Allogene Therapeutics Inc (ALLO) 2022 Q2 法說會逐字稿

Hello. Thank you for standing by, and welcome to Allogene Therapeutics Second Quarter of 2022 Conference Call. (Operator Instructions) 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 our Q2 call. After market close, we issued a business update and financial results press release for the second quarter of 2022. This press release and today's webcast are available on our website. We ask you to limit your questions to one per person and we'll do our best to get to as many as possible during the hour.

Joining me today are Dr. David Chang, President and Chief Executive Officer; Dr. Rafael Amado, Executive Vice President of Research and Development; and Dr. Eric Schmidt, Chief Financial Officer.

During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities and 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 the 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. Since our last update, we have continued to make significant progress across our pipeline from our lead CD19 candidate, ALLO-501A and our lead BCMA candidate, ALLO-715 to our first solid tumor candidate, ALLO-316. We believe each of these programs have promising potential and we remain focused on advancing these candidates in a way that will allow us to define, shape and expand the future of cell therapy.

This month marks the 5-year anniversary of the first approval of an autologous CAR-T therapy targeting CD19. Since that time, the field has benefited from additional successes. Spec tact to our data sets, reaffirming the treatment benefit coming from onetime infusion, labor expansions to earlier lines as well as to other B-cell lymphomas and approval of new CAR-T therapies targeting BCMA for multiple myeloma. Yet one thing that has not changed is the challenges associated with delivery. As recently published in the Journal of Clinical Oncology, real-world access to autologous CAR-T remains constrained due to individualized patient manufacturing, among other challenges.

This study reported that the median waiting time for an FDA-approved CAR-T treatment for multiple myeloma patients was 6 months, and that only 25% of patients eventually receive CAR-T therapy. While the focus in this study was multiple myeloma, long wait times and supply limitations on cell therapy have also been documented in non-Hodgkin lymphoma. Clinicians have been forced into the unsatiable position of needing to choose which of their patients will receive potential life-saving therapy. As you may recall from market research we presented in May 2021 at our CD19 forum from over 2,000 separate physician appraisals, efficacy parameters are the single most important consideration in decision-making. But importantly, this research foreshadows the current market crisis by uncovering other factors that influence physician decision-making.

These included the likelihood that a patient receives the prescribed treatment, the time to treatment and other logistical considerations. We started Allogene with the goal of correcting this limitations associated with the delivery of autologous CAR-T therapy by developing our CAR-T products and making them readily available to all eligible patients. 4 years into our journey, we believe we are in a path to transform CAR-T therapy from a complex individualized procedure to an off-the-shelf, on-demand pharmaceutical product.

Last year, we embarked on a complex set of regulatory discussions directed at enabling the first potential pivotal Phase II trial of an allogeneic CAR-T therapy. I am very pleased by the progress we have made and confident that in coming weeks, we could be initiating the industry's first pivotal trial for an allogeneic CAR-T product, thereby paving the road not just for ALLO-501A and our pipeline candidates, but for the field more broadly. The protocols we have put before FDA for the ALPHA2 Phase II trial was informed by clinical and translational data we accumulated in Phase I trials, and we look forward to sharing study details once FDA clearance for the study has been obtained.

Throughout the development process, clinical data often gets the spotlight. But for complex cell and gene therapy products, chemistry manufacturing and controls or CMC work is often rate limiting. We are optimistic regarding the package of CMC information we have provided to the FDA. As we have previously noted, we believe the ability to launch ALLO-501A Phase II pivotal trial with cell products that have been manufactured at our intended commercial facility would be a major competitive advantage at the time of BLA submission and launch of ALLO-501A. We are grateful to the FDA for its ongoing co-operative engagement over the course of many clinical, regulatory and manufacturing discussions, especially given their staff constraints and increased workload.

As we wait for the initiation of our ALLO-501A Phase II pivotal trial, we are already thinking about what comes next, including how to expand access of AlloCAR T to earlier lines of therapy and how to bring AlloCAR T products to other patient populations. This includes evaluating the opportunity to advance ALLO-715, our lead candidate for relapsed refractory multiple myeloma into a potential pivotal trial and continued execution on our Phase I trial for ALLO-316 in renal cell carcinoma. I am incredibly grateful to our one Allogene team that remains laser-focused on our vision to deliver the first AlloCAR T products.

I'm also grateful to have many insights coming from Allogene by way of people who are equally energized about our mission. To that end, we welcome Dr. Stephen Mayo, a world renowned expert in computational protein design to Allogene's Board of Directors. Dr. Mayo is the Bren Professor of Biology and Chemistry, and Merkin Institute Professor at the California Institute of Technology. His decade strong success record in both academia and the biopharmaceutical industry will help us to advance our pipeline of investigational AlloCAR T products. Together, with each advances we make across our AlloCAR T pipeline, we are one step closer to creating a new reality for patients. We are grateful for your support.

I will now turn the call over to Rafael.

Thank you, David. Let me first start briefly as it relates to our planned ALPHA2 Phase II pivotal trial of ALLO-501A in third line large B cell lymphoma or LBCL. While the initiation of the trial remains subject to final FDA review, we are confident in our proposed design of this trial and appreciative of the collaboration we have had with our investigators as we analyze all the data across doses and schedules from the Phase I portion. Prior to submitting our proposed protocol to the FDA, we undertook an in-depth analysis of our data to determine the best dosing strategy to pursue in the pivotal trial.

This included assessment of the depth and durability of clinical responses, analysis of translational data on AlloCAR T cell expansion and persistence, feedback from investigators and engagement with regulatory authorities. We look forward to sharing more with you once we have initiated the trial. As you may recall, we are planning to conduct the EXPAND trial to establish the contribution of ALLO-647 to the lymphodepletion regimen. We have also conducted a thorough analysis of ALLO-647 dosing, pharmacokinetics and pharmacodynamics. We believe the use of ALLO-647 is critical to enabling safe and effective indication and uniquely able to create a needed window for AlloCAR T expansion and persistence. The wealth of Phase I dose ranging data that we have generated across our CD19 program has shown us that ALLO-647 dosing is critical to achieving optimal efficacy and has allowed us to zero in on the preferred (inaudible) regimen.

We have shown a strong correlation between serum concentrations of ALLO-647 and the likelihood of clinical response. Our data as well as those of our partners and competitors substantiate our belief that this trial will not only result in a positive outcome, but also differentiate our platform by demonstrating that including ALLO-647 in the lymphodepletion regimen continues to secure outcomes, including durability of response. The EXPAND trial is expected to begin later in 2022.

We also plan to provide an update on the Phase I portion of the ALPHA and ALPHA2 trials at the end of 2022. This update will focus on longer-term follow-up of patients previously treated in both trials. I am incredibly proud of the hard work across functions as we prepare for this first of its kind trial. Our goal has been to supply pivotal trial material from Cell Forge 1 to reduce complexity and risk through our regulatory strategy, including the requirement that we establish comparability between material used in our pivotal trial and material intended for commercialization. We chose to mitigate future risks, including at the BLA submission stage, by working to have material sourced from Cell Forge 1 using an optimized process available prior to the start of the pivotal program. We believe our strong process and profitalization capabilities support our ability to deliver a well-characterized biologic with minimal variability and hopefully will allow us to avoid the undue delays that have been observed in the cell therapy field.

I am grateful for the partnership with Dr. Alison Moore, our Chief Technical Officer, and thank the team for its leadership, collaboration and focus, all admirable traits that are required to be a pioneer in this field. Our second most advanced program and potentially next pivotal program in ALLO-715 targeting BCMA for myeloma. As David indicated, the current marketplace for autologous cell therapy is highly constrained with supply and delivery issue. We know this affects not just patients with non-Hodgkin's lymphoma, but even more so patients living with multiple myeloma. This devastating situation has pushed us to think about how we might be able to accelerate decision-making around our lead BCMA candidate.

Enrollment continues in the UNIVERSAL trial exploring a single dose of ALLO-715 and ALLO-647 based (inaudible). UNIVERSAL also includes a cohort exploring consolidation dosing with ALLO-715. At the end of 2022, we intend to provide a clinical update that will focus on the longer-term follow-up of patients in UNIVERSAL treated with a single dose of ALLO-715. We have made the decision not to advance ALLO-715 in combination with nirogacestat from SpringWorks Therapeutics. The decision is based on the absence of a clear indication that the combination would meaningfully improve the benefit risk of ALLO-715 as a monotherapy.

The IGNITE trial with our TurboCAR candidate ALLO-605 continues to enroll patients in the dose escalation portion of this Phase I study. As we advance clinical programs, I am pleased to announce that I have promoted Dr. Arun Balakumaran from its current position as Head of Clinical Development to Chief Medical Officer, reporting to me. Arun is both certified in hematology and medical oncology with a master's degree in health care management. He began his industry career at Amgen after being recruited out of the NIH where he was the medical lead of the bone marrow stromal cell transplant center. Prior to joining Allogene in the fall of 2018, Arun was Executive Director and Product Development Lead of hematological malignancies at Merck, driving the approval of pembrolizumab in lymphomas. Arun has been and will continue to be a great top and execution partner, and highly capable of providing day-to-day leadership and strategic oversight to our important clinical programs.

Lastly, I would like to echo David in thanking you for your ongoing support. Our science and clinical teams are making consistent and promising progress advancing the AlloCAR T portfolio to bring this revolutionary treatment option to all patients. I will now turn the call over to Eric.

Thank you, Rafael, and good afternoon, everyone. As David and Rafael have conveyed, Allogene is nearing a very important milestone as we progress on this journey to bring cell therapy to many more patients, we are in the fortunate position of having the financial resources required to persist and advance toward our goal. We ended the quarter with $686 million in cash, cash equivalents and investments. While we expect our spending to increase in the second half of 2022, we do realize the need to be efficient and thoughtful about how we deploy our resources.

We now expect full year GAAP operating expenses to be at the low end of the previous range of $360 million to $390 million. This includes estimated noncash stock-based compensation expense of $90 million to $100 million and excludes any impact from potential business development activities. Our cash burn for 2022 is expected to be approximately $250 million.

Moving to our second quarter financials. In Q2 2022, our research and development expenses were $57.2 million, which includes $13 million of noncash stock-based compensation expense. General and administrative expenses were $19.5 million for the second quarter of 2022, which includes $9.9 million of noncash stock-based compensation expense. Our net loss for the second quarter of 2022 was $74.8 million or $0.52 per share, including noncash stock-based compensation expense of $22.9 million.

With that, we will now open the call for your questions.

(Operator Instructions) Your first question is from the line of Tyler Van Buren with Cowen.

My question is just as you think about the ongoing durability and CR rate for ALLO-501A and the comparison to autologous CAR T, can you discuss your confidence in the data at 6 months relative to autologous and the likelihood of those responses being durable?

Tyler, this is Dave Chang. Thank you for the call. I think you're asking probably one of the most important question. And as we've been saying, we have the utmost confidence that 6-month benchmarking is a good prediction of what is to be -- happen in the longer-term follow-up. So with that, let me ask Rafael to elaborate a little bit.

Yes. Tyler, this is really a very well-established fact in the autologous setting, the 6-month CR predicts for long-term durability of response and even cures. The question was, is that going to be the same in the allogeneic setting? And what I can say is that we are really recapitulating what the autologous setting has been seen with lymphodepletion that we use and the strategy that we use. So we're pretty confident that this 6-month CR, which is in the order of 30% to 40% predicts for a similar percentage of long-term durability of response.

Your next question is from the line of Salveen Richter with Goldman Sachs.

Could you just talk about how you're thinking about utilization of 501A given the move of autologous products to earlier line setting?

Let me defer to Rafael to elaborate what our plans are with the 501A. Certainly, our focus right now is studying the pivotal study in the third-line, but we are definitely eyeing into the earlier lines.

Yes, it's a great question because products are moving into second line, clearly. But I think one fact that sometimes to ignore is that a lot of patients that have -- they could only receive products prior to the approvals in second-line in third-line were receiving (inaudible) therapy to be able to get into the third-line space. So it's unclear to what extent the second-line will be a quantumly difference from the status that there was before. I mean, clearly, some patients will go straight to second-line. But what we know is that there's a great percentage of patients that are eligible for treatment that don't get treatment.

And what we hear from investigators is that there's not going to be any shortage of patients that are refractory not just to 2 lines of regimens, but even more that could come into not just our studies, but eventually when the product is approved into treatment with an allogeneic cell therapy. Having said that, we have plans to move our product into second line, and this is something that we are thinking about and projecting to get started sometime towards the end of this year or early next year.

Your next question is from the line of Michael Yee with Jefferies.

Looking ahead to BCMA and the development in myeloma, you made some comments about planning for the next step. So maybe you could talk a little bit about what the bar is to have made that decision given the existing therapies that are out there. Obviously, analogous to what everyone's asked on CD19, there is already a bar here with BCMA and look at the labels and what the confidence is that you can be at least as good and how you're thinking about the landscape there?

Our intent is to provide overall update of the BCMA program at the year-end. But as we have made comments in the prepared remarks, we are looking into how to best speed up the program, especially with the confidence that we are getting with the 715 single-dose treatment where we have the most data. And obviously, we are following the data for longer-term durability, especially the duration of response. But as we have previously presented at ASH 2021 already by then, the data was looking in a pretty comparable to what one of the approved autologous CAR T therapy, specifically (inaudible) has shown. It has a little bit of gap compared to CAR T, but on the other hand, you're talking about allogeneic off-the-shelf product that can be made readily available to the patient.

And we've been told by the investigator for quite some time. And certainly, I think that noise has amplified quite a bit over the last few months when it comes to the availability of the autologous CAR T therapy. As we have made comments, we are learning that the limited availability is essentially taking away the opportunity for the patients who could benefit from the autologous CAR T therapy, not getting the therapy. So obviously, this is a window that we have and I think window will last for some time, and which is one of the reasons that we are trying to find a way to accelerate our 715 program.

Your next question is from the line of Michael Schmidt with Guggenheim.

This is Kelsey on for Michael. I guess first, for the CD19 update later this year. I guess, can you just clarify what regimen the additional patients from ALPHA2 would have been treated with? And then secondly, I guess what else needs to be done or shown to the FDA with respect to Cell Forge 1 before it can kind of be used as the main facility for the pivotal study? And then can you just remind us of the capacity expectations for Cell Forge 1?

Yes. Kelsey, this is Rafael. I'll talk about the dose regimens that we're treating patients with. The study has been going on for over 3 years and we're fortunate to actually have a very large data set, both with monotherapy across multiple cell doses as well as lymphodepletion regimens, and a lot of translational data that we can mine ourselves as well as together with investigators and experts in the field to try to understand what the optimal lymphodepletion regimen will be. Obviously, we have designed the trial and submitted it for review to FDA. So we already have chosen a lymphodepletion regimen and we will make data available once the study is a (inaudible) from regulators to get it started.

Until then, we continue to treat patients in the Phase I study, and I think that's really important, first, to keep the investigators engaged, but most importantly, to be able to make the product available to patients in need. So stay tuned with regards to the final lymphodepletion regimen.

I think with regards to Cell Forge 1, it is incredibly expensive activity level that took place as well as the package that needed to be submitted to FDA, both with regards to comparability as well as the methodology for validation of the release assays. And all of that package has been submitted to FDA, it is under review, and it included a lot of details and a lot of runs showing comparability between the 2 previous sites as well as the optimization of the process.

So without going into further detail, just to remark on the fact that it was an enormous amount of work and we're really very proud of the organization that was able to get this done on a timely fashion and put it really in front of regulators for them to review it, and we're awaiting the response at the moment. And then with regards to capacity, maybe I'll pass it on to Eric to comment.

Yes. Thanks, Kelsey. We've talked in the past about having the capacity to dose from Cell Forge 1 alone up to 20,000 patients worth of material from that facility in a given year. So that would be at full scale up and full capacity.

Your next question is from the line of Reni Benjamin with JMP Securities.

Can you talk a little bit about the go-no-go criteria you utilized when evaluating the combination with nirogacestat and how many patients did you evaluate before making this decision?

We believe that we actually did the right trial within the trial, if you will, of nirogacestat. And as you know, very clearly, the hypothesis was that we would get less soluble BCMA and higher BCMA in the expression in the plasma cells and lead to better outcomes. We used -- our cell dose as well as lymphodepletion that we knew was active and a dose of nirogacestat that we knew was active in desmoid tumors, which is where the lead indication of this product is. So we treated a number of patients -- a sufficient number of patients to make comparisons with 715 by itself. And I think the off shot of it, as I said in the prepared remarks is that we did see activity, but in terms of increasing benefit risk that wasn't really a clear distinction.

And so just to the root of your question, what I would say is that we treated sufficient patients to be able to make, I think, a sound conclusion. Now having said that, the patients haven't been followed long enough for us to make a final determination. But the data that we have so far suggests that there isn't really an advantage over 715 alone to continue to test the product. So I think that's what I would say about this experiment. We're really happy that it was conducted and the decision was made.

Your next question is from the line of Jason Gerberry with Bank of America.

Apologies if I missed this, but when you think ahead to the BCMA decision fourth quarter, just given the overall market size is much bigger than CD19 and the supply challenges are so notable, does this make the bar for advancement sort of worst autologous approach or like a bispecific and not shooting for like a legend like bar? And then just the investment being made in Cell Forge, I just wanted to confirm, I would assume that there's a presumed synergy to having multiple of the CAR-T programs in-house and not partnering off one or the other. But just if you could confirm that, that would be great.

Jason, let me take your first question about the product profile that we're shooting for in myeloma and the market size. Yes, this is a tremendously large market by most estimates. There are over 50,000 patients in the U.S. alone with refractory multiple myeloma. So clearly, there is a need to produce cell therapy at much greater scale than is currently available and to treat many more patients with this modality. In terms of our profile with ALLO-715, I think it's pretty clear that what we're targeting here is first-in-class off-the-shelf therapy that can be dosed on demand over a defined treatment interval. This would obviously be a high-potency product with an accessible safety profile and would enable patients to truly get away from their disease, hopefully, for an extended period of time.

We think this profile could be unique. And thus far, we haven't seen any other product with a similar profile and certainly highly attractive to patients. You referenced CARVYKTI and certainly, the efficacy of that product is extraordinary. And for that matter, a backbone baby, the second most potent product ever developed for myeloma patients. But in the real world, unfortunately, neither of these therapies are going to be relevant to the patients who can't get access. So that's our primary thrust to make sure that many more patients can access cell therapy and benefit from its potency.

Your next question is from the line of Mark Breidenbach with Oppenheimer.

Just wondering if exploring a pivotal study for the BCMA program implies that you've got a formal Type B meeting with the FDA scheduled for later this year. And I'm also wondering how we should be interpreting that you're thinking about advancing 715 into a pivotal trial before showing this data from 605 or from consolidation dosing with 715. Thanks for any color you can give on that.

Yes. Mark, let me take that question. As some of you may know, in the BCMA from the beginning, we have taken a relatively broad approach, not just the 715 as a single infusion, but also the combination with the gamma secretase inhibitor that Rafael has just covered. We also tested a next generation and that study is still ongoing. And the last one that we added is the exploration with the consolidation where we plan to give 2 doses in a very tight interval, hoping that would improve the overall outcome. Obviously, some of the studies are ongoing, but in drug development, time is of essence. And also, we believe that currently there is a great opportunity, as Eric has just covered, and the target product profile that we have set out and the data that we are seeing in the 715 program is very promising.

So that's really the genesis of our interest in exploring, moving the 715 program into the pivotal. And what needs to be done as we have learned during the 501A experience is pretty extensive. Not only we have to take care of the CMC issues, we have to take care of the protocol. And this is where we feel that the fact that we have the control of the manufacturing at the CF1 will be a plus. And in fact, I think that's going to add in terms of quite a bit about how fast we can move. And as that activity is going on, certainly the regulatory discussion will have to occur. The timing of regulatory discussion, we do not go into that, but 715 currently has the RMAT designation, which would allow us a much hopefully quick regulatory interaction than what we have experienced with 501A.

Your next question is from the line of David Dai with SMBC.

So I have one question on the 605, (inaudible) CAR-T program. Could you just remind us what dose level we currently estimate the patient at? And then could you just provide some color in terms of when should we expect an update from that program?

So 605 is currently in dose escalation as you know. We are going to explore doses that we know that have been active in 715, and we are very close to achieving those doses. And then after that, we will also explore various lymphodepletion regimens, just like what we did with 605 -- sorry, with 715 as well as with 501 and 501A. So there will still be a little bit of time before we complete the dose escalation and we get a good picture of what this next-generation product can do compared to 715. So it may take us more time than the rest of the year. So it is possible that the next update or the first update that you may see with 605 may be next year rather than at the end of this year.

Your next question is from the line of John Newman with Canaccord.

Just curious in terms of the potential design for the pivotal study for 501A, do you expect that you would exclude patients previously treated with other CD19 targeted therapies? And then second question I had regarding the 715 program. Just curious if we might see some consolidation data at the end of this year. The press release mentioned a single agent, but just not sure if the consolidation data might come this year, or maybe in 2023.

Yes. So the answer to the first question is that the pivotal trial will exclude patients that are previously treated with CD19 directed therapy. I think that's a way for us to be able to establish allogeneic benefit risk in the setting where the autologous products were developed. And so that decision has been made. You know that we have retreated patients in the past and we've seen some activity before. But for the purpose of the pivotal trial, these patients would be excluded. And then the 715 consolidation data is ongoing. I believe that in order to present sufficient durability, we may need to wait until early next year. But that cohort will finish relatively soon. And it depends on what we see, but most likely, my projection is that it will probably cross into next year.

Your next question is from the line of Luca Issi with RBC Capital.

I think it was mentioned a couple of times during the call, a little bit of a gap versus CARVYKTI on efficacy. And obviously, I appreciate all the benefit of AlloCAR Ts versus auto. But is it possible that the FDA will initially ask you to run a pivotal trial for BCMA post auto CAR-T in studying auto CAR-T naive? Any color there would be great.

I do not want to speculate on behalf of the FDA. But if you think about what we are doing with ALLO-501A, we are going into the same third-line patient population that the auto CAR T have currently label in. So the discussions on the multiple myeloma that's coming up. But our current expectation is that the FDA position would not have significantly shifted over the last few months from how they've been advising us about the 501A pivotal study design.

Your next question is from the line of Raju Prasad with William Blair.

Just regarding Cell Forge 1, can you just give us a sense of where the CMC is at now compared to where you anticipated a potential commercial launch? And just how many aspects of the manufacturing process are still relying on CDMOs? Is it vectors or something of that nature versus what you'd anticipate kind of the commercial launch?

Raj, great question. CMC issues are obviously very hot ticket item, current days, and it's also a very complex issues. But let me simplify, in terms of CF1, that's our state of our manufacturing facility that we plan to going forward, not just produce the clinical materials, but also convert that facility for the launch of the product upon the approval. So it's really designed as a multipurpose manufacturing facility. And that facility is already operational and we are making the clinical grade materials. In terms of what is needed, it's probably too much information to go into the details but our plan is use that facility for the cell manufacturing. And going forward, we will continue to rely on CDMOs for the viral vector manufacturing.

Your next question is from the line of Asthika Goonewardene with Truist Securities.

So I want to know what the current capacity of Cell Forge 1 is? And also, how long would it take to get up to 20,000 per year anticipated?

Let me take the question. That facility at full capacity, we have said, will produce 20,000 ALLO-501A. Current capacity is really based on our need. And certainly, the capacity far exceeds what we need to support all of our ongoing clinical programs. So this is really one of the best manufacturing facility that I have dealt with. And we're very happy that it will not only meet our current need, but it will meet our future need for foreseeable years.

Your next question is from the line of Kalpit Patel with B. Riley Securities.

You noted that you're waiting on FDA clearance for the ALPHA2 study, but have you received a thumbs-up for the EXPAND study already? Or is that guidance also expected along with the clearance of the ALPHA2 study? And if you have received clearance, are you able to disclose any additional details for the design of that trial?

Yes. In terms of, Kapil, the question about 2 pivotal studies that we plan to do, one is ALLO-501A single-arm study that we plan to demonstrate the benefit risk of ALLO-501A. And the second EXPAND study is the one that -- where we will demonstrate the contribution of ALLO-647 in the lymphodepletion. Right now our focus is getting the 501A single-arm study up. We believe that, that is on the critical path, and that's what we are waiting for. As for 647, we already have had discussions and we expect that study to be initiated after we start the ALLO-501 study.

Your next question is from the line of Jack Allen with Baird.

Congratulations to the team on the progress. I was hoping you might be able to speak to any color as it relates to the data you shared with the FDA to secure the RMAT designation in June for ALLO-501A. Did the FDA see any updated durability data? And any comments you can make as it relates to that conversation would be great.

Yes. Thanks, Jack. This is Rafael. Great question. We got first RMAT designation with 715 and then with 501A, as you may know. We submitted data that was updated, obviously, from the last presentation, and it was across doses and schedules on lymphodepletion regimen. FDA really was interested in, obviously, the response, the durability of response, interested on long-term durability. But importantly, interested in how many patients actually received the product versus how many patients were enrolled.

And what was the time between enrollment and receipt of the product and also whether or not they received bridging therapy. So these questions really speak to, I think, the interest of the agency on the allogeneic technology, which we believe is something of interest to the regulators. And I can say that we have received similar questions in the past with 715. So I think it reiterated the benefit of the allogeneic technology, both in the eyes of clinicians, investigators, but also regulators.

That concludes our question-and-answer session. I would like to turn the conference back over to management for any additional comments.

Thank you. I want to end the call by thanking you for joining us today and your ongoing support as we pave new roads les in the development of allogeneic CAR-T products. We very much look forward to what lies ahead for the rest of the year and updating you on our progress. Operator, you may now disconnect.

Thank you. Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program, and you may now log off and disconnect.