Lyell Immunopharma, Inc. ($LYEL)
Earnings Call Transcript · April 14, 2026
Earnings Call Speaker Segments
Gil Blum
AnalystsGood morning, everyone, and thank you for joining us at the second day of the Needham Healthcare Conference. My name is Gil Blum, and I'm a senior biotech analyst here at Needham & Company, and I cover the cell and gene therapy space. It is my pleasure to have with me today, Lynn Seely, the CEO of Lyell Biopharma or is it Immunopharma now?
Lynn Seely
ExecutivesImmunopharma.
Gil Blum
AnalystsImmunopharma, to discuss their very exciting programs, specifically in the CAR-T space. Very happy to have you here, Lynn. It's good to continue to see some efforts in this space despite certain investor sentiment. So maybe just starting with a broad overview of the company and its lead assets.
Lynn Seely
ExecutivesSure. Well, thank you, Gil, for inviting me. And yes, I think investor sentiment is clearly changing in the CAR T cell therapy space. For those of you who don't know Lyell, Lyell Immunopharma is a late clinical stage cell therapy company, really focused on bringing next-generation cell therapies to patients, both with hematologic malignancies as well as solid tumors. And we have 2 programs in clinical development for large markets. The first is ronde-cel. This is a dual targeting CD19, CD20 CAR T cell therapy, which we have really designed to replace the CD19 CAR T cell therapies. We know this is an established $3 billion marketplace, but it needs better therapies. And ronde-cel has been very rationally designed to bring higher and more durable lasting complete responses. So we are currently in 2 pivotal trials for ronde-cel. One is a single-arm fast to approval study in the third-line setting. And the other is a first of its kind head-to-head randomized Phase III CAR T cell therapy trial of ronde-cel versus investigator's choice of 1 of the 2 leading CAR T cell, CD19 CAR T cell therapies. So these programs are well underway, and we're very excited about that. And then in addition, we have a very novel next-generation CAR T cell therapy for metastatic colorectal cancer. And this is a program that is in Phase I dose escalation in the United States, but it's based on a program invented in China that has already shown very nice clinical activity, both in China and in the U.S. So I'm excited to tell you about both of those. And then lastly, one thing that you should know about Lyell is that we have our own manufacturing center that is capable of commercial launch. And so we are, as we speak, manufacturing with our commercial manufacturing process for ronde-cel. So in many ways, we're very fortunate to control our own destiny when it comes to manufacturing.
Gil Blum
AnalystsExcellent. So let's start with ronde-cel. A first look as it relates to -- how do you feel it's differentiated from the standard of care CAR-Ts?
Lynn Seely
ExecutivesYes. So it was designed very rationally from the beginning to be differentiated and to bring a new value proposition for patients over and above the CD19 CARs. And so the first feature of ronde-cel that really differentiates it is the fact that it has 2 targets instead of just one. So it has CD19 and it has CD19 at full potency, but it also has CD20. So it's designed as this tandem CAR to have full potency at either CD19 or CD20. And this is important for 2 reasons. First, it kind of makes sense that if you're targeting 2 antigens, you can drive more complete responses. And that's because some malignant B cells have low or no CD19 and might not respond to the current CD19 CARs, but they do have CD20 and so would respond to a dual targeting 19/20 CAR. In addition, one of the key mechanisms of escape from CAR T cell therapy is, in fact, antigen loss. So these malignant cancer cells can drop an antigen like CD19, but it's much more difficult for them to drop 2 antigens and sort of escape the benefit of a dual targeted CAR. But that's not all. So in addition, our CAR is differentiated because we have a very special manufacturing process where we enrich for naive and central memory T cells. These are -- we call them more fit T cells so that they basically can persist longer, have a little softer adverse profile and actually expand quite nicely. So the combination of this dual targeting and the fact that we have more naive T cells in our cell product, we think, is a very important combination to bring the outcomes that we're seeing with ronde-cel.
Gil Blum
AnalystsOne really important aspect of your development program is this really aggressive head-to-head study where you're pitting CAR-Ts against each other. I think this is the first such study in this space. What makes you confident that you can outperform on efficacy of the existing standard of care CAR-T, specifically Breyanzi, that has some like pretty decent long-term follow-up.
Lynn Seely
ExecutivesSo it is a bold strategy, and it's a bold strategy, which suggests we are very confident. And traditionally, in development, you're not -- you're taught not to run head-to-head studies. But in this case, it's the right study to do. And it's for several reasons. And first and foremost, we're developing products for patients. And if we expect physicians to change their prescribing behavior from CD19 to 19/20s, and we believe this is the next-generation CAR T cell therapy, we need to provide the data to support that. And we do believe this is the next generation. We do believe the data are better. And so as always, we are very science-driven. So we understand the biology here and the mechanism as we just talked about. So it makes intuitive sense biologically that a 19/20 could drive more complete responses with longer duration of response. And then we've generated data. And this product, we presented data in an oral presentation at ASH last year in the third and later line setting, where we've shown 93% overall response rate, 76% complete response rate and very importantly, a median progression-free survival of 18 months, data which are significantly improved compared to the third-line data from the CD19 CAR. So that's the first set of data. We've also presented data in the second line in a very difficult-to-treat patient population. Patients who have failed even frontline chemotherapy. So they never even responded to chemotherapy. These are primary refractory patients. And there, again, we're seeing very nice complete response rates and duration of response, better significantly than what has been presented or published for the CD19 CARs. So when we put this data together, we feel very confident in our design of this head-to-head study. And I think we're looking to bring value to patients not only in outcomes, better complete response, longer duration of response, better event-free survival and also the safety profile. And so I think we know that the currently approved CD19 CARs have some neurotoxicity. They have some Grade 3 or higher CRS, and we're looking to bring a better safety profile as well to allow for more outpatient administration.
Gil Blum
AnalystsSo would you say that copying is a form of flattery? What are your views on the announced head-to-head study that's pitting Kite's own dual targeting CAR-T 753 versus their own YESCARTA? And do you feel this complicates the therapeutic landscape in the second line?
Lynn Seely
ExecutivesI feel like at Lyell, we are leading with ronde-cel, and we, more than a year ago, started this trial. We are currently well underway in dosing patients as we speak. So this is something that we have been working on for quite some time leading the field. And so of course, if you have this beautiful study design, others may have to copy, and it sounds like Kite Gilead is beginning to work on their trial. But again, they're substantially behind and being first matters in this space. And I think being able to bring out our data and to get there first with our single-arm pivotal trial, we hope to be the first CD19, CD20 CAR T cell therapy approved gives us a substantial advantage because with the safety data that we're showing to date and the outcomes, we think we have a really nice opportunity to supplant the currently approved CD19 CARs. But then it's going to take a lot to supplant the data that we're bringing because there's not much room left in terms of efficacy or safety benefit.
Gil Blum
AnalystsMaybe a more pointed question there. I mean taking of the details matter. You guys' control arm is both assets, while Kite is going to just go against their own YESCARTA, which we already have an idea, has some issues. So I'm just wondering what the therapeutic landscape may look like with kind of like a separate labels and how would physicians and payers navigate that?
Lynn Seely
ExecutivesWell, I think we designed our study to be as real-world and inclusive as possible. So we know that physicians today are choosing some use Breyanzi, some use YESCARTA, some use both depending upon the patient. And so in our trial, patients come in and then they're either randomized to ronde-cel, our CD19/20 or investigators' choice of either YESCARTA or Breyanzi so that the physician can do what the physician wants to do, and it makes it very real world for them. And I think so it really will give them the data that they need to make these decisions by looking at both, right? So we believe that we're going to be able to show superiority despite including both products in the control arm. So we think that's a real advantage to our product. And I think complexity, I don't know. I think physicians, we've designed our trial to bring data to the patients and physicians that they're looking for. And we think that, that will be quite clarifying, quite frankly. And the beauty of the randomized controlled head-to-head trial is that patients are stratified. So we're not going to have to look at cross-trial comparisons. We're not going to have to worry about what was done many years ago. We're going to be able to look at this trial and say, is ronde-cel superior to the approved CD19 CARs or not? And that's what doctors and patients want to know. So it's bold, but it's also the right thing to do. And when you think about it commercially, it's going to be very easy for take this data out. And you can -- these are data-driven physicians, and they're going to be able to see very clear data or not based upon the superiority of this product. And if we're not superior, we shouldn't be on the market. But we believe that the science and the data clearly indicate that we have a great opportunity here.
Gil Blum
AnalystsI do want to spend a second on the safety profile. This is an important selling point for products and so-called second-gen products in general. So there's no high-grade CRS, but there's still a low level of high-grade ICANS. Is that a barrier for adoption in the community setting? How do physicians treat low incidence of high-grade ICANS?
Lynn Seely
ExecutivesYes. So we've seen, as you pointed out, no Grade 3 or higher CRS, cytokine release syndrome in our program. We have seen less than 5% grade 3 or higher ICANS. This is generally short-lived and readily treatable with current standard of treatment. And so I think this is being administered in the outpatient setting today and in our pivotal trials. So we think it's very amenable to outpatient administration. And I think one thing this is uncommon, right? And I think one of the things that we know is physicians are more and more getting used to things like how to treat and diagnose ICANS as well as CRS. So we don't think this is going to be any barrier to outpatient administration. In fact, it's so low, we think it's going to be a great advantage of our product. And yes, all patients given CAR T cell therapy need to be monitored certainly in the first couple of weeks after treatment. But again, this is a very, very low incidence. So we think the safety profile is quite favorable versus what we're seeing with CD19 CARs.
Gil Blum
AnalystsYou currently allow bridging in your studies. This is not something that was common in many CAR T studies. I think in the past, it was only steroids, at least for a few of these. Any specific comments there? I mean, it feels more real world, I think that's probably the takeaway here.
Lynn Seely
ExecutivesSo that's right. And in the past, different companies have done different things. We feel like allowing bridging therapy is important because we want any patient who's eligible for CAR to be able to come into our study. And some patients are progressing rapidly, right? And they can't wait for CAR manufacturing without, for example, bridging therapy. So by excluding bridging therapy, you're excluding a group of patients that could potentially benefit for the product. So we are allowing bridging therapy in our trial, and we think that's an advantage of the trial design.
Gil Blum
AnalystsI know we did this a little backwards, but going back to your third-line study, what would you say the commercial strategy is here? I mean it's a single-arm accelerated approval study.
Lynn Seely
ExecutivesI think this third-line study is incredibly important and probably more important than most people realize. And let me tell you why. First of all, the data, which I described to you, but let me do so in a little bit more detail, are quite compelling. I mean we have a 93% overall response rate with a 76% complete response rate. That remission rate or complete response rate compares to 50% complete response rate for the currently approved CD19 CARs. But more importantly, the median progression-free survival, which is the time at which 50% of patients have progressed or died, in the CD19 CARs is 6 to 7 months. It's 18 months as of our ASH presentation last year. That's a big difference. So we know that the prescribers of CAR T cell therapy, they're very data-driven. And so they may be loyal to CAR and believe in CAR because of its curative intent, but they will change CARs based upon safety or efficacy. And with ronde-cel, we intend to bring both, okay? So we want to get into this marketplace as fast as possible and begin this process of switching from the CD19 CARs. And it turns out that in the third or later line, which is what our first approval is planned to be in is a much larger market than people think, we believe. And the reason I say that is because we know from a series from Memorial Sloan Kettering that patients who undergo apheresis. So 50% of patients who undergo apheresis for CAR have already seen 2 regimens of chemotherapy. Now physicians may count lines a little bit differently, but really, it's 2 lines of chemotherapy. This could be a third-line patient if you are counting on label for our approved 19/20. So we think this is a 6,000 to 7,000 patient market opportunity, which is very important and will allow us to get this strong foothold. And so commercially being first, which we're currently in the lead in this space is really important for us, and we think gives us this commercial advantage because once we get there, what are you going to bring to switch us out? I mean the primary endpoint of this trial is overall response rate. We're sort of sitting at north of 90%. That's going to be hard to make a meaningful benefit over.
Gil Blum
AnalystsSo one of the challenges, and this is easily figured out is that there are quite a few patients who are theoretically eligible for CAR-Ts. But if you only look at the label, it's much, much, much narrower than that. How do you bridge this gap as it relates to patients who should be eligible but are currently not receiving therapy?
Lynn Seely
ExecutivesYes. That's -- I mean it's a great question. And the field has changed a lot, right? It used to be we talked about transplant eligible and transplant ineligible. Those days are kind of gone, right? And one of the things that Lyell we're doing with ronde-cel is we don't have any upper age limit. So you can -- we've successfully treated 85, 87 year olds. And this is important in large B-cell lymphoma because these patients have a median age of 65. That means there are a lot of patients older than 65 who need this treatment. We want to make it as available as we can. So for example, in our head-to-head trial, we're taking patients of any age who have primary refractory disease, early relapsed disease, late relapsed disease, if you have bridging therapy or not bridging therapy. So we're really trying to give this a broad label. So if you're eligible for CAR, you can sort of be on label is sort of our ultimate goal.
Gil Blum
AnalystsAnd just to remind everyone kind of the time lines as it relates to data disclosures from the pivotal study and when its final readout is expected.
Lynn Seely
ExecutivesYes. So the third later line study, we call it PINACLE, we're going to be having a significant data update in the second half of this year, which will really be the last look at the data before the pivotal trial data comes. So we think is a real opportunity to get a good look at what it will be. And then the data, the pivotal data itself, the data we'll use for BLA submission will be available expectation is mid next year, so coming very soon and then with the BLA submission to follow next year. So this is upon us. We're super excited. And we think this is a really meaningful commercial opportunity, which is going to give us every opportunity to be first-in-class, which we think is going to be a big deal in this marketplace.
Gil Blum
AnalystsSo I want to touch on other competitive dynamics, recent readout just yesterday from Allogene in the frontline setting consolidation, really interesting idea where you can use an allogeneic CAR-T for a mop-up. My question is, does this like -- let's say it's approved, this consolidation. Does this change the type of patients that might come down and receive your product?
Lynn Seely
ExecutivesYes. So you're referring to the data put out by Allogene yesterday with their product, cema-cel, which they're evaluating this consolidation therapy after frontline therapy in MRD-positive patients, right? And so first and foremost, I'm always pleased to see a cell therapy company have positive data. So that's great for the field. And hopefully, at some point, will be great for patients. I think what we have to look at, this was a futility analysis. So the goal was to say whether or not the company should continue to enroll patients. It wasn't an efficacy analysis. It wasn't the primary endpoint of the study. So it's early days, right? So I think there is some encouraging MRD positivity data, some safety data, but we're going to have to see how that translates in durability into the primary endpoint, which is a change in event-free -- benefit to event-free survival. At Lyell, we are full-on believers in autologous CAR T cell therapy. This has the potential for curative intent. We already have data showing that we have better complete responses and have median progression-free survival that have been seen with the CD19 CARs. And so we are barreling forward. I mean I think this idea, there's a long road to go to get, first of all, to the efficacy analysis for new allogeneic treatments, then we have to get MRD testing done. We have to change the practice, get consolidation therapy and sort of embedded into the community practice. And quite frankly, it's still a relatively small segment of the overall large B-cell lymphoma population, right? It's patients who are MRD positive with response after their first-line therapy. Maybe it's -- we don't know they didn't say, but maybe it's 20%, 25% of patients, maybe optimistically half of those are going to get MRD testing. It's going to end up being maybe 12.5% of the patient population. We're not worried about it. I think the benefit of autologous is still very real. And if Allogene is available to increase accessibility of cell therapy for patients, that's a good thing. We don't think that in any way changes the outcome for ronde-cel.
Gil Blum
AnalystsGreat. Maybe a more real topic because this is further down the line. We've talked to a lot of physicians over time, specifically on T cell engagers, which have been kind of positioned in late-stage patients. Everyone kind of expects these to move forward. They've had some challenges, but I think it's a bit of a matter of time. How do you think that changes the type of patient that you get at later line?
Lynn Seely
ExecutivesYes. So it's -- Gil always asked the hard question. So bispecifics are here. They are being evaluated in the front line. And I think I'm always very focused on patients, right? What's in the best interest of patients. And I think what patients typically want and that we hear consistently is a onetime treatment that gets them back to their normal lives with disease-free treatment-free periods. And that's exactly what CAR T cell therapy is designed to do. That's not what bispecific therapy does. Now there's a role for bispecifics, absolutely. But I think many people who know the most about CAR T cell therapy and bispecifics believe, quite frankly, that CAR T cell therapy -- that bispecifics may harm actually the benefit of CAR T cell therapy, and it may be in the patient's best interest to get CAR T cell therapy before bispecifics. And so yes, they may add some benefit in the front line, but the current chemotherapies work quite well. And it may be better actually to use bispecifics after CAR T cell therapy. So this is going to be evolving over time. The bispecifics are here, I agree. But I think in no way, I've been able to show the sorts of data that, for example, ronde-cel is showing. So the onus is on us is to get our trial data out there and completed so that patients can see the choice that they have.
Gil Blum
AnalystsSo just focusing for a second on manufacturing before we shift to solid tumors. Just how scalable is ronde-cel manufacturing? And what level of capital investment are you guys putting in? And also, how should we think about margins because most cell therapies in the beginning are negative margins?
Lynn Seely
ExecutivesSo great question. So Lyell is quite unusual here in the sense that we have already invested years ago in building a commercial manufacturing center. And so that sort of some cause. We have now control of our own destiny. This manufacturing center is staffed with people highly experienced in cell therapy manufacturing. And we are running today our commercial manufacturing process for ronde-cel. We're capable of commercial launch, well into commercial launch. We can make more than 1,200 doses per year at that facility. So we are in a very good position to control our own destiny. We're currently making all of our clinical trial material there, and then we'll continue on into commercial launch. Our process is very reliable and robust. We have more than a 95% success rate. It's a simple process. The vein to site time is 16 days, which is quite competitive with Kite, Gilead and better, quite frankly, than BMS. And the process is simple. So fortunately, for us, the cost of goods is very reasonable, and it will only get better over time, but we're estimating something like 20% of overall for cost of goods. So we're in a very good position for manufacturing. And again, I have -- it's tremendously grateful for the manufacturing team that we have at Lyell.
Gil Blum
AnalystsGreat. I do want to spend some time here on the LYL273 program. It's a very interesting program. Maybe just start with the unique mechanism of action for this particular CAR-T.
Lynn Seely
ExecutivesYes. So we've talked a lot about ronde-cel, which is sort of our late stage on the way to pivotal and I think is really our lead program. But now we have this very potentially transformative program coming up behind, which is in the clinic, and we call it LYL273. It's a guanylyl cyclase-C targeted CAR with a novel mechanism, which Gil is alluding to. GCC is expressed on more than 95% of colorectal cancers in the metastases. So very highly expressed. So we don't need a biomarker for this. And also, a lot of people don't know, it's expressed on the majority of pancreatic cancer. So it's a really great target. But cell therapy for solid tumors had kind of a rough road and just a great target alone is sort of not sufficient. And this was invented in China and the thinking was a target is not enough. You have to couple that CAR with something else to overcome some of the barriers we've seen. And the biggest barrier in solid tumor is to get enough cell expansion to allow the CAR T cells to infiltrate into the cancer. And these cancers are oftentimes very cold. So you also have to flip the hostile tumor microenvironment. You have to warm it up, so to speak. So here's the concept. This GCC targeted CAR, which is a great colorectal target is coupled with CD19. Well, that's unusual, right? Because that's a B-cell target. But what happens is these CD19 CARs are also engineered to release cytokines. So as you infuse these cells into patients, the CD19 CARs get activated when they hit the B cell, start to release cytokines. There are these very special doublet cells, which have both CD19 and GCC CARs, which then expand and release cytokines. These can now -- these increased cell numbers can infiltrate into the tumor, continue to release cytokines and help warm up this hostile tumor microenvironment. And then, of course, the GCC CARs expand and persist over a very long period of time. And so together, this is giving us a window, I think, into how to treat solid tumors large. It gives us this opportunity to get the right cell expansion. And with this very specific cytokine secretion, help get a better immune response in the solid tumor itself. So it's a novel mechanism. Fortunately, the manufacturing is quite straightforward. And the bottom line is this is in Phase I study in the U.S., and we're seeing very nice clinical activity.
Gil Blum
AnalystsSo maybe a bit of a general question here. One of the off-tumor on-target effects is B-cell aplasia. Do you expect any pushback from the agency as it relates to elimination of a cell population and a sick individual, but that's not the target cell.
Lynn Seely
ExecutivesYes. And that's a fair comment. But as you know, these patients have a life expectancy of 12 months or less. These patients are dying. The B cell, it is a true statement that the B cell does get targeted, but it's very short-lived. And so maybe a month or so in duration, they start to repopulate relatively quickly. So there's almost like the CD19 spike in cell expansion in the CAR T cells and then it tends to dwindle away and the B cells repopulate. So we haven't seen any pushback or issues with B-cell aplasia because it's relatively short-lived.
Gil Blum
AnalystsAnd also a related question, GCC targeting has been attempted. It's not easy. There's some expression in the gut, which leads to diarrhea, can be severe. I know you guys have seen some of that in your own studies. Can you walk us through some of the mitigation strategies there?
Lynn Seely
ExecutivesYes. So that is absolutely a fair comment. So GCC tends to be overexpressed in cancer cells that is expressed at low levels in normal gut. So this is a potential on tumor -- on-target off-tumor toxicity that we have to be very careful about. And we have seen some GI toxicity. So what's been implemented into the program is a quite robust prophylactic regimen as well as a very standard treatment management plan to work with that. And when we brought on this program at the end of last year, we presented data in about 12 patients. We -- that prophylactic regimen had just been sort of implemented. And we sort of said that since then, we've enrolled another 7 patients, including escalation to dose level 3 without any dose-limiting toxicity. So that at least gives you an idea that the program is continuing and that the diarrhea is being managed. So -- but this is a side effect to watch. It's one of the reasons we said we're going to be doing a safety update in the first half to really let people know how that safety management plan is working.
Gil Blum
AnalystsGreat. And just to remind our viewers what the efficacy data looks like in the first couple of cohorts and how does that compare to existing standard of care or even emerging therapies?
Lynn Seely
ExecutivesYes. So maybe I'll start with emerging therapies, which unfortunately are not what we might hope for, for the patients. And I would say, in particular, because this is a disease that is surging in younger people, and we're seeing patients more and more frequently in their 40s, 30s. I mean it's very -- it's a devastating disease. And so one might imagine CAR T cell therapy, a one-and-done treatment for these -- particularly these younger patients are incredibly important so they can get back to their families, their work. The current therapies that are approved in the third or later line for metastatic colorectal cancer, which is what we're currently studying, have single-digit response rates like 6% or less. The median progression-free survival is 6 months or less and the median overall survival is less than 12 months. So we need better therapies. The bar for a response rate for this CAR T cell therapy is anything 20% above could be approvable without -- much above a 6-month PFS, I mean, very honestly. So anything more than that is, of course, even better. I would say what have we seen so far? So the -- I think I mentioned that this product was invented in China. They ran a single center study in China, which was published in JAMA Oncology, where they studied it in Chinese patients and showed a 40% overall response rate and a 25-month or a 2-year median overall survival. They saw such promising results that the company brought the product to the U.S. They got an IND approved as they set up manufacturing, and they got some premier medical centers to participate with them, Dana-Farber Cancer Institute, the University of California, San Francisco, City of Hope and the University of Colorado. And have -- at the time we last presented data, we had 12 patients, 6 at dose level 1 and 6 at dose level 2. And across the 2 dose levels saw about a 50% overall response rate with some really 1 patient in particular with a partial response -- 100% partial response that is now getting close to 2 years out from her initial treatment. So an active CAR, the -- I think we are continuing to optimize dose and regimen. And then, of course, it's coming on us to manage the safety profile. And I think if we can do those things, this can move quite quickly simply because, as I said, there's so little for these patients.
Gil Blum
AnalystsSo let's talk about what guidance you can provide as it relates to the data disclosures upcoming in this program.
Lynn Seely
ExecutivesYes. So we have 2 data disclosures this year. The first, we said will be sort of a company announcement. I mean we just got this at the end of the last year. So there really wasn't time for major medical meetings in the first half, but we did want to update on how that safety management plan is working. So it will largely be a safety update. But then in the back half of the year, we intend hopefully to have a presentation at a major medical meeting where we can show more outcomes.
Gil Blum
AnalystsSounds very exciting. Maybe ESMO? Maybe.
Lynn Seely
ExecutivesAlways fishing for information, Gil. But I think, again, this program can move quite rapidly. And our goal is to get the data we need to move it to the regulators to talk about what a pivotal trial might look like.
Gil Blum
AnalystsAnd maybe kind of the last comment as it relates to emerging therapeutics. We saw some interesting data on ADCs and others. There is a sense that there's maybe a cutoff at about 30% response rates. But given this is a CAR-T, what we should really be looking for is probably long-term efficacy. Would you agree on that point?
Lynn Seely
ExecutivesSo I think the good news about response rates is typically because they drop disease burden, they tend to also prolong outcomes for patients. And I think it would be great to see nice response rates because that's something that, of course, is very helpful for patients. And also, it makes it easier on clinical trial design. So I think the fact that we're seeing response rates is something that is very helpful to us. And then I think right now, the best drug approved has in the third or later line has a median progression-free survival of 6 months. So yes, we need something longer than that. And the longer, the better for patients, no question about it. So I think that's what the agency -- if we can see some meaningful response rates that have some durability, which, as I said, we've already got patients that are showing that, then I think that can be very helpful to us. But the data needs to mature for sure.
Gil Blum
AnalystsLast couple of points, cash runway, cash position.
Lynn Seely
ExecutivesYes. So as of our last Q, we had $247 million or this I should say, as of our 10-K. We took a second tranche of $100 million private placement we had of $50 million. So that gives us a cash runway well into Q2 next year.
Gil Blum
AnalystsAnd kind of as the last one, anything you would like to highlight as it relates to what you think investors are missing in the story or just open-ended?
Lynn Seely
ExecutivesYes. I would say, I think the most important thing investors are missing is that ronde-cel is in the lead for the next-generation CD19/20 class with a third or later line approval that is coming very soon. And I think what they're missing is this is a much bigger market potential than people appreciate because of this fact that even despite how lines are counted, 50% of patients have received 2 regimens of chemotherapy before they undergo apheresis for CAR. And so that's a really important point. We think there's a significant number of patients out there, and it allows us to be first and get this stronghold as the next-generation CD19/20, then it's going to be much harder to replace us because of the data set that we're bringing. So we think this third-line lead that we have is really important and that we are looking forward to executing on that.
Gil Blum
AnalystsThank you very much for attending today.
Lynn Seely
ExecutivesWell, thanks for having me. I really appreciate it.
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