Good morning. Thank you so much for joining us for another session at the 44th JP Morgan Healthcare Conference. I'm Brian Cheng, one of the senior biotech analysts here at the firm. On stage, we have Kyverna Therapeutics. I'll now pass the mic to their CEO, Warner Biddle, for a short presentation followed by a live audience Q&A. Warner, the stage is yours.
Thank you, Brian. Thanks for the invite and great to be back here at JP Morgan. Really excited to be sharing with you the exciting progress we're making at Kyverna as we continue to pioneer the way forward for CAR T therapies in the field of autoimmune diseases. These are our forward-looking statements. You can find them in more detail on our website. Now, I was standing here a year ago laying out the vision and strategic priorities for our organization, and I'm really, really pleased to come back here and report that 2025 was a fantastic year, just really an incredible year and transformative year for our company.
I'm going to walk you through over the next 20 minutes or so the progress we're making, how we're demonstrating transformational clinical data in our two leading indications with stiff person syndrome and myasthenia gravis, how we've established a clear regulatory pathway for both of these indications, how we're thinking ahead from a commercialization perspective, leveraging our first mover advantage to come to this market, start serving these patients, and start growing our young organization to greater heights, and how we've also been progressing, particularly at the back part of the year, to strengthen our financial position, putting us on a cash runway that takes us well into 2028 and allowing us to execute on this milestone and these visions. Now, our mission at Kyverna is to transform the lives of CAR T patients through the transformative and curative intent of CAR T therapy.
I think nothing displays this more than actually looking at patient videos. So I'm going to show you two patient videos now that are on our website, but these are actual patients from our Stiff Person Syndrome registrational trial. The first patient is a 62-year-old female. She's been living with the disease for many, many years. And you can see once the video starts that she's actually got all the classic hallmark symptoms of Stiff Person Syndrome. She's got this hunched-over posture, a really slow walking gait. She doesn't want to swing her arms because she's extremely fearful of falling. Now, after one single treatment with Mivcel, and 16 weeks later, you're seeing the confidence of this patient dramatically improve. The gait and speed and arm swing are all there. In fact, her Timed 25-Foot Walk test was reduced from 17.3 seconds down to 4.5 seconds.
That's a 74% reduction, and she's basically effectively walking like you and I would taking this test. The second patient is a 52-year-old male. He is also suffering with stiff person syndrome, but has been suffering with this disease for over 20 years. In fact, he needs a walker to walk normally. And you can see here as he's taking the test, he's walking sideways because he has this intense fear of falling, and he's trying to use the wall as a gauge to help him prevent falling. He's refractory to IVIG and is on daily and multiple doses of supportive medications and Valium, et cetera.
Now, you can see again after one treatment with Mivcel, 16 weeks later, the confidence of this patient moving, the ability and ambulation is dramatically improved, and we saw a significant reduction in the Timed 25-Foot Walk test from 18 seconds down to five seconds. So again, really, really revolutionary impact on these patients that has never been seen before in this disease. What's really important to keep in mind when you're thinking about stiff person syndrome is this is a progressive disease. Patients don't get better. The prognosis in natural history is that patients get progressively worse over time. The muscles continue to stiffen, and actually patients end up in wheelchairs or bedbound over the course of their disease, which is truly a horrific prognosis for them.
What's also really important to keep in mind is there's no approved FDA therapies, and all the off-label treatments that patients get access to and try don't actually impact the underlying cause of the disease, which is why the fact that we've now completed our first registrational trial and we're not only seeing highly statistically significant results on key clinical endpoints, but we're actually seeing this reversal of disability is truly remarkable, and then if you think about it in the context of being able to eliminate the background immunosuppressants and other therapies that these patients are taking so they don't have to be burdened with these other therapies that they've been trying before, again, this really indicates that we've got a paradigm shift in how to manage this disease and how to think about treating these patients moving forward.
In addition, I do want to stress that we've now treated over 100 patients with Mivcel, and in this particular study, the safety profile that we're seeing confirms what we're seeing across all these other patients with no high-grade CRS or ICANS, making this construct very amenable to commercialization, particularly using it in an outpatient setting. This is the design of our pivotal clinical study that we have alignment with the FDA using and leveraging our orphan drug designation and RMAT designations. What's really important to note here is that this trial was rapidly enrolled. We enrolled it in under seven months, which indicates two things. One, we're very effective and focused at Kyverna and we're able to execute. Second, there's a high unmet need here because patients were striving for something new and unique to treat their disease.
These are the primary endpoints and secondary endpoints, and you can see the results are really remarkable, not just our impact on the Timed 25-Foot Walk test, which was our primary endpoint, and you can see the significant p-value here, but this consistency and dramatic impact on secondary endpoints as well. In fact, if you ask our leading investigators, one of them came up to us and said, "In all of her decades of treating Stiff Person Syndrome patients, she'd never seen this kind of an impact on patients before, particularly when you look at these secondary endpoints that are specifically designed to measure the impact of Stiff Person Syndrome. She's never seen any treatment improve this in patients." So we're really seeing something here revolutionary and game-changing.
Taking a deeper look at the primary endpoint, which is the Timed 25-Foot Walk test, this chart documents the improvement in Timed 25-Foot Walk over the months post-treatment with Mivcel. I want to draw your attention to the green line. This is the validated clinically meaningful improvement line that's been validated through other diseases and where this test is used to measure the impact in other conditions, and you can see as early as four weeks, we're already seeing a clinically significant impact that continues to deepen and be sustained over time. And by the time you get to 16 weeks, which is the primary endpoint, we're seeing a 46% reduction in the Timed 25-Foot Walk test, which again is unprecedented, and this continues to be sustained for those patients we were able to measure out to 24 weeks.
All in all, 80% or more than 80% of patients have this clinically meaningful response to therapy, which is truly remarkable, and another thing of note, at the beginning of the study, 12 patients actually required walking devices, either a cane or a walker or wheelchair, and at the end of the study, 67% of these patients were able to get rid of their walking devices and walk normally like we saw in the videos, which I think, again, is a truly remarkable undertaking and a truly remarkable result that we're seeing in a patient group that typically doesn't have any hope at all in terms of their long-term prognosis. Now, I want to take a couple of minutes and talk about myasthenia gravis. We've talked about Denise before, but I want to show her case study again.
She's now 24 months, two years past her Mivcel treatment and still going strong. She's not on background immunosuppressants or any other background treatments. You can see from this video, she's living a remarkably normal life for somebody who's been burdened by this disease for over 12 years. She's a German patient, so I'll just note that there are subtitles here to the video.
[Foreign language]
I was intrigued by the option to apply CAR T cell therapy. We have been trying to stabilize her disease for the past three years. She needed ICU care several times with ventilation and intubation despite an efficient immune therapy.
[Foreign language]
Again, a really remarkable and transformational impact on these early patients that we were treating through the compassionate use program. And this really propelled our organization forward, and we rapidly started a Phase II program, which we read out interim results in the back half of last year. And again, what we were seeing through this clinical trial is these unprecedented disease control across multiple primary and secondary endpoints that are used in the myasthenia gravis disease. And even more importantly, we're seeing a majority of patients either at or trending towards MSE or minimal symptom expression. This is ultimately what patients want. They want to live without the knowledge or this daily reminder that they have their condition. And MSE is that ultimate target that what patients are working towards. And with Mivcel, we get more patients to that clinical endpoint.
Again, we're doing this while also transforming how patients are being managed. In many cases, patients like Denise and others are on chronic immunosuppressants. When they're taking the FcRns or complement inhibitors, this is on top of these background immunosuppressants and other therapies that these patients have. The daily burden and chronic treatment burden that these patients are undergoing is tremendous, and the fact that we can actually see these transformational clinical results while also removing all these background therapies, again, is a paradigm-shifting way of managing this disease, and we're doing this with a really well-tolerated and safety and manageable safety profile again, which again is conducive for using these therapies in a commercial setting and an outpatient setting. Looking more closely at the primary endpoints, this is the MG-ADL score and QMG score.
Again, the green line represents a clinically significant improvement in terms of these two endpoints. You can see on both counts, we're actually achieving significant clinical improvement as early as four weeks. Again, this is sustained and even improved over time. I do want to draw your attention to the absolute reduction in MG-ADL and QMG. A reduction of eight points and 7.7 points are truly unprecedented. No other therapies in myasthenia gravis have demonstrated this kind of an impact in terms of these key endpoints on patients. This is our Phase III registrational trial. Based on the results we were seeing from the Phase II, we quickly pivoted into the Phase III trial design. This is a really bold and unique design.
We're comparing Mivcel to a standard of care, and we're going to demonstrate superiority to standard of care in this clinical setting. We've already received a lot of inquiries from physicians and patients, a lot of interest on this based on the data they were seeing in the Phase II study, and we've already enrolled our first patients, and I'm looking forward to updating you on the progress of this trial and the enrollment over the course of 2026. Through all this, we've also been working with the FDA on establishing our clear regulatory path for Mivcel for both SPS and MG, and we've got alignment on both of these fronts. We've had regular and consistent conversations with the FDA. They've been very positive and constructive, and we're actually on track to file our first BLA for stiff person syndrome in the first half of this year.
So we have the clinical development program in place. We've got the regulatory strategy moving forward. We're already now starting to look forward and think about commercialization. And I can tell you, I've been working in the CAR T space now for over five years. And what's really exciting to see is this advance in the environment, in the ecosystem for CAR T therapies. There's been a number of positive developments that are only going to help us and other companies as we bring these therapies to market. There's increased capacity in all the key academic centers, and they're particularly of interest as they're converting the purely oncology hematological CAR T centers into broader use, including use for autoimmune patients. We're seeing improved access with this really dramatic shift to outpatient usage and being able to use these therapies in an outpatient setting.
We're seeing more favorable site economics, and the payer dynamics are working themselves through. We're also seeing simplified regulatory frameworks as well as simplified treatment paradigms through improved REMS programs and updated FACT standards. All of these things are coming together at a very, very important time because they're opening up the aperture for these academic centers to treat more patients and for patients to have easier access to therapy. So this is going to positively impact all CAR T therapies, but as the leader and first mover advantage in the autoimmune space, we're going to be able to take advantage of this so we can propel ourselves forward and have a very, very successful launch. And we are thinking about our commercialization strategy in more detail. We're already activating new centers while taking the clinical sites and converting them to commercial centers. That work is ongoing now.
We're also spending a lot of time with the patient advocacy groups. There's a huge amount of interest from the patient advocacy groups. The Stiff Person Syndrome Research Foundation, in particular, has been a strong voice for the need for new treatments. They were very, very vocal when the new data came out, as I just presented to you, and they're very, very excited because these patients are desperate for therapy, and the Stiff Person Syndrome Research Foundation is connecting these patients with physicians so that they can get access to therapy as soon as we actually get approved. Of course, we're also working with our commercial manufacturing suppliers, and we're scaling up not just to make sure we continue to address the ongoing clinical study work that we're doing, but that we're ramping up to meet the commercial demand as well for stiff person syndrome.
Overall, there's a very attractive market for stiff person syndrome that I think a number of people are underappreciating at this point. There's 6,000 patients that are already diagnosed with this disease, which we believe a majority are CAR T eligible. But there's a specific subsegment between 2,000 and 2,500 that are particularly at need of a new therapy. These are the ones that are already refractory to existing therapies. These are the ones that are desperate for therapy, the ones that are well-known to us as well and well-known to the academic centers. These are the ones that we're going to be focusing in on from a launch perspective so that we can get off to an early and fast launch trajectory.
In addition, these patients are predominantly of working age, and this is really important because the impact that this disease has on a patient's life extends beyond them. They're unable to work. They're unable to have an impact with the families, which means there's a sense of urgency to treat these patients and do something transformational so they can have their life back. In addition, the off-label treatments that patients are often using in this setting are costly. IVIG alone costs patients in the system hundreds of thousands of dollars a year. It doesn't really work. Patients get progressively worse over time, but there's a really strong value argument here from both a payer perspective as well as a health economic perspective on a new treatment that can transform patients' lives and remove these chronic therapies and actually deliver something completely new for this patient population.
Because these patients are concentrated and well-known to physicians, we've got a very efficient commercialization strategy in mind, starting with approximately 10 authorized treatment centers, and we'll refine that number as we get closer to launch. But we know these are the centers that have high volume in terms of SPS treaters where the patients are known and either being managed directly or being referred to on a regular basis. This is where we're going to start, but we won't stop there. We're going to continue to onboard additional authorized treatment centers over time because we're going to be preparing for myasthenia gravis. And there's a huge synergy between these two indications. So as we add new centers for MG, these centers can also be treating SPS as well and continue to accelerate that launch.
Looking at the progress we made as this organization over this past year, I think you can agree with me that we've just come a tremendously long way. When I was standing here last year, we were really sitting on this really interesting and intriguing early set of data across multiple indications. But through our strategy and focused execution, we've now transformed this company. So with a strong focus on our two lead indications with Stiff Person Syndrome and Myasthenia Gravis and a clear pathway forward to bring these to patients in a commercial setting. But we're not stopping there. We're looking forward. We have some very promising data in other larger indications like MS, RA, Lupus Nephritis. We're also working on a second-generation platform that will simplify access for patients by removing the apheresis step as well as speeding up manufacturing and reducing cost of goods.
We're calling this KYV-102, and we filed our IND, and we are going to disclose more around the development program over the course of 2026. We've also bolstered our cash position. We ended the year with $279 million, and this was bolstered by the equity financing that we put in place towards the end of the year, as well as a debt facility that happened back in Q4 as well. All in all, this puts us on a cash runway well into 2028, and it fully funds the plans we have around stiff person syndrome, the BLA filing, the commercial launch, as well as the myasthenia gravis Phase III trial. 2026 is starting with a bang, and we're really, really looking forward to a number of key catalysts in the exciting year ahead.
We talked a little bit about stiff person syndrome and the key catalysts here being filing the BLA in the first half of this year and preparing for commercialization. From an MG perspective, we're going to read out maturing data on the Phase II, as well as heads down on the Phase III program and continuing enrolling that. And we're also going to be looking at the additional pipeline opportunities because we have maturing and new data with MS, RA, and lupus nephritis. And we're going to think about this in a very strategic and focused way on what the next possible indications could be for Mivcel. But we know that the opportunity to change patients' lives in a larger and greater sense is in front of us, and we have an opportunity to do that first here at Kyverna.
Overall, I think you can feel my excitement and feel the excitement that we're generating around this space. We've had an amazing 2025. We've delivered on the clinical outcomes that we wanted to see from these first two key indications. We've established a clear regulatory pathway. We're already thinking about and implementing a commercialization strategy, and we strengthen our financial position. I'm really proud to be working with my leadership team and the entire Kyverna team on this tremendous progress that we're making for patients, and we're really excited to keep you informed about the progress that we're making over the coming months. We believe we're putting ourselves in a leadership position and a first mover advantage to really transform the lives for patients in autoimmune diseases. Thank you.
I'll speak in the Q&A session. For those of you who are in the audience, if you have any questions, feel free to raise your hand. For those joining us virtually, you can also submit questions on the portal. Warner, I guess just before we talk about some of the details around the SPS, can you talk about the unmet needs in SPS? I think a lot of us who are in the audience, they haven't heard of the SPS indication. So can you talk about the unmet needs here? I think it'll be interesting to hear what you're hearing from the ground as well. You talk to, you engage with a lot of the physicians who manage a lot of these SPS patients. What is their first take? What is the feedback that you're hearing on the pivotal data that you have presented last month?
The first take is, like I was indicating, this is truly remarkable. These physicians that have been treating and following these patients for many, many years never see an improvement in the patients. The prognosis and the natural history, which is now well documented, it's been published at the University of Colorado, and others have published on the natural history of this condition, only shows that the patients get worse over time. They might be stable for a while, but eventually they get progressively worse. 80%-85% of patients will require walking aids or become bedbound over time. We also know that these patients have a prognosis of a higher rate of mortality. There's been a Nordic study as well that's been validating that. The prognosis for these patients is horrible.
The initial reaction that we got from the physicians that were treating these patients in the clinical trial settings was just surprise. They were expecting that we would hit on the primary endpoint, but the ability to actually impact these secondary endpoints and do so in a really meaningful way and transformative way, I think was really remarkable. They were actually commenting as well when the patients saw the data. They were coming back into their offices and hugging the physicians and saying, "Finally, we have something that can treat this disease," which I think really underscores what we're doing here.
Just in terms of the preparation towards filing, it's very clear that you have started mapping out the payer side, how many centers you're targeting, and all the good stuff. How do you think about just the gating factors toward the BLA filing milestone? What else is left in terms of your road towards filing?
There's no gating factors. We've just read out the data just before Christmas, and my CMO's in the front row here, and their team is hard at work right now in terms of preparing the BLA filing. Obviously, we've got TFLs that we need to double-check and make sure that those are ready to insert into the modules, but we've also been pre-working on the modules. So we've shown that we've been able to execute and move at speed in terms of the recruitment of the clinical trials. We're going to apply the same discipline around our focus to get the BLA filing in place. And like I said, we're on track to file in the first half of this year, and we'll update you guys more on specifics around that timing as things progress.
Okay. Any questions from the audience?
Quick question for you. With respect to your commercial launch strategy, how do you think about launch ex-US? And what's the size of the market for SPS ex-US?
Yeah, we're considering that, but just to be clear, we really believe the initial opportunity and where our focus as an organization is going to be is initially here in the U.S. So we're mapping that out and have a really clear pathway forward. But of course, Stiff Person Syndrome and Myasthenia Gravis, the epidemiology is very similar when you look at Europe and look at some of these other countries around the world. So we're assessing what those opportunities are, and we'll be looking at that as we continue to advance our program.
Hi.
Hi.
Amazing talk. Thank you so much. I have two questions. One, in your longer-term follow-ups, have you seen any reversion at all? And the second question is, what do you predict that your price will be for a single dose?
Right. Well, what's been amazing is in these target indications, we haven't seen any need to retreat patients. And patients are off their background immunosuppressants and other therapies that they've been burdened with, as I said. So we're going to continue to track this over time. But obviously, examples like Denise really underscore this durability impact, which I think is really, really important for patients. And the trials go out to one year and 18 months for MG, but we're going to be enrolling these patients in long-term follow-up studies. So we're going to continue to monitor their efficacy over time. We know from physicians and patients that one year is definitely a bellwether. You get a majority, most patients past one year, that is already transformative.
But now we're seeing multiple patients getting out to 18 months and two years, and that becomes a game changer in terms of how you think about treating this disease. So maybe to dovetail that into the second part of your question, you look at the chronic, again, treatment burden that these patients are under, which is not inconsequential. IVIG alone, like I said, is hundreds of thousands of dollars a year. If you look at myasthenia gravis, these FcRns and complement inhibitors cost $400,000, $500,000, $600,000 a year. And that's on top of other immunosuppressants that patients have to take. So the cost burden for these patients and for the system is very, very high. So when you think about pricing in this market, we definitely think that the CAR-T pricing is the floor.
We believe that there's a premium to current CAR-T pricing that we can justify and provide really strong value to the system while also providing huge benefit for patients and their families.
Hi. I wonder if you could elaborate a little bit on the myasthenia gravis market landscape?
Yeah.
Obviously, huge number of patients, the anti-FcRns have made a significant difference. Many patients benefit, many patients do not.
Yeah.
Do you imagine that this would potentially be a replacement for FcRn, or are you looking at the subset of patients, as you showed on your video? There are a subset of patients who are intractable and really need the next generation, which is not an immunosuppressive or anything else.
Yeah, well, I think as these things naturally progress, I think they will continue to expand over time, particularly going back to the other question, we see the durability in these patients continue to build over time. We're going to have a more compelling story, but already, when you look at the MG market, despite all these therapies that are there, and it's been great for patients to have this choice and these options, but you look at FcRns, there's still patients walking around with MG-ADL scores of three, four, five, and six, which is not inconsequential, and they're having to take FcRns, like I said, on this backbone of immunosuppressants, so the chronic burden of treatment while not getting to MSE is huge, and we know there's an immediately addressable MG patient population that is quite large.
We are estimating at least 12,000 patients that are already in this refractory setting that will be immediately amenable to CAR-T therapy. But we also know as this durability improves and the value proposition of what CAR-T therapies can do, this one and done, remove your other therapies, have this opportunity to get to MSE and a sustained MSE, we believe that we'll be able to capture larger patient populations and move up into earlier lines of therapy over time.
Maybe just kind of layer on top of that question. I mean, I think there's questions around T-cell engager, right, over the course of the last couple of years. How do you think about them as a competitor, or are they not a competitor? How do you think about that space, right? Yeah, how do you think about the emergence of that versus where you sit and potentially you'll be commercial within the near term? How are you going to disrupt the space?
Right. I think we're doing something fundamentally different than the other therapies, including TCEs, this ability to get this deep B-cell depletion, and we're now demonstrating this through the translational medicine. You're getting into targeted tissues. You're crossing the blood-brain barrier into CSF. You're actually changing the underlying cause of this disease and resetting the immune system, not just from a B-cell depletion perspective. We had an IR call earlier last year, and the translational medicine expert was up speaking on this, and we're actually seeing a normalization of B-cells and naive B-cells coming back, repopulating in a normal way, but this is also positively impacting Tregs and T-cells, as well as impacting cytokines and reducing the inflammatory cytokine, so we're, in effect, resetting the immune system. This is something that other therapies, including the TCEs, just can't do and haven't demonstrated at this point.
You have presented data, not just in MG and SPS. I think one of the most interesting data for us is really the multiple sclerosis data. How do you think about just an expansion opportunity for Mivcel? How do you tackle everything else outside of SPS and MG?
Yeah, I think you're touching on something that's really exciting. I mean, again, when I was here a year ago, we had these two IITs ongoing in multiple sclerosis, and I think a lot of us were thinking this would maybe bear fruit or have some impact on patients over time. I think what surprised us, it also surprised the physicians treating these patients that they were able to see not just the stabilization of EDSS, but actually an improvement of EDSS as quickly as we're seeing. Dr. Dunn from Stanford, one of the leading investigators, says, "I've been treating patients for 30 years, primary progressive MS patients, and never seen an impact like this." So I think this is really increasing our confidence that Mivcel has utility outside of these initial two indications.
And this ability, again, to have this deep B-cell depletion in targeted tissues probably gives us a huge advantage, particularly in neuromuscular conditions. And this is something we're going to continue to build on as we advance our strategy. So we're going to see the maturing of the MS data over this coming year. And based on that, we're going to evaluate whether it's this or another indication that we want to progress as a company.
Where are you standing today? How do you view other modalities, specifically the in vivo CAR T that is emerging? How do you see yourselves standing against that modality?
Yeah, I mean, while in vivo CAR-T could provide some benefits for patients, but they're still a long way off. I mean, even the experts in this area are saying they're at least eight to 10 years away from actually reaching patients in a clinical setting, and what we know, we've got something proven now. What we're doing with autologous CAR-T and what we're specifically doing with Mivcel and doing this from a leading position really allows us to get to market and start to addressing really high unmet needs in diseases that need new therapies and start doing that on a relatively short-term basis, so we're going to focus on this. Of course, we'll be looking to the future and how we can continue to evolve our company in terms of other modalities, but really, the unmet needs are here.
The CAR-T ecosystem, like I was saying in my presentation, are evolving, making it easier to treat more patients and treat them closer to home and in the community. We're going to continue to leverage and build on that because there's a very foreseeable market that's addressable now and a very valuable one for us.
Yep. Any questions from the audience?
Just on the manufacturing front, any updates on how prepared you are in terms of capacity and just how are you building that out just to prepare for the launch of SPS and then also MG launch following that?
We feel very confident about our manufacturing. We've got two manufacturing suppliers on board. Both of these have been validated. The comparability studies, the PPQ batches have all been completed, so we feel very, very strong about our CMC regulatory package, and we have also been working with them, of course, sharing our forward-looking forecasts, not only thinking about the clinical demand we have for the clinical studies, but obviously the commercial demand as well. In addition, I think something that maybe hampered other CAR-T companies earlier on when CAR-Ts were first getting launched was this manufacturing success rate. We've been reporting 95% plus manufacturing success, and in fact, in our Stiff Person Syndrome trial, we had 100% manufacturing success, so we feel really good about the reproducibility of what we're doing and how we can scale for commercialization.
KYV-102, your IND is filed. How does that fit into the big picture? Is this a strategy from a lifecycle management strategy? How does that fit in, and I guess ultimately, where do you see it tackling in terms of indications?
Yeah, well, we're really excited that our IND was filed and actually the FDA accepted our IND, which is great, and we'll provide more details around our development strategy there, but what KYV-102 does is I think really takes the core construct of KYV-101 or Mivcel from the CAR perspective. It's the same CAR, so we know it works and it's de-risked from that perspective, but puts it on a new manufacturing platform that allows us to use whole blood, so we can skip the apheresis step, make it easier for patients to start their CAR-T journey, maybe even do this first step closer to home, which I think is going to be really important, and in addition, it speeds up the manufacturing process and also significantly reduces cost of goods.
So maybe one way of thinking about it is a few years ago, there was this promise of allogeneic CAR-T therapies that would come to market, and everybody was really excited about those therapies. I think they've really fallen to the wayside a little bit over the past couple of years. But this idea of making CAR-T easier, less expensive, improving patient access is still there. And we believe KYV-101 actually bridges that. It takes the confidence and efficacy that we're actually delivering from KYV-101, the initial CAR, and actually then transcends it on this new platform, making it easier for patients to get the therapies.
Great. Well, just to kind of wrap up our conversation here, I guess any questions from the audience before we wrap up? Just kind of maybe forward-looking, what are you most excited about as we think about having the same conversation, let's say December 2026? Where do you think investor focus should be?
Are you coming over for Christmas?
I will come over for Christmas. Is that an invite?
I got you. Well, honestly, I think what we've shown over this past year is that when we're focused and we bring a highly dedicated and skilled team to the table, we can accomplish a lot. And I think we've surprised a lot of people with our ability to execute, not just on stiff person syndrome, put us in a position to file the first BLA. We could be the first CAR-T to launch in the autoimmune space, and we're really, really proud of that. And we're not just stopping there. We've got the next generation construct. We could be the second indication to launch as well. So we feel really, really confident with what we can do. And if you look at the year ahead, it's really heads down. It's an execution story. It's finishing the pivotal Phase III for myasthenia gravis.
It's filing the BLA for Stiff Person Syndrome and getting ourselves ready for commercialization. But we've assembled a fantastic team with late-stage development, CAR-T experience, launch experience. We know we've got this and we can do it. And we've actually laid out a strategy that's very, very capital efficient as well and focused that it's going to allow us to execute it.
Great. Well, thank you so much, Warner. Looking forward to your head. Thank you.
Thank you.