All right, good morning. I'm Eric Joseph, Senior Biotech Analyst with J.P. Morgan, and our next presenting company is Lyell Immunopharma. Presenting on behalf of the company is CEO Lynn Seely. There's a Q&A after the presentation. If you have a question, just raise your hand. We'll bring a mic around to you. And for folks tuning in via the webcast, feel free to submit questions through the portal. And so with that, Lynn, thanks for joining us.
Good morning, everyone, and thank you, Eric and J.P. Morgan, for inviting us to present here today. Lyell Immunopharma is a cell therapy company focused on next-generation CAR T cell therapies, designed with innovative technologies to realize the full potential of cell therapy to defeat cancer. I will be making forward-looking statements during this presentation, so please consult our website and securities filings for additional information, so Lyell is advancing next-generation CAR T cell therapies. These cell therapies are being developed both in aggressive hematologic malignancies, but also in solid tumors. We arm our CAR T cell therapies with novel technologies to really bring meaningful benefit to patients, and this is consistent with Lyell's vision since its founding, to really harness the latest scientific discoveries to bring T cell therapies to patients that really enhance their lives.
One of the things that we have done in the fourth quarter, which I think has really broadened this vision and allowed us to move into hematologic malignancies, is to acquire a private company known as ImmPACT Bio and its lead asset, IMPT-314, which is a dual-targeting CD19/CD20 CAR for aggressive large B-cell lymphoma, with really compelling Phase I data that I look forward to telling you about. Now, this is interesting because it really allows us to build upon all the expertise that we have today, because the same cell therapy centers that treat patients with solid tumors also, of course, deliver to heme malignancies, and so we can take full advantage of our clinical expertise, our manufacturing expertise, and in fact, it's easier because cell therapy is so established in the hematologic malignancies, so here we are with this recent acquisition.
We have really transformed ourselves and are a late-stage clinical company about to enter pivotal trials with a strong balance sheet. Our lead program is now 314, which is this dual-targeting CD19/CD20 CAR T cell, which we really believe has the potential to be a disruptive innovation for the treatment of second- and third-line large B-cell lymphoma, and we'll be beginning pivotal trials in mid-2025. In addition, we're continuing to accelerate our solid tumor program with next-generation CAR T cell programs fully armed with a suite of proprietary technologies. Now, we've talked a lot about our proprietary clinically validated anti-exhaustion and durable stemness technologies. We're continuing these, but we also have new enhancements designed to overcome the hostile tumor microenvironment that I'll be telling you about. Lyell is also in very good position because we have our own in-house manufacturing.
We have a highly experienced team and the ability at full capacity to launch out of our Lyell manufacturing center. We have a capacity of up to 1,000 products per year. In addition, we have a strong balance sheet, $460 million in cash as of our last filing, and with disciplined expenses, and we've recently guided to net cash use moving forward of $175-$185 million in 2025, which gives us the cash runway into 2027 through multiple clinical milestones that I look forward to telling you about. We have a team of seasoned cell therapy pioneers, oncology drug developers on our board, on our management team, and throughout our company. So we have the right team and the right capabilities to deliver for patients. So let's dive into our lead product, IMPT-314, this dual-targeting CD19/CD20 CAR.
It's expected to enter third-line pivotal trials in mid-2025 in aggressive large B-cell lymphoma. This comes based upon phase I data that we presented for the first time, the initial data from this program at the American Society of Hematology just in December. There we talked about a 94% overall response rate and a 71% complete response rate with a manageable safety profile. The key differentiators, what makes this CD19/CD20 dual-targeting CAR so special is because it was designed for more complete responses with longer duration of response. It is a true CD19/CD20 bispecific CAR. What that means is it has full potency at both CD19 and at CD20. So if a malignant B cell expresses either one, it will work with full potency.
And we also enrich it with a CD62L selection process, which we believe is a special added benefit to bring one-time treatment to patients that has the potential to provide patients with longer disease-free, treatment-free periods, which is what they're looking for, and of course, even possibly the potential for cure. So we are enormously excited about the potential of this program. We are doubling down. We are committing to publicly start two pivotal trials, both in the second and the third line. And you'll see these represented here on our pipeline slide, which talks about multiple clinical milestones that are upcoming and are supported by our strong cash runway into 2027. So you can see at the top, we're continuing to enroll in the phase I trial in the third-line CAR naive patient population. We just presented the initial data at ASH.
We'll be presenting more mature data in mid-2025, and again, expect to initiate the pivotal trial by mid-2025. In addition, we're continuing to enroll patients in the second line, and we'll be presenting the first data from the second-line CAR naive cohort in mid-2025, with more mature data coming by the end of 2025. And we expect to initiate the pivotal trial in the second line by early 2026. So lots of clinical data coming from this program in the near term. In addition, as I alluded to, we're continuing to push forward on our solid tumor programs. We have some new undisclosed targets, which we're moving through preclinical development aggressively. And these will be fully armed CARs with both our anti-exhaustion, durable stemness technologies, as well as some new enhancements really to bring sustained cytokine signaling to address the hostile tumor microenvironment.
And we expect the first IND in this program in 2026. So some may be saying, "Wow, I thought CAR T cell therapy had already addressed the lymphoma marketplace. Why do we need another CAR T cell therapy in lymphoma?" So I want to talk you through that and tell you why we believe there's tremendous unmet need in this marketplace. We need higher complete response rates and longer duration of response. No question, CD19 CAR T cell therapy has been transformative, but there remains significant benefit that patients deserve yet left to achieve. And this data that I'm presenting on this slide are from the third-line setting. About 50% of patients in the third line treated with CD19 CAR T cell therapy do not achieve complete responses. 30% of patients don't respond at all.
Approximately 50% of third-line patients treated with an approved CD19 CAR T cell therapy progress within six months. The overall survival at one year is only 50%-60%, and only 30% of patients remain in remission at two years. It's a lot of facts, but what it tells you is there remains significant unmet medical need. When you look at the graph on the right-hand side, this is from the registration trial of Yescarta in the third-line setting. When you can say that 50% of the patients progressed or died by six months. We intend to develop 314 to be a disruptive innovation in this multi-billion-dollar marketplace. We think that we can really bring benefit above and beyond what you've already seen.
Now, we know the CD19 CAR T cell therapies are already selling $3 billion, and they're expected to grow to double that by 2030. The growth is largely going to be driven by use in the second-line setting and also by growth in the community hospitals and as larger community centers adopt cell therapy. We know there are a lot of patients in the second line awaiting treatment. 30%-40% of patients don't respond to their first-line therapy, and of those, about 65% have the performance status and are eligible for CAR T cell therapy, and yet only a small fraction of those patients are currently being treated, so we believe this growth can be even more extensive as we bring better response rates, longer duration of response, and safer products into this marketplace, so that's our objective.
This is a busy slide, but it's also very important to understand why we're so excited about 314. We believe that with higher response rates and longer duration of responses, we can get better penetration into the CD19 CAR T cell therapy marketplace. You see in the top panel the approved CD19 CAR therapies. This is our third-line data from their pivotal labels, and you can see that the market leader, Yescarta, Breyanzi, Kymriah. And let's look in the middle column, overall response rate, 72%, 73%, 50%. Those are good response rates, but let's look now down below to the phase I trials, the data from two different trials. One is from UCLA. This is where our CAR T cell construct was invented. They ran a single-center study, 13 patients and a mixed histologies, 92% overall response rate. This was then licensed and put into a multi-center trial.
These are the data that were just presented at ASH in the third-line setting, 94% overall response rate. Very clinically meaningful difference from what you see above. Now, these data are early. They're going to have to mature. But if they mature in this way, this really has the opportunity to be practice-changing. And then you look over to the complete response rate for the market leader, Yescarta, 51%, Breyanzi, 54%. And then you look down below at the two Phase I trials, 77% and 71%. These are remarkably consistent and give us confidence, although, of course, we'll need to see the data maturing. And I then want to highlight out the progression-free survival that I was talking about earlier. For both Yescarta and Breyanzi, the six-month progression-free survival in the third line is 6- 7 months. That's a nice bar to be able to achieve and beat.
We'll look forward to the data developing to show that. Then finally, on the safety side, 31% neurotoxicity with Yescarta, Breyanzi up and coming with 10%. And when you look down below, this is a 4-1BB CAR with a Breyanzi-like developing safety profile. So we're excited, more to come. We are committing to both second and third-line pivotal development for this product candidate. People say, "Why? Why aren't you just going to do second line if that's where the most patients are?" And yes, that's where the most patients are. But there remain a lot of patients in the third line who are untreated. And we believe by capturing both marketplaces, it's going to be a substantial opportunity. Patients are largely treated in the community in the first line. Maybe they get R-CHOP or other combination chemotherapy, and they progress there.
But it takes time to get referred to a CAR T cell center. And so oftentimes, they're started on second-line therapy in the community as they make their way to the CAR T cell therapy. So we're currently enrolling a third-line cohort, even though there are approved CAR T cell therapies in the second line without difficulty because these patients are present at these centers. And then, of course, the second line is where the real market potential lies. So we're very excited and developing in both lines moving forward. The third line represents the most rapid path to approval, we believe, based upon the substantial benefit we're observing. So let's dive in a little bit more down into the mechanism of why we believe this is such an important new therapy. And the first one is, as I alluded to before, this is a true OR-logic-gated CAR.
It has both CD19 and CD20 binders. It has full potency at each of those. Full potency for CD19 and full potency for CD20. As I said before, it's a 4-1BB CAR. In addition, we are selecting or enriching for CD62L-positive cells in our products that are infused. That means we have a very high proportion of naive T cells and central memory T cells. These are the types of T cells that are associated with better engraftment, improved persistence, reduced exhaustion, and lower cytokine production. Now, there's a lot of basic science and research data in support of this, but there's also some nice clinical data that I'll show you here. This is clinical data from Zuma-7, which is a clinical trial of Yescarta. They're looking at overall survival here.
They looked at it based upon the percent of Naive T cells in the product infused into the patients. And what they observed was that if you had high Naive T cells in your infused product, you had better overall survival than if you had lower Naive T cells. That's one of the reasons why we are enriching for Naive and central memory T cells in our product. We're adding CD20 because there is concern, of course, about CD19 antigen escape. And you can see here that both CD19 and CD22, too, are less stable than CD20 when exposed to single-targeted CAR. So we believe that CD20 represents a very stable antigen. And by targeting both CD19 and CD20, it brings a strong benefit. Now, some people may not realize that there's heterogeneous antigen expression on these malignant B cells. And some malignant B cells have high CD19.
Some have dim or negative CD19. And so by having CD19 and CD20, we get more opportunity to bring about complete responses. So this construct and the CD62L enrichment was taken into single-center data at UCLA. So I want to show you these data now. What you're seeing here is a swimmer's plot. And you can see that each line represents a patient. This is mixed tumor histology with follicular lymphoma and diffuse large B-cell lymphoma. But all of these were very aggressive relapsed refractory patients that had failed multiple lines of or been failed by multiple lines of prior therapy. And I want to show you a couple of things. So first of all, 92% overall response rate, 77% complete response rate. But look at the duration. This x-axis is in years. So they have followed patients out through four years and treated with only 50 million cells.
And what you can see if you look particularly at this one patient who was treated for four years, the patient relapsed after four years, was retreated with the same construct and went back into complete response. So really remarkable single-center data. They recently updated this data in data cut of May 2024. And their median progression-free survival was 50 months. Small numbers, but still really impressive with an overall survival median not yet reached, but the three-year overall survival is 65% with a very favorable safety profile. And I just want to show you one patient that sort of brings home maybe some of the advantages of our CD19-20 CAR. This is a patient who at screening was CD20 positive, but CD19 dim or negative. So maybe wouldn't have responded well to a CD19 CAR.
But in this case, got the CD19-20, had a beautiful complete response, duration of 18 months, and then relapsed. This time had a mixed population of cells, some of which were CD19 negative, got retreated with the same cells manufactured originally, and went back into complete response. So again, really nice data emerging. This product candidate was then licensed and moved into a multi-center trial. And these are the initial trial data that were presented at ASH. You can see that these were patients with now very much focused on large B-cell lymphoma, the majority diffuse large B-cell lymphoma, but other aggressive types. And the study objectives are, as you would expect, safety, tolerability, overall response rate. Three cohorts were designed, CAR experience cohort, second line and third line.
We are focusing now just on the second and the third line because we believe the response rates warrant this to really move upstream and not after CAR T-cell therapy. We expect the recommended phase two dose to be 100 million cells. That's the bulk of the data I'm going to be showing you. And we've got about 15 centers open or continuing to enroll well in both the second and third lines. So let me now show you some of the data from this ASH meeting. This is now from the third line cohort that we shared. The median age was 65. You can see it's a typical large B-cell lymphoma population with mostly diffuse large B-cell. And on the right-hand side, importantly, this is really a standard multi-center population. The median lines of prior therapy range from two to six with a median of three.
The LDH level was elevated in about 50% of patients, which references higher disease burden. And then 53% of patients received bridging therapy, which again suggests a more aggressive patient population. So here are the safety data. And the headline is no high-grade CRS and low rates of grade 3 ICANS. So you can see that there were no cases of grade 3 CRS. There were some grade 1, 2 that were either easily treated with tocilizumab if needed. The grade 3 ICANS rate was 13%. And again, the ICANS resolved with standard treatment with a median of five days. So I think, again, the safety profile looking very good for CD19/CD20 CAR. Now, the efficacy data, this was done in the efficacy evaluable population included patients who had a response assessment at day 84 and/or had a CRPD before that.
You can see here the overall response rate of 94% and a complete response rate of 71%. The median follow-up is 6.3 months, and 71% of patients were in response at that last follow-up. Here are the data. Again, each line representing an individual patient, and what you can see here is the green is complete response. The blue is a partial response, and again, very nice overall response rate and complete response rate. And I just want to highlight that you can see that in some patients with blue, we have partial response, which then deepens at month three into complete response, so I hope this gives you some idea about why we are as excited as we are about our CAR T cell therapy for aggressive large B-cell lymphoma.
Before I conclude, I do want to take some time to talk about our next generation programs in solid tumors. I think those of you who've been following the company know that we are very much focused on technologies to really help enhance CAR T-cell function so that we can get the type of efficacy in the solid tumor patients that has been seen in hematologic malignancies. We continue to be focused on our anti-exhaustion technologies. We have two of them. You can see them, the top, c-Jun, which we overexpress. The reason we do this is because one of our founders, Crystal Mackall in her lab, discovered that if you can enhance signaling through the AP-1 transcription factor pathway, you can actually help the T cells resist exhaustion. And so by overexpressing c-Jun, we can do that.
We've clinically validated that anti-exhaustion technology in the ROR1 clinical program. We are coupling it now with NR4A3, which is a negative regulator of that exact same pathway. What that pathway does is when we knock it out with gene editing and we couple it with c-Jun overexpression, what we're seeing in our preclinical studies is really markedly even more powerful anti-exhaustion technology. On the enhanced stemness, which is something we've continued to pursue, we use our Ep-R technology, which is a novel way of manufacturing the cells to get more stem-like cells. Of course, I've talked to you about the CD62L selection for more naive and central memory cells. We have a novel way of activating our T cells, which we call Stim-R. This is done during manufacturing. It doesn't increase the time to manufacture.
But what it does do is it allows activation of the T cells in a much more physiological way that allows us to generate more potent T cells. And then finally, we have some undisclosed new technologies, which we're applying to some new targets so we can have fully armed CARs, which have this sustained cytokine signaling for the hostile tumor microenvironment. And we're doing this by expressing chimeric proteins. So in summary, we're really excited about our lead program, IMPT-314, expected to be in pivotal trials this year. Lots of clinical milestones coming up to follow the very exciting initial data we presented at ASH in December. And we're really pleased with the 94% overall response rate and the 71% complete response rate.
We have the scientific expertise, the capabilities, and the capital to drive continuous innovation with our proprietary technologies, our in-house manufacturing, and a strong balance sheet with runway into 2027, allowing us to get through multiple clinical milestones. And I just summarized those here for you on this slide with mature data in the third line setting coming in mid-2025, along with the start of the pivotal trial. More mature data coming, initial clinical data coming in the second line in mid-2025, with more mature data to follow by the end of the year, and then initiation of the pivotal trial in the second line. And in 2026, the first IND with our new fully armed CAR T cells and solid tumors.
So I think Charlie Newton, our Chief Financial Officer, and Gary Lee, our Chief Scientific Officer, are going to join me as Eric asks us some questions, or maybe those of you in the audience.
Indeed. Yes, we have time for a few questions. So I think I'll pick up. I'll start by picking up on the IMPT-314 presentation at ASH and starting on the safety profile, in a bit of a departure from the UCLA study, you did see some ICANS events. Can you just talk about the extent to which anything, or were there any trends or anything particular in the patient backgrounds or histologies that may have contributed to those events?
Yeah, thanks for that question. So it's about sort of the risk factors for ICANS. So there were no cases of grade 3 ICANS seen in the UCLA study. We have three cases.
So again, very small numbers, and we're delighted, by the way, with our ICANS maturing safety profile. We're learning more and more about ICANS. I think there is some suggestion that there is more ICANS observed in diffuse large B-cell or large B-cell lymphoma than, for example, in follicular lymphoma. Certainly, age, high disease burden, prior neuro disease all lead to worsening ICANS. I think right now we're also using a little bit higher dose, so most of the patients treated at UCLA were at 50 million cells. We're using 100 million cells. We're quite pleased with the safety profile and think that it's a very competitive one.
And then just looking at the efficacy reported thus far. Well, I guess just going from the safety evaluable population to the efficacy evaluable population, I guess what should we infer from the six patients not contributing to the efficacy evaluable population? Sort of what drove their discontinuation?
Oh, so why were there six patients more in the safety evaluable patient population and the efficacy evaluable patients? There were two patients that we excluded that were treated early on in the study that had T-cell/ histiocyte-rich lymphoma, which is a variant subtype of lymphoma with a poor prognosis. It's not been studied by the other CD19 CARs or included in their registration trials. And we're not enrolling those patients moving forward. So those were two patients, one with partial response and one with progressive disease.
There are four patients who didn't have their day 84 scan. And so to be evaluable, you had to have day 84. And one of the reasons we did that is you can see that there are a lot of partial responses at day 84 that then convert to complete responses. I can tell you that of those four patients, three of them are continuing on trial in response. One discontinued before having their first scan. So nothing unusual in those patients. They just weren't far enough along yet.
Okay. Got it. And just looking forward, I guess, what should investors anticipate in terms of the cadence of additional news flow from the third-line plus portion? I guess one aspect is the fact that you're now concentrating exclusively on CAR T naive patients. So I guess within that cohort, how should we think about the additional readouts?
Yeah. So initially, because people were thinking, well, maybe this is good for CAR-experienced patients, but as the data started to roll out, it became very clear with these sorts of response rates that this is something that could come up front. So we are focusing on second- and third-line. So the data that you'll be seeing moving forward. Next, we've said more mature data. I think people, we showed these data for the first time to investigators as well as other experts in lymphoma at the ASH meeting. And sort of very consistently, the feedback was, wow, these are beautiful results. If they continue to mature, this really has an opportunity to be practice-changing. But we need to see more data. And so that data is going to be coming mid-2025. We're very pleased with the way the data are emerging.
And so we'll look forward to sharing that in mid-2025. And then also, we're enrolling in the second line cohort. And so that initial data set will be coming out in mid-2025. So I think you're going to get to see some nice rolling data emerging from this program.
Is there clear support for enhanced or PFS extension in the third line, kind of translating into longer PFS, yeah, either PFS extension or survival extension in the second line treated population?
So I think what are the endpoints in non-Hodgkin lymphoma and in particular diffuse large B-cell lymphoma? I think what people are really looking for is durable remission, complete response that's lasting six months. And so I think when we talk to experts or investigators, what they're really looking at is how many patients are swimming past that six-month mark.
I talked to you about the median progression-free survival of the approved CAR therapies. We really want to see this long duration of response, much the way you saw in the UCLA data. We think we have a very good opportunity to do that. I think durable responses, certainly in the third line, we think there's an opportunity for approval with a single arm trial. I think as we move forward, we'll go from there.
How large of a third line? How large do you expect a pivotal study in the third line setting to be and sort of a loose operational timeline you anticipate as you launch that study?
We've not given guidance on the exact timeline, and we've not completed our regulatory interaction.
One of the reasons we're not saying we're in a pivotal trial yet is because we want to have that finished. But our initial phase 1/2 trial is designed and set up really to move straight into a pivotal single-arm study. I think that's what we would hope to be able to do in general. Again, we've not had any conversations with regulators specifically about this yet. In general, a safety database of 100 patients would be sort of around what one might expect in this study. I think this is something that we believe as we enhance capacity. One of the things we're doing is really accelerating this program. It's one of the reasons we acquired it, because we have the ability to accelerate the program. We have our own manufacturing capacity. Having control over your own manufacturing is a huge advantage.
And so we're very thrilled to be able to use the expertise that we've already built to help accelerate this.
Thank you. Well, great presentation. Thanks for sharing the data. How does this program stack up against the Cargo Therapeutics triple targeting CD19, CD20, CD22? You're obviously ahead of the game here, but I mean, what are your thoughts? Does it address a different patient population or is it direct competition?
So I think what is coming, what are our competitors? And I think a couple of things.
I'll just say one of the reasons we feel very confident that these data are going to emerge in the way that we think they are is because there have been some data from China that have been reported at ASH where they studied about 40 patients with large B-cell lymphoma with a CD19, CD20 construct, very similar to the one that was published by UCLA. They have much longer. They have a median around 30 months follow-up and very nice results that are similar to ours, but with longer duration. I think with respect to the CD22s that are coming, I think if I have a choice, I think I alluded to already the CD19/20 is really strong because of the stability of CD20. What CD19/20/22 is going to bring, other than some manufacturing complexities, it's unclear to me.
I think these data are going to be hard to beat. And I think we believe we're in the lead and we are the only multicenter U.S. data that we're aware of. And execution is going to be the name of the game.
Thank you for the nice presentation. I was just wondering if you're considering expanding indications to autoimmunity.
Oh, that's a great question. Certainly, and I'll let Gary maybe talk about the advantages of CD19/CD20 in autoimmunity because we're very interested in that. But right now, we are focused. I think it's dangerous to try and do too many things. And if you're going to play in autoimmunity, you got to go all in. And so this is here and now with a rapid path to approval. But Gary, why don't you talk about CD19/CD20 a bit?
Yeah, so thank you for the question.
So as many of you may know, using CD19 CARs as B cell depletion therapy in the autoimmune setting has been quite transformative in the last few years. The benefit of adding CD20 above CD19, actually, there are a number of studies that highlight the downregulation of CD19 in lupus, for example. And so adding a CD20 could potentially benefit that patient subset. And beyond that, in multiple sclerosis, for example, the pathogenesis has been associated with CD20 positive B cells as well, which makes sense that Ofatumumab was also approved as an antibody drug for multiple sclerosis. So I think the benefit of targeting both 19 and 20 can be significantly differentiated from CD19 alone in several different diseases in that setting.
Okay. All right. Well, I think with that, we will, one more question. Sure. Maybe one more question to a different topic.
Your ROR1 CAR T product. There were two patient deaths, I believe, or one in the trial. What is your analysis of that situation? And was it the overexpression of c-Jun? Was it patient-specific factors that contributed there?
We did have some pneumonitis in that program, which was the reason we had to stop the 797 clinical program. There, we believe that there was more about local cytokine release in the lungs. Part of it is there was no evidence that this was due to c-Jun. In fact, obviously, we're moving forward with that. I think if anything, there was no evidence that we had on-target off-tumor toxicity. What really appeared to be was local cytokine release. A lot of the indications we're going after had significant lung involvement.
So we don't know, but there was a very narrow therapeutic window and we just couldn't get the doses high enough to see the duration that we needed.
Whether it's in relation to that, but also in an earlier comment that you made about in relation to ICANS, it does seem that perhaps burden of disease may be a contributing factor in some cases. Is that going to sort of impact eligibility, let's say, right with these products in the commercial setting? And sort of how do you account for that?
No, I don't believe so. I think right now, with this low level of ICANS rate, I don't believe that that's going to be a substantial issue. I think physicians are more and more understanding who to be concerned about and to watch them a little bit more carefully.
But again, the ICANS that we've seen have been readily treatable with the standard therapies with rapid resolution. So I think I don't see that as something we're not excluding. For example, you can see that in the disease burden, the LDH that we had. And we don't intend to do that moving forward.
And then I guess the translation of the safety profile that you see in the third line setting to earlier line setting, would it be inline improved or
yeah, well, I think that's a great question. One would hope, given the lower burden of disease, everything that it might be better, but we wouldn't tout to that right now. I think right now, what we're trying to keep, what we are looking for, and I think what the field has adopted is a very manageable safety profile as a Breyanzi-like safety profile.
That's sort of where we are and what we're targeting. More and more of these patients are being treated as outpatient. So having a safe profile, we believe, is going to or a safe, I won't say safe, but a manageable safety profile will allow us to move more into the outpatient setting, which is great for the community.
Okay. Great. So I think we will leave it there for questions. So thanks so much, Lynn and team, for the presentation. And thanks for the questions, everybody. Have a great rest of your day.
All right. Thank you.