared remarks, you know, the data is pretty encouraging with conversions from PR to CRs. We are, as is part of your question, dosing also patients that have stable disease as well. We look forward to updating that at ASH with you know, additional patients and additional follow-up. Okay, thank you. Your next question comes from the line of Luca Issi from RBC Capital. Your line is now open. Oh, great. Thanks so much for taking my question. I'll try to not ask questions on the clinical hold. Maybe on the pivotal trial, can you just remind us why you believe that the pivotal trial can be single arm? It looks like Genmab has started a pivotal trial for CD3, CD20 bispecific antibody head-to-head versus physician's choice chemotherapy in a similar settings. Wondering why that's not the right comp for us to think about it. Maybe on competition, obviously we've seen the data from CRISPR couple weeks back. I know their data will not be at ASH, but wondering if you have any comment on what's your take on their data set. Thanks so much. Okay, Luca, thanks for not asking a question about the FDA clinical hold. But your question around the clinical study design and our approach as we prepare for end of phase I meeting and, you know, in preparation of the pivotal phase II study, you know, we don't wanna go too much ahead of the FDA discussion and make sure that we communicate once we finalize the study design. There are many aspects. I mean, certainly the question around whether we're gonna approach as a single dose or consolidation, I know that is an outstanding question, and we've been sort of dodging the question. It's not. We're not dodging because we don't have a position. We have a position, but I think it's a little bit ahead of the game for us to talk and communicate about the exact study design. Your question around, you know, given the evolving environment in the non-Hodgkin's lymphoma, you know, the question around the single arm versus, you know, controlled study, that's a great one. I think there are enough precedents in terms of how regulatory agency, especially FDA, has reviewed the data, you know, when the dataset shows, significant improvement over what could be considered as a standard of care. I think there are many ways that you can sort of review the different regulatory precedents. Our position still stands that in terms of the efficacy demonstration of our AlloCAR T program, we believe that can be done from an uncontrolled single-arm study. Look on CRISPR and the competition. Obviously it's really not our place to comment on other parties' data. You know, we welcome competition. We think competition makes the field stronger. Certainly, there's plenty of unmet medical need to support multiple potential entrants in the allogeneic cell therapy space. Obviously, our focus is just on continuing to execute, try and lead this field and optimize our first-in-class products. Got it. Thanks so much. Your next question comes from the line of Salveen Richter from Goldman Sachs. Your line is now open. Good afternoon. Thanks for taking my question. With regard to the investigation, I don't know if you can comment whether you've been able to rule anything out at this point. Secondly, on the multiple myeloma data, are you hitting a plateau here in terms of dose response just, you know, with regard to dose level four versus dose level three? Any thoughts there would be helpful. Yeah, Salveen, this is David. Let me take the first question, and I'll pass the second question to Rafael. I mean, our investigation has been very active and very productive. We know quite a bit, but we wanna follow the due process. Our main audience for the investigation is the FDA, and until we complete the response letter and come out of the clinical hold, I think it is premature to detail about, you know, what has been done and, you know, where our position is. I mean, you know, from our perspective, you know, the path towards lifting the clinical hold, you know, is straightforward. I mean, there are some data generation that we have to do, but we see a clear path forward. Yeah, with regards to multiple myeloma, well first, we will present on $320 million and $480 million. We don't have any intention of continuing to dose escalate. Whether we've reached a plateau or not, I think it's still premature to tell. You know, with more cells, particularly at the medium doses of ALLO-647, we see slightly higher responses with 480, but the numbers are still very small to be able to tell. I think, you know, the overall answer is that we will probably stop at 480 and analyze the data, and then make a final decision as to what the recommended phase II dose will be. Thank you. Your next question comes to the line of Jason Gerberry from Bank of America. Your line is now open. Hey, this is Perry on the line for Jason. Thanks for taking our question. I guess just an additional question on kind of assuming resolution of the clinical holds. Do you anticipate any updates to, I guess, screening protocols for this type of, you know, chromosomal abnormality that could happen? And then a second question, you know, in terms of once you respond to the clinical hold letter to the FDA, how long do you anticipate kind of their processing that and when you could restart the trials? I guess just wanna better understand, you know, when the pivotal trial initiation could start following that, following response to the FDA. Perry, let me take the question. I mean, you know, the questions that you are asking are very important questions. You know, we are working hard to come to a resolution to the issues related to our clinical hold. I mean, some of the, you know, question at this point, you know, we don't believe that we're gonna have to change what we do in the clinical setting, that much. For that matter, I think much of the focus is just, you know, generating some additional data to include in our clinical response letter. You know, that's what we are doing. In terms of the second question about how long it's gonna take, I mean, I don't wanna speak for the FDA, so, let's just, you know, defer that, you know, to when that happens. I'm just gonna add by saying that FDA has been very engaged in this discussion with us. Thank you. Your next question comes to the line of Cory Kasimov from J.P. Morgan. Your line is now open. Hey, good afternoon, guys. Thanks for taking the questions. Two for me as well. First one is, with your update today on the ALPHA study saying four of the seven patients in consolidation cohort who are evaluable for response are all follicular lymphoma. Curious in terms of not having evaluable LBCL patients yet, is this a function of limited follow-up or baseline disease or something else? Second question, there's obviously some patients who respond very well to a single dose treatment. Are there learnings you can take from the initial data as to why that might be or how to determine what patients get consolidation? Or is this eventually a market where you think everybody goes on to get consolidation with allogeneic therapy? Thank you. Let me take that question, Cory. The reason why in ALPHA study the consolidation patients are in follicular lymphoma is because we've been preferentially channeling the large B-cell lymphoma patients towards ALLO-501A study ALPHA2. There, you know, we've reported the conversion of three PR to CRs and, you know, 67% CR rate. We will update those results at ASH. Then can you repeat the second question, please? Yeah. In terms of having patients who respond well to single dose treatment and kinda what you can learn from that, why some will be better with single versus the consolidation, is this a marketplace you think eventually everyone just goes to get consolidation therapy? Yeah, it is true that some patients may do well with single dose. You know, we've reported extensively on that on the ALPHA study, and we will provide an update on those patients. We just believe that the second dose can provide an increase in response rate and hopefully durability as well, as we'll show more data at ASH. It's really that delta that we're looking for in terms of being able to improve upon beyond what is seen with the autologous therapy. You know, once we make a decision, every patient will be treated uniformly in the pivotal trial. Thank you. Your next question comes to the line for Raju Prasad from William Blair. Your line is now open. Thanks. Great question. I want to get your thoughts on two separate topics. First, kind of piggyback on the last question on consolidation therapy. In the UNIVERSAL trial or—I'm sorry, in the GSI and turboCAR therapies, are you thinking about consolidation therapy there or using GSI twice? And then also want to get your thoughts on kind of the TRANSFORM and ZUMA-7 data and how that may pertain to kind of second-line transplant-eligible usage when you get to that level for ALLO-501A. Thanks. Yeah. The GSI study has a period of time of administration of GSI. It's not a single dose. You know, that study is ongoing. We were accruing up to the hold, and we will resume once the hold is lifted, obviously. We hope to report next year on that experience. 605 had already started. That's the TurboCAR. You know, we were making really good progress in that trial. We will report on that study after we continue to put patients following the hold. So essentially, you know, the point with GSI is there's a finite period of time where they receive it after receiving cells. Your additional question? I just wanted to get your thoughts on the TRANSFORM and ZUMA-7 data, and potential for, you know, CD19 allo in second-line transplant-eligible patients. Yeah. I mean, obviously the therapies in the autologous setting are moving into earlier lines of therapies. This is not a surprise. You know, this is obviously great for patients. I think those results were fantastic, and they will have an influence on how we end up developing ALLO-501A. You know, we will follow a pathway of starting with relapsed/refractory patients, but we have plans for full development of the product, as you know, time goes on. Clearly, you know, the data you know, from TRANSFORM, you know, has been very encouraging for us to really move ALLO-501A as well into earlier lines of therapy when the time's come. Let me just add, you know, by saying, you know, we and others, I mean, certainly after we started talking about consolidation, you know, our peers are also talking about consolidation as an approach. There's a lot of, you know, good rationale, including very exciting emerging data. We are encouraged by it. You know, the way that we will approach in terms of consolidation in other programs, you know, that, you know, really have to depend on evidence-based, especially with the TurboCAR. I mean, that is a novel technology. I mean, you know what we, you know, a single infusion of TurboCAR, you know, construct will do is our key question. You know, stay tuned. You know, great questions. You know, we will do this step-by-step manner. Your next question comes to the line of Mark Breidenbach from Oppenheimer. Your line is now open. Hey. Hey, good afternoon. Thanks for taking the question. This is kind of related to one of the previous questions, but I guess I'm wondering, before the clinical holds were imposed, if you were able to enroll enough patients in the UNIVERSAL nirogacestat combination cohort and the consolidation dosing cohort and even the IGNITE study to potentially arrive at some sort of answer in 2022 as to which prong of your multi-prong strategy is working best in myeloma. Or if you really think you'll have to enroll additional patients from what you already have in these studies, before you'll be able to make any sort of conclusion one way or the other. Thank you. Mark, let me take the question. Obviously, clinical hold, you know, was a headwind for us. I mean, it-- we had to stop the enrollment in the clinical study. That will definitely impact, you know, some of the timelines that we have previously communicated. At this point, you know, we are not ready to really talk about, you know, the data flow. Much of what you're talking about, including the data from the IGNITE, our solid tumor study, the TurboCAR study of ALLO-605, as well as the combination, you know, with GSI, they were all planned in, you know, for 2022. We will make our best, attempt to keep the same timeline, but as expected, I mean, the clinical hold is, delaying the enrollment, obviously we cannot enroll any patients and the data generation timeline. Okay, fair enough. Thank you. Your next question comes to the line of Reni Benjamin from JMP Securities. Your line is now open. Hey, good afternoon, guys. Thanks for taking the questions. David, I know that you mentioned that you didn't wanna comment on how long the FDA may take, but could you maybe provide some bookends as to how long it might take for you guys to respond, you know, to the FDA? And I guess just, you know, maybe one for Eric. Is there any impact of the clinical hold on the Overland joint venture, or do you think any of the learnings that you kind of discover here or learn here can be automatically transferred to the China opportunity? Yeah. In terms of the first question, I know that, you know, that is central to, you know, in a lot of people's mind. You know, we will not provide any, you know, timeline on the resolution of the clinical hold. You know, be assured, I mean, you know, the team's working very productively for some additional data generation, and I think we are in pretty good shape to complete the response to the clinical hold. You know, the question around how long does FDA take before they respond to the response, you know, when a company responds to the clinical hold letter, the PDUFA clock for that is 30 days. I mean, that is a window during which they would have to respond, you know, they will have to act based on response that the sponsor provides to the clinical hold letter. Reni, thanks for the question on our Allogene Overland joint venture in China. Obviously we'll apply any learnings from our our interactions with the FDA and our investigation of the chromosomal abnormality to, you know, everything we do going forward. With regard to specific and direct impact on China and timelines, no, I don't think there is any. That joint venture is proceeding quite well. Obviously, we're still in the phase of building out infrastructure, including a manufacturing facility, so we can use the time to continue to lay that groundwork and hopefully be ready to conduct tech transfer in the future at an appropriate time. Great. Thanks for taking the questions. Your next question comes to the line of Benjamin Burnett from Stifel. Your line's now open. Yeah, good afternoon. This is Neil Hoolooman on for Ben. On ALLO-501 and the protocol around consolidated dosing, can you remind us what triggers the second dose? Do patients need to achieve a minimum response in order to get a second dose? Yes. That's correct. The patient has to have stable disease or better to get the second dose. They also get, as you know, ALLO-647 prior to the second dose if they meet some study criteria. If they progress after the first dose, then they don't go on the second dose. Great. Thank you. Your next question comes from the line of Asthika Goonewardene from Truist Securities. Your line's now open. Hi, guys. Thanks for taking my questions. I'm gonna do two as well. Just to follow up on Reni's question, what do you plan on announcing in regarding to the ongoing process? I'm wondering whether you will announce when you formally submit a response to the FDA's letter, or any other particular part of the whole process that's gonna happen here. Then maybe an academic question. How do you figure out the right window in which to give the second consolidation dose and maintain adequate pressure on the tumor? We noticed you guys did address that correctly with LBCL, but maybe the folks at CRISPR waited a little bit too long. As we think about rollouts in the other tumor types, what's your approach to really figure that out? Thanks. Asthika, it's Eric. Let me take the first question on our disclosure strategy. You know, we aren't intending to give a play-by-play of day-to-day activities at Allogene and interactions with the FDA. I don't honestly think that suits anyone well. Of course, we're committed to providing updates in a timely fashion when we do have something meaningful and relevant to report. Stay tuned. With respect to the, you know, second question, yes, it is a scientific question. You know, for us, one of the key things that we are trying to do with the consolidation is to give consolidation without having to give chemotherapy based on lymphodepletion. If we wait too long and when the patient cells do recover, I mean, you know, our, you know, belief is that you will need both ALLO-647, our anti-CD52 antibody as well as chemotherapy. I don't think we, you know, wanna go that direction, you know, which is why we are giving the consolidation right now, you know, essentially between 28 and 35 days after the first cell infusion is given. I think that really optimizes the, you know, cell expansion kinetics as well as our ability to use only ALLO-647 for the second cell infusion. Great. Thanks for taking my question, guys. Your next question comes to the line of Dane Leone from Raymond James. Your line's now open. Thank you for taking the questions two from me. Firstly, was the clone with the chromosomal abnormality found in the starting batch material ahead of infusion into the patient? Then, the second question I'd like to ask is, do you have any updated clarity in discussions around the design of a potential pivotal study for ALLO-501A, whether that study would contain a control arm or it would be a single arm study? Thank you. Okay, Dane, let me take the first question, and I'll ask Rafael to respond to the second one. In terms of, you know, when the chromosomal abnormality occurred, that's an important question. You know, there is a reasonable hypothesis that we believe that is making us say that this could be from the gene editing nuclease that we employ for the manufacturing of AlloCAR T cells. Equally possible is that, you know, this is more of a natural phenomenon that can occur at some frequency when T cells undergo expansion. Let me just stop there without going too much into the details of how much we know at this point. With regards to the trial design, as you know, David mentioned before, you know, these products have been all approved based on single-arm trials, including, you know, the most recent ones both in lymphoma and the most recent one in multiple myeloma. You know, we believe that we will follow the same path, particularly given the fact that we're an off-the-shelf therapy with, you know, the advantages of lack of apheresis and the ability to treat every patient and the differentiation with autologous products. At this point, that is our expectation and our belief that this will be a single-arm trial. Your next question comes from the line of Robert Burns from H.C. Wainwright. Your line is now open. Hi, this is Mitchell on for Robert. Thank you for taking our questions. The first question is, can you comment on any change in development plans after the clinical hold is lifted? Would there be potentially a faster route to approval with the post-CAR T setting that you anticipate pursuing? Okay. In terms of, you know, any changes in the clinical study design, obviously, you know, we will not, you know, go into that kind of details. But you know, we, you know, do a lot of careful thinking before we finalize clinical design, and we stand by in terms of, you know, how we are designing, studies, to safeguard the patients, as well as asking, you know, many questions that could advance the field of allogeneic CAR T therapy. Okay, great. Thank you. For 501A and the data that we could see at the actual ASH presentation, what incremental data set can we expect there versus what we have in the abstract? I think it's, you know, hard to sort of, you know, speak to that ahead of the Congress. I mean, we want to reserve the ability to present this and keep the confidentiality until the timelines of the Congress. You know, apologies for dodging the question, but stay tuned and you'll see the answer. ASH is only four weeks from now. Great. Thank you very much. Your next question comes from the line of Kalpit Patel from B. Riley. Your line is now open. Yes. Hi, good afternoon. Thanks for taking the question. Maybe a little more color on the planned phase II for ALLO-501A. I guess if you were to implement both single and consolidation dosing into your protocol, would it just simply be designed as two separate cohorts? I'm just trying to understand, you know, if you may need a greater number of total patients or even a larger study, and what was required if you were to add that extra cohort. Thanks for the question. Yeah. As I said before, I mean, without going into the details of how we will define the trial, we plan to have a single regimen in the study. You know, we don't plan to have a single dose and consolidation dose. It would be a single regimen and a single arm trial. That's as far as you know, we can go with regards to study design. Your last question comes from the line of David Dai from SMBC. Your line is now open. Hey, guys. Thanks for taking my questions. My last question around the ALLO-605, the triple CAR T. Could you share with us some of the type of cytokine armoring you're using to further improve the cytotoxic activity of the cells? And also, could you remind us for your clinical trial, are you using consolidation therapy? And also, are you also combining with GSK for the ALLO-605? Yes. The triple CAR study, we're extremely excited about that. The potential of these CARs to actually resist exhaustion and have a greater antitumor activity and potentially perhaps be able to use fewer cells. You know, these are cytokine signaling that are generally gamma chain, you know, cytokines that are, you know, trophic to T cells. You know, we haven't gone into the details of the specifics, but you can imagine that these are, you know, the kinds of cytokines that one sees, you know, to recover homeostasis after lymphodepletion. We may decide to use GSI. That is a decision that hasn't been made yet. In terms of consolidation, I think it's premature to tell whether or not we're gonna need consolidation or not. You know, we will know it when we have a little bit more data once we resume the trial. Thank you so much. Thank you. That concludes our question and answer session. I would like to turn the conference back over to management for any additional comments. Thank you again for joining the call today. We are deeply committed to patient safety. Excuse me. We are deeply committed to patient safety and continuing our work with FDA to find not only the best resolution today, but the best way to move our field forward tomorrow as we lead the field in the development of allogeneic CAR T products. Developing novel science into innovative therapies is not easy, but we are confident that we are the team to bring the first allogeneic CAR T therapies to patients. We are proud to take the lead to expand boundaries and to revolutionize the future of cancer immunotherapy. Operator, you may now disconnect. Thank you. Ladies and gentlemen, thank you for your participation in today's conference call. This does conclude the program, and you may now log off and disconnect.