Excellent. Well, maybe just to level set everyone here, talk to us a little bit about what Kyverna is working on. You guys have been very busy, lots going on. Maybe you could talk to us about your miv-cel program, SPS, and then we can get into the specifics.
Sure. Well, at Kyverna, we're really leading the industry, as you know, Derek, bringing these transformative cell therapies to patients and bringing it to them very quickly. Starting with stiff person syndrome, which is our lead indication. We read out our pivotal data earlier this year, and we showed some very transformative results in these patients that have no approved therapy and where the disease continues to progress to a point of disability in a majority of these patients. What we saw for the first time ever is not just an improvement in clinical symptoms, but for the first time ever, a reversal of disability, which has never been seen before in stiff person syndrome, all with a one-time treatment with miv-cel that allowed patients to come off their background therapies and actually live a drug-free, disease-free remission.
On the basis of this data, we've actually started our rolling BLA submission with the FDA, and that's been a really positive milestone for us. In fact, earlier with our Q2 earnings, we announced that we actually finished our CMC filing of the CMC module, which is the key milestone in a cell therapy registry submission, which puts us on track to finish the filing in Q4 of this year and will put us on track, once approved, to be the first therapy ever approved in stiff person syndrome, but more importantly, the first company ever to bring a cell therapy to autoimmune diseases anywhere in the world.
Yeah. Pioneers. Maybe, you guys are in this rolling BLA process. Maybe talk to us where you are with that and the submission and what modules have been submitted and completed.
Well, up to this point, we filed all the key modules except for the clinical module, and we've stated this publicly that we'll be reading out our one-year data, which is coming imminently here as a key milestone in Q3. We'll be including that one-year data in the BLA submission, along with additional analysis of our natural history study, which we did in stiff person syndrome. We read out the top-line data on this natural history study earlier this year, but we're providing additional analyses on that for the FDA, and we're going to include those two things in our clinical package. As I say, we're on track to complete the filing in Q4, which puts us on track to be launch-ready in 2027.
Excellent. What should we expect in this one-year data? I guess, can you tee it up for us, are we looking for people that are still in response or still off ISTs? What would be good data at one year?
Well, if you recall from our primary analysis that we read out earlier this year, we saw a significant clinical response across all the primary, secondary, and exploratory endpoints. So significant improvement in the timed 25-foot walk, which was our primary endpoint, as well as secondary endpoints specific for SPS as well as general movement disorders. We also saw a significant improvement in the six-minute walk test, which is another landmark indicator of improved mobility in patients. In fact, we saw an over 90 m improvement, which has never been seen before in this disease. On the basis of this and what we're hoping to read out here in the next couple of weeks is a continued progression on that data. Can we show a majority of patients continuing to have this significant remission in their disease and significant improvement in their clinical findings?
Can we also see a significant number of these patients remain off background immunosuppressants like IVIG that they've been chronically burdened from for years? If we're able to show this and continue to demonstrate that durability effect, I think we continue to reinforce that we have a very transformative therapy here for stiff person syndrome. Again, a disease that has no approved therapy and where patients naturally progress over time.
Got you. As you think about the different scenarios for the review, would you expect priority review for stiff person syndrome, small indication, no approved treatments? Should we expect an Advisory Committee here or do you think this is pretty clear-cut?
Well, it is difficult to predict on an Advisory Committee, but we do have an RMAT designation, as we have discussed before, and we will be filing with a priority review. We think all of the things that would support that really line up very nicely, including a couple of things that you mentioned, the high unmet need in this disease, the transformative clinical results that we are seeing, the amazing safety profile that we are actually seeing in these patients as well, and the fact that there is no approved therapies in this space. I think all of those things justify a priority review, and we will come back to you and everyone with a status update once we have received that.
Can you discuss through the RMAT designation and your increased dialogue with the FDA? Overall, how have they viewed SPS and the development plan? This is probably clearly a learning experience because it is a novel kind of therapy and also essentially a novel indication. There is not a lot of development here. How has that attitude from the FDA maybe changed, or has it been always pretty productive and constructive?
Well, through the RMAT designation, we have had regular contact with the FDA, and the dialogue has been very productive. In fact, the review committee that we are working with has been largely unchanged throughout the entire process, including the CMC review committee, and they have been very supportive. There is a strong understanding that there is nothing approved, that the prognosis for stiff person syndrome patients is horrendous. The natural history of these patients at best stays flat, but we know over 80% of them will progress to debilitating disease that requires a walker or a wheelchair or even being bed bound over the course of their diagnosis. There is really, truly a high unmet need here, and like I said earlier, miv-cel is really showing a transformative result, not just an improvement in clinical symptoms, but actually reversal of the course of the disease.
In fact, we know that two-thirds of the patients that required a walker or an assisted walking device at the beginning of the clinical trial didn't need that walking device at the end of the trial. We're doing something here very revolutionary, and something that also allows patients to come off their background immunosuppressants and other chronic therapies that they've been burdened with many, many years and still achieve this dramatic clinical result.
Got you. Maybe in terms of the CMC aspect here, there was a recent news with Bristol and Novartis and their programs, and some questions around safety, around their manufacturing approaches. Can you just talk to us about the miv-cel manufacturing, how it differs, and ultimately the construct? Because ultimately, how confident can we be in the safety of miv-cel?
Yeah. Well, first of all, I think let's acknowledge that it's very unfortunate that these announcements by some of our peers came out for these patients. I think it really underscores the differences in what we're doing here at Kyverna on two key fronts. First of all, we have a very different construct. We're a CD19, but we have a CD28 costimulatory domain. In fact, we're the only CAR T therapy being studied in autoimmune diseases with a CD28 costimulatory domain and a fully human design. We think those differences are really important, because they actually have contributed to the efficacy and safety profile that we're now seeing with miv-cel. Miv-cel was specifically in-licensed from the NIH as a next generation CAR T construct with significantly improved safety while still maintaining potency. Now we're seeing this bear out in the over 100 patients we've now treated.
We're seeing really dramatic clinical results, as we just talked about, but we're also seeing no high-grade CRS, no high-grade ICANS, no instances of IEC-HS side effects, which is what some of our peers have been now noting. In fact, we have a very, very strong safety profile that underscores and supports the use in autoimmune patients more broadly. That's the construct. But the other thing to keep in mind as well is what you just mentioned, is the manufacturing. Some of our peers are using rapid manufacturing techniques. We're not using that. We are using a traditional, well-established, validated manufacturing process that, again, we've now established over 100+ patients. We've now seen we've 98% manufacturing success rates, and we're actually very confident that we can do this not only within the clinical setting, but scale this up for a commercial setting as well.
I think both these things come into play as key differences in why we believe we're not seeing the kind of safety profile that some of our peers are seeing.
Very helpful. Do you think, based on the safety profile of miv-cel today, that you've talked about outpatient administration, do you think that's still on the table and how do you get there in the early launch?
Well, right now it's important to note that of the CAR T therapies that are being used on the oncology side, approximately 70% of the time they're being administered in the outpatient setting already. There's well-established protocols in all these academic centers for using cell therapies in this manner. In fact, going back to the safety profile with miv-cel, what's critically important here is not just the fact that we have no high-grade CRS or ICANS. That's important, but it's also important to have a predictability of the side effect profiles and when these AEs are occurring. In many cases, our patients will have a low-grade CRS, which is essentially fever. It can be easily managed. But we know it's coming around the time of the T-cell expansion, which happens really predictably between day five and day 10.
This is really important for academic centers because they can plan around that, and they can adjust their outpatient protocols in order to monitor and make sure that patients have the adequate response time. But it allows them actually to use this in an outpatient setting so they can save on physician and staff resources and increase their effective capacity within their hospitals to treat more patients.
Got you. All right. Let's talk about the launch here. Get approved. How have you been preparing some of these centers that you've identified and patient identification efforts? Where are you in that process, and will you be ready for launch there?
We'll definitely be ready for launch. This is a very concentrated market from a rare disease perspective, and that's one of the advantages and reasons why we chose stiff person syndrome as our first indication. It's going to allow us to move forward with a very capital efficient manner, not only from a commercialization perspective, but our use of CDMOs is also allowing us to scale for this launch and do it in a very, very efficient manner. We know there's 6,000 diagnosed patients in the U.S. We believe that may be underrepresented, because as with any rare disease, as you bring a new approved therapy to market, that could actually expand over time. But even just starting with those 6,000 patients, we know these patients are highly concentrated in a few centers.
In fact, the refractory patients, the 2,000- 2,500 patients that are already refractory to immunosuppressants and treatments like IVIG, are even more concentrated in a number of key centers. Which is why at launch, we're targeting just 10 centers where we know a majority of these refractory patients are already being treated and already being seen by these physicians. Again, that allows us to go forward with a very concentrated commercial footprint, allows us to actually be really focused with our launch, and we're investing right now developing those centers and preparing them for launch. In terms of cell orchestration, all the work we're doing behind the scenes in order to prepare for the payer dynamics and supporting the payer groups, as well as supporting the infrastructure that it's going to need in order to help patients through their journey.
These centers that you're focused on are already set up for CAR T. These are basically centers that are already either doing it for oncology or are involved in the trial. Is that fair?
Exactly. That was the critical part of the selection process, is not only are they experts and have a high degree of expertise in neuroimmunology and stiff person syndrome disease specifically, but they are also established CAR T centers. They also have positive site economics and a supportive C-suite that wants to see and expand the use of CAR T therapies more broadly in autoimmune diseases. We are working with all of those factors as we are choosing these centers, and like I said, the work has already started. We have been working with the centers now to prepare for an eventual launch along a number of different factors, and we believe we are going to be ready.
Can you talk about some of the economics and, I guess, how this helps the hospital system in terms of whether it be reimbursement or, I guess, walk us through how CAR T reimbursement is likely going to work here for the autoimmune side.
Well, we believe there is going to be a mix of patients, and what we have seen from our research is there is approximately half of patients that are going to be Medicaid, Medicare, but the other half will be in a commercial setting. I think between the combination of those, we are reaching out right now to discuss with payers the value proposition that we are putting forward with miv-cel. The feedback that we have received so far has been extremely positive. Because when you take a look at the cost of managing a stiff person syndrome patient, drug costs alone cost hundreds of thousands of dollars a year, sometimes north of $1 million to manage these patients. Then you add on the additional costs like home care costs, caregiver costs, lost time from work. Many of these patients also suffer from depression, so there are psychological costs.
They also have a number of accidents because they fall, unfortunately, and then they end up in the emergency room. All these things add up to a considerable cost to care and a cost burden to not only the patient but the society as a whole, which is why the conversations we have been having with payers up to this point are very supportive.
of the value proposition of a one-time therapy like miv-cel, that can not only have a dramatic clinical impact on patients, but allow these patients to come off all these other background immunosuppressants and other therapies that they've been taking. This puts us in a really strong position from a pricing perspective. We've been guiding to a pricing for miv-cel that would be a significant premium to current CAR T pricing, and I think that puts us in a very strong launch position from a commercialization perspective.
Got it. That makes sense. One of the things that we get from investors is just the fact that one-and-done therapy, what is that? If the patient only gets it once, and it's very low in incidence because it's such a small indication, how do you build a business around that? How do you guys think about that for SPS?
Well, I think there's an under appreciation of just what that size of the SPS market could be. If you talk about 6,000 patients, even at current CAR T pricing, which again, we're guiding to a significant premium over current CAR T pricing, but this is a multi-billion dollar market opportunity. I think that's extremely important to keep in mind, because if you take that into consideration and see stiff person syndrome as a very valuable first indication, that then becomes a de-risking proof of concept that allows us to launch future indications like generalized myasthenia gravis, and we've got some very interesting data in progressive MS. This starts to shape a neuroimmunology franchise that can start to build and become very, very valuable over time, and one that I think is very executable given the strategy that we've been laying out.
Got you. When you talk to docs, and we've talked to our own, but want to hear from you, but I guess if there are candidates with SPS that are not suitable for miv-cel, and if there are, why?
Well, we believe the majority of patients, of those 6,000 patients, will be miv-cel candidates at some point over the course of their disease. Going back to those 2,000- 2,500 that we are calling the immediately addressable, those are already refractory to IVIG and other therapies. These are patients that are essentially waiting for a treatment now. In fact, we are getting calls. Our physicians are getting calls. A number of us attended the patient advocacy group, The Stiff Person Syndrome Research Foundation meeting earlier this year. There are patients essentially telling us that they're waiting for this therapy. Those are the immediately addressable patient population that we know that we can tap into immediately at launch. We do know this disease progresses. 80% of patients, through their natural history, will progress to significant disability over time.
They will require a walker or a wheelchair or something worse. The patients know that. These patients are talking to one another. They are looking at their friends that are progressing over the course of their disease, and they frankly don't want that to happen to them.
There's an urgency factor.
There's the sense of urgency factor, the fact that these patients are progressing over time, and the fact that as we launch, we're going to continue to generate more data around not only the clinical impact that miv-cel is having, but the durability of effect that miv-cel is happening. We believe all these things coming together, as well as the increased frequency of diagnosis and education around this disease more broadly, is going to start to generate more of a groundswell. We believe a majority of these 6,000 patients will seek treatment with miv-cel over time.
Got you. This is an unknowable question at the moment, but if we think the durability is not going to be forever, but it is pretty durable, a couple of years, is there opportunity to re-treat with miv-cel?
In theory, yes. We haven't had to re-treat a patient.
In fact, our first patients that have been treated through the compassionate use program before we started our pivotal clinical study are now out past two years, and still drug-free, disease-free, and in remission. So we know it is possible to have these long-term durable remissions. We want to see that data bear out.
in the longer-term data with KYSA-8, our pivotal study. But in theory, you could re-treat patients, and that's actually one of the strengths of the miv-cel construct. It's been designed specifically for autoimmune patients, but because it's a fully human design, there's less immunogenicity there. In theory, you could re-treat patients and potentially get an even long-term durable effect over patients over time.
Excellent. Anything else in terms of SPS, or maybe we can just start segue into MG, but the overlap between a physician treating SPS, MG, is that already priming the market a little bit for the expansion in MG?
Well, this is a big reason why we've taken a unique approach here at Kyverna, and this focus on neuroimmunology diseases. To your point, there's a lot of synergy there that's helping us in a number of different ways. The academic centers that are treating stiff person syndrome, these neuroimmunology centers are also seeing MG. They're also seeing progressive MS. We believe there's a natural synergy there that's helping us with our recruitment in clinical trials. It's helping us from an establishment of a KOL base that we're going to continue to tap into over time. It's also creating a nice synergy for us as we continue to move forward with our commercialization because we can concentrate in a few of these key centers, develop these strong relationships, and entrenched relationships with Kyverna, and we believe that's going to be a strength for us over time.
Got it. So maybe, let's talk about that opportunity, MG, and you guys have the ongoing trial right now, the pivotal trial. So maybe just talk about how you guys came to that design with the FDA and, ultimately what you think the probability of success is for that trial.
Well, we believe the probability of success with the MG trial is very high. The reason we are so confident is because of the phase II data that we read out earlier this year. If you recall, we actually saw transformative clinical results across the two key primary endpoints, MG-ADL score reductions, as well as QMG reductions. In fact, I will say it, no one has demonstrated these results, either in existing therapies or therapies being studied up to this point. So we saw reductions of MG-ADL of 8.5 and QMG of 11.3. These are transformative for patients. More than that, we are actually getting a significant number of patients to MSE, which is minimal symptom expression. This is ultimately what patients want, is they want to live without the symptoms of their disease.
Again, we are doing it with a one-time therapy that allows these patients that have been burdened with chronic treatments to come off those therapies. So by the very nature of using miv-cel, you are giving patients an opportunity to come off their FcRns, the complement inhibitors, the high-dose steroids, and the other immunosuppressants that they have chronically been burdened with. So overall, there is a very, very strong value proposition that we are bringing, and a very unique value proposition that we are bringing for MG patients. If you translate that into the phase III clinical design, which again is based on the results that we are seeing in the phase II, this is a randomized phase III trial with miv-cel versus standard of care.
Given the results that we are seeing in our phase II study, we have a high degree of confidence that we are well-powered, and that we are going to actually achieve dramatic success there as well.
What I thought was unique about that trial was the fact that you are also looking at pre-biological, pre-advanced therapies patients as well. So essentially, a pretty broad opportunity within MG and really allowing you to basically have the ability to treat any type of patient with MG. Is that fair to say?
Definitely. The trial criteria is specifying that patients must have been treated with one previous immunosuppressant plus IVIG or PLEX, or two immunosuppressants. We are not specifying which ones, so they could be more traditional or older therapies or the newer therapies like the FcRns and complements. What we do know so far is that we are recruiting patients in from a variety of different backgrounds. We think this is really important because this is going to demonstrate the impact of miv-cel in the real-world clinical setting where patients are getting a number of different therapies and cycling through things, and we want to be able to demonstrate our superiority versus these therapies. We believe the phase III trial is designed to do that.
Do you think it is wrong for people to just assume that miv-cel and CAR T is just going to be a very late-line therapy? What would get you confident that that is not going to be the case?
Well, we believe that is not going to be the case because the results that we are seeing with miv-cel are so transformative. Again, none of the other therapies right now are doing what miv-cel is doing. No one is giving the significant reduction in these clinical symptom scores like MG-ADL and QMG like miv-cel is doing. No one is giving patients a chance to come off background therapies with a one-time therapy and live a drug-free, disease-free remission. This is what ultimately patients want. They are telling us that they want this. In fact, the patients that are coming forward in our clinical trial, we are getting patients that are refractory to existing therapies requesting to be in the trial. We are hearing from our KOLs that patients that even have lower scores on QMG and MG-ADL scores want to be in the trial as well. Why?
Because they do not want to be on these chronic burdenly therapies over time. They do not want to be on multiple therapies that frankly do not work or only work partially for their symptoms. I think we have got a value proposition here that is going to completely change the way physicians and patients think about managing their MG disease. In fact, if we can provide them with a one-time therapy that gives them this long-term remission, and then we can see this durability in these patients continue to play out over time, I think we have got an opportunity here to really define what long-term remission or even a potential cure at some point would look like in this disease.
Like what sort of education do you need to do with the physicians to get them on board with that? We kind of hear split messages of like, "This is transformative, use it more broadly," versus, folks who just want to use it more late line and be like, "Oh, after all treatments are exhausted, I would consider using a CAR T therapy." What sort of education do you need to do beyond just producing the excellent data to get the physicians to kind of make the move and maybe bring this earlier in the treatment paradigm?
Well, I think it's a combination of things. It's not just talking about the clinical data, but I think it's helping physicians understand the specific patients that could benefit from miv-cel. Again, underscoring the fact that MG is more than just the clinical symptom. It's this chronic burden of disease across multiple therapies that these patients are taking. I think the voice of the patient is going to be extremely important in this conversation. I think the longer-term durability that we continue to play out is going to play an even bigger role, because that's when the value proposition really starts to shift in our favor. In fact, our first patients, again, treated through the Compassionate Use Program, our first patient, Denise, which we've talked publicly about, she's now well past her two-year mark and still in a drug-free, disease-free remission.
All of our patients with MG have not had to be retreated again. We're starting to build the data set that really tells us long-term durability of effect, and when you start to take that into consideration with what patients have to deal with on a day-to-day basis in terms of managing their disease, this is going to be something that I think is going to shift the paradigm.
Got you. Shifting gears to the larger of the neuro indications, MS. You've produced data there. Talk to us about how you're thinking about the development plan and moving forward in that indication.
Well, we're really excited about the data in progressive MS. We read out some of this data through our IIT programs earlier this year, and what we've seen in progressive MS for the first time is not only an ability to stabilize EDSS, but in a majority of the patients we've treated, seeing an improvement in EDSS. If you ask the experts that have been treating these patients for many years, they will tell you plainly they've just never seen this before. Most of the time, physicians, when they're thinking about progressive MS, are thinking about slowing the progression as opposed to completely stopping the progression like we're doing or even reversing that. So when you think of that in terms of a transformative effect, this is why we're so excited at Kyverna.
In fact, this is why we filed and, as we recently announced, received our third RMAT designation, and we received it in non-active secondary progressive MS, which is the largest proportion of patients in progressive MS. This is the patient population that's hardest to treat. There's no approved therapies, and again, the CD20s don't effectively work because this is really the smoldering disease that really requires additional therapy like a miv-cel in order to provide a real clinical impact. This is why we're really excited about continuing the dialogue with the FDA, and we've announced that we'll come forward with a clinical development plan early in 2027 that'll provide more details on how we continue to develop this for these patients.
Got you. Maybe, obviously you don't know today, but what would be optimal based on what we've seen happen in SPS, which is basically single arm. Now with MG, where you're kind of going after a control arm. There's also what your competitors are doing with some of their trials. I guess, where do you think they'll come down on this type of trial in terms of comparator arm and what we might like to see for the trial in terms of duration and things like that? What would you see as being more reasonable for a trial like this?
Well, we need to have the discussions. We just received the RMAT designation, and so I think that's an important part of the dialogue that we will have with the FDA. I think what I said just a couple of minutes ago is really important to underscore. If you look at maybe more traditional therapies in this space that are only looking to slow the progression of this disease, that creates sort of a framework, if you will, for one type of clinical trial and the size of the clinical trial and what that might look like. But when you start to change the paradigm and you're actually stopping the progression of EDSS or actually improving EDSS for the first time, that really unlocks a number of possibilities of where we can go in terms of the clinical development program.
This is what we are really excited to talk to the FDA about and get more clarity on. We have some really interesting ideas that we want to share with them, and this is something we will come forward with early in 2027.
It seems to me that this, given it is a more progressive disease, kind of like an SPS, they are deteriorating over time versus like an MG. To me, it would seem that that kind of style would be more reasonable. Is that off base or no?
Well, you can speculate, but we are going to have the dialogue with the FDA. I can tell you the fact that they gave us an RMAT designation on the basis of 11 patients only tells you how transformative these results are. We are really excited with our CMO and the team to continue to have this positive dialogue with the FDA and come forward with a clinical development plan. Our goal here is to put something in place that can get this to patients as quickly as possible. That is our ultimate goal here.
Got you. In terms of this would be a larger indication, so we have talked about CMC and manufacturing for SPS and MG, and you are kind of covered there. What would you need to do to launch an indication like MS like that?
Well, we've talked a little bit about the two dual manufacturing sources that we have with ElevateBio and Minaris Advanced Therapies. We believe between these two CDMOs that we have the capability and capacity to serve our clinical work that we need to do over the next few years, as well as serve the SPS launch, as well as the initial launch of the MG indication. So we know we're good there, but we're not stopping with that. We're continuing to assess our manufacturing platform. We're looking to make enhancements in the manufacturing platform that will make this easier and more cost-effective. Part of that additional analysis is also looking at alternative manufacturing suppliers. We'll come forward with more details on that in due course.
You guys are close to this in terms of the manufacturing. It's so important for CAR T. So, what sort of innovations are going on there and how are you guys thinking about either partnerships or at least working with those types of players that are innovating in that space?
Well, ElevateBio, who we're obviously working with and have just signed our commercial agreement to go forward with the commercial launch with SPS, they are constantly innovating, and we're working with them on those innovations. Things that could improve the turnaround time and reduce QC testing. Things that we can use that will help make it easier for patients to get access, like using whole blood. These are things that we're working on right now with ElevateBio and looking to bring that to fruition to patients over time.
Do you think CAR T manufacturing will look totally different in five years, or do you think it's going to be more of a slower evolution?
I think there's been just tremendous progress, even if you think back just six,seven, eight years from when the initial CAR T products were coming off the ground. I know some of the initial companies had to build this really large infrastructure, and that was a lot of capital put in place to build large manufacturing facilities that largely stayed empty until the demand filled the capacity. That puts a lot of pressure on an organization. I think we're in a totally different position here at Kyverna. We're able to tap into the CDMO capacity and leverage different CDMOs with different innovations in order to help us manage the financial costs of scaling to bring CAR T to patients, but also to take advantage of new innovations so that we can continue to improve on this over time.
Got it. Maybe a last question in terms of just, again, sketch out the next 12- 18 months that are going to be pretty exciting. Just run through the catalysts and the kind of the updates we should be expecting.
Yeah. We've got a lot of exciting things to look forward to. As we've indicated, we've got exciting readout on our one-year data with stiff person syndrome, as well as longer-term follow-up with our MG data, our Phase II MG data. That's coming in the next few weeks, so we'll be seeing that before the end of Q3. As I mentioned, we're on track to finish a filing of the stiff person syndrome BLA. That will happen in Q4, which puts us on track to be launch-ready in 2027. These are really, really important milestones for us, and we will announce the filing and the acceptance of the BLA filing when those occur. In addition, we are looking at reading out additional data in the progressive MS patients, these IIT patients.
These patients continue to seeing improved durability of effect and deepening of effect, and we're going to have an additional readout in those patients here in Q4. A lot of very interesting milestones here coming up very, very shortly. More to come, and in particular, the launch of SPS and the planning around that going into 2027, as well as the MG trial, which I neglected to mention. We're in full recruitment now mode of our phase III MG trial, which we've now projecting to finish completion by mid of 2027 as well. Many exciting milestones. As I said at the top of this fireside chat, Kyverna is really leading the way. We're bringing this to patients first.
We believe we have got a unique advantage with our construct and our manufacturing that can do this with a high degree of efficacy, but also this high degree of safety. We are confident in the strategy that we are executing in order to bring this to patients, starting with SPS, but really using this as a proof of concept so we can bring this to larger indications over time.
Excellent, Warner. We will leave it there. Thank you so much. Great to see you again.