Hello, and thank you for standing by, and welcome to Allogene Therapeutics fourth quarter and year-end 2021 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during this session, you'll need to press star one on your telephone. 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 welcome to all who have joined this call. After the market closed today, Allogene issued a press release that provides a business update and financial results for the fourth quarter and full year 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, Dr. Eric Schmidt, Chief Financial Officer, and a new voice on our quarterly calls, Dr. Alison Moore, Chief Technical 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 2022 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and 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. Thanks, Christine, and thank you all who have joined our call. I am very excited to talk about what we believe will be an important year for Allogene as we are working to advance three exciting clinical programs, from initiating our first pivotal trial in non-Hodgkin's lymphoma to progressing our mid-stage program in multiple myeloma to pivotal readiness and advancing our solid tumor clinical program to potential proof of concept. 2021 was both a year of significant pipeline achievement and unexpected challenge associated with a clinical hold, both of which played a meaningful role in moving Allogene and the field of allogeneic cell therapy forward. With our CD19 program, we demonstrated an important first for our field as the baseline data from our ALPHA trials continue to support the promise of our platform and our ability to provide safe and durable alternative to approved autologous CAR T therapies in patients with relapsed/refractory non-Hodgkin's lymphoma. Our next most advanced clinical program targeting BCMA is the leading AlloCAR T program in multiple myeloma. Our UNIVERSAL study opened the door for this modality as the first and still only trial to demonstrate substantive proof of concept for AlloCAR T in this disease setting. While we are proud to have established proof of concept, safety, and efficacy data in both lymphoma and myeloma, we are even more excited about the potential for AlloCAR T products to overcome the inherent limitations of autologous therapies. Today's marketplace for autologous cell therapy is constrained by treatment delays, supply limitations, and often a requirement that patients receive bridging chemotherapy. No matter how compelling the data on autologous therapies might be, they are of no value to the many patients who cannot gain access. With our AlloCAR T products, we have shown the ability to deliver treatments to patients within days rather than weeks. Patients who enroll in our studies can be nearly guaranteed to receive our products. In the ALPHA trials, 98% of enrolled patients received our products within a median time of two to five days from enrollment to the start of treatment. By comparison, in trials deploying autologous therapies for non-Hodgkin's lymphoma, up to 30% of patients who underwent successful leukapheresis for cell manufacturing were still unable to receive treatments due to interval disease progression while waiting for CAR T-cell products or due to manufacturing failures. Treatment delays are even more critical in the multiple myeloma setting, as many patients with rapidly progressing disease require bridging therapy as they wait for the manufacturing of their autologous CAR T-cells, and those who are unable to tolerate effective bridging chemotherapy may not be considered candidates for autologous therapy. Shortening time to treatment and ensuring access for nearly all suitable patients is just the beginning of how we are leveraging the attributes of AlloCAR T products. Our first allogeneic candidates are only the beginning of product innovation in the field of AlloCAR T. Our next generation products based on our TurboCAR and other technologies are aiming to enhance the efficacy and safety of allogeneic cell therapy. After the data presented in 2021 came an unexpected challenge, our clinical hold. While no company wants to be faced with a hold, the situation provided us the opportunity to retest our manufacturing processes and reconfirm the quality of our products. In responding to and quickly resolving the hold, our team, under the deft stewardship of Rafael, demonstrated the quality of leadership, collaboration, innovation, and focus required to be a pioneer in the field of AlloCAR T. I am incredibly proud of the manner in which our employees rose to this challenge. In retrospect, this experience provided us with the insight that we believe will give us a competitive edge as we look to lead the field of allogeneic cell therapy. We look forward to sharing the results from our scientific investigation in a peer-reviewed forum. As we prepare for the next stage in our life cycle with a planned ALLO-501A pivotal trial for relapsed refractory large B-cell lymphoma in mid-2022, we are also determined to minimize hurdles that could create delays at the time of our Biologics License Application submission. This brings us to our technical operations, product sciences, and manufacturing organizations. From the beginning, we have maintained that having in-house manufacturing capabilities is key to controlling the delivery of off-the-shelf CAR T therapies faster, more reliably, and at a greater scale, and we have invested heavily in this area. Our state-of-the-art manufacturing facility in Newark, California, called Cell Forge One, is now fully operational and producing GMP material with the intent of supplying ALLO-501A in our planned pivotal study. Our incredible technical operations team is led by Dr. Alison Moore. In early 2018, as we were forming Allogene, I knew Alison was the person I wanted as our Chief Technical Officer. When you are building something that has never been built before, there is no blueprint. You need someone who knows technology operations inside out. Alison came to Allogene with over 25 years of experience in chemistry, manufacturing, and controls, or CMC, at Amgen and Genentech, from process and product development to manufacturing, supply chain, global operations planning, and CMC regulatory affairs. I am immensely proud to work alongside Alison and knows there is no one better to navigate the evolving CMC landscape. We are excited to have her join the call today. I now would like to invite Rafael to preview our R&D priorities for the upcoming year. Thank you. As David has noted, I would like to focus my remarks today on the year ahead and our clinical programs as we prepare for our pivotal trial targeting CD19 and advance our BCMA and CD70 programs. As most are aware, we issued a press release on January tenth announcing that the FDA had removed the clinical hold on our AlloCAR T clinical trial. After our extensive investigation, it was determined that the chromosomal abnormality detected in a single patient treated with ALLO-501A was unrelated to TALEN gene editing or Allogene's manufacturing process and had no clinical significance. The abnormality was not detected in any manufactured AlloCAR T product or in any other patient treated with the same ALLO-501A lot. The abnormality developed after the cell product was administered and involved regions of the T-cell receptor and immunoglobulin genes known to undergo rearrangement as part of the T-cell or B-cell maturation process. During our hold, our engagement with study investigators was robust, and it was clear many were anxious for Allogene to resume study. We are pleased to have quickly resumed clinical trial activities and are enrolling patients focused on ALLO-715 and ALLO-605 for multiple myeloma and ALLO-316 for renal cell carcinoma. We have completed accrual in the ALLO-501 ALPHA study, and the study will now continue to assess longer-term patient follow-up. As such, we will be directing the full CD19 focus on ALLO-501A and finalize with the FDA a registrational approach prior to starting the pivotal ALPHA2 study. Prior to the start of phase II, we plan to resume enrollment in the phase I study in order to offer AlloCAR T to patients in need. Our ultimate goal is to deliver the first approved allogeneic CAR T product. We remain on track to start our ALLO-501A pivotal trial mid-year. One of the most commonly asked questions from investors is about pivotal trial design. Given the competitive nature of the field, we are prioritizing the finalization of our discussions with the FDA. We will share additional details on our single-arm 501A study at the time of trial initiation. Separately, and as Alison will discuss, we're front-loading many of the activities that address evolving CMC requirements ahead of what would be needed for a potential BLA submission. We believe our lymphodepletion regimen is differentiated through the use of ALLO-647, our anti-CD52 monoclonal antibody intended to enable enhanced expansion and persistence of AlloCAR T product candidates. Separate from our single-arm pivotal trial with ALLO-501A, we also intend to launch a standalone registrational trial for ALLO-647 at the time of the ALLO-501A pivotal trial. This randomized trial, referred to as the EXPAND trial, is intended to demonstrate the safety of ALLO-647 and its contribution to the overall benefit of the lymphodepletion regimen. Based on the data we have previously presented at medical conferences, we believe ALLO-647 enables a highly competitive product profile for patients with large B-cell lymphoma. We also remain very excited by the potential of our anti-BCMA program. Autologous CAR T therapies targeting BCMA have recently shown unprecedented response rates which appear well in excess of what has been achieved with any other modality in relapsed refractory myeloma. Yet there are few allogeneic BCMA programs in development with the potential to bring cell therapy to the large population of patients in need. This has been reinforced by discussions with investigators. Our multi-pronged strategy to address this opportunity includes the phase I UNIVERSAL trial, which has cohorts evaluating ALLO-715 as a monotherapy consolidation dosing and the combination of ALLO-715 with niraparib. The phase I IGNITE trial evaluating ALLO-605 is our first TurboCAR candidate which allows cytokine activation signaling to be engineered selectively into CAR T cells intended to improve the potency and persistence of allogeneic cells. Trial activity has resumed, and we plan to provide a BCMA program clinical update by the end of 2022. Findings from our UNIVERSAL trial on ALLO-715 indicate that an allogeneic CAR T therapy can be delivered rapidly and without the need for bridging therapy to patients with refractory multiple myeloma, and that a single dose of therapy was capable of inducing deep responses. We are pleased that ALLO-715 as a monotherapy could achieve and maintain meaningful response rates similar to the approved autologous CAR T therapy with a high rate of MRD negativity for patients achieving VGPR or better responses. The benefits of an allogeneic option are especially valuable in aggressive disease like relapsed refractory multiple myeloma even with new potential therapies in the horizon. Through ample discussions with investigators, the need for more therapy options is clear, and they often emphasize that an allowable margin for efficacy is offset by benefits provided by the off-the-shelf alternative. Before I welcome Alison to discuss our technical operations, I would like to comment briefly on our clinical development of ALLO-316, our anti-CD70 AlloCAR T candidate for solid tumors. Clinical trial activities have resumed for our phase I TRAVERSE trial, which is designed to evaluate the safety, tolerability, and antitumor efficacy of ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma. Metastatic solid tumors have historically been a challenge regardless of treatment modality. The five-year survival rate for patients with advanced kidney cancer is less than 15%. This underscores not only the unmet need but also the necessity for scientific innovation. CAR T therapies in general have faced significant challenges in solid tumors, which can be summarized in three areas, target recognition and selectivity, trafficking, and survival within the tumor. We're working to overcome these issues with our AlloCAR T platform, including several next generation approaches to overcome the inhibitory signals of the tumor microenvironment. Meanwhile, we look forward to generating data from our ongoing phase I dose escalation trial. I would now like to turn the call over to Alison. Thank you, Rafael. I've been fortunate in my career to build high-performing teams, bring multiple medicines to market, build state-of-the-art manufacturing facilities, and redefine the scope of process development. However, a career highlight and something I am most proud of has been the progress we've made in making AlloCAR T a reality for patients. When I joined Allogene in 2018, we were a small team working to do something that had never been done before, create off-the-shelf CAR T products for patients with cancer from the T cells of healthy donors. Our first clinical data presentation in 2020 provided initial proof of concept for the industry, showing that our allogeneic products have the potential to improve patients' lives. It represented two years of rigorous work, creativity, problem-solving, and collaboration. Understanding product quality is paramount to the development of safe and effective products. In our increasingly complex world of biopharmaceutical development, the design and control of product quality is far from simple, and we've seen time and time again in cell therapy how manufacturing delays or issues translate into patients not getting treatment. That is why excellent CMC science is so critical. It is the convergence of multiple disciplines coming together to solve some of our most difficult challenges. I've been fortunate to have worked on many modalities, including monoclonal antibodies, viruses, and bispecifics, but I'm particularly excited about advancing cell therapies. While we stand on the shoulders of the autologous pioneers, the field continues to evolve dramatically as the science, the industry, and regulators become increasingly sophisticated. The evolution is clear. In the emerging cell and gene therapy field, the CMC work toward a BLA submission cannot be an afterthought. It is critical for demonstrating the quality of our product, the reproducibility of the process, and the control strategy. Any gaps or weaknesses can compromise the entire submission. In the development of monoclonal antibodies, for instance, teams may have years during phase II and phase III clinical development in which we could study performance of the process and methods and the opportunity to optimize production. In the development of CAR T therapy for late stage cancer, we have the privilege of starting pivotal trials relatively quickly following the recognition that these product candidates have game-changing potential for patients. This expedited timeline is unique for CMC practitioners, and ensuring the right experience within our teams is of utmost importance. Failure to understand the evolving landscape and FDA requirements can be a common pitfall and a cause of delay for new product approvals. The ability to produce safe and effective biologic products from complex raw materials is the difference between hope and reality for patients in need. While the start of any pivotal trial is exciting, approval is the ultimate goal. At Allogene, we are focused on mitigating risks as we look ahead to the BLA submission by moving up the timeline for important CMC validation work prior to the start of the pivotal program. This improves our measurement of quality attributes and enables robust characterization for approval. Strong process and product validation support our ability to deliver a well-characterized biologic with minimized variability. We believe this will work to our advantage in the long term and set us up for success. Understanding a live product requires collaboration across many disciplines, including process development, clinical research, translational sciences, and biometrics. I am so proud of the proactive work being done by our incredible teams to eliminate the potential downstream delays and to, more importantly, be able to say with confidence that we can safely and effectively deliver to patients the promise of our AlloCAR T product. We look forward to advancing this important area of drug development and building a robust regulatory dossier that effectively communicates the strategic design and strong execution of our CMC activities. I will now turn the call over to Eric. Thank you, Alison. During meetings with investors, we often get a multitude of questions on manufacturing and the evolving gene and cell therapy CMC landscape. We're quite privileged to have in Alison someone so experienced and visionary at the helm of our operations technology group. Before I provide a brief overview of our financials for the quarter and year-end, I'd like to spend a few minutes on a topic that's been at the forefront of the industry in today's very challenging market environment, cash runway. We are very fortunate to be in a strong financial position, ending the year with $810 million in cash equivalents, and investments and no debt. As you may have been able to discern from comments by David, Rafael, and Alison, one of the most critical elements of our corporate and financial strategy is to efficiently deploy our capital resources to support value-enhancing programs that will drive long-term growth. In 2022, we have taken important measures designed to keep our cash burn below $300 million. This means focusing on our most critical activities, including one, starting of our ALLO-501A pivotal trial, two, capitalizing on the tremendous opportunity in multiple myeloma, and three, continued exploration of the role of AlloCAR T in solid tumors. We strongly believe we have the operational capabilities, scientific prowess, and resources needed to succeed in all three. Taking into account the incremental investment needed to support our first pivotal trial and fully operationalize Cell Forge 1, we expect our full year 2022 GAAP operating expenses to be between $360 million and $390 million, including estimated non-cash stock-based compensation expense of $90 million-$100 million. This guidance excludes any impact from potential business development activities. As we review our financials for 2021, for the full year of 2021, research and development expenses were $220.2 million, which includes $39.6 million in expenses associated with non-cash stock-based compensation. For the full year of 2021, general and administrative expenses were $74.1 million, which includes $41.2 million of non-cash stock-based compensation expense. For the full year of 2021, our net loss was $257.0 million or $1.89 per share, including non-cash stock-based compensation expense of $80.8 million. With that, we will now open the call for your questions. Thank you. As a reminder, to ask a question, you'll need to press star one on your telephone. To withdraw your question, press the pound key. Our first question comes from Michael Yee with Jefferies. Your line is open. Hey guys, thanks for the call, and thanks for the update. We had two questions. One was appreciating all the color you discussed around CMC and manufacturing. I guess maybe you could shed some light without giving too much away competitively on what you're working on and what competitive advantage or what, you know, what insights you can provide us on that advantage that you would have confidence that you will start the pivotal CD19 study by mid-year. In other words, you're commenting about all of this, and those are the gating factors. Maybe give us some color on that. The second relates to later this year, there's a myeloma update. Can you just remind us on expectations? Presumably, that's mostly data on the first generation, but not likely to have real data on TurboCAR. Thank you. Hey, Michael, this is David. Thanks for, you know, those two questions. Obviously, the CMC, you know, question, that's not something that we have spoken about in our previous earnings call. Also, this is an area that probably is, you know, very complex and you know, we don't wanna tip too much of our hand about revealing too much. Since Alison has joined in, I'll ask her to provide some high-level response to your questions about what's being done on the CMC side. Alison? Thanks, David, and thanks, Michael. Yeah, obviously, on the CMC side, we are really excited to advance product from Cell Forge 1. Cell Forge 1 was designed and built to support commercial supply, and we're so excited that that is already generating GMP material. We are really interested and excited, as I described in my comments, to really demonstrate that we understand our product really well. We think that this helps all the way through development. It helps me provide the best support for our clinical colleagues, and it allows us to make modifications, optimizations, and refinements as we go towards BLA filing. Thank you. It sounds like it's really about Cell Forge 1. That's a big part of this, given that that's gonna support commercialization. On myeloma. Yeah. You know, just on that, I mean, you know, as Alison had said, you know, we are trying to front load as much CMC activity, you know, ahead of the BLA filings. You know, we are taking very careful measures to address, you know, what's known, as well as potential issues that may come up down the line. You know, the being able to launch the pivotal study with the materials coming from the CF1 is one of the big things that we are trying to do. With that, on the myeloma data, you know, Rafael? Yeah, thanks, Michael. As you know, we presented at ASH data on 43 patients, and in my remarks, I spoke about how excited we were about the data and how, you know, it did really compares very well to the approved product that's out there in terms of responses, VGPR plus as well as durability. The interesting thing is that the follow-up was actually not long, so we continued to follow up these patients, and the durability may still improve. We are really excited about the fact that it's being really well received both by investigators and non-investigator opinion leaders in terms of the results that are obtained with a product that essentially is able to treat virtually every patient as opposed to the autologous product. We look forward to providing an update. As I mentioned before, that would be towards the end of the year, and it would include the patients that we have treated with nirogacestat. We are now treating, now that the hold is over, patients on ALLO-605. Depending on the number of patients on the follow-up, we may be able to include some of those patients in that update towards the end of the year. Stay tuned. It's a really exciting program that, you know, we are testing several approaches, and it will be a big decision point for us this year. Thank you. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Good afternoon. Thanks for taking my question. Could you just speak to the ongoing discussions that you're having with the FDA that have to be finalized prior to commencing the pivotal ALPHA2 trial? And then secondly, with the CD70 program, how should we think about what the bar is here for what you'd want to see for that to be kind of a positive step to then move forward? Salveen, you're making my job easy. I can defer again to Rafael to answer both of those questions. Rafael? Yes. We've been having discussions with the FDA during the whole, which you know, I think speaks to the interest and mutual interest on moving this allogeneic program forward. We, as you know, are co-developing ALLO-647 as well. We have had discussions as well in terms of how to develop that product. ALLO-647, you know, gives us a lot of precision with regards to lymphodepletion. In order for it to be approved as co-development, the agency obviously requires evidence of benefit-risk. Those discussions are being finalized. We are actually quite advanced on them. We are very confident that the ALLO-501A study will start by mid-year, followed shortly by the ALLO-647 trial. Both trials are going to be in execution mode. We are working very closely with Alison and her team to ensure that we work together in sync and that we finish this trial without any issues with regards to designs or any issues with regards to CMC that may jeopardize you know our ability to complete the trial. Stay tuned, but the discussions are proceeding according to plan, and we have full confidence on our ability to start by mid-year. CD70. On the CD70 program, the CD70 program has resumed. It's really exciting program. We had started treating patients, and we're continuing now. There's excitement in the investigator community about this program. It's in renal cell carcinoma, as you know, but it's got a lot of potential in other solid tumors and hematologic malignancies. With regards to the bar, as I said before, you know, these patients unfortunately once they fail checkpoint inhibitors and angiogenesis inhibitors, even if they get more than one line of therapy, their five-year survival is quite low, you know, in the order of 10%-15%. Obviously it's early for us to have discussions with regards to what is it that would you know be a meaningful regulatory threshold for approval. You know, this is something that we will obviously evaluate as we see it. Clearly, investigators would be happy with response rates because really after patients are exhausting the therapies, there really isn't very much that works. You know, we will have those discussions once we know a little bit more. It's a little bit early in the program for us to be able to tell. Thank you. Thank you. Our next question comes from Tyler Van Buren with Cowen. Your line is open. Hey, guys. Thanks very much for taking the questions. Related to the separate ALLO-647 registrational trial, beyond safety, can you provide more specifics on what needs to be demonstrated for approval? The second question is, it should allow you guys to comprehensively detail the safety profile and demonstrate if it's adding any safety events to the AlloCAR T regimen, which could be beneficial given the historical theoretical concerns of infections, right? Other than endpoints required for approval, is this a significant purpose of the trial in your eyes? Yes. As I said before, ALLO-647, we view it as a competitive advantage. As you know, lymphodepletion is critical in the allogeneic space, and ALLO-647 has provided us with incredible precision with regards to T-cell depletion, which is required in the allogeneic setting for the avoidance of rejection. But because it's co-development, and I've been involved in the development of many drugs, including co-development drugs, FDA requires the benefit-risk to be shown and demonstrated for each one of the components, both ALLO-647 and ALLO-501A. Hence the second study that's required. It is going to be a randomized trial. It will compare two FC. We are pretty confident that ALLO-647 leads to better outcomes and you know, the need for lymphodepletion has been shown not just in our program, but in other programs as well. ALLO-647, it's been a component that has been studied at multiple doses in our program. We're very confident that this is a study that's gonna show that ALLO-647 shows superiority to FC alone. Importantly, that the safety of it is actually you know, very comparable with regards to what you see in the autologous setting. We haven't actually seen with the use of ALLO-647 more infections or grade 3+ infections than are seen in the autologous setting. You are absolutely right. We expect to demonstrate that ALLO-647 is superior to FC alone, and also that the tolerability of FCA is on par with what's seen with autologous CAR Ts. Thank you. Our next question comes from Michael Schmidt with Guggenheim Securities. Your line is open. Hey, this is Kelsey on for Michael. Thanks for taking our questions. I guess just to confirm one thing, will there be any update on the phase I datasets from the CD19 program? Secondly on BCMA, I guess, will you wait to see the ALLO-605 data before making a go-forward decision for the franchise? Or would you consider advancing both ALLO-715 and ALLO-605? Thank you. Hi, Kelsey. I'm gonna ask Eric to respond to both of your questions. Eric? Thanks, Kelsey. In terms of the CD19 updates, yes, you can expect that we'll present a longer-term follow-up data set, you know, at some future medical meeting as we continue to observe and monitor patients that have been previously dosed in that study. We don't exactly, you know the form for that yet. But just as a reminder, we've been really pleased with the durability in particular that we have been able to show, as of the ASH data cutoff, gratifying to see 10 out of the 14 patients who achieved a complete response still in a complete response. We're keen to see just how much longer those responses can last. Then on your second question, the evaluation of our BCMA program, it's nice to be back in control of this program, back in the clinic, with the ability to execute across our multi-pronged strategy. Yes, we think 2022 is gonna be a critical year for generating datasets across many of our strategies. Hopefully by the end of the year, as Rafael has already mentioned, we'll have enough data to begin to make a decision on next program steps. Got it. Thank you. Thank you. Our next question comes from Mark Breidenbach with Oppenheimer. Your line is open. Hey, guys. Good afternoon. Thanks for taking the question. I know you said you wouldn't tell us much about the pivotal study design, but I'll try anyway. Just given the closeness between the ORR and the CR rates you've seen in ALPHA2, I'm wondering if you're currently viewing CR rate as a potential or likely registrational endpoint in that study. If so, I'm just wondering if you can point us to any precedents, you know, that have recent approvals in DLBCL or large B-cell lymphomas that might serve as a kind of a model to build this trial after. Thank you. Hey, Mark, let me take on that question. As Rafael has said, ALLO-501A, you know, that's proceeding as a single pivotal study. In any single study, two important, you know, elements of the efficacy measure is the response rate or objective response rate, and then the second one is the durability of the response. That has been part of the discussion with FDA, and, you know, we expect that those two primary and co-primary, you know, endpoint will be the key way, you know, measures of efficacy. Certainly, you know, safety is another part, you know, which will be also part of, you know, I expect to be the data review. Okay, super helpful. Thanks for taking the question. Our next question comes from Reni Benjamin with JMP Securities. Your line is open. Hey, good afternoon, guys. Thanks for taking the questions. There's two for me. Yeah, just going back to the ALLO-647 study. Can you talk a little bit about, you know, if for some reason, you know, it's a randomized study and that trial fails, how that might impact the entire application of ALLO-501A and ALLO-647. If it works, just, you know, kind of thinking out of the box here, could this be used as a general lymphodepletion regimen, potentially even with autologous therapies, so almost, you know, sold sort of separately? Just something for, I'm sure this is more for Eric, just a status update on the development partnerships. The ones that interest me in particular are Notch and your recent collaboration with Aethon. I'm kinda curious, you know, when you're striking these relationships, yeah, well, how do you plan on uncovering the value, or is this just something that you wanna, you know, kinda keep abreast on because it's pretty novel and new technology? Any update on Overland, the joint venture, if there's a deliverable this year we can keep track of? Thanks. You know, both, you know, all three great questions. You know, the question about the ALLO-647, you know, this is a drug co-development where we have to demonstrate the contribution of ALLO-647 to lymphodepletion. This is an area that we have, you know, at this point, more than, you know, enough datasets coming from both CD19, ALLO-501A program, as well as multiple myeloma program. Certainly, you know, there is a possibility of, you know, study failure, but all the information that we have right now, you know, we feel very comfortable and confident that the study will demonstrate the contribution of ALLO-647 in a meaningful way. The second question, this is something that we frequently, you know, have a discussion internally. You know, which is really how can we best leverage the potential benefit of ALLO-647, not just in our own allogeneic setting, but can it extend to, you know, other settings such as autologous? I would not rule that out. For now, you know, our main focus is optimizing the use of ALLO-647. Also in some of our studies, we are trying to see whether we can tease out and lower the chemotherapy-based lymphodepletion, you know, moving more towards the biologic lymphodepletion, which we find to have, you know, several benefits. That will be our, you know, initial attention. Certainly your question of, you know, can this be used in an autologous setting is something that we are also looking into, but, you know, that will not be immediate. Yo u know, third question I'm gonna ask, you know, Eric to respond to. Okay. Thanks, Ren. I guess I'll get your third question, all three or four or five subparts, however many were in there, relating to our technology partners. Yeah, at this point in time, we've formed a number of relationships that we really feel give us as much access to gene engineering and cell engineering as we could probably want, including some of the relationships you've mentioned with Notch, Aethon, and the joint venture, but others that have been undisclosed that provide additional domain expertise and engineering modality relationships. In terms of Notch in particular, where we're looking at the ability to make fully functional T cells from an iPSC source, that partnership is going really quite well. Notch has made a lot of progress in the almost two years now since we've been working with them. Much of the work is focused on continued engineering and scale-up of their product. On the Aethon side, a new relationship for us, where we're partnering to look at their multiplex knockdown technology to add greater functionality to some of our gene and cell engineering capabilities. Very new relationship, but we view them as leaders in this space and very pleased that we think Allogene will be a focus project for them. Lastly, on the joint venture with Allogene Overland in China, giving us access to an important commercial territory, that entity has begun building out a manufacturing facility in China, which will be required to commercialize our therapies, and they're making quite good progress as well. We'd hope to be able to launch that facility later this year. Thank you for the question. Thank you. Thank you. Our next question comes from Luca Issi with RBC. Your line is open. Oh, great. Thanks so much for taking my question. Maybe on ALLO-647, you know, obviously the FDA is asking you to study the contribution of ALLO-647. Is this something that is just limited to non-Hodgkin's lymphoma, or should we expect the FDA may ask you for similar trials also for multiple myeloma and solid tumors? Maybe on business development, we've seen a couple of deals recently, where companies have decided to monetize some of their extra manufacturing capability to extend their runway, including Atara, Fujifilm, or Homology, Oxford. Wondering what was your reaction to those deals, and this is something that you may consider. Lastly, for CD70, I think I've seen on clinicaltrials.gov that the size of TRAVERSE actually has increased from 48 patients to 120 patients a couple of weeks back. Wondering if you have any color on that. Thanks so much. Okay. The first question? Yeah. You know, the ALLO-647, you're asking whether for different indications there's a need to do additional studies. I mean- Correct. We see the lymphodepletion as something that is, you know, generalizable and extendable to other indications. I mean, that's our current position. We have not had any specific discussion with the regulatory agencies about how to deal with the contribution of ALLO-647 in lymphodepletion in different indications. You know, stay tuned. On our manufacturing plans, Luca, no is the short answer there. As you heard from Alison Moore, we view ownership of the CF 1 facility, our Cell Forge 1 facility, is absolutely critical to our ability to function and commercialize across a slew of product opportunities. Given our strong cash position, $800 million+, we don't see any need or interest in monetizing that in any way, shape, or form. Just the opposite. We're gonna continue to invest. On the TRAVERSE clinicaltrials.gov listing, I wouldn't read much into that, honestly. The clinical team often includes in a number of different parameter changes to our studies, and those changes are designed to provide the utmost in flexibility going forward. Certainly we don't have plans at this stage to enroll the full cohort of patients that you referenced. Thank you. As a reminder, in the interest of time, please limit yourself to one question. Our next question comes from Asthika Goonewardene with Truist. Your line is open. Hi, guys. Thanks for taking the questions. I wanna pick on Alison since she's on the call today, if I may. Alison, a while back, in discussion, we were talking about the goal of the allogeneic cell therapies is to get maybe around 1,000 or more batches out of a single donor draw. But you had some ways to go in reaching that. And a little while back, I think I remember you telling us that you were getting around maybe 100 batches per draw. Where are you on that today? And then also related, more generally, as you are you able to get these incremental innovations to manufacturing incorporated into the production of cell therapies that are already in the clinic, or does that essentially require a lot of new work and maybe even a new IND? Thanks. Thank you. Yes, great question. Our goal at Allogene has been from a single leukapheresis enables approximately 100 doses. That has been our goal. That's still what we are working towards. I can say that we know that we can do that, and already we have been very successful in optimizing yield. I think that our focus right now is to ensure supply across all of these programs. Certainly, as a process developer, I can see that there is extensive potential for us to continue to optimize yield. I would answer you by saying that we have more than an adequate performance there in terms of doses. There's definitely the opportunity for further improvement there in the future. Regarding your question with respect to the introduction of novel technologies, this is certainly not just a question across all biologics products. It really relates to the magnitude of the technology change and how well you understand your product and your process. We certainly have been able to introduce some novel technologies that we're very excited about, but we will always do that in collaboration with the agency and with the very best analytical measures. That's why focusing on product quality and the measurement of product quality is always in our best interest. Great. Thanks for the call. I appreciate that. Thank you. Our next question comes from John Newman with Canaccord. Your line is open. Hey, guys. Thank you for all the information on the call, and thank you for taking my question. My question is just wondering if you're confident that you can get the patient population in the pivotal study that is representative of patients that are currently receiving the autologous therapies. The reason I'm asking is I feel like you're, you know, some of the most recent updates, you've had some patients that have already had treatment with CD19 therapies and failed them. I feel like to get a true accurate picture of the true potential of this product, the ALLO-501 product, the agency might be curious as to what it looks like in a population similar to the autologous therapy. Without getting into too much detail about the design, just curious if you're confident that you'll be able to do that in the pivotal trial. Thanks. Thanks, John, for the question. It's a great question. I can tell you that in a phase I study, you know, we go through a variety of clinical situations with regards to the kinds of patients that we enroll. You know, one of the questions obviously is what happens to patients that have received CD19 directed therapy as an example, which you mentioned. We, that doesn't mean that the population that we put in the phase I study, where we're looking at doses and we're looking at populations, et cetera, is going to be the one that is actually in the pivotal study. Those discussions are, as I said, you know, will take place and have been taking place with FDA. We fully expect, and our investigators are backing us up with regards to this, that they will be representative of the patients that are entering into autologous therapies with the caveat that obviously they will enter sooner and obviously they won't need apheresis and will be able to get the therapy, the majority of the patients. We have actually no doubt that, you know, this is achievable. Thank you. Our next question comes from Raju Prasad with William Blair. Your line is open. Thanks for the question. Just wanted to get a sense of the bar on the BCMA program in terms of maybe patient numbers and durability at the kinda go-forward dose that you're looking at before taking whichever program forward. Just curious to know how much data that you need from the nirogacestat program as well as ALLO-605 to really make that decision and how much the potential, you know, efficacy improvements of the autologous, approved autologous therapies if Cilta-cel is approved on the 28th plays a role into kind of the decision-making process. Thanks. Great question. I'm gonna ask Eric to respond to that. Yeah, thanks for that, Raj. You know, first again, I think we're in a fortunate position to be evaluating multiple different strategies, starting off of a strong foundation with what we've already shown on ALLO-715. You know, specifically there, as Rafael has already commented, that ALLO-715 profile essentially being right on par with the approved autologous therapy. Obviously we're trying to build off that foundation with either, you know, the combination approach that you mentioned or consolidation therapy or the ALLO-605 TurboCARs that we're also very keen on. In terms of where the bar is going forward, you know, you referenced, I think the Cilta-cel PDUFA date, which is upcoming here. You know, we and everyone else are very persuaded by the compelling results that Johnson & Johnson and Legend Biotech have been able to produce with that product. I think it really highlights what's possible with an autologous cell therapy, and the results are unprecedented. You know, it also is quite clear that even the most efficacious drugs Excuse me, they are important if they can't be delivered to patients in need. As you know, the current market for autologous therapies is quite capacity constrained. While we would expect supply to increase, we don't know by how much without approval. Even more importantly, the autologous cell therapies are, you know, unlikely to ever be applicable to certain patient subset populations. Specifically, I guess I'm thinking about those patients who can't wait weeks to months to be scheduled for collection and manufacturing. Also those patients who can't tolerate the bridging chemotherapy, which is being given to the majority of patients in the autologous study. You know, for those reasons, we really think we have a pretty clean opportunity with our off-the-shelf product, and we're very focused on making the most of that opportunity as we collect the data and move forward. Thank you. Our next question comes from Jason Gerberry with Bank of America. Your line is open. Hi, this is Terry on the line for Jason. Thanks for taking our question. I've two parts. One is regarding manufacturing, the other is kind of on the broader BCMA development. For in-house manufacturing, I guess, are you expecting your in-house capabilities to fully support both the physical pivotal as well as the commercial demand for five oh one? Does in-house manufacturing address vector supply, or is that something that's partnered with a third-party manufacturer? Regarding BCMA development, you know, think about the broader spaces, some of the autologous market leaders are moving into the third-line setting, potentially having data by the time that you start a pivotal in one of your approaches. I'm wondering, is there potential to start a pivotal trial in the third line setting, given the way that the space is evolving towards earlier lines? Thanks. Yeah, Alison, do you wanna take the manufacturing question? I'll take the manufacturing question very quickly. Our facility is designed and built to be focused on CAR T at this time, although the build is modular, and we could do other things in addition. The answer is yes, it will have the capacity to supply commercial product for 501A. Regarding other raw materials, including critical raw materials, we have a broad network of third-party suppliers that we work with on a daily basis. Yeah. I think the point that you make about BCMA is a good one. You know, these therapies will make their way into earlier lines of therapy. You know, as you know, they start in later lines of therapy first. Just like we plan to do in lymphoma, once we make the decision, then we will be developing a comprehensive program on BCMA. Thank you. In the interest of time, we can take one more question, and that is from Dane Leone with Raymond James. Your line is open. Hi, thanks for taking the questions. One kind of interrelated question. This is just something we get asked almost in every meeting with investors. Do you have an updated view on the impact of prior CD19 therapy, like tafasitamab within the lymphoma program? That was an outstanding question that continues to be discussed since the presentation, the update of the ALPHA program during ASH. Within that vein, of developing in multiple myeloma, does your team have a view of why or why not prior BCMA targeted therapy would have a similar potential detrimental effect in responses to an allogeneic cell therapy product, like has been discussed in lymphoma with CD19? Thank you. Yeah. With respect to CD19 prior therapy, I mean, the data in autologous is actually, you know, very telling as well. Many patients do not respond, particularly if they were primary refractory or they relapse relatively quickly. This is something that we are seeing as well in the allogeneic setting. We are not keen on enrolling these patients, you know, going forward. With respect to BCMA, we actually don't have much experience with BCMA-experienced patients, so we can't really answer the question. You know, whether there are parallels with CD19 in BCMA, I think that's a question to be answered. You know, currently, we plan to study BCMA-naive patients. Thank you. That concludes the 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. Based on our strong execution since inception, coupled with healthy cash position and our focused approach on drug development, I believe we remain positioned to transform and lead the field of allogeneic CAR T. We look forward to sharing our continued progress with you throughout the year. Operator, you may now disconnect. Thank you. Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now log off and disconnect.