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spk01: Thank you for standing by and welcome to Allogene Therapeutics first quarter 2022 conference call. At this time, all participants on a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. Please be aware that today's call is being recorded. If you require any further assistance, please press star zero. I would now like to turn the call over to Christine Calciano. Chief Communications Officer, please go ahead.
spk13: Thank you, Operator, and welcome to all who have joined this call. After the market closed today, Allogene issued a press release that provides a business update and financial results for the first quarter of 2022. This press release and today's webcast are both available on our website. As a reminder for this call, we ask that all keep their questions to one per person. Joining me on the call today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer, and Dr. Eric Schmidt, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, and 2022 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and the latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and Allergan disclaims any obligation to update these statements. I'll now turn the call over to David.
spk04: Thank you, Christine, and good afternoon. This month marks the fourth anniversary of Allergen's inception. We founded Allergen with a belief that for cell therapy to truly change the landscape, it would need to be industrialized. Today, as a report on the first quarter of 2022, I'm immensely proud of all we have accomplished in the last four years. This includes delivering peripheral concept data from our CD19 and BCMA programs, that is differentiated in the field, including the most comprehensive set of allogeneic CAR-T data demonstrating durability, as well as operationalizing CellForge-1, advancing our allo-CAR-T programs into solid tumors, progressing multiple clinical programs with each testing innovative concepts that have the potential to fuel the growth of allogeneic CAR-T, and most importantly, bringing our lead Allocardy product candidate to a cusp of a pivotal trial. We are proud to have treated more patients with our Allocardy candidates than any other player in the field. But the true promise of allogeneic therapy comes not from treating tens or even hundreds of patients in clinical trials, but from being able to serve tens of thousands of patients in a commercial setting. With each advance we make in manufacturing, clinical development, research, and execution, we are one step closer to achieving our vision of creating a new reality for patients, a reality in which all eligible patients can access this important modality. As someone who has had the privilege of playing a role in the development of autologous CAR T therapy, I am proud of the progress the field is continuously making. Just last month, the first autologous CAR T therapy was approved by the FDA as the second-line treatment for adults with large B-cell lymphoma that is resistant to initial therapy or relapsed within one year of the start of the frontline treatment. This treatment is also the first CAR T therapy to receive a National Comprehensive Cancer Network Category 1 recommendation based on high level of clinical evidence that the therapy is appropriate. In February, the FDA approved the second BCMA-directed otologous cardiac therapy for patients with relapsed or refractory multiple myeloma. These are meaningful advances that will change the practice of medicine, and we are pleased to see the increase in the number of patients who can potentially benefit from cardiac therapy. but broader treatment recommendations create inherent challenges for therapists that must be manufactured and delivered on an individual patient basis. The logistical challenges and cost of manufacturing, patient by patient, as well as waiting times and potential for manufacturer failure must all be addressed in order for the field to move forward. Markets like Second Line Large B-cell Lymphoma and relapsed refractory multiple myeloma are large, consisting of many thousands of potentially suitable patients. Autologous therapies have simply not been able to keep up with demand. Sadly, no matter how efficacious an autologous cardiac therapy may be, its benefits do not extend to those patients who are left in waiting. The recent approvals and expected approval of additional indications will place more pressure on the supply bottleneck. Autologous companies are building up manufacturing capacity in response to growing demand, but creating ready, available, and scalable supply with personalized therapies simply isn't possible when production runs need to be individually tailored. For an autologous therapy to serve 25,000 patients, it must successfully execute 25,000 manufacturing runs. The most efficient way to meet such demand is an allogeneic CAR-T product, which also provides the promise of growing the market. Based on our experience with Allo501A, we project that at scale we can manufacture approximately 20,000 patient doses annually and reduce the number of required manufacturing runs hundredfold as compared to autologous CAR-T therapies, while importantly delivering this product on demand to any eligible patient in need. We think this type of step function improvement in both efficiency and production and speed of treatment will be a requisite for treating the large number of patients who stand to benefit from CAR-T therapy. We recently conducted a virtual unveiling of our new manufacturing facility, Cell Forge One, or CF1, in Newark, California. From the beginning, we knew that controlling the production of our allocarty products would be key to our ability to deliver off-the-shelf carty products faster, more reliably, and at greater scale. Hence, our decision to build out our own cell manufacturing facility at an early time point. CF1 was built to support clinical and commercial manufacturing, analytical testing, and the distribution of our cell therapy products with a flexibility that would allow optimization of all steps in the manufacturing process and incorporation of new learnings for next generation of allocarpy products. Thank you for those who participated in this facility's virtual unveiling. In this case, I truly believe a picture is worth a thousand words, and our virtual event provided powerful visualization of the unique aspects of our facility design. And based on the feedback, we are thrilled so many of you found this event to be insightful and highly educational. On the clinical front, as most are aware, we promptly resumed clinical study activities after the FDA lifted our clinical hold early this year. We are actively enrolling patients in our trials for allo715 and allo605 in relapsed refractory multiple myeloma and allo316 in advanced or metastatic renal cell carcinoma. We have also chosen to continue enrollment in our Phase I study of allo501A in advance of initiating our pivotal trial that is projected to start mid-year. We are completing CMC activities that should enable us to initiate the pivotal program using materials produced at CF1. We view this as strategically important and a major competitive advantage that could reduce timeline to BLA filing and potential FDA approval. Lastly, I would like to take a few minutes to welcome Susie Lundeen, our new Chief People Officer, to our senior leadership team. In this newly created position at Allogene, Susie will oversee our human resources efforts as we scale our teams in support of advancing our pipeline. Her breadth of experience in designing and implementing systems and strategies to support companies as they transition from development to commercial stage will be key to our success. Thank you for joining us today. We are grateful for your support as our vision for the future of allogeneic heart disease continues to materialize with each patient we treat. I will now turn the call over to Rafael for further updates on our research and development activities. Thank you, David. Our clinical teams have been incredibly engaged with clinical trial sites and investigators as we enroll patients across four active studies. Universal for Allo715 and Ignite for Allo605 in relapse or refractory multiple myeloma, Traverse for Allo316 in renal cell carcinoma, and the extended Phase I portion of the Alpha-2 trial for Allo501A in relapse or refractory large-scale lymphoma. We are keenly focused on initiating our pivotal trial on allo501A in third-line large piece of lymphoma around the middle of this year. Given ongoing FDA discussions directed at finalizing clinical trial design, chemistry, manufacturing, and controls requirements, and the competitive nature of the field, we will share details about this single-arm study at the time of initiation. In the meantime, and as noted by David, We continue to enroll in the Phase I portion of the study to offer Allo501A to patients in need. Separate from Alpha-2 pivotal trial, we are preparing to launch the EXPAND trial to support registration of Allo647, our proprietary anti-CD52 monoclonal antibody. EXPAND is designed to establish the contribution of Allo647 to the lymphodepletion regimen. We deploy Allo647 as part of our lymphodepletion regimen in order to enable enhanced expansion and persistence of Allocard T cells, and we have shown a strong correlation between serum concentrations of Allo647 and the likelihood of clinical response. Based on this data, we believe this trial will not only result in a positive outcome, but also competitively differentiate our platform by demonstrating that Allo647 contributes to superior outcomes. In particular, we believe the rate and durability of responses demonstrated to date with allo501A is in part related to the degree of lymphodepletion enabled by the use of allo647, which differentiates our platform from that of others in the allogeneic field. To that end, we do intend to have an update on longer-term follow-up from the alpha studies by the end of the year. Our BCMA program is the first and only allocarty BCMA program to generate clear proof-of-concept data. Data from the universal trial on allo715 continue to be well-received by investigators, and we are optimistic that we will have a competitive product for the treatment of relapsed refractory multiple myeloma. As David mentioned, there is tremendous unmet need in myeloma, and despite the recent approvals of autologous CAR-T therapies, There remains strong interest in a product that can be delivered in days and without need of bridging chemotherapy. Our approach to myeloma gives us four shots in all, with our first allo715 as a monotherapy, already demonstrating a profile that appears attractive relative to that of abecma, and approved autologous CAR T-therapy. We are also evaluating Allo715 utilizing consolidated dosing and in combination with SpringWorks Therapeutics Investigational Gamma Secretase Inhibitor Neogazostat. Lastly, Allo605, our first TurboCAR candidate, is in Phase 1 evaluation. As you may recall, TurboCARs are designed to provide selective, programmable cytokine signaling to CAR T cells to counter T cell exhaustion, improved T cell function and potency, and potentially reduced cell dose requirements. Just last week, allo-605 was granted orphan drug designation by the FDA. Notably, in March, we announced the publication of clinical results in cancer research communications, which demonstrated strong evidence of the superior long-term myeloma-killing activity of allogeneic anti-BCMA CAR T cells manufactured from healthy donors compared with anti-BCMA CAR T cells from patients with multiple myeloma. We intend to provide a holistic update on our BCMA program by the end of the year. We remain eager to better understand the potential of our allocardies in solid tumors. Our first candidate, allo316, targeting CD70 for the treatment of advanced or metastatic clear cell renal cell carcinoma, is proceeding through phase 1 dose escalations. Last month, we presented preclinical data at the 2022 American Association for Cancer Research annual meeting, which supports the clinical evaluation of ALO316 for the treatment of patients with renal cell carcinoma and other CD70-expressing tumors. The findings, simultaneously published in Cancer Research, followed our announcement in March that the FDA granted ALO316 fast-track designation based on its potential to address the unmet need for patients with renal cell carcinoma who have failed standard therapy. Metastatic solid tumors have historically been a challenge regardless of treatment modality, and the five-year survival rate for patients with advanced kidney cancer is less than 15%, creating a necessity for scientific innovation. While we still have a long road ahead of us, we continue to make progress and look forward to generating data from our ongoing Phase I Traverse trials as we plan for the testing of Allo 316 in other CD70 expressing two more times. In addition to advancing our clinical work, our research teams are making good progress progressing multiple preclinical candidates and innovative technologies. We expect these to ensure Allogene's leadership position in the field of allogeneic heart disease for years to come. I'd like to now turn the call over to Eric for an update on our financials.
spk05: Thank you, Rafael, and good afternoon, everyone. The current bear market for biotech has been long and steep. This is truly a time where experience is critical. At Allogene, we are very fortunate that our leadership team has weathered such markets before and that we have the financial strength to weather the current downturn. We have a strong balance sheet and a sizable cash runway that should allow us to focus on execution as we advance multiple potentially first and best-in-class Allocarti candidates through pivotal trials. We ended the quarter with $733 million in cash, cash equivalents, and investments. In the first quarter of 2022, our research and development expenses were $60.2 million, which includes $11.1 million of non-cash stock-based compensation expense. General and administrative expenses were $19.9 million for the first quarter of 2022, which includes $11.2 million of non-cash stock-based compensation expense. Our net loss for the first quarter of 2022 was $79.9 million, or 56 cents per share, including non-cash stock-based compensation expense of $22.3 million. We continue to expect our full year 2022 operating expenses to be between $360 and $390 million. This includes an estimated non-cash stock-based compensation expense of $90 million to $100 million, and excludes any impact from potential business development activities. With that, we will now open the call for your questions.
spk06: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by. We compiled the Q&A roster. And we do ask that you limit yourself to one question. Again, we ask that you limit yourself to one question. And our first question comes from Tyler Van Buren from Cowan. Your line is now open.
spk08: Hey, guys. Congrats on the progress. Thanks very much for taking the question. So there's a continuous focus, of course, on comparing your Allocarti data to the autologous data for the approved products, but can you just remind us what exactly you need to show in a pivotal Allo 501A trial for approval and Just as a quick follow-up, when Allo 501 reaches the market, is the goal to focus on patients who don't have access to autologous products, who are the low-hanging fruit, or are you just as focused on competing head-to-head with the autologous products?
spk04: Hi, Tyler. I'll take your question. This is Rafael. In general, we are incredibly pleased by the data that we've generated thus far, and it was last presented at ASH since 2021. You could see the response rates, you could see the durability showing 14 complete responders, 10 of whom were still in complete response. And of all the patients that had had an opportunity to be followed for six months, they were all still in complete response, and some of them are out to six months. So we think that there is comparable durability and complete response And then the safety profile of the product actually with regards to icons and CRS, particularly grade three and beyond is actually very denying with comparable infection rates. So I think regarding, you know, your premise, we think that these products are going to be comparable to autologous. And so we're not looking for the nature of patients that cannot be treated with autologous. We're looking to really establish this as a therapy that can be off the shelf and treat everybody that needs it within a very short period of time and really transform the way that self-therapy is used today.
spk06: Ed, thank you. And our next question comes from Michael Yee from Jefferies. Your line is now open.
spk10: Hi, this is Yiqi on for Mike. So what are the dating steps to starting the pivotal phase two DLBCL study, and what are still the manufacturing things that need to be signed off? What are the limiting steps, and can you give us some additional visibility into these things? And is there any difference now than between the tight days or other days when people didn't have issues starting a pivotal study?
spk04: Yeah, so, you know, multiple questions there. And, you know, this is Dave Cheng. You know, we won't be giving any play-by-play details, you know, other than to say that ALO501A Pivotal Study is on schedule to start mid-2022. And as we have commented in the prepared remarks, we are completing CMC activities that should enable us to initiate the pivotal studies using commercial-ready materials produced at Salt Forge One, which we believe is a strategic importance and competitive advantage. Our goal, obviously, is to position Allo501A to be the first allogeneic CAR-T products to gain approval.
spk06: And thank you. And our next question comes from Corey Kazimoff from JP Morgan. Your line is now.
spk17: Hey, good afternoon, guys. Thank you for taking my question. Wanted to ask about trial design for for alpha two and is consolidation therapy going to be standard for all patients? Or will you look to have a robust sample with and without and kind of how do you determine that what the appropriate time to institute consolidation therapy. Thank you.
spk04: Yeah. Hi, Corey. This is Rafael. I'll take the question. We treated, I think, more patients than anyone else in large piece of lymphoma with various residents and schedules. And we have a wealth of data, not just clinical, but also translational. And this has allowed us to go into deep analysis to really look into what is the most favorable regimen. Because of the comparative nature of this field, we're not reviewing these and other details of the phase one study until the study starts. But we are very confident that we do not need any more information to actually come up with a dosing schedule that we're going to use. And, you know, therefore the study with regards to the design and the dosing is already set and ready to start in the middle of the year.
spk06: Thank you. And our next question comes from . Your line is now open.
spk12: Thanks for taking my question. How comfortable or confident are you that you'll know how to proceed with the BCMA program with all your data, but by your end.
spk04: Yes, hi, Serene. So we actually are very pleased by the pace of our BCMA program. You know about our data at ASH, which resemble very much, you know, the data with the BEDMA. We're using 320 million cells, but we had over, you know, 20 patients' worth of data with responses upwards of 70% and BGPR plus in the 46% range. And this was relatively early data. We continue to follow these patients. The median follow-up is obviously increasing and we look forward to giving an update towards the end of the year. But as you know, we continue to look for ways to improve this data in addition to, you know, seeing what's happening with the patients that we've treated thus far. We mentioned 605, which is our turbo car, which is enrolling now after the fall was lifted. And we are also using Neogastastat as well as consolidation to look at outcomes. So everything that we are hearing from investigators is that we've got a profile that is actually worthy of pursuing in pivotal studies. So given the competitive nature of this field, we want to actually be able to position this with the optimal benefit-risk profile. So that's why we're looking at this, all the modalities of treatment, And with regards to whether we're confident to make a decision by the end of the year, the answer is yes. Accrual is proceeding briskly, and we are confident that we will have the data to make the decision.
spk06: Thank you. And our next question comes from John Newman from Canaccord. Your line is now open.
spk07: Hi, team. Thank you very much for taking my questions. My one question is, given you're intending to use commercial-ready product from Selforge, in your pivotal study, do you have any plans at all to work on the phenotype of the product, maybe to push that more towards younger memory type cells, or are you happy with the current formulation from that aspect? Thanks.
spk04: Hi, John. Thanks for that question. You know, this is David, and I'll take the question. You know, I have to say that, you know, having been involved in cell therapy, you know, manufacturing for some time, you know, I'm extremely proud of what the team at Allogene has done. I mean, this is, of course, you know, many different aspects of manufacturing, not just manufacturing the cells, but analytic assay development and deployment. you know, continuously improving the manufacturing process and also taking care of all the supply chain issues, including distribution of Allocard T products to multiple clinical sites. You know, your question around the cell phenotype, we get asked quite a lot. But, you know, we have looked at this in multiple different ways. And what we are finding is, starting with the healthy donor cells, we end up with cell products that generally has much so-called juvenile phenotype, either central memory or sometimes naive cells constituting the majority of the cells. You know, we will certainly continue to look for additional ways to improve, you know, the quality of the cell products. as well as the use of manufactured products. But as for the cell phenotype, you know, we are at a pretty comfortable place. And, you know, nothing will stop us from moving forward into the pivotal program using the manufactured cells coming from CF1.
spk06: Thank you. And our next question comes from Mark Vredenbach from Oppenheimer. Your line is now open.
spk11: Hi, this is Jacqueline for Mark. Thanks for taking our question. So a couple questions on the expense study. Does the pivotal Phase II portion of Alpha-2 have to start enrolling before the expense can begin? Like instead of enrolling more patients in the Phase I portion of Alpha-2, could they instead be redirected into the expense study?
spk04: Yeah, I'll take that question. This is Rafael. It is a good question. The EXPAND study is going to start after the Alpha-2 study. The Alpha-2 study, obviously, is the registration trial for 5018, the most important trial of the two. Obviously, we need the co-development of ALO647. And just to remind us on the line that may not be as familiar, this is a study that is really isolating the effect of 647, and therefore randomized with fluorabine cyclophosphamide to fluorabine cyclophosphamide and 647. It is a relatively small study. We have a wealth of translational data that indicates that there is a dose-dependent degree of lymphodepletion that correlates with expansion, that correlates with clinical outcomes, There is data out there from other sponsors where they're having used anti-CD52 antibody in at least nine patients worth of data from programs in anti-CD19 and anti-CD22 showing no expansion whatsoever and no responses. So I think the fact that lymphodepletion and optimization with an agent like an anti-CD62 antibody is required, I don't think there's much doubt of that. So it is going to be randomized because we need that information, and it will start after the 501A single-arm study starts. So this is sort of the cadence that we're going to follow this year, finish the Phase I study, the 501A first, and then expand.
spk06: Thank you. And our next question comes from Luca Isai from RBC Capital. Your line is now open.
spk16: Oh, great. Thanks so much for taking my question, and congrats on all the progress. Maybe one on expand. Can you just talk about how you're thinking about the primary endpoints for that trial? Do you just need to show, like, higher T cell expansion, or do you actually need to show better efficacy versus traditional lymph depletion? And then, if I may, I know you mentioned in the past the 501A trial, and 647 will ultimately be approved simultaneously. It's kind of similar to IL-6 and Yaskarta back in the day. But do they require two separate BLA, or can you have one BLA for both combined? Thanks so much.
spk04: Yeah, thanks for the question. I think in terms of the endpoint, I'm going to sort of reserve the answer until the study opens. These are, you know, discussions that we've had with the agency and, you know, that finalized and we know well what needs to happen. With regards to, I mean, it is something for the breeding agent, but the actual endpoint, you know, we will reveal once we talk about the design of the study in more detail. You know, how we're going to register this, I think we've mentioned in the past that it's a core development, so each one of the agents will require its own BLA, and that's the pathway that we intend to follow.
spk06: Thank you. And our next question comes from Ren Benjamin from JMP Security. Your line is now open.
spk15: Hey, good afternoon, guys. Thanks for taking the questions. I just wanted to talk a little bit about Allo 316. You know, you guys had some interesting preclinical data at AACR showing that these cells didn't undergo fratricide. And I'm just trying to understand a little bit better this whole idea of masking and how, while masking might, you know, protect and help with the longevity of the cells, how it might, you know, could it impact efficacy as well? And then, Or do we just need to kind of see how things progress in the clinical trials? We'd just love to get your thoughts based on, you know, some of the mechanisms that were uncovered at AACR.
spk04: Yeah. Hi, Dren. Thanks so much for the question. It is, I think, a fascinating story. The team tested a number of CARs, and obviously, Fratricide is it's a problem with anti-CD70 because as you activate the cells to grow them and make sufficient cells to treat patients, they start expressing CD70 and therefore the cells, the CAR positive cells like them and there's a part of toxicity to those cells. So you essentially are unable to produce these cells. And so some have resorted to actually knocking out CD70, which includes another gene edit, which has its own complexity. Our team opted for a car that is able to actually mask the CD70 epitope so that the neighboring cells are not able to encounter CD7T receptor and therefore life those cells. Now your question is what happens in vivo. You know, this masking occurs during manufacturing. Then once the cells are in circulation, we believe that the epitopes that are exposed in the CD7T positive cells could be targeted by the CAR positive cells. And this is probably just in terms of, you know, how many cells or how many epitopes are covered versus free and exposed. Obviously, it's very early to know what that's going to show because we're still in dose escalation. But we are confident that this mask will allow us to produce the product and at the same time have an effect.
spk06: Thank you. And our next question. It comes from Kalpit Patel from B. Reilly. Your line is now open.
spk09: Yes, hi. Thanks for taking my question. You mentioned the approval of AxiCell in the second-line treatment for B-cell lymphoma. I guess, how are you thinking about the potential impact that this approval would have on the pool of patients that would be eligible to receive an allogeneic heart T in the third-line setting? Is there a percentage or is there a number in mind that you have internally discussed? Calphitt, this is Eric.
spk05: Thanks for the question. It's a good one and one that we, you know, are actually frequently asked, so appreciate the opportunity to address it here. You know, these are game-changing results that we're seeing with Yiscarda and Breonzi in the second-line setting, and certainly we expect them to have practice-changing implications. But even five years after the launch of these products and similarly game-changing results in third-line LBCL, only a very small minority of appropriate third-line patients are receiving CAR-T therapy. I think our market research suggests between 20% and 30% of all third-line patients are getting therapy. So it's obviously going to take some time before these agents move up front into the second-line setting. And I think You know, that time really, in many ways, reflects the complexity of delivering an autologous product. Obviously, with an off-the-shelf product, we think we're going to do much better in terms of our penetration, grow the market, and certainly treat patients more rapidly who need on-demand treatment.
spk06: Thank you. And our next question comes from Enance Kenner from Truist. Your line is now open.
spk02: Hi, this is Inan Chan for Osteca. While the near-term priority is on the pivotal alpha-2 study, when do you guys actually plan to start rolling out studies in second-line LBCL, and what specific patient subgroups do you think would make the most sense to target first? Thank you.
spk04: So we are aware of obviously the to second line, although we think that this is going to be slow and that there's still going to be sufficient number of patients as Eric just alluded to in the relapse refractory setting. But given the fact that these products are so active in second line, we intend to move the product into second line therapy as well. Obviously, we have a total order to get two clinical trials, pivotal studies, standing this year, the EXPAND trial as well as the Alpha-2. But very shortly after, we intend to start the second-line study as well. So stay tuned to, you know, the cadence of our studies. This is something that we will be doing and, you know, it will be following shortly. that people who are on trials and relapse refractory.
spk06: Thank you. And our next question comes from Raju Prasad from William Blair. Your line is now open. Thanks for checking the question.
spk14: We, you know, we get a lot of questions on kind of the vector supply for some of the autologous therapies. And obviously, given the fact that you're talking about 20,000 doses annually at scale, I was just kind of curious to know how you're viewing kind of the potential competition with autologous products that might be having, you know, vector supply issues and how you kind of view that from a potential, you know, competitive perspective.
spk04: Thanks. Rod, I'll answer that question. Back to as well as manufacturing supply, this is something that we have been working very closely over the last two and a half years. I think we are at a very comfortable place. Also, another thing that I emphasize is that we currently estimate that our manufacturing facility can produce you know, 20,000 doses per year, you know, which is a, you know, tremendous capacity, you know, coming out of a single manufacturing facility. But as an allergenic cell product, I mean, we expect that each manufacturing run, you know, to produce 100 plus doses. So obviously that is, you know, totally different, you know, sort of demand compared to the autologous manufacturing. And, you know, this is really, you know, some of the things that should really be highlighted as, you know, the advantages of allogeneic manufacturing. So, you know, there's a lot more that we can go into what we are doing into the LBB supply, but just be assured we have covered that area very well.
spk06: Thank you. And our next question comes from Dane Leon from Raymond James. Your line is now open.
spk03: Pat, thank you for taking the questions. Congratulations on progress. Could you maybe provide a little bit more color in terms of what the clinical learnings you expect to present for CD19 and BCMA in the back half of the year are, and then any expectation in terms of when we might see first data out of the CD70 program? It sounds like it might be more of a 2023 event. Thank you.
spk04: Okay, so this is David. Let me take the question. You know, our plan is to, you know, provide additional updates on both CD19 program and, you know, BCNA program. Rafael talked about, you know, how we will, you know, make a decision on the BCNA program. And, you know, that's really part of the, you know, update that we will be presenting at the year end. You know, that's, of course, not just 715 studies, but other strategies that we are we have been, you know, employing, you know, over the last year and a half. In terms of details and how many patients, you know, we will, you know, just have to hold that, you know, until more appropriate time. You know, CD19 is additional program that we will be presenting the update. Last year at ASH, you know, we presented the long-term durability, and as Rafael has covered, we are very excited about the durability data that we are seeing. 14 complete responders, and once the responses last six months, after that, we are not seeing many people, and in fact, You know, the seven patients who have passed a six-month time point, none had progressed at the time of the data cut. So these are, you know, very encouraging data that really differentiated allogeneic CAR-T therapy products, you know, from other allogeneic programs. And we are following those patients, and the long-term follow-up will be a big part of the additional data presentation at the year end. 316, that one, you know, we are still, you know, in the dose escalation. You know, there's a lot of excitement on that study from the investigator perspective, but we will be generating additional data, and exactly when we will present, I mean, at this point, we're guiding more towards next year rather than this year, but we will see.
spk06: Dan, thank you. And I'm showing no further questions. I would now like to turn the call back over to management for closing remarks.
spk04: Well, thank you for joining us today and for taking part in our journey to define, shape, and advance the future of not just Allergenic South Darkly, but the South Darkly market as a whole. We are pleased with our ongoing progress and look forward to what lies ahead for the rest of the year. Operator, you may now disconnect.
spk06: This concludes today's conference call. Thank you for participating. You may now disconnect.
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