Allogene Therapeutics, Inc. Q3 FY2022 Earnings Call

Hello, and thank you for standing by, and welcome to Allogene Therapeutics Third Quarter of 2022 Conference Call. 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 Q3 call. After market close, we issued a business update and financial results press release for the third 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 as we will keep this call to an hour and do our best to get to as many as possible. 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 capability, 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.

Thank you, Christine, and good afternoon. I will start today's call focused on our most important milestone, the initiation of our Phase 2 trial with ALLO-501A for the treatment of relapsed or refractory large B-cell lymphoma. Advancing our off-the-shelf allogeneic CD19 CAR T product candidate to a Phase 2 trial brings us one step closer to making this potentially life-saving therapy more readily available to patients. It is a combination of our singular focus over the last three years and signifies our leadership in the development of AlloCAR T products, and in my view, an advancement for the entire field of cell therapy. As you might imagine, we were very pleased last month to share that we have initiated the industry's first potentially pivotal Phase 2 trial for an allogeneic CAR T product. Being the first comes with a special set of challenges, but it also comes with an enormous sense of accomplishment and responsibility. When we started our journey, we knew there would be a unique set of challenges that we would have to address, ensuring the safety of AlloCAR T products, especially with respect to graft versus host disease, protecting AlloCAR T cells from being prematurely rejected by the patient's immune system, demonstrating meaningful responses, and managing reliable manufacturing of AlloCAR T products. Our depth of understanding around each of these elements, combined with the breadth of our clinical programs and the translational knowledge we have generated, puts us at the forefront of science. The journey of drug development is often a winding road. And as we proceed through this journey and work towards addressing the challenges, we remain focused. We have been unwavering in our commitment to ourselves, patients, and investors to create and lead the next revolution in cancer treatment by delivering to patients the first allogeneic CAR-T products for blood cancers and solid tumors. Initiating this Phase 2 trial places us one meaningful step closer to that ultimate goal. To that end, we are very much looking forward to providing a clinical update on our CD19 alpha studies and our BCMA UNIVERSAL trial at our R&D Showcase in New York on November 29. While our usual practice for such updates is to target medical conferences, we believe our R&D Showcase will provide more time and flexibility to fully review the clinical findings of our lead programs and discuss that in the context of a gradually evolving landscape. Before I turn the call over to Rafael, I would like to make a few more comments related specifically to the importance of collaboration with like-minded individuals and institutions. Our success to date in cell therapy can only be accomplished with the partnership and support of engaged patient-focused investigators and clinical trial sites. Their dedication to patient care is commendable, and their desire to bring options for their patients is underscored by the launch of our first-of-its-kind effort we call CAR T Together. Real-world access challenges have emerged since the commercial introduction of autologous CAR T five years ago. Chief among them are the supply bottlenecks created by the complex individualized manufacturing process inherent in the delivery of autologous CAR T therapy. This pioneering initiative conducted in collaboration with key opinion leaders from top oncology centers is aimed at supporting the advancement of allogeneic CAR T products to address bottlenecks through collaboration, education, and clinical trial enrollment. Inaugural members of this initiative include lead investigators from Moffitt Cancer Center, the Sarah Cannon Colorado Blood Cancer Institute, the Mayo Clinic, and City of Hope. These dedicated physicians and many others who participate in clinical trials sponsored by Allogene and others are leading the vanguard of scientific innovation. On a personal note, I had the pleasure of working with many of the same key opinion leaders as we traveled the road towards bringing autologous CAR T therapies to patients, and I'm honored that they have chosen to join us again on this next chapter. As we noted last quarter, we started Allogene with the goal of making CAR T readily available to all eligible patients. As we near the conclusion of our fourth year together, we believe we are well along the path to transforming CAR therapy from a complex individualized procedure to an off-the-shelf, on-demand pharmaceutical product. My sincere thanks to all our employees, investors, collaborators, and patients who have joined us on this journey. I will now turn the call over to Rafael.

Thank you, David. As David noted, our teams are very pleased to have initiated our potentially registrational ALPHA2 trial. Activities are also underway to launch our companion EXPAND Phase 2 trial. The ALPHA2 trial utilizing ALLO-501A in patients with relapsed or refractory large B-cell lymphoma will deploy a single dose of ALLO-501A at 120 million CAR positive cells with a lymphodepletion regimen comprised of fludarabine and cyclophosphamide plus ALLO-647. This single-arm trial will enroll approximately 100 patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy. The primary endpoint of this trial is overall response rate with a key secondary endpoint of duration of response. As we onboard clinical sites for ALPHA2 in the U.S., we're also continuing our discussions with the European Medicines Agency to initiate the ALPHA2 study at European clinical sites. The EXPAND trial, a separate potentially registrational trial, is intended to demonstrate the contribution of ALLO-647 to the standard fludarabine and cyclophosphamide lymphodepletion regimen. Patients will be randomized to receive the same single 120 million cell dose of ALLO-501A as in the ALPHA2 trial and either lymphodepletion with fludarabine and cyclophosphamide alone control arm or the same lymphodepletion regimen of the ALPHA2 trial active arm. The trial is expected to enroll approximately 70 patients with a primary endpoint of progression-free survival and the key secondary endpoints of overall response rate and duration of response. We are looking forward to sharing clinical data from our CD19 program at our R&D Showcase at the end of the month. We are planning to share longer-term follow-up data from the ALPHA and ALPHA2 Phase 1 trial, including our rationale for selecting the dose and schedule of ALLO-501A being deployed in Phase 2. We also expect to share outcomes from patients treated with our Alloy manufacturing process. Our R&D Showcase will also feature updated data from our BCMA program, the only such allogeneic cell therapy program to have established proof of concept. At the event, we plan to share longer-term data from a single dose ALLO-715 in the treatment of patients with relapsed or refractory multiple myeloma. The ALLO-715 program is increasingly exciting as we recognize the growing unmet need for BCMA-directed cell therapy and the transformational opportunity that AlloCAR T may play in addressing the need for treatment in these advanced patients. We recognize that the myeloma market is dynamic and believe that multiple innovative approaches will be required to further advance patient care. This is exactly what has transpired in the past 20 years in myeloma. Nonetheless, the profile we are targeting with ALLO-715 appears differentiated among the competition in having the potential to provide patients an immediate off-the-shelf option with onetime dosing. Based upon physician interest in this profile and the clinical outcomes that we have previously shared, we believe that ALLO-715 could play a very important role in the myeloma treatment paradigm. Over the next few days and weeks, we expect a lot of discussion around the potential for innovation in the treatment of blood cancers. At Allogene, we believe we now have line of sight not just to potential innovation but to potential products. We look forward to continuing to execute on this mission and sharing an update with you on November 29th. I'll now turn the call over to Eric.

Thank you, Rafael, and good afternoon. As I begin my formal remarks, I'd like to focus on a brief update on activities outside of the United States, starting first in China. As many of you will recall, Allogene and Overland partnered a little less than two years ago to create Allogene Overland Biopharm. This joint venture focused on the development, manufacturing, and commercialization of AlloCAR T therapies targeting BCMA, CD70, FLT3, and DLL3 in Greater China, Taiwan, South Korea, and Singapore arose from a shared vision that cell therapy represented a revolutionary new technology. Developing allogeneic CAR T options was especially important as we knew that autologous therapies would face even greater hurdles to adoption in China, where the population was large, diverse, and geographically dispersed. Since inception in late 2020, much has been accomplished. Allogene Overland Biopharm has built many of the necessary components to succeed, including assembling a strong leadership team with highly skilled employees. Most recently, it launched a state-of-the-art large-scale manufacturing facility. Through this venture, we have had the honor of partnering not just with Overland, but also with CEO, Dr. Shuyuan Yao and his team in Shanghai. It is this partnership that will allow us the opportunity to extend the reach of AlloCAR Ts into China, and we look forward to supporting Allogene Overland as they begin to manufacture AlloCAR T cells. Rightfully so, our focus today has been on CD19 and ALLO-501A, a program that we advanced with the support of Servier under our license and collaboration agreement. We'd obtained rights to ALLO-501A and other CD19 candidates in the U.S. from Servier, while Servier had retained ex-U.S. rights. In September, Servier informed us that they would no longer seek to commercialize ALLO-501A or other CD19 products outside of the United States. We are pleased to have obtained the right to opt into ex-U.S. rights, which we are carefully evaluating. Our U.S. commercial rights are unchanged. Moving to our third quarter financials. We ended the quarter with $637 million in cash, cash equivalents, and investments. Our Q3 2022 research and development expenses were $63.6 million, which includes $11 million of noncash stock-based compensation expense. General and administrative expenses were $18.9 million for the third quarter of 2022, which includes $10.1 million of noncash stock-based compensation expense. Our net loss for the third quarter of 2022 was $83.1 million or $0.58 per share, including noncash stock-based compensation expense of $21.1 million. We are revising our 2022 guidance for spending down modestly. We now expect GAAP operating expenses to be slightly below the low end of our prior 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. Cash burn for 2022 is now expected to be less than $250 million. With that, we will now open the call to your questions.

Thank you. Our first question will come from Salveen Richter of Goldman Sachs. Your line is open.

Hi everyone. This is Andrea on behalf of Salveen. Thanks for taking our question. David, maybe could you speak a little bit more on the process that will be necessary as you transition between your current manufacturing and the Alloy manufacturing? And in particular, what your plans are for comparability studies?

Okay. Andrea, this is David Chang. So let me take on that question. I think what you are asking is in reference to what we have said that will be used in our pivotal study, the Alloy process. This is something that we took a lot of time to come to that decision, and that is based on a lot of data review. The Alloy process has been used in a number of patients that we have treated across our clinical programs. So, the next step, which is an all-important question about what we are doing with the Alloy process. We are doing exactly what you're saying, trying to bring that manufacturing process to our own manufacturing facility at CF1, and that involves the steps that we are very familiar with, validating a few pieces of equipment and deploying our manufacturing personnel from different processes that we were using to the Alloy process. So, we expect that to occur in a relatively short period.

Thank you. Our next question will come from Michael Yee of Jefferies. Your line is open.

Hey David and team. Thanks for the question. With regards to the multiple myeloma update, can you help us set some expectations from the standpoint of the CR rate and PFS and overall response rates, which we can all look at just the tables and the labels and the concept that they were perhaps treating different types of patients versus what you will show? And what is the bar to say that this is a good drug and we should be going forward versus what we have out there?

Mike, so yes, 715 will be a part of R&D Showcase, and we will provide an update on the 715. And as we've been talking about, the big component of the 715 update is the longer-term follow-up on the patients that we essentially have reported the initial findings back in ASH 2021. So following those patients, both from durability as well as other response parameters, will be key. So the important question that you're asking about what is the bar, as we've been saying, the multiple myeloma field is evolving pretty quickly. And this is also where the treatment paradigm has really changed significantly over the last couple of decades from limited treatment to a combination as well as sequential therapies. So what we are looking for here is really differentiation from other treatments. CAR T currently has two autologous products approved, but we are coming as an allogeneic CAR T product, and there are many benefits that we can talk about regarding why allogeneic therapy is needed. This is also a space where bispecifics are being approved, but there are differing attributes that we can emphasize about why allogeneic CAR T cell therapy is essential. This is really something that we engage in constant discussion with the investigators and others. But let me also emphasize, no matter how great the results are, the treatment has to be available to the patients in need, and that is one of the key differentiations. And with that, let me ask Rafael to comment on some of the detailed questions about response rates and all that, which always evolve with a small number of patients on which we will be making decisions.

Yes, Michael. The data we shared at ASH last year was encouraging, showing results similar to one of the approved products with the capacity to treat nearly every patient in the study. Physicians particularly valued the lack of need for bridging therapy and observed high response rates above 45%. Initially, the durability of response exceeded eight months, and at our upcoming R&D Day, we will have another year of follow-up data with more patients treated at a given lead for depletion. The data is looking increasingly appealing as we are approaching the efficacy seen in autologous therapy. While CAR T therapies show superior numbers, we have patients who cannot wait and enter the study needing therapy within days. Investigators have expressed that they would definitely use this treatment and encourage us to advance with clinical trials. There is a place for multiple products in any disease, and particularly for allogeneic cell therapy, there is clearly an opportunity for a product like this. We expect the profile to improve over time since our last presentation in 2021.

Thank you. Our next question will come from Tyler Van Buren of Cowen. Your line is open.

Hey guys. Thanks very much for the update. I understand it's a trade secret, but is there anything more you can tell us with respect to what is unique about the actual Alloy manufacturing process at a high level? And to be clear, when you provide the update on November 29, will you stratify the CD19 and/or BCMA data for patients who received Alloy versus those who have not?

Yes. So, Tyler, you are absolutely right. Regarding manufacturing, there are a lot of trade secrets that we will not be able to talk about. But in the R&D Showcase, we will give some insights into why we landed with the Alloy process as we're launching the pivotal II study. So stay tuned for the R&D Showcase.

Thank you. The next question will come from Asthika Goonewardene of Truist. Your line is open.

Hi guys. Thanks for taking my question. Rafael, you just mentioned that in the UNIVERSAL update coming up, you indicated that there will be a few more patients. I was wondering if you could help us out and communicate if that is like five more patients, ten more patients, any sense would be helpful. And I guess related, since the October 18, 2021, data cut from the ALPHA2 Phase 1 data presented at ASH, did you enroll and dose more patients on the Phase 1 portion of the study as well?

Asthika, let me take that one. It's Eric. We're not going to get into exactly how many additional patients we've treated. But of course, at the conference, the Showcase on the 29th, we'll give you a full and comprehensive update of where we are with the program. And certainly, we look forward to your participation in that event. As we've talked about, our focus for both of these programs has been on following up patients longer-term that were treated some months ago and getting a better sense of how they're performing over time. So I think that will be the focus with the Phase 1 program in particular, we've really been eyeing towards starting the Phase 2 for CD19 instead of treating a lot more patients.

Thank you. Our next question will come from Raju Prasad of William Blair. Your line is open.

Thanks for taking the question. Just wanted to get a sense of the EXPAND trial. So it sounds like it's a dose of ALLO-501A with flu cy versus flu cy plus 647 with PFS as the endpoint. So is it really just a show non-inferiority here between the two arms? Or do you want to see increased expansion? I'm just kind of curious to know the measures that will be considered as a success from that trial?

Yes. Thanks for the question. This is Rafael. Yes, you're right on the design. It's really to isolate the contribution of 647, both to safety and efficacy. As such, everybody gets 501A at the same cell dose as ALPHA2, we did two lymphodepletion regimens. In terms of the design, we have abundant data regarding dose response and ability to lymphodeplete from real data. This is not model data showing a dose response and also correlations between concentrations of ALLO-647 and clinical outcomes, which obviously leads us to believe that 647 is required, and it's one of the critical components of lymphodepletion. We thought the appropriate lymphodepletion was key to achieving meaningful clinical outcomes, and therefore, we have a lot of conviction that this is going to be a positive trial. The endpoint is a clinical endpoint, which is progression-free survival, and the sample size will be 70 patients. So that gives you a sense of the fact that we are looking for a difference that is meaningful because we really believe that the addition of 647 is going to be critical to achieve really meaningful outcomes.

Thank you. Our next question will come from Reni Benjamin of JMP Securities. Your line is open.

Good afternoon everyone. Thank you for the questions, and I look forward to November 29th. Can you discuss the registrational study, particularly regarding treating patients who have had more than two lines of therapy? What was the average number of therapy lines in the earlier studies? Did you observe any changes, either improvements or declines, in responses based on different therapy exposures? Additionally, were there any patients post-indiscernible in any of the studies?

This is Rafael. Yes, these patients were heavily pretreated. Most of them had received about three to four lines of therapies. We looked at a number of predictors, like therapy with one of them, chromosomal abnormalities such as double head, triple heads, and other parameters such as LDAs, etc. We actually saw efficacy that was relatively comparable across multiple parameters, and certainly, lines of therapy didn't stand out. That's one of the parameters that would discriminate good responders from poor responders. So in that regard, the critical criteria is that they are refractory to two lines or more.

Thank you. Our next question will come from Mark Breidenbach of Oppenheimer. Your line is open.

Hey good afternoon guys. So, on the last earnings call, I seem to remember you were talking about exploring pivotal trial options in multiple myeloma by year end. And I guess I'm wondering if that's still the case. And also, can you remind us if UNIVERSAL is excluding patients with any prior BCMA-directed therapies, including Blenrep and some of the BCMA CD3 bispecifics or just the BCMA CAR Ts?

Mark, this is Eric. Let me take the first part of that question, and then I'm going to turn it over to Rafael to answer your UNIVERSAL question. In terms of our communications around the BCMA program, I think we've been fairly consistent in saying that we'll be providing next steps for the program at year end, not guaranteeing what those next steps could be. And of course, that's something we intend to follow through on at our Showcase on the 29th. So again, please join us at that event, and you'll get our latest thinking on what's next for the BCMA program.

Yes. With regards to BCMA-directed therapy, those were allowed in UNIVERSAL. No patients that had received cell therapy, the patients that have received antibody therapy. And in general, we saw no difference between those that have received that and those that hadn't, but the numbers are small.

Thank you. Our next question will come from John Newman of Canaccord Genuity. Your line is open.

Hi guys. Thank you for taking my question. I'm just curious regarding the Alloy process, if you could talk a little bit about how you plan on incorporating that product manufactured at Cell Forge One after the process is approved for Cell Forge One into the pivotal Phase 2? I'm just curious as to how you’re thinking about comparability there with the CDMO product that's being manufactured using the Alloy process at the moment.

Yes, John, this is David. Let me take that question. Alloy process, obviously, that is the process that we have announced as the product that will support the pivotal study. In terms of some of the questions which are going into the technical details, let me just say that in terms of demonstrating the comparability, we have done that already as we were testing different processes across different programs. So I do have confidence in our technical operations team about the key things that one has to do to demonstrate the analytic comparability. So those things we have experienced, and we will apply the knowledge that we have as we have to show the analytic comparability. And we'll provide some additional details in the R&D Showcase about why we chose the Alloy process. I realize that we are talking about the R&D Showcase in a lot of our answers. Let me just talk a little bit about our decision to have the R&D Showcase, which is something that we have thought very carefully. The ultimate driver for us to go with a Showcase is when we think about the topics that we have to cover based on all the inputs from you, our analysts, as well as some of the investors, it's really trying to recap the history of 501 and 501A development and why we landed with the final study design as well as the dose and the lymphodepletion regimen. This is really a complex issue, and we felt that the best way to provide clarity and not confuse the presentation was more in a setting that has a little more time and also provides other context. So I think this was really the key driver for us to opt for the R&D Showcase to provide the important update on both the CD19 and BCMA programs. So it's coming up. I mean November 29 is only about less than about four weeks away. So stay tuned, really.

Thank you. Our next question will come from Michael Schmidt of Guggenheim Partners. Your line is open.

Thank you for taking my question. I found it interesting that you decided to proceed with a one-time dosing regimen for ALPHA2 after considering consolidation. Many other therapy companies are still exploring this, which I thought was noteworthy. I'm curious if you believe this one-time dosing concept could apply to other programs, like 715, or if it is unique to CD19.

Yes, Michael, that's a very important question. Ultimately, the main reason for choosing the single dose is that it is a data-driven decision. We have explored both consolidation and single dose options. After comparing the data, we determined that the single dose is just as effective as consolidation and offers greater clarity regarding the treatment along with the convenience of completing it in one dose. Considering all these factors, our conclusion became very clear, and this is the route we will take moving forward. Regarding your second question about the applicability across different programs, we will continue to make data-driven decisions and will assess each future program accordingly.

Thank you. Our next question will come from Luca Issi of RBC Capital Markets. Your line is open.

Hello, great. Thanks so much for taking the question. Maybe one on the randomized trial for CD19. Can you just talk about why the FDA asked you to use PFS as the primary endpoint and response rate, a secondary endpoint and not the opposite? It feels to me that asking for statistical superiority in PFS at some risk to the trial and also will make the trial much longer. But again, I'd love to hear your thoughts.

Hey Luca, this is Dave Chang. Great question. And I think this is more of a technical response. So bear with me. In a single study, the FDA always has used the response rate and duration of response. However, when it goes to a randomized study, there have certainly been many randomized studies where the best way to power the study, as well as looking at both components of overall response rate as well as duration of response, is through a time-dependent endpoint of progression-free survival. So, I apologize if my response is technical, but this is the most efficient way to really look at the contribution of 647 to the standard full-dose regimen, which is the primary objective of that randomized EXPAND study.

Thank you. Our next question will come from Jason Gerberry of Bank of America. Your line is open.

Hi guys. Thanks for taking my questions. I just wanted to clarify on that last question, just to be clear, David, is there an explicit regulatory bar for this EXPAND study to support registrational moving forward? If you can just maybe get more specific on that point, that would be really helpful.

So Rafael, do you want to take that?

Sure. I mean it is a study that's powered for superiority in PFS, which in cell therapies, because it is really CR that drives long-term responses, there's not a whole lot of difference between durability of response and PFS. So the study is powered for superiority, and the bar is set based on the sample size. There's also a question of safety as well, which is important. But there really isn't a set bar other than the one that is detectable by the sample size, which is relatively small, and you can imagine that based on that, it is a reasonable difference that we're looking for.

Thank you. The next question will come from Kalpit Patel of B. Riley. Your line is open.

Good afternoon. Thank you for taking my question. I wanted to ask about ALLO-605. Can you provide an update on how the enrollment for that trial is progressing? Has interest in it increased due to the manufacturing limitations of approved BCMA therapies? Also, will you be sharing any updates from this study at the R&D event?

Kalpit, hey it's Eric. Thanks for that question. On 605, yes, as you know, we're in a dose-ranging study, a Phase 1 dose escalation study, and that continues. We've talked about having the R&D Showcase focus on the 715 products. So you won't be seeing any data from 605 towards the end of this year, and we'll update you on that program as it goes forward. As you can imagine, yes, there's a fair bit of investor and investigator interest as well in all our BCMA programs.

Thank you. Our next question will come from David Dai of SMBC. Your line is open.

Hey great. Thanks for taking my question. I just have a clarifying question on the ALPHA2 trial. Following on the question on the single dose regimen, maybe could you just talk more about the potential to redose the patients in the trial? And would that be put into the potentially later in the trial that you actually could be a redose of patients? And if so, what would be the criteria for redosing?

Yes. So David, this is Dave Chang. The redosing question we frequently get. When I think about the development of autologous CAR T, that's something that we investigated. But from the Phase 2 clinical trial perspective, keep in mind the objective of the Phase 2 study is to demonstrate the treatment effect of the single dose. When someone requires a redosing, which usually will be the case when there is no benefit or someone after responding progresses. In those patients, when that happens, any patients who get redosed will be censored from the efficacy analysis. So going forward, with the pivotal study, redosing is not part of the study plan regarding the primary objective of the study. But when there is an opportunity, we will definitely investigate redosing as an exploratory analysis.

Thank you. Our next question will come from Jack Allen of Baird. Your line is open.

Thank you so much and congratulations to the team on the progress this quarter. I wanted to touch on the Servier relationship. And I was hoping you can provide an update as to where things sit there and when we might hear more news? And then as it relates to the ALPHA2 study, how quickly do you think you can get sites initiated in Europe? Or would you do that prior to settling the Servier JV well? Thank you so much.

Hey Jack, would you mind repeating the initial part of the question, there was a little bit of glitch. We didn't clearly hear the beginning part of your question.

Yes. Sorry about that. I was asking about the Servier relationship. I was hoping to understand when we may get an update regarding the European rights for CD19 and how quickly you could start to initiate studies in Europe as well.

Okay. Thank you, Jack, for that question. Yes, on Servier, as you know, and as we disclosed back in September, they made the decision to no longer participate in the development of CD19, essentially allowing us the secondary rights outside the U.S. should we choose. We have the option to take over the global rights to CD19. Right now, as you know, under our collaboration with Servier, we just have the United States rights. So that's an option that we're going to consider quite carefully. It does come if we choose to with some extra costs, where we would be paying for 100% of the program as opposed to our current rate of 60%. But certainly, the potential to market the product globally is also an attractive opportunity. In terms of what we're doing right now with the CD19 Phase 2 study, we already planned through the collaboration with Servier to enroll patients in Europe. So our plan was always to conduct the global study that would provide for global registration should it prove positive.

Thank you. Our next question will come from Brian Cheng of JPMorgan. Your line is open.

Hey David and team, thanks for taking my question. Regarding the Alloy process, if it is only used for CD19, is CD19 part of Alloy or is there a similar Alloy system also used in your BCMA program? Could you share how long Alloy has been implemented? Thank you.

David here. I'll address the question regarding the Alloy process, which we have already touched on a few times during this call. The Alloy process is one of the methods we've been testing across our programs, and it has definitely been utilized beyond just the 501A programs. It has certainly helped us generate data from various programs that informs our decision-making. In the upcoming R&D Showcase, we will outline our reasoning along with supporting data that led us to the decision to employ the Alloy for the pivotal study.

Thank you. The next question will come from Robert Burns of H.C. Wainwright. Your line is open.

Hi guys. Thanks for taking my question. Just one from me, if I may. I know you terminated the collaboration with SpringWorks to evaluate ALLO-715 in combination with nirogacestat. I was just curious if during the R&D Day update, we would gain greater clarity as to the reasoning and some of the pharmacodynamic and pharmacokinetic measures from that evaluation? Thank you.

Rob, this is Eric. Thanks for the question. It's an important consideration that we were trying to answer whether or not a gamma secretase inhibitor added to the benefit of ALLO-715 in our hands. And yes, as you know, we discontinued that arm of the study because we didn't see meaningful benefit from the addition of the gamma secretase inhibitor 715, and we'll certainly try and make that data available to you in the future. I'm not sure that the R&D Showcase is the right form to do so. Honestly, we already have a lot of things that we want to talk about, and this trial arm is again not something we're going to be moving forward with in the development going forward.

Thank you. Our next question will come from Dane Leone of Raymond James. Your line is open.

Hi, thank you for taking questions. I look forward to the R&D Showcase. Could you maybe just clarify what steps still need to happen internally to get the pivotal ALLO-501A studies up and going, both the study itself and then the EXPAND study as well? Just kind of blocking and tackling type stuff what still needs to be done there? Thank you.

Okay. Dane, this is Dave Chang. So in terms of the Alloy process, what's needed, everything is already done. We have products that are made in the Alloy process that will be used as we enroll patients into the pivotal study. There is nothing that is on the critical path in terms of enrolling patients in the pivotal study. Probably what's underlying your question is, what would it take for us to bring the Alloy process to our manufacturing facility? This involves qualifying machines as well as utilizing the cell manufacturing operators. These are the people who actually manufacture the cells at the CF1 and start making the products using the Alloy. This is something that we are very familiar with how to go about doing this, and the work is already ongoing.

Thank you. Our next question will come from Ben Burnett of Stifel. Your line is open.

Hey, thank you very much. I had a question on your multiple myeloma strategy. I guess do you think there's any value or is there any interest in trying to elucidate the efficacy profile of 715 or even the TurboCAR in BCMA experienced patients just in the event that autologous BCMA CAR T ends up moving upstream?

Ben, this is Rafael. It certainly is an interesting question. We know that a lot of patients with progression after BCMA-directed therapy still are BCMA positive, unlike many patients in the CD19 space, and whether another BCMA-directed therapy may be effective or not is definitely a question of clinical interest. I think it's premature for us to really tackle that question with ALLO-605. We are, as Eric said, in dose escalation in the BCMA-naive patients, but it's a question that we may consider in the future.

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

Thank you. First of all, thanks for joining us today, and thank you very much for the insightful questions, and we look forward to seeing many of you in person, I hope, at our R&D Showcase later this month. 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. Have a pleasant day.