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spk18: 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.
spk07: Thank you, Christine, and good afternoon.
spk06: Since our last update, we have continued to make significant progress across our pipeline. from our lead CD19 candidate, Allo501A, and our lead PCMA candidate, Allo715, to our first thalassemia candidate, Allo316. 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 therapies.
spk07: This month marks the five-year anniversary of the first approval of an otolus CAR-T therapy targeting CD19.
spk06: Since that time, the field has benefited from additional successes. Spectacular data sets reaffirming the treatment benefits coming from one-time infusion, label expansions to earlier lines, as well as to other B-cell lymphomas,
spk07: 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.
spk06: As recently published in the Journal of Clinical Oncology, real-world access to a palace 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 six months, and that only 25% of patients eventually received CAR-T therapy. While the focus in this study was multiple myeloma, long wait time and supply limitations on cell therapy have also been documented in non-Hodgkin's lymphoma. Clinicians have enforced into the unfathomable position of needing to choose which of their patients will receive potential lifesaving 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 foreshadowed 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 studied allogene with the goal of correcting these limitations associated with the delivery of otolaryngocardial therapy by developing our CAR-T products and making them readily available to all eligible patients. Four years into our journey, we believe we are on a path to transform CAR-T therapy from a complex individualized procedure to an off-the-shelf, on-demand pharmaceutical product.
spk07: Last year, we embarked on a complex set of regulatory discussions directed at enabling the first potential pivotal phase two trial
spk06: 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 Allo501A and our pipeline candidates, but for the field more broadly. The protocols we have put before FDA for the Alpha 2 Phase 2 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 LL501A phase two 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 LL501A. We are grateful to the FDA for its ongoing cooperative 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 Allo501A phase 2 pivotal trial, we are already thinking about what comes next, including how to expand access of Allocarti to earlier lines of therapy and how to bring Allocarti products to other patient populations. This includes evaluating the opportunity to advance allo715, our lead candidate for relapsed refractory multiple myeloma, into a potential pivotal trial and continued execution on our Phase I trial for allo316 in renal cell carcinoma.
spk07: I am incredibly grateful to our One Allogene team that remains laser-focused on our vision to deliver the first Allocarti products.
spk06: I'm also grateful to have many insights coming from Allergen by way of people who are equally energized about our mission. To that end, we welcome Dr. Stephen Mayer, award-renowned expert in computational protein design, to Allergen's Board of Directors. Dr. Mayer is the Brent Professor of Biology and Chemistry and Merkin Institute Professor at the California Institute of Technology. His decades-long success record in both academia and the biopharmaceutical industry will help us to advance our pipeline of investigational Allocarti products. Together, with each advances we make across our Allocarti pipeline, we are one step closer to creating a new reality for patients.
spk07: We are grateful for your support. I will now turn the call over to Rafael.
spk08: Thank you, David. Let me first start briefly as it relates to our Plan Alpha 2 Phase 2 Pivotal Trial of Allo501A Interline Large Pistal 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've had with our investigators as we analyze all the data across doses and schedules from the Phase 1 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 allocard 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 allo647 to the lymphodeficient regimen. We have also conducted a thorough analysis of allo647 dosing, pharmacokinetics, and pharmacodynamics. We believe the use of allo647 is critical to enabling safe and effective lymphodeficient and uniquely able to create the needed window for allopathy expansion and persistence. The wealth of Phase I dose ranging data that we have generated across our Team 19 program has shown us that Allo647 dosing is critical to achieving optimal efficacy and has allowed us to zero in on the preferred dosing regimen. We have shown a strong correlation between serum concentrations of Allo647 and the likelihood of clinical response. Our data, as well as those of our partners and competitors, to substantiate our belief that this trial will not only result in a positive outcome, but also differentiate our platform by demonstrating that including L0647 in the lymphodepletion regimen contributes to superior outcomes, including durability of response. The expanded trial is expected to begin later in 2022. We also plan to provide an update on the Phase I portion of the Alpha and Alpha 2 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 at Cross Functions as we prepare for this first-of-its-kind trial. Our goal has been to supply pivotal trial material from Cell 421 to reduce complexity and risk to 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 DLA submission stage, by working to have materials sourced from Self-Forged One using an optimized process available prior to the start of the pivotal program. We believe our strong process and product validation capabilities support our ability to deliver a well-characterized style logic with minimal variability and hopefully will allow us to avoid the undue delays that have been observed in the self-help field. I am grateful for the partnership with Dr. Allison 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 is ALO715, targeting BCMA for myeloma. As David indicated, the current marketplace for autologous cell therapy is highly constrained with supply and delivery issues. 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 elite PCMA candidates. Enrollment continues in the universal trial, exploring a single dose of allo715 and allo647 based on the patient. Universal also includes a cohort exploring consolidation dosing with allo715. 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 allo715. We have made the decision not to advance Allo715 in combination with NeurogastroSat from spring-worked SodaPerix. The decision is based on the absence of a clear indication that the combination would meaningfully improve the benefit-risk of Allo715 as a monotherapy. The IGNITE trial with our two-vocar candidate, Allo605, continues to enroll patients in the dose escalation portion of this phase 1 study. As we advance clinical programs, I am pleased to announce that I have promoted Dr. Arun Balakumaran from his current position as head of clinical development to chief medical officer reported to me. Arun is board certified in hematology and medical oncology with a master's degree in healthcare management. He began his industry career at Amgen after being recruited out of the NIH when he was the medical lead at the bone marrow stromal cell transplant center. Prior to joining AllerGene in the fall of 2018, Arun was Executive Director and Product Development Lead of Hematological Malignancies at MADS, driving the approval of Pembrolizumab in lymphomas. Arun has been and will continue to be a great thought and execution partner and highly capable of providing day-to-day leadership and strategic oversight to our important clinical programs. 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 AlloCyte T portfolio to bring this revolutionary treatment option to all patients. I'll now turn the call over to Eric.
spk10: 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 gap operating expenses to be at the low end of the previous range of $360 million to $390 million. This includes estimated non-cash 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 non-cash stock-based compensation expense. General and administrative expenses were $19.5 million for the second quarter of 2022, which includes $9.9 million of non-cash stock-based compensation expense. Our net loss for the second quarter of 2022 was $74.8 million, or 52 cents per share, including non-cash stock-based compensation expense of $22.9 million. With that, we will now open the call for your questions.
spk11: At this time, I would like to remind everyone in order to ask a question, simply press star, then the number one on your telephone keypad. Your first question is from the line of Tyler Van Buren with Cowan. Please go ahead.
spk09: Tyler Van Buren Hey, guys. Good afternoon and thank you very much for all the updates. My question is just as you think about the ongoing durability and CR rate for LO501A and the comparison to autologous CAR T, can you discuss your confidence in the data at six months relative to autologous and the likelihood of those responses being durable?
spk06: All right, Tyler, this is Dave Chang. Thank you for the call. I think, you know, you're asking probably one of the most important questions. And as we've been saying, you know, we have the utmost confidence that six-month benchmarking is a good prediction of what is to happen in the longer-term follow-up. So with that, let me ask Rafael to elaborate a little bit. Yeah, Tyler, this is Dave. really a very well-established fact in the autologous setting that six months CR predicts for long-term durability of response and even cures. The question was, you know, is that going to be the same in the allogeneic setting? And what I can say is that, you know, we are really recapitulating what the autologous setting has been seen with the lymphodepletion that we use and the strategy that we use. We're pretty confident that this six-month CR, which is in the order of 30% to 40%, predicts for a similar percentage of long-term durability of response.
spk11: Your next question is from the line of Salveen Richter with Goldman Sachs. Please go ahead. Good afternoon.
spk19: Thanks for taking my question. Could you just talk about how you're thinking about utilization of 501s given the move of autologous products to earlier line settings?
spk06: David Chang. Let me defer to Rafael to elaborate what our plans are with the 501 . Certainly our focus right now is studying the pivotal study in the third line, but we are definitely eyeing into the earlier lines. Yeah, it's a great question because products are moving into second line, clearly. But I think one fact that, you know, sometimes it's ignored is that a lot of patients that had, that could only receive products prior to the approvals in second line, in third line, were receiving salvage therapy to be able to, you know, get into the third line space. So, you know, it's unclear to what extent the second line will be, you know, a quantum leap difference, you know, 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 two 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, you know, get started, you know, sometime towards the end of this year, early next year.
spk11: Your next question is from the line of Michael Yee with Jefferies. Please go ahead.
spk17: Hey, thanks for the question and thanks for the updates. Looking ahead to BCMA and the development of myeloma, you made some comments about planning for the next step.
spk16: 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 asking 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. Thank you.
spk06: Hi, Mike. Great question. Our intent is to provide overall update of our BCMA program at the year end. But as we have made comments in the prepared remarks, we are looking into You know, 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 otolus CAR-T therapy, specifically AVECMA, has shown. It has a little bit of gap compared to CAR-VICT-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, you know, quite some time, and certainly I think, you know, that noise has amplified quite a bit over the last few months when it comes to the availability of the otolascar therapy. As we have made comments, we are learning that The limited availability is essentially, you know, 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, which is one of the reasons that, you know, we are trying to find a way to accelerate our 715 program.
spk11: Your next question is from the line of Michael Schmidt with Guggenheim. Please go ahead.
spk01: Hey, this is Kelsey on for Michael. Thanks for taking our question. I guess first for the CD19 update later this year, I guess can you just clarify what regimen the additional patients from Alpha-2 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 One before it can kind of be used, you know, as the main facility for the pivotal study. And then can you just remind us of the capacity expectations for Cell Forge One? Thanks so much.
spk06: Yes, Kelsey, this is Rafael. I'll talk about the dose regimens that we're treating patients with. This study has been going on for over three 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 that available once the study is approved and we have green light 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 Self-Forge I, it is incredibly extensive, the 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's under review. It included a lot of details and a lot of runs showing comparability between the two 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 their response at the moment. And then with regards to capacity, maybe I'll pass it on to Eric to comment.
spk10: Yeah, thanks, Kelsey. We've talked in the past about having the capacity to dose from Self-Forge One alone up to 20,000 patients' worth of material from that facility in a given year. So that would be at full scale up in full capacity.
spk11: Your next question is from the line of Ren Benjamin with JMP Securities. Please go ahead.
spk03: Hey, good afternoon, guys. Thanks for taking the questions. Can you talk a little bit about the go, no-go criteria you utilize when evaluating the combination with, there I guess, and how many patients did you evaluate before making this decision? Thanks.
spk06: Hi, Randy. It's Rafael. Thanks for the question. We believe that we actually did the right trial within the trial, if you will, of Neurogastastat. 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 a cell dose as well as lymphodepletion that we knew was active and a dose of Neurogastastat that we knew was active in decimoid tumors, which is where the lead indication of this product is. So we treated a number of patients and 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, you know, increasing benefit-risk, there 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, you know, 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 that the decision was made.
spk11: Your next question is from the line of Jason Gerberry with Bank of America. Please go ahead.
spk13: Hey, guys. Thanks for taking my questions. 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 buy specific and not shooting for like a legend-like bar? And then, you know, just the investment being made in Self Forward, 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.
spk10: 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, you know, 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 Allo715, I think it's pretty clear that what we're targeting here is a 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 Carvicti, 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, you know, unfortunately, neither of these therapies are going to be relevant to the patients who can't get access. So, you know, that's our primary thrust to make sure that many more patients can access cell therapy and benefit from its potency.
spk11: Your next question is from the line of Mark Bradenbath with Oppenheimer. Please go ahead.
spk22: Hey, good afternoon, and thanks for taking the question. 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 us data from 605 or from consolidation dosing with 715? Thanks for any color you can give on that.
spk06: 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, you know, 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, you know, the last one that we added is the, you know, exploration with a consolidation where we plan to give two doses in a very tight interval. hoping that 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 done during the 501 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, you know, we do not go into that, but 715 currently has the RMIT designation, which would allow us a much, hopefully, you know, quick regulatory interaction than what we have experienced with 501 .
spk11: Your next question is from the line of David Dye with SMBC. Please go ahead.
spk05: Great, thank you for taking my questions. So I have one question on the 605, the BCMH for Part T program. Could you just remind us what dose level you're currently escalating the patients at? And then could you just provide some color in terms of when should we expect an update from that program?
spk06: Yeah, so this is Rafael. So 605 is currently in dose escalation as You know, we're going to explore doses that we know that have been active in 715, and we're very close to, you know, 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, you know, the rest of the year. So it is possible that the next update or the first update that you may see with 605 maybe next year rather than at the end of this year.
spk11: Your next question is from the line of John Newman with Canaccord. Please go ahead.
spk04: Hi, guys. Thanks for taking my question. 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 CV-19 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 single agent, but it's not sure if the consolidation data might come this year or maybe 2023. Thanks.
spk06: Yeah, so the answer to the first question is that the PIVOTOV trial will exclude patients that are previously treated with CD19 directed therapy. I think that's a way for us to be able to established the allogeneic F-benefit risk in the setting where the autologous products were developed. And so, you know, 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, you know, that cohort will finish, you know, relatively soon. And, you know, it depends on what we see. But most likely, you know, my projection is that it will probably cross into next year.
spk11: Your next question is from the line of Luca Cici with RBC Capital. Please go ahead.
spk12: Oh, great. Thanks so much for taking my question. I think it was mentioned a couple of times during the call, you know, a little bit of a gap versus Karvicki on efficacy and obviously appreciate all the benefits of auto CAR-T versus auto. But is it possible that the FDA will initially ask you to run a pivotal trial for BCMA post-auto CAR-T instead of auto CAR-T naive? Any call there would be great.
spk06: Yeah, look, this is David Chang. You know, I do not want to speculate on behalf of the FDA, but if you think about what we are doing with the Allo 501A, we are going into the same third-line patient population that the AutoCard T have currently labeled in. So, you know, 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.
spk11: Your next question is from the line of Raju Prasad with William Blair. Please go ahead.
spk21: Thanks for taking the question. Just regarding Salesforce 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, you know, relying on CDMOs? Is it, you know, vectors or something of that nature versus what you'd anticipate kind of at a commercial launch? Thanks.
spk06: Hey, Raj. I mean, great question. I mean, CMC issues are obviously very, you know, hot ticket item current days, and, you know, it's also very complex issues. But let me simplify, you know, in terms of CF1, that's our state-of-art manufacturing facility that we plan to, going forward, not just produce the clinical materials, but also convert that facility for you know, the launch of the product, you know, upon the approval. So it's really designed as a multipurpose manufacturing facility. And that facility is already operational and we are, you know, making the, you know, clinical grade materials. In terms of what is needed, it's probably, you know, too much information to go into the details. But our plan is use that facility for the cell manufacturing. And, you know, and going forward, we will continue to rely on CDMOs for the viral vector manufacturing.
spk11: Your next question is from the line of Astika Gunwarden with Truist Securities. Please go ahead.
spk20: What is the capacity currently?
spk11: Hello? Yes, please go ahead.
spk02: Oh, sorry. Yeah, so I want to know what the current capacity of Salt Forge One is, and also how long will it take to get up to 20,000 per year? I'm frustrated.
spk06: Let me take the question. I mean, you know, that facility at full capacity, we have said, you know, we'll produce, you know, 20,000 out of 501A. You know, current capacity is really, you know, based on our need, and certainly the capacity far exceeds what we need to support all our ongoing clinical programs. So, you know, this is really, you know, one of the best manufacturing facilities that I have dealt with, and, you know, we're very happy that it will not only meet our current need, but it will meet our future need for foreseeable years.
spk11: Your next question is from the line of Kaupath Patel with B. Riley Securities. Please go ahead.
spk15: Yeah, hey, good afternoon and thanks for getting the question. You noted that you're waiting on FDA clearance for the Alpha 2 study, but have you received a thumbs up for the EXPAND study already or is that guidance also expected, you know, along with the clearance of the Alpha 2 study? And if you have received clearance, are you able to disclose any additional details for the design of that trial?
spk06: Yeah. In terms of Kapil, you know, the question about two pivotal studies that we plan to do, you know, one is allofibro 1A single-arm study that we plan to demonstrate the, you know, benefit risk of allofibro 1A. And the second expanded study is the one that where we will demonstrate the contribution of allo647 in the lymphodepletion. You know, 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, you know, we already have had discussions, and we expect, you know, that study to be initiated after we start the allo501A study.
spk11: Our next question is from the line of Jack Allen with Baird. Please go ahead.
spk14: Hi. Thank you so much for taking the question, and 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? Any comments you can make as it relates to that conversation would be great. Thank you so much.
spk06: Yes, thanks, Jack. This is Rafael. Great question. You know, we got first ARMA designation with 715 and then with 501A, as you may know. We submitted data that was updated, obviously, from, you know, the last presentation. And it was across doses and schedules and lymphodepletion regimens. 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 receive 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 regulators. And I can say that we have received similar questions in the past with 715. So, I think it reiterated, you know, the benefit of the allogeneic technology, both in the eyes of clinicians, investigators, but also regulators.
spk11: Thank you. That concludes our question and answer session. I would like to turn the conference back over to management for any additional comments.
spk06: Thank you. You know, I want to end the call by thanking you for joining us today. and your ongoing support as we pave new roads in the development of allogeneic CAR-T products. We very much look forward to what lies ahead for the rest of the year and update you on our progress. Operator, you may now disconnect.
spk11: 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.
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